Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hidradenitis, SARS-CoV-2 test
Clinical narrative: Hidradenitis suppurativa; COVID-19; COVID-19; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2K-163-4488994-00.  A 43-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for hidradenitis. The patient's relevant medical history included: "surgeries" (unspecified if ongoing), notes: had six surgeries with hidradenitis suppurativa.; "hidradenitis suppurativa" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19"; HIDRADENITIS (medically significant), outcome "unknown", described as "Hidradenitis suppurativa". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: In April 2022, the patient experienced COVID. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of hidradenitis. Clinical course: On an unknown date, the patient experienced hidradenitis suppurativa flare up. In Apr2022, the patient experienced covid. pfizer. Patient had a little bit of hidradenitis suppurativa flare up and had six surgeries with hidradenitis suppurativa. He had taken antibiotics. He did not had abscess in the last two years as of 30Jul2022. In Apr2022, he had covid. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Drug: Humira Causality: hidradenitis suppurativa (hidradenitis): Causality as per reporter: not reported; Causality as per mfr: no reasonable possibility.  Covid-19 (covid-19): Causality as per reporter: not reported; Causality as per Mfr: no reasonable possibility. Drug: Pfizer Biontech Covid-19 Vaccine. Causality: hidradenitis suppurativa (hidradenitis), Causality as per reporter: not reported. Covid-19 (covid-19), Causality as per reporter: possible.  The reporter's assessment of the causal relationship of "covid-19" and "hidradenitis suppurativa" with the suspect product(s) BNT162b2 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. 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.