Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
things floating around in body from taking the COVID and the booster; woke up after her flu shot with pain in her left eye, waited a couple of weeks and got her COVID shot and the eye pain got worse; COVID; Although a non-specific finding, the pattern appears most suggested of the sequela of chronic small vessel ischemic change; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE (Although a non-specific finding, the pattern appears most suggested of the sequela of chronic small vessel ischemic change) in a 63-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. No Medical History information was reported. In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 21-Feb-2024, the patient experienced CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE (Although a non-specific finding, the pattern appears most suggested of the sequela of chronic small vessel ischemic change) (seriousness criterion medically significant). In September 2024, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced FEELING ABNORMAL (things floating around in body from taking the COVID and the booster) and EYE PAIN (woke up after her flu shot with pain in her left eye, waited a couple of weeks and got her COVID shot and the eye pain got worse). At the time of the report, CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE (Although a non-specific finding, the pattern appears most suggested of the sequela of chronic small vessel ischemic change), FEELING ABNORMAL (things floating around in body from taking the COVID and the booster), EYE PAIN (woke up after her flu shot with pain in her left eye, waited a couple of weeks and got her COVID shot and the eye pain got worse) and COVID-19 (COVID) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2024, Magnetic resonance imaging head: A small hyper handing focus of vessel was in the high left frontal cerebrum. With a drainage information and overlaying cortical vein, several small patchy paraventricular subcortical and deep white matter flare. Although a non-specific finding, the pattern appears most suggested of the sequela of chronic small vessel ischemic change. No abnormal post contrast enhancement of these lesions. Results of chronic small blood related damage. On an unknown date, Antibody test: before the vaccines they tested their antibodies and tested again in 2 weeks, and their antibodies were always up and off the scale. On an unknown date, Scan brain: everything was ok. No concomitant medication was reported. The patient did not have a shot in a long time, probably since this time last year. The patient had one small reaction from the Moderna COVID vaccine. She had only received the Moderna COVID vaccine, one in 2023 and in Sep-2024. The patient woke up after her flu shot with pain in her left eye, waited a couple of weeks and got her COVID shot, and the eye pain got worse. The pain was in the region behind left eye. The patient went to the ophthalmologist who advised her that it was not her vision, as her vision had not been affected. The patient was then sent to a specialist in ophthalmology where they conducted a brain scan and everything was ok. Every now and then she would feel it and that she would feel that her left eye was weaker. The patient was unsure if she had too much medication at once, things floating around in her body from taking the COVID and the booster. Even though she took the testing to understand that she was fully protected and her antibodies were off the chart, every time she took the booster, and went back and checked it and her antibodies were lower so the patient did not know if she still had some and then she got the flu shot and then it was just too much for her body. The patient also stated that she had COVID for the first time in Sep-2024. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790492 (E2B Linked Report).; Reporter's Comments: Flu vaccine remains as a co-supect drug. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790492:Husband case
Test Name: antibodies; Result Unstructured Data: before the vaccines they tested their antibodies and tested again in 2 weeks, and their antibodies were always up and off the scale; Test Date: 20240221; Test Name: MRI Brain report; Result Unstructured Data: A small hyper handing focus of vessel was in the high left frontal cerebrum. With a drainage information and overlaying cortical vein, several small patchy paraventricular subcortical and deep white matter flare. Although a non-specific finding, the pattern appears most suggested of the sequela of chronic small vessel ischemic change. No abnormal post contrast enhancement of these lesions. Results of chronic small blood related damage; Test Name: brain scan; Result Unstructured Data: everything was ok