Received Feb 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | 014C21A | IM |
hallucination; fatigued; disoriented; heart palpitations; weakness; burning in feet; muscle twitching; blurry vision; My muscles and my body keep melting away; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION (hallucination) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 054C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucination) (seriousness criterion medically significant), FATIGUE (fatigued), DISORIENTATION (disoriented), PALPITATIONS (heart palpitations), ASTHENIA (weakness), BURNING SENSATION (burning in feet), MUSCLE TWITCHING (muscle twitching), VISION BLURRED (blurry vision) and MUSCLE ATROPHY (My muscles and my body keep melting away). At the time of the report, HALLUCINATION (hallucination), FATIGUE (fatigued), DISORIENTATION (disoriented), PALPITATIONS (heart palpitations), ASTHENIA (weakness), BURNING SENSATION (burning in feet), MUSCLE TWITCHING (muscle twitching), VISION BLURRED (blurry vision) and MUSCLE ATROPHY (My muscles and my body keep melting away) outcome was unknown. Concomitant product use was not provided by the reporter. He was fatigued when he got his shot. The caller narrated that after he received the vaccine, he experienced disorientation, heart palpitations, hallucinations, weakness, burning in the feet, muscle twitching, blurry vision. The caller also added that his muscles and body keep melting away. The caller further narrates that after the second dose, everything goes downhill. The patient had been fighting for his life every second of the day, every second of the day from then, every second, and was used to being strong and healthy, but could barely walk to the bathroom. It was bad. This was unfair. The patient was a big strong man, going to the gym 5 days a week and now, he was an individual that could barely walk to the restroom. It was unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2025-782272 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-782272:Invalid case for multiple patients