Age: 19.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Atrial fibrillation, Gait inability, Incorrect route of product administration, Myocardial infarction, Seizure
Clinical narrative: Seizure; Atrial fibrillation; Heart attack; BNT162B2, Route of Administration: Intra-articular; Unable to walk; This is a solicited report facilitated based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-4004879-00) via a contactable consumer (patient). A 19-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intra-articular on an unspecified date (Batch/Lot number was not reported) (at the age of 19-year-old) as single dose for COVID-19 Vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg, (1 in 14-2)(1 in 1 Once) for ankylosing spondylitis. Medical history included ongoing ankylosing spondylitis, epilepsy and recurrent seizures, covid from Apr2020 (no information whether ongoing). Concomitant medication included levetiracetam (KEPPRA) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) and experienced drug allergy, benzoyl peroxide and experienced drug allergy, adalimumab (HUMIRA) from 2016 to Apr2020 for ankylosing spondylitis and experienced covid hit. On unknown dates, the patient experienced seizure, atrial fibrillation, heart Attack and could not walk. In 2020, the patient experienced covid. Pfizer BIONTECH Covid-19 vaccine was also considered suspect. The patient had been on and off with HUMIRA since 2016. She stopped taking HUMIRA when covid hit, around Apr2020. She stopped due to scared of respiratory complications with covid and physician was aware. She started having seizure 10 minutes after receiving Pfizer vaccine, developed arterial fibrillation and a heart attack and was hospitalized from an unspecified date. She had not been with HUMIRA since. She could not walk around. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received COVID-19. The action taken in response to the events for adalimumab was temporarily withdrawn on an unspecified date. The outcome of the events was unknown. Abbvie's opinion is that there is no reasonable possibility that the events of seizure, atrial fibrillation, Heart attack, covid and could not walk are related to humira 40mg/0.4ml(adalimumab).  The reporter's assessment of the causal relationship of the events 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: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Myocardial Infarction, Atrial fibrillation and Seizures. 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.