Fast hundert Fälle von Nebenwirkungen via Muttermilch in EMA Datenbank

Symbolbild: freepik / @freepic.diller

Die bisherige Berichterstattung von Report24 („Schock: Schon mehrere tote Kinder nach Impfungen. Wie ist das möglich?„) und („Drei weitere tote Kinder und Jugendliche nach Covid-Impfung„) hat vielerorts für helle Aufregung gesorgt. Faktenchecker arbeiten sich an uns ab, können aber auch nicht mehr als bestätigen, dass es die bislang erwähnten Fälle von Nebenwirkungen in der EMA Datenbank tatsächlich gibt. Dass diese Datensätze mit Vorsicht und Umsicht zu interpretieren sind, haben wir stets erwähnt. Nun belegen wir: Es gibt zahlreiche Fälle von Nebenwirkungen, wo der Impfstoff oder dessen Folgeprodukte eventuell durch die Muttermilch weitergegeben wurden.

Ein wesentlicher Aspekt der Nebenwirkungen in der EMA Datenbank sind all jene, die sich auf eine „Übertragung des Impfstoffs durch die Muttermilch“ beziehen. Dies wird von offiziellen Stellen, Hofmedien und Faktencheckern bislang vehement bestritten. „Es gäbe keine Hinweise.“ Diese Aussage verstehen wir als Hohn, denn natürlich gibt es keine Daten über einen Sachverhalt, dessen Untersuchung bestenfalls am Anfang steht. Hinzu kommen aktuelle Bestrebungen, auch Schwangere durchzuimpfen, welche neuerdings zur „Risikogruppe“ zählen würden. Die unglaubliche Menschenverachtung eines solchen Ansinnens ist kaum in Worte zu fassen. Bislang gab es einen medizinischen Konsens, gerade Schwangere und Stillende so weit es nur irgendwie geht von Medikamenten aller Art fern zu halten. Exemplarisch erwähnt sei diese Studie mit 84 (!) Teilnehmerinnen, von denen man auf die ganze Welt schließen möchte. Dabei wird im Text festgehalten, dass Muttermilch die SARS-CoV-2 Viren ohnehin neutralisiert.

Verantwortungslose Kniefälle der Systemjournalisten

Anstelle zu hinterfragen, weshalb dieser bislang unantastbare Konsens für einen Virus, der im Gefahrenpotential der Grippe rangiert, aufgehoben wird und ein Experimentalimpfstoff an Schwangere und Stillende verimpft werden soll, üben sich Systemmedien in Kniefällen und Lobeshymnen. Man setzt junge Mütter, welche eine Chance um die Null Prozent für einen schweren oder gar tödlichen Krankheitsverlauf haben, wissentlich und vorsätzlich Risiken aus, von denen man zum heutigen Zeitpunkt in Ermangelung von Langzeitstudien noch überhaupt nichts weiß.

Die österreichische Gesundheitsagentur AGES schreibt dazu schwammig: „Allgemein gilt, dass auf Grund der physiologischen und immunologischen Umstellungen während der Schwangerschaft eine erhöhte Empfänglichkeit für Infektionen nicht ganz ausgeschlossen werden kann.

Was aber gesichert ist, da es der Hersteller bereits zugegeben hat: Speziell junge Menschen entwickeln nach der Impfung mit einer extrem hohen Chance von 1-10% potenziell lebensbedrohliche Thrombosen.

Es sollte Grenzen für die Aussage geben, dass der Nutzen mögliche Risiken überwiegt. Diese Grenzen sollten angesichts der vielfach beobachteten Folgen auch vor Gericht gezogen werden.

Die Inhalte der EMA-Datenbank

Nachdem im Zuge unserer Berichterstattung der Detailgrad der öffentlich einsehbaren Inhalte der Datenbank schon reduziert wurde, gehen wir davon aus, dass im Hintergrund die komplette Schließung für die Öffentlichkeit vorangetrieben wird. Bis dahin werden wir unsere Auswertungen publizieren und der Öffentlichkeit zur Verfügung stellen. Die Geheimniskrämerei um Daten zur angeblichen Pandemie war seit Anbeginn ein Hinweis darauf, dass nicht alles mit rechten Dingen zugeht. Denn eigentlich müsste Politik und Wissenschaft daran interessiert sein, stets alle Fakten auf den Tisch zu legen um auf dieser Basis Entscheidungen zu treffen.

Zum Datum des 1. Mai 2021 finden sich 15 Einträge im Zusammenhang mit dem Impfstoff von Moderna, 40 Einträge im Zusammenhang mit AstraZeneca und 41 in Zusammenhang mit Pfizer / Biontech.

Der „Faktencheck“ des Kurier geht an zahlreichen Stellen darauf ein, dass es „nicht wahrscheinlich“ wäre, dass der Impfstoff über die Muttermilch weitergegeben werden kann. Das steht in krassem Gegensatz zu den EMA-Daten.

