Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: Tested positive for COVID Virus; Tested positive for COVID Virus; Lost a little sense of taste; Chest cold; 3rd dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 (Lot number: FA7484) at the age of 41 years as dose 3 (booster), single, administered in arm left, administration date 11Feb2021 11:00 (Lot number: EL9269) as dose 2, single and administered in arm left, administration date 21Jan2021 10:00 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 09Oct2021, outcome "unknown", described as "3rd dose"; VACCINATION FAILURE (medically significant) with onset 14Dec2021 09:45, outcome "unknown", COVID-19 (medically significant) with onset 14Dec2021 09:45, outcome "not recovered" and all described as "Tested positive for COVID Virus"; AGEUSIA (non-serious) with onset 14Dec2021 05:00, outcome "not recovered", described as "Lost a little sense of taste"; LOWER RESPIRATORY TRACT INFECTION (non-serious) with onset 14Dec2021 05:00, outcome "not recovered", described as "Chest cold". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Dec2021) positive.  Clinical Course: Patient lost a little sense of taste and has a chest cold and that was all he really feels. The COVID was going around his job and he thought he should get tested. Events neither required Emergency Room and Physician Office visit nor hospitalization. He had a rapid COVID test not a PCR test. He went to an urgent care. No further details provided, just that it was a positive result. Medical History (including any illness at time of vaccination) and family Medical History Relevant to AE(s) were none. Prior Vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations were none.   This is a notification generated from the withheld system. 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 withheld and/or withheld. 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. Investigation results from product quality group:  Lot-# (CR); EL3247 (Dose 1) Conclusion of Previously Completed Investigation (FCI/SI/OffCI):  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/prevent ative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Lot-# (CR); EL9269 (Dose 2) Conclusion of Previously Completed Investigation (FCI/SI/OffCI):  The complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EL9269 , fill lot EL9260, the bulk formulated drug product lot EL9251. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed.  Lot-# (CR); FA7484 (Dose 3) Conclusion of Previously Completed Investigation (FCI/SI/OffCI):  The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FA7484 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FA7484, fill lot ET8457, and the bulk formulated drug product lot FA9188. 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.