Vaccine Adverse Events Reporting System

 

The CDC has further responded to ICAN’s demand to HHS’s Acting Secretary and the CDC’s Director that all adverse events following COVID-19 vaccination reported to the CDC’s new V-safe tool be automatically reported to the Vaccine Adverse Events Reporting System (VAERS).  The CDC did not alleviate ICAN’s concerns and a letter of follow-up was sent seeking further information.    Because of the well-known underreporting to VAERS and the CDC’s new smartphone-based tool used to track adverse events following COVID-19 (V-safe), ICAN has serious concerns that adequate post-vaccination safety surveillance is, at worst, not being adequately conducted and, at best, not being disclosed to the public.    While at first glance V-safe may seem like a welcome development – a modern tool that should easily allow vaccine recipients to report, and CDC to track, any adverse events experienced following a vaccination – there is a serious concern that V-safe intercepts reports that would have otherwise been made to VAERS.  Only if the CDC deems an adverse event reported to V-safe worthy will it be added to the VAERS database.  This leaves a large universe of data regarding adverse events outside of VAERS and, therefore, outside the public’s view.    This is why ICAN reached out to the acting director of the HHS and the new CDC Director in February to demand that all adverse events reported through V-safe are added to the VAERS database.  This is absolutely necessary for complete and consistent data as well as for transparency as the public does not have access to any information exchanged through V-safe.     ICAN received a response from Sandra Cashman, Executive Secretary of the Office of the Chief of Staff at CDC.  Ms. Cashman’s letter, however, did not make clear under what circumstances V-safe data would also be reported to VAERS.    The V-safe “script” looks similar to this:     The CDC has explained that if a reported adverse event is “clinically important” then the CDC will follow up with the vaccine recipient by telephone and “if appropriate,” will take a VAERS report on their behalf.  However, Ms. Cashman’s response states that “v-safe provides telephone follow-up to anyone who reports medically significant AEs and if a serious AE is identified in v-safe, a VAERS report will be filed on behalf of the individual after the follow-up telephone call.”   ICAN has replied to Ms. Cashman seeking clarification as to the following point:   ·      If a v-safe user checks “miss work?”, “unable to do your normal daily activities?”, and/or “get care from a doctor or other healthcare professional?” in the V-safe application … will each such user  (1) receive a follow-up phone call from the CDC and (2) will the CDC  submit a report to VAERS on behalf of the user?   ICAN wants to confirm that every person who selects one of these options will receive a phone call from the CDC.  ICAN also wants to confirm that a VAERS report will be submitted for each of those individuals.    ICAN also asked Ms. Cashman for clarification regarding the following point:   ·      Are there any instances the CDC would reach out to a V-safe user or submit a VAERS report if one of “miss work?”, “unable to do your normal daily activities?” and/or “get care from a doctor or other healthcare professional?” is not checked by the vaccine recipient?   For example, if a V-safe user checks that he or she is suffering from severe chills, severe headache, severe fatigue, and severe nausea and diarrhea but does not check any of the above three quoted options, it is unclear whether the CDC will place a follow-up phone call to that recipient and/or whether it will submit a VAERS report on the recipient’s behalf.   ICAN awaits Ms. Cushman’s response to these two specific and pointed questions and will share those when received.  Until the CDC fixes its broken VAERS system, ICAN will not rest.

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