Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, FLUX
Symptoms: COVID-19, Drug ineffective, Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: I had a Flu vaccine at the same time; I had a Flu vaccine at the same time; I got sick with Covid after having 5 shots; I got sick with Covid after having 5 shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 59 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8733) and on 22Apr2022 as dose 2, single (Lot number: EW0171) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 07Sep2022 as unk, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Nov2022, outcome "unknown" and all described as "I got sick with Covid after having 5 shots"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "I had a Flu vaccine at the same time". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: It was reported that the patient received his 5th COVID booster shot on 07Sep2022 of this year and on 15Nov2022, he tested positive for COVID. The patient stated that he got sick with COVID after having 5 shots and he was kind of pissed that after trying to have a safe. The patient reported that "So yeah, I got sick after kind of avoid it for 3 years and having 5 vaccinations and within 2 months of getting COVID so its not working. Guess that's the key, I thought I would be safe and I started relaxing on my precautions, not wearing a mask in public as much as I was and I still got COVID. Before proceed, is this going to make any difference, this call? Is this the kind of information you are looking for?"  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot EW0171 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0171, fill lot EP8702, and formulated drug product lot EP8604. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause or CAPA were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot ER8733 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8733, fill lot EP8685, and the bulk formulated drug product EP8572. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.