Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4339408-00 (RA), 2022US004372 (RA). A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for Covid-19 immunisation; infliximab "PRIVATE" (INFLIXIMAB "PRIVATE") (Batch/Lot number: unknown); adalimumab (HUMIRA) (Batch/Lot number: unknown) for ankylosing spondylitis, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Route of administration: Intramuscular), administration date: 01Mar2021, when the patient was 46 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 02, Route of administration: Intramuscular), administration date: 01Apr2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (hospitalization), outcome "not recovered", described as "throbbing pain in finger". The action taken for infliximab "private" and adalimumab was unknown. Additional information: solicited report by a consumer of an adult female with events of reaction with COVID booster and reaction with infliximab and non-serious throbbing pain in finger and surgery with Humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced reaction with COVID booster, reaction with infliximab, throbbing pain in finger and surgery. Pfizer BioNTech COVID-19 vaccine (tozinameran) and infliximab were also considered suspect. On unknown dates, the patient experienced reaction with COVID booster, reaction with infliximab, throbbing pain in finger and surgery. Pfizer BioNTech COVID-19 vaccine (tozinameran) and infliximab were also considered suspect. Patient had throbbing pain in fingers since having to stop Humira due to surgery. She had reaction between infliximab or COVID booster, she had to go to hospital, she was not sure which because it happened simultaneously. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Causality for Humira (adalimumab). The reporter's causality for the event (s) of reaction with COVID booster, reaction with Infliximab and surgery was not provided. The reporter's causality for the event (s) of throbbing pain in finger with Humira (adalimumab) was a reasonable possibility. Regulatory Authority opinion is that there is no reasonable possibility that the events of reaction with COVID booster, reaction with infliximab, throbbing pain in finger, and surgery are related to Humira (adalimumab). The reporter's assessment of the causal relationship of the events with the suspect product 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. No further information is expected. Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event pain in extremity. The case will be reassessed if additional information becomes available. 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.