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.
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 03/13/2021. On 8/6/2021, pt presented to ED with increasing diffuse abdominal pain that started 3 days prior. Pt reports he was diagnosed with COVID-19 on 8/5/21 and had increasing shortness of breath with cough and headache which began 8/1/21. CT showed acute uncomplicated appendicitis and confirmed patchy ground-glass opacities within the bilateral lung bases consistent with COVID pneumonia. He was given 1 g of Tylenol, 1 g of IV Rocephin, 6 mg of Decadron, 500 mg of IV Flagyl, 2 doses of 4 mg of morphine, 4 mg of Zofran and 40 mg of IV Protonix in the ED. Pt also received remdesivir. He developled hypoxia on HFNC 50/50 sating 84-87%. pO2 49. Patient was able to maintain sats in the lower 90's CXR showed worsening pulmonary edema and he was given 20mg IV lasix. Patient transferred to MICU service for worsening respiratory status on 8/13. Patient was intubated and started on proning protocol. He continued to require pressors and sedation with propofol, versed, and dilaudid. Palliative was consulted and discussed with family comfort care. Patient expired on 8/24/21.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (JANSSEN)) | 1 | COVID19 | JANSSEN | 1805031 | IM | RA |
| RECVDATE: | 09-01-2021 | RPT_DATE: |
| CAGE_YR: | 63 |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 08-24-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 18 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Covid positive (8/6/21) |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | amlodipine 5mg daily, aspirin 81mg daily, atorvastatin 40mg daily, basaglar inject up to 30 units daily, Os-cal 3tabs TID, ceterizine 10mg daily, Vitamin D3 4,000unit 2 tab daily, famotidine 20mg BID, folic acid 1mg daily, Norco 10-325mg q8 |
| CUR_ILL: | |
| HISTORY: | Anemia, CAD, T2DM, GERD, HTN, RA, obesity, HLD, hypercalcemia, hyperparathyroidism s/p parathyroidectomy |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 08-30-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | NKDA |
| 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.