Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for Covid19 on 19Jul2021/COVID-19 confirmed by positive COVID-19 test; I tested positive for Covid19 on 19Jul2021/COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 28-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247, Expiration date: 31May2021) intramuscular, administered in left arm on 19Jan2021 at 13:15 pm (age at vaccination was 28 years) as dose 1, single for COVID-19 immunization and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247, Expiration date: 31May2021) intramuscular, administered in right arm on 08Feb2021 at 11:45 am (age at vaccination was 28 years) as dose 2, single for COVID-19 immunization. The patient's medical history acute gastritis. The patient had no allergies. The other medications the patient received in two weeks included Once a day Men's Multivitamin. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Jul2021 at 12:00 pm, the patient developed symptoms of congestion, cough, runny nose, head and muscle aches and loss of smell and taste) of COVID-19 which got worsened on 16Jul2021. The symptoms started to decrease each day after but the patient tested positive for COVID-19 on 19Jul2021. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab test Lumiradx Sars-Cov-2 AG, nasal swab: positive and COVID-19 test: positive on 19Jul2021. No treatment was received for the adverse events. On Document 20Jul2021, the report from Quality Complaints was reported. 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. Product Description (CR): Compound BNT162 Covid-19 Vaccine Suspension for Intramuscular 2ml Multiple Dose Vial X 1. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE Lot EL3247 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 EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified. Fill Date: This is the date the formulation product is filled into the primary container 05Dec2020. Package Date: This is the start date when the finished product is packaged into the commercial presentation 07Dec2021. (Parent) evaluation comment included 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. QA Review & Rationale included this is a complaint for lack of effect of lot EL3247 of product PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. 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. The initial scope of this investigation is limited to EL3247 pending review of lot genealogy to determine other in-scope lots. The investigation will include a include a review of the returned complaint sample (if received) and reserve samples, if necessary. A full investigation will be performed. Reviewed on: 01Mar2021. Investigation findings: Summary of Investigation included 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 EL3247, fill lot EL3230, and the formulated drug product lot EL3223. 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. Root Cause Analysis/Identified included Pfizer (Site name) 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 Pfizer (site name). Impact Analysis included 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 included 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 included the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3247 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 EL3247, fill lot EL3230, and the formulated drug product lot EL3223. 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. Batch/Process record review: Scope of Compl. Investigation included the scope of this investigation included the reported finished goods lot EL3247, fill lot EL3230, and the bulk formulated drug product EL3223. 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. There was one deviation recorded that was related to the in-scope lots. Event report # was initiated after a process engineer discovered a warped vent filter on the Bioburden Reduction (BBR) pathway. There is no quality impact as a result of this incident because there is downstream bioburden reduction filtration and 2x sterile filtration from this point in the process. Additionally, Bioburden results from the sample taken post BBR and pre-dilution were acceptable. The batch remains acceptable for use. 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 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 -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 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. Lot History: Complete-Acceptable. The results of all tests and inspections met required specifications at the time of release for distribution on 10Jan2021. Rsrv. Sample Eval. Rationale included visual examination of a reserve sample would not be expected to indicate the potency of the drug product. 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 included the complaint history for the reported PFIZER-BIONTECH COVID-19 VACCINE lot EL3247 was reviewed. As of 12Mar2021, there were a total of four complaints for this lot and classification. No lot specific trend was identified. Lot trend actions taken included there were no lot trend actions as a result of this investigation. The outcome of the events was resolving.  Follow-up attempts are completed. No further information is expected.