Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Hospitalisation, Hypersensitivity, Hypotension, Product dose omission issue
Clinical narrative: Hospitalization; Allergy; Chest pain; Balance issue; Lightheadiness; Low blood pressure; Been 3 months and he has not gotten his second shot yet; Large rash on stomach, arms, legs, and back; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Hospitalization) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by reporter.  Concomitant products included APIXABAN (ELIQUIS), METOPROLOL, FLECAINIDE, HYDROCHLOROTHIAZIDE, VITAMIN B NOS (B PLUS [VITAMIN B NOS]), PROBIOTICS NOS, COLECALCIFEROL (VITAMIN D3), SERENOA REPENS EXTRACT (PROSTONIL), TAMSULOSIN and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Large rash on stomach, arms, legs, and back). On 18-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Been 3 months and he has not gotten his second shot yet). On an unknown date, the patient experienced HOSPITALISATION (Hospitalization) (seriousness criterion hospitalization), HYPERSENSITIVITY (Allergy), CHEST PAIN (Chest pain), BALANCE DISORDER (Balance issue), DIZZINESS (Lightheadiness) and HYPOTENSION (Low blood pressure). On 18-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Been 3 months and he has not gotten his second shot yet) had resolved. At the time of the report, HOSPITALISATION (Hospitalization) had resolved and HYPERSENSITIVITY (Allergy), CHEST PAIN (Chest pain), BALANCE DISORDER (Balance issue), DIZZINESS (Lightheadiness), HYPOTENSION (Low blood pressure) and RASH (Large rash on stomach, arms, legs, and back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: (Positive) Patient had a ton of antibodies after the first dose. On an unknown date, Cardiac stress test: (Inconclusive) They checked his heart with a stress test. On an unknown date, Echocardiogram: (Inconclusive) They checked his heart with an echocardiograph.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient missed second dose (his second shot was scheduled for 18Feb2021, which he missed).  Treatment information was not provided. Patient consulted doctor for events. Company comments: Based on reporter's causality the events, low pressure, balance disorder, Dizziness and  Low blood pressure  are assessed as unlikely related to mRNA-1273.Based on the current available information and temporal association between the use of the product and the start date of the events allergy and rush , a causal relationship cannot be excluded.  For the event product dose omission causality is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field.; Sender's Comments: Based on reporter's causality the events, low pressure, balance disorder, Dizziness and  Low blood pressure  are assessed as unlikely related to mRNA-1273.Based on the current available information and temporal association between the use of the product and the start date of the events allergy and rush , a causal relationship cannot be excluded.  For the event product dose omission causality is assessed as not aplicable.