Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dyspnoea, Fatigue, Gait inability
Clinical narrative: admitted into hospital; admitted into hospital; tired; Very bad reaction after the first shot; breathing problems; close to death; Diarrhea; threw up - couldn't keep anything down for 2 days; was incapacitated, Weak; couldn't walk/could not get out of bed/couldn't sit and wait at the ER,unable to walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of the first episode of HOSPITALISATION (admitted into hospital), the second episode of HOSPITALISATION (admitted into hospital) and NEAR DEATH EXPERIENCE (close to death) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in August 2020. Concurrent medical conditions included Coronary artery disease, Peripheral arterial disease, Breast cancer, Heart failure (More events at night) and Heart disease, unspecified. Concomitant products included APIXABAN (ELIQUIS), LORATADINE, LOSARTAN, DILTIAZEM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K) and EZETIMIBE (ZETIA) for Heart failure, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid enlarged.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ASTHENIA (was incapacitated, Weak) and GAIT INABILITY (couldn't walk/could not get out of bed/couldn't sit and wait at the ER,unable to walk). On 19-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (threw up - couldn't keep anything down for 2 days). On an unknown date, the patient experienced the first episode of HOSPITALISATION (admitted into hospital) (seriousness criterion hospitalization), the second episode of HOSPITALISATION (admitted into hospital) (seriousness criterion hospitalization), NEAR DEATH EXPERIENCE (close to death) (seriousness criterion medically significant), VACCINATION COMPLICATION (Very bad reaction after the first shot), DYSPNOEA (breathing problems) and FATIGUE (tired). The patient was hospitalized from 01-May-2021 to 06-May-2021 due to HOSPITALISATION, and then from 13-May-2021 to 21-May-2021 due to HOSPITALISATION. The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, last episode of HOSPITALISATION (admitted into hospital), NEAR DEATH EXPERIENCE (close to death), VACCINATION COMPLICATION (Very bad reaction after the first shot), DYSPNOEA (breathing problems) and FATIGUE (tired) outcome was unknown and DIARRHOEA (Diarrhea), ASTHENIA (was incapacitated, Weak), GAIT INABILITY (couldn't walk/could not get out of bed/couldn't sit and wait at the ER,unable to walk) and VOMITING (threw up - couldn't keep anything down for 2 days) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received contain information about patient information, medical history, vaccine facility information, and concomitant medications, new serious events and updated out come of events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded