Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: Covid 19 PCR swab positive; Covid 19 PCR swab positive; dose 1 on 18Dec2020, dose 2 on 18Feb2021; dose 1 on 18Dec2020, dose 2 on 18Feb2021; This is a spontaneous report from contactable nurse and a consumer. The reporter reported similar events for different patients. This is 7th of the 11 reports.  A 60-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscularly administered in right deltoid on 18Dec2020 (Batch/Lot Number: EH9899) as single dose, dose 2 intramuscularly administered in right deltoid on 18Feb2021 (Batch/Lot Number: EK9231) as single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, blood cholesterol increased, mitral valve prolapse, seizure; from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for type 2 diabetes mellitus, start and stop date were not reported; atorvastatin calcium (ATORVASTATIN CALCIUM) taken for blood cholesterol increased, start and stop date were not reported; zonisamide (ZONISAMIDE) taken for seizure, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; fenofibrate (FENOFIBRATE) taken for an unspecified indication, start and stop date were not reported. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. No other vaccine within 4 weeks.   The patient had a positive Covid 19 PCR swab test on 30Mar2021. It's unknown if the patient had SARS-CoV2 antibodies at diagnosis. The patient was not hospitalized, not admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness. Supplemental oxygen or mechanical ventilation was not required. These was no new or worsened symptoms/signs during the COVID-19 illness. He had respiratory symptoms including nasal congestion and sore throat, and neurological symptoms including loss of taste and smell since 27Mar2021. No other symptoms. No pre-existing diseases worsened during the SARS-CoV2 infection. The event did not require the initiation of new medication or other treatment or procedure. The event COVID-19 was resolved on an unspecified date.   Product Quality Investigational report conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EH9899 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EH9899, fill lot EH9783, and the formulated drug product lot EH9782. 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.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective, COVID-19, Off label use, Inappropriate schedule of vaccine administered and the suspect drug BNT162B2.,Linked Report(s) : US-PFIZER INC-2021389615 Same reporter/ drug/ event, different patient