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.
Immediately after injection complained of severe pain at site. Fell off table and fainted for approximately 10 - 15 seconds. Hyperventilated and cried progressing Chvostek's sign in hands and feet. Rebreathing into a bag progressing to clearing of symptoms. Complained of headache, blurry vision; Vision test was normal. Vomiting x 1 in parking lot and speech was momentarily inarticulate. Sent to ER. At ER neuro exam was normal except for word recall "coffee instead of coughing" "Sired instead of tired." Continued complaint of headache. Vomited x 2. All symptoms spontaneously cleared approximately 6 hours after incident. Overnight hospitalization for observation. Neurological evaluation before discharge was normal. Diagnosis also included dehydration. No fluids were taken from 7/10/2006 PM until IV in ER. Anion gap noted on chemistries and concentration of urine obtained after several hours of hydration. Discharge diagnosis: Dehydration, Vasovagal syncope secondary to shot vs pain at injection site. 7/17/06 Medical records received from reporter/provider which included vax record, office note of 7/11 & neuro consult of 7/15 by MD who also saw her in the hospital on 7/11-12. Neuro report indicates the CT scan of head was WNL & that dx is syncope probably precipitated by pain of vax injection along w/dehydration (no fluid intake since evening of 7/10 until IVF given in ER). As of 7/15 patient continued to have throbbing HA when bending down & also c/o strong heart beats ocassionally. PMH: dehydration requiring hospitalization at age 3 yo. Also has hx of mild anxiety. Family hx: patient's mother has Fuch's disease (genetic degenertive corneal disease which her mother also had) & patient's father has depression. There are no siblings. It was noted that she had 3 episodes of emesis following vax along w/ sustaining mild concussion when fell from exam table which was characterized by brief episode of aphasia, slurred speech & possible right facial paresis noted only by patient's mother./ss 10/27/06 Received medical records from hospital which reveal patient seen in ER after LOC with head trauma. Noted to have slurred speech, word finding difficulty, HA & emesis x 2 which resolved after several hours. Admitted for overnight observation. Given IVF & IV Toradol. Head CT was WNL. Neurology consult done which was essentially WNL with mild generalized weakness, speech intact & mental status clear. Final dx: LOC with head trauma, vasovagal syncope.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| HPV (GARDASIL) | 1 | HPV4 | MERCK & CO. INC. | 0637F | RA |
| RECVDATE: | 07-14-2006 | RPT_DATE: | 07-11-2006 |
| CAGE_YR: | 14 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 1 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | LABS: WBC 11.7, neutros 84, lymphs 9.7. |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | NONE |
| CUR_ILL: | |
| HISTORY: | Allergic rhinitis, spring pollens/ragweed/dust/mold |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: | PVT |
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