Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive on 29Jan/she contracted Sars-Cov-2 infection before her second dose on 04Feb2021; tested positive on 29Jan/she contracted Sars-Cov-2 infection before her second dose on 04Feb2021; This is a spontaneous report from a contactable consumer (the patient) via the Pfizer Sponsored Program.  A 69-year-old female patient started to receive the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3302), via an unspecified route of administration on 14Jan2021 (at the age of 69-years) as a single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On 29Jan2021 the patient tested positive/she contracted sars-cov-2 infection before her second dose on 04Feb2021. The patient inquired as to how long she needed to wait before receiving her second dose. The patient had lab tests and procedures which included sars-cov-2 test: positive on 29Jan2021. The clinical outcome of the patient tested positive/she contracted sars-cov-2 infection before her second dose on 04feb2021 was unknown. On 23Feb2021, the investigation results was received from a company. The product is BNT162B2, Lot #: EL3302, Expiry: 31May 2021. Reasonably Suggest Device Malfunction was reported as No. Severity of Harm was N/A. Site Sample Status: Not Received. Confirmed Complaint Sample Defect  Not Received. 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 EL3302, fill lot EL3300, and the formulated drug product lot EL3299. Manufacturing and packaging batch records were reviewed for the reported complaint lot. The company 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. 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 continues to meet potency specifications. Root Cause Analysis:  a company could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. Review of the manufacturing and packaging batch records and release test results confirmed that the batch continues to meet potency specifications. It is unknown how the product was handled, stored, or administered after it left the (name). Impact Analysis: Based on the results of this investigation, the manufacturing and packaging batches remain acceptable and the reported complaint is not representative of the lot. No regulatory notification is needed. Corrective/Preventive Action: There were no corrective actions as a result of this complaint investigation. The results of all tests, inspections, and in-process controls have been reviewed and all results met the established requirements prior to the release of the reported batch for distribution. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3302 as 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 EL3302, fill lot EL3300, and the formulated drug product lot EL3299. 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. Scope of Complaint Investigation: The scope of this investigation included the reported finished goods lot EL3302, fill lot EL3300, and the bulk formulated drug product EL3299. Acceptable review of related documentation, including manufacturing 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. Manufacturing Batch Records: Complete - Acceptable. The bulk manufacturing batch record for the complaint batch was reviewed as part of this investigation and found to be acceptable. All processing steps were performed within pre-established parameters. The review of the manufacturing record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. All raw materials used in the complaint batch were of the correct weight and identity. All the manufacturing temperatures mix speeds and mixing times were within acceptable ranges. In-process appearance and specific gravity test results were all within acceptable ranges. A review of the solution filtration documentation confirmed that all materials, filters and Water for Injection (WFI) were used within their expiration dates, and that all the filtration times, pH results, and pressure specifications were met. The manufacturing processes of raw material usage, solution formulation and filtration were all found to be acceptable. All manufacturing parameters met established requirements. A log is maintained throughout the manufacturing process of the amount of elapsed time that the product is out of refrigeration. A review of the elapsed time tracking logs confirmed that all times were within allowable limits. Packaging Batch Records: Complete - Acceptable: The review of the packaging record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. Audits are performed on the finished packaged units by  personnel at regular intervals throughout the final packaging process. This is done in order to ensure that all required labeling and packaging is present, complete, and meets all establishments requirements. During the audits, inspectors visually check the appearance of the finished product for defects. Reserve Sample Testing Result: A reserve sample was not sent to the 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. Confirmed Reserve Defect: No. Lot Trend Assessment & Rationale: The complaint history for the reported PFIZER-BIONTECH COVID-19 VACCINE lot EL3302 was reviewed. As of 19Feb2021, there is one complaint for this lot and classification. No lot specific trend was identified that would require additional investigation. Lot Trend Actions Taken: There were no lot trend actions taken as a result of this investigation.