PDF file: 451-0459_December_3_2025_adverse_events_and_reproductive_health_COVID_19_vaccine.pdf
OPQ ID: 451-0459
Session: 451
Question number: Q-0459
Sessional paper: 8555-451-459
Title: December 3, 2025, adverse events and reproductive health COVID 19 vaccine
Short description: 
Topic: vaccines
Identified concern: 
Keywords: 
Agencies: HC, PHAC, NACI
Date asked: 2025-10-16
Date tabled: 2025-12-03
Submitted by: Tamara Jansen (Cloverdale—Langley
Reply by: the Minister of Health
Responded by: Signed by Maggie Chi
Pages: 6
Status: not processed
Alert: yellow
Questions asked: 6
Questions answered: 
Percent responded: 0%
Referenced sources: (none extracted)
Referenced links: (none extracted)
Official link: https://www.google.com/search?q=8555-451-459+ourcommons.ca
PDF URL: https://ivim.ca/foi/opq/r/451-0459_December_3_2025_adverse_events_and_reproductive_health_COVID_19_vaccine.pdf
TXT URL: https://ivim.ca/foi/opq/r/451-0459.txt
Original filename: Q-459  December 3, 2025, adverse events and reproductive health COVID 19 vaccine.pdf
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Question text preview:
With regard to the government's response to adverse events following vaccination in relation to reproductive health
(pregnancy, menstrual disorders, maternal outcomes): (a) does the Vaccine Injury Support Program, the Public Health Agency of Canada or Health Canada maintain any statistics on claims or medical reports submitted by pregnant persons (either who were pregnant at the time of vaccination or subsequently) whose alleged injury involves obstetric, fetal, neonatal, or reproductive outcomes (such as miscarriage, stillbirth, preterm birth, congenital anomalies, etc.), and, if so, what are the numbers, broken down by year, and how many such claims have been accepted or rejected;
(b) does the Vaccine Injury
Support Program or the Public Health Agency of Canada collect or monitor