she has been covid-19 infected for one and a half weeks, she produced a positive test; she has been covid-19 infected for one and a half weeks, she produced a positive test; this is a spontaneous report received from contactable reporter(s) (other hcp) from medical information team and product quality. the reporter is the patient. a 48 year-old female patient (unknown if pregnant) received bnt162b2 (comirnaty), administration date 29jan2021 (lot number: ej6134) as dose 2, single and administration date 08jan2021 (lot number: el1484) as dose 1, single for covid-19 immunisation. the patient's relevant medical history and concomitant medications were not reported. the following information was reported: covid-19 (medically significant), vaccination failure (medically significant), outcome "unknown" and all described as "she has been covid-19 infected for one and a half weeks, she produced a positive test". the patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. product quality investigation: ej6134 conclusion: for this lot adverse event safety request for investigation and/or lack of effect was previously investigated. all analytical results were checked and were within registered limits. the investigation included reviewing the involved batch records, deviation investigation and 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 ej6134. a complaint sample was not returned. no related quality issues were identified during the investigation. there is no impact on product quality, regulatory, validation and stability. regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. the ntm process determined that no regulatory notification was required. the reported defect could not be confirmed. no root cause or capa were identified as the complaint was not confirmed. el1484 conclusion: for this lot adverse event safety request for investigation and/or lack of effect was previously investigated. all analytical results were checked and were within registered limits. the investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, 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 'el1484'. a complaint sample was not returned. no related quality issues were identified during the investigation. there is no impact on product quality, regulatory, validation and stability. regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. the ntm process determined that a regulatory notification was required. the reported defect could not be confirmed on the evaluation of reference samples. no root cause or capa were identified as the complaint was not confirmed.; sender's comments: based on the available information, a plausible temporal relationship and known product safety profile, a causality between the suspect product bnt162b2 (comirnaty) to the reported events vaccination failure and covid-19, cannot be excluded.,linked report(s) : hu-pfizer inc-202200350307 same reporter, patient and suspect product, different dose and events (2nd dose);hu-pfizer inc-202200291452 same reporter, patient and suspect product, different dose and events (1st dose)