Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder, Hidradenitis, Immunisation reaction, Mobility decreased
Clinical narrative: gastric sleeve surgery six months; She had Hidradenitis Suppurativa flare up with minor surgery to remove drainage; could hardly get off of the couch; non-serious bad reaction to covid vaccine; 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): 20K-163-3709636-00.  A 42 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 22Feb2022 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 11Oct2019 (Batch/Lot number: unknown) at citrate free for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: Gastric disorder (medically significant), outcome "recovered", described as "The patient had gastric sleeve surgery six months"; HIDRADENITIS (medically significant), outcome "recovering", described as "She had Hidradenitis Suppurativa flare up with minor surgery to remove drainage"; VACCINATION COMPLICATION (medically significant) with onset Feb2022, outcome "recovered" (2022), described as "non-serious bad reaction to covid vaccine"; MOBILITY DECREASED (medically significant), outcome "unknown", described as "could hardly get off of the couch". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of hidradenitis (She was placed on antibiotic to help with the issue).  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of gastric sleeve, hidradenitis suppurativa flare up and bad reaction to covid vaccine with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of could hardly get off of the couch was not provided.  Causality for Pfizer BioNTech Covid-19 Vaccine(Tozinameran): The reporter's causality for the event(s) of gastric sleeve, hidradenitis suppurativa flare up and could hardly get off of the couch was not reported. The reporter's causality for the event(s) of bad reaction to covid vaccine with HUMIRA(ADALIMUMAB) was reasonable possibility.  AbbVie's opinion is that there is no reasonable possibility that the events of gastric sleeve, hidradenitis suppurativa flare up, bad reaction to covid vaccine and could hardly get off of the couch are related to Humira (adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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.