Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 5 | — | IM |
tremors; feeling of being cold to the bone; He felt unsteady and thought he had a fever; respirations were rapid and labored; chills; nausea; unsteady and thought he had a fever; he felt a bit unwell earlier in the day; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (tremors), FEELING COLD (feeling of being cold to the bone), FEELING ABNORMAL (He felt unsteady and thought he had a fever), RESPIRATION ABNORMAL (respirations were rapid and labored) and MALAISE (he felt a bit unwell earlier in the day) in an 80-year-old male 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. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included Unspecified septicemia (septicemia). Previously administered products included for Product used for unknown indication: Pfizer (dose 2), Pfizer (dose 1), Pfizer (dose 4) and Pfizer (dose 3). Past adverse reactions to the above products included No adverse effect with Pfizer, Pfizer, Pfizer and Pfizer. On 13-Oct-2025 at 10:30 AM, the patient received fifth 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. On 13-Oct-2025, the patient experienced MALAISE (he felt a bit unwell earlier in the day). On 13-Oct-2025 at 4:00 PM, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced TREMOR (tremors), FEELING COLD (feeling of being cold to the bone), FEELING ABNORMAL (He felt unsteady and thought he had a fever), RESPIRATION ABNORMAL (respirations were rapid and labored), CHILLS (chills), NAUSEA (nausea) and PYREXIA (unsteady and thought he had a fever). At the time of the report, TREMOR (tremors), FEELING COLD (feeling of being cold to the bone), FEELING ABNORMAL (He felt unsteady and thought he had a fever), RESPIRATION ABNORMAL (respirations were rapid and labored), MALAISE (he felt a bit unwell earlier in the day), CHILLS (chills), NAUSEA (nausea) and PYREXIA (unsteady and thought he had a fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2025, Blood test: Negative. In October 2025, Computerised tomogram: Negative. In October 2025, Culture: Negative. In October 2025, Urine analysis: Negative. No concomitant medication was reported. On 13-Oct-2025, the patient experienced a sudden onset of chills, tremors, and a feeling of being cold to the bone in the afternoon. He felt unsteady and thought he had a fever. He also had some nausea but no vomiting. His respirations were rapid and labored. The patient received the shot around 10:30 AM, and these symptoms began around 4:00 in the afternoon. Initially, he felt a bit unwell earlier in the day, but the significant symptoms started at 4:00 PM. His condition did not improve overnight, leading him to visit the ER, where he spent 7.5 hours. The medical team was concerned about sepsis due to his history of septicemia, but all tests, including blood work, cultures, urinalysis, and a CT scan, were negative. This led to the consideration that the COVID shot might be the cause, as this was his first Moderna vaccine after four Pfizer doses. The patient was not specifically informed about receiving Moderna, and since previous COVID shots were uneventful, patient did not inquire further. After several hours and test results, it was concluded that the vaccine was the likely cause, as no other factors changed that day. He did not have sepsis on 13-Oct-2025, although there was concern due to his history in Nov-2024 and Dec-2024. Following a battery of tests, sepsis was ruled out. A week later, an infectious disease doctor confirmed it was not an infection. It was unknown if the patient experienced any additional symptoms/events. He received treatment, including IVs, and began to feel better. Most recent FOLLOW-UP information incorporated above includes: On 07-Nov-2025: Live follow-up received: Reporter email id corrected, ROA updated, and reference ids added.
Medical History/Concurrent Conditions: Unspecified septicemia (septicemia)
Test Date: 202510; Test Name: blood work; Test Result: Negative ; Test Date: 202510; Test Name: CT Scan; Test Result: Negative ; Test Date: 202510; Test Name: cultures; Test Result: Negative ; Test Date: 202510; Test Name: urinalysis; Test Result: Negative