Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: high fever; body and muscle pain; body and muscle pain; Looks like she has Covid; This is a spontaneous report from a contactable consumer (husband). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 14:45 (Batch/Lot Number: EN6208; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history included ongoing diabetes and high blood pressure. Concomitant medication included metformin taken for diabetes, ongoing from an unknown date. It was reported that consumer and his wife received the COVID-19 vaccine. consumer is fine. He is reporting on his wife. On Saturday, she felt well. 24 hours later on 28Mar2021, patient experienced high fever, had body and muscle pain. Patient still has fever and pain that comes and goes. On an unknown date in Mar2021, patient looks like she has COVID and it is not good. On 24Mar2021 patient had COVID-19 test, which shows negative results, which was prior to vaccination. These adverse events did not require any visit to emergency Room nor physician office. The patient did not receive any prior vaccinations within 4 weeks. The outcome of the event looks like she has COVID was unknown. The outcome of rest all the events was recovering.   Description of Product Complaint: Description of complaint: wife looks like she has Covid and it is not good. Was tested prior to getting the vaccine and was negative  QA Review & Rationale: 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 EN6208 of the Pfizer-BioNTech Covid-19 Vaccine Injectable. The initial scope of this investigation is limited to the reported finished goods lot EN6208 pending review of lot genealogy. The investigation will 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 EN6208, fill lot EN5338, and the bulk formulated drug product lot EN5329. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records were examined for the reported complaint batch. Pfizer (Site name) 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). Root Cause Analysis/Identif: 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 meets potency specifications. It is unknown how the product was handled, stored, or administered after it left the (Site name). 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. Root Cause Category (Tier 1): Non-assignable (Complaint Not Confirmed)  Corrective / Preventive Action: 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 Injectable lot EN6208 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 EN6208, fill lot EN5338, and the formulated drug product lot EN5329. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Scope of Compl. Investigation: The scope of this investigation included the reported finished goods lot EN6208, fill lot EN5338, and the bulk formulated drug product lot EN5329. 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. Therefore, the scope was not expanded   No follow-up attempts are possible. No further information is expected.