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
"324479,EU-EC-10009305404,Spontaneous,2021-07-08 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,12-17 Years,Not Specified,No,Male,""Cardiomegaly (n/a - Fatal - Results in Death),
Death (n/a - Fatal - Results in Death),
Pericardial effusion (n/a - Fatal - Results in Death)"",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a]),Not reported,""ICSR"""
"214577,EU-EC-10009817992,Spontaneous,2021-08-27 00:00:00,Healthcare Professional,European Economic Area,Not available,12-17 Years,Adolescent,No,Male,""Pulmonary embolism (n/a - Fatal - Results in Death),
Thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation)"",COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a]),Not reported,""ICSR"""
"19598,EU-EC-10009668305,Spontaneous,2021-08-12 00:00:00,Healthcare Professional,European Economic Area,Not available,12-17 Years,Adolescent,No,Female,""Cardiac arrest (1d - Fatal - Results in Death, Life Threatening)"",COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular]),Not reported,""ICSR"""
"297956,EU-EC-10009743215,Spontaneous,2021-08-20 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,12-17 Years,Not Specified,No,Male,""Death (n/a - Fatal - Results in Death, Other Medically Important Condition)"",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a]),Not reported,""ICSR"""
"332069,EU-EC-10009129480,Spontaneous,2021-06-24 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,12-17 Years,Not Specified,No,Male,""COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition),
Chills (n/a - Not Recovered/Not Resolved - ),
Completed suicide (n/a - Fatal - Results in Death),
Decreased appetite (n/a - Not Recovered/Not Resolved - ),
Diarrhoea (n/a - Not Recovered/Not Resolved - ),
Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition),
Fatigue (n/a - Not Recovered/Not Resolved - ),
Feeling abnormal (n/a - Not Recovered/Not Resolved - ),
Headache (n/a - Not Recovered/Not Resolved - ),
Hypersomnia (n/a - Not Recovered/Not Resolved - ),
Illness (n/a - Not Recovered/Not Resolved - ),
Lethargy (n/a - Unknown - ),
Pain in extremity (n/a - Unknown - )"",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular - More in ICSR]),Not reported,""ICSR"""
"310305,EU-EC-10009528413,Spontaneous,2021-07-29 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,12-17 Years,Not Specified,No,Male,""Sudden death (n/a - Fatal - Results in Death, Other Medically Important Condition)"",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a]),Not reported,""ICSR"""
"293965,EU-EC-10009815542,Spontaneous,2021-08-27 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,12-17 Years,Not Specified,No,Female,""Death (n/a - Fatal - Results in Death, Other Medically Important Condition)"",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a]),Not reported,""ICSR"""
"218676,EU-EC-10009730047,Spontaneous,2021-08-19 00:00:00,Healthcare Professional,European Economic Area,Not available,12-17 Years,Adolescent,No,Male,Death (n/a - Fatal - Results in Death),COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular]),Not reported,""ICSR"""
"218319,EU-EC-10009747324,Spontaneous,2021-08-20 00:00:00,Healthcare Professional,European Economic Area,Not available,12-17 Years,Adolescent,No,Male,""Disseminated intravascular coagulation (23h - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation),
Multiple organ dysfunction syndrome (23h - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation),
Pulmonary haemorrhage (23h - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation),
Pyrexia (23h - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation),
Septic shock (23h - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)"",COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a]),Not reported,""ICSR"""
"264772,EU-EC-10008557015,Spontaneous,2021-05-06 00:00:00,Healthcare Professional,European Economic Area,Not available,12-17 Years,Adolescent,No,Male,""Cardiac arrest (0d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition),
Pulmonary embolism (0d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)"",COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular]),""[AZITHROMYCIN] (C - n/a - Not applicable - [n/a - 500mg - Oral]),
[CICLOSPORIN] (C - n/a - Not applicable - [n/a - 50mg - Oral]),
[METHYLPREDNISOLONE] (C - n/a - Not applicable - [n/a - 16mg - Oral])"",""ICSR"""
"10024,EU-EC-10009749988,Spontaneous,2021-08-20 00:00:00,Healthcare Professional,European Economic Area,Not available,12-17 Years,Not Specified,No,Female,Arrhythmia (n/a - Fatal - Results in Death),COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a]),Not reported,""ICSR"""
"328772,EU-EC-10009208703,Spontaneous,2021-06-30 00:00:00,Non Healthcare Professional,Non European Economic Area,Not available,12-17 Years,Not Specified,No,Male,""Cardiomegaly (n/a - Fatal - Results in Death),
Myocarditis (n/a - Fatal - Results in Death),
Pericardial effusion (n/a - Fatal - Results in Death)"",TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a]),Not reported,""ICSR"""