Document text
Page 1 of 36
As of Date: 01-OCT-2021
1.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 1
Patient Demographic
Sex Age Height (cm) Weight (kg) Race Country Where Event Occured
FEMALE 14 YEARS NO DATA - NO DATA ROMANIA
This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative.
A 14-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19
immunisation. The patient medical history and concomitant medications were not reported. The patient experienced "it seems that" 2 days after immunisation patient died. The patient died on an unspecified
date. It was not reported if an autopsy was performed.
No follow-up attempts are possible. The information about lot number and expiration date cannot be obtained. No further information is expected.Event Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
"it seems that" 2 days after
immunisation diedUnknown cause of death Death SERIOUS FATAL NO DATA NO DATA
Lab Data: Unknown Lab Data
Lab Narrative:
Suspect Product(s) Therapy Information
Suspect Product(s) Unit Dose Total Daily Dose Regimen Dose Route of Admin Therapy Date(s) Therapy Duration Anatomical
LocationVaccination
Dose No.Lot No. Batch No.
BNT162B2 NO DATA - NO DATATest Name Normal Value Test Date Test Result Lab Comments
Suspect Product(s) Information
Suspect Product(s) Indication(s) Form of Admin First Total Daily Dose Action Taken Dechallenge Rechallenge Interacting Drug
BNT162B2 COVID-19 immunisation SOLUTION FOR
INJECTIONNOT APPLICABLE N/A N/A NO DATACase Comments
Based on the current available limited information in the case provided, the causal association between the event of Death due to unknown cause and the use of suspect product BNT162B2 cannot be fully
assessed. The case will be reassessed if additional information becomes available.
The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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As of Date: 01-OCT-2021
1.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 2
Patient Medical History
Concomitant Product(s) Conmed Tradename As Reported Therapy Date(s) Route of Admin
-
Report History
Source HP/Medically
ConfirmedCase Report Type Reporter Occupation Protocol/Study No. Center ID & Other ID Patient ID Initial Safety
Receipt DateEUDRACT No.
Spontaneous Y SPONTANEOUS PHYSICIAN 23-JUL-2021ConMed: Unknown Concomitant Product(s)Product(s) and Event(s) Information
Suspect Product(s) Event(s) CDS Latency Group Rechallenge Causality per Reporter Causality per Company
BNT162B2 Death N Unknown N/A N/A N/A
References
Reference Type Reference ID Reference Notes
LOCAL REFERENCE NO.
E2B COMPANY NUMBERCause of Death/Autopsy
Other Death Information:
Suspect or Conmed Devices
Suspect Devices
Device Type Device
IndicatorModel No. Serial No. NDC No. Date of
ManufactureCatalog No. Device
OperatorDevice
Available for
EvaluationDevice
Evaluated by
ManufacturerSingle Use Evaluation
TypeEvaluation Code
NO DATA NO DATA NO DATA NO DATAPatient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Type Patient/Parent Indicator Coded Condition Notes
DEATH PATIENT Death
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
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As of Date: 01-OCT-2021
2.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization Required,Life Threatening,Medically SignificantSection Page: 1
Patient Demographic
Sex Age Height (cm) Weight (kg) Race Country Where Event Occured
MALE 12 YEARS CAUCASIAN - NO DATA ITALY
This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number .
A 12-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in deltoid right on 03Jul2021 20:31 (Lot Number: FE2707; Expiration Date: Oct2021) as DOSE 2, 0.3ML
SINGLE for COVID-19 immunisation. Medical history included infantile cerebral palsy of the spastic tetraparesis type, epilepsy (symptomatic drug resistant), severe intellectual disability, gastroesophageal
reflux, and respiratory infections. Concomitant medications included clobazam (FRISIUM); esomeprazole magnesium (LUCEN [ESOMEPRAZOLE MAGNESIUM]); valproate sodium (DEPAKIN). Historical
vaccine included first dose of COMIRNATY on 12Jun2021 for COVID-19 immunisation. On 08Jul2021, the patient experienced septic shock which was considered serious (hospitalization, life threatening,
death). Date of death reported as 03Aug2021. Patient was in resuscitation sedated with midazolam and hemodialysis; administration of merrem 760 mg, linezolid 1200 mg, fluconazole, urbason 40 mg,
Rocefin 2 g, Zithromax 400 mg, Konakion 10 mg were initiated. The patient underwent lab tests and procedures which included Fibrin D dimer with unknown results; alanine aminotra
nsferase (normal range: 5- 40 IU/l): 904 IU/l, aspartate aminotransferase (normal range: 5- 40 IU/l): 341 IU/l, creatine kinase (normal range: 24- 170 IU/l): 4664 IU/l, lactate dehydrogenase (normal range:
120- 240 IU/l): 1792 IU/l, thromboplastin: 42.9 seconds, C-reactive protein (normal range: 0- 5 mg/l): 15.68 mg/l, myoglobin blood (normal range: 20- 72 ng/ml): 30000 ng/ml, thrombopenia (normal range:
140000- 440000 /mm3): 59.00 x10 /mm3, troponin (normal range: 0- 0.5 ng/ml): 104.64 ng/ml all on 08Jul2021; alanine aminotransferase: 3429 IU/l, aspartate aminotransferase: 946 IU/l, creatine kinase:
19627 IU/l and 10900 IU/l, lactate dehydrogenase: 5856 IU/l, thromboplastin: 35.40 seconds, C-reactive protein: 47.38 mg/l, myoglobin blood: 30000 ng/ml, thrombopenia: 68.00 x10 /mm3, troponin: 105.08
ng/ml all on 09Jul2021; thromboplastin: 145 seconds on 11Jul2021; creatine kinase: 3791 IU/l on 11Jul2021; alanine aminotransferase: 1727 IU/l, aspartate aminotransferase: 553 IU/l, creatine kinase:
253900 IU/l, lactate dehydrogenase: 4184 IU/l, C-reactive protein: 8.55 mg/l, myoglobin blood: 15013.00 ng/ml, thrombopenia: 41.00x10 /mm3 all on 12Jul2021. Aspartate aminotransferase on 09Jul2021
with result 904 u/l and range 5-40. Fibrin D dimer on 09Jul2021 with result 10900 ng/ml and range 0-270; Plateletcrit on 08Jul2
021 with result 104.64 ng/ml and range 0-0.5; Cardiac troponin on 08Jul2021 with result 3681 ng/L and range 1-14; Finding: septic shock. The outcome of the event was fatal. It is unknown if autopsy was
done.
Reporter's comment: It should be noted that the patient is affected by infantile cerebral palsy of the spastic tetraparesis type, epilepsy (symptomatic drug resistant), severe intellectual disability,
gastroesophageal reflux disease and respiratory infections.
Follow-up (06Sep2021): New information received from contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance- included: Lab data and
death information.
