Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Computerised tomogram, Flushing, Hypertension, Inappropriate schedule of product administration
Clinical narrative: Unspecified psychosis / behavioural changes / patient was confused / hallucinations; Had high blood pressure; Incontinence (no control of her bladder); Insomnia/ was unable to sleep at all; Muscle twitching; Flushing; Acute systolic congestive heart failure / a lot of edema in the whole body'; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Acute systolic congestive heart failure / a lot of edema in the whole body'), PSYCHOTIC DISORDER (Unspecified psychosis / behavioural changes / patient was confused / hallucinations), HYPERTENSION (Had high blood pressure), INCONTINENCE (Incontinence (no control of her bladder)), INSOMNIA (Insomnia/ was unable to sleep at all), MUSCLE TWITCHING (Muscle twitching) and FLUSHING (Flushing) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 011021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (worsening.), Heart disease, unspecified (worsening), Mitral valve prolapse (Mitral valve prolapse from rheumatic fever since she was 5. Worsening.), Fibromyalgia (worsening. but long time ago.), Arteriosclerosis (worsening), Ehlers-Danlos syndrome (probably her whole life Worsening.), Chronic idiopathic constipation (worsening), Hepatitis C (recently discovered this year. Worsening.), Alcohol allergy (Allergy to rubbing alcohol), Allergy to chemicals (Allergic to chemical sensitivity to cleansers and that stuff.), Latex allergy (Latex), Drug allergy (Allergic to Kenalog.), Drug allergy (Allergic to Epinephrine), Drug allergy (Allergic to Lidocaine), Drug allergy (Allergic to codeine) and Drug allergy (Allergic to beta blockers). Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) for Hypertension, ALPRAZOLAM, POTASSIUM CHLORIDE, CARVEDILOL, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), METHYLPHENIDATE and VITAMINS NOS for an unknown indication.   On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 23-Nov-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Acute systolic congestive heart failure / a lot of edema in the whole body') (seriousness criteria hospitalization and medically significant), INSOMNIA (Insomnia/ was unable to sleep at all) (seriousness criteria hospitalization and medically significant), MUSCLE TWITCHING (Muscle twitching) (seriousness criterion hospitalization) and FLUSHING (Flushing) (seriousness criterion hospitalization). On 17-Mar-2022, the patient experienced PSYCHOTIC DISORDER (Unspecified psychosis / behavioural changes / patient was confused / hallucinations) (seriousness criteria hospitalization and medically significant), HYPERTENSION (Had high blood pressure) (seriousness criteria hospitalization and medically significant) and INCONTINENCE (Incontinence (no control of her bladder)) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 17-Mar-2022 due to CARDIAC FAILURE CONGESTIVE, FLUSHING, HYPERTENSION, INCONTINENCE, INSOMNIA, MUSCLE TWITCHING and PSYCHOTIC DISORDER. The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) for Adverse event, at a dose of 40 to 80 mg; CLONIDINE for Psychotic behavior, at an unspecified dose and frequency and HALOPERIDOL (HALDOL [HALOPERIDOL]) for Hallucinations, at an unspecified dose and frequency. At the time of the report, CARDIAC FAILURE CONGESTIVE (Acute systolic congestive heart failure / a lot of edema in the whole body'), PSYCHOTIC DISORDER (Unspecified psychosis / behavioural changes / patient was confused / hallucinations), HYPERTENSION (Had high blood pressure), INCONTINENCE (Incontinence (no control of her bladder)), INSOMNIA (Insomnia/ was unable to sleep at all), MUSCLE TWITCHING (Muscle twitching) and FLUSHING (Flushing) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: inconclusive (Inconclusive) Inconclusive.         