Adverse Event Reporting
| VAERS ID | 2013545 |
|---|---|
| Gender | Male |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | FH3219 |
| Number of vaccinations | 2 |
| Vaccinated | 2021-11-25 |
| Onset | 2021-11-25 |
| Condition | Died |
Symptoms
- Inappropriate schedule of product administration
- Death
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Bedridden (Bedridden for several months.); COPD (COPD, Gold stage 4. Chronic respiratory failure, bedridden for several months.)
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
DEATH; Dose no.
1 (six months before dose no.
2); This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB.
Regulatory number: NO-NOMAADVRE-FHI-2021-V4edwg (regulatory authority).
Other Case identifier(s): NO-NOMAADVRE-E2B_00067075 (regulatory authority).
A 66 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: FH3219) as dose 2, single for covid-19 immunisation.
Relevant medical history included: "Bedridden" (unspecified if ongoing), notes: Bedridden for several months.
; "COPD" (unspecified if ongoing), notes: COPD, Gold stage 4.
, Chronic respiratory failure, bedridden for several months.
The patient's concomitant medications were not reported.
Vaccination history included: Covid-19 vaccine (Dose 1 (six months before dose no.
2), Batch/lot number: Unknown.
Manufacturer unknown.
), for Covid-19 immunisation.
The following information was reported: DEATH (death) with onset 30Nov2021, outcome "fatal", described as "DEATH"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 25Nov2021, outcome "unknown", described as "Dose no.
1 (six months before dose no.
2)".
The patient date of death was 30Nov2021.
The reported cause of death was "Unknown cause of death".
It was unknown if an autopsy was performed.
Additional information: Death five days after vaccination with dose no.
2.
No complications after vaccination with dose no.
1 (six months before dose no.
2).
In the last month before the death, he had a stable poor condition, had several visits from relatives.
Stop Date/Time for Death event with Outcome of Event: Fatal: 30Nov2021 00:00.
Pharmacovigilance assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible.
No follow-up attempts are possible.
No further information is expected.
; Reported Cause(s) of Death: Unknown cause of death