Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a Contactable consumer. This consumer reported for a 46-year-old male patient (husband) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6204) via an unspecified route of administration on 08Apr2021 on right arm (at 46-year-old) as dose 1, single and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8736) via an unspecified route of administration on 29Apr2021 at 08:00 hours on right arm (at 46-year-old) as dose 2, single for COVID-19 immunization. Medical history included ongoing hypertension. Concomitant medications included losartan potassium (Cozaar) taken for hypertension and hydrochlorothiazide taken for hypertension. It was mentioned that history of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the pfizer suspect were reported as none. The prior vaccinations (within 4 weeks), events following prior vaccinations and family medical history relevant to events were reported as no. On 14Jul2021 the patient underwent lab tests and procedures which included sars-cov-2 test: positive, it was mentioned that patient had come down with covid after having been vaccinated also (vaccination failure) and covid-19 (medically significant). The patient did not require emergency Room visit, but needed urgent care at physician office. It was mentioned that COVID diagnosis was given to him yesterday using a rapid test. The also had a PSRN molecular test but that will take a few days, those results are not back yet. It was assumed he has it though, since she was already positive. He was given steroids to treat. The patient had not recovered. Product Complaint:This report included that: This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6204 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 EN6204, fill lot EN5335, and the formulated drug product lot EN5325. A complaint sample was not returned, and photographs were not received. No related quality issues were id. It was mentioned that investigation was required. Description of complaint: Covid 19 Vaccine, Lack of Effect: Caller calling for information, but reports that she tested positive to Covid after the second vaccinations. Evaluation Comment: Pfizer (site name) reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid and an investigation will be performed. 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 related to lot EN6204 of PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot EN6204 pending review of lot genealogy. The investigation will include a include a review of the returned complaint sample (if received) and reserve samples, if necessary. Investigation findings: 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 EN6204, fill lot EN5335, and the formulated drug product lot EN5325. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer (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. 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. Company Quality Operations 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 Company site. 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. Special or Common Cause: Common Cause Root Cause is always present to some degree in the process. Special Cause Root Cause is something different happening at a certain time or place in the process. 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 EN6204 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 EN6204, fill lot EN5335, and the formulated drug product lot EN5325. 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 EN6204, fill lot EN5335, and the formulated drug product lot EN5325. 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. Review Q9 Findings: The results of all tests and inspections met required specifications at the time of release for distribution on 18Feb2021. DEVIATIONS: Complete -Acceptable There were no deviations or unusual incidents associated with the manufacture of the lot which may have resulted in a complaint of this nature. MANUFACTURING BATCH RECORDS: Complete -Acceptable The manufacturing 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. 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 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. A review of the audit results for the reported lot confirmed that all specifications were met. All labeler, tray label grader, and barcode grader checks and challenges passed at the beginning and end of the lot. 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 -67°C and -73°C. Freezer shelves were 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 was notified. Additionally, after the freezer temperature drops below -60°C, the temperature recorded may be warmer due to the freezer operation caused by the freezer cycling to maintain the freezer set point, which is acceptable. A review of the log for the reported batch confirmed that all freezer temperatures were acceptable. Samples are then stored until the product is released for distribution. There were no issues recorded during the packaging or storage process which may have impacted the potency of the drug product. LOT HISTORY: Complete -Acceptable The results of all tests and inspections met required specifications at the time of release for distribution on 18Feb2021. Reserve Sample Testing Result: 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. Lot Trend Assmt. & Rationale: The complaint history for the reported PFIZER-BIONTECH COVID-19 VACCINE lot EN6204 was reviewed. As of 7Apr2021, there are a total of 2 complaints 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. Follow-up attempts are completed. No further information was expected.