Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bronchitis, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with covid on 16Oct2022; diagnosed with covid on 16Oct2022; bronchitis; This is a spontaneous report received from contactable reporter (Consumer) from medical information team and product quality group. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 09Jul2021 as dose 1, single (Lot number: EW0191), in left arm, on 30Jul2021 as dose 2, single (Lot number: FA7484), in left arm and on 19Jan2022 as dose 3 (booster), single (Lot number: FL9896) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 2007 (unspecified if ongoing); "Severe Osteoporosis.", start date: 2020, stop date: 2021, notes: It was recently. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; GLIPIZIDE taken for diabetes mellitus.  Even though she took her normal dose of Glipizide 10mg twice a day, she was on 5mg previously, she did not tell her doctor she upped it, and it really is not helping. It is not making it come down. She is type 2 diabetic. Vaccination history included: Flu shot in 2020 (This was years ago and she does not have a manufacturer, lot or expiration. She did not get any the last 5 years she was working in healthcare). The following information was reported: BRONCHITIS (non-serious) with onset 16Oct2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Oct2022, outcome "unknown" and all described as "diagnosed with covid on 16Oct2022". The patient stated her symptoms of COVID were bronchitis, fever and diarrhea. The day she tested positive for COVID, she did not feel good and had bronchial continuous deep cough and could not sleep. As she took medication, it started to get better on 3rd, 4th day. On 5th day, still coughing but not as bad as before.  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, bronchitis.  Investigation results received on 26Oct2022: The complaint for lack of effect of the Pfizer Biontech COVID-19 vaccine injectable lot FA7484 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FA7484, fill lot ET8457, and the bulk formulated drug product lot FA9188. 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 Pfizer Biontech COVID-19 vaccine lot EW0191 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EW0191, fill lot EP8738, and bulk formulation lot EP8619. 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.