Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Tracheal disorder, Upper-airway cough syndrome, Vaccine breakthrough infection
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; She has received first, second, third dose of Pfizer COVID-19 Vaccine. She also received fourth dose of the Moderna COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Solution for injection), on 27Feb2021 as dose 1, single (Lot number: EN6213), on 20Mar2021 as dose 2, single (Lot number: ER2613) intramuscular, in left leg and on 01Oct2021 as dose 3 (booster), single (Lot number: 30135BA) intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 4 (booster), single (Lot number: 048627A) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DAYQUIL, start date: 01May2022, stop date: 04May2022; NYQUIL, start date: 01May2022, stop date: 04May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "She has received first, second, third dose of Pfizer COVID-19 Vaccine. She also received fourth dose of the Moderna COVID-19 Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive; (May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, interchange of vaccine products.  Additional information: This is a notification generated from the gQTS system. 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 according to in PQSQ# and/or Q#. Refer to the below table for details. AE Ref No. (CC): 202200744745. PR ID (CR): 7197874. Product-Description (CR): Compound BNT162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1. Lot-# (CR): 30135BA. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for a Lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot 30135BA was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk, and is manufactured, labeled and packaged by Pfizer. The final scope was determined to be lot 30135BA. No quality issues were identified during the investigation. There is no impact on product quality. An NTM was not issued for the complaint. No regulatory notification or AQRTs were held as a result of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to manufacture or vendor processes. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior any lot being released to the market. No further investigation required. PR ID of previously completed Inv: 6596581. PR Link (Previously investigated CR): 6594876. AE Ref No. (CC): 202200744745. PR ID (CR): 7197875. Product-Description (CR): Compound BNT162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1. Lot-# (CR): ER2613. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot ER2613 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. The final scope included the reported finished goods lot ER2613, fill lot EP8678, and the formulated drug product lot EP8565. 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/preventati ve actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.. PR ID of previously completed Inv: 5917226. PR Link (Previously investigated CR): 5916982. 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 patient did not receive any treatment. The patient did not had any known allergies.  Follow-up attempts are completed. No further information is expected.