Received Jun 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 7+ | 3043837 | IM |
were unable to sleep due to pain or discomfort; were unable to sleep due to pain or discomfort; were unable to sleep due to pain or discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (were unable to sleep due to pain or discomfort), DISCOMFORT (were unable to sleep due to pain or discomfort) and INSOMNIA (were unable to sleep due to pain or discomfort) in a 76-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043837) for COVID-19 prophylaxis. No Medical History information was reported. On 25-May-2025, the patient received tenth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 25-May-2025, the patient experienced PAIN (were unable to sleep due to pain or discomfort), DISCOMFORT (were unable to sleep due to pain or discomfort) and INSOMNIA (were unable to sleep due to pain or discomfort). At the time of the report, PAIN (were unable to sleep due to pain or discomfort), DISCOMFORT (were unable to sleep due to pain or discomfort) and INSOMNIA (were unable to sleep due to pain or discomfort) outcome was unknown. No concomitant medication was reported. Patient and her husband had no issues or problems until they received the 10th COVID-19 vaccines on 24-May-2025. On 25-May-2025, both were unable to sleep without waking up from pain or discomfort every 15-20 minutes. The pharmacist started injecting the shots into the shoulders. Patient's husband asked him to inject the vaccine in the bicep at the widest point of the arms (into the softest padded area of the upper arm), but he said he had to inject them in the shoulder. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.