Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3248), on 11Feb2021 as dose 2, single (Lot number: EL9262) and on 21Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ATORVASTATIN, stop date: 11May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Negative; (11May2022) Positive; (17May2022) Negative; (24May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 12May2022 to 17May2022. Clinical course: Adverse event COVID-19 relapse. Initial symptom onset 10May2022 with negative antigen swab at home same day.11May2022 positive antigen swab at home. Started Paxlovid 12May2022 evening dose. Significant dysgeusia, no other side effects. Symptom reduction was notable after 24-36 hours on Paxlovid, with majority of symptoms resolved and negative home antigen swab on 17May2022. Symptoms started to worsen again evening 22May2022, with positive antigen swab at home 24May2022. Relapse symptoms so far are somewhat milder than initial symptoms (cough, nasal discharge, sneezing, fatigue, myalgias, mild fevers). No shortness of breath at any time. This is a notification generated from the 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 PQS Q1215 and/or Q1252. Conclusion of Previously Completed Investigation: The complaint for a lack of effect in a vial of Pfizer BioNTech covid-19 vaccine was investigated. The investigation included reviewing incoming quality and manufacturing and packaging batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk, and is manufactured, labelled, and packaged by Pfizer (Name withheld). The final scope included the reported finished goods lot 30155BA, lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224, lot EL9262, fill lot EL9253, and the formulated drug product lot EL9244. No related quality issues were identified during the investigation. There is no impact on product quality. An NTM was not issued for the complaint. No regulatory notifications were held because of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to the manufacture or vendor processes as incoming quality component testing and all analytical tests performed at the time of lot release confirmed that the batch met potency specifications. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior to any lot being released to the market. A complaint sample was not returned, and photographs were not received. There 5605231 5585470 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. There were no deviations that may have caused a complaint of this nature.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the Vaccination failure and Covid 19 cannot be completely excluded.