In der EMA-Datenbank finden sich Meldungen von Nebenwirkungen, die in die Kategorien „Health Professionals“ und „Non Health Professionals“ – also medizinische Fachleute und Nicht-Fachleute unterteilt sind. Zudem unterscheidet man zwischen Meldungen aus dem Europäischen Wirtschaftsraum – und außerhalb. Experten gehen davon aus, dass bestenfalls 6% der tatsächlichen Nebenwirkungen überhaupt gemeldet werden, wobei auch diese Zahl mit Vorsicht zu genießen ist. Nachdem aber inzwischen jeder aus seinem Bekanntenkreis Menschen mit milden bis starken Nebenwirkungen nach Impfungen kennt, welche aus verschiedenen Gründen nie gemeldet wurden, ist eine hohe Dunkelziffer wahrscheinlich. Die Einträge in der Datenbank sagen nichts über die Kausalität aus. Es handelt sich schlichtweg um Ereignisse, die in zeitlicher Nähe zur Impfung beobachtet wurden.

96 Fälle von Nebenwirkungen nach vermuteter Impfstoff-Weitergabe via Muttermilch

Das Zauberwort in der Datensuche war hier „Exposure via Breast Milk“. Das genaue Ereignis, welches zur Meldung führte, ist in keinem Fall bekannt, außer dass eine Covid-Impfung im Spiel war. In manchen Datensätzen wurde offenbar das Alter der Mutter, in anderen jenes der Säuglinge vermerkt. In anderen Fällen scheinen Symptome der Säuglinge und der Mütter vermischt worden zu sein, also in einem Datensatz kombiniert.

Einige Beispiele:

  • Bauchschmerzen
  • Schmerzen und Missempfindungen
  • Kurze Bewusstlosigkeit
  • Durchfall
  • mehrtägiges Fieber
  • Erbrechen, Erbrechen von Blut
  • Innere Blutungen im Magen-Darm-Trakt
  • Magen-Darm-Beschwerden verschiedener Intensität
  • Übelriechender Stuhl, Blut im Stuhl
  • Benommenheit
  • Entzündungen
  • Infektionen
  • Hautablösungen
  • Frösteln
  • Ausschlag
  • Lethargie
  • Schläfrigkeit
  • lebensbedrohlich verringerte Körpertemperatur
  • Schwellungen
  • Allergische Reaktion (anaphylactic reaction)

und vieles mehr.

Todesfälle wurden zum Glück nicht protokolliert, allerdings einige Fälle welche stationäre Behandlung erforderten. Wir veröffentlichen diese Daten, da wir der Ansicht sind, dass die Öffentlichkeit vollständige Information und Aufklärung verdient hat und das ständige Zudecken aller nicht zur offiziellen Erzählung passenden Informationen ein Ende finden muss.

Zum selbst erforschen: Die Line Reports

Wir stellen der Öffentlichkeit hier die gesamten Rohdaten der betroffenen Datensätze zur Verfügung, auch wenn ein gewisses Wissen um Datensätze vonnöten ist, um daraus etwas sinnvolles herauszulesen.

Datenschlüssel

EU Local Number,Report Type,EV Gateway Receipt Date,Primary Source Qualification,Primary Source Country for Regulatory Purposes,Literature Reference,Patient Age Group,Patient Age Group (as per reporter),Parent Child Report,Patient Sex,Reaction List PT (Duration – Outcome - Seriousness Criteria),Suspect/interacting Drug List (Drug Char - Indication PT - Action taken - [Duration - Dose - Route]),Concomitant/Not Administered Drug List (Drug Char - Indication PT - Action taken - [Duration - Dose - Route]),ICSR Form

MODERNA (15)

