Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Drug ineffective, Pyrexia, Suspected COVID-19
Clinical narrative: Drug ineffective; COVID-19 recurrent/the patient experienced covid twice; fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single and intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 04Nov2020 (Lot number: 1158135) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (medically significant) with onset Mar2021, outcome "recovered" (2021), described as "fever"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "COVID-19 recurrent/the patient experienced covid twice". The patient underwent the following laboratory tests and procedures: body temperature: (Mar2021) 102 to 103; (Apr2021) 102 to 103. The action taken for adalimumab was unknown.  Additional Information: Solicited report by a consumer of a 52 year old female with events of non-serious Covid twice and Fever with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced covid twice. In Mar2021, the patient experienced Fever. In Apr2021, the patient experienced Fever. In 2021, the Fever resolved. On unknown dates, covid twice and Fever resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The reporter's causality for the event(s) of covid twice, fever onset in Mar2021 and Fever onset in Apr2021 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The reporter's causality for the event(s) of covid twice, fever onset in Mar2021 and Fever onset in Apr2021 with Pfizer BioNTech Covid-19 Vaccine was Possible.  Humira (Solution for injection in pre-filled pen) (ADALIMUMAB), 1158135, 2) Fever (Pyrexia), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A 3) Fever (Pyrexia), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A Humira (Solution for injection in pre-filled pen) (ADALIMUMAB), 1158135, 1) COVID-19 recurrent (COVID-19), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. 2) Fever (Pyrexia)  Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN), Causality, 2) Fever (Pyrexia), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A, 3)Fever (Pyrexia), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A,. Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN), Causality, 1) COVID-19 recurrent (COVID-19), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events pyrexia, drug ineffective and suspected covid-19 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.