Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Electrocardiogram, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got confirmed Covid; got confirmed Covid; 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 63-year-old female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 13Apr2021 as dose 2, single (Lot number: EP7533), in left arm, on 22Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: She had breast cancer like 7 years ago; "irregular heart beat", start date: 16Mar1982 (unspecified if ongoing), notes: irregular heart beat don't know the cause tied tubes in 15Mar1982 when woke up did EKG and showed it; "high blood pressure" (unspecified if ongoing), notes: high blood pressure diagnosed 10-15 years ago; "lung cancer surgery", start date: Jul2022 (unspecified if ongoing), notes: lung cancer surgery Jul2022; "slow down the little acid producers in her stomach" (unspecified if ongoing), notes: slow down the little acid producers in her stomach. Concomitant medication(s) included: LOSARTAN oral taken for hypertension (ongoing); PANTOPRAZOLE oral taken for achlorhydria, start date: Mar2022 (ongoing); VITAMIN C [ASCORBIC ACID]; ZINC; D3; TYLENOL EXTRA STRENGTH. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "got confirmed Covid". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; Electrocardiogram: (15Mar1982) irregular heart beat, notes: irregular heart beat don't know the cause tied tubes in 15Mar1982 when woke up did EKG and showed it. didn't know she had; SARS-CoV-2 test: (unspecified date) Positive, notes: positive for Covid after Pfizer Covid 19 vaccine; Weight: (unspecified date) 128-130 lbs, notes: Weight - at this point about 128-130 pounds. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The report was not related to a study or program. Vaccine Administered was not at specific Facility. The patient had not received Prior Vaccinations (within 4 weeks). The patient has had 2 doses shot and the 1st 2 boosters and queried if it normal to get sick for more than more a couple days. She was on day 4-5 now and does not know what to think. The patient got confirmed Covid on Thursday at home test and went to pharmacy and had more extensive quick one done. The patient received Paxlovid on 09Dec2022 at 11 AM pink and white pills. took twice a day, ongoing. NDC number of Paxlovid: 0069-0345-30. Product investigation summary conclusion included Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FJ9943 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation was limited to the reported finished goods lot FJ9943, fill lot FJ9942 and the bulk formulated drug product FJ9940. The final scope included the reported finished goods lot FF8841, fill lot FF8835, and the formulated drug product lot FA9156. The final scope was determined to be the reported finished goods lot EP7533, fill lot EP7531, and the bulk formulated drug product lot EP7527. The final scope included the reported finished goods lot EN6207, fill lot EN5340, and the formulated drug product lot EN5328. A complaint sample was not returned. No related quality issues were identified during the investigation. There was 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.