Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain, Vulval cancer, Weight
Clinical narrative: Vulvar cancer; crohns disease; Vaccination site erythema; Vaccination site pain; Irritability; Hidradenitis suppurativa; Post procedural infection; This is a solicited report based on information by Pfizer, Manufacturer control number: 21K-163-4085386-00. A non-contactable consumer (patient) reported for herself, 40-years-old female patient received bnt162b2 (BNT162B2), intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 Vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose (Citrate free), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unknown dose (Citrate free) for moderate to severe hidradenitis suppurativa, moderate to severe adult crohn's disease. The patient medical history and concomitant medications were not reported. The patient had events of vulvar cancer reconstruction surgery and had 10 unspecified surgeries and non-serious redness at injection site due to covid vaccine, pain at injection site due to covid vaccine, irritability, crohn's disease acting up/crohns flare ups, minor cysts/boils from hidradenitis suppurativa and infection from split sutures from surgery. Patient reported that Humira was working well she had to miss few doses of Humira due to unspecified surgeries for unknown reason and on unknown date after she began with Humira therapy. She underwent for vulvar cancer reconstruction surgery. She had infection from split sutures from surgery. She had her crohns disease acting up and had weight loss since unknown date. She stated these events had nothing to do with Humira. She had minor cysts or boils from hidradenitis suppurativa, experienced irritability, she had redness and pain at injection site from covid vaccine. She did not agree to have physician contacted. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient experienced vulvar cancer on an unspecified date with outcome of recovering, crohn's disease on an unspecified date with outcome of not recovered, vaccination site erythema on an unspecified date with outcome of recovered, vaccination site pain on an unspecified date with outcome of recovered, irritability on an unspecified date with outcome of recovered, hidradenitis suppurativa on an unspecified date with outcome of not recovered, post procedural infection on an unspecified date with outcome of unknown. The action taken in response to the event(s) for adalimumab was unknown. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of vulvar cancer reconstruction surgery and minor cysts/boils from hidradenitis suppurativa was not provided. the reporter's causality for the event(s) of had 10 unspecified surgeries, redness at injection site due to covid vaccine, pain at injection site due to covid vaccine, irritability, crohn's disease acting up/crohns flare ups, clostridium difficile caused by clindamycin and infection from split sutures from surgery with humira(adalimumab) was no reasonable possibility. abbvie's opinion is that the events of vulvar cancer reconstruction surgery and infection from split sutures from surgery are not assessable. abbvie's opinion is that there is no reasonable possibility that the events of had 10 unspesified surgeries, redness at injection site due to covid vaccine, pain at injection site due to covid vaccine, irritability, crohn's disease acting up/crohns flare ups, clostridium difficile caused by clindamycin and minor cysts/boils from hidradenitis suppurativa are related to humira(adalimumab).   The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of 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: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.