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.
Subarachnoid hemorrhage due to a ruptured aneurysm; Subarachnoid hemorrhage due to a ruptured aneurysm; This case was received via company (Reference number: 2021TJP088181) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This case, initially reported to the regulatory authority by a (physician), was received via the regulatory authority (Ref, v21126334). On 01-Jul-2021, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before vaccination: 36.4 degrees Celsius. On 30-Jul-2021, the patient received the 2nd dose of this vaccine. On 03-Aug-2021, around 12:40, the patient was urgently transferred to hospital due to sudden disturbed consciousness. The patient's level of consciousness on arrival was JSC3-100 and GCS E1V1M4. Head CT showed acute hydrocephalus and subarachnoid hemorrhage. After immediate cerebral ventricular drainage, cerebral angiography revealed bilateral vertebral artery dissecting aneurysms. It was considered to be subarachnoid hemorrhage caused by a ruptured aneurysm, and the patient was hospitalized. Because the left side was largely dominant, the vertebral artery was occluded through an emergency craniotomy to prevent rebleeding, but rupture recurred on the same day, causing clinical brainstem dysfunction. On 20-Aug-2021, the patient was confirmed dead. Autopsy was performed on the same day, and the results were pending. The outcome of subarachnoid hemorrhage due to a ruptured aneurysm was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter's Comments: The patient's cause of death was brainstem injury due to ruptured vertebral artery dissection and is most likely to be due to hypertension and arteriosclerosis. Although the causal relationship with this vaccine is thought to be low, it would be best to make a final decision based on the results of the autopsy. Other factors may include hypertension and arteriosclerosis. Although the events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), it is also considered that the events are due to effects from concomitant disease or the patient's predisposing factors, etc.; Sender's Comments: This case concerns a 45 year old male patient, who experienced unexpected serious events of subarachnoid hemorrhage and vertebral artery dissection (both fatal). The serious events occurred 3 days after the second dose of mRNA-1273 vaccine. The events were considered possibly related to mRNA-1273 vaccine per the reporter's assessment. Autopsy was performed and the results were pending. The benefit-risk relationship of the vaccine is not affected by this report.; Reported Cause(s) of Death: Subarachnoid haemorrhage; Vertebral artery dissection
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (MODERNA)) | 2 | COVID19 | MODERNA | 3002618 | OT | Unknown |
RECVDATE: | 09-17-2021 | RPT_DATE: |
CAGE_YR: | |
CAGE_MO: | |
DIED: | Y |
DATEDIED: | 08-20-2021 |
L_THREAT: | Y |
ER_VISIT: | |
HOSPITAL: | U |
HOSPDAYS: | |
X_STAY: | U |
DISABLE: | U |
RECOVD: | N |
LAB_DATA: | |
V_ADMINBY: | |
OTHER_MEDS: | |
CUR_ILL: | |
HISTORY: | |
PRIOR_VAX: | |
SPLTTYPE: | JPMODERNATX, INC.MOD20213 |
FORM_VERS: | |
TODAYS_DATE: | 09-17-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.