Follow-up (17Sep2021): Follow-up attempts are completed. No further information is expected.Event Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
septic shock Septic shock Septic shock 08-JUL-2021 SERIOUS FATAL NO DATA NO DATA
Lab Data: Present Lab Data
Lab Narrative:
Test Name Normal Value Test Date Test Result Lab Comments
Alanine aminotransferase 5 - 40 08-JUL-2021 * | 904 | IU/l
Alanine aminotransferase 5 - 40 09-JUL-2021 * | 3429 | IU/l
Alanine aminotransferase 5 - 40 12-JUL-2021 * | 1727 | IU/l
Aspartate aminotransferase 5 - 40 08-JUL-2021 * | 341 | IU/l
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2.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization Required,Life Threatening,Medically SignificantSection Page: 2
Test Name Normal Value Test Date Test Result Lab Comments
Aspartate aminotransferase 5 - 40 09-JUL-2021 * | 904 | IU/l
Aspartate aminotransferase 5 - 40 09-JUL-2021 * | 946 | IU/l
Aspartate aminotransferase 5 - 40 12-JUL-2021 * | 553 | IU/l
Blood creatine phosphokinase 24 - 170 08-JUL-2021 * | 4664 | IU/l
Blood creatine phosphokinase 24 - 170 09-JUL-2021 * | 10900 | IU/l
Blood creatine phosphokinase 24 - 170 09-JUL-2021 * | 19627 | IU/l
Blood creatine phosphokinase 24 - 170 11-JUL-2021 * | 3791 | IU/l
Blood creatine phosphokinase 24 - 170 12-JUL-2021 * | 253900 | IU/l
Blood lactate dehydrogenase 120 - 240 08-JUL-2021 * | 1792 | IU/l
Blood lactate dehydrogenase 120 - 240 09-JUL-2021 * | 5856 | IU/l
Blood lactate dehydrogenase 120 - 240 12-JUL-2021 * | 4184 | IU/l
Blood thromboplastin 08-JUL-2021 * | 42.9 | seconds
Blood thromboplastin 09-JUL-2021 * | 35.40 | seconds
Blood thromboplastin 11-JUL-2021 * | 145 | seconds
C-reactive protein 0 - 5 08-JUL-2021 * | 15.68 | mg/l
C-reactive protein 0 - 5 09-JUL-2021 * | 47.38 | mg/l
C-reactive protein 0 - 5 12-JUL-2021 * | 8.55 | mg/l
Fibrin D dimer 0 - 270 09-JUL-2021 * | 10900 | ng/ml
Fibrin D dimer 0 - 270 * | unknown results | ng/ml
Myoglobin blood 20 - 72 08-JUL-2021 * | 30000 | ng/ml
Myoglobin blood 20 - 72 09-JUL-2021 * | 30000 | ng/ml
Myoglobin blood 20 - 72 12-JUL-2021 * | 15013.00 | ng/ml
Plateletcrit 0 - 0.5 * | 104.64 | ng/ml
Thrombocytopenia 140000 - 440000 08-JUL-2021 * | 59.00 x10 | /mm3
Thrombocytopenia 140000 - 440000 09-JUL-2021 * | 68.00 x10 | /mm3
Thrombocytopenia 140000 - 440000 12-JUL-2021 * | 41.00x10 | /mm3
Troponin 0 - 0.5 08-JUL-2021 * | 104.64 | ng/ml
Troponin 1 - 14 08-JUL-2021 * | 3681 | ng/L
Troponin 0 - 0.5 09-JUL-2021 * | 105.08 | ng/ml
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2.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization Required,Life Threatening,Medically SignificantSection Page: 3
Suspect Product(s) Therapy Information
Suspect Product(s) Unit Dose Total Daily Dose Regimen Dose Route of Admin Therapy Date(s) Therapy Duration Anatomical
LocationVaccination
Dose No.Lot No. Batch No.
BNT162B2 .3 mL .3 mL INTRAMUSCUL
AR03-JUL-2021 -
03-JUL-2021DELTOID
RIGHT2 FE2707
Patient Medical History
Concomitant Product(s) Conmed Tradename As Reported Therapy Date(s) Route of Admin
CLOBAZAM FRISIUM - NO DATA
ESOMEPRAZOLE MAGNESIUMLUCEN [ESOMEPRAZOLE
MAGNESIUM] - NO DATA
VALPROATE SODIUM DEPAKIN - NO DATAConMed: Present Concomitant Product(s)Product(s) and Event(s) Information
Suspect Product(s) Event(s) CDS Latency Group Rechallenge Causality per Reporter Causality per Company
BNT162B2 Septic shock N Post Therapy N/A N/A N/A
Cause of Death/Autopsy
Other Death Information:Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
PATIENT Cerebral palsy NO DATA
PATIENT Epilepsy NO DATA symptomatic drug resistant
PATIENT Gastrooesophageal reflux
diseaseNO DATA
PATIENT Intellectual disability NO DATA severe
PATIENT Respiratory tract infection NO DATA
Type Patient/Parent Indicator Coded Condition Notes
DEATH PATIENT Septic shockSuspect Product(s) Information
Suspect Product(s) Indication(s) Form of Admin First Total Daily Dose Action Taken Dechallenge Rechallenge Interacting Drug
BNT162B2 COVID-19 immunisation SOLUTION FOR
INJECTION.3 mL NOT APPLICABLE N/A N/A NO DATA
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2.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization Required,Life Threatening,Medically SignificantSection Page: 4
Report History
Source HP/Medically
ConfirmedCase Report Type Reporter Occupation Protocol/Study No. Center ID & Other ID Patient ID Initial Safety
Receipt DateEUDRACT No.
Spontaneous Y SPONTANEOUS PHYSICIAN 26-JUL-2021
References
Reference Type Reference ID Reference Notes
E2B AUTHORITY NUMBER
E2B REPORT DUPLICATESuspect or Conmed Devices
Suspect Devices
Device Type Device
IndicatorModel No. Serial No. NDC No. Date of
ManufactureCatalog No. Device
OperatorDevice
Available for
EvaluationDevice
Evaluated by
ManufacturerSingle Use Evaluation
TypeEvaluation Code
NO DATA NO DATA NO DATA NO DATA
Conmed Devices
Device Type Model No. Serial No.
NO DATA
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
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As of Date: 01-OCT-2021
3.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 1
Patient Demographic
Sex Age Height (cm) Weight (kg) Race Country Where Event Occured
MALE 13 YEARS NO DATA - NO DATA MEXICO
This is a spontaneous report from a non-contactable consumer received via a Pfizer sponsored program Instagram Pfizer Mexico. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH
COVID-19 mRNA VACCINE), unknown dose number, via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as a single dose for COVID-19 immunisation. Medical
history was not reported. Concomitant medications were not reported. It was reported that the 13-year-old patient died after receiving the BNT162B2 vaccine on an unspecified date. It was not reported if an
autopsy was performed and the cause of death was not provided.
No follow-up attempts poss ble; information about lot/batch number cannot be obtained.Event Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
13-year-old dies after
receiving Pfizer vaccineUnknown cause of death Death SERIOUS FATAL NO DATA NO DATA
Lab Data: Unknown Lab Data
Lab Narrative:
Suspect Product(s) Therapy Information
Suspect Product(s) Unit Dose Total Daily Dose Regimen Dose Route of Admin Therapy Date(s) Therapy Duration Anatomical
LocationVaccination
Dose No.Lot No. Batch No.
BNT162B2 NO DATA - NO DATA
Patient Medical HistoryTest Name Normal Value Test Date Test Result Lab Comments
Product(s) and Event(s) Information
Suspect Product(s) Event(s) CDS Latency Group Rechallenge Causality per Reporter Causality per Company
BNT162B2 Death N Unknown N/A N/A N/A
Cause of Death/Autopsy
Other Death Information:Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing NotesSuspect Product(s) Information
Suspect Product(s) Indication(s) Form of Admin First Total Daily Dose Action Taken Dechallenge Rechallenge Interacting Drug
BNT162B2 COVID-19 immunisation SOLUTION FOR
INJECTIONNOT APPLICABLE N/A N/A NO DATA
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Concomitant Product(s) Conmed Tradename As Reported Therapy Date(s) Route of Admin
-
Report History
Source HP/Medically
ConfirmedCase Report Type Reporter Occupation Protocol/Study No. Center ID & Other ID Patient ID Initial Safety
Receipt DateEUDRACT No.
Spontaneous N SPONTANEOUS NA 26-JUL-2021ConMed: Unknown Concomitant Product(s)
References
Reference Type Reference ID Reference Notes
NCSP
E2B COMPANY NUMBERSuspect or Conmed Devices
Suspect Devices
Device Type Device
IndicatorModel No. Serial No. NDC No. Date of
ManufactureCatalog No. Device
OperatorDevice
Available for
EvaluationDevice
Evaluated by
ManufacturerSingle Use Evaluation
TypeEvaluation Code
NO DATA NO DATA NO DATA NO DATAType Patient/Parent Indicator Coded Condition Notes
DEATH PATIENT Death
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
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4.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization Required,Life Threatening,Medically SignificantSection Page: 1
Patient Demographic
Sex Age Height (cm) Weight (kg) Race Country Where Event Occured
FEMALE 15 YEARS 188.0 56.0 NO DATA - NO DATA FRANCE
This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-
A 15-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 11Jul2021 07:30 (Lot Number: Unknown) (at the age of 15-year-old) as dose 1, single for COVID-19 immunization. Medical
history included ongoing asthma, ongoing Barlow's syndrome, ongoing Marfan's syndrome. The patient's concomitant medications were not reported. In good health overall, apart from a loss of 10kg over
one year (since entering high school). During the day (11Jul2021), asthenia and isolated arm pain. The next day (12Jul2021), headaches yielding under Doliprane. On 13Jul2021, around 16:30 (last
moment conscious view), her mother drops her off to her father. Father watered the garden and she cleaned the garage to prepare for her birthday party. On 13Jul2021 17:20, her father found her in cardio
respiratory arrest, back to the ground, next to a ladder. No flow was unknown. At 17:30 arrival of firefighters: 2 external electric shocks were given and 1 mg of adrenaline injected. Moderately reactive
pupils. At 17:50 arrival of Specialist mobile emergency unit: asystole (Life-threatening). Two injections of 1 mg of adrenaline, transition to ventricular fibrillation. 2
external electric shock, 2 ampule of Cordarone and one ampule of Calcium Gluconate. Return to regular sinus rythme without disturbance of repolarization and resumption of a pulse. Orotracheal intubation
(probe no 6). New: 1 external electric shock, one ampule of Cordarone and 1 mg of adrenaline. Return of a sinus rhythm but presence of a sub ST in infero lateral. 90/60 mmHg arterial pressure excluding
sedation. Tight areactive bilateral miosis pupils. Ventilated in Ventilator-Associated Conditions but presence of spontaneous ventilation requiring sedation by Hypnovel and Sufentanyl and 10 mg of Nimbex.
