Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 4 | — | IM |
tingling/tingling was intermittent; very sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling/tingling was intermittent) and VACCINATION SITE PAIN (very sore injection site) in a 66-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 03-Oct-2025, the patient received fourth 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 October 2025, the patient experienced PARAESTHESIA (tingling/tingling was intermittent) and VACCINATION SITE PAIN (very sore injection site). In October 2025, VACCINATION SITE PAIN (very sore injection site) had resolved. At the time of the report, PARAESTHESIA (tingling/tingling was intermittent) had not resolved. No concomitant medications were provided. The patient had injection on 03-Oct-2025. Initially the patient had a very sore injection site for 4 days but then the tingling started and was still happening. This was 4th Moderna vaccine, but this was a new reaction. The patient was currently 66 years old with no other health issues. The tingling was intermittent and lasted about 10 seconds. No pain or other symptoms. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790376 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790376:Same patient different product