Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Hypersomnia, Pain
Clinical narrative: sleeps all day; knocked out for 5 days; fever/running a high fever, 102.7 being the highest; body aches; won't eat; sleeping a lot; This is a spontaneous report received from contactable Consumer (patient's husband). A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 at 15:30 as dose 5 (booster), single (Lot number: GH9703) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Metastatic breast cancer", start date: 2007 (unspecified if ongoing), notes: Does not remember month. , Patient did not have chemo or radiation.; "hear it is for blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "something for stomach" (unspecified if ongoing); "water retension" (unspecified if ongoing); "heart transplant recipient", start date: 09Apr2020 (unspecified if ongoing); "blood clot", start date: 2020 (unspecified if ongoing), notes: 2 years ago, found blood clot after transplant.; "Headache" (unspecified if ongoing). The patient's family history included: "slight heart condition" (unspecified if ongoing), notes: elder brother. Concomitant medication(s) included: PREDNISONE taken for prophylaxis against transplant rejection, start date: 09Apr2020 (ongoing); TACROLIMUS taken for prophylaxis against transplant rejection (ongoing); TYLENOL taken for headache (ongoing); ELIQUIS taken for thrombosis (ongoing); LOSARTAN taken for blood cholesterol (ongoing); PANTOPRAZOLE taken for gastric disorder (ongoing); ROSUVASTATIN (ongoing); CARVEDILOL taken for blood pressure abnormal (ongoing); MIRALAX (ongoing); CALCIUM CITRATE/VITAMIN D (ongoing); ALBUTEROL [SALBUTAMOL SULFATE] (ongoing); FUROSEMIDE taken for fluid retention. Past drug history included: Warfarin for blood clot; Clonidine for blood pressure medicine, notes: Was a 24 hour patch, don't remember dosage; Sirolimus for heart transplant, notes: Was taking Sirolimus, through Pfizer and she is not longer taking that. Vaccination history included: BNT162b2 (Dose 1, Batch / Lot No.: looks like EN6200), administration date: 22Feb2021, when the patient was 58-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Batch / Lot No.: EN6208), administration date: 15Mar2021, when the patient was 58-year-old, for Covid-19 immunization; BNT162b2 (Dose 3, Booster, Batch / Lot No.: FC3181, EXP: 31Oct2021), administration date: 21Aug2021, when the patient was 58-year-old, for Covid-19 immunization, reaction(s): "involving the high fever occurring within 10 hours of the vaccine was the same experience with the last 2 booster shots"; BNT162b2 (Dose 4 Second Booster:  , LOT: FJ4989), administration date: 13Apr2022, when the patient was 59-year-old, for Covid-19 immunization, reaction(s): "knocked out for 5 days", "fever", "Body aches", "lays up for two days/sleeps all day"; Flucelvax pfs (Flucelvax PFS 2022-23), for immunisation. The following information was reported: PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "body aches"; PYREXIA (medically significant) with onset Oct2022, outcome "unknown", described as "fever/running a high fever, 102.7 being the highest"; FATIGUE (medically significant) with onset Oct2022, outcome "unknown", described as "knocked out for 5 days"; HYPERSOMNIA (non-serious) with onset Oct2022, outcome "unknown", described as "sleeping a lot"; DECREASED APPETITE (non-serious) with onset Oct2022, outcome "unknown", described as "won't eat"; SOMNOLENCE (non-serious) with onset 24Oct2022, outcome "unknown", described as "sleeps all day". Started Tacrolimus after first heart transplant. Was started on this and switched to Sirolimus for period time (Was taking Sirolimus, through Pfizer and she is no longer taking that), clarified that she stopped this medication prior to this all occurring with the Covid vaccines. Was probably in the last 2 years. Now back on Tacrolimus. Paracetamol has taken the last 4 years, apixaban has been taking probably for a year, was on Warfarin before that. 2 years ago, found blood clot in 2020 after transplant. Furosemide has been on all along, had been cutting back last 4 months per doctor's orders. Losartan has been on from the beginning, about the last 2 and a half years. Pantoprazole has been taking the last 4 years. The husband believes Rosuvastatin is for diabetes or whatever but, patient is not diabetic. Carvedilol has been taking a little more than a year. Was on another blood pressure medicine. Calcium Citrate/Vitamin D has been taking the last 2 and half years. Patient's husband reported for his wife (patient) who is a transplant recipient from 2 and a half years ago. She has also had Covid twice in the last 2 years. The last 2 boosters she has gotten knocked her out for like 5 days and had been running fevers. Talked to the cardiologist and transplant doctor and got a message out to them this morning. Patient got the shots Sunday (23Oct2022) at 3:30PM. Within 10 hours or so, 8 or 10 hours, she just got knocked out, turns fever, had body aches, sleeping a lot and won't eat (Oct2022). Was not sure of anything, as her husband and caregiver, was trying to figure something out, if there was something they need to do for the next booster. This is her fifth vaccine shot in the last 2 years. Yesterday (24Oct2022), she was running a fever and slept all day, had been asleep all day yesterday and today (25Oct2022). Got some food down and a lot of water. Was not saying this is the Covid vaccine doing this but the one she had Sunday, and Aug2022, when she got the fourth booster, it happened the same way. Clarified this occurred after the last 2 boosters. Sunday, 23Oct2022, had the third booster and within 10 hours, she was running a high fever, 102.7 being the highest. Patient tried eating and her husband would have to force her to eat. The husband is still getting annoyed that the cardiologist hasn't called him back yet. The husband is concerned and and does not want this to happen again. He wondered if this is possibly because of the Covid vaccine. The husband highlighted knocked out for 5 days, running fevers as serious.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201256326 Same patient/drug, different dose;US-PFIZER INC-202201256327 Same patient/drug, different dose;