Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from contactable consumer. This consumer reported similar events for 37 patients. This report is for 23rd of 37 patients. This consumer reported for a 65-year-old female patient. A 65-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE,Formulation:Solution for injection Lot Number: EN5318 Expiration date: 31May2021) via an unspecified route of administration on 06Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EJ1686 Expiration date: 31Mar2021) via an unspecified route of administration on 16Jan2021 as dose 1, single for COVID-19 immunisation. Age at time of onset of reaction/event was 65 years. On 29Jul2021, the patient tested positive for Covid virus, after being fully vaccinated, longer than two weeks after both doses. The patient underwent lab tests and procedures which included BMI resulted as 24.3 on an unspecified date, NAAT COVID test resulted as positive on 29Jul2021. The clinical outcome of the events was unknown. She states they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their 37 breakthrough cases had received. Product Quality Complaints report concluded that: Conclusion of Previously Completed Investigation: this lot Adverse Event Safety Request for Investigation and/or Lack of Effect was previously investigated. TA 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 5585551 (see File attachment in this investigation record) The complaint for a positive COVID test after vaccination of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, 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 EJ1686. A complaint sample was not returned. No related quality issues were identified during the investigation. Product Quality Complaints report concluded that: this lot Adverse Event Safety Request for Investigation and/or Lack of Effect was previously investigated. TA 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 5585551 (see File attachment in this investigation record) The complaint for a positive COVID test after vaccination of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, 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 EJ1686. A complaint sample was not returned. No related quality issues were identified during the investigation.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients