Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | 8081260 | IM |
the arm was achy/Arm pain; little body ache; had some chills; Muscle ache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (the arm was achy/Arm pain), PAIN (little body ache), CHILLS (had some chills) and MYALGIA (Muscle ache) in a 75-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8081260) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX 2024-2025 PFS (First Booster dose) in September 2024. Past adverse reactions to the above products included No adverse effect with SPIKEVAX 2024-2025 PFS. On 28-Mar-2025, the patient received second dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 28-Mar-2025, the patient experienced PAIN IN EXTREMITY (the arm was achy/Arm pain), PAIN (little body ache), CHILLS (had some chills) and MYALGIA (Muscle ache). On 30-Mar-2025, PAIN IN EXTREMITY (the arm was achy/Arm pain) and MYALGIA (Muscle ache) had resolved. At the time of the report, PAIN (little body ache) and CHILLS (had some chills) had resolved. Patient did not receive any vaccines within the past 4 weeks. The concomitant medication was not reported. Patient had received second Booster shot from Moderna. Patient had sore arm for two days, felt a little chilly, no fever but then a little achy, the little bit body ache, but that was it. The symptoms started on 28-MAR-2025 in the morning, and it was started after 12 hours exactly for patient. Within the 24 hours, the first 12 hours, patient generally didn't feel anything, and then the arm got sore and sore and then the next day it was really sore. But that didn't bother her. 2 days later, that is 30th, basically it was mostly gone. She had said, it was 48 hrs. Patient had Moderna COVID vaccines all the way through since day one. It was unknown if the patient experienced any additional symptoms/events The treatment drug information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-785217 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2025: Live follow up received that contains significant information includes reporter details, initials, historical vaccine, lot number, dose details, event latency and date of birth was added and event verbatim and coding for arm pain was updated. On 22-Apr-2025: Live Significant follow up received includes new event of Muscle ache and reference were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785217:Husband case