Parallel introduction of Noradrenaline 0.8 mg/h. No filling. In total: low flow of 30 minutes. Recovered and transfer to intensive care. Examinations: biology: complete blood count normal, C-reactive protein
1.4. Coroner considered as normal no coronary dissection. Computed tomography scan Computed tomography arterial portography: No aortic dissection or large vsx, no intracranial bleeding, the super
sigmoid aortography does not show any aortic insufficiency. The ascending aorta is moderately dilated. Computerised tomogram head: no bleeding, no traumatic injury. Electrocardiogram: Not very
evocative. Respiratory rate. Maintenance of sedation, temperature control at 36 degrees. Complicated cardiac arrest of
a Takotsubo. Trans-thoracic echocardiography finding a 30% altered left ventricular ejection fraction with kinetic disorders suggestive of Takotsubo (post stress?). More doubt about intra-left ventricular
thrombus. Low left ventricular filling pressures. Integral time speed= 8. Inferior vena cava= 15. 15Jul2021 Appearance in the morning of continual clonies of the multiple sulfatase deficiency, put under
Keppra increased to 750x2. Electroencephalography results pending + Left transcranial doppler more disturbed than the right (Vdiastolic 20 vs 40 on the right), Control contrast enhanced computed
tomography scan superimposable at the level of large vsx, but appearance of parenchymal parenchymal hemispherical hemispherical right upper cerebellar areas of ischemic appearance. 20Jul2021
pathological awakening, inhalation lung disease, myocarditis assessment in progress (negative). 23Jul2021 no sign of wakign up flat electroencephalogram alternating with a few waves of intermittent
activity. Computered tomography scan stability of ischemic lesions appearance of cerebral edema compatible with anoxo-ischemic lesions, put under Mannitol. Cardio: cardiac magnetic resonance imaging
in favor of a takotsubo, myocarditis unl kely, infective and immunological workup negative. 27Jul2021 Pathological electroencephalogramEvent Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
Cardiac arrest/asystole Cardiac arrest Cardiac arrest 13-JUL-2021 SERIOUS FATAL NO DATA NO DATA
Anoxia cerebral Anoxia cerebral Brain hypoxia SERIOUS FATAL NO DATA NO DATA
vegetative coma Coma Coma 30-JUL-2021 SERIOUS UNKNOWN NO DATA NO DATA
retro-rolandic aspect of brain
deathBrain death Brain death 30-JUL-2021 SERIOUS UNKNOWN NO DATA NO DATA
asthenia Asthenia Asthenia 11-JUL-2021 NONSERIOUS UNKNOWN NO DATA NO DATA
arm pain Pain in arm Pain in extremity 11-JUL-2021 NONSERIOUS UNKNOWN NO DATA NO DATA
headaches Headache Headache 12-JUL-2021 NONSERIOUS UNKNOWN NO DATA NO DATA
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, Keppra introduction. Computered tomography scan increase in cerebral edema reaching almost the entire sustentorial stage, sudden episodes of desaturation. The COVID serology returns positive (Ig G
antiS and antiN and IgM), re-reading of the entry serology concluded with a Covid infection starting at the same time as the anti-covid vaccination. 30Jul2021 retro-rolandic aspect of brain death, vegetative
coma. Decision to limit therapy. Complete file no further information. The patient died on 07Aug2021. An autopsy was not performed. Cause of Death: Anoxia cerebral and Cardiac arrest while outcome
of the other events was unknown.
No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lab Data: Present Lab Data
Lab Narrative:
Suspect Product(s) Therapy Information
Suspect Product(s) Unit Dose Total Daily Dose Regimen Dose Route of Admin Therapy Date(s) Therapy Duration Anatomical
LocationVaccination
Dose No.Lot No. Batch No.
BNT162B2 INTRAMUSCUL
AR11-JUL-2021 -
11-JUL-2021NO DATA 1 UnknownTest Name Normal Value Test Date Test Result Lab Comments
Blood pressure increased 13-JUL-2021 * | 90/60 | mmHg
Body temperature decreased 13-JUL-2021 * | 36 | Centigrade
Computerised tomogram 13-JUL-2021 * | The ascending aorta is
moderately dilated |No aortic dissection or large vsx, no intracranial bleeding, the super sigmoid
aortography does not show any aortic insufficiency
Computerised tomogram 15-JUL-2021 * | appearance of parenchymal
parenchymal hemispherica |appearance of parenchymal parenchymal hemispherical hemispherical right
upper cerebellar areas of ischemic appearance
Computerised tomogram head 13-JUL-2021 * | no bleeding | no traumatic injury
Computerised tomogram head 23-JUL-2021 * | stability of ischemic | lesions appearance of cerebral edema compatible with anoxo-ischemic lesions,
put under Mannitol
Computerised tomogram head 27-JUL-2021 * | increase in cerebral edema | reaching almost the entire sustentorial stage, sudden episodes of desaturation.
C-reactive protein 13-JUL-2021 * | 1.4 |
Echocardiogram * | finding a 30% | altered left ventricular ejection fraction with kinetic disorders suggestive of
Takotsubo
Electrocardiogram 13-JUL-2021 * | Not very evocative | Respiratory rate
Electroencephalogram 23-JUL-2021 * | flat | with a few waves of intermittent activity
Electroencephalogram 27-JUL-2021 * | Pathological | Keppra introduction
Full blood count 13-JUL-2021 * | normal |
Magnetic resonance imaging 13-JUL-2021 * | cardio | in favor of a takotsubo
SARS-CoV-2 ant body test positive 13-JUL-2021 POSITIVE | positive | (Ig G antiS and antiN and IgM), re-reading of the entry serology concluded with a
Covid infection starting at the same time as the anti-covid vaccination
Ultrasound Doppler 13-JUL-2021 * | left more disturbed | than the right (Vdiastolic 20 vs 40 on the right)
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Patient Medical History
Concomitant Product(s) Conmed Tradename As Reported Therapy Date(s) Route of Admin
-ConMed: Unknown Concomitant Product(s)Product(s) and Event(s) Information
Suspect Product(s) Event(s) CDS Latency Group Rechallenge Causality per Reporter Causality per Company
BNT162B2 Cardiac arrest N Post Therapy N/A N/A N/A
BNT162B2 Brain hypoxia N Unknown N/A N/A N/A
BNT162B2 Coma N Post Therapy N/A N/A N/A
BNT162B2 Brain death N Post Therapy N/A N/A N/A
BNT162B2 Asthenia Y Pre-Therapy N/A N/A N/A
BNT162B2 Pain in extremity Y Pre-Therapy N/A N/A N/A
BNT162B2 Headache Y Post Therapy N/A N/A N/A
Cause of Death/Autopsy
Other Death Information:Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
PATIENT Asthma ONGOING
PATIENT Marfan's syndrome ONGOING
PATIENT Mitral valve prolapse ONGOING
Type Patient/Parent Indicator Coded Condition Notes
DEATH PATIENT Brain hypoxia
DEATH PATIENT Cardiac arrestSuspect Product(s) Information
Suspect Product(s) Indication(s) Form of Admin First Total Daily Dose Action Taken Dechallenge Rechallenge Interacting Drug
BNT162B2 COVID-19 immunisation SOLUTION FOR
INJECTIONNOT APPLICABLE N/A N/A NO DATA
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Report History
Source HP/Medically
ConfirmedCase Report Type Reporter Occupation Protocol/Study No. Center ID & Other ID Patient ID Initial Safety
Receipt DateEUDRACT No.
Spontaneous Y SPONTANEOUS PHYSICIAN 16-AUG-2021
References
Reference Type Reference ID Reference Notes
E2B AUTHORITY NUMBER
E2B REPORT DUPLICATESuspect or Conmed Devices
Suspect Devices
Device Type Device
IndicatorModel No. Serial No. NDC No. Date of
ManufactureCatalog No. Device
OperatorDevice
Available for
EvaluationDevice
Evaluated by
ManufacturerSingle Use Evaluation
TypeEvaluation Code
NO DATA NO DATA NO DATA NO DATA
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Pfizer, Confidential
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5.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization Required,Life Threatening,Medically SignificantSection Page: 1
Patient Demographic
Sex Age Height (cm) Weight (kg) Race Country Where Event Occured
MALE 13 YEARS 140.0 32.0 NO DATA - NO DATA GERMANY
Event Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
Disseminated intravascular
coagulationDisseminated intravascular
coagulationDisseminated intravascular
coagulation13-AUG-2021 SERIOUS FATAL NO DATA NO DATA
Lung hemorrhage Lung hemorrhage Pulmonary haemorrhage 13-AUG-2021 SERIOUS FATAL NO DATA NO DATA
Pyrexia Pyrexia Pyrexia 13-AUG-2021 SERIOUS FATAL NO DATA NO DATA
Multiorgan failure Multiorgan failure Multiple organ dysfunction
syndrome13-AUG-2021 SERIOUS FATAL NO DATA NO DATA
Septic shock Septic shock Septic shock 13-AUG-2021 SERIOUS FATAL NO DATA NO DATA
haemorrhagic hemithorax Thoracic haemorrhage Thoracic haemorrhage ---AUG-2021 SERIOUS FATAL NO DATA NO DATA
massive liver failure Liver failure Hepatic failure ---AUG-2021 SERIOUS UNKNOWN NO DATA NO DATA
creatinine elevated Blood creatinine increased Blood creatinine increased ---AUG-2021 SERIOUS UNKNOWN NO DATA NO DATA
bleeding in bladder and
abdomenIntra-abdominal bleeding Intra-abdominal haemorrhage ---AUG-2021 SERIOUS UNKNOWN NO DATA NO DATA
bleeding in bladder and
abdomenUrinary bladder bleeding Urinary bladder haemorrhage ---AUG-2021 SERIOUS UNKNOWN NO DATA NO DATA
anuria Anuria Anuria ---AUG-2021 SERIOUS UNKNOWN NO DATA NO DATA
respiratory insufficient Respiratory failure Respiratory failure 13-AUG-2021 SERIOUS UNKNOWN NO DATA NO DATA
epilepticus Status epilepticus Status epilepticus SERIOUS UNKNOWN NO DATA NO DATA
At admission the platelets
were 150.000/ml and
declined to 53.000/mlPlatelets decreased Platelet count decreased 13-AUG-2021 SERIOUS UNKNOWN NO DATA NO DATA
Inappropriate schedule of
vaccine administeredInappropriate schedule of
vaccine administeredInappropriate schedule of product
administration11-AUG-2021 NONSERIOUS UNKNOWN NO DATA NO DATA
Pfizer, Confidential
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FDA-CBER-2022-5812-0235508
Page 14 of 36
As of Date: 01-OCT-2021
5.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization Required,Life Threatening,Medically SignificantSection Page: 2
This is a spontaneous report from a non-contactable other HCP downloaded from the European Medicines Agency (EMA) EudraVigilance- . A 13-year-old male patient received
second dose of bnt162b2 (COMIRNATY, Solution for Injection, Lot Number: 10020A) via an unknown route of administration on 11Aug2021 (at the age of 13-year-old) as dose 2, 0.3 ml single for COVID-19
immunization. The patient's medical history included extremely preterm (less than 28 weeks), Hypox-ic-ischaemic encephalopathy, posthaemorrhagic hydrocephalus, symptomatic epilepsy, dysphagia,
respiratory insufficiency, reflux oesophagitis on an unspecified date. The patient born at gestation 24+4 with Grad iV (right) and Grad II (left) intra cranial heamorrage. Further complication post-natal were
broncho pulmonal dysplasia including implementing a liquor shunt. Further complication was a treatment resistant epilepsy despite long term treatment with Valproate. Regular control of liver function ware
performed without major deteriation (last control 2 weeks prior to death). At the age of ten year the patient received a repair of the gastroesophageal reflux and which appeared to be solved since. In
addition, the patient received a major hip operation for hipdyplasia, exact timepoint of the surgery is following. The patient previously
received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for Injection) dose 1, Batch/Lot number unknown) for COVID-19 immunisation on 16Jun2021. Concomitant medications were not
reported. The patient underwent lab tests and procedures which included platelets min 3410x 31uml, Quick <10, INR>4.9, pTT >180 sec, proBNP 24937 pg/ml, Trop T 1580 pg/ml on an unknown date. The
patient experienced multiorgan failure, lung hemorrhage, disseminated intravascular coagulation, pyrexia and septic shock on 13Aug2021. The patient died on 14Aug2021. Seriousness for the events was
reported as death, hospitalization and life threatening. At admission on the 13Aug2021 the patient was respiratory insufficient and needed intubation and ventilation. At admission the platelets were
150.000/ml and declined to 53.000/ml after app. 12h treatment. In addition, the coagulation system deteriorated and finally the patient appeared with a haemorrhagic hemithorax which eventually lead to
death of the patient. Status epilepticus on admission. So far about 1-2 seizures per month, seizures also always during fever. Therapy with IVIG and cortisone. In the course of the disease massive liver
failure, anuria, creatinine elevated, bleeding in bladder and abdomen. The Autopsy was not performed. The full Hospital letter with additional detai
ls will follow. Outcome of multiorgan failure, lung hemorrhage, disseminated intravascular coagulation, pyrexia and septic shock, Thoracic haemorrhage was fatal, outcome of other events was unknown.
Relatedness of drug to reaction(s)/event (s) Source of assessment PEI. Result of Assessment D. Unclassifiable.
Sender Comment: Platelets min 3410^31uml, Quick <10, INR>4,9; pTT >180 sec, proBNP 24937 pg/ml, Trop T 1580 pg/ml. Inflammatory parameters not elevated. CSF examination with shunt in place
blande, no signs of meningitis. Blood culture results not yet available. Status epilepticus on admission. So far about 1-2 seizures per month, seizures also always during fever. Therapy with IVIG and
cortisone.
No follow-up attempts poss ble. No further information expected.
Follow-up (23Aug2021 and 24Aug2021): New information received from a non-contactable other HCP downloaded from the European Medicines Agency (EMA) EudraVigilance-
included: new events (liver failure, anuria, creatinine elevated, bleeding in bladder and abdomen, haemorrhagic hemithorax, respiratory insufficient, the platelets were 150.000/ml and declined to 53.000/ml,
Status epilepticus), lab tests, medical history, Autopsy (not performed), death cause (haemorrhagic hemithorax).
Follow-up (30Aug2021): New information r
eceived from product quality complaints department included: no investigation could be performed due to batch/lot no. provided within source doc was not found to be valid.
No follow-up attempts poss ble. No further information expected.
Lab Data: Present Lab Data
Lab Narrative:
Test Name Normal Value Test Date Test Result Lab Comments
Activated partial thromboplastin time * | >180 | seconds
Amniotic fluid index * | shunt in place blande, no signs
of meningitis |
Blood culture * | Not yet avalaiable |
International normalised ratio * | 4.9 |
Liver function test * | with out major deteriation |
N-terminal prohormone brain natriuretic
peptide* | 24937 | pg/mL
Pfizer, Confidential
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Page 15 of 36
As of Date: 01-OCT-2021
5.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization Required,Life Threatening,Medically SignificantSection Page: 3
Suspect Product(s) Therapy Information
Suspect Product(s) Unit Dose Total Daily Dose Regimen Dose Route of Admin Therapy Date(s) Therapy Duration Anatomical
LocationVaccination
Dose No.Lot No. Batch No.
