Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Catheterisation cardiac, Diarrhoea, Ejection fraction, Ejection fraction decreased
Clinical narrative: HOLD off restarting TEPEZZA related to her Glaucoma; Ejection fraction low; vomiting; weakness; diarrhea; Heart attack/ right chest pain/Back pain/ Broken heart syndrome; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): HZN-2021-006800.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 20Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; teprotumumab trbw (TEPEZZA), first regimen since 09Sep2021 (Batch/Lot number: unknown) at 20 mg/kg (20 mg/kg, (2040 mg in 100 ml ns over 60 minutes instead of 90 minutes)), second regimen since 01Oct2021 (Batch/Lot number: unknown) and third regimen since 01Nov2021 (Batch/Lot number: unknown), all intravenous for endocrine ophthalmopathy. The patient's relevant medical history included: "Graves' disease" (ongoing); "Hypothyroidism" (ongoing); "Diabetes mellitus/Diabetes" (ongoing); "Hypertension" (ongoing); "right atrium enlargement" (ongoing); "heart murmur" (ongoing); "Endocrine ophthalmopathy" (ongoing). Concomitant medication(s) included: CELEXA [CITALOPRAM HYDROBROMIDE]; ARICEPT; LASIX [FUROSEMIDE]; LISINOPRIL; METFORMIN taken for diabetes mellitus; NAMENDA; POTASSIUM; PRILOSEC [OMEPRAZOLE MAGNESIUM]; SYNTHROID taken for graves' disease, hypothyroidism; WELLBUTRIN; ZANTAC. Vaccination history included: BNT162b2 (Dose 1), administration date: 22Jan2021, for Covid-19 immunization; BNT162b2 (Dose 2), administration date: 13Feb2021, for Covid-19 immunization. The following information was reported: STRESS CARDIOMYOPATHY (hospitalization, medically significant) with onset Nov2021, outcome "unknown", described as "Heart attack/ right chest pain/Back pain/ Broken heart syndrome"; DIARRHOEA (hospitalization, medically significant) with onset Nov2021, outcome "unknown", described as "diarrhea"; VOMITING (hospitalization, medically significant) with onset Nov2021, outcome "unknown"; ASTHENIA (hospitalization, medically significant) with onset Nov2021, outcome "unknown", described as "weakness"; EJECTION FRACTION DECREASED (hospitalization, medically significant) with onset Jan2022, outcome "unknown", described as "Ejection fraction low"; GLAUCOMA (hospitalization, medically significant) with onset 05May2023, outcome "unknown", described as "HOLD off restarting TEPEZZA related to her Glaucoma". The patient was hospitalized for stress cardiomyopathy (start date: 01Jan2022, discharge date: Jan2022, hospitalization duration: 6 day(s)); for ejection fraction decreased, vomiting, asthenia, diarrhoea (start date: 01Jan2022, discharge date: 06Jan2022, hospitalization duration: 6 day(s)). The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: (Jan2022) unknown result, notes: no stents, diagnosed with broken heart syndrome; Ejection fraction: (Jan2022) low, notes: decreased. The action taken for teprotumumab trbw was temporarily withdrawn. Therapeutic measures were taken as a result of stress cardiomyopathy, vomiting, asthenia, diarrhoea.  Clinical course: The patient received TEPEZZA (teprotumumab) for Thyroid eye disease. On 01Jan2022, the patient had heart attack and was seen at a hospital and referred to a medical center for observation. The patient was on hold for now. It was reported that the patient received infusions on 01Oct2021 and 01Nov2021. Physician reported that the patient had heart attack on 01Jan2022, had a slight chance to be linked to Covid vaccine. The physician also reported that 6 weeks prior to heart attack the patient had diarrhea with weakness, followed by vomiting, right chest pain and back pain and was admitted in hospital on 01Jan2022. The physician also stated that the patient was currently at home at the time of reporting and cardiac functions were monitored weekly. Patient reported that her case was still on hold. Patient had new contact info and agreed to call with any needed. Next Outreach was on 11Apr2022. In mid Nov2021, events diarrhea, weakness, vomiting, right chest pain and back pain had started. Patient was hospitalized on 01Jan2022 for 6 days and diagnosed with broken heart syndrome after Heart catheterization done with no stents. Ejection fraction was low. No discharge summary. Cardiac functions were monitored weekly. On 11May2022, the physician stated that Heart attack was the cause for the Ejection fraction low. On an unknown date, the patient was told to hold off restarting TEPEZZA related to her Glaucoma (Glaucoma). The patient reported that she has been told by her HCP to hold off restarting TEPEZZA related to her Glaucoma. No treatment medications was reported. Action taken regarding TEPEZZA (teprotumumab) was withdrawn (on hold) for the event heart attack/ right chest pain, back pain, broken heart syndrome and unknown for the rest all events. Action taken with TEPEZZA (teprotumumab-trbw) was withdrawn for the event Glaucoma.   The reporter assessed the Ejection fraction low as not related to the TEPEZZA. The reporter did not provide causality assessment of the rest of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.