Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052671 | IM / LA |
soreness; extended fatigue/extreme fatigue; a couple of bumps; This spontaneous case was reported by a physician and describes the occurrence of PAIN (soreness), SKIN MASS (a couple of bumps) and FATIGUE (extended fatigue/extreme fatigue) in an 88-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052671) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE; for COVID-19 prophylaxis: SPIKEVAX NOS. Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE and SPIKEVAX NOS. On 26-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. In 2025, the patient experienced SKIN MASS (a couple of bumps). On 26-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced FATIGUE (extended fatigue/extreme fatigue). On 27-Sep-2025, the patient experienced PAIN (soreness). In 2025, SKIN MASS (a couple of bumps) had resolved. At the time of the report, PAIN (soreness) and FATIGUE (extended fatigue/extreme fatigue) had not resolved. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient had received vaccine on 26-Sep-2025, since then, she had an extended period of extreme fatigue, no rash, no fever, no cardiac manifestations, no nothing except extraordinary fatigue. Sometimes she can stand for 10 minutes and then has to lie down. No rash that they can see, a couple of bumps that have been there for a while but nothing else. No fever, no dizziness. She also had soreness. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789931 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2025: Live significant follow-up information received included: event couple of bumps was added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789931:Husband case