Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test, Secretion discharge, Vaccination failure
Clinical narrative: could not breathe; She had a lot of mucus; She tested positive for Covid infection; She tested positive for Covid infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team and product quality group for a Pfizer sponsored program (159558). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 03Jun2021 (Lot number: EW0177) at the age of 49 years as dose 2, single and administration date 13May2021 (Lot number: EW0185) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: She has allergies and sinuses; "Sinuses" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DYSPNOEA (hospitalization), outcome "unknown", described as "could not breathe"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "She tested positive for Covid infection"; SECRETION DISCHARGE (medically significant) with onset Dec2021, outcome "unknown", described as "She had a lot of mucus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive, notes: Home test. Therapeutic measures were taken as a result of dyspnoea, covid-19, secretion discharge. Clinical information: Stated that, she does not have asthma, states the nurse said she had her oxygen was good, states she can't breathe because she has everything blocked, states she had a lot of mucus, caller clarified that this is what happened when she had Covid at the end of Dec2021, states she went to the hospital and they gave her Benedryl and Motrin, states they checked her chest and and everything and said it was fine, states they only gave her saline solution, sent her home, states she went to another hospital and they would not give her breathing treatment and she did not know why, states they told her they do not do that for Covid patients, states they sent her home, states she had to call her doctor and he gave her an antibiotic. Doctor gave her an antibiotic. Caller wants to know how long she needs to wait after testing positive for Covid 19 to get her booster shot. Caller states someone told her 3 weeks and someone else told her 90 days so she just wants to get the right answer. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for 'Lack of Effect' of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0185 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 analytical release test results. The final scope included the reported finished goods lot EW0185, fill lot EP8735, and the bulk formulated drug product lot EP8616. 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. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for 'Lack of Effect' of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0177 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 EW0177, fill lot EP8728, and the bulk formulated drug product lot EP8609. A complaint sample was not returned. 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.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Dyspnoea, Secretion discharge, vaccination failure and covid-19 and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.