Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052733 | IM |
meningoencephalitis; had a lot of diarrhea; GI problems; sleep was disturbed; sleepier; still foggy and did not remember things - the patient's memory was not what it was before and was forgetful; This spontaneous case was reported by a consumer and describes the occurrence of ENCEPHALITIS (meningoencephalitis), DIARRHOEA (had a lot of diarrhea) and GASTROINTESTINAL DISORDER (GI problems) in a 74-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052733) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection (batch no. 3052733) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 pneumonia (The patient had COVID pneumonia in June of 2020 so she thought she should get the vaccines in order to avoid another bad case of COVID) in June 2020. Concurrent medical conditions included Controlled hypertension (It was pre-existing to any vaccines. Her blood pressure was running low and that the patient was off her hypertensive meds) and Asthma (It started after the patient had a severe case of COVID). On 06-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced ENCEPHALITIS (meningoencephalitis) (seriousness criteria hospitalization and medically significant), DIARRHOEA (had a lot of diarrhea) (seriousness criterion hospitalization), GASTROINTESTINAL DISORDER (GI problems) (seriousness criterion hospitalization), SOMNOLENCE (sleepier) and MEMORY IMPAIRMENT (still foggy and did not remember things - the patient's memory was not what it was before and was forgetful). On an unknown date, the patient experienced SLEEP DISORDER (sleep was disturbed). The patient was hospitalized from 07-Oct-2025 to 14-Oct-2025 due to DIARRHOEA, ENCEPHALITIS and GASTROINTESTINAL DISORDER. The patient was treated with Paracetamol (Tylenol) in October 2025 at an unspecified dose and frequency; Ibuprofen in October 2025 at an unspecified dose and frequency; Aciclovir (Acyclovir) in October 2025 for Meningoencephalitis, at an unspecified dose and frequency and Dexamethasone (Decadron) in October 2025 for Meningoencephalitis, at an unspecified dose and frequency. At the time of the report, ENCEPHALITIS (meningoencephalitis), DIARRHOEA (had a lot of diarrhea), GASTROINTESTINAL DISORDER (GI problems), SOMNOLENCE (sleepier), MEMORY IMPAIRMENT (still foggy and did not remember things - the patient's memory was not what it was before and was forgetful) and SLEEP DISORDER (sleep was disturbed) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2025, Magnetic resonance imaging: showed meningoencephalitis. The patient had no vaccines within past 4 weeks from the date of vaccination. No concomitant medications were reported. It was reported that, the patient received the vaccine on 06-Oct-2025 between 3-4 pm. At night, she started to get a terrible headache up her neck and in her head. She took some Tylenol and Ibuprofen and then went to bed. It was reported that, around 2-4 am, the patient was found on the floor, barely responsive. The ambulance came and took her to a local hospital, she did not remember anything for 2 days. It was reported that, the patient remembered getting an MRI and falling asleep in the machine but did not remember the end of it and going to the hospital either. It was reported that, the patient was able to answer questions like her name, but she did not know the date or time and was slow to respond. The MRI showed meningoencephalitis and ended up staying in the hospital until 14-Oct-2025. She was given 3 antibiotics plus acyclovir and Decadron. It was reported that, the patient was seeing the neurologist again on 18-Feb-2026. She already saw him once and was following up again. He did not see her in the hospital but told her that the hospital did a really good job. It was reported that the patient was not like that before. She was also sleepier, and her sleep was disturbed. She did not have mental changes until that fact. In the hospital and ever since her hospitalization, she also had GI problems. She had a lot of diarrheas and had to see a GI specialist for that and had testing done. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: Company comment: Treatment with multiple different antibiotics and dexamethasone is a risk factor for gastrointestinal issues and diarrhoea. The benefit-risk relationship of product is not affected by this report.
Asthma (It started after the patient had a severe case of COVID); Controlled hypertension (It was pre-existing to any vaccines. Her blood pressure was running low and that the patient was off her hypertensive meds)
Medical History/Concurrent Conditions: COVID-19 pneumonia (The patient had COVID pneumonia in June of 2020 so she thought she should get the vaccines in order to avoid another bad case of COVID)
Test Date: 202510; Test Name: MRI; Result Unstructured Data: showed meningoencephalitis