Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 6 | 3052741 | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
hot flashes, that last 10 minutes to 2 hours and come intermittently through out the day but not a night; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes, that last 10 minutes to 2 hours and come intermittently through out the day but not a night) in an 82-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052741) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052741) for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. No Medical History information was reported. On 19-Sep-2025, the patient received sixth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 22-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced HOT FLUSH (hot flashes, that last 10 minutes to 2 hours and come intermittently through out the day but not a night). At the time of the report, HOT FLUSH (hot flashes, that last 10 minutes to 2 hours and come intermittently through out the day but not a night) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2025, Blood pressure measurement: normal. On 14-Oct-2025, Blood test: everything was perfectly normal; test date September 2025. On 14-Oct-2025, Body temperature: normal. On 14-Oct-2025, Laboratory test: everything was perfectly normal; test date September 2025. On 14-Oct-2025, Renal function test: everything was perfectly normal; test date September 2025. On 14-Oct-2025, Thyroid function test: everything was perfectly normal; test date September 2025. On 14-Oct-2025, Urine analysis: everything was perfectly normal; test date September 2025. On an unknown date, Gynaecological examination: everything was fine. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter considered HOT FLUSH (hot flashes, that last 10 minutes to 2 hours and come intermittently through out the day but not a night) to be related. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medication was not provided. It was reported that the patient believed that the side effects she had been experiencing were caused by the mNEXSPIKE vaccine, as she had undergone extensive medical testing over the past month and all results had been normal. Also reported that the symptoms began on 22 September 2025 and consisted of hot flashes lasting between 10 minutes and 2 hours, occurring intermittently throughout the day but not at night. She mentioned that she had received both the mNEXSPIKE vaccine and a flu shot on 19 September 2025, although she did not know the brand name of the flu shot. She described the flu shot as the "super flu shot" typically administered to older individuals. It was explained that she had been evaluated for heat waves but not specifically for hot flashes. She stated that the first heat wave occurred on 22 September 2025. She had undergone several tests. According to her, all results were normal, and her doctor had confirmed this after reviewing the laboratory findings. She also noted that her body temperature and blood pressure had been checked during episodes of hot flashes and were found to be within normal ranges. Despite this, she described feeling extremely hot during these episodes. She indicated that the tests had been conducted on the Tuesday prior to the call, which she believed might have been 14 October 2025, although she was not certain of the exact date. She emphasized that she had continued to experience these symptoms daily since 22 September 2025. During the call, she mentioned that she was experiencing a heat wave at that very moment. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2025: Live follow-up received and significant information includes reporter causality updated.
Test Date: 20251014; Test Name: blood pressure; Result Unstructured Data: normal; Test Date: 20251014; Test Name: blood work; Result Unstructured Data: everything was perfectly normal; test date September 2025; Test Date: 20251014; Test Name: body temperature; Result Unstructured Data: normal; Test Name: gynecologist check up; Result Unstructured Data: everything was fine; Test Date: 20251014; Test Name: protein tests; Result Unstructured Data: everything was perfectly normal; test date September 2025; Test Date: 20251014; Test Name: kidney function test; Result Unstructured Data: everything was perfectly normal; test date September 2025; Test Date: 20251014; Test Name: thyroid test; Result Unstructured Data: everything was perfectly normal; test date September 2025; Test Date: 20251014; Test Name: urine analysis; Result Unstructured Data: everything was perfectly normal; test date September 2025