Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract infection, Streptococcal infection, Tooth fracture
Clinical narrative: Tooth fracture; Respiratory Infection; Rash on legs; Psoriasis on both shins in front; Strep Infection; Ear Infection; fever; Red bumps; This is a solicited report from a marketing program facilitated collect received from a contactable consumer (patient) based on information received by Pfizer from AbbVie (manufacturer control number: 21K-163-4090412-00). A 58-year-old female patient received bnt162b2 (BNT162B2) dose 1 intramuscular on 01Jan2021 (at the age of 57 years old, Batch/Lot number was not reported) as dose 1, single and dose 2 intramuscular on 01Feb2021 (at the age of 58 years old, Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen) subcutaneous from an unspecified date (Batch/Lot number was not reported) at CF for psoriatic arthritis. Medical history included psoriatic arthropathy. The patient's concomitant medications were not reported. On unknown dates in 2021, the patient experienced rash on legs, strep infection, respiratory infection, ear infection, fever and red bumps that would had psoriasis on both shins in front. In Aug2021, the patient experienced cracked tooth. PFIZER BIONTECH COVID-19 VACCINE was also considered suspect. The action taken in response to the events for adalimumab was unknown. The outcome of event Tooth fracture was recovering and other events was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for the events of tooth fracture, strep infection, respiratory infection, ear infection, fever, red bumps that would had psoriasis on both shins in front unknown onset for adalimumab was not provided. The reporters causality for the event of rash on legs with adalimumab was no reasonable possibility. The reporters causality for the events of rash on legs, strep infection, respiratory infection, ear infection, fever, red bumps that would had psoriasis on both shins in front unknown onset for BNT162B2 was Probable and for event Tooth fracture was not provided.  The reporter's assessment of the causal relationship of the event tooth fracture with the suspect product 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 lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events Respiratory tract infection, fever, Rash on both legs, Streptococcal infection, ear infection, psoriasis, rash papular 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 RAs, Ethics Committees, and Investigators, as appropriate Based on available information , event Tooth fracture is unrelated to BNT162B2