Adverse Event Reporting
| VAERS ID | 2033325 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | |
| Vaccinated | 2012-04-01 |
| Onset | 2021-12-12 |
| Condition | Permanent Disability |
Symptoms
- SARS-CoV-2 test negative
- Off label use
- Maternal exposure during pregnancy
- Interchange of vaccine products
- Drug interaction
- Unintended pregnancy
Current Illness
Preexisting Conditions
Other Medications
RIGEVIDON (28)
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
Write-up
Drug interaction; Pregnancy; Off label use; Interchange of vaccine products; Booster; Maternal exposure during pregnancy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority.
The reporter is the patient.
Regulatory number: GB-MHRA-WEBCOVID-202201011024352730-YYQA8.
Other Case identifier(s): GB-MHRA-ADR 26423863.
A 33 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), administration date 12Dec2021 (Lot number: FK9712) as dose 3 (booster), single for covid-19 immunisation; ethinylestradiol, levonorgestrel (RIGEVIDON (28)), from 01Apr2012 (Batch/Lot number: unknown) to 24Dec2021 for contraception.
Date of last menstrual period: 29Nov2021.
The patient was 1 weeks pregnant at the time of exposure to bnt162b2.
The patient was 2 weeks pregnant at the event onset.
The patient is expected to deliver a baby(s) on 05Sep2022.
The patient's relevant medical history and concomitant medications were not reported.
Past drug history included: Folic acid.
Vaccination history included: Covid-19 vaccine ("DOSE X; MANUFACTUERER UNKNOWN" (where X=1, 2, or number unknown)), for Covid-19 immunisation; Covid-19 vaccine ("DOSE X; MANUFACTUERER UNKNOWN" (where X=1, 2, or number unknown)), for COVID-19 immunisation.
Patient had not had symptoms associated with COVID-19.
Patient is not currently breastfeeding.
The following information was reported: OFF LABEL USE (disability, medically significant) with onset 12Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 12Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 12Dec2021, outcome "unknown", described as "Booster"; MATERNAL EXPOSURE DURING PREGNANCY (disability, medically significant), outcome "unknown", described as "Maternal exposure during pregnancy"; UNINTENDED PREGNANCY (disability, medically significant), outcome "unknown", described as "Pregnancy"; DRUG INTERACTION (disability, medically significant), outcome "unknown", described as "Drug interaction".
The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) negative, notes: No - Negative COVID-19 test.
The action taken for ethinylestradiol, levonorgestrel was unknown.
clinical course included patient had been taking Rigevidon consistently with perfect use whole life, on and off.
She last went off it in Dec2019 and got back on it in Apr2021.
Since April, patient had been taking it consistently, with the recommended break in between packets in order to have a period.
Patient had never had an issue before.
She was now pregnant.
Conception would had occurred around the time she received booster.
She had no clue how got so unlucky as to get pregnant with perfect use of the pill, but she was concerned Pfizer booster interacted with it somehow to cause ovulation and a pregnancy.
It could be a coincidence, but that's the only different factor in my life this month.
No follow-up attempts are possible.
No further information is expected.