Adverse Event Reporting
|Number of vaccinations||1|
- SARS-CoV-2 test
- Pregnancy test
- Menstruation delayed
- Menstruation irregular
Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Test Name: pregnancy tests; Test Result: Negative ; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
Menses delayed; Menses delayed; This is a spontaneous report from a contactable consumer (Patient herself).
The regulatory authority report number is GB-MHRA-WEBCOVID-202104121437099680.
A 43-years-old female (non-pregnant) patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), dose 2 via an unspecified route of administration on 25Feb2021(at the age of 43-years-old) (Batch/Lot Number: ERI741: Expiry date: not reported) as 2nd dose, and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, both as single for covid-19 immunization.
Medical history included suppressed lactation from an unknown date and unknown if ongoing and suspected covid-19 from 15Apr2020 to 30Jun2020.
Patient was not pregnant, and she was always been very regular.
Patient has not tested positive for COVID-19 since having the vaccine.
Patient was not enrolled in clinical trial.
Patient was not pregnant, and patient was not currently breastfeeding.
Concomitant medication included ramipril (RAMIPRIL) taken for blood pressure indication, start and stop date were not reported.
After patient received her first vaccine, her period was 2 weeks early.
After second jab her period was over 2 weeks late.
On 30Mar2021, Reaction to the 2nd vaccine, the patient experienced menses delayed (medically significant) and menses irregular (medically significant).
On an unspecified date, the patient underwent lab tests and procedures which included pregnancy test results negative and sars-cov-2 test results no - negative covid-19 test and confirmed by Doctor.
Outcome of the events was not recovered.
Information about lot/batch number for 1st dose cannot be obtained.
Follow-up attempts are completed.
No further information is expected