Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: knocked out for 5 days; fever; Body aches; lays up for two days; sleeps all day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "heart transplant recipient", start date: 09Apr2020 (unspecified if ongoing); "Metastatic breast cancer", start date: 2007 (unspecified if ongoing), notes: did not have chemo or radiation; "Headache" (unspecified if ongoing); "blood clot" (unspecified if ongoing); "water retension" (unspecified if ongoing); "hear it is for blood pressure" (unspecified if ongoing); "something about cholesterol or whatever" (unspecified if ongoing); "something for stomach" (unspecified if ongoing); "believes it is for diabetes or whatever but, she is not diabetic" (unspecified if ongoing); "COVID-19", start date: Apr2021 (unspecified if ongoing), notes: first time having covid; hospitalized; "COVID-19", start date: Aug2021 (unspecified if ongoing), notes: covid after receiving booster on 21Aug2021; hospitalized on 22Aug2021. 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 blood pressure measurement, blood cholesterol (ongoing); PANTOPRAZOLE taken for abdominal discomfort (ongoing); ROSUVASTATIN taken for diabetes mellitus (ongoing); CARVEDILOL taken for blood pressure measurement (ongoing); ALBUTEROL [SALBUTAMOL SULFATE] (ongoing); MIRALAX (ongoing). Past drug history included: Sirolimus, notes: stopped taking prior to all vaccines. Vaccination history included: BNT162b2 (Dose 1, Batch / Lot No.: looks like EN6200, EXP: Unknown), administration date: 22Feb2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Batch / Lot No.: EN6208, EXP: Unknown), administration date: 15Mar2021, when the patient was 58-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose 3, Booster, Batch / Lot No.: FC3181, EXP: 31Oct2021), administration date: 21Aug2021, when the patient was 60-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". The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "Body aches"; PYREXIA (non-serious) with onset 2022, 10 hrs after the suspect product(s) administration, outcome "unknown", described as "fever"; HYPERSOMNIA (non-serious) with onset 2022, outcome "unknown", described as "knocked out for 5 days"; INSOMNIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "lays up for two days"; SOMNOLENCE (non-serious) with onset 2022, outcome "unknown", described as "sleeps all day". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient received the second booster shot on 13Apr2022 (dose 4). It just completely knocks her out. within 10 hours, started running a high fever. Body aches and everything like that. Further reporter that the last two shots (second booster/dose 4 on 13Apr2022 and third booster/dose 5 on 23Oct2022), patient had the same reaction which she lays up for two days, sleeps all day. She slept a couple of days and fever was up and down. Took like 4th or 5th day that she started coming around pretty good (outcome was still unknown). Patient tried eating and caller would have to force her to eat.  It was after the first booster shot on 21Aug2021 (as clarified) that the patient went to the hospital. 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. Further clarified that the hospitalization that was first referenced as 22Aug2022 was after receiving the booster on 21Aug2021 (it 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.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201256280 Same patient/drug, different dose (dose 5) and events;US-PFIZER INC-202201256327 Same patient/drug, different dose (dose 3) and events;US-PFIZER INC-202201256343 Same patient/drug, different dose and different event (LOE after dose 5);US-PFIZER INC-202201259725 Same patient/drug, different dose and different event (LOE after dose 2);