Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | 8081260 | IM |
sore arms at injection site and a bit chilly/achiness/had some chills and the arm was achy/Arm pain/Sore arm; We felt a little chilly, no, no fever, but, and then a little achy, you know, the body a little bit/little body ache; sore arms at injection site and a bit chilly/achiness; sore arms at injection site and a bit chilly/achiness chills/had some chills and the arm was achy/Chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore arms at injection site and a bit chilly/achiness/had some chills and the arm was achy/Arm pain/Sore arm), PAIN (We felt a little chilly, no, no fever, but, and then a little achy, you know, the body a little bit/little body ache), VACCINATION SITE PAIN (sore arms at injection site and a bit chilly/achiness) and CHILLS (sore arms at injection site and a bit chilly/achiness chills/had some chills and the arm was achy/Chills) in a 74-year-old male 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 (sore arms at injection site and a bit chilly/achiness/had some chills and the arm was achy/Arm pain/Sore arm), PAIN (We felt a little chilly, no, no fever, but, and then a little achy, you know, the body a little bit/little body ache), VACCINATION SITE PAIN (sore arms at injection site and a bit chilly/achiness) and CHILLS (sore arms at injection site and a bit chilly/achiness chills/had some chills and the arm was achy/Chills). On 30-Mar-2025, PAIN IN EXTREMITY (sore arms at injection site and a bit chilly/achiness/had some chills and the arm was achy/Arm pain/Sore arm), PAIN (We felt a little chilly, no, no fever, but, and then a little achy, you know, the body a little bit/little body ache), VACCINATION SITE PAIN (sore arms at injection site and a bit chilly/achiness) and CHILLS (sore arms at injection site and a bit chilly/achiness chills/had some chills and the arm was achy/Chills) had resolved. Concomitant product use was not provided by the reporter. Patient had received second Booster shot from Moderna. Patient and his wife had received all the Moderna Covid-19 vaccines included another jab this spring. Only reaction patient had this spring were sore arms at injection site and a bit chilly/achiness. Patient and his wife had some chills and the arm was achy and that they were a little, achy. Patient had the sore arm for two days. They felt a little chilly, no, no fever, but, and then a little achy, the body a little bit, but that was it. It resolved. The symptoms started in 28-MAR-2025 in the morning stating after 12 hours exactly for the wife and the patient got it probably 4 hours later than that. So within the 24 hours, but the 1st 12 hours, they generally didn't felt anything and then the arm got sore and sore and then the next day it was really sore. But that didn't bother them. 2 days later, on 30-Mar-2025, basically it was mostly gone, 48 hours later. The patient had experienced sore arm but not much achy and subsided eventually. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2025-785213 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2025: Live significant information follow-up received: Reporter details added. Lot number along with dosing details were added. Patient details added. Event verbatim updated and new event General body pain added. Event Ache NOS was updated to Pain in arm. Outcome of the events were updated. Reference Id added. On 22-Apr-2025: Live Significant follow up received: Patient initials updated. Event verbatim updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785213:Patient 2 of 2