Adverse Event Reporting
| VAERS ID | 1834491 |
|---|---|
| Gender | Unknown |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 1 |
| Vaccinated | 2021-08-11 |
| Onset | 2021-08-11 |
| Condition |
Symptoms
- Ultrasound scan
- Maternal exposure during pregnancy
- Limb reduction defect
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Foetal tobacco exposure (Gestation Period at Exposure: 8 weeks)
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210927; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:normal first trimester ultrasound.
The embryo has; Comments: normal first trimester ultrasound.
The embryo has normal vitality, morphology and biometrics for the term.
The trophoblast and amniotic fluid also appear normal.
No visualization of the right foot, good mobility of the 2 lower limbs.
; Test Date: 20211004; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:ultrasound check-up at 14 weeks +1 day of gestatio; Comments: ultrasound check-up at 14 weeks +1 day of gestational age: confirmation of transverse agenesis of the right foot or of the right forefoot, the rest of the examination is normal
Write-up
Foot agenesis / No visualization of the right foot / confirmation of transverse agenesis of the right foot or of the right forefoot; received BNT162B2 via transplacental / mother vaccination against covid at 6 weeks + 3 days and 9 weeks + 4 days; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LM20213103.
This physician reported information for both mother and fetus.
This is a fetus report.
An unspecified gender and age patient received the first dose of BNT162B2 (COMIRANTY) via transplacental on 11Aug2021 (Lot Number: Unknown) as single dose for COVID-19 immunization.
Medical history included foetal tobacco exposure (Gestation Period at Exposure: 8 weeks).
Concomitant medication was not reported.
On an unspecified date, the patient experienced foot agenesis.
The mother vaccination against covid at 6 weeks + 3 days and 9 weeks + 4 days.
Lab data included: On 27Sep2021: normal first trimester ultrasound.
The embryo has normal vitality, morphology and biometrics for the term.
The trophoblast and amniotic fluid also appear normal.
No visualization of the right foot, good mobility of the 2 lower limbs.
On 04Oct2021: ultrasound check-up at 14 weeks of amenorrhea + 1 day: confirmation of transverse agenesis of the right foot or of the right forefoot, the rest of the examination is normal.
The outcome of foot agenesis was not recovered.
The outcome of other events was unknown.
No follow-up attempts are possible.
No further information is expected.
; Sender's Comments: Linked Report(s) : FR-PFIZER INC-202101422012 mother/fetus