Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052733 | IM |
Sick; Followed by sweats; Terrible chills; Nausea; The discomfort was disabling; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (The discomfort was disabling), MALAISE (Sick), HYPERHIDROSIS (Followed by sweats), CHILLS (Terrible chills) and NAUSEA (Nausea) in a 71-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052733) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052733) for COVID-19 prophylaxis. The patient's past medical history included COVID-19. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX 2024-2025 (Got Moderna 2024-2025 COVID-19 vaccine 12 plus year. Dose was 0.5ml) in December 2024, Spikevax 2023-2024 formula (Previously received Moderna 2023-2024 on October 23rd (did not provide year). Dose was 0.5ml) and Spikevax NOS; for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse effect with Pfizer, SPIKEVAX 2024-2025, Spikevax 2023-2024 formula and Spikevax NOS. On 22-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced DISCOMFORT (The discomfort was disabling), HYPERHIDROSIS (Followed by sweats), CHILLS (Terrible chills) and NAUSEA (Nausea). On 22-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced MALAISE (Sick). In October 2025, HYPERHIDROSIS (Followed by sweats), CHILLS (Terrible chills) and NAUSEA (Nausea) had resolved. On 24-Oct-2025 at 9:00 AM, MALAISE (Sick) had resolved. At the time of the report, DISCOMFORT (The discomfort was disabling) outcome was unknown. Concomitant medication use information was not provided by reporter. This week, the patient received the Moderna vaccine. The reaction to that shot was the worst they had ever experienced with Covid vaccines. The patient received Covid vaccines since they were first available. The patient had severe side effects including terrible chills, followed by sweats and nausea. It lasted for about 24 hours or so. However, the discomfort was disabling. Nothing like that was ever wanted to be repeated. The patient's age was over 65. The reporter wondered if the new vaccine with a smaller dose might be a better choice and inquired about the potential for fewer side effects with a smaller dose vaccine. The patient felt as bad as having COVID, even if it was only a day. The mNEXSPIKE dose was absolutely brutal for the patient. Despite previous positive experiences with COVID vaccines, the patient now hesitated about future vaccinations. The reaction was awful, unlike anything ever experienced before, and the patient had been getting them all along, either Pfizer or Moderna. This one, the effect seemed over a minor loginess the day after. The patient had gotten Moderna COVID-19 vaccines before. This was awful. The patient would never go through this again and had COVID before. This was as bad as having COVID, although it was only for a day. The patient was sick starting in the evening of 22-Oct-2025 until about 9 a.m. on 24-Oct-2025. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2025: Live follow up received that contains significant information includes added historical vaccines in medical history and historical condition, updated suspect product coding, added suspect product details (start date, batch lot number and dose details), added feeling sick as additional event and narrative was updated.
Medical History/Concurrent Conditions: COVID-19