Adverse Event Reporting
| VAERS ID | 1845094 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 2 |
| Vaccinated | 2021-08-01 |
| Onset | 2021-08-01 |
| Condition |
Symptoms
- Maternal exposure during pregnancy
- Morning sickness
- Hormone level abnormal
- Hyperemesis gravidarum
Current Illness
Pregnancy
Preexisting Conditions
Other Medications
VITAMIN B1 [THIAMINE]; VITAMIN B6; VITAMIN B12 [CYANOCOBALAMIN]; SOLGAR FOLACIN; OMEGA 3 NATURAL
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Frequent vomiting (got pregnant this summer); Severe nausea (became pregnant this summer); disrupting hormone levels; Drug exposure during pregnancy, first trimester; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number NO-NOMAADVRE-PASRAPP-2021-U4294w.
This consumer reported information for mother.
This is a maternal report.
A 32-year-old pregnant (including at the time of vaccination-as reported) female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left in Jul2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE then via an unspecified route of administration in Aug2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for COVID-19 immunization.
It was reported that the patient became pregnant at the end of Jul2021.
Concomitant medications included thiamine (VITAMIN B1); vitamin b6 (VITAMIN B6); cyanocobalamin (VITAMIN B12); folic acid (SOLGAR FOLACIN); and linolenic acid (OMEGA 3 NATURAL) all taken as dietary supplement from unknown therapy dates.
It was reported that the patient received the both doses of COVID-19 vaccine from Pfizer in Jul2021and Aug2021 while she got pregnant at the end of Jul2021.
Since the end of Aug2021, the patient experienced severe nausea.
Since the first week of Sep2021 (on 06Sep2021) the patient had frequent vomiting (4-7xday).
The patient mentioned that the symptoms were far stronger and more prolonged.
The patient suspect that the vaccine has exacerbated the nausea and vomiting tendencies.
Maybe this was through disrupting hormone levels (increased HcG hormone production for example)? The patient had been on sick leave since mid-Sep2021.
The patient administered antiemetics POSTAFEN, CARIBAN and NAUSEEMA.
The patient had been in contact with the physician for the events.
Outcome of severe nausea and frequent vomiting was not recovered while unknown for disrupting hormone levels Reporter comment: The patient reported sick leave since mid-Sep2021 due to the ADRs.
The patient reported to have taken Comirnaty: dose no.
1 in Jul2021 and dose no.
2 in Aug2021.
The patient reported to get pregnant in between dose no.
1 and 2, in the end of Jul2021.
The patient reported to have severe nausea since the end of Aug2021 and excessive vomiting since the first week of Sep2021(4-7 times a day).
The patient administered antiemetics (Postafen, Cariban and Nauseema) against ADRs.
Health authority comment: The Suspect was changed to Comirnaty due to the patient reporting "suspected drug: Pfizer-BioNTech COVID-19 Vaccine (NOT Janssen- had to choose this due to the only option available).
The patient does not state whether she thinks the ADRs is due to dose no.
1 or 2, or the combination of them.
No other individual report was found.
No follow-up attempts are possible, information on batch number cannot be obtained.
; Reporter's Comments: The patient reported sick leave since mid-Sep2021 due to the ADRs.
The patient reported to have taken Comirnaty: dose no.
1 in Jul2021 and dose no.
2 in Aug2021.
The patient reported to get pregnant in between dose no.
1 and 2, in the end of Jul2021.
The patient reported to have severe nausea since the end of Aug2021 and excessive vomiting since the first week of Sep2021(4-7 times a day).
The patient administered antiemetics (Postafen, Cariban and Nauseema) against ADRs.