Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: breakthrough infection detected 27Nov (PCR confirmed); breakthrough infection detected 27Nov (PCR confirmed); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jun2021 08:30 (Lot number: EW0217) at the age of 14 years as dose 2, single and administered in arm left, administration date 15May2021 08:30 (Lot number: EW0186, Expiration Date: 31Aug2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Nov2021, outcome "recovering" and all described as "breakthrough infection detected 27Nov (PCR confirmed)". The event "breakthrough infection detected 27nov (pcr confirmed)" and "breakthrough infection detected 27nov (pcr confirmed)" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive, notes: Nasal Swab; (01Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient did not receive other medications within 2 weeks of vaccination. No known allergies, no other medical history. No treatment was received.  Prior to vaccination, the patient was not diagnosed with COVID-19.   Product Quality Group provided investigational results on 03Dec2021 for BNT162B2: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot EW0217 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0217, the fill lot ET8456, and the bulk formulated drug product lot EP8638. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause or CAPA were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature.   The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EW0186 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 and product type. The final scope included the reported finished goods lot EW0186, fill lot EP8736, and bulk formulation lot EP8617. 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.