EU-EC-10008493456,Spontaneous,2021-04-30 00:00:00,Healthcare Professional,European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Paraesthesia (n/a - Unknown - ),<BR><BR>Vaccination site pain (n/a - Unknown - )",COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) MODERNA [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Unknown]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008493456&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008453614,Spontaneous,2021-04-27 00:00:00,Healthcare Professional,European Economic Area,Not available,Not Specified,Adult,No,Female,"Exposure via breast milk (1d - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Injection site reaction (1d - Recovered/Resolved - Other Medically Important Condition)",COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) MODERNA [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008453614&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008434774,Spontaneous,2021-04-26 00:00:00,Healthcare Professional,Non European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Chills (n/a - Recovered/Resolved - ),<BR><BR>Exposure via breast milk (1d - Recovered/Resolved - ),<BR><BR>Fatigue (n/a - Recovered/Resolved - ),<BR><BR>Headache (n/a - Recovered/Resolved - ),<BR><BR>Myalgia (n/a - Recovered/Resolved - ),<BR><BR>Nausea (n/a - Recovered/Resolved - ),<BR><BR>Pyrexia (n/a - Recovered/Resolved - ),<BR><BR>Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)",COVID-19 MRNA VACCINE MODERNA (CX-024414) [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular - More in ICSR]),"[ASCORBIC ACID, FOLIC ACID, NICOTINAMIDE, ASCORBIC ACID, RETINOL] (C - Product used for unknown indication - n/a - ),<BR><BR>[CETIRIZINE DIHYDROCHLORIDE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008434774&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008445491,Spontaneous,2021-04-26 00:00:00,Non Healthcare Professional,European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Chills (1d - Recovered/Resolved - ),<BR><BR>Disturbance in attention (9d - Recovered/Resolved - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Fatigue (n/a - Recovering/Resolving - ),<BR><BR>Headache (3d - Recovered/Resolved - ),<BR><BR>Lymphadenopathy (n/a - Not Recovered/Not Resolved - ),<BR><BR>Malaise (n/a - Recovering/Resolving - ),<BR><BR>Myalgia (3d - Recovered/Resolved - ),<BR><BR>Nausea (0d - Recovered/Resolved - ),<BR><BR>Pyrexia (0d - Recovered/Resolved - ),<BR><BR>Suppressed lactation (6d - Recovered/Resolved - )",COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) MODERNA [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008445491&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008359610,Spontaneous,2021-04-19 00:00:00,Non Healthcare Professional,European Economic Area,Not available,Not Specified,Infant,Yes,Male,"Diarrhoea (4wk - Recovered/Resolved - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Mucous stools (n/a - Recovered/Resolved - )",COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) MODERNA [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),"NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a]),<BR><BR>[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - [n/a - n/a - n/a]),<BR><BR>[VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008359610&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008359632,Spontaneous,2021-04-19 00:00:00,Non Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Infant,Yes,Male,"Crying (1d - Recovered/Resolved - ),<BR><BR>Exposure via breast milk (1d - Unknown - )",COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) MODERNA [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008359632&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007934975,Spontaneous,2021-03-15 00:00:00,Non Healthcare Professional,European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Suppressed lactation (n/a - Not Recovered/Not Resolved - )",COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) MODERNA [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a]),"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007934975&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007801509,Spontaneous,2021-03-05 00:00:00,Non Healthcare Professional,European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Chills (4h - Recovered/Resolved - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Injection site pain (n/a - Recovering/Resolving - ),<BR><BR>Malaise (n/a - Recovering/Resolving - ),<BR><BR>Nausea (n/a - Recovering/Resolving - )","COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) MODERNA [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),<BR><BR>[NOT AVAILABLE] (S - n/a - Drug withdrawn - [n/a - 250mg - n/a])",Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007801509&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007802929,Spontaneous,2021-03-05 00:00:00,Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Infant,No,Female,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Pyrexia (4d - Recovered/Resolved - )",COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) MODERNA [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Prophylaxis - Not applicable - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007802929&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007802966,Spontaneous,2021-03-05 00:00:00,Non Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Male,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Pyrexia (n/a - Not Recovered/Not Resolved - ),<BR><BR>Rash (n/a - Not Recovered/Not Resolved - )",COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) MODERNA [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007802966&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007780759,Spontaneous,2021-03-03 00:00:00,Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Male,"Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Gastric ulcer (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition),<BR><BR>Gastrointestinal haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition),<BR><BR>Haematemesis (n/a - Unknown - Other Medically Important Condition),<BR><BR>Melaena (n/a - Unknown - Caused/Prolonged Hospitalisation)",COVID-19 MRNA VACCINE MODERNA (CX-024414) [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular]),"[ASCORBIC ACID, FOLIC ACID, NICOTINAMIDE, ASCORBIC ACID, RETINOL] (C - Product used for unknown indication - Unknown - [n/a - n/a - n/a])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007780759&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007729681,Spontaneous,2021-02-26 00:00:00,Non Healthcare Professional,European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Arthralgia (2d - Recovered/Resolved - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Headache (2d - Recovered/Resolved - ),<BR><BR>Injection site inflammation (n/a - Recovered/Resolved - ),<BR><BR>Injection site pain (n/a - Recovered/Resolved - ),<BR><BR>Injection site swelling (n/a - Recovered/Resolved - ),<BR><BR>Myalgia (n/a - Recovering/Resolving - )",COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) MODERNA [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007729681&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007718624,Spontaneous,2021-02-25 00:00:00,Non Healthcare Professional,European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Breast pain (1wk - Recovering/Resolving - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Fatigue (2d - Recovered/Resolved - ),<BR><BR>Headache (0d - Recovered/Resolved - ),<BR><BR>Injection site inflammation (n/a - Recovering/Resolving - ),<BR><BR>Injection site pain (n/a - Recovering/Resolving - ),<BR><BR>Injection site swelling (n/a - Recovering/Resolving - ),<BR><BR>Lymphadenopathy (n/a - Recovering/Resolving - ),<BR><BR>Malaise (2d - Recovered/Resolved - ),<BR><BR>Myalgia (2d - Recovered/Resolved - ),<BR><BR>Pain in extremity (n/a - Recovering/Resolving - )",COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) MODERNA [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),"[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007718624&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007638419,Spontaneous,2021-02-17 00:00:00,Non Healthcare Professional,European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Fatigue (n/a - Recovering/Resolving - ),<BR><BR>Headache (n/a - Not Recovered/Not Resolved - ),<BR><BR>Lymphadenopathy (n/a - Not Recovered/Not Resolved - ),<BR><BR>Malaise (n/a - Recovering/Resolving - ),<BR><BR>Myalgia (4d - Recovered/Resolved - )",COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) MODERNA [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),"[ETHINYLESTRADIOL, ETONOGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007638419&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007564366,Spontaneous,2021-02-09 00:00:00,Non Healthcare Professional,European Economic Area,Not available,Not Specified,Infant,No,Male,"Abdominal pain (2d - Recovered/Resolved - ),<BR><BR>Exposure via breast milk (2d - Recovered/Resolved - ),<BR><BR>Frequent bowel movements (2d - Recovered/Resolved - ),<BR><BR>Infant irritability (2d - Recovered/Resolved - ),<BR><BR>Mucous stools (2d - Recovered/Resolved - ),<BR><BR>Poor feeding infant (2d - Recovered/Resolved - )",COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) MODERNA [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Dose not changed - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007564366&_xpt=1&_xf=pdf"">ICSR</a>"
Datenschlüssel

