Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: This is a spontaneous report from a sponsored program via a consumer (patient). A 44-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP7533, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 25Mar2021 (age at vaccination was 43 years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 15Apr2021 (age at vaccination was 43 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received both COVID 19 vaccines, one in Mar2021 and the other in Apr2021. On 27Jul2021, the patient was COVID positive and tested positive for COVID. She really wanted to know if she could receive a 3rd dose asap when she was COVID negative without waiting 6 months after her last dose. She had a question about getting a third dose when she was negative. She cannot go through that again. It had been awful. There are six people in her house, and they all got COVID. She and her husband both got COVID and were both vaccinated. She did not have a prescribing doctor. After the second vaccine, she didn't feel anything at all. The adverse events did not require a visit to Emergency Room or Physician Office. The patient underwent lab tests which included SARS-COV-2 test: positive on 27Jul2021. There was a Product Complaint. Product-Description: COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 Lot# ER8735. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot ER8735 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. Analytical release test results were also reviewed. The final scope included the reported finished goods lot ER8735, fill lot EP8687, and 6040511 the formulated drug product lot EP8574. A complaint sample was not returned, and photographs 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 EP7533, fill lot EP7531, and the bulk formulated drug product lot EP7527. A complaint sample was not returned. No related quality issues were identified. Product Complaint Exchange had the vaccine double shot. And I have the COVID I feel really bad asthma is chronic now. Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE-ER8735- Lack of Effect. This record will not require further investigation as the Lot reported has been previously investigated as part of ID 5881105 and the following is the Conclusion of the field from that investigation. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8730 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 ER8730, fill lot EP8682, and the formulated drug product lot EP8569. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root causes were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. 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 ER8735 of PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot ER8735 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. 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 ER8735, fill lot EP8687, and the formulated drug product lot EP8574. Manufacturing and packaging batch records were reviewed for the reported complaint lot. 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 or preventative 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 is no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left the site. Quality 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 site. Impact Analysis Based on the final scope of the investigation, which was limited to the reported finished goods lot and associated fill and formulated drug product lots, and that a root cause related to the production process was not identified, the reported issue is not representative of the lot and does not indicate a negative impact on product quality. No regulatory notification is required. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8735 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. Analytical release test results were also reviewed. The final scope included the reported finished goods lot ER8735, fill lot EP8687, and the formulated drug product lot EP8574. 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 causes 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 ER8735, fill lot EP8687, and the bulk formulated drug product EP8574. 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. Therefore, the scope was not expanded. Lot history Completed, Acceptable. The results of all tests and inspections met required specifications at the time of release for distribution on 19Mar2021. 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. The complaint history for the reported PFIZER-BIONTECH COVID-19 VACCINE lot ER8735 was reviewed. As of 21Jun2021, this is the only complaint for this lot and classification. No lot specific trend was identified that would require additional investigation. Product-Description (CR): COMPOUND BNT162 COVID-19VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1, Lot-#EP7533. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot ER8735 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. Analytical release test results were also reviewed. The final scope included the reported finished goods lot ER8735, fill lot ER8735, and 6040511 the formulated drug product lot ER8735. A complaint sample was not returned, and photographs 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 EP7533, fill lot EP7531, and the bulk formulated drug product lot EP7527. A complaint sample was not returned. No related quality issues were identified. Reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid and a review of the lot 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 of lot EP7533 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot EP7533, fill lot EP7531, and the formulated drug product lot EP7527. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot EP7533, fill lot EP7531, and the bulk formulated drug product lot EP7527. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records were examined for the reported complaint lot. 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 or preventative 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 is no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left the site. 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 meets potency specifications. It is unknown how the product was handled, stored, or administered after it left the site. Based on the final scope of the investigation, which was limited to the reported finished goods lot and associated fill and formulated drug product lots, and that a root cause related to the production process was not identified, the reported issue is not representative of the lot and does not indicate a negative impact on product quality. No regulatory notification is required. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EP7533 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 EP7533, fill lot EP7531, and the bulk formulated drug product lot EP7527. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root causes 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 EP7533, fill lot EP7531, and the bulk formulated drug product lot EP7527. 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. MANUFACTURING BATCH RECORDS (Lot# ER8735 and Lot# EP7533): Completed, Acceptable. The bulk and fill 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. 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 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 (Lot#ER8735 and Lot#EP7533): Completed, 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 degree C and -73 degree C. 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 -60 degree 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 quality of the batch and potency of the drug product. 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. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.