Source: VAERS.HHS.GOV
VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
Key considerations and limitations of VAERS data:
VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.
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
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| 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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