Adverse Event Reporting
| VAERS ID | 1146771 |
|---|---|
| Gender | Unknown |
| Age | |
| StateCode | CA |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EL1283 |
| Number of vaccinations | 2 |
| Vaccinated | 2021-01-19 |
| Onset | 2021-03-18 |
| Condition | Life Threatening Permanent Disability |
Symptoms
- Maternal exposure during pregnancy
- Ventricular hypertrophy
- Pulmonary arterial pressure abnormal
- Ductus arteriosus premature closure
- Neutropenia neonatal
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
is pregnant: Yes; severe neutropenia; premature closure of the ductus arteriosus; severe right ventricular hypertrophy and pulmonary arterial pressures; severe right ventricular hypertrophy and pulmonary arterial pressures; This is spontaneous report from a contactable Physician.
This Physician reported information for both mother and baby.
This report is for baby.
The parent received first dose of BNT162B2 (So-lution for injection; Lot number: EL 1283) via Intramuscular in left arm on 29Dec2020 at 08:30 at single dose for COVID-19 immunisation, a baby received second dose of BNT162B2 (Solution for injection; Lot number: EL 1283) on via Transmammary route on 19-JAN-2021 08:45 at single dose for COVID-19 immunisation.
Medical history and concomitant medication were not reported.
On 18-MAR-2021 07:45 the Baby was born at (Withheld) with premature closure of the ductus arteriosus and severe neutropenia.
Baby has been in NICU for the last 5 days with severe right ventricular hypertrophy and pulmonary arterial pressures and has been placed on Neupogen, is pregnant: Yes [Hospitalization, Life threatening, Disability, Congenital anomaly), Treatment received for the events.
The outcome of the events was unknown.
; Sender's Comments: Based on available information a contributory of BNT162B2 to the reported neutropenia cannot be totally excluded.
The reported premature closure of the ductus arteriosus with severe right ventricular hypertrophy and pulmonary arterial pressures are unrelated to BNT162B2.
The premature closure of the ductus arteriosus is a developmental complication and the right ventricular hypertrophy and pulmonary arterial pressures are probably due to the premature closure of the ductus arteriosus.
Case will be reassessed if additional information is received.
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.
,Linked Report(s) : US-PFIZER INC-2021314932 same drug, different AE and patient, baby and mother