Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: HG4628) at the age of 71 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Irregular heartbeat" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: HUMIRA, start date: 01Apr2018; METOPROLOL TARTRATE, start date: 01Aug2014; PRESERVISION; VITAMIN D3. Past drug history included: Codeine, reaction(s): "Allergy", notes: known allergies: Codeine; Morphine, reaction(s): "Allergy", notes: known allergies: Morphine. Vaccination history included: bnt162b2, bnt162b2 omi ba.4-5 (Dose 5 (booster), single, Batch/Lot No: GL0447, Location of injection: Arm Left), administration date: 13Jul2023, when the patient was 71-year-old, for COVID-19 immunization; bnt162b2, bnt162b2 omi ba.4-5 (Dose 4 (booster), single, Batch/Lot No: GJ2524, Location of injection: Arm Left), administration date: 22Sep2022, when the patient was 70-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 3, Batch/Lot No: FM0698, Location of injection: Arm Left), administration date: 02Mar2022, when the patient was 70-year-old, for COVID-19 immunization; Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included (Anti-viral, brand Pfizer) started on 22Nov2023 and stopped on 27Nov2023.  Clinical information: The patient received other vaccine. The patient received other medication in 2 weeks included Humira (RA), Metoprolol tartrate, Preservision, Vitamin D3 and Hair Skin and Nails, gummies. Adverse event was reported as None.  Conclusion of investigation results for lot number HG4628: The complaint of "PFIZERBIONTECH COVID-19 VACCINE INJECTABLE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and 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 "HG4628". A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS (Site name withheld) 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. Conclusion of investigation results for lot number GL0447: The complaint of "PFIZERBIONTECH COVID-19 VACCINE INJECTABLE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and 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 "GL0447". A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. RA (Site name withheld) 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. Conclusion of investigation results for lot number FM0698: 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 was no impact on product quality, regulatory, validation and stability. PGS (Site name withheld) concludes that the reported defect was 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 information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.