Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EJ1685), in left arm and as dose 2, single (Lot number: EJ1686) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Nov2021 as dose 3 (booster), single (Lot number: 046H21A), in left arm and on 23Apr2022 as dose 4 (booster), single (Lot number: 028X21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN oral; ESCITALOPRAM oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Low grade, notes: I had very little in the way of Covid symptoms initially, just a low grade temp once; SARS-CoV-2 test: (unspecified date) Unknonw results; (unspecified date) Positive, notes: Tested positive on day four via home antigen test; (May2022) Positive, notes: I did a nasal PCR panel and the Covid was positive!. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound Covid. Patient had a significant exposure driving her daughter home from the train on 13May2022. Tested positive on day four via home antigen test. She began Paxlovid and took this for 5 days. No side effects except metal taste (similar to Lunesta). She had very little in the way of Covid symptoms initially, just a low grade temp once. Then today (25May2022) developed runny nose and sore throat. She did a nasal PCR panel and the Covid was positive! Should the Paxlovid be a longer initial course? 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. Product-Description (CR): Compound BNT162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1 with Lot (CR): EJ1685 and Lot (CR): EJ1686.  Conclusion of Previously Completed Investigation: For this lot Adverse Event Safety Request for Investigation and/or Lack of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5646861 and 5585551 respectively. The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ1685 and EJ1686 respectively. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS (withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.