Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hidradenitis
Clinical narrative: Hidradenitis suppurativa; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4199276-00.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1st Dose), administration date: 11Mar2021, when the patient was 36-year-old, for Covid-19 immunization; BNT162b2 (2nd Dose), administration date: 08Apr2021, when the patient was 36-year-old, for Covid-19 immunization. The following information was reported: HIDRADENITIS (medically significant), outcome "unknown", described as "Hidradenitis suppurativa". The action taken for adalimumab was temporarily withdrawn. The reporter's assessment of the causal relationship of "surgery" 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.  Additional information: On unknown dates, the patient experienced Surgery and Hidradenitis suppurativa Flare up. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was reported that patient was temporarily off Humira for 21 days due to surgery. She had very bad covid vaccine which cause a bad flare up of hidradenitis suppurative with new painful lesions developing in her groin and under her breasts. Patient also stated that she was doing very well until she received her covid booster last week and then developed the new lesions a few days later. it was unknown if patient was enrolled in a covid-19 vaccine trial. Causality for Humira (adalimumab): The reporter's causality for the event(s) of Surgery and Hidradenitis suppurativa Flare up was not provided. An agent opinion is that there is no reasonable possibility that the events of surgery and Hidradenitis suppurativa Flare up are related to Humira (adalimumab). Change history: On 16May2022, received updates to event information reporter opinion of causality company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of "SURGERY" was added. Suspect drug(s) information: Drug: Pfizer BioNTech Covid-19 vaccine(tozinameran) (tozinameran), un- known, unknown. Daily dose: Pfizer (1 in 1 once), Route of administration: intra-muscular, Indications for use: covid-19 vaccination, Therapy dates(from/to): 11Mar2021. Suspect drugs: product-reaction level, drug: Humira (solution for injection in pre-filled pen) (adalimumab), Daily dose: Subcutaneous, Therapy Dates/Duration: UNK  Discontinued. seq.no.: 2 drug: pfizer Biontech covid-19 vaccine(tozinameran)(injection)(tozinameran), unknown, unknown. Daily dose: 1) Pfizer 1st Dose (1 in 1 once), 2) Pfizer 2nd Dose (1 in 1 once), 3) Pfizer Booster Dose (1 in 1 Once), Route of admin: intra-muscular, Therapy dates/duration: 11Mar2021-11Mar2021. 2) 08Apr2021- 08Apr2021. 3) 30Sep2021- 30Sep2021.   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 known safety profile and Limited information in the case report a casual association between reported event and the suspect drug BNT162B2 cannot be 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