Received Apr 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 7+ | 3052586 | IM |
mild fever/probably 99 degrees/only felt a little hot that night that was it; a little bit of feeling aches and pains for 24 hours; This spontaneous case was reported by a physician and describes the occurrence of PAIN (a little bit of feeling aches and pains for 24 hours) and PYREXIA (mild fever/probably 99 degrees/only felt a little hot that night that was it) in a 68-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052586) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052586) for COVID-19 prophylaxis. Concurrent medical conditions included Autoimmune disorder. On 29-Sep-2025, the patient received ninth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (a little bit of feeling aches and pains for 24 hours) and PYREXIA (mild fever/probably 99 degrees/only felt a little hot that night that was it). At the time of the report, PAIN (a little bit of feeling aches and pains for 24 hours) and PYREXIA (mild fever/probably 99 degrees/only felt a little hot that night that was it) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: probably 99 F. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. It was unknown if there were any vaccines within the past 4 weeks prior to receiving the Moderna COVID-19 vaccine. No concomitant medication was reported. The patient thought they gave her that medicine because she was always looking at the bottle or looking at the vial and they were always busy and she would try to see how much had been, these were the individual ones for sure and later confirmed that the 2025-2026 formula given to her were all in prefilled syringes. The patient had every dose with Moderna COVID-19 vaccine. Reporter also confirmed that every time the patient had the said vaccine, she would have side effects. The reporter reiterated that the side effects experienced by the patient were normal. All the side effects of the patient were very mild, nothing severe like a necessity to visit the doctor. She never even took the temperature. It was first time the patient had the fever, just a little bit, it was a little bit off, but then the next day it was fine. Patient was happy that she had a little bit of feeling aches and pains for 24 hours but nothing like getting COVID. It was nothing like getting COVID. The patient knew so many people and family and friends who have had it and had no vaccine and were not alive or her cousin, they did not have a vaccine and had long term COVID for 5 years. The reporter asked about the difference between mNEXSPIKE and Spikevax about recommendation for administration, which one was the current formulation, when would the new formulation be out, and their intention to order the vaccines. She also asked for the temperatures intended for storage for both the refrigerator and the freezer, as well as the minimum orders to be done. She also asked for the verification of the lot number for the dose 29-Sep-2025. The patient did not experience any additional symptoms/events. No concomitant medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2026-794709, US-MODERNATX, INC.-MOD-2026-794711, US-MODERNATX, INC.-MOD-2026-794715, US-MODERNATX, INC.-MOD-2026-794716, US-MODERNATX, INC.-MOD-2026-794720, US-MODERNATX, INC.-MOD-2026-794719, US-MODERNATX, INC.-MOD-2026-794717 (E2B Linked Report). This case was linked to MOD-2026-794718 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2026-794709:Husband case US-MODERNATX, INC.-MOD-2026-794711:Daughter case US-MODERNATX, INC.-MOD-2026-794715:Her friends, her friend US-MODERNATX, INC.-MOD-2026-794716:Sister case US-MODERNATX, INC.-MOD-2026-794720:Hausband case different dose US-MODERNATX, INC.-MOD-2026-794719:Daughter case - different dose US-MODERNATX, INC.-MOD-2026-794717:Mother-in-law case
Autoimmune disorder
Test Name: Body temperature; Result Unstructured Data: probably 99 F