EU Local Number,Report Type,EV Gateway Receipt Date,Primary Source Qualification,Primary Source Country for Regulatory Purposes,Literature Reference,Patient Age Group,Patient Age Group (as per reporter),Parent Child Report,Patient Sex,Reaction List PT (Duration – Outcome - Seriousness Criteria),Suspect/interacting Drug List (Drug Char - Indication PT - Action taken - [Duration - Dose - Route]),Concomitant/Not Administered Drug List (Drug Char - Indication PT - Action taken - [Duration - Dose - Route]),ICSR Form

ASTRAZENECA (40)

EU-EC-10008478718,Spontaneous,2021-04-29 00:00:00,Non Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Not Specified,No,Male,"Crying (n/a - Not Recovered/Not Resolved - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Pain (n/a - Not Recovered/Not Resolved - ),<BR><BR>Poor feeding infant (n/a - Not Recovered/Not Resolved - ),<BR><BR>Pyrexia (n/a - Not Recovered/Not Resolved - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008478718&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008447629,Spontaneous,2021-04-27 00:00:00,Non Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Not Specified,"Exposure via breast milk (1d - Recovered/Resolved - ),<BR><BR>Somnolence (n/a - Unknown - ),<BR><BR>Vomiting (1d - Recovered/Resolved - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008447629&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008451007,Spontaneous,2021-04-27 00:00:00,Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Not Specified,No,Not Specified,"Exposure via breast milk (2d - Unknown - ),<BR><BR>Pyrexia (2d - Unknown - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008451007&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008432854,Spontaneous,2021-04-26 00:00:00,Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Not Specified,"Cough (n/a - Recovering/Resolving - ),<BR><BR>Exposure via breast milk (n/a - Recovering/Resolving - ),<BR><BR>Malaise (n/a - Recovering/Resolving - ),<BR><BR>Nasopharyngitis (n/a - Recovering/Resolving - ),<BR><BR>Pyrexia (n/a - Recovering/Resolving - ),<BR><BR>Tachypnoea (n/a - Recovering/Resolving - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008432854&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008402719,Spontaneous,2021-04-22 00:00:00,Non Healthcare Professional,European Economic Area,Not available,Not Specified,Infant,Yes,Not Specified,"Crying (n/a - Unknown - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Listless (n/a - Unknown - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008402719&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008403146,Spontaneous,2021-04-22 00:00:00,Non Healthcare Professional,European Economic Area,Not available,Not Specified,Infant,Yes,Not Specified,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Listless (n/a - Recovered/Resolved - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008403146&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008346565,Spontaneous,2021-04-17 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Dizziness (n/a - Unknown - Disabling, Other Medically Important Condition),<BR><BR>Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition),<BR><BR>Hallucination (n/a - Unknown - Disabling, Other Medically Important Condition),<BR><BR>Headache (3d - Recovered/Resolved - Disabling, Other Medically Important Condition),<BR><BR>Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition),<BR><BR>Vomiting projectile (2d - Recovered/Resolved - Disabling, Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral]),"[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - 49mg - n/a]),<BR><BR>[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 150mg - n/a])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008346565&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008346566,Spontaneous,2021-04-17 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Infant,Yes,Not Specified,"Chills (n/a - Unknown - Other Medically Important Condition),<BR><BR>Crying (n/a - Unknown - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Myalgia (n/a - Unknown - Other Medically Important Condition),<BR><BR>Pyrexia (n/a - Unknown - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008346566&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008303706,Spontaneous,2021-04-14 00:00:00,Non Healthcare Professional,European Economic Area,Not available,Not Specified,Not Specified,No,Female,Exposure via breast milk (n/a - Unknown - ),COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008303706&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008294220,Spontaneous,2021-04-13 00:00:00,Non Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Not Specified,"Chills (n/a - Recovering/Resolving - ),<BR><BR>Crying (n/a - Recovering/Resolving - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Pyrexia (n/a - Recovering/Resolving - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary]),"[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - Transmammary])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008294220&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008261443,Spontaneous,2021-04-10 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Arthralgia (n/a - Unknown - Other Medically Important Condition),<BR><BR>Fatigue (n/a - Unknown - Other Medically Important Condition),<BR><BR>Headache (n/a - Unknown - Other Medically Important Condition),<BR><BR>Maternal exposure during breast feeding (n/a - Unknown - Other Medically Important Condition),<BR><BR>Myalgia (n/a - Unknown - Other Medically Important Condition),<BR><BR>Nausea (n/a - Unknown - Other Medically Important Condition),<BR><BR>Neonatal insufficient breast milk syndrome (n/a - Recovering/Resolving - Other Medically Important Condition),<BR><BR>Tremor (n/a - Unknown - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008261443&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008180700,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Headache (n/a - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Maternal exposure during breast feeding (n/a - Unknown - Other Medically Important Condition),<BR><BR>Neonatal insufficient breast milk syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition),<BR><BR>Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008180700&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008188285,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,No,Not Specified,"Chills (1d - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Influenza (1d - Recovered/Resolved - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [1d - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008188285&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008188287,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Exposure via breast milk (n/a - Not Recovered/Not Resolved - Other Medically Important Condition),<BR><BR>Maternal exposure during breast feeding (n/a - Unknown - Other Medically Important Condition),<BR><BR>Suppressed lactation (n/a - Unknown - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008188287&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008188290,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,18-64 Years,Not Specified,No,Female,Exposure via breast milk (n/a - Unknown - Disabling),COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008188290&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008188298,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Infant,No,Female,"Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition),<BR><BR>Rash (n/a - Unknown - Other Medically Important Condition),<BR><BR>Rhinorrhoea (n/a - Unknown - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Other]),"[FLUCLOXACILLIN, FLUCLOXACILLIN SODIUM, FLUCLOXACILLIN SODIUM MONOHYDRATE] (C - Mastitis - n/a - [n/a - n/a - n/a])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008188298&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008188299,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Infant,No,Not Specified,"Body temperature increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [1d - n/a - n/a]),"[IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN PH. EUR., IBUPROFEN SODIUM, IBUPROFEN SODIUM DIHYDRATE] (C - Headache - n/a - [n/a - n/a - n/a])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008188299&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008188305,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Not Specified,Yes,Not Specified,"Exposure via breast milk (2d - Recovered/Resolved - ),<BR><BR>Maternal exposure during breast feeding (n/a - Unknown - ),<BR><BR>Poor feeding infant (n/a - Unknown - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [1d - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008188305&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008188313,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,No,Male,"Chills (1d - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Fatigue (n/a - Unknown - Other Medically Important Condition),<BR><BR>Pyrexia (n/a - Unknown - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008188313&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008189461,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Male,"Abdominal discomfort (n/a - Unknown - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Transmammary]),"[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - n/a])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008189461&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008189512,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Infant,No,Male,"Dermatitis diaper (n/a - Unknown - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Lethargy (n/a - Unknown - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008189512&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008189597,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Infant,Yes,Not Specified,"Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008189597&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008189604,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Not Specified,"Diarrhoea (n/a - Unknown - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Faeces discoloured (n/a - Unknown - Other Medically Important Condition),<BR><BR>Infant irritability (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008189604&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008189670,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Not Specified,"Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Vomiting projectile (n/a - Recovering/Resolving - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008189670&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008189734,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Child,Yes,Female,"Accidental exposure to product (n/a - Unknown - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Malaise (n/a - Unknown - Other Medically Important Condition),<BR><BR>Pyrexia (n/a - Unknown - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008189734&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008189735,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,No,Male,"Chills (n/a - Recovering/Resolving - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Nasal congestion (n/a - Recovering/Resolving - Other Medically Important Condition),<BR><BR>Pyrexia (2d - Recovering/Resolving - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008189735&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008189736,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,No,Female,"Exposure via breast milk (n/a - Unknown - Disabling),<BR><BR>Suspected COVID-19 (n/a - Unknown - Disabling)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008189736&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008190044,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Not Specified,"Emotional disorder (n/a - Unknown - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Somnolence (n/a - Unknown - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008190044&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008191218,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Exposure via breast milk (1d - Recovered/Resolved - ),<BR><BR>Maternal exposure during breast feeding (n/a - Unknown - ),<BR><BR>Pyrexia (2d - Recovered/Resolved - ),<BR><BR>Pyrexia (n/a - Recovering/Resolving - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008191218&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008191441,Spontaneous,2021-04-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Not Specified,"Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Somnolence (11h - Recovered/Resolved - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a]),"[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008191441&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008161588,Spontaneous,2021-04-01 00:00:00,Non Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Child,Yes,Male,"Anxiety (n/a - Recovered/Resolved - ),<BR><BR>Crying (0d - Recovered/Resolved - ),<BR><BR>Exposure via breast milk (0d - Unknown - ),<BR><BR>Poor quality sleep (0d - Recovered/Resolved - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008161588&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008161679,Spontaneous,2021-04-01 00:00:00,Non Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Infant,Yes,Female,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Rash (n/a - Not Recovered/Not Resolved - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008161679&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008153580,Spontaneous,2021-03-31 00:00:00,Non Healthcare Professional,European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Body temperature increased (n/a - Recovering/Resolving - ),<BR><BR>Chills (n/a - Recovering/Resolving - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Fatigue (n/a - Recovering/Resolving - ),<BR><BR>Headache (n/a - Recovering/Resolving - ),<BR><BR>Malaise (n/a - Recovering/Resolving - ),<BR><BR>Myalgia (n/a - Not Recovered/Not Resolved - ),<BR><BR>Nausea (n/a - Recovering/Resolving - ),<BR><BR>Vomiting (30min - Recovered/Resolved - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008153580&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008116313,Spontaneous,2021-03-27 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Male,"Abnormal faeces (n/a - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Infant irritability (n/a - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Lethargy (n/a - Recovered/Resolved - Other Medically Important Condition)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Transmammary]),"[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - Transmammary])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008116313&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008083985,Spontaneous,2021-03-26 00:00:00,Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Not Specified,"Exposure via breast milk (3d - Recovered/Resolved - ),<BR><BR>Faeces soft (2d - Recovered/Resolved - ),<BR><BR>Restlessness (3d - Recovered/Resolved - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008083985&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008011856,Spontaneous,2021-03-20 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Infant,Yes,Not Specified,"Accidental exposure to product (n/a - Recovering/Resolving - ),<BR><BR>Crying (n/a - Recovering/Resolving - ),<BR><BR>Exposure via breast milk (n/a - Recovering/Resolving - ),<BR><BR>Infant irritability (n/a - Recovering/Resolving - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008011856&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008014545,Spontaneous,2021-03-20 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Infant,Yes,Male,"Accidental exposure to product (n/a - Unknown - ),<BR><BR>Crying (n/a - Unknown - ),<BR><BR>Disorientation (n/a - Unknown - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Feeling abnormal (n/a - Unknown - ),<BR><BR>Lethargy (n/a - Unknown - ),<BR><BR>Pyrexia (n/a - Unknown - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [1d - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008014545&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007934931,Spontaneous,2021-03-15 00:00:00,Non Healthcare Professional,European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Chills (30min - Recovered/Resolved - ),<BR><BR>Dizziness (3h - Recovered/Resolved - ),<BR><BR>Exposure via breast milk (0d - Unknown - ),<BR><BR>Headache (1d - Recovered/Resolved - ),<BR><BR>Myalgia (n/a - Recovering/Resolving - ),<BR><BR>Pyrexia (3h - Recovered/Resolved - ),<BR><BR>Suppressed lactation (n/a - Unknown - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007934931&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007867071,Spontaneous,2021-03-09 00:00:00,Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Not Specified,No,Female,"Exposure via breast milk (3d - Recovered/Resolved - ),<BR><BR>Malaise (3d - Recovered/Resolved - ),<BR><BR>Pyrexia (3d - Recovered/Resolved - ),<BR><BR>Urticaria (3d - Recovered/Resolved - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007867071&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007802920,Spontaneous,2021-03-05 00:00:00,Non Healthcare Professional,European Economic Area,Not available,Not Specified,Infant,Yes,Male,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Pyrexia (n/a - Not Recovered/Not Resolved - )",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007802920&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007790718,Spontaneous,2021-03-04 00:00:00,Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,No,Male,"Body temperature decreased (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation),<BR><BR>Crying (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation),<BR><BR>Exposure via breast milk (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation),<BR><BR>Sick relative (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)",COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [1d - n/a - Intramuscular]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007790718&_xpt=1&_xf=pdf"">ICSR</a>"
Datenschlüssel

