Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: breakthrough Covid positive through PCR test; breakthrough Covid positive through PCR test; This is a spontaneous report from a contactable consumer (patient).A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 12:00 PM as a single dose and dose 2 via an unspecified route of administration, administered in Arm Left at public health clinic/facility on 01Apr2021 at 12:00 PM (Batch/Lot Number: ER8737; Expiration Date: 31Jul2021) as a single dose for COVID-19 immunization (at the age of 67-years-old). Medical history included atrial fibrillation, Heart arrhythmias, perianal fistula, and seasonal asthma. Concomitant medications included sotalol (SOTALOL), apixaban (ELIQUIS), cyanocobalamin (VIT B12), colecalciferol (VIT D3), and magnesium (MAGNESIUM) taken for an unspecified indication. The patient previously took mobic and chlorhexidine and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 since the vaccination. The patient had not taken any treatment for reported events. On 11Aug2021, the patient experienced breakthrough covid positive through pcr test (vaccination failure) and (covid-19). On 02Apr2021 at 15:00, the patient experience flu like symptoms, fever, chills, severe headache, body aches. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): positive on 11Aug2021. The outcome of the events breakthrough covid positive through pcr test (vaccination failure) and (covid-19) was unknown. The outcome of the event fever was recovered on 03Apr2021. The outcome of the other events was recovered on an unspecified date in 2021.  Conclusion of Previously Completed Investigation (Lot: EN6202): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6202 was 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 EN6202, fill lot EN5334, and the formulated drug product lot EN5323. 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.  Conclusion of Previously Completed Investigation (Lot: ER8737): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8737 was 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 ER8737, fill lot EW3426, and the formulated drug product lot EP8586. 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.