Document text
Page 1 of 11
As of Date: 01-OCT-2021
1.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 13 YEARS NO DATA - NO DATA UNITED STATES
This is a spontaneous report from a non-contactable consumer (columnist). A 13-year-old male patient received second dose of BNT162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation:
Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and
concomitant medications were not reported. It was reported that remained strangely silent over the sudden death of a 13-year-old child who had a second dose of Pfizer vaccine. The patient died on an
unspecified date. It was not reported if an autopsy was performed.
No follow-up attempts are possible, 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
sudden death of a
13-year-old (place)child who
had a second dose of Pfizer
vaccineSudden death Sudden 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 2
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 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 DATA
Pfizer, Confidential
090177e1997500bf\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235532
Page 2 of 11
As of Date: 01-OCT-2021
1.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 N SPONTANEOUS NA 20-JUL-2021ConMed: Unknown Concomitant Product(s)
References
Reference Type Reference ID Reference Notes
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 Sudden death
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Pfizer, Confidential
090177e1997500bf\Final\Final On: 25-Feb-2022 14:34 (GMT)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0235533
Page 3 of 11
As of Date: 01-OCT-2021
2.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
FEMALE 13 YEARS NO DATA - NO DATA UNITED STATES
This is a spontaneous report from a Pfizer-sponsored program COVAX US Support by a non-contactable consumer. This report reported same event for two patients. This is the first dose of two reports. A
13-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE at the age of
13-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) for covid-19
immunisation. A 13 years old female is dead from second dose of Pfizer Covid 19 vaccine. Both had no prior conditions with the heart and now are dead. The patient died on an unspecified date. It was
unknown if an autopsy was performed.
No follow-up attempts are possible; information about lot/batch number cannot be obtainedEvent Information and Narrative
Verbatim Term Lowest Level Term Preferred Term Onset Date Event
SeriousnessClinical Outcome Procedure
Causality Per
CompanyProcedure Causality
Per Reporter
dead from second dose of
Pfizer Covid 19 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 2
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/AutopsyPatient/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
090177e1997500bf\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235534
Page 4 of 11
As of Date: 01-OCT-2021
2.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 N SPONTANEOUS NA 23-AUG-2021ConMed: Unknown Concomitant Product(s)
References
Reference Type Reference ID Reference Notes
MEDICAL INFORMATION NO.
NO. CASE COPIES
E2B LINKED REPORT
NCSP
E2B COMPANY NUMBEROther 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
Pfizer, Confidential
090177e1997500bf\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235535
Page 5 of 11
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 UNITED STATES
This is a spontaneous report from a contactable consumer or other non-health care professional in response to mail trail sent regarding the confirmation of below mentioned query. A 13-year-old male
patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported) via an unspecified route
of administration in an unspecified anatomical location on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The
patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported) via an
unspecified route of administration in an unspecified anatomical location on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, three days after receiving his second
Covid vaccine, the patient died. Autopsy result showed enlarged heart and fluid surrounding the heart caused by the Covid vaccination. The outcome of the events was fatal.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Follow-up (25Jun2021): This is a follow up spontaneous report in response to ma
il trail sent regarding the confirmation of below mentioned query. New information included: Updated narrative.
No follow-up attempts are possible; 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
died three days after Covid
vaccinationUnknown cause of death Death SERIOUS FATAL NO DATA NO DATA
Autopsy showed enlarged
heart and fluid surrounding
the heartPericardial effusion Pericardial effusion SERIOUS FATAL NO DATA NO DATA
Autopsy showed enlarged
heart and fluid surrounding
the heartEnlargement heart Cardiomegaly 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
Pfizer, Confidential
090177e1997500bf\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235536
Page 6 of 11
As of Date: 01-OCT-2021
3.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 22-JUN-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
BNT162B2 Pericardial effusion N Unknown N/A N/A N/A
BNT162B2 Cardiomegaly N Unknown 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
AUTOPSY PATIENT Cardiomegaly
AUTOPSY PATIENT Pericardial effusion
DEATH PATIENT 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
Pfizer, Confidential
090177e1997500bf\Final\Final On: 25-Feb-2022 14:34 (GMT)
(b) (6)
FDA-CBER-2022-5812-0235537
Page 7 of 11
As of Date: 01-OCT-2021
3.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 3
References
Reference Type Reference ID Reference Notes
E2B COMPANY NUMBER
Parent Medical History
Patient/Parent Indicator Coded Condition Start Date Stop Date Ongoing Notes
Pfizer, Confidential
090177e1997500bf\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235538
Page 8 of 11
As of Date: 01-OCT-2021
4.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 13 YEARS NO DATA - NO DATA UNITED STATES
This is a spontaneous report from a contactable consumer. A 13-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of
administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.
Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient experienced died in his sleep, 3 days after taking Pfizer COVID
vaccine on 16Jun2021. This is coincidental, this is not causative. Cause of death was unknown. No investigation assessment. The patient died on 16Jun2021. The county health department confirmed the
investigation and the autopsy was being performed. The information is being sent the CDC to see if there is a correlation. The reporter mentions that we all know a lot of 13-year-old falling over for that.
Information on the lot/batch number has been requested.
Follow-up (05Aug2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and 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
died in his sleep 3 days after
taking the Pfizer covid
vaccineDied in sleep Death 16-JUN-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 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 DATA
Pfizer, Confidential
090177e1997500bf\Final\Final On: 25-Feb-2022 14:34 (GMT)
(b) (6)
FDA-CBER-2022-5812-0235539
Page 9 of 11
As of Date: 01-OCT-2021
4.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 02-JUL-2021ConMed: Unknown Concomitant Product(s)
References
Reference Type Reference ID Reference Notes
LOCAL REFERENCE NO.
CALL CENTER NO.
NO. CASE COPIES
CROSS-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
Pfizer, Confidential
090177e1997500bf\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235540
Page 10 of 11
As of Date: 01-OCT-2021
5.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 UNITED STATES
This is a spontaneous report from a contactable consumer via Pfizer Colleague. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot
number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant
medications were not reported. On an unspecified date, the reporter read a Newsweek headline online that said a thirteen-year-old died in his sleep after taking the Pfizer vaccine and the CDC was
investigating. Another article headline may have said it was a boy, but reporter can't find that article again. The reporter don't have a subscription to newsweek so could not read the article and get more
specifics.The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of event was reported as fatal.
Follow up needed, further information was requested.
Follow-up (05Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts 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
I read a Newsweek headline
online that said a thirteen
year old died in his sleep
after taking the Pfizer
vaccine and the CDC is
investigating. Another article
headline may have said it
was a boy butUnknown 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 DATA
Pfizer, Confidential
090177e1997500bf\Final\Final On: 25-Feb-2022 14:34 (GMT)
(b) (6)
FDA-CBER-2022-5812-0235541
Page 11 of 11
As of Date: 01-OCT-2021
5.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 04-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
COVAES 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
Pfizer, Confidential
090177e1997500bf\Final\Final On: 25-Feb-2022 14:34 (GMT)
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FDA-CBER-2022-5812-0235542