BNT162B2 .3 mL .3 mL NO DATA 11-AUG-2021 -
11-AUG-20211 DAY(S) NO DATA 2 10020ATest Name Normal Value Test Date Test Result Lab Comments
Platelet count 13-AUG-2021 * | 150.000 | /ml
Platelet count 13-AUG-2021 * | 53.000 | /m
Platelet count * | 3410^31 | min 3410x31uml
Prothrombin time * | <10 |
Troponin T * | 1580 | pg/mL
Suspect Product(s) Information
Suspect Product(s) Indication(s) Form of Admin First Total Daily Dose Action Taken Dechallenge Rechallenge Interacting Drug
BNT162B2 COVID-19 immunisation SOLUTION FOR
INJECTION.3 mL NOT APPLICABLE N/A N/A NO DATA
Pfizer, Confidential
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FDA-CBER-2022-5812-0235510
Page 16 of 36
As of Date: 01-OCT-2021
5.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization Required,Life Threatening,Medically SignificantSection Page: 4
Patient Medical HistoryProduct(s) and Event(s) Information
Suspect Product(s) Event(s) CDS Latency Group Rechallenge Causality per Reporter Causality per Company
BNT162B2 Disseminated intravascular
coagulationN Post Therapy N/A N/A N/A
BNT162B2 Pulmonary haemorrhage N Post Therapy N/A N/A N/A
BNT162B2 Pyrexia N Post Therapy N/A N/A N/A
BNT162B2 Multiple organ dysfunction syndrome N Post Therapy N/A N/A N/A
BNT162B2 Septic shock N Post Therapy N/A N/A N/A
BNT162B2 Thoracic haemorrhage N Unknown N/A N/A N/A
BNT162B2 Hepatic failure N Unknown N/A N/A N/A
BNT162B2 Blood creatinine increased N Unknown N/A N/A N/A
BNT162B2 Intra-abdominal haemorrhage N Unknown N/A N/A N/A
BNT162B2 Urinary bladder haemorrhage N Unknown N/A N/A N/A
BNT162B2 Anuria N Unknown N/A N/A N/A
BNT162B2 Respiratory failure N Post Therapy N/A N/A N/A
BNT162B2 Status epilepticus N Unknown N/A N/A N/A
BNT162B2 Platelet count decreased N Post Therapy N/A N/A N/A
BNT162B2 Inappropriate schedule of product
administrationY <= 1 day N/A N/A N/A
Pfizer, Confidential
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FDA-CBER-2022-5812-0235511
Page 17 of 36
As of Date: 01-OCT-2021
5.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization Required,Life Threatening,Medically SignificantSection Page: 5
Concomitant Product(s) Conmed Tradename As Reported Therapy Date(s) Route of Admin
-ConMed: Unknown Concomitant Product(s)Cause of Death/Autopsy
Other Death Information:
Suspect or Conmed Devices
Suspect Devices
Device Type Device
IndicatorModel No. Serial No. NDC No. Date of
ManufactureCatalog No. Device
OperatorDevice
Available for
EvaluationDevice
Evaluated by
ManufacturerSingle Use Evaluation
TypeEvaluation Code
NO DATA NO DATA NO DATA NO DATAPatient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
PATIENT Bronchopulmonary dysplasia NO DATA
PATIENT Dysphagia
PATIENT Epilepsy
PATIENT Gastrooesophageal reflux
disease
PATIENT Haemorrhage intracranial NO DATA born at gestation 24+4 with Grad iV (right) and Grad II (left) intra cranial heamorrage
PATIENT Hip deformity NO DATA
PATIENT Hip surgery NO DATA
PATIENT Hypoxic-ischaemic
encephalopathy
PATIENT Posthaemorrhagic
hydrocephalus
PATIENT Premature baby
PATIENT Respiratory failure
Type Patient/Parent Indicator Coded Condition Notes
DEATH PATIENT Disseminated intravascular coagulation
DEATH PATIENT Multiple organ dysfunction syndrome
DEATH PATIENT Pulmonary haemorrhage
DEATH PATIENT Pyrexia
DEATH PATIENT Septic shock
DEATH PATIENT Thoracic haemorrhage
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FDA-CBER-2022-5812-0235512
Page 18 of 36
As of Date: 01-OCT-2021
5.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization Required,Life Threatening,Medically SignificantSection Page: 6
Report History
Source HP/Medically
ConfirmedCase Report Type Reporter Occupation Protocol/Study No. Center ID & Other ID Patient ID Initial Safety
Receipt DateEUDRACT No.
Spontaneous Y SPONTANEOUS OTHER HEALTH
PROFESSIONAL19-AUG-2021
References
Reference Type Reference ID Reference Notes
E2B AUTHORITY NUMBER DE-PEI-202100168078 PEI
E2B REPORT DUPLICATE DE-PEI-202100168078 PEI
PRODUCT COMPLAINT NO. 6284782 CITI PR ID
PRODUCT COMPLAINT NO. INT-183670 INT ID
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
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Page 19 of 36
As of Date: 01-OCT-2021
6.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 1
Patient Demographic
Sex Age Height (cm) Weight (kg) Race Country Where Event Occured
MALE 15 YEARS NO DATA - NO DATA AUSTRIA
This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB Regulatory Authority number . A
15-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 01Jul2021 (Batch/Lot Number: FD6840) as dose 1, single for covid-19 immunisation. The patient medical history and
concomitant medications were none. Patient was found dead in bed on the morning of 20Jul2021. There were no known previous illnesses. The forensic autopsy could not find a cause of death until today.
Also reported on 20Jul2021 the patient experienced death/NOS death. An autopsy was performed, and results were not provided.
Sender Comment: BASGAGES-comment: Follow-up information has been requested. Comirnaty/ Death NOS/ Health Care Professional/ WHO Assessment/ Possible.
No follow-up attempts are possible. No further information is expected.Event Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
Death/NOS death Unknown cause of death Death 20-JUL-2021 SERIOUS FATAL NO DATA NO DATA
Lab Data: Unknown Lab Data
Lab Narrative:
Suspect Product(s) Therapy Information
Suspect Product(s) Unit Dose Total Daily Dose Regimen Dose Route of Admin Therapy Date(s) Therapy Duration Anatomical
LocationVaccination
Dose No.Lot No. Batch No.
BNT162B2 INTRAMUSCUL
AR01-JUL-2021 -
01-JUL-20211 DAY(S) NO DATA 1 FD6840 FD6840
Patient Medical HistoryTest Name Normal Value Test Date Test Result Lab Comments
Product(s) and Event(s) Information
Suspect Product(s) Event(s) CDS Latency Group Rechallenge Causality per Reporter Causality per Company
BNT162B2 Death N Post Therapy N/A N/A N/A
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing NotesSuspect Product(s) Information
Suspect Product(s) Indication(s) Form of Admin First Total Daily Dose Action Taken Dechallenge Rechallenge Interacting Drug
BNT162B2 COVID-19 immunisation SOLUTION FOR
INJECTIONNOT APPLICABLE N/A N/A NO DATA
Pfizer, Confidential
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As of Date: 01-OCT-2021
6.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 2
Concomitant Product(s) Conmed Tradename As Reported Therapy Date(s) Route of Admin
-
Report History
Source HP/Medically
ConfirmedCase Report Type Reporter Occupation Protocol/Study No. Center ID & Other ID Patient ID Initial Safety
Receipt DateEUDRACT No.
Spontaneous Y SPONTANEOUS PHYSICIAN 23-AUG-2021ConMed: None Concomitant Product(s)
References
Reference Type Reference ID Reference Notes
E2B AUTHORITY NUMBER
E2B REPORT DUPLICATE
PRODUCT COMPLAINT NO.
PRODUCT COMPLAINT NO.Cause of Death/Autopsy
Other Death Information:
Suspect or Conmed Devices
Suspect Devices
Device Type Device
IndicatorModel No. Serial No. NDC No. Date of
ManufactureCatalog No. Device
OperatorDevice
Available for
EvaluationDevice
Evaluated by
ManufacturerSingle Use Evaluation
TypeEvaluation Code
NO DATA NO DATA NO DATA NO DATAType Patient/Parent Indicator Coded Condition Notes
DEATH PATIENT Death
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
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7.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Medically SignificantSection Page: 1
Patient Demographic
Sex Age Height (cm) Weight (kg) Race Country Where Event Occured
MALE 15 YEARS ASIAN - NO DATA JORDAN
This is a spontaneous report from a contactable consumer (parent, father of patient). A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via
unspecified route of administration, administered in the left arm on 09Aug2021 at 09:00 am (batch/lot number FF2154 and expiry date unknown) at 15 years of age as dose 1, single for covid-19
immunisation. The patient's medical history and concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient prior to
vaccination, was not diagnosed with COVID-19. On 13Aug2021 at 04:30, the patient passed away without any history of illness. On 05Sep2021, the reporter informed that it was reported that the reason for
death on the report was respiratory and circulatory failure (13Aug2021 at 04:30). The event resulted in emergency room/department or urgent care. The patient since the vaccination, had not tested for
COVID-19. The patient had no treatment received. The outcome of the events was fatal. The reporter informed that it was not reported if an autopsy was performed. The patient was scheduled the second
dose on 31Aug21. On 09Sep2021, the investigational results for the product description: compound bnt 162 covid-19 vaccine suspension for intramu
scular 2ml multiple dose vial x 1, lot # and expiration date: FF2154, Oct2021 with description of complaint: product quality investigation request: request for investigations for vaccine case per medical
judgement for fatal event for lot number: FF2154 reasonably suggest device malfunction: no; severity of harm was not applicable, site sample status was not received. The summary of investigations was no
related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. The PGS Puurs conclude that the reported defect is not representative
of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. No corrective or preventive actions were identified as all reviewed
records for the involved batch indicated that the batch met the established requirements at time of release. Final confirmation status: not confirmed; root cause: non-assignable (complaint not confirmed).
