Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1, 2, 3: Pfizer; Dose 4, 5: Moderna; 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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: ER8731), in left arm, on 24Apr2021 as dose 2, single (Lot number: EP7534), in left arm and on 04Dec2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27May2022 at 18:00 as dose 4 (booster), single (Lot number: 037A22B), in left arm and on 04Nov2022 at 18:30 as dose 5 (booster), single (Lot number: 010H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergic and non-allergic rhinitis" (unspecified if ongoing), notes: other medical history: allergic and non-allergic rhinitis; "Asthma" (unspecified if ongoing); "Acne" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MIGRELIEF; FISH OIL; VITAMIN D [VITAMIN D NOS]; COQ10 [UBIDECARENONE]; MUCINEX DM, start date: 23Nov2022, stop date: 27Nov2022. Past drug history included: Pseudoephedrine, reaction(s): "Known allergies: Sensitive to stimulant like pseudoephedrine", notes: Known allergies: Sensitive to stimulant like pseudoephedrine; Albuterol, reaction(s): "Known allergies: Sensitive to stimulant like pseudoephedrine and albuterol", notes: Known allergies: Sensitive to stimulant like pseudoephedrine and albuterol. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27May2022 at 18:00, outcome "unknown", described as "Dose 1, 2, 3: Pfizer; Dose 4, 5: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Covid 19 Treatment; (29Nov2022) Negative, notes: Covid rebound. Home Rapid test negative; (03Dec2022) Positive, notes: Home rapid test positive; (09Dec2022) Negative, notes: More mild than original Covid. Home rapid test negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medications in 2 weeks. Patient was treated with Paxlovid, treatment started on 23Nov2022, treatment stopped on 28Nov2022.  Conclusion: This is a daily 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 PQS Q1215 and/or Q1252. Refer to the below table for details: AE Ref No (CC): 2 202201364593 PR ID (CR): 7951415 PR State (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1 Lot# (CR): EP7534: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizerbiontech Covid-19 Vaccine lot EP7534 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 EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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.  PR ID of Previously Completed Inv: 5862218 PR Link (Previously Investigated CR): 5851167 AE Ref No (CC): 2202201364593 PR ID (CR): 7951416 PR State (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1. Lot# (CR): ER8731: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizerbiontech Covid-19 Vaccine lot ER8731 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 ER8731, fill lot EP8683, and the bulk formulated drug product lot EP8570. 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/preventa tive 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: 5866621 PR Link (Previously Investigated CR): 5865125 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.  Lot Number EJ1620 is invalid as per SAP.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201364602 Same patient, same drug/different dose, different AE;