Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Felt like I was at my lifes end; more Afib eposides; Still weaker; I was so ill with vaccine one; feel pain; heart rate increased; intentional dose omission; threw up; chill/severe chills; Was tired / tired all the time; fever; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (Felt like I was at my lifes end) and ATRIAL FIBRILLATION (more Afib eposides) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Lymphadenectomy. Concurrent medical conditions included Hypertension (More episodes), Atrial fibrillation (high blood pressure) and Thyroid disorder. Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation, METOPROLOL, OXYBUTYNIN HYDROCHLORIDE (OXYBUTIN) and LEVOTHYROXINE for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chill/severe chills) and FATIGUE (Was tired / tired all the time). On 12-Apr-2021, the patient experienced VOMITING (threw up). On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (Felt like I was at my lifes end) (seriousness criterion medically significant), ATRIAL FIBRILLATION (more Afib eposides) (seriousness criterion medically significant), ASTHENIA (Still weaker), ILLNESS (I was so ill with vaccine one), PAIN (feel pain), HEART RATE INCREASED (heart rate increased) and INTENTIONAL DOSE OMISSION (intentional dose omission). The patient was treated with ACETAMINOPHEN on 11-Apr-2021 for Fever, at an unspecified dose and frequency. On 11-Apr-2021, PYREXIA (fever) had resolved. On 13-Apr-2021, CHILLS (chill/severe chills) had resolved. At the time of the report, NEAR DEATH EXPERIENCE (Felt like I was at my lifes end), ATRIAL FIBRILLATION (more Afib eposides), ILLNESS (I was so ill with vaccine one), PAIN (feel pain), VOMITING (threw up), FATIGUE (Was tired / tired all the time), HEART RATE INCREASED (heart rate increased) and INTENTIONAL DOSE OMISSION (intentional dose omission) outcome was unknown and ASTHENIA (Still weaker) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: fast (High) Fast. On an unknown date, Heart rate: irregular (abnormal) Irregular.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient was still weaker and could mow tiny yard in 12 minutes but now takes 35minutes.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Patient stated of still being weaker and tired all the time, was so ill with vaccine one and will not take second and felt like was at life end and firmly believe it cause to have more Afib episodes that actually felt pain with them now.  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 19-Jul-2021: Additional information includes-reporters address, patients-race, height and weight, patient history-thyroid, Indication for concomitant medication Xarelto and added the events and case upgraded to serious; 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.