Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
ADEM/paralyzed/brain, the thorax and the spine were all inflamed/couldn't speak, write, see, walk/no control over their bowels or bladder/wearing a diaper/choking risk/blindness and inability to take solid food/came close to death/seizure; blood pressure was 60/40/went into septic shock; had a bed sore now for 8-9 months; Patient had lost 40 pounds; hair fell out; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE DISSEMINATED ENCEPHALOMYELITIS (ADEM/paralyzed/brain, the thorax and the spine were all inflamed/couldn't speak, write, see, walk/no control over their bowels or bladder/wearing a diaper/choking risk/blindness and inability to take solid food/came close to death/seizure), SEPTIC SHOCK (blood pressure was 60/40/went into septic shock), DECUBITUS ULCER (had a bed sore now for 8-9 months), WEIGHT DECREASED (Patient had lost 40 pounds) and ALOPECIA (hair fell out) in a 60-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect products included non-company products RSV vaccine for an unknown indication and Influenza vaccine for an unknown indication. The patient's past medical history included Road traffic accident (had a motorcycle accident when she was 16yo that severely damaged the leg but recovered from it and was still able to walk.). Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Patient received all Moderna Covid vaccines). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included Wheelchair user. In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form, dose of RSV vaccine (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 06-Oct-2024, the patient experienced ACUTE DISSEMINATED ENCEPHALOMYELITIS (ADEM/paralyzed/brain, the thorax and the spine were all inflamed/couldn't speak, write, see, walk/no control over their bowels or bladder/wearing a diaper/choking risk/blindness and inability to take solid food/came close to death/seizure) (seriousness criteria hospitalization, disability, medically significant and life threatening), SEPTIC SHOCK (blood pressure was 60/40/went into septic shock) (seriousness criteria hospitalization, disability, medically significant and life threatening), DECUBITUS ULCER (had a bed sore now for 8-9 months) (seriousness criteria hospitalization, disability, medically significant and life threatening), WEIGHT DECREASED (Patient had lost 40 pounds) (seriousness criteria hospitalization and disability) and ALOPECIA (hair fell out) (seriousness criteria hospitalization and disability). The patient was treated with Dipyridamole (Platelet) at an unspecified dose and frequency. At the time of the report, ACUTE DISSEMINATED ENCEPHALOMYELITIS (ADEM/paralyzed/brain, the thorax and the spine were all inflamed/couldn't speak, write, see, walk/no control over their bowels or bladder/wearing a diaper/choking risk/blindness and inability to take solid food/came close to death/seizure), SEPTIC SHOCK (blood pressure was 60/40/went into septic shock), DECUBITUS ULCER (had a bed sore now for 8-9 months), WEIGHT DECREASED (Patient had lost 40 pounds) and ALOPECIA (hair fell out) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2024, Blood pressure measurement: 60/40. On 06-Oct-2024, Weight: lost 40 pounds. No concomitant medications were reported. The patient had gotten sick a week earlier and had received both the flu shot and the COVID shot. A week later, the patient's brain, thorax, and spine became inflamed. The patient unable to speak, write, see, or walk. The patient still had no control over their bowels or bladder. The patient was still wearing a diaper a year later. The patient had been to 7 facilities. The patient was taken by ambulance, was transported from a hospital near where she lives. The patient spent 2 weeks on a neurological CCU unit because they did not know what was wrong with the patient. They drained their blood and added platelets. Typically, it was done 3 times. They did it 5 times. The patient was on antibiotics for 8 months. Due to symptoms, the patient had to eat baby food because she was choking at risk. Patient had baby food for the first two weeks. The blindness and inability to take solid food resolved after 2 weeks. The patient went into septic shock at the first rehab and had to be transported, where the patient had a seizure. They packed the patient in ice, and the blood pressure was 60/40. It was reported that patient came close to death twice (referring to first the initial ADEM symptoms and the septic shock). Currently, the patient was in total care. Still cannot walk and she was in a nursing home, had regained the use of the arms and legs but had no feeling in the midsection. The patient was still paralyzed, still wearing a diaper, and was going to be in a wheelchair the rest of life. The patient's brain was foggy since all this happened. That was one of the residual effects because the brain was inflamed, it caused damage. The patient had a bed sore now for 8-9 months. The patient's hair fell out. Between the reporter and patient, they had lost 100 pounds. Patient had two medical professionals and told her that the reactions were caused by the COVID shot. She also added she was told that nobody in her bloodline can never have the shot again. The reporter imagined that patient had about 6 Moderna COVID-19 shots but had no further details as she did not have the vaccine card. They drained blood and added platelets. Typically, it was done 3 times, and they did it 5 times. This case was linked to US-MODERNATX, INC.-MOD-2025-790250 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2025: Live follow-up received which contains significant information, patient initial, event verbatim and start date were updated. This case was linked to US-MODERNATX, INC.-MOD-2025-790250 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2025: Live follow-up received which contains significant information, patient initial, event verbatim and start date were updated.; Reporter's Comments: Company comment: RSV vaccine was considered as a co-suspect product. Events septic shock and decubitus ulcer were assessed as not related due to lack of biological plausibility. The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790250:Reporter's case
Wheelchair user
Medical History/Concurrent Conditions: Road traffic accident (had a motorcycle accident when she was 16yo that severely damaged the leg but recovered from it and was still able to walk.)
Test Date: 20241006; Test Name: blood pressure; Result Unstructured Data: 60/40; Test Date: 20241006; Test Name: Weight loss; Result Unstructured Data: lost 40 pounds