Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is the second time having covid; she got covid; she got covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 18May2021 as dose 1, single (Lot number: EW0182), in left arm, on 08Jun2021 as dose 2, single (Lot number: EW0217), in left arm and on 06Jan2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Tripple heart attack", start date: Nov2016 (unspecified if ongoing), notes: Information for Other medicines Lipitor:Indication:Triple heart attack in 2016 in November; "Heart disease" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for myocardial infarction, start date: 2016 (ongoing); METFORMIN taken for diabetes mellitus (ongoing); LISINOPRIL taken for blood pressure abnormal (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "she got covid"; DISEASE RECURRENCE (medically significant) with onset 20Oct2022, outcome "not recovered", described as "This is the second time having covid". The events "she got covid" and "this is the second time having covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive, notes: when she got covid the first time; (18Oct2022) Negative, notes: Result: Negative; Unit: Not Provided; (20Oct2022) positive, notes: Result: Positive; Unit: Not Provided.  Clinical course: Reporter mentioned she is fully vaccinated with the Pfizer Covid 19 Vaccine and has the newest Omicron virus. This is the second time having covid. She is really sick and miserable at this moment. None of the vaccines worked for her. She is very upset and mentioned Pfizer Medications make health worse. Reporter confirmed details after transfer. She confirmed now she has the newest Omicron virus and she is boosted. She stated she is deathly sick. This is the second time having covid. The first time she got covid was after having both vaccines and getting boosted. Reporter initially stated she reported these details before. This was her second time reporting. She later clarified, she reported on her son initially who received the Pfizer Vaccine, clarified as the Covid Vaccine and then got myocarditis. Reporter clarified and confirmed this is the first time reporting on herself. First time got Covid- The first time she got Covid, initially provided that it was Apr2022, then Feb2022. She later clarified and confirmed it was Jan2022 when she got covid the first time. A week after getting the Pfizer Covid Booster, which she got on 06Jan2022. Has the omicron virus- She is currently on day 7 and is feeling worse. She explained she feels like she cannot breathe, it's hard to breathe, her chest feels like it has bronchitis, her head is full. On Tuesday 18Oct2022, she woke up feeling awful and she did a home test and it came back negative. Then on Thursday 20Oct2022 she took another one and it cam back positive. She has been sick ever since Tuesday 18Oct2022 and she still feels awful . She said she has every new symptom with this new virus. Her sinus feels full, her chest feels full almost like she has covid bronchitis, it's hard to breathe, she has stomach aches, back aches, she is just miserable. Right now she is sick as a dog. At seven days she was hoping would get better, but now it's worse. The worse part is the breathing and stomach ache. She is wondering what's the point in getting boosted if keep getting the virus. Did not want to get covid again, wanted to be safe. Is a diabetic and heart disease and did not want to give to anyone else. Reporter was planning on getting the Omicron Booster and then got the virus itself. Confirmed has only received these three vaccines. She explained there is no reason she should have covid. She wears a mask, still wears it anytime in the store or around other people. She has no idea how she got it. She reiterated, it's so hard to breath now. It's in in the lungs. She occasionally has a cough, but it's mainly in chest and sinuses are full. She then added, the worst part is the medicine that we have to help with covid is even worse than getting the virus. She clarified and confirmed it's Paxlovid. She was prescribed it, but cannot take it because it raises blood pressure. She also did not take it because she would have to stop taking Lipitor for five days and she cannot afford to stop taking Lipitor. She did not want to stop taking Lipitor and end up having a heart attack. Reporter also added was going to try IV drips, but told was worse because could cause heart problems. Patient did not try it, clarified name to be, Monoclonal IV Therapy. She reiterated she did the home test on Tuesday when she felt weird. She was thinking it was just a cold and the result was negative at first. By Thursday it was really bad. When she did the test on Thursday the result was quickly positive.   At end of call, reporter reiterated she did everything she was supposed to do. This is awful. She got all the shots. It would be nice if Pfizer can make a drug to get over Covid that's not worse than having Covid. The IV drip, Monoclonal IV Therapy , as clarified causes heart palpitations, causes heart to stop, and goes after the liver. Her doctor does not want to prescribe to patients. All the drugs for getting rid of Covid it's like you have to be healthy person in order to take it. The risk is not worth it. We need to make something not as bad as having covid. Description of Product Complaint: Patient is fully vaccinated with the Pfizer Covid 19 Vaccine and has the newest Omicron virus. This is the second time having covid. The first time she got covid was after having both vaccines and getting boosted. It was Jan2022 when she got covid the first time.  A week after getting the Pfizer Covid Booster, which she got on 06Jan2022. Now she has the omicron virus. 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. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot EW0217 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 EW0217, the fill lot ET8456, and the bulk formulated drug product lot EP8638. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause or CAPA were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FL3198 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 FL3198, fill lot FJ8804, and the formulated drug product lot FL3162. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/prevent ative 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 of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EW0182 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 EW0182, fill lot EP8733, and the formulated drug product lot EP8614. A complaint sample was not returned. 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. ID of Previously Completed Inv. Link (Previously Investigated CR).