Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; Asymptomatic COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 18May2021 as dose 1, single (Batch/Lot number: unknown), on 08Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 13Mar2022 as dose 3 (booster), single (Lot number: FK9896) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; ASYMPTOMATIC COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: testing positive for the antigen. Clinical course: Patient was asking if she was still contagious, tested positive 5-7 days. She was recently in jail, in a room with 15 women, from which 9 or 10 were sick or were recently sick. One of them who was right next to her, tested positive for COVID 19. Patient mentioned they were not provided with masks and had. She was heavily exposed for 48 hours with the sick woman, and the day when she got released today from jail, on the 7th day of her stay, she was tested for COVID and came up positive. She was seriously asymptomatic. Besides being sleep deprived, for being in the howling cell, they were making noise all night long, non-stop, she could not sleep, but as far as COVID symptoms, she was not sneezing, the test she took it when she came back, and in 3 minutes it came up positive. It had been a while ago from these shots, and it was kind of interesting, that she still had immunity obviously, she was heavily exposed for 48 hours. She was heavily exposed to COVID and all the women next to her, all of them were sick, and she was heavily exposed, and came back with a positive on the antigen test, that's not something usual. She had 2 shots of primary and 1 booster of Pfizer, she was relatively symptom free just a headache, she was tested positive 5-7 days, she was exposed for 48 hours with 10 others who were tested positive too, others had symptoms and suffering and did not receive the vaccine. Her latency, 7th day after first exposure, and she was talking about a massive exposure. People who did not get the vaccine, who did not wear a mask and she was exposed to them, who gave her covid. She ended up being in jail for a week, but for two days, she was exposed to these seriously sick women, for 48 hours and they moved her to a different place in the jail because they needed to. She tested positive at the jail and then they all freaked out. She got covid from the other woman who was in the jail already. She went home and she was exposing her daughter.  Conclusion of Previously Completed Investigation: The complaint for Pfizer-biontech Covid-19 vaccine was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FK9896. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.