Received May 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
more frequent flares of interstitial cystitis; more frequent flares of interstitial cystitis; hemorrhagic cystitis; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS HAEMORRHAGIC (hemorrhagic cystitis) in a 71-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Patient had taken the Moderna covid vaccines every year in the past years). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included Chronic interstitial cystitis. In March 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced CYSTITIS HAEMORRHAGIC (hemorrhagic cystitis) (seriousness criterion medically significant). On an unknown date, the patient experienced CYSTITIS INTERSTITIAL (more frequent flares of interstitial cystitis) and CONDITION AGGRAVATED (more frequent flares of interstitial cystitis). At the time of the report, CYSTITIS HAEMORRHAGIC (hemorrhagic cystitis), CYSTITIS INTERSTITIAL (more frequent flares of interstitial cystitis) and CONDITION AGGRAVATED (more frequent flares of interstitial cystitis) had resolved with sequelae. Concomitant medication was not reported. Patient had taken the Moderna covid vaccines every year in the past years and the last vaccine she took was in March 2025, 5 days after, she started developing blood in the urine. She was used to having episodes of interstitial cystitis but never had a hemorrhagic one. She was dripping red blood, not like the one in a urinary tract infection. Doctor said that it was an immune response to the vaccine and stated that it was good that her body gave that response. The hemorrhagic cystitis had cleared however she now had more frequent flares of interstitial cystitis. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Company comment: Concurrent medical condition of Chronic interstitial cystitis is considered a confounder. The benefit-risk relationship of product is not affected by this report.
Chronic interstitial cystitis