Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: having COVID-19/  I am fully vaccinated/ had a breakthrough positive case of COVID with a lot of symptoms; had a breakthrough positive case of COVID with a lot of symptoms; This is a spontaneous report from a contactable other health care professional (patient, reported for herself) via medical information team. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number: EK923), via unspecified route of administration on 11Jan2021 (at the age of 46-year-old) as a dose 2, single and patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number: EL0140), via unspecified route of administration on 21Dec2020 (at the age of 46-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history include Asthma, Sleep apnoea. The patients Concomitant medications was not reported. It was reported that reporter was an interventional radiotechnology technician but is calling as a patient. She queried if there was information regarding receiving the Pfizer-BioNTech COVID-19 Vaccine booster after receiving the Regeneron's monoclonal antibodies. She even queried for if Pfizer-BioNTech COVID-19 Vaccine booster can be given after having COVID-19 as she had a breakthrough case. It was reported that patient was fully vaccinated and on unspecified date had a breakthrough positive case of COVID with a lot of symptoms. Patient had not received any other vaccine 4 weeks prior vaccination. Product- Description (CR) COMPOUND BNT 162 COVID- 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 Lot-# (CR): EL0140) Conclusion of Previously Completed Investigation (FCI/SI/OffCI): [Truncated Conclusion - See PR ID of Previously Completed Inv for full text] For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5515143 (see File attachment in this investigation record) The complaint for "Adverse Event Safety Request" of "PFIZER-BIONTECH COVID-19" was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, 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 "EL0140". 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.  concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The  process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. The outcome of event was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine.