Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Headache; Received Pfizer Covid vaccine second booster dose/ tested positive for Covid; Received Pfizer Covid vaccine second booster dose/ tested positive for Covid; He just walked out with a sore arm; sleep a little more for a couple of days/He felt a little sleepy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL1284), on 01Feb2021 as dose 2, single (Lot number: EL9261), on 30Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Mar2022 at 10:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing); "Pneumonia" (unspecified if ongoing), notes: 20, by Pfizer within 4 weeks. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2022, outcome "recovered" (Apr2022), described as "He just walked out with a sore arm"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "Received Pfizer Covid vaccine second booster dose/ tested positive for Covid"; HEADACHE (non-serious) with onset 11Apr2022, outcome "unknown"; SOMNOLENCE (non-serious) with onset 2022, outcome "unknown", described as "sleep a little more for a couple of days/He felt a little sleepy". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Apr2022) Positive; (Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: He had only went into Afib once in the last 2.5 years, and he will be okay if it happens. He can just take a dose which will take him out of it. He would rather get rid of the virus. He thought he had shrunk over the years. He got it to avoid getting infected, and to increase his chances of a good outcome if he was infected. He didn't really had side effects to any of them like most people. He hasn't had a reaction. He even went golfing after he got his shot, And shot very well. He just thought he was one of the people that need to be vaccinated more often. He normally sleeps 7 hours, but he was sleeping 8.5 hours instead. He also takes Flecainide. He had to discontinue that because it is contraindicated with Paxlovid. He takes it for A fib. So far he is not taking it. The Flecainide he usually takes three time a day. He chose to stop the Flecainide. He noticed it was a conflict drug and stopped it on his own. The previous agent said the Flecainide can be enhanced by the Paxlovid. It can make it work too much. So he personally feels he can do without it for the next 4 days. He has only went into Afib once in the last 2.5 years, and he will be okay if it happens. He can just take a dose which will take him out of it. He would rather get rid of the virus. AE's does not require a visit to emergency room/physician office. Patient's Medical History (including any illness at time of vaccination):   Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was no. Relevant Tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI) was no.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.