Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 vaccine: COVID positive; COVID-19 vaccine: COVID positive; 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 male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6199), on 25Mar2021 as dose 2, single (Lot number: EP7534) and on 01Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High cholesterol" (ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol increased, start date: 2018; ICOSAPENT ETHYL taken for blood cholesterol increased, start date: 2022; NIRMATRELVIR (ongoing); RITONAVIR (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Sep2022, outcome "unknown" and all described as "COVID-19 vaccine: COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Sep2022) Positive, notes: Unit: Not Provided. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Pfizer COVID-19 vaccine: Even though patient got COVID-19, patient didn't know, it was last Thursday at 06:00PM. patient had a little chill, slight fever, like a cold. His appetite was strong, patient had no headache or body aches, zero symptoms. patient had awesome taste and no loss of taste or appetite. It started to travel down to his lungs, but he was blessed patient took Pfizer vaccine and it would not let it get really bad. patient's vaccine card has little stickers and stamps but no NDC/EXP were provided. Patient took a rapid test and decided to go see him Saturday because it started to travel to his lungs, he has asthma, and think he is COVID positive and the positive result was real fast for the rapid test. He had done rapid tests when he had worked during the summer in (Withheld)he had exposure to people who had COVID and he put his mask on, there were small case of people testing positive during summer school but he never got it. Indication: Caller says he was high risk in going back to school with children, and got COVID because he had exposure to children that are sick. Paxlovid: Patient started Paxlovid two days ago, it was prescribed at an urgent care by a physician's assistant with Prednisone, then when the pharmacist dispensed it he said he can't take both of them. He called the doctor who said he should be ok, but he decided to return the Prednisone since it was on the list as bad to take with Paxlovid. After starting Paxlovid patient started feeling better immediately, within 2-4 hours, it was phenomenal. No further details provided about Prednisone. The Paxlovid altered patient taste, patient has a bitter metallic taste. To treat that patient bought Gatorade, which helps out a lot, the bitter taste goes away. Patient's taste is altered like everything says, patient is losing a little bit of taste, before Paxlovid patient had full taste after COVID hit him, he didn't have any of that then Paxlovid altered his taste. This is a notification generated from the 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 system.   Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6199 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 EN6199, fill lot EN5331, and the formulated drug product Lot EN5320. 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 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. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP7534 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations and an analysis of the 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. Conclusion: The complaint for lack of effect PFIZER-BIONTECH COVID-19 VACCINE lot FH8030 was investigated. The investigation included review of manufacturing and packaging batch records, deviation investigation, and an analysis of the complaint history for the reported lot. The final included the reported finished goods lot FH8030, fill lot FH4343, and the formulated drug product lot FA9187. 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 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.