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Life Threatening? No
Write-up: cramps; bloating; pain; Painful periods; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202106050857014410-GA5JY, Safety Report Unique Identifier GB-MHRA-ADR 25425239. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported), via an unspecified route of administration at 1st dose single on 03Jun2021 for COVID-19 immunization. Medical history included Lactation decreased, inflammatory bowel disease (Crohn disease, ulcerative colitis). Patient had not experienced any flare up symptoms from IBD since the vaccine and have been well controlled for around a year. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced cramps, bloating, pain on an unspecified date, painful periods on 04Jun2021. Events outcome were recovering. Clinical course reported as following: usually have painful periods, maybe some cramps or bloating but period was extremely painful after coincidentally coinciding with the vaccine. The pain woke her up in the night and although taken paracetamol, still quite uncomfortable. Patient has not tested positive for COVID-19 since having the vaccine. Case reported serious due to Other medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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