Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got sick with COVID virus; got sick with COVID virus; This is a spontaneous report from a contactable consumer reporting for herself. A 87-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 14:00 (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as dose 2, single, dose 1 via an unspecified route of administration, administered in Arm Right on 25Jan2021 08:00 (Batch/Lot Number: EL9261; Expiration Date: 31May2021) as dose 1, 0.3 ml single for (at the age of 86 years old) covid-19 immunization at clinic. Medical history included breast cancer from an unknown date and unknown if ongoing (treated for breast cancer since 6 years ago: mastectomy 6 years ago and then cancer reoccurred two years ago in 2019 and she started IBRANCE). Concomitant medication included palbociclib (IBRANCE) taken for breast cancer from 2019 and ongoing. Patient did not receive other vaccine within 4 weeks of COVID vaccine. No Adverse events (AE) following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer Suspect. Family Medical History Relevant to AE(s) was none. The patient experienced got sick with covid virus on 15Aug2021. Event reported as, she got sick with COVID virus two weeks ago on 15Aug2021 (Drug ineffective) and her 14 days was completed. She feels she was fully recovered. She knew other people who got it and it was not that bad. Relevant Tests was none. The patient did not visit Emergency Room or Physician Office due to adverse events. Outcome of the events was recovered on 27Aug2021.  Investigation results included: the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EL9261 was investigated. The investigation included reviewing manufacturing and packaging batch records, release test results, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EL9261, fill lot EL9252, and the bulk formulated drug product EL9243. 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 were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6201 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 EN6201, fill lot EN5333, and the formulated drug product lot EN5322. 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.   Follow-up attempts are completed. No further information is expected.