Received Jun 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
Wake up feeling like got the flu and it takes at least, takes a couple of days to get over it; A very sore arm even into shoulder; A very sore arm even into shoulder; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Wake up feeling like got the flu and it takes at least, takes a couple of days to get over it), ARTHRALGIA (A very sore arm even into shoulder) and VACCINATION SITE PAIN (A very sore arm even into shoulder) in an 80-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included COVID-19. Concurrent medical conditions included CLL (7 years ago) and Cardiac valve prosthesis user (Patient reported that his aortic valve was aged, calcified, and had become closed. He thought that the condition progressed rapidly following COVID-19; however, he was uncertain about this association. According to (withheld) Clinic evaluation, the condition was estimated to be present for approximately 3 years and was not considered as related to COVID-19.) since 2024. In September 2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced INFLUENZA LIKE ILLNESS (Wake up feeling like got the flu and it takes at least, takes a couple of days to get over it), ARTHRALGIA (A very sore arm even into shoulder) and VACCINATION SITE PAIN (A very sore arm even into shoulder). In 2025, INFLUENZA LIKE ILLNESS (Wake up feeling like got the flu and it takes at least, takes a couple of days to get over it), ARTHRALGIA (A very sore arm even into shoulder) and VACCINATION SITE PAIN (A very sore arm even into shoulder) had resolved. Patient had all covid vaccines from Moderna since release and then about yearly. No concomitant medication was reported. Patient had turned 80, but people thought he was just 40. It was reported that after getting vaccine patient was on the sofa for two days. He woke up next morning with a very sore arm that went into shoulder and then woke up feeling like got the flu. It took at least a couple of days to get over it, but he was aware that would probably happen and his doctor was like quit complaining and lay down. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2026-797609 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2026-797609:Same patient, different product (Spikevax NOS)
Cardiac valve prosthesis user (Patient reported that his aortic valve was aged, calcified, and had become closed. He thought that the condition progressed rapidly following COVID-19; however, he was uncertain about this association. According to (withheld) Clinic evaluation, the condition was estimated to be present for approximately 3 years and was not considered as related to COVID-19.); CLL (7 years ago)
Medical History/Concurrent Conditions: COVID-19