Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052034 | IM |
HLH/Decreased blood pressure/Lethargy/Slight fever/Chills; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH/Decreased blood pressure/Lethargy/Slight fever/Chills) in a 72-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052034) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052034) for COVID-19 prophylaxis. Hypertension Herpes- genital I have previously had pneumonia and sepsis- twice since 2018. The patient's past medical history included Pneumonia (twice since 2018) in 2018 and Sepsis (twice since 2018) in 2018. Concurrent medical conditions included Hypertension and Herpes genital. On 11-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 19-Sep-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH/Decreased blood pressure/Lethargy/Slight fever/Chills) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 25-Sep-2025 due to HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS. The patient was treated with Etoposide (oral use) ongoing since an unknown date at a dose of UNK, once a week; Dexamethasone sodium succinate (Dexamethasone) ongoing since an unknown date at a dose of 2 milligram and Heparin sodium (Heparin) at an unspecified dose and frequency. At the time of the report, HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH/Decreased blood pressure/Lethargy/Slight fever/Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Sep-2025, Blood electrolytes: not all normal. On 25-Sep-2025, Blood pressure measurement: 90/68. On 25-Sep-2025, Serum ferritin: elevated. The patient did not have any additional medical history, concomitant disease or risk factor. No concomitant medications were reported. It was reported that, since the first Covid vaccines the patient had been vaccinated regularly. Her usual reaction was a slight fever, and it resolved in 24 hours. That reaction started that way, but she never quite fell back to normal. A week later, she became sicker with chills and then decreased blood pressure and lethargy. On 23-Sep-2025, she went to the hospital emergency room and was sent home after a few hours. On 25-Sep-2025, she went to the hospital emergency Room for BP of 90/68, chills and lethargy. Her electrolytes were not all normal and her Ferratin was elevated. She was admitted with probable HLH. On Monday, 29-Sep-2025 after a bone marrow biopsy she was diagnosed with HLH. She was admitted to MICU. The prognosis was grave, but she got better after high dose IV steroids and Etoposide chemotherapy. She still had not recovered and still received dexamethasone 2 mg and PO Etoposide once a week. She was not back to her previous activity level but was walking a lot and working hard on recovery. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. The patient was treated with IV blood transfusions 3 times, heparin and various electrolytes.; Reporter's Comments: Hemophagocytic lymphohistiocytosis (HLH) is a rare disease caused by caused by genetic mutations, or triggered by factors like infections, cancer, or autoimmune disease, tus based on above the company assessed the event as not related to vaccine. The benefit-risk relationship of product is not affected by this report.
Herpes genital; Hypertension
Medical History/Concurrent Conditions: Pneumonia (twice since 2018); Sepsis (twice since 2018); Comments: Hypertension Herpes- genital I have previously had pneumonia and sepsis- twice since 2018
Test Date: 20250925; Test Name: electrolytes; Result Unstructured Data: not all normal; Test Date: 20250925; Test Name: BP; Result Unstructured Data: 90/68; Test Date: 20250925; Test Name: Ferratin; Result Unstructured Data: elevated