It was reported that patient had no medical history of COVID-19 diagnosis and no had no other vaccines administered one month prior to Moderna COVID-19 vaccine. It was reported that patient visited to regular doctor and went to ER 3 times in an ambulance, but doctors sent patient back to home, and when events got worse, patient went to see primary HCP and doctor sent her to ER, later patient spent 5 days in the hospital and doctors transferred her to a psychiatric hospital. On 23Nov2021 her mother started to experience a lot of edema in the whole body, flushing, muscle twitching, insomnia, and acute systolic congestive heart failure. Her mother visited a doctor, and also asked for an ambulance and visited ER 3 times, and after trying to treat symptoms, doctors sent her back to home. On 17Mar2022 her mother visited ER again, because her symptoms were getting worse. It was reported that lab test and CT scan were done and patient was referred to neurology but before patient could go, mental symptoms got worse.  Company Comment - This spontaneous case concerns a 56-year-old, female patient, with the relevant medical history of hypertension, heart disease, mitral valve prolapse, and hepatitis C, who experienced the unexpected, medically significant serious events of an AESI Cardiac failure congestive, Psychotic disorder, Hypertension, Incontinence, Insomnia as well as Muscle twitching and Flushing that led to hospitalization. The patient received two doses of mRNA-1273 COVID-19 vaccine 38 days apart (Inappropriate schedule of vaccine administration). Her symptoms reportedly began as "a lot of edema in the whole body, flushing, muscle twitching, insomnia, and acute systolic congestive heart failure" that prompted visits to the emergency room department on three occasions 12 days post-vaccination with her second dose of mRNA-1273 COVID-19 vaccine. Her condition reportedly worsened with new events of incontinence (no control of her bladder), behavioral changes, confusion, hallucinations, and unspecified psychosis 114 days from the onset of her initial symptoms that eventually led to hospitalization for 5 days. Unspecified laboratory tests and Cranial CT scan with no result were reportedly done. Treatment details included Lasix 40 mg shifted to 80 mg and clonidine for her psychotic irrational thinking and Haldol injection for her hallucinations. Due to the ongoing insomnia (unable to sleep at all), high blood pressure, and worsening of mental symptoms, the patient was reportedly referred to a neurologist and was also sent to a psychiatric hospital for further management. The patient's medical history of hypertension, heart disease, mitral valve prolapse, and hepatitis C remain as confounders to the events Cardiac failure congestive and Hypertension. The patient's medical history of hepatitis C could be a predisposing risk factor to Incontinence. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56-year-old, female patient, with the relevant medical history of hypertension, heart disease, mitral valve prolapse, and hepatitis C, who experienced the unexpected, medically significant serious events of an AESI Cardiac failure congestive, Psychotic disorder, Hypertension, Incontinence, Insomnia as well as Muscle twitching and Flushing that led to hospitalization. The patient received two doses of mRNA-1273 COVID-19 vaccine 38 days apart (Inappropriate schedule of vaccine administration). Her symptoms reportedly began as "a lot of edema in the whole body, flushing, muscle twitching, insomnia, and acute systolic congestive heart failure" that prompted visits to the emergency room department on three occasions 12 days post-vaccination with her second dose of mRNA-1273 COVID-19 vaccine. Her condition reportedly worsened with new events of incontinence (no control of her bladder), behavioral changes, confusion, hallucinations, and unspecified psychosis 114 days from the onset of her initial symptoms that eventually led to hospitalization for 5 days. Unspecified laboratory tests and Cranial CT scan with no result were reportedly done. Treatment details included Lasix 40 mg shifted to 80 mg and clonidine for her psychotic irrational thinking and Haldol injection for her hallucinations. Due to the ongoing insomnia (unable to sleep at all), high blood pressure, and worsening of mental symptoms, the patient was reportedly referred to a neurologist and was also sent to a psychiatric hospital for further management. The patient's medical history of hypertension, heart disease, mitral valve prolapse, and hepatitis C remain as confounders to the events Cardiac failure congestive and Hypertension. The patient's medical history of hepatitis C could be a predisposing risk factor to Incontinence. The benefit-risk relationship of mRNA-1273 is not affected by this report.