Reporte zur Charge 031L20AE

Symptomtext

fainted; Patient was dizzy; migraine; Patient had a panic attack before heading to the emergency room; fatigue; uncontrollable vomiting; temperature was 103; injection site pain; joint pain; Headache; neck pain; back pain; general body pain; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (fainted) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21AE and 031L20AE) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included THYROID (ARMOUR THYROID) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced NECK PAIN (neck pain), BACK PAIN (back pain), PAIN (general body pain), VACCINATION SITE PAIN (injection site pain), ARTHRALGIA (joint pain) and HEADACHE (Headache). On 17-Apr-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), DIZZINESS (Patient was dizzy), MIGRAINE (migraine), PANIC ATTACK (Patient had a panic attack before heading to the emergency room), FATIGUE (fatigue), VOMITING (uncontrollable vomiting) and PYREXIA (temperature was 103, high temperature). On 17-Apr-2021, SYNCOPE (fainted) had resolved. At the time of the report, DIZZINESS (Patient was dizzy), MIGRAINE (migraine), PANIC ATTACK (Patient had a panic attack before heading to the emergency room), NECK PAIN (neck pain), BACK PAIN (back pain), PAIN (general body pain), FATIGUE (fatigue), VOMITING (uncontrollable vomiting), PYREXIA (temperature was 103, high temperature), VACCINATION SITE PAIN (injection site pain), ARTHRALGIA (joint pain) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 103 (High) 103. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment included Imitrex, Tylenol, Steroids, Benadryl, Zofran, and Morphine. 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.; 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.