Follow-up (05Sep2021): New information received from the patient's father included: death certificate and the initial report for autopsy (final report not yet issued) were shared. The batch number was
FF2154. The reason for death on the report was respiratory and circulatory failure added.
Follow-
up (09Sep2021): New information received from Pfizer Product Quality Group included: suspect drug data (expiry date), investigational results.
No follow-up attempts are needed. No further information is expected.Event Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
respiratory and circulatory
failureRespiratory failure Respiratory failure 13-AUG-2021 SERIOUS FATAL NO DATA NO DATA
respiratory and circulatory
failureCirculatory failure Circulatory collapse 13-AUG-2021 SERIOUS FATAL NO DATA NO DATA
Lab Data: Unknown Lab Data
Lab Narrative:
Suspect Product(s) Therapy Information
Suspect Product(s) Unit Dose Total Daily Dose Regimen Dose Route of Admin Therapy Date(s) Therapy Duration Anatomical
LocationVaccination
Dose No.Lot No. Batch No.
BNT162B2 NO DATA 09-AUG-2021 -
09-AUG-2021ARM LEFT 1 FF2154Test Name Normal Value Test Date Test Result Lab Comments
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As of Date: 01-OCT-2021
7.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Medically SignificantSection Page: 2
Patient Medical History
Concomitant Product(s) Conmed Tradename As Reported Therapy Date(s) Route of Admin
-
Report History
Source HP/Medically
ConfirmedCase Report Type Reporter Occupation Protocol/Study No. Center ID & Other ID Patient ID Initial Safety
Receipt DateEUDRACT No.
Spontaneous N SPONTANEOUS NA 29-AUG-2021ConMed: Unknown Concomitant Product(s)Product(s) and Event(s) Information
Suspect Product(s) Event(s) CDS Latency Group Rechallenge Causality per Reporter Causality per Company
BNT162B2 Respiratory failure N Post Therapy N/A N/A N/A
BNT162B2 Circulatory collapse N Post Therapy N/A N/A N/A
Cause of Death/Autopsy
Other Death Information:
Suspect or Conmed Devices
Suspect Devices
Device Type Device
IndicatorModel No. Serial No. NDC No. Date of
ManufactureCatalog No. Device
OperatorDevice
Available for
EvaluationDevice
Evaluated by
ManufacturerSingle Use Evaluation
TypeEvaluation Code
NO DATA NO DATA NO DATA NO DATAPatient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Type Patient/Parent Indicator Coded Condition Notes
DEATH PATIENT Circulatory collapse
DEATH PATIENT Respiratory failureSuspect Product(s) Information
Suspect Product(s) Indication(s) Form of Admin First Total Daily Dose Action Taken Dechallenge Rechallenge Interacting Drug
BNT162B2 COVID-19 immunisation SOLUTION FOR
INJECTIONNOT APPLICABLE N/A N/A NO DATA
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As of Date: 01-OCT-2021
7.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Medically SignificantSection Page: 3
References
Reference Type Reference ID Reference Notes
COVAES REFERENCE NO.
E2B COMPANY NUMBER
PRODUCT COMPLAINT NO.
PRODUCT COMPLAINT NO.
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
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As of Date: 01-OCT-2021
8.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 1
Patient Demographic
Sex Age Height (cm) Weight (kg) Race Country Where Event Occured
MALE 15 YEARS NO DATA - NO DATA SPAIN
This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance- . A 15-year-old male patient received unknown
dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: unknown), via an unspecified route on 02Aug2021 as a single do tion. The patient has no prior history medical
history. The patient concomitant medications were not reported. On 09Aug2021 at 09:02, with no prior pathology family found the patient without a pulse. Upon arrival of the emergency team, he has no
pulse. Some stiffness of limbs. There is no prior Cardiorespiratory arrest. Time of evolution of Cardiorespiratory arrest is unknown. Judicial protocol is activated. Sudden death unexplained on 09Aug2021
00:00. It was unknown if autopsy has been done. The outcome of the events was fatal.
No follow-up attempts are possible, information on batch number cannot be obtained.Event Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
Sudden death unexplained Sudden death unexplained Sudden death 09-AUG-2021 SERIOUS FATAL NO DATA NO DATA
Cardiorespiratory arrest Cardio-respiratory arrest Cardio-respiratory arrest 09-AUG-2021 SERIOUS FATAL NO DATA NO DATA
Lab Data: Unknown Lab Data
Lab Narrative:
Suspect Product(s) Therapy Information
Suspect Product(s) Unit Dose Total Daily Dose Regimen Dose Route of Admin Therapy Date(s) Therapy Duration Anatomical
LocationVaccination
Dose No.Lot No. Batch No.
BNT162B2 NO DATA 02-AUG-2021 -
02-AUG-20211 DAY(S) NO DATA 1 UnknownTest Name Normal Value Test Date Test Result Lab Comments
Product(s) and Event(s) Information
Suspect Product(s) Event(s) CDS Latency Group Rechallenge Causality per Reporter Causality per Company
BNT162B2 Sudden death N Post Therapy N/A N/A N/A
BNT162B2 Cardio-respiratory arrest N Post Therapy N/A N/A N/ASuspect Product(s) Information
Suspect Product(s) Indication(s) Form of Admin First Total Daily Dose Action Taken Dechallenge Rechallenge Interacting Drug
BNT162B2 COVID-19 immunisation SOLUTION FOR
INJECTIONNOT APPLICABLE N/A N/A NO DATA
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As of Date: 01-OCT-2021
8.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 2
Patient Medical History
Concomitant Product(s) Conmed Tradename As Reported Therapy Date(s) Route of Admin
-
Report History
Source HP/Medically
ConfirmedCase Report Type Reporter Occupation Protocol/Study No. Center ID & Other ID Patient ID Initial Safety
Receipt DateEUDRACT No.
Spontaneous Y SPONTANEOUS PHYSICIAN 01-SEP-2021ConMed: Unknown Concomitant Product(s)
References
Reference Type Reference ID Reference Notes
E2B AUTHORITY NUMBER
E2B REPORT DUPLICATECause of Death/Autopsy
Other Death Information:
Suspect or Conmed Devices
Suspect Devices
Device Type Device
IndicatorModel No. Serial No. NDC No. Date of
ManufactureCatalog No. Device
OperatorDevice
Available for
EvaluationDevice
Evaluated by
ManufacturerSingle Use Evaluation
TypeEvaluation Code
NO DATA NO DATA NO DATA NO DATAPatient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Type Patient/Parent Indicator Coded Condition Notes
DEATH PATIENT Cardio-respiratory arrest
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
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9.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 1
Patient Demographic
Sex Age Height (cm) Weight (kg) Race Country Where Event Occured
MALE 14 YEARS NO DATA - NO DATA SPAIN
This is a spontaneous report from a Pfizer-sponsored program "Pfizer Colleagues" Immediate Family and Household Vaccination Program - Spain, from a contactable consumer (patent's uncle) through the
Pfizer company doctor.
A 14-year-old male patient received bnt162b2 (COMIRNATY), 1st dose on 06Jul2021 (Lot Number: EX0893) and 2nd dose on 27Jul2021 (Lot Number: EW2246, both via an unspecified route of
administration as single dose for COVID-19 immunization. Medical history none. Concomitant medications were not reported. The patient experienced pulmonary edema (death) on 03Sep2021. The patient
died on 03Sep2021. The autopsy revealed that the cause of death was pulmonary edema.Event Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
pulmonary edema Pulmonary edema Pulmonary oedema 03-SEP-2021 SERIOUS FATAL NO DATA NO DATA
Lab Data: Unknown Lab Data
Lab Narrative:
Suspect Product(s) Therapy Information
Suspect Product(s) Unit Dose Total Daily Dose Regimen Dose Route of Admin Therapy Date(s) Therapy Duration Anatomical
LocationVaccination
Dose No.Lot No. Batch No.
