Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abscess limb, Cellulitis, Immunisation
Clinical narrative: Cellulitis; booster; Abscess on buttock; 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): 21K-163-4167587-00 (RA). BNT162B2 is under agreement with the regulatory authority. . A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Oct2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at HCF for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 16Oct2021, outcome "unknown", described as "booster"; CELLULITIS (hospitalization, medically significant), outcome "recovering", described as "Cellulitis"; ABSCESS LIMB (non-serious) with onset 31Oct2021, outcome "unknown", described as "Abscess on buttock". The action taken for adalimumab was dosage permanently withdrawn.  Additional information: The patient was hospitalized for a week due to cellulitis. On 31Oct2021, she had developed abscess to her buttock and drained it at urgent care. She was done with Humira because she thought it caused the infection. She also reported that this was started due to covid booster. 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 Cellulitis with Humira(Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of abscess to buttock was not provided. The regulatory authorities opinion is that there is a reasonable possibility that the events of cellulitis and abscess to buttock are related to Humira (Adalimumab). Check all appropriate to adverse reaction: Involved or prolonged inpatient hospitalization Seq.No.:1 Drug: Humira (Solution for injection in pre-filled pen) (Adalimumab), Unknown Daily Dose:  Route of Administration: Subcutaneous Indications for use: Moderate to severe hidradenitis suppurativa Therapy Dates(From/To): UNK- Discontinued  Causality 1) Cellulitis Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Reasonable possibility Causality as per Mfr.(Drug/Vaccine): Reasonable possibility Dechallenge: Yes  2) Abscess on buttock Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): Reasonable possibility Dechallenge: UNK  Seq.No.: 2 Drug: Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Injection) (Tozinameran), Unknown, Unknown, Unknown Daily Dose: Booster dose (1 in 1 Once) Route of Administration:  1)Intra-muscular 2)Intra-muscular 3)Intra-muscular Indications for use: Covid-19 vaccination Therapy Dates/Duration: 16Oct2021-16Oct2021  Causality 1) Cellulitis Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  2) Abscess on buttock Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A Did event abate after stopping drug: Yes  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the  reported events 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