Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Dose Number: 1, 2, 3; COVID 19 Treatment; Dose Number: 1, 2, 3; 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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 at 14:00 as dose 1, single (Lot number: EL3302), in left arm, on 04Feb2021 at 14:00 as dose 2, single (Lot number: EL9269), in left arm and on 28Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "chronic asthma" (unspecified if ongoing); "borderline high BP" (unspecified if ongoing). Concomitant medication(s) included: PSEUDAFED, start date: 14May2022; ROBITUSSIN DM taken for cough, start date: 14May2022; PROAIR HFA; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 14May2022; FLUTICASONE + SALMETEROL, start date: 14May2022; VICTOZA, start date: 14May2022; METFORMIN, start date: 14May2022; MONTELUKAST, start date: 14May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Dose Number: 1, 2, 3; COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Clinical course: Patient received covid vaccine and Other medication in 2weeks. Other medication details were as reported. Patient had no Known allergies. Patient took Paxlovid for COVID 19 treatment from 15May2022 to 20May2022. Adverse event reported as Rebound symptoms of Covid-19 after finishing plaxlovid. Adverse start date: 25May2022 at 07:00 AM. If patient was Recovering and no treatment received for Rebound symptoms of Covid-19. Conclusion: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EL3302, EL9269 and FF2590 as 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 EL3302, fill lot EL3300, and the formulated drug product lot EL3299 and lot EL9269, fill lot EL9260, the bulk formulated drug product lot EL9251 and lot FF2590, fill lot FF2559, and the bulk formulated drug product lot FE5320. 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.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.