Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 4 | — | — |
severe illness; sepsis; exacerbated pre-existing conditions like blood cancer; rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (severe illness), SEPSIS (sepsis) and MALIGNANT NEOPLASM PROGRESSION (exacerbated pre-existing conditions like blood cancer) in a 73-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 Hematological malignancy. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1 (lot: 006B21A)) on 26-Mar-2021, Moderna COVID-19 Vaccine (Dose 2) on 27-Apr-2021 and Moderna COVID-19 Vaccine (Dose 3) on 09-Nov-2021. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Hematological neoplasm (Blood cancer). On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2023, the patient experienced SEPSIS (sepsis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ILLNESS (severe illness) (seriousness criterion hospitalization), MALIGNANT NEOPLASM PROGRESSION (exacerbated pre-existing conditions like blood cancer) (seriousness criterion medically significant), RASH (rash) and FATIGUE (fatigue). The patient was hospitalized on sometime in 2023 due to SEPSIS, and then on 12-Oct-2025 due to ILLNESS. At the time of the report, ILLNESS (severe illness), SEPSIS (sepsis), MALIGNANT NEOPLASM PROGRESSION (exacerbated pre-existing conditions like blood cancer), RASH (rash) and FATIGUE (fatigue) had not resolved. No concomitant medications were reported. The patient experienced severe side effects after receiving the fourth Moderna booster shot. She described persistent health issues, including a rash, fatigue, and exacerbated pre-existing conditions like blood cancer, following the vaccination. In addition, she had to take a break due to severe illness and ended up in the hospital on Sunday. Despite undergoing numerous tests, the cause of her condition remained unidentified. She visited her doctor recently and needed to undergo additional tests to determine the issue. She recalled a severe episode of sepsis two years ago that left her hospitalized for seven days. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.; Reporter's Comments: Due to lack of biological plausibility, the causality of the events sepsis and malignant neoplasm progression was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
Hematological neoplasm (Blood cancer)
Medical History/Concurrent Conditions: Hematological malignancy