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    Date: 2022-06-20 12:14:24.141811

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    Date: 2022-06-20 16:40:55.173771

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    Date: 2022-06-28 11:30:23.316443

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Reports on Suspected Adverse Reaction Following Covid-19 Vaccination

Requested from DOH by S. Clakr at 12:14 PM on Jun 20, 2022.
Purpose: Research and Development
Date of Coverage: 06/12/2022 - 06/19/2022
Tracking no: #DOH-406848262394

Clakr 12:14 PM, Jun 20, 2022

Please provide the following information, or indicate if it does not exist.

1. Please indicate where the reports come from (% contribution). Ie. Patient, Family, Medical Professional, etc.
2. Please indicate how many reports, after initially being included in the report database, were subsequently removed / deleted.  Please indicate cause for deletion.
3. Please update for the latest available report how many of the serious events during pregnancy and lactation included death of the mother and/or the baby.
4. Does DOH/ FDA have any idea of the Under Reporting Factor (URF) applicable?

Receiving Officer 04:40 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 on Suspected Adverse Reaction Following Covid-19 Vaccination.

We received your request on Jun 20, 2022 and will respond on or before Jul 11, 2022 12:14:24 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 https://www.foi.gov.ph/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC00MDY4NDgyNjIzOTQM, for request with ticket number #DOH-406848262394.

Thank you.

Respectfully,

FOI Receiving Officer
FOI Officer

Maker 08:23 AM, Jun 21, 2022

Dear Sally Clakr

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 11:30 AM, Jun 28, 2022

June 28, 2022

Dear Sally Clakr,

Greetings!

Thank you for your request dated Jun 20, 2022 12:14:24 PM under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.

Your Request

You asked for Reports on Suspected Adverse Reaction Following Covid-19 Vaccination.

Response to Request

Your FOI request is approved. 

Below are the responses from FDA on your request

• Received reports came from all vaccinees/priority groups and healthcare
professionals from different regions.

• All reports are being evaluated and validated. Deletion of reports are due to the duplicate entry encoded by the reporters

• As of 12 June 2022, there are 315 serious AEFIs from pregnant mothers and 17 from lactating mothers.

• A cumulative of 2,451 (2.39%) were reported with fatal outcomes. The mean age for fatal cases were from age group 60 years old and above; and are most likely due to multiple existing comorbidities.

• The FDA together with other public health partners are continuously monitoring the adverse experience as more people are being
vaccinated with COVID-19 vaccines. Such monitoring will provide reassurance that the vaccines are safe and effective for use.

Kindly accomplish the FOI Request Feedback form at the link: https://bit.ly/DOHFOIFeedbackForm

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 foi@doh.gov.ph. 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.

Respectfully,

FOI Decision Maker
FOI Receiving Officer

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