Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Electrocardiogram
Clinical narrative: Her and her husband both got COVID; Her and her husband both got COVID; 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 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Apr2021 (Lot number: ER8729) at the age of 49 years as dose 2, single and intramuscular, administered in arm left, administration date 24Mar2021 (Lot number: ER8733, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "total hysterectomy", start date: May2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu shot, administration date: Oct2021, when the patient was 49 years old, for Immunization. The following information was reported: COVID-19 (medically significant) with onset Aug2021, outcome "recovered" (2021), DRUG INEFFECTIVE (medically significant) with onset Aug2021, outcome "unknown" and all described as "Her and her husband both got COVID". The patient underwent the following laboratory tests and procedures: electrocardiogram: unknown.  Clinical information: She would like to add, her and her husband got the second dose of the Pfizer COVID vaccine 21Apr2021. In Aug2021, their son went to school. He got COVID , and brought it home to them. Her and her husband both got COVID. They didn't have to go to the hospital. It lasted three days, and then they were okay.The caller is also working and in college .Everything has been fine with them , but they wanted to get the booster just in case. Her and her husband got the same lot numbers on the same dates for all three doses.The area on her arm still hurts and is still swollen.Her husband said his injection arm really hurts , but that is it.She knows nobody forced them to take it. She is a teacher, and it was her decision. She wanted to get it before school re opened. She is just really scared. Even right now she is holding her breath because it is hurting. What is Pfizer going to do?She is saddened now that she has to deal with this stress. Now she has to pay for an EKG , so she can know and stop worrying.  Product-Description (CR): COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8729 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8729, fill lot EP8681, and the formulated drug product lot EP8568. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8733 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8733, fill lot EP8685, and the bulk formulated drug product EP8572. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Product quality investigation request LOT ER8733, BNT162B2. Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE - ER8733 - Lack Of Effect. (Parent) Brand/Trade-Name: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. QA Review & Rationale: The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot ER8733 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot ER8733 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Product Quality Impact: No, Market / Clinical Impact: No SQRT Review Required: No, Stability Impact: No AQRT Review Required: No. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8733 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8733, fill lot EP8685, and the bulk formulated drug product EP8572. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.Root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.