Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Pain, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: she had aches and pains; She had the second dose Wednesday 10Feb2021 and her positive COVID test was 12Feb2021; She had the second dose Wednesday 10Feb2021 and her positive COVID test was 12Feb2021; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (BNT162B2), the first dose via an unspecified route of administration and unspecified date (Batch/Lot Number: E13247, expiry date: 31May2021) and second dose via an unspecified route of administration on 10Feb2021 (Batch/Lot Number: EM9809, expiry date: 30Jun2021) as SINGLE DOSE both for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient is calling about the COVID 19 vaccine. She knows that she read after she got vaccine that you can't get COVID. She got the second dose Wednesday (10Feb2021) and she was supposed to be having surgery this week so she had a COVID test 2 days after (12Feb2021) her second dose and to her surprise they called her and told her it was positive which she finds very hard to believe. She wants to know is it possible that it could be a false positive because she had a reaction following the second dose. The following day she had aches and pains. She did not have fever and by the evening the aches and pains were gone. She is very careful that she knows of she has not been around anyone that had it and she does not see anybody if she goes to the store everyone is double masked and everything so it is hard to believe. She has been tested before and she has always been negative (unspecified date). Even though she has read it is not possible, she wants to see if someone could have a false positive after the Pfizer second dose recently. It was added that she had the second dose Wednesday 10Feb2021 and her positive COVID test was 12Feb2021. The patient asks if there have been reports like that. People don't have a reason to take test after getting the vaccine she just got one because she was having a procedure. The outcome of the event had aches and pains was recovered and for all other events was unknown.   On 02Mar2021 the product quality complaints group reported investigation reports (for Pfizer-Biontech Covid-19 Vaccine Injectable (SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1): Lack of Effect). It was reported that investigation was required. The sample of the product was not available to be returned. It was reported (RESPONSE FROM employee: Per attached CONS) the covid-19 vaccine will not make you test positive for the infection, the COVID-19 vaccine might not protect everyone, the efficacy information sated that the vaccine has a 95% efficacy 7 days after the second dose. Referred to her physician for treatment recommendations. No reasonably suggest device malfunction. Severity of Harm and Failure Mode: N/A. FPRS Evaluation Comment: Pfizer 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. No repeat investigation, no CAPA previously identified, and full investigation Required. 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 EM9809 of the PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot EM9809 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. The final scope was expanded to include the reported finished goods lot EM9809, fill lot EM9807, and the formulated drug product lot EM9805. 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/CAPA: not process/ vendor related and Final Confirmation Status: Not Confirmed. Root Cause Analysis/Identif: 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. 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. Improve/Control: 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. It was concluded that: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EM9809 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 EM9809, fill lot EM9807, and the formulated drug product lot EM9805. 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): The scope of this investigation included the reported finished goods lot EM9809, fill lot EM9807, and the bulk formulated drug product EM9805. 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. Document Review Summary: DEVIATIONS, MANUFACTURING BATCH RECORDS, PACKAGING BATCH RECORDS, and LOT HISTORY were complete (Acceptable).  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. No confirmed Reserve Defect. Lot Trend Actions Taken: There were no lot trend actions taken as a result of this investigation. Sample site status was not received.