BNT162B2 NO DATA 06-JUL-2021 -
06-JUL-20211 DAY(S) NO DATA 1 EX0893
BNT162B2 NO DATA 27-JUL-2021 -
27-JUL-20211 DAY(S) NO DATA 2 EW2246
Patient Medical HistoryTest Name Normal Value Test Date Test Result Lab Comments
Product(s) and Event(s) Information
Suspect Product(s) Event(s) CDS Latency Group Rechallenge Causality per Reporter Causality per Company
BNT162B2 Pulmonary oedema N Post Therapy N/A N/A N/A
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing NotesSuspect Product(s) Information
Suspect Product(s) Indication(s) Form of Admin First Total Daily Dose Action Taken Dechallenge Rechallenge Interacting Drug
BNT162B2 COVID-19 immunisation SOLUTION FOR
INJECTIONNOT APPLICABLE N/A N/A NO DATA
Pfizer, Confidential
090177e1997500c0\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235521
Page 27 of 36
As of Date: 01-OCT-2021
9.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 2
Concomitant Product(s) Conmed Tradename As Reported Therapy Date(s) Route of Admin
-
Report History
Source HP/Medically
ConfirmedCase Report Type Reporter Occupation Protocol/Study No. Center ID & Other ID Patient ID Initial Safety
Receipt DateEUDRACT No.
Spontaneous N SPONTANEOUS NA 07-SEP-2021ConMed: Unknown Concomitant Product(s)
References
Reference Type Reference ID Reference Notes
NCSP
E2B COMPANY NUMBER
PRODUCT COMPLAINT NO.
PRODUCT COMPLAINT NO.Cause of Death/Autopsy
Other Death Information:
Suspect or Conmed Devices
Suspect Devices
Device Type Device
IndicatorModel No. Serial No. NDC No. Date of
ManufactureCatalog No. Device
OperatorDevice
Available for
EvaluationDevice
Evaluated by
ManufacturerSingle Use Evaluation
TypeEvaluation Code
NO DATA NO DATA NO DATA NO DATAType Patient/Parent Indicator Coded Condition Notes
DEATH PATIENT Pulmonary oedema
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Pfizer, Confidential
090177e1997500c0\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235522
Page 28 of 36
As of Date: 01-OCT-2021
10.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Medically SignificantSection Page: 1
Patient Demographic
Sex Age Height (cm) Weight (kg) Race Country Where Event Occured
MALE 15 YEARS NO DATA - NO DATA GREECE
This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number
A 15-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 10Sep2021 (Batch/Lot Number: FG4442) as single dose for covid-19 immunisation. The patient medical history and
concomitant medications were not reported. The patient experienced sudden death on 13Sep2021. The patient died on 13Sep2021. An autopsy was performed and results were not provided.
No follow-up attempts poss ble. No further information expected.Event Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
Sudden death Sudden death Sudden death 13-SEP-2021 SERIOUS FATAL NO DATA NO DATA
Lab Data: Unknown Lab Data
Lab Narrative:
Suspect Product(s) Therapy Information
Suspect Product(s) Unit Dose Total Daily Dose Regimen Dose Route of Admin Therapy Date(s) Therapy Duration Anatomical
LocationVaccination
Dose No.Lot No. Batch No.
BNT162B2 INTRAMUSCUL
AR10-SEP-2021 -
10-SEP-20211 DAY(S) NO DATA 1 FG4442
Patient Medical HistoryTest Name Normal Value Test Date Test Result Lab Comments
Product(s) and Event(s) Information
Suspect Product(s) Event(s) CDS Latency Group Rechallenge Causality per Reporter Causality per Company
BNT162B2 Sudden death N Post Therapy N/A N/A N/A
Cause of Death/Autopsy
Other Death Information:Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing NotesSuspect Product(s) Information
Suspect Product(s) Indication(s) Form of Admin First Total Daily Dose Action Taken Dechallenge Rechallenge Interacting Drug
BNT162B2 COVID-19 immunisation SOLUTION FOR
INJECTIONNOT APPLICABLE N/A N/A NO DATA
Pfizer, Confidential
090177e1997500c0\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235523
Page 29 of 36
As of Date: 01-OCT-2021
10.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Medically SignificantSection Page: 2
Concomitant Product(s) Conmed Tradename As Reported Therapy Date(s) Route of Admin
-
Report History
Source HP/Medically
ConfirmedCase Report Type Reporter Occupation Protocol/Study No. Center ID & Other ID Patient ID Initial Safety
Receipt DateEUDRACT No.
Spontaneous Y SPONTANEOUS PHYSICIAN 20-SEP-2021ConMed: Unknown Concomitant Product(s)
References
Reference Type Reference ID Reference Notes
E2B AUTHORITY NUMBER
E2B REPORT DUPLICATE
PRODUCT COMPLAINT NO.
PRODUCT COMPLAINT NO.Suspect or Conmed Devices
Suspect Devices
Device Type Device
IndicatorModel No. Serial No. NDC No. Date of
ManufactureCatalog No. Device
OperatorDevice
Available for
EvaluationDevice
Evaluated by
ManufacturerSingle Use Evaluation
TypeEvaluation Code
NO DATA NO DATA NO DATA NO DATAType Patient/Parent Indicator Coded Condition Notes
DEATH PATIENT Sudden death
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Pfizer, Confidential
090177e1997500c0\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235524
Page 30 of 36
As of Date: 01-OCT-2021
11.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization RequiredSection Page: 1
Patient Demographic
Sex Age Height (cm) Weight (kg) Race Country Where Event Occured
MALE 12 YEARS 145.0 39.0 NO DATA - NO DATA GERMANY
This is a spontaneous report from a consumer or other non hcp downloaded from the European Medicines Agency (EMA) EudraVigilance- and Sender's (Case) Safety
Report Unique Identifier
Verbatim: This spontaneous report was received from a Consumer or other non health professional from Germany and concerns a patient (Male), age: 12 Year (born: unknown date). This report is serious -
hospitalization. The patient's medical history and concurrent conditions included: no relevant medical history reported. The patient's weight was 39 kg, and height was 145 cm.
The patient was treated with Comirnaty (mRNA TOZINAMERAN), unknown dosage. Concomitant medications were: no concomitant medication reported. On 20Aug2021 the patient experienced Dyspnoea,
Unknown cause of death. The patient's outcome was: not recovered/not resolved for Dyspnoea, fatal for Unknown cause of death.
Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no
Information on risk factors or previous illnesses: none / malaise, fever, palpitations and shortness of breath. Up to cardiac arrest.
Result of assessment for events /PEI / : D. Unclassifiable
No follow-up attempts poss ble. Lot number cannot be obtained. No further information expected.Event Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
Unknown cause of death Unknown cause of death Death 20-AUG-2021 SERIOUS FATAL NO DATA NO DATA
Pyrexia Pyrexia Pyrexia 20-AUG-2021 SERIOUS NOT
RECOVERED/NOT
RESOLVEDNO DATA NO DATA
Unwell Unwell Malaise 20-AUG-2021 SERIOUS NOT
RECOVERED/NOT
RESOLVEDNO DATA NO DATA
Dyspnoea Dyspnoea Dyspnoea 20-AUG-2021 SERIOUS NOT
RECOVERED/NOT
RESOLVEDNO DATA NO DATA
Lab Data: Unknown Lab Data
Lab Narrative:
Suspect Product(s) Therapy Information
Suspect Product(s) Unit Dose Total Daily Dose Regimen Dose Route of Admin Therapy Date(s) Therapy Duration Anatomical
LocationVaccination
Dose No.Lot No. Batch No.
BNT162B2 NO DATA 19-AUG-2021 -
19-AUG-20211 DAY(S) NO DATA UnknownTest Name Normal Value Test Date Test Result Lab Comments
Pfizer, Confidential
090177e1997500c0\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235525
Page 31 of 36
As of Date: 01-OCT-2021
11.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization RequiredSection Page: 2
Patient Medical History
Concomitant Product(s) Conmed Tradename As Reported Therapy Date(s) Route of Admin
-
Report History
Source HP/Medically
ConfirmedCase Report Type Reporter Occupation Protocol/Study No. Center ID & Other ID Patient ID Initial Safety
Receipt DateEUDRACT No.
