Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: I had a fever; bad headache; sore throat; coughing; got very little sleep last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Lot number: FH8020) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Lot Number: EL9264), administration date: 28Jan2021, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Lot Number: EL9266), administration date: 20Feb2021, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "I had a fever"; HEADACHE (non-serious) with onset 2022, outcome "recovered" (2022), described as "bad headache"; COUGH (non-serious) with onset 2022, outcome "unknown", described as "coughing"; INSOMNIA (non-serious) with onset 2022, outcome "unknown", described as "got very little sleep last night"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive, notes: patient tested positive today, 04May2022, for COVID-19. It was reported that, patient tested positive today, 04May2022, for COVID-19. Patient had previously been vaccinated and boosted with the Pfizer BNT vaccine. Event took place after use of product. Patient was not feeling well today at the time of the report and will be offline. Patient wanted to share that he had tested positive for Covid-19 and will likely be offline for the rest of the week. It was reported that, yesterday I had a fever, bad headache and sore throat/coughing. I got very little sleep last night, but at least the headache and fever have subsided. I'm going to try and rest today and tomorrow.  Product quality group providing Investigation results for lot FH8020: As part of the  simplification process, the following Complaint Records were classified 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. Refer to the below table for details: AE Ref No.  Product Description (CR): COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCUL AR 2ML MULTIPLE DOSE VIAL was 1  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9264 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 and product type. The final scope included the reported finished goods lot EL9264, fill lot EL9255, and the formulated drug product lot EL9246. A complaint sample was not returned. No related quality issues were identified during the investigation. There was 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.  Product quality group providing Investigation results for lot EL9264: As part of the LOE simplification process, the following Complaint Records were classified as Product  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.   Product Description (CR): COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL was 1 Lot- (CR): EL9264 Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9264 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 and product type. The final scope included the reported finished goods lot EL9264, fill lot EL9255, and the formulated drug product lot EL9246. A complaint sample was not returned. No related quality issues were identified during the investigation. There was 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.   Product quality group providing Investigation results for lot EL9266:  As part of the LOE simplification process, the following Complaint Records were classified as Product 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. Refer to the below table for details:  Product-Description (CR): COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9266 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 EL9266, fill lot EL9257, and the formulated drug product lot EL9248. 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.  When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record.  No follow-up attempts are possible. No further information is expected.  Follow up (04May2022): New information received from a contactable consumer. This consumer reported in response to Non- HCP letter via Email follow-up activity: Updated information included: New events (I had a fever, bad headache, sore throat, coughing. I got very little sleep last night) were added.  No follow-up attempts are possible. No further information is expected.  Follow-up (06May2022): This is a follow-up spontaneous report from product quality group providing investigation results. This report included that: Updated Information Included: Batch and lot tested and found within specifications was checked.( All release testing performed prior to the release of the reported batch was within specifications.). Additional Information: This is a notification generated from the  system.   Follow-up (06May2022): This is a follow-up spontaneous report from product quality group providing investigation results. This report included that: Additional Information: This is a notification generated from the system.  Follow-up (09May2022): This is a follow-up report from product quality group providing investigation results. This report included that: Updated information included: Batch/lot tested found within specifications ticked in product tab and investigational results were updated in narrative.  Follow-up attempts completed. No further information expected.  Follow-up (15May2022): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included:  Updated information included: Dose 1 and 2 captured as Historical Vaccine. Events "Vaccination failure" and "Covid-19" removed as this case is for dose 3 with events insomnia, pyrexia, headache, cough, oropharyngeal pain as the events occurred in 2022 after dose.