EU Local Number,Report Type,EV Gateway Receipt Date,Primary Source Qualification,Primary Source Country for Regulatory Purposes,Literature Reference,Patient Age Group,Patient Age Group (as per reporter),Parent Child Report,Patient Sex,Reaction List PT (Duration – Outcome - Seriousness Criteria),Suspect/interacting Drug List (Drug Char - Indication PT - Action taken - [Duration - Dose - Route]),Concomitant/Not Administered Drug List (Drug Char - Indication PT - Action taken - [Duration - Dose - Route]),ICSR Form

PFIZER / BIONTECH (41)

EU-EC-10008478704,Spontaneous,2021-04-29 00:00:00,Non Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Infant,Yes,Male,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Pyrexia (5d - Recovered/Resolved - ),<BR><BR>Rash (3d - Recovered/Resolved - )",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008478704&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008483909,Spontaneous,2021-04-29 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Exposure via breast milk (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition),<BR><BR>Lactation disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition),<BR><BR>Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008483909&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008469970,Spontaneous,2021-04-28 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Neonate (Preterm and Term newborns),Yes,Not Specified,"Abnormal faeces (n/a - Unknown - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008469970&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008471827,Spontaneous,2021-04-28 00:00:00,Healthcare Professional,Non European Economic Area,Not available,Not Specified,Not Specified,Yes,Female,"Crying (n/a - Unknown - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Throat tightness (n/a - Unknown - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008471827&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008446981,Spontaneous,2021-04-27 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Male,"Exposure via breast milk (3d - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Swelling (3d - Recovered/Resolved - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008446981&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008449790,Spontaneous,2021-04-27 00:00:00,Non Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Male,"Exposure via breast milk (n/a - Recovered/Resolved - ),<BR><BR>Pyrexia (4d - Recovered/Resolved - )",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008449790&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008438231,Spontaneous,2021-04-26 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Not Specified,No,Not Specified,"Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Illness (n/a - Unknown - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008438231&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008438244,Spontaneous,2021-04-26 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Infant,Yes,Male,"Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008438244&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008440375,Spontaneous,2021-04-26 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Not Specified,Yes,Male,"Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Rash (n/a - Unknown - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008440375&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008386439,Spontaneous,2021-04-21 00:00:00,Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Not Specified,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Fever neonatal (3d - Unknown - Other Medically Important Condition),<BR><BR>Illness (n/a - Unknown - ),<BR><BR>Rash (1wk - Unknown - )",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Other]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008386439&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008379126,Spontaneous,2021-04-20 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Body temperature (7d - Recovered/Resolved - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition),<BR><BR>Rash (3d - Recovered/Resolved - )",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008379126&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008355561,Spontaneous,2021-04-19 00:00:00,Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Not Specified,"Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Cough (n/a - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Infant irritability (n/a - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Wheezing (n/a - Recovered/Resolved - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008355561&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008323550,Spontaneous,2021-04-15 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Male,"Exposure via breast milk (n/a - Recovering/Resolving - Other Medically Important Condition),<BR><BR>Fever neonatal (n/a - Recovering/Resolving - Other Medically Important Condition),<BR><BR>Rash neonatal (n/a - Recovering/Resolving - )",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008323550&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008301956,Spontaneous,2021-04-14 00:00:00,Healthcare Professional,Non European Economic Area,Not available,Not Specified,Infant,Yes,Female,"Agitation (n/a - Unknown - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008301956&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008304699,Spontaneous,2021-04-14 00:00:00,Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,No,Male,"Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Malaise (n/a - Unknown - Other Medically Important Condition),<BR><BR>Pyrexia (7d - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Viral infection (n/a - Unknown - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008304699&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008304779,Spontaneous,2021-04-14 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Not Specified,No,Female,"Abnormal behaviour (n/a - Not Recovered/Not Resolved - Other Medically Important Condition),<BR><BR>Agitation (n/a - Unknown - Other Medically Important Condition),<BR><BR>Asthenia (n/a - Unknown - Other Medically Important Condition),<BR><BR>Asthenopia (n/a - Unknown - Other Medically Important Condition),<BR><BR>Crying (n/a - Unknown - Other Medically Important Condition),<BR><BR>Depressed level of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Not Recovered/Not Resolved - Other Medically Important Condition),<BR><BR>Feeling abnormal (n/a - Unknown - Other Medically Important Condition),<BR><BR>Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition),<BR><BR>Flushing (n/a - Unknown - Other Medically Important Condition),<BR><BR>Somnolence (n/a - Unknown - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008304779&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008292585,Spontaneous,2021-04-13 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Infant,Yes,Not Specified,"Constipation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition),<BR><BR>Dehydration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition),<BR><BR>Poor feeding infant (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition),<BR><BR>Weight decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008292585&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008274942,Spontaneous,2021-04-12 00:00:00,Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Not Specified,"Ear infection (n/a - Recovering/Resolving - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Nasopharyngitis (n/a - Unknown - ),<BR><BR>Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition),<BR><BR>Rhinorrhoea (7d - Recovered/Resolved - )",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary]),"[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 137ug - Transmammary]),<BR><BR>[SULFASALAZINE] (C - Arthritis - n/a - [n/a - 1000mg - Transmammary])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008274942&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008282818,Spontaneous,2021-04-12 00:00:00,Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,No,Male,"Exposure via breast milk (n/a - Recovered/Resolved - ),<BR><BR>Respiratory distress (n/a - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Wheezing (n/a - Recovered/Resolved - )",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008282818&_xpt=1&_xf=pdf"">ICSR</a>"
EU-EC-10008253546,Spontaneous,2021-04-09 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Not Specified,No,Not Specified,Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008253546&_xpt=1&_xf=pdf"">ICSR</a>"
EU-EC-10008253564,Spontaneous,2021-04-09 00:00:00,Healthcare Professional,Non European Economic Area,Not available,Not Specified,Infant,Yes,Male,"Diarrhoea haemorrhagic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008253564&_xpt=1&_xf=pdf"">ICSR</a>"
EU-EC-10008221718,Spontaneous,2021-04-07 00:00:00,Non Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Infant,Yes,Female,"Crying (n/a - Recovering/Resolving - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Fatigue (n/a - Recovering/Resolving - ),<BR><BR>Malaise (n/a - Recovering/Resolving - ),<BR><BR>Pyrexia (n/a - Recovering/Resolving - )",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008221718&_xpt=1&_xf=pdf"">ICSR</a>"
EU-EC-10008204549,Spontaneous,2021-04-06 00:00:00,Non Healthcare Professional,European Economic Area,Not available,Not Specified,Infant,Yes,Not Specified,"Abdominal pain (2d - Recovered/Resolved - ),<BR><BR>Exposure via breast milk (2d - Recovered/Resolved - )",COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008204549&_xpt=1&_xf=pdf"">ICSR</a>"
EU-EC-10008150280,Spontaneous,2021-03-31 00:00:00,Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Not Specified,Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008150280&_xpt=1&_xf=pdf"">ICSR</a>"
EU-EC-10008128272,Spontaneous,2021-03-29 00:00:00,Non Healthcare Professional,European Economic Area,Not available,18-64 Years,Adult,No,Female,Breast milk discolouration (2d - Not Recovered/Not Resolved - ),COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [2s - 1{DF} - Intramuscular]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008128272&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10008073203,Spontaneous,2021-03-25 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Neonate (Preterm and Term newborns),No,Not Specified,Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10008073203&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007950306,Spontaneous,2021-03-16 00:00:00,Non Healthcare Professional,European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Arthralgia (n/a - Recovering/Resolving - ),<BR><BR>Chills (n/a - Recovering/Resolving - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Fatigue (n/a - Not Recovered/Not Resolved - ),<BR><BR>Feeling of body temperature change (n/a - Not Recovered/Not Resolved - ),<BR><BR>Headache (n/a - Recovering/Resolving - ),<BR><BR>Malaise (n/a - Not Recovered/Not Resolved - ),<BR><BR>Myalgia (n/a - Recovering/Resolving - ),<BR><BR>Nausea (1d - Recovered/Resolved - ),<BR><BR>Suppressed lactation (n/a - Not Recovered/Not Resolved - )",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007950306&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007951498,Spontaneous,2021-03-16 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,Not Specified,Not Specified,Yes,Female,"Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Limb mass (n/a - Unknown - ),<BR><BR>Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007951498&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007929546,Spontaneous,2021-03-15 00:00:00,Non Healthcare Professional,European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Fatigue (n/a - Recovering/Resolving - ),<BR><BR>Headache (n/a - Recovering/Resolving - ),<BR><BR>Injection site pain (n/a - Recovering/Resolving - ),<BR><BR>Malaise (n/a - Recovering/Resolving - ),<BR><BR>Myalgia (n/a - Recovering/Resolving - ),<BR><BR>Pyrexia (n/a - Recovering/Resolving - ),<BR><BR>Suppressed lactation (n/a - Recovering/Resolving - )",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007929546&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007894070,Spontaneous,2021-03-11 00:00:00,Non Healthcare Professional,European Economic Area,Not available,Not Specified,Infant,Yes,Female,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Pyrexia (n/a - Not Recovered/Not Resolved - )",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a]),"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007894070&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007857596,Spontaneous,2021-03-09 00:00:00,Non Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Infant,Yes,Not Specified,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Infant irritability (5d - Recovered/Resolved - )",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007857596&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007859661,Spontaneous,2021-03-09 00:00:00,Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Female,"Exposure via breast milk (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition),<BR><BR>Illness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007859661&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007866321,Spontaneous,2021-03-09 00:00:00,Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Male,"Angioedema (n/a - Unknown - Other Medically Important Condition),<BR><BR>Exposure via breast milk (n/a - Unknown - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007866321&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007799468,Spontaneous,2021-03-05 00:00:00,Non Healthcare Professional,European Economic Area,Not available,18-64 Years,Not Specified,No,Female,"Arthralgia (n/a - Recovering/Resolving - ),<BR><BR>Chills (n/a - Recovering/Resolving - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Headache (1h - Recovered/Resolved - ),<BR><BR>Malaise (n/a - Not Recovered/Not Resolved - ),<BR><BR>Myalgia (n/a - Not Recovered/Not Resolved - ),<BR><BR>Pyrexia (n/a - Not Recovered/Not Resolved - )",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),"[ETHINYLESTRADIOL, ETONOGESTREL] (C - n/a - n/a - [n/a - n/a - n/a]),<BR><BR>[MINERALS NOS, VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])","<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007799468&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007781698,Spontaneous,2021-03-03 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Male,"Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Infant irritability (n/a - Unknown - Other Medically Important Condition),<BR><BR>Skin exfoliation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007781698&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007771100,Spontaneous,2021-03-02 00:00:00,Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Infant,No,Male,"Exposure via breast milk (3d - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Faeces discoloured (2d - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Headache (3d - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Infant irritability (3d - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Vomiting (2d - Recovered/Resolved - Other Medically Important Condition)",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007771100&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007664316,Spontaneous,2021-02-19 00:00:00,Non Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Infant,Yes,Female,"Exposure via breast milk (1d - Unknown - ),<BR><BR>Listless (1d - Recovered/Resolved - ),<BR><BR>Pyrexia (1d - Recovered/Resolved - )",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007664316&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007635391,Spontaneous,2021-02-16 00:00:00,Non Healthcare Professional,European Economic Area,Not available,Not Specified,Infant,No,Not Specified,"Exposure via breast milk (n/a - Unknown - ),<BR><BR>Malaise (n/a - Unknown - ),<BR><BR>Pyrexia (n/a - Unknown - )",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007635391&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007586270,Spontaneous,2021-02-11 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,2 Months - 2 Years,Not Specified,No,Female,"Exposure via breast milk (n/a - Recovering/Resolving - Other Medically Important Condition),<BR><BR>Illness (1d - Recovered/Resolved - Other Medically Important Condition)",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007586270&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007548415,Spontaneous,2021-02-08 00:00:00,Healthcare Professional,European Economic Area,Not available,Not Specified,Child,No,Not Specified,"Anxiety (n/a - Unknown - ),<BR><BR>Diarrhoea (n/a - Unknown - ),<BR><BR>Exposure via breast milk (n/a - Unknown - ),<BR><BR>Pyrexia (n/a - Unknown - )",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007548415&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007531350,Spontaneous,2021-02-05 00:00:00,Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Male,"Exposure via breast milk (n/a - Unknown - Other Medically Important Condition),<BR><BR>Rash (n/a - Recovered/Resolved - Other Medically Important Condition),<BR><BR>Urticaria (24h - Recovered/Resolved - Other Medically Important Condition)",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007531350&_xpt=1&_xf=pdf"">ICSR</a>"

EU-EC-10007363834,Spontaneous,2021-01-18 00:00:00,Healthcare Professional,European Economic Area,Not available,2 Months - 2 Years,Not Specified,Yes,Not Specified,"Eructation (n/a - Not Recovered/Not Resolved - ),<BR><BR>Exposure via breast milk (n/a - Not Recovered/Not Resolved - )",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Transmammary]),Not reported,"<a target=""_blank"" href=""https://bi.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007363834&_xpt=1&_xf=pdf"">ICSR</a>"


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