Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: In Jul2022 the patient tested positive for covid; In Jul2022 the patient tested positive for covid; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4410114-00         .  A 63-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown), on 17Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 12Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1160294) and second regimen (Lot number: 1157573), all subcutaneous for crohn's disease, hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "In Jul2022 the patient tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (Jul2022) Positive. The action taken for adalimumab was unknown.  Clinical Course: A 62 year old female with events of Epilepsy and Tinnitus on both ears/Deaf in left ear tinnitus  and non-serious sick after second Covid-19 vaccine/It put patient  down, first covid vaccine and booster patient was sick and sleep for about one day, Covid positive, dizziness tinnitus on both ears/Deaf in left ear tinnitus and occurrence of asthmatic bronchitis and nausea with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced Epilepsy, Tinnitus on both ears/Deaf in left ear tinnitus, dizziness  and occurrence of asthmatic bronchitis and Nausea. In Mar2021, the patient experienced first covid vaccine and booster patient was sick and sleep for about one day and first covid vaccine and booster patient was sick and sleep for about one day. In Mar2021, the first covid vaccine and booster patient was sick and sleep for about one day resolved. In Apr2021, the patient sick after second Covid-19 vaccine/It put patient down. In Apr2021, the sick after second Covid-19 vaccine/It put patient down resolved. In Dec2021, the patient experienced first covid vaccine and booster patient was sick and sleep for about one day. In 2021, the first covid vaccine and booster patient was sick and sleep for about one day resolved. In Dec2021, the first covid vaccine and booster patient was sick and sleep for about one day resolved. In Jul2022, the patient experienced Covid positive. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. In Jul2022 the patient tested positive for covid and when retested resulted negative. patient had deaf in left year. Patient experienced dizziness and nausea due to left ear tinnitus. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "in jul2022 the patient tested positive for covid" 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.   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 temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.