Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive for Covid.  She took the booster and Covid vaccines.; Positive for Covid.  She took the booster and Covid vaccines.; 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 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL9265, Expiration Date: 31May2021), on 04Mar2021 as dose 2, single (Lot number: EL9267, Expiration Date: 31May2021), on 28Sep2021 as dose 3 (booster), single (Lot number: 30135BA) and on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation", start date: 2018 (unspecified if ongoing), notes: Atrial fibrillation Had cardiac ablation surgery on 08Dec2022.; "cardiac ablation surgery", start date: 08Dec2022 (unspecified if ongoing), notes: Atrial fibrillation Had cardiac ablation surgery on 08Dec2022. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Mar2023, outcome "unknown" and all described as "Positive for Covid. She took the booster and Covid vaccines.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Mar2023) Postiive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Calling about Paxlovid. Wants to report for the sake of science and information. Came down with symptoms on 28Mar2023 and started Paxlovid on 30Mar2023 at midnight, first dose. On 03Apr2023 at 6PM her upper lip started to swell and it was numb and continued to swell through the evening. By bedtime she had welts everywhere, shoulders, neck, chest, and legs, it was wide spread. Spent the night itching like crazy. Prior Vaccinations (within 4 weeks) was none. Patient had not visit to emergency room, physician office and intensive care unit. Fourth Dose Date: 05Apr2022, given at doctor's office and they didn't have sticker or write the information about NDC/LOT/EXP. Fifth dose: there is sketchy information written on the card. Date: 10Sep2022, Manufacturer: Pfizer, Given at a pharmacy. GJ252Y is written on the card, but it doesn't say that it is the LOT.   Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL9265 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 EL9265, fill lot EL9256, and the formulated drug product lot EL9247. 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.  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL9267 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. The final scope included the reported finished goods lot EL9267, fill lot EL9258, and the formulated drug product lot EL9249. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for a Lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot 30135BA was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk, and is manufactured, labeled and packaged by Pfizer (Name withheld). The final scope was determined to be lot 30135BA. No quality issues were identified during the investigation. There is no impact on product quality. An RA was not issued for the complaint. No regulatory notification or AQRTs were held as a result of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to manufacture or vendor processes. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior any lot being released to the market. No further investigation required.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.