VAERS ID: 2331156

AGE: 72| SEX: M|STATE: FR

Description

Anaemia haemolytic autoimmune; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-MP20222192) on 23-Jun-2022 and was forwarded to Moderna on 23-Jun-2022. This regulatory authority case was reported by a physician and describes the occurrence of AUTOIMMUNE HAEMOLYTIC ANAEMIA (Anaemia haemolytic autoimmune) in a 72-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Depression and Pulmonary fibrosis. On 11-May-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-May-2022, after starting mRNA-1273 (Spikevax), the patient experienced AUTOIMMUNE HAEMOLYTIC ANAEMIA (Anaemia haemolytic autoimmune) (seriousness criterion death). The patient died in June 2022. The reported cause of death was anemia. An autopsy was not performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications information were provided. Company comment-This is a fatal regulatory authority case concerning a 72-year-old male patient with medical condition of pulmonary fibrosis who experienced the unexpected and serious (death) event of autoimmune haemolytic anaemia 15 days after a dose of mRNA-1273 vaccine was administered. It is not known if an autopsy was performed. Exact date of death is unknown. Cause of death was reported as autoimmune haemolytic anaemia. Medical condition of pulmonary fibrosis remains as a contributory risk factor for the fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a fatal regulatory authority case concerning a 72-year-old male patient with medical condition of pulmonary fibrosis who experienced the unexpected and serious (death) event of autoimmune haemolytic anaemia 15 days after a dose of mRNA-1273 vaccine was administered. It is not known if an autopsy was performed. Exact date of death is unknown. Cause of death was reported as autoimmune haemolytic anaemia. Medical condition of pulmonary fibrosis remains as a contributory risk factor for the fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Anemia

Symptoms

Autoimmune haemolytic anaemia

Vaccines

VAX DATE: 05-11-2022| ONSET DATE: 05-26-2022| DAYS TO ONSET: 15
NameDose #TypeManufacturerLotRouteSite
COVID19 (COVID19 (MODERNA)) Unknown COVID19 MODERNA OT Unknown

RECVDATE:06-24-2022
RPT_DATE:
CAGE_YR:
CAGE_MO:
DIED:Y
DATEDIED:06-01-2022
L_THREAT:U
ER_VISIT:U
HOSPITAL:U
HOSPDAYS:
X_STAY:U
DISABLE:U
RECOVD:N
LAB_DATA:
V_ADMINBY:
OTHER_MEDS:
CUR_ILL:Depression; Pulmonary fibrosis
HISTORY:
PRIOR_VAX:
SPLTTYPE:FRMODERNATX, INC.MOD20225
FORM_VERS:2
TODAYS_DATE:06-23-2022
BIRTH_DEFECT:U
OFC_VISIT:U
ER_ED_VISIT:U
ALLERGIES:
V_FUNDBY:

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