Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 1 | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
tired; tremors/hand tremors; cold; flu; generally weak and had a weak voice/lacked energy; restless; poor sleep; warm; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (tremors/hand tremors), NASOPHARYNGITIS (cold), INFLUENZA (flu), ASTHENIA (generally weak and had a weak voice/lacked energy) and RESTLESSNESS (restless) in a 90-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On 02-Oct-2025, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 02-Oct-2025 at 11:00 AM, the patient received first dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 02-Oct-2025, the patient experienced TREMOR (tremors/hand tremors), NASOPHARYNGITIS (cold), INFLUENZA (flu), ASTHENIA (generally weak and had a weak voice/lacked energy), RESTLESSNESS (restless), POOR QUALITY SLEEP (poor sleep), FEELING HOT (warm) and CHILLS (chills). On 03-Oct-2025, the patient experienced FATIGUE (tired). At the time of the report, TREMOR (tremors/hand tremors), NASOPHARYNGITIS (cold), INFLUENZA (flu), ASTHENIA (generally weak and had a weak voice/lacked energy), RESTLESSNESS (restless), POOR QUALITY SLEEP (poor sleep), FEELING HOT (warm), CHILLS (chills) and FATIGUE (tired) had not resolved. No concomitant medications were provided. Patient had received the COVID-19 vaccine on 02-Oct-2025 at her local pharmacy, along with a flu shot. After the vaccination at 11 AM EST on 02-Oct-2025, she began experiencing chills and tremors around 4 PM EST. She also felt generally weak and had a weak voice. Despite having supper, she became warm, lacked energy, and had a restless night with poor sleep. By 8 AM EST on 03-Oct-2025, she experienced hand tremors and continued to feel very weak and tired, although she did not have a fever. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2025: Live follow-up received which contains significant information, patient details, suspect product information and events details were updated.