Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: sick with Covid 4 days ago; sick with Covid 4 days ago; This is a spontaneous report from a contactable consumer (Patient's mother). A 12-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0181; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Arm Left on 06Jun2021 as dose 2, single for COVID-19 immunisation. Patient had earlier received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0176; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Arm Left on 14May2021 as dose 1, single for COVID-19 immunisation. Related lot numbers: fill lot EP8727, and formulated drug product lot EP8608. Medical history included mild asthma from 2019 and ongoing, diagnosed 2 years ago. The patient's concomitant medications were not reported. Prior vaccination within 4 weeks none. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Family Medical History Relevant to AE(s) were none. Predisposing factors were unknown. The patient experienced sick with covid 4 days ago on 23Jul2021, this should be looked into to see if the dosages he received had an issue in production. It was reported that Patient received two doses of the Covid Vaccine and was fully vaccinated and ended up sick with Covid 4 days ago. Reporter want to report this as this should be looked into to see if the dosages he received had an issue in production or others who received doses from the same batch are positive for Covid. reporter would like to speak with someone about this since your clinical findings for his age group indicate 100% protection. Caller was not sure if there was an issue during the manufacturing process for that batch of vaccines. Caller verified the information provided by the transferring agent and states the patient was diagnosed with covid on Sunday 25Jul2021 and his symptoms of covid started late Friday or early morning Saturday. Relevant Tests were none. Primary infection site was reported as unknown. Adverse events did not require a visit to emergency room nor Physician Office. Stated that the patient had no treatment for the reported event. Patient received no treatment for reporting events. Upon follow-up received on 29Jul2021 from a Product Quality Complaint Group. This report included Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot EW0176 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0176, fill lot EP8727, and the bulk formulated drug product lot EP8608. A complaint sample was not returned. No re. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EW0181 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 EW0181, fill lot EP8732, and bulk formulation lot EP8613. A complaint sample was not returned. No related quality issues were identified during the investing. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EW0176 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0176, fill lot v EP8727, and the formulated drug product lot EP8608. 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. Reporter seriousness for was fully vaccinated and ended up sick with covid four days ago was unspecified. The outcome of events was Unknown.   Follow-up attempts are completed. No further information is expected.