Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Suspected COVID-19, Swelling, Vaccination complication
Clinical narrative: heart wasn't working right; has been weak; red patch on her arm; swelling; itching; feels like the vaccine has given her the COVID-19 virus; anxiety; Infected right eye; felt terrible; dry cough; Unable to sleep; big raised oval rash which was hot to the touch; slight temperature; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (heart wasn't working right) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac) from 18-Mar-2021 to 19-Mar-2021. Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (slight temperature) and FATIGUE (fatigue). On 04-Mar-2021, the patient experienced INSOMNIA (Unable to sleep) and RASH (big raised oval rash which was hot to the touch). On 08-Mar-2021, the patient experienced VACCINATION COMPLICATION (felt terrible) and COUGH (dry cough). On 17-Mar-2021, the patient experienced EYE INFECTION (Infected right eye). On an unknown date, the patient experienced CARDIAC DISCOMFORT (heart wasn't working right) (seriousness criterion hospitalization), ASTHENIA (has been weak), ERYTHEMA (red patch on her arm), SWELLING (swelling), PRURITUS (itching), SUSPECTED COVID-19 (feels like the vaccine has given her the COVID-19 virus) and ANXIETY (anxiety). The patient was hospitalized from 18-Mar-2021 to 19-Mar-2021 due to CARDIAC DISCOMFORT. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CARDIAC DISCOMFORT (heart wasn't working right), EYE INFECTION (Infected right eye), VACCINATION COMPLICATION (felt terrible), COUGH (dry cough), ASTHENIA (has been weak), INSOMNIA (Unable to sleep), ERYTHEMA (red patch on her arm), SWELLING (swelling), PRURITUS (itching), SUSPECTED COVID-19 (feels like the vaccine has given her the COVID-19 virus), ANXIETY (anxiety), RASH (big raised oval rash which was hot to the touch), PYREXIA (slight temperature) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Heart rate: 33 (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. However, the medical history/ occurrence of Pacemaker insertion (cardiac) could be a contributory factor.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Added new events (infected right eye and heart wasn't working right), procedure, lab and hospitalization.; 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. However, the medical history/ occurrence of Pacemaker insertion (cardiac) could be a contributory factor.