Received Oct 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
she experienced a severe flare-up diagnosed as pan colitis, leading to hospitalization with symptoms including significant bleeding; Weakness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS (she experienced a severe flare-up diagnosed as pan colitis, leading to hospitalization with symptoms including significant bleeding) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Delivery (The Patient had only two childbirths), Pregnancy, Tonsillectomy, Heat therapy (ultrasonic heat therapy) and Polyp removal. Concurrent medical conditions included Colitis and Bone spur (The Patient had Bad arm and spine). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In June 2025, the patient experienced COLITIS (she experienced a severe flare-up diagnosed as pan colitis, leading to hospitalization with symptoms including significant bleeding) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ASTHENIA (Weakness) and FATIGUE (Fatigue). The patient was treated with Potassium chloride (Potassium) at an unspecified dose and frequency. At the time of the report, COLITIS (she experienced a severe flare-up diagnosed as pan colitis, leading to hospitalization with symptoms including significant bleeding), ASTHENIA (Weakness) and FATIGUE (Fatigue) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications provided by the reporter. The patient used to experience symptoms of significant fatigue and weakness. It was reported that the patient had a history of colitis last year, which was initially linked to a polyp that was removed. In June-2025 the patient experienced a severe flare-up, and which was diagnosed with pancolitis. Due to pancolitis, the patient was hospitalized with symptom of significant bleeding. The patient received treatment medication of potassium and antibiotics. The physician stated that all of the patient's colon was inflamed and infected. The patient was going to the chiropractor for ultrasonic heat therapy for a bone spur in her arm and back. It was also reported that symptom of pancolitis might cause possible links between COVID-19 vaccines and bowel issues. The patient had no family history of colitis and was generally healthy. This case was linked to US-MODERNATX, INC.-MOD-2025-790267 (Patient Link).; Reporter's Comments: Concurrent medical condition Colitis is a contributor for the mentioned event. Due to lack of biological plausibility, the causality of the event colitis was assessed as not related . The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Bone spur (The Patient had Bad arm and spine); Colitis
Medical History/Concurrent Conditions: Delivery (The Patient had only two childbirths); Heat therapy (ultrasonic heat therapy); Polyp removal; Pregnancy; Tonsillectomy