Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Furuncle, Headache, Parosmia, Rheumatoid arthritis
Clinical narrative: Thrombosis; Rheumatoid arthritis flare up; Boil on thigh; Taste alteration; Nose bleed; Smell alteration; Headache; This is a solicited report from the marketing program received from a non-contactable consumer (patient) based on information received by Pfizer (manufacturer control number:( 21K-163-4022373-00).  A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 Vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free for moderate to severe hidradenitis suppurativa. The patient medical history was not reported. Concomitant medication included methotrexate taken for an unspecified indication, start and stop date were not reported.  Solicited report from a consumer of an adult female with events of nose bleed and blood clots from mouth, boil right thigh, no sense taste, no sense of smell, headaches and rheumatoid arthritis flare up with Humira (Adalimumab). There was no reported medical history. Taste, no sense of smell, headaches and rheumatoid arthritis flare up. On an unknown date, nose bleed and blood clots from mouth resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer. The patient experienced thrombosis, rheumatoid arthritis flare up, boil on thigh, taste alteration, nose bleed, smell alteration and headache. The action taken in response to the events for adalimumab was unknown. The outcome of events thrombosis and nose bleed was recovered on an unspecified date, rheumatoid arthritis flare up was unknown, of other events was recovering. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of nose bleed and blood clots from mouth unknown onset, no sense taste, nose bleed and blood clots from mouth unknown onset, no sense of smell and headaches with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of boil right thigh with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of rheumatoid arthritis flare up was not provided. Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN): The reporter's causality for the event thrombosis with vaccine was probable, for other events was not provided.  The reporter's assessment of the causal relationship of the events (except thrombosis) with the PFIZER BIONTECH COVID-19 VACCINE was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events Thrombosis, Furuncle, Taste disorder, Epistaxis, Parosmia, Headache  and the suspect BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.