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Life Threatening? No
Write-up: Menstrual cramp; cramps; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041220156360-FAN4A, Safety Report Unique Identifier is GB-MHRA-ADR 25419947. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 20May2021 as second dose, single for COVID-19 immunization. Medical history included pain and cramps. Patient has not had symptoms associated with COVID-19, has not had a COVID-19 test, and was not enrolled in clinical trial. Concomitant medication included paracetamol taken for pain. The patient experienced cramps on an unspecified date in 2021, and menstrual cramp on 04Jun2021. Both events were reported as serious, with seriousness criteria of other medically important condition. The clinical course was reported as follows: Cramps were extremely severe, far worse than anything she had previously. Nearly made her call an ambulance. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event cramps was unknown, while outcome of menstrual cramp was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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