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.
Cerebral haemorrhage; Cerebral ventricular rupture; This case was received via the Regulatory Authority (Reference number: JP-TAKEDA-2021TJP095727) on 24-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Regulatory Authority by a clerical work, was received via the RA(Ref, v21128837). The patient's underlying condition, cerebral arteriovenous malformation, was discussed with the interviewing physician, and the possibility of vaccination was discussed. On 16-Sep-2021, at 11:00, the patient received the 1st dose of this vaccine. Around 20:00, the patient had a headache and vomiting, so the patient's family called for ambulance. At 20:50, the patient was taken to the hospital. The patients JCS3 was 300 on arrival. CT showed cerebral haemorrhage and cerebral ventricular rupture from cerebral arteriovenous malformation. On 20-Sep-2021, the patient was confirmed dead. The outcome of cerebral haemorrhage and cerebral ventricular rupture was reported as fatal. Follow-up investigation will be made. Company Comment: Although the events "cerebral haemorrhage" and "cerebral ventricular rupture" developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), factors such as concurrent conditions and predisposing factors of the patient may have also had an influence.; Reporter's Comments: Although the events "cerebral haemorrhage" and "cerebral ventricular rupture" developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), factors such as concurrent conditions and predisposing factors of the patient may have also had an influence.; Sender's Comments: This case concerns a 15-year-old, male patient with medical history of cerebral arteriovenous malformation, who experienced the unexpected serious adverse event of special interest of cerebral haemorrhage and unexpected serious adverse event of cerebral ventricular rupture . The events occurred approximately 9 hours after the first dose of Spikevax (Moderna COVID-19 vaccine) and had fatal outcome with death occurring 3 days after following day. The rechallenge was not applicable as the events occurred after the first dose. The event was considered related to the vaccine per the reporter's assessment. The medical history of the patient of previous cerebral arteriovenous malformation remain as a significant confounder. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Cerebral haemorrhage; Cerebral ventricular rupture
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)) | 1 | COVID19 | MODERNA | 3005239 | OT |
| RECVDATE: | 10-02-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 09-20-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| 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: | 10-01-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
Questions? Comments? Bugs?
[email protected]
Due to the high volume of inquiries, please be patient with response times.
AND PLEASE read the FAQ first.
OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.