Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Hidradenitis suppurativa; Sinus infection; urinary tract infection; pneumonia; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4385389-00 (Company).  A 41-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown), on 11May2021 as dose 2, single (Batch/Lot number: unknown) and on 17Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for hidradenitis. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "recovered" and all described as "COVID-19"; SINUSITIS (non-serious) with onset Mar2022, outcome "recovered" (2022), described as "Sinus infection"; PNEUMONIA (medically significant) with onset Mar2022, outcome "recovered" (2022); URINARY TRACT INFECTION (non-serious) with onset Mar2022, outcome "recovered" (2022); HIDRADENITIS (non-serious), outcome "recovered", described as "Hidradenitis suppurativa". The action taken for adalimumab was unknown. Clinical Course: Solicited report by a consumer with events of Covid, Break Outs of hidradenitis suppurativa in inner thigh and underarms, sinus infection, urinary tract infection and pneumonia with Humira (Adalimumab). On an unknown date, the patient experienced break outs of hidradenitis suppurativa in inner thigh and in underarms. In 2021, the patient experienced Covid. In Mar2022, the patient experienced sinus infection, urinary tract infection and pneumonia. In 2022, the sinus infection, urinary tract infection and pneumonia resolved. On unknown dates, covid and break outs of hidradenitis suppurativa in inner thigh and underarms resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. 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 covid, break outs of hidradenitis suppurativa in inner thigh and underarms, sinus infection, urinary tract infection and pneumonia was not provided. Causality: not reported. Causality Drug: Pfizer BioNTech Covid-19 Vaccine (Tozinameran): possible. Concomitant drugs and dates of administration (Exclude those used to treat event): Concomitant Drugs Not Reported. No Known allergies. No Concomitant drugs taken. No relevant medical history.  The reporter considered "covid-19", "pneumonia", "hidradenitis suppurativa", "sinus infection" and "urinary tract infection" related to BNT162b2.  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 in the case report, a possible causal relationship between the reported events and the suspect drug BNT162B2 cannot be completely excluded.   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.