Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received the second dose of bnt162b2 (BNT162B2, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left/ Left shoulder area on 11May2021 at 01:00 PM (Batch/Lot Number: EW0164; Expiration Date: 31Aug2021) as a single dose and the first dose via an unspecified route of administration, administered in Arm Left/ Left shoulder area on 03Apr2021 (Batch/Lot Number: ER8737; Expiration Date: 31Jul2021) as a single dose for COVID-19 immunization. Medical history included ongoing gastro reflux (has silent reflux and the doctor put him on a generic form of Prilosec). The patient did not have any family history. The patient's concomitant medications were not reported. Age at time of vaccination was 45 years. The patient had tested positive for rapid COVID antibody test for COVID-19 on 18Jul2021. Patient has had both doses of the Covid vaccines and took a rapid test 2 months afterwards and it came back positive. He wants to know if Pfizer has heard of anything like this before. Patient would like to know if there have been any other reports of people testing positive for COVID-19 after receiving both doses. Patient would like to know if there was any information regarding someone showing a false positive test result on a rapid test for COVID-19. Patient stated he will be going for a blood test to confirm the test result. Patient would like to know if the efficacy of the Pfizer COVID vaccine is 94.8 percent. Stated he was going to have a blood test, since it was more accurate. Thinks his appointment for that was at 11am today. He thought he should go ahead and have the antibody test as well, but then decided to call the source since Pfizer should have this information available, so he decided to call and ask Pfizer if this was something heard of. No further details provided. Got the shots around his birthday. Had the first Covid dose on 03Apr2021 in the left shoulder area at 11am. Unable to provide the NDC, expiry, or dose, but provides Lot number of ER8737. Had the second dose on 11May2021 in the left shoulder area. Unable to provide the NDC, expiry, or dose, but does provide lot number details. No problems with vaccines in past. Had the rapid test yesterday. He went to the (pharmacy name) and got a test kit, but wasn't comfortable about the result since he works in food service and this affects his work. It was the Covid antibody rapid test and it had a 5 digit number behind it. Does not provide any further details. States he does not know if this matters, but he has silent reflux and the doctor put him on a generic form of Prilosec for gastro reflux. No further details provided. The outcome of the event tested positive for COVID-19 was not recovered.  Conclusion of Previously Completed Investigation stated that the complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot EW0164 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0164, fill lot EP8696, and the formulated drug product lot EP8593. A complaint sample was not returned. No related quality issues were identified. QA Review and Rationale stated that the complaint and it was 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 ER8737 of PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot ER8737 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 ER8737, fill lot EW3426, and the formulated drug product lot EP8586. 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. 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 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 name) site. Pfizer (site name) o 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 Pfizer (site name) site. Impact Analysis stated 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. 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 stated the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8737 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 ER8737, fill lot EW3426, and the formulated drug product lot EP8586. 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 ER8737, fill lot EW3426, and the formulated drug product lot EP8586. 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. There were no planned or unplanned deviations recorded during the manufacturing of the reported lot or associated batches that may have caused 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, filter integrity tests, 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. A review of the audit results for the reported lot confirmed that all specifications were met. All labeler, trayer, and tray label 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 celcius and -73 degree celcius. 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 expected freezer temperature, supervision is notified. 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. 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 INJECTABLE lot ER8737 was reviewed. As of 27Apr2021, a total of two complaints have been received for this lot and classification. No lot specific trend was identified that would require additional investigation.