Age: 79.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal distension, Abdominal pain upper, Defaecation disorder, Gastric haemorrhage
Clinical narrative: bad bowel movements; Stomach cramps; Stomach Bleeds; stomach bloating; MARKETING PROGRAM NOT AVAILABLE  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-163-4296720-00 (Agency).  A 79 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Nov2021 (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single, intramuscular, administration date 26May2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 05May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (cf (40 mg,1 in 2 wk)) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTRIC HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "Stomach Bleeds"; ABDOMINAL PAIN UPPER (medically significant) with onset 25Nov2021, outcome "unknown", described as "Stomach cramps"; DEFAECATION DISORDER (medically significant), outcome "unknown", described as "bad bowel movements"; ABDOMINAL DISTENSION (medically significant) with onset 2021, outcome "unknown", described as "stomach bloating". The action taken for adalimumab was unknown.  Causality for Pfizer Biontech COVID-19 vaccine (TOZINAMERAN): The dechallenge was N/A, action taken with drug was unknown, causality as per reporter (drug/vaccine) was possible for the events defaecation disorder, stomach cramps (abdominal pain upper), disorder abdominal bloating (abdominal distension), stomach haemorrhage (gastric hemorrhage). Causality for Humira: The causality for the events stomach haemorrhage (gastric haemorrhage), stomach cramps (abdominal pain upper), disorder abdominal bloating (abdominal distension), stomach haemorrhage (gastric haemorrhage). the action(s) taken with drug was unknown causality as per reporter (drug/vaccine) was not reported, causality as per MFR. (drug/vaccine) was not assessable. Causality for SKYRIZI (RISANKIZUMAB): The reporter's causality for the event(s) of psoriasis flare ups with SKYRIZI (RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the event(s) of patient took skeptical of booster and had a temperature was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug 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.