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.
73 year old male, vaccinated with the Janssen Covid-19 vaccine at the time of hospital admission (5/31/21) for a type 3 odontoid fracture; C2 vertebral body fracture extending into bilateral transverse foramina and nasal bone fracture from a fall from standing. Admitted to the trauma service for pain control. Noted to be somnolent throughout admission. On 6/2, developed AKI, likely related to dehydration vs. contrast nephropathy. On the early morning of 6/3, found unresponsive. Given naloxone 0.02 mg x 3 with no documented response. Transferred to the ICU, intubated and had PEA arrest on induction for intubation. CPR was initiated and he received epi x 1 with ROSC within 3 minutes. Remained intubated and sedated in the ICU with labile pressures on 2 pressors throughout the day on 6/3. The patient expired following compassionate extubation 6/3 2211.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (JANSSEN)) | 1 | COVID19 | JANSSEN | 205A21A | IM | LA |
| RECVDATE: | 07-07-2021 | RPT_DATE: |
| CAGE_YR: | 73 |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 06-03-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | amlodipine, duloxetine, nitroglycerin SL tablets prn, rosuvastatin 5 mg daily, tamsulosin |
| CUR_ILL: | |
| HISTORY: | sleep apnea, TIA, HTN, CVA, asthma, alcohol dependence, cardiac murmur, CAD, Cervical fusion 2017 (C3-6), Lumbar spine surgery 2018 (L2-4 hemilaminectomy) |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 07-07-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | Cefazolin - anaphylaxis |
| 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.