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.
19yo male who received the vaccinia vaccine on 16Feb2018 presents to MC worsening skin lesions. On 3/11/18 the patient noticed he had ~6 erythematous papules ~0.5-1cm in diameter on his right index finger, wrist, and bicep. The lesions on his index finger and upper extremity erupted over previous breaks in his skin from grappling. The lesions where not pruritic at first, but became pruritic later that day. On 3/12, he had more lesions on his right extremity and chest. He was diagnosed with molluscum contagiosum and given hydrocortisone cream. The following day, he continued to have new lesions including one under his right eye where there was a previous grappling cut and worsening puritis. He visited the ER where he was diagnosed with MRSA and started on BACTRIM. He continued to have more lesions on his neck and left arm and made a dermatology appointment. The dermatologist was concerned for a vaccinia reaction and transferred the patient to MC. The patient states he scratches these lesions constantly, occassionally opening them up and he sees clear fluid draining from them. The patient states he is otherwise at his baseline health. Denies fever, chills, SOB, cough, abdominal pain, diarrhea. The patient states that the night before the erruptions began he had unprotected sex with a new partner. He asked both the new partner and his grappling partners if they have any skin issues and they denied. He has also been non-compliant with covering his vaccinia vaccination site. He has repeatedly manipulated it and has not had it covered throughout the day.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| SMALLPOX (ACAM2000) | 1 | SMALL | SANOFI PASTEUR | 4795H | SYR | LA |
| RECVDATE: | 03-16-2018 | RPT_DATE: |
| CAGE_YR: | 19 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | U |
| HOSPITAL: | Y |
| HOSPDAYS: | 2 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | CBC: 4.6>15.4/44.4<207; CHEM10: 141/4.4|103/25|16/1.4(H)|97 9.4/2.0/3.8; Viral load pending;HIV 4th gen pending; Oraquick neg |
| V_ADMINBY: | MIL |
| OTHER_MEDS: | sulfamethoxazole/trimethoprim 800-160mg PO BID |
| CUR_ILL: | none |
| HISTORY: | none |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 03-16-2018 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | Y |
| ALLERGIES: | NKDA |
| V_FUNDBY: |
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