Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 antibody test
Clinical narrative: Tested Positive for Covid 19; Tested Positive for Covid 19; Dose 1 on 09Mar2021 (Batch/Lot Number: EN6199) as DOSE 1, SINGLE, and dose 2 on 09Mar2021 (Batch/Lot Number: ER8732) as DOSE 2, SINGLE; This is a spontaneous report from a non-contactable consumer (Patient). A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: EN6199) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: ER8732) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient did not have other vaccine in four weeks. Patient did not had covid prior vaccination. Patient tested covid post vaccination. The patient tested positive for covid 19 on an unspecified date, Patient received Dose 1 on 09Mar2021 (Batch/Lot Number: EN6199) as DOSE 1, SINGLE, and dose 2 on 09Mar2021 (Batch/Lot Number: ER8732) as DOSE 2, SINGLE (Inappropriate schedule of vaccine administered). Lab test included Covid 19: Positive on unspecified date. The outcome of the event was unknown. Conclusion of Previously Completed Investigation stated that the complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6199 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 EN6199, fill lot EN5331, and the formulated drug product lot EN5320. A complaint sample was not returned, and photographs were not received. No related quality issues were identified. QA Review and Rationale included that the complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot EN6199 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot EN6199 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Summary of Investigation stated that 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 EN6199, fill lot EN5331, and the formulated drug product lot EN5320. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer (Site name) 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 results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. The product requires storage in ultra-low temperature freezers. A review of the temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. Other Conclusion was that the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6199 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 EN6199, fill lot EN5331, and the formulated drug product lot EN5320. 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. The scope of this investigation included the reported finished goods lot EN6199, fill lot EN5331, and the bulk formulated drug product EN5320. 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. The bulk manufacturing and fill batch records for the complaint batch were reviewed as part of this investigation and were 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. 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 Packaging Operations 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. The Pfizer-BioNTech COVID-19 Vaccine vials are loaded into trays containing 195 vials each. Five trays are then banded together into a bundle. The vaccine requires ultra-low temperature freezer storage. Prior to loading, freezer temperatures were verified to between -67C and -73C. Freezer shelves were then loaded with bundles of product. During the freezing phase, which occurs 60 hours after loading, the temperature of the freezers is monitored. If the temperature is warmer than the previously recorded temperature, supervision is notified. Additionally, after the freezer temperature drops below -60C, the temperature recorded may be warmer due to the freezer operation caused by the freezer cycling. This is acceptable. A review of the log for the reported batch confirmed that all freezer temperatures acceptable. Samples are then stored until the product is released for distribution. 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. The complaint history for the reported PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN6199 was reviewed. As of 12May2021, this is the only complaint that has been received for this lot and classification. No lot specific trend was identified that would require additional investigation. There were no lot trend actions taken as a result of this investigation. These fields are provided for investigating sites to document other trending requirements as needed. (i.e., A review of Site Investigations related to the lot(s) in scope, and any broader trend investigations related to this Complaint, etc.).  No follow-up attempts are possible. No further information is expected.