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Life Threatening? No
Write-up: Stomachache; Fever; Nauseous; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106022022348930-PKYKQ, Safety Report Unique Identifier GB-MHRA-ADR 25408307. A female patient of an unspecified age received b BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ey5456), via an unspecified route of administration on 01Jun2021 15:30 as 1st dose, single dose for COVID-19 immunization. Medical history included suspected COVID-19 from 28Dec2020 to 10Jan2021, acne from an unknown date and unknown if ongoing and COVID-19 from 04Jan2021 to an unknown date. Patient is not enrolled in clinical trial. Concomitant medications included lymecycline taken for acne from 20Mar2021 to an unspecified stop date. The patient experienced nauseous on 01Jun2021 18:00, stomachache and fever on 02Jun2021. It was reported that the patient got the jab around 3:30 PM, started feeling nauseous since 6 PM until next day. She had an episode of very bad stomachache in the afternoon the following day. Had a high fever in the afternoon day following the jab. The reporter assessed all events as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: positive (yes/positive COVID-19 test) on 04Jan2021. The outcome of the event nauseous was not recovered while the outcome of all other events was recovering. No follow-up attempts are possible. No further information is expected.
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