Age: 58.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Dyspepsia, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Heartburn; Pain in hand; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from Regulatory Authority, manufacturer control number: 21K-163-4052045-00 from a contactable 59-year-old male consumer (patient).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 04Mar2021 (Batch/Lot number was not reported), dose 2 on 04Apr2021 (Batch/Lot number was not reported), both at age of 58-year-old intramuscular as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Lot Number: 1142175) and ongoing, at Citrate Free for Moderate to severe rheumatoid arthritis, methotrexate sodium (METHOTREXATE SODIUM), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced gallbladder removal (medically significant) on 30Jul2021, heartburn, rheumatoid arthritis flare up, adverse drug reaction, pain in hand on unknown date.  The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was dose not changed, for methotrexate sodium was permanently withdrawn on an unspecified date.  the outcome of gallbladder removal was recovered in 2021, Rheumatoid arthritis flare up, Adverse drug reaction (as reported) was not recovered , for other event was unknown. Clinical course: Solicited report by a consumer of a 59-year-old male with events of gallbladder removal and non-serious heartburn, rheumatoid arthritis flare up, had reaction to methotrexate and occasional pain in hands with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced heartburn, rheumatoid arthritis flare up, had reaction to methotrexate and occasional pain in hands. On 30Jul2021 the patient experienced gallbladder removal. On an unknown date, gallbladder removal resolved. Methotrexate was also considered suspect. Patient had reaction to methotrexate which caused heartburn and had to stop the drug. It was unknown if he was enrolled in a covid-19 vaccine trial. On 04Mar2021, he received first dose covid-19 vaccine manufactured by Pfizer. On 04Apr2021, he received second dose covid-19 vaccine manufactured by Pfizer.  Causality for Humira (Adalimumab): The reporters causality for the event(s) of gallbladder removal, heartburn and had reaction to methotrexate with Humira (Adalimumab) was no reasonable possibility. The reporters causality for the event(s) of rheumatoid arthritis flare up with Humira (Adalimumab) was a reasonable possibility. The reporters causality for the event(s) of occasional pain in hands was not provided. RA opinion is that there is no reasonable possibility that the events of gallbladder removal, heartburn, rheumatoid arthritis flare up, had reaction to methotrexate and occasional pain in hands are related to Humira (Adalimumab).  The reporter's assessment of the causal relationship of the events with the suspect products bnt162b2 and methotrexate sodium 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 needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and known drug profile, a possible causal relationship cannot be excluded between the suspect vaccine product bnt162b2 and the reported event rheumatoid arthritis flare up. The other events are not considered likely related to the suspect product bnt162b2. Based on available information and possible temporal association, a possible causal relationship cannot be excluded between the suspect vaccine product methotrexate sodium and the reported events heartburn and pain in hand. The event rheumatoid arthritis flare up is not considered related to the suspect product methotrexate sodium based on negative dechallenge result that the event not recovered after methotrexate sodium withdrawn. This case will be reassessed once additional information is available.