Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive less than three (3) weeks after the booster shot; I tested positive less than three (3) weeks after the booster shot; 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 50-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, 0.3 ml single (Lot number: EW0164, Expiration Date: 30Aug2021), in left deltoid, on 04May2021 as dose 2, 0.3 ml single (Lot number: EW0182, Expiration Date: 31Aug2021), in left deltoid and on 18Nov2021 as dose 3 (booster), 0.3 ml single (Lot number: FF2593, Expiration Date: 31Dec2021) at the age of 50 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA taken for immunisation, start date: 26Oct2021, stop date: 26Oct2021. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 16Jan2022, outcome "unknown" and all described as "I tested positive less than three (3) weeks after the booster shot". The patient underwent the following laboratory tests and procedures: Body temperature: (16Jan2022) 97.5 Fahrenheit, notes: Celsius: 36.4; (17Jan2022) 97.6 Fahrenheit, notes: Celsius: 36.4; (17Jan2022) 97.6 Fahrenheit, notes: Celsius: 36.4; (18Jan2022) 96.9 Fahrenheit, notes: Celsius: 36.1; (18Jan2022) 96.9 Fahrenheit, notes: Celsius: 36.1; (19Jan2022) 97.1 Fahrenheit, notes: Celsius: 36.2; (20Jan2022) 97.2 Fahrenheit, notes: Celsius: 36.2; (21Jan2022) 97.3 Fahrenheit, notes: Celsius: 36.3; (22Jan2022) 97.0 Fahrenheit, notes: Celsius: 36.1; (23Jan2022) 97.2 Fahrenheit, notes: Celsius: 36.2; (24Jan2022) 98.7 Fahrenheit, notes: Celsius: 36.7; (25Jan2022) 98.7 Fahrenheit, notes: Celsius: 37.1; (26Jan2022) 97.1 Fahrenheit, notes: Celsius: 36.2; Oxygen saturation: (13Jan2022) 97 %; (17Jan2022) 95 %; (18Jan2022) 97 %; (19Jan2022) 98 %; (20Jan2022) 98 %; (21Jan2022) 98 %; (22Jan2022) 98 %; (23Jan2022) 100 %; (24Jan2022) 96 %; (25Jan2022) 96 %; (26Jan2022) 96 %; SARS-CoV-2 test: (09Jan2022) Negative; (16Jan2022) Positive.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EW0182 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 EW0182, lot FF2593 and lot EW0164 , fill lot EP8696, lot FF5584 and EP8733, and formulated drug product lot EP8614, lot EP8593 and lot FA9147. A complaint sample was not returned. 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.  Clinical course: This is a notification generated from the RA 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 nvestigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in RA #and/or #. Refer to the below table for details.   No follow-up attempts are possible. No further information is expected.