Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient's first time having Covid, that was back in Apr2021, which was after receiving first 2 shots Covid vaccine.; patient's first time having Covid, that was back in Apr2021, which was after receiving first 2 shots Covid vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 58-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6200) and on 15Mar2021 as dose 2, single (Lot number: EN6208) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "heart transplant recipient", start date: 09Apr2020 (unspecified if ongoing), notes: heart transplant recipient; "Metastatic breast cancer", start date: 2007 (unspecified if ongoing), notes: Does not remember month. Patient did not have chemo or radiation.; "to prevent organ rejection" (unspecified if ongoing), notes: organ rejection; "Headache" (unspecified if ongoing); "blood clot" (unspecified if ongoing), notes: blood clot; "water retension" (unspecified if ongoing); "hear it is for blood pressure" (unspecified if ongoing), notes: it is for blood pressure; "something about cholesterol or whatever" (unspecified if ongoing), notes: something about cholesterol; "something for stomach" (unspecified if ongoing), notes: something for stomach. Concomitant medication(s) included: PREDNISONE taken for organ transplant, start date: 09Apr2020 (ongoing); TACROLIMUS taken for organ transplant (ongoing); TYLENOL taken for headache (ongoing); ELIQUIS taken for thrombosis (ongoing); FUROSEMIDE taken for fluid retention (ongoing); LOSARTAN taken for hypertension, blood cholesterol abnormal (ongoing); PANTOPRAZOLE taken for abdominal discomfort (ongoing); ROSUVASTATIN taken for diabetes mellitus (ongoing); CARVEDILOL taken for hypertension (ongoing); CALCIUM CITRATE + D3 (ongoing); ALBUTEROL HFA (ongoing); MIRALAX (ongoing).  The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Apr2021, outcome "not recovered" and all described as "patient's first time having Covid, that was back in Apr2021, which was after receiving first 2 shots Covid vaccine.". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 5 day(s)). The event "patient's first time having covid, that was back in apr2021, which was after receiving first 2 shots covid vaccine." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2021) Positive, notes: positive for Covid once after first 2 Covid shots. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that, the events were serious and Caused/prolonged hospitalization. Concomitant Prednisone from 09Apr2020 Dosage text: 5mg once a day used to prevent organ rejection. Concomitant drug Tacrolimus. Dosage text: 1mg twice a day. It was started after first heart transplant. Was started on this and switched to Sirolimus for period time. Now back on Tacrolimus used to prevent organ rejection. Concomitant Tylenol was taken the last 4 years. Dosage text: 500mg tablet, 2 tablets, at least twice daily used for Headache. Concomitant Eliquis has been taking, probably for a year. Was on Warfarin before that. 2 years ago, found blood clot after transplant. Dosage text: 5mg twice a day used for blood clot. Concomitant Furosemide has been on all along, had been cutting back last 4 months per doctor orders. Dosage text: 20mg once a day used for water retention. Concomitant Losartan has been on from the beginning, about the last 2 and a half years Dosage text: 25mg once a day used for blood pressure or something about cholesterol or whatever. Concomitant Pantoprazole has been taking the last 4 years. Dosage text: 40mg once a day used for something for stomach. Concomitant Rosuvastatin. Dosage text: 10mg once a day used for believes it was for diabetes or whatever but, she was not diabetic. Concomitant Carvedilol has been taking a little more than a year. Was on another blood pressure medicine, was on Clonidine patch prior to starting this medication. Was a 24-hour patch, don't remember dosage. Dosage text: 6.25mg twice a day used for Blood pressure. Concomitant drugs Calcium Citrate, Vitamin D, has been taking the last 2 and half years. Dosage text: 315mg/5mcg 200 unit, 2 tablets a day. Concomitant drug Albuterol, only does maybe 5 or 6 times a week. Dosage text: 90 mcg inhaler, 2 puffs every 6 hours. Concomitant MiraLax, 17 g. All concomitant drugs were Ongoing. Concomitant Products were taking Sirolimus, through Pfizer and she was no longer taking that. Just stopped taking that 4 months ago. Clarified that she stopped this medication prior to this all occurring with the Covid vaccines. Was probably in the last 2 years. No other Investigations. NDC number and Expiry Date of Covid shot was Unknown. Knows for sure, the third booster, she went to the hospital for having Covid. Did a home test yesterday and back in Aug2021 last year. The fourth booster shot, they did the Covid test that came up negative. With the third booster, she was in the hospital with Covid after the scenario. After the third shot, within a 12-hour period. Had the first Covid shot 22Feb2021, second shot 15Mar2021, First Booster 21Aug2021, Second Booster: 13Apr2022, Third Booster on 23Oct2022, which was just the other day, Sunday. Test results: Everything was looking good. The cardiologist, Doctor, the transplant coordinator may have more information. She does not know where this was going. was still getting annoyed that the cardiologist hasn't called back yet. The patient had Third Booster on left upper arm on 23Oct2022 with lot number: GH9703. Indication for Use in Case was being immunocompromised, cardiologist told her to get it. AE(s) require a visit to Emergency Room and Physician Office. After the first episode, she saw the cardiologist and even saw her primary doctor. The patient was hospitalized for 6 days. The first time she had Covid, was at Hospital for 6 days but was transferred over to Hospital. Clarified that patient was in the hospital for 4 days, then was transferred to other Hospital for 2 days, for being in the hospital a total of 6 days. Clarified that this hospitalization was back in Aug2021 that caller previously mentioned, after getting the second booster 21Aug2021. Clarified that when caller mentioned patients first time having Covid, that was back in Apr2021, which was after receiving first 2 shots Covid vaccine. They gave her Monoclonodial infusion, which he does not remember the exact name. They have her that infusion while she was in the hospital. Clarified that patient was in the hospital for 5 days during that time, which was clarified as her first time having Covid. At that time, she was admitted to Hospital. She did not go to that time. Further clarified that the hospitalization that was first referenced as 22Aug2022 was after receiving the second booster, 21Aug2021 was not the first time patient came down with Covid, as previously stated. The first hospitalization occurred after being diagnosed with Covid in Apr2021, where she was in the hospitalized for 5 days.  Clarified that during both hospitalizations, patient was positive with Covid. No Prior Vaccinations within 4 weeks of covid vaccine. No AE(s) following prior vaccinations. Family Medical History Relevant to AE(s) was, thinks everything was fine there. She has a brother who was 2 years older and he has a slight heart condition. Relevant Tests were None. When clarifying if caller had questions to address, she was getting impatient waiting day after day, after day. Hoping she was becoming better. Was concerned and and does not want this to happen again. Was possible this was because of the Covid vaccine. Trying to let everybody know. She does not know what they are looking for. Can provide the number that she contacts for, asking about vaccines and shots. Everything was registered there for here. Caller advised that Pfizer may contact him for further details if needed. Caller declined to be transferred to address questions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201256326 Same patient/drug, different dose and different event (LOE after dose 2);