Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19 Vaccine: Got Covid after vaccination and boosters; Covid-19 Vaccine: Got Covid after vaccination and boosters; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9261), on 26Feb2021 as dose 2, single (Lot number: EN6205), on 23Sep2021 as dose 3 (booster), single (Lot number: FC3184) and on 11Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 83 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 Vaccine: Got Covid after vaccination and boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive for Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: She had taken Paxlovid and she had been vaccinated and boosted by Pfizer. Went traveling for a graduation and picked up Covid. Was tested by a nurse practitioner (NP) and it came back positive for Covid, so she was put on Paxlovid. One of her daily medications was Simvastatin. So, she stopped that and took Paxlovid 07Jun2022 through 12Jun2022. The following week around 14Jun2022 to 16Jun2022, she was at home and had some vomiting off and on with dry heaves for at least three days. Would eat in between, but she knew she was dehydrated, so she went to the emergency department. One of the doctors there stated that it could have been a side effect of the Paxlovid. Gave her three bags of fluid. Released to come home on 19Jun2022. Had been fine since then. Just getting stronger. Her age was another reason to get vaccinated and boosted. Had no problems with the vaccines. Might have been a little tired after one of the vaccines. Must have been Jan2022 when she first got vaccinated. Patient received dose 4 before noon. Paxlovid: On the 07Jun2022, she started with the evening pills and the rest of the time she took the rest of it as 3 pills in the morning and 3 pills at night. Finished the medication on the morning of 12Jun2022. She has been on Simvastatin for years. She did take Simvastatin. And was told to discontinue until 3-5 days after completing course of Paxlovid. Patient did not visit emergency room and physician office. Prior Vaccinations (within 4 weeks) was none. Prior vaccinations adverse events was none reported. Reporter's husband and some of the family are fully vaccinated and boosted. Some family are vaccinated and boosted. Some had Moderna and some J&J. Some had Pfizer.   Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for PFIZERBIONTECH 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 FM0698. 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. RA concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM 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. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot EL9261, EN6205 was investigated. The investigation included reviewing manufacturing and packaging batch records, release test results, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope was determined to be the reported finished goods lot EL9261, fill lot EL9252, and the bulk formulated drug product EL9243, the final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326. 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. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FC3184 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 of this investigation is limited to the reported finished goods lot FC3184, fill lot EY0563, and the bulk formulated drug product lot EP8663. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No corrective or preventative actions were identified because it was determined that the controls currently in place are sufficient for preventing and removing any vial damage as observed in the complaint sample. All release testing performed prior to the release of the reported batch was within specifications.