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Life Threatening? No
Write-up: Hypothermia; Feverish/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-202106020854309260-3YPVM, Safety Report Unique Identifier: GB-MHRA-ADR 25402865. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31May2021 (lot number: not known) at 2nd dose, single for COVID-19 immunisation. Medical history included lactation decreased, fever , nucleic acid test (NADIAs) which showed no active signs of AOSD. The patient is weaning off prednisolone. Patient has not had symptoms associated with COVID-19. 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 previously took prednisolone. The patient experienced fever on an unspecified date; and hypothermia, feverish, and nauseous on 01Jun2021. Clinical course reported: the main unusual side effect was an intermittent very (v) low temperature that the thermometer cannot record. It oscillated between v low (34) and a mild fever (38). The low temperature caused more concern. 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: no - negative COVID-19 test on an unspecified date. The outcome of the events nauseous was recovered on an unspecified date; and hypothermia and feverish was not recovered. Regulatory authority assessed the events as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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