Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for Covid after 4 Doses of the Pfizer Covid 19 Vaccines; Positive for Covid after 4 Doses of the Pfizer Covid 19 Vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group and medical information team, Program ID: (172086). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9262), on 15Feb2021 as dose 2, single (Lot number: EN5318), on 07Aug2021 as dose 3 (booster), 0.3 ml single (Batch/Lot number: unknown) and on 08Jan2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 57 years for COVID-19 immunization. The patient's relevant medical history included: "Migraine" (ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: DEPAKOTE taken for migraine; NEFAZODONE taken for migraine; BENADRYL taken for hypersensitivity; FROVATRIPTAN; TYLENOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive for Covid after 4 Doses of the Pfizer Covid 19 Vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) positive; (02May2022) Negative; (06May2022) Negative; (08May2022) Positive; (17May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Caller stated she wanted to say that she is a fan of Pfizer and she has had the Pfizer 2 COVID Shots and the 2 Boosters and it was all about it and she wanted Pfizer to get closer to understanding these Variants and Medications. Caller stated her doctor was telling her that testing positive again was not a problem and that she didn't need to quarantine anymore and she knew that couldn't be right, so she wanted to inform people of the correct information. Caller stated on 27Apr2022, she tested positive for COVID. Caller stated her first dose of Paxlovid was in the evening on 27Apr2022 and she took all of them and completed the medication on 02May2022. Caller stated she took all of them and they left the nastiest taste in her mouth, it was so bitter and it lasted for the entire 5 days. Caller stated on 02May2022, she tested negative for COVID, but she still didn't feel super great. Caller stated on 06May2022, she tested for COVID again because she wasn't feeling super great, but it was negative. Caller stated she has a friend that is a nurse and told her she can get rebound, it was brand new info at that time. Caller stated on 08May2022, she got an itchy nose and new symptoms and she tested positive for COVID on that day, ragingly positive. Caller stated she tested everyday and continued testing positive through 16May2022 at which point she tested negative and she confirmed it the next day or 2. Caller stated the symptoms that she had with the first episode of COVID were different than with the second episode of COVID. Caller states she started Paxlovid the same day she tested positive, so she doesn't know if the symptoms were from Paxlovid or COVID. Caller stated that the First Episode she was Lightheaded and Dizzy, she had Flashing in the Periphery of her Vision especially upon waking for 3 days and then it went away. Caller stated these occurred 30Apr, 31Apr, 01May and it may have been another day but it was not as obvious. Caller stated she thought it was weird because she has migraines but not with an aura, so she thought she wondered if she was getting an aura, but it didn't stay the whole day, just a half hour and then it would go away. Caller stated she looked on Read It and some other people had that. Caller stated she also had insomnia, sore throat, and malaise where she would just be laying around, a sniffle or tickle in the nose like allergies, and she was tired. Caller stated she tested negative and then the next day she tested positive. Caller stated with the Rebound Covid, it was all upper respiratory and no insomnia, but super fatigued. Caller states it was like there were 3 stages. Caller stated the First Stage when she was positive for Covid and taking Paxlovid she experienced insomnia, dizziness, and she teaches yoga and has good balance, but she almost fell over in the shower, flashing lights and it was like neurological. Caller stated then the Second Stage when she was testing negative, she would sleep for 10-12 hours a night and need a nap during the day, and she is normally a crappy sleeper. Caller stated that was the in between time, which is why she said she didn't feel better. Caller states she had a cough the whole time. Caller states then the 3rd Stage when she tested Positive for Covid again/Rebound was very much upper respiratory with crushing fatigue but not sleepiness, but she was really tired and apathetic, like she doesn't feel like it and was really demotivated and lazy and unable to concentrate. Caller states she would like to see this happen. Caller states she would like it to be that the doctor calls a patient and tells them they have Covid and they would then ask would you like to help give feedback to Pfizer yes or no and then depending on the answer, he could give them a card or send them to a link, that would provide them with some things they should know or watch for like they did after the Covid injection. Caller states she participated in all of that with the Covid Vaccine and she feels like it is needed with this because the variant it is prescribed for isn't the same variant it is was approved for on 22Dec2021, that was for Delta and we are 4 variants later on Omicron. It was reported that the treatment none, Fluids and Quarantine.  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 PQS Q1215 and/or Q1252. Refer to the below table for details: Product- Description (CR): COMPOUND BNT162 COVID- 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot-# (CR): EL9262: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL9262 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 EL9262, fill lot EL9253, and the formulated drug product lot EL9244. 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. Product- Description (CR): COMPOUND BNT162 COVID- 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot-# (CR): EN5318: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN5318 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 EN5318, fill lot EN5317, and the formulated drug product lot EN5316. 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. 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 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-202200696468 Same reporter/patient, different drug/events