Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Interchange of vaccine products, Off label use, Rheumatoid arthritis, Vaccination site pain
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-163-4330274-00 (RA). A 55 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 55 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis; Covid-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), intramuscular, administration date 20Mar2022 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine product"; RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "Rheumatoid arthritis flare up on hands and knees"; VACCINATION SITE PAIN (non-serious), HEADACHE (non-serious), outcome "recovered" and all described as "Injection hurt and slight headache due to vaccine". The action taken for upadacitinib was dosage permanently withdrawn. Clinical Course: Solicited report by a consumer of an adult male with events of non-serious rheumatoid arthritis flare up on hands and knees and injection hurt and slight headache due to vaccine with Rinvoq (Upadacitinib). There was no reported medical history. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) and Moderna COVID-19 Vaccine (Elasomeran) were also considered suspect. The patient had rheumatoid arthritis flare up on hands and knees due to being off of it to get booster. His injection hurt and slight headache due to COVID vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Seq. No: 1: Causality for Rheumatoid arthritis flare up (Rheumatoid arthritis), Vaccination site pain, headache under the suspect Pfizer BioNTech COVID-19 Vaccine (Tozinameran) (Tozinameran), Unknown, was reported as "not reported" Seq. No.: 2: Causality for Rheumatoid arthritis flare up (Rheumatoid arthritis), Vaccination site pain, headache under the suspect Pfizer BioNTech COVID-19 Vaccine (Tozinameran) (Tozinameran), Unknown, was reported as "possible". Seq. No: 3 Causality for Rheumatoid arthritis flare up (Rheumatoid arthritis), under the suspect Moderna COVID-19 Vaccine (Elasomeran) Unknown was reported as "not reported" and for events Vaccination site pain, headache reported as "possible" and dechallenge under all suspect reported as N/A. The reporter considered "off label use", "interchange of vaccine product", "rheumatoid arthritis flare up on hands and knees" and "injection hurt and slight headache due to vaccine" related to bnt162b2. 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 information in the case report, a possible causal relationship between the reported events: "Off label use", "Interchange of vaccine product", "Rheumatoid arthritis", "Headache", "Vaccination site pain" and the suspect drug BNT162B2 cannot be completely excluded. 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.