Spontaneous N SPONTANEOUS NA 27-SEP-2021ConMed: Unknown Concomitant Product(s)Product(s) and Event(s) Information
Suspect Product(s) Event(s) CDS Latency Group Rechallenge Causality per Reporter Causality per Company
BNT162B2 Death X Post Therapy N/A N/A N/A
BNT162B2 Pyrexia X Post Therapy N/A N/A N/A
BNT162B2 Malaise X Post Therapy N/A N/A N/A
BNT162B2 Dyspnoea X Post Therapy N/A N/A N/A
Cause of Death/Autopsy
Other Death Information:
Suspect or Conmed Devices
Suspect Devices
Device Type Device
IndicatorModel No. Serial No. NDC No. Date of
ManufactureCatalog No. Device
OperatorDevice
Available for
EvaluationDevice
Evaluated by
ManufacturerSingle Use Evaluation
TypeEvaluation Code
NO DATA NO DATA NO DATA NO DATAPatient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Type Patient/Parent Indicator Coded Condition Notes
DEATH PATIENT Cardiac arrestSuspect Product(s) Information
Suspect Product(s) Indication(s) Form of Admin First Total Daily Dose Action Taken Dechallenge Rechallenge Interacting Drug
BNT162B2 COVID-19 immunisation SOLUTION FOR
INJECTIONNOT APPLICABLE N/A N/A NO DATA
Pfizer, Confidential
090177e1997500c0\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235526
Page 32 of 36
As of Date: 01-OCT-2021
11.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Hospitalization RequiredSection Page: 3
References
Reference Type Reference ID Reference Notes
E2B AUTHORITY NUMBER
E2B REPORT DUPLICATE
E2B REPORT DUPLICATE
E2B REPORT DUPLICATE
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Pfizer, Confidential
090177e1997500c0\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235527
Page 33 of 36
As of Date: 01-OCT-2021
12.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 1
Patient Demographic
Sex Age Height (cm) Weight (kg) Race Country Where Event Occured
FEMALE 12 YEARS NO DATA - NO DATA ITALY
This is a spontaneous report from a contactable consumer, received via COVAES portal.
A 12-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN,
SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced sudden death (sudden death) on
unspecified date in Sep2021. It was not reported if an autopsy was performed.
Additional information provided included:
Does Pfizer have permission to contact the reporter about this event?: Yes
Does Pfizer have permission to contact your/the patient's healthcare provider about this report?:No
Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion
Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine:Unknown
Reported Event: Sudden death
Prior to vaccination, was the patient diagnosed with COVID-19?:Unknown
Since the vaccination, has the patient been tested for COVID-19?:Unknown
Follow-up (29Sep2021): additional information provided by the same contactable consumer included the following: The reporter was contacted as per the immediate follow-up activity of A
ER # (sudden death). She said she had no further information because she heard in a bar, people ta king about the event that happened to a 12-year-old girl. They said the girl was found
dead in her bed by her parents about 3 weeks ago, the day after vaccination with BNT162B2 (unknown dose). She confirmed that she had no further information and was unable to obtain it.
No follow-up attempts are possible, information about batch/lot number cannot be obtained.Event Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
Sudden death Sudden death Sudden death ---SEP-2021 SERIOUS FATAL NO DATA NO DATA
Lab Data: Unknown Lab Data
Lab Narrative:
Suspect Product(s) Therapy Information
Suspect Product(s) Unit Dose Total Daily Dose Regimen Dose Route of Admin Therapy Date(s) Therapy Duration Anatomical
LocationVaccination
Dose No.Lot No. Batch No.
BNT162B2 NO DATA - NO DATATest Name Normal Value Test Date Test Result Lab Comments
Pfizer, Confidential
090177e1997500c0\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235528
Page 34 of 36
As of Date: 01-OCT-2021
12.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 2
Patient Medical History
Concomitant Product(s) Conmed Tradename As Reported Therapy Date(s) Route of Admin
-
Report History
Source HP/Medically
ConfirmedCase Report Type Reporter Occupation Protocol/Study No. Center ID & Other ID Patient ID Initial Safety
Receipt DateEUDRACT No.
Spontaneous N SPONTANEOUS NA 28-SEP-2021ConMed: Unknown Concomitant Product(s)Product(s) and Event(s) Information
Suspect Product(s) Event(s) CDS Latency Group Rechallenge Causality per Reporter Causality per Company
BNT162B2 Sudden death X Unknown N/A N/A N/A
References
Reference Type Reference ID Reference Notes
COVAES REFERENCE NO.Cause of Death/Autopsy
Other Death Information:
Suspect or Conmed Devices
Suspect Devices
Device Type Device
IndicatorModel No. Serial No. NDC No. Date of
ManufactureCatalog No. Device
OperatorDevice
Available for
EvaluationDevice
Evaluated by
ManufacturerSingle Use Evaluation
TypeEvaluation Code
NO DATA NO DATA NO DATA NO DATAPatient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Type Patient/Parent Indicator Coded Condition Notes
DEATH PATIENT Sudden deathSuspect Product(s) Information
Suspect Product(s) Indication(s) Form of Admin First Total Daily Dose Action Taken Dechallenge Rechallenge Interacting Drug
BNT162B2 COVID-19 immunisation SOLUTION FOR
INJECTIONNOT APPLICABLE N/A N/A NO DATA
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Pfizer, Confidential
090177e1997500c0\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235529
Page 35 of 36
As of Date: 01-OCT-2021
13.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 1
Patient Demographic
Sex Age Height (cm) Weight (kg) Race Country Where Event Occured
MALE 13 YEARS NO DATA - NO DATA GERMANY
This is a spontaneous report from a contactable physician and an Other Health Professional (Other HCP) based on information received by Pfizer from Biontech [manufacturer control number: 71619],
license party for BNT162B2 (COMIRNATY). A 13-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration at single dose on an unspecified
date for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had died on an unspecified date. Reporter confirmed that the adverse event came up in video
for a PMR project in Germany. Cause of death was not provided. It was unknown if an autopsy was performed. The outcome of event was fatal.
Follow-up (22Jul2021): New information reported includes: event details.
No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.Event Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
death Death Death SERIOUS FATAL NO DATA NO DATA
Lab Data: Unknown Lab Data
Lab Narrative:
Suspect Product(s) Therapy Information
Suspect Product(s) Unit Dose Total Daily Dose Regimen Dose Route of Admin Therapy Date(s) Therapy Duration Anatomical
LocationVaccination
Dose No.Lot No. Batch No.
BNT162B2 NO DATA - NO DATA 2Test Name Normal Value Test Date Test Result Lab Comments
Product(s) and Event(s) Information
Suspect Product(s) Event(s) CDS Latency Group Rechallenge Causality per Reporter Causality per Company
BNT162B2 Death N Unknown N/A N/A N/ASuspect Product(s) Information
Suspect Product(s) Indication(s) Form of Admin First Total Daily Dose Action Taken Dechallenge Rechallenge Interacting Drug
BNT162B2 COVID-19 immunisation SOLUTION FOR
INJECTIONNOT APPLICABLE N/A N/A NO DATACase Comments
Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 on causing the event death cannot be excluded.The impact of this report on the benefit/risk profile
of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pfizer, Confidential
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FDA-CBER-2022-5812-0235530
Page 36 of 36
As of Date: 01-OCT-2021
13.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 2
Patient Medical History
Concomitant Product(s) Conmed Tradename As Reported Therapy Date(s) Route of Admin
-
Report History
Source HP/Medically
ConfirmedCase Report Type Reporter Occupation Protocol/Study No. Center ID & Other ID Patient ID Initial Safety
Receipt DateEUDRACT No.
Spontaneous Y SPONTANEOUS OTHER HEALTH
PROFESSIONAL07-JUL-2021
Y SPONTANEOUS PHYSICIANConMed: Unknown Concomitant Product(s)
References
Reference Type Reference ID Reference Notes
E2B REPORT DUPLICATE
LICENSE PARTNER NO.
E2B COMPANY NUMBERCause of Death/Autopsy
Other Death Information:
Suspect or Conmed Devices
Suspect Devices
Device Type Device
IndicatorModel No. Serial No. NDC No. Date of
ManufactureCatalog No. Device
OperatorDevice
Available for
EvaluationDevice
Evaluated by
ManufacturerSingle Use Evaluation
TypeEvaluation Code
NO DATA NO DATA NO DATA NO DATAPatient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Type Patient/Parent Indicator Coded Condition Notes
DEATH PATIENT Death
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Pfizer, Confidential
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FDA-CBER-2022-5812-0235531