Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID; This is a spontaneous report received from a contactable consumer or other non hcp. A 41-years-old male patient received 1st dose of bnt162b2 (Pfizer COVID19 Vaccine,Solution for injection,Batch/Lot Number: EN6205; Expiration Date: 30Jun2021), via an unspecified route of administration on 09Mar2021 as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced covid on 13Mar2021.The patient underwent lab tests and procedures which included pyrexia: 104, sars-cov-2 test: negative on 08Mar2021 and sars-cov-2 test: positive on 13Mar2021.The caller wanted to report an issue with the vaccine. Her husband was vaccinated back in March2021. Five days later her husband displayed symptoms of COVID. He was tested positive for COVID. She believes the vaccine gave him COVID. She says it was mild COVID because he wasn't on a ventilator.Her husband went to ER to receive the medication.He was tested for covid19 positive after receiving the vaccine 3 days and a week prior.Caller thinks that vaccine is safe but still she thinks Pfizer should be more responsible with this. People are afraid to take the vaccine. For example, if this isn't said that people could develop COVID and then they develop mild COVID then they will be skeptical of the vaccine.Caller clarified that she has not received the vaccine. She is a stay at home mom. She doesn't go out. She Her husband tested so many times prior and 24 hours prior and he got the results while in line.Caller stated that since she has 2 kids and her husband had fever of 104,it was stressful for the family.They have medical bills. Is there a fund for Pfizer to pay the medical bills.She has 300 dollar bill and her husband has 300 dollar bill. She thinks it is the principal. She got COVID from her husband's vaccine. They were not warned for him to quarantine as a precaution. She has been so careful all this time. Follow-up attempts completed. No further information expected. Follow up (16Aug2021): The is a follow-up spontaneous report received from product quality complaints group. This report included about product quality investigation of Pfizer covid vaccine with ,Batch/Lot Number: EN6205.This is a complaint for Lack of Effect of lot EN6205 of product PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. 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.This is a complaint for Lack Of Effect of lot EN6205 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 EN6205 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.Pfizer 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 results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications.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.There were two deviations related to the inscope lots.QAR [Redacted] concerns formulation batch EN5326. The investigation was initiated after a formulation operator, during the removal of the mRNA drug substance bags from a Freeze/Thaw Unit, noticed that two of the four mRNA bags had unthawed material present.Thawing of the mRNA bags requires a target range of 4 to 6 hours at 25 degrees Celsius.QAR 5612677 was initiated after a shift engineer noticed that the product tank temperature was below 2 degrees Centigrade (C), during routine product temperature checks for filling of COVID Vaccine Lot EN5332. Lowest temperature was 1.4 C and was below 2 C for an extended period of time.There is no impact to batch EN5337 even though the tank temperatures were outside the registered critical process control parameter.The 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.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.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°C and -73°C. Freezer shelves were then loaded with bundles of product.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.The complaint history for the reported PFIZER-BIONTECH COVID-19 VACCINE lot EN6205 was reviewed. As of 01Apr2021, a total of two complaints have been received for this lot and classification. No lot specific trend was identified that would require additional investigation.  Follow-up attempts are completed. No further information is expected.