Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) and also received via Pfizer-sponsored program. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 14:30 (Batch/Lot Number: EL3247) and second dose on 13Feb2021 14:30 (Batch/Lot Number: EL9264; Expiration Date: 31May2021) both doses given at the age of 63-year-old via unspecified route of administration administered on arm Left as SINGLE DOSE for COVID-19 immunization at the hospital (auditorium attached to a building at a hospital). Medical history included asthma. Concomitant medications included benralizumab (FASENRA) and budesonide, formoterol fumarate (SYMBICORT) both taken for asthma since unknown dates. The patient mentioned that she got both doses- first dose given 23Jan2021 and 2nd dose on 13Feb2021 2nd dose on 13Feb2021 and she was tested positive for COVID infection on 03Mar2021 (Wednesday). She narrated that she went to the doctor's office because she was having wet sneezes, coughing, tired, loss of taste and smell, and fatigue. The sneezing started either Friday or Saturday evening (26Feb or 27Feb2021). She noticed a little coughing started last week, but it was nothing drastic. The coughing would come and pas through. At times, a cough may take her into a deeper version. Then it would go away. Sometimes she would cough a few times back to back, but it was not constant. From when she first experienced the events, they continued to get worse, like the fatigue (felt more fatigued) and realized something was wrong. At She provided these symptoms to the doctor and the doctor informed her even though she had the vaccine still need to get tested for COVID. She did and she was positive for COVID on 03Mar2021 and started isolation. She does not have not fever (only 96 or 97) and she felt she should have had fever, but never did and her lungs were clear. She was given an antibiotic for my nasal passage. She was also given fluids, hydrate, and rest (would lay in bed). Outcome of the events were unknown.  Investigation results were also received on 10Mar2021 for PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE Lack Of Effect. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot EL9264, fill lot EL9255, and the formulated drug product lot EL9246. Manufacturing and packaging batch records were reviewed for the reported complaint lot. (Site Name) QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. During formulation of PBS Buffer, there was an undercharge of disodium hydrogen phosphate dihydrate, but this was found to have no impact on product quality. All other raw materials used in the complaint batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch meets potency specifications. Not process/vendor related. Final Confirmation Status: Not Confirmed. Batch record review included the reported finished goods lot EL9264, fill lot EL9255, and the bulk formulated drug product EL9246. Acceptable review of related documentation, including manufacturing and packaging batch records and review of release test results at the time of lot release confirmed that there were no issues which may have resulted in a complaint of this nature. Visual examination of a reserve sample would not be expected to indicate the potency of the drug product. A reserve sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months of the release date of the involved batch. The results of all analytical tests performed at the time of lot release were confirmed to be within registered specifications. All available stability results for this product were within registered specification and stability studies (including accelerated studies) are ongoing for this product. No lot trend or other trend identified. As of 10Mar2021, a total of three complaints have been received for this lot and classification. No lot specific trend was identified that would require additional investigation. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9264 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 EL9264, fill lot EL9255, and the formulated drug product lot EL9246. 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.