Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | IM |
pancreatitis; multiple organ failure; HLH - Secondary induced by 2nd does of Moderna covid vaccine.; fainting; leaky gut; low bp; swelling; headache; nausea; light headedness after 1st dose; vomiting's, could not keep any food down/only liquid diet/stomach upset/Severe stomach upset; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (pancreatitis), MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiple organ failure), HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH - Secondary induced by 2nd does of Moderna covid vaccine.) and SYNCOPE (fainting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hemoglobin low and Blood transfusion (due to low Hb, required blood transfusion (10 years before moderna vaccine) - but nothing after that) in 2011. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PANCREATITIS (pancreatitis) (seriousness criteria death and medically significant), MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiple organ failure) (seriousness criteria death and medically significant), HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH - Secondary induced by 2nd does of Moderna covid vaccine.) (seriousness criteria death and medically significant), SYNCOPE (fainting) (seriousness criterion medically significant), INTESTINAL BARRIER DYSFUNCTION (leaky gut), HYPOTENSION (low bp), SWELLING (swelling), HEADACHE (headache), NAUSEA (nausea), DIZZINESS (light headedness after 1st dose) and VOMITING (vomiting's, could not keep any food down/only liquid diet/stomach upset/Severe stomach upset). The patient died in April 2021. The reported cause of death was hlh (secondary), pancreatitis, multiple organ failure, hlh (secondary), pancreatitis, multiple organ failure and hlh (secondary), pancreatitis, multiple organ failure. It is unknown if an autopsy was performed. At the time of death, SYNCOPE (fainting), INTESTINAL BARRIER DYSFUNCTION (leaky gut), HYPOTENSION (low bp), SWELLING (swelling), HEADACHE (headache), NAUSEA (nausea), DIZZINESS (light headedness after 1st dose) and VOMITING (vomiting's, could not keep any food down/only liquid diet/stomach upset/Severe stomach upset) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: low. It was unknown if the patient had any additional medical history, concomitant disease, or risk factor. No concomitant medications were reported. The patient died 15 days after 2nd dose administration. All medicine in response to adverse event administered at emergency room by IV or oral, medicines and dosage details were not available. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: HLH (Secondary), Pancreatitis, Multiple organ failure; HLH (Secondary), Pancreatitis, Multiple organ failure; HLH (Secondary), Pancreatitis, Multiple organ failure
Medical History/Concurrent Conditions: Blood transfusion (due to low Hb, required blood transfusion (10 years before moderna vaccine) - but nothing after that); Hemoglobin low
Test Name: Hemoglobin; Result Unstructured Data: low