Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Dizziness, Hypotension, Insomnia, Nausea
Clinical narrative: patient collapsed and taken to emergency department; low blood pressure; becoming depressed; difficulty sleeping due to rash; felt itchy on the inside of the body; rash that covered his arms, upper torso, shoulders and went down the back/rash developing on face and neck; nausea; dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (patient collapsed and taken to emergency department) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided.).    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nausea). On 31-Mar-2021, the patient experienced DEPRESSION (becoming depressed), INSOMNIA (difficulty sleeping due to rash), PRURITUS (felt itchy on the inside of the body) and RASH (rash that covered his arms, upper torso, shoulders and went down the back/rash developing on face and neck). On 01-Apr-2021, the patient experienced SYNCOPE (patient collapsed and taken to emergency department) (seriousness criterion medically significant) and HYPOTENSION (low blood pressure). At the time of the report, SYNCOPE (patient collapsed and taken to emergency department), HYPOTENSION (low blood pressure), DEPRESSION (becoming depressed), DIZZINESS (dizziness), INSOMNIA (difficulty sleeping due to rash), PRURITUS (felt itchy on the inside of the body), RASH (rash that covered his arms, upper torso, shoulders and went down the back/rash developing on face and neck) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   A pharmacist suggested the patient take Children's Benadryl followed by Zyrtec to help with the itching. These medicines have not helped alleviate his intense itching. On 1Apr2021, the patient collapsed and was taken to the emergency department. The patient was treated at the emergency department after he collapsed from low blood pressure. He was prescribed Hydroxyzine HCI 10mg for the itching by the emergency room physician, but the medicine has done nothing to alleviate the patient's symptoms.  Based on the current available information which includes a temporal association between the use of the product and onset of the reported events of vaccination site reaction, a causal relationship cannot be excluded. Ras and nausea are consistent with the known safety profile of the vaccine.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events of vaccination site reaction, a causal relationship cannot be excluded. Ras and nausea are consistent with the known safety profile of the vaccine.