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    Date: 2022-06-20 12:33:22.055442


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    Date: 2022-06-20 16:42:33.333274


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    Date: 2022-06-28 11:38:41.141941

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Reports of Suspected Adverse Reaction to Covid-19 Vaccines 12 June 2022

Requested from DOH by S. Clakr at 12:33 PM on Jun 20, 2022.
Purpose: Research and Development
Date of Coverage: 06/06/2022 - 06/12/2022
Tracking no: #DOH-690939616690

Clakr 12:33 PM, Jun 20, 2022

The 12 June 2022 Report included 102,512 reports of adverse reaction of which 8,441 were serious (2,451 (29%) were deaths).

The report states "as per risk-benefit analyses, these reports do not provide basis for revising the current recommendations"..  for vaccination of all persons 5 years and older!

Please provide:-
1. Copy of the Risk-Benefit Analysis / Rationale being used.
2. Please indicate which level of reported AEFI or Deaths will trigger revision of the recommendations.
3. What % of deaths, reported injuries, are currently considered suspicious as related to the vaccines.

Receiving Officer 04:42 PM, Jun 20, 2022

June 20, 2022

Dear Sally,

Thank you for your request dated Jun 20, 2022 under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for Reports of Suspected Adverse Reaction to Covid-19 Vaccines 12 June 2022.

We received your request on Jun 20, 2022 and will respond on or before Jul 11, 2022 12:33:22 PM, in accordance with the Executive Order's implementing rules and regulations.

Should you have any questions regarding your request, kindly contact me using the reply function on the eFOI portal at, for request with ticket number #DOH-690939616690.

Thank you.


FOI Receiving Officer
FOI Officer

Maker 08:25 AM, Jun 21, 2022

Dear Ms. Sally Clark

Please be informed that we have endorsed this request to the Food and Drug Administration for action. Kindly await for their response, thank you

Maker 11:38 AM, Jun 28, 2022

June 28, 2022

Dear Sally Clakr,


Thank you for your request dated Jun 20, 2022 12:33:22 PM under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.

Your Request

You asked for Reports of Suspected Adverse Reaction to Covid-19 Vaccines 12 June 2022.

Response to Request

Your FOI request is approved. 

Below are the responses from FDA on your request:

* Based on their submitted Risk Management Plan (RMP) of each vaccine manufacturer, the benefits of vaccination continue to outweigh any risks.

• The DOST Vaccine Expert Panel conducts technical evaluation of safety and efficacy of candidate vaccines. The AEFI reports that the Pharmacovigilance Section receives are not a basis that the product causes the reactions. Some reports are just a mere suspicion and not necessarily caused by the vaccine. The Health Technology Assessment Council (HTAC) Core Committee is responsible for the development and submission of final recommendations to
policy- and decision-making. If the DOHHTAC grants positive recommendation, the vaccine can be considered for procurement and use in the Covid-19 vaccination program. All guidance and recommendations regarding Covid-19
vaccines were posted on their website

• A report of adverse reaction does not necessarily mean that the vaccine caused the reactions. Undiagnosed illness, underlying comorbidities, and pre-existing medical conditions unrelated to vaccination can be factors in reporting adverse reactions. The FDA issues weekly overview of the reports in our website.

Kindly accomplish the FOI Request Feedback form at the link:

Thank you

Your right to request a review

If you are unhappy with this response to your FOI request, you may ask us to carry out an internal review of the response by writing to Undersecretary Lilibeth C. David, Chair of Data Governance Oversight Committee/ DOH Central Appeals and Review Committee, at Your review request should explain why you are dissatisfied with this response, and should be made within 15 calendar days from the date when you received this letter. We will complete the review and tell you the result within 30 calendar days from the date when we receive your review request.

If you are not satisfied with the result of the review, you then have the right to appeal to the Office of the President under Administrative Order No. 22 (s. 2011).

Thank you.


FOI Decision Maker

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