Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: achy; tested positive for the Coronavirus after receiving the Covid 19 vaccine; tested positive for the Coronavirus after receiving the Covid 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 30Jan2021 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Batch/Lot Number: EL9264; Expiration Date: 31May2021) as single dose, both at the age of 31-year-old for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination) was none. Predisposing factor included Contact with infected person (She was in contact with the person who had the Coronavirus on 11Jul2021). There were no concomitant medications. The patient did not receive any additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient did not have any AE(s) following prior vaccinations. The patient reported that she and some friends got the Coronavirus after being exposed to it and she and her friends all had received the Covid 19 vaccine. She reports 4 people who were together for a couple hours. She was in contact with the person who had the Coronavirus on 11Jul2021. She tested positive for the Coronavirus on 14Jul2021. She reported being achy on an unspecified date. The AE(s) did not require a visit to Emergency Room or Doctor's office. Outcome of the events was unknown.  Summary and Conclusion of product quality Investigation of lot EN5318: The initial scope of the investigation was limited to the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records were examined for the reported complaint batch. Pfizer (city) QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. No probable root cause for the complaint related to the manufacturing process of the reported lot was identified. There were no corrective actions taken as a result of this complaint investigation. No related quality issues were identified during the investigation. 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. All raw materials and amounts used in the manufacture of the 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. There was no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left the (city) site. The complaint for lack of effect of the Pfizer-biontech Covid-19 vaccine injectable lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. 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.  Summary and Conclusion of product quality Investigation of lot EL9264: 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. Pfizer (city) 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. 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.  Follow-up attempts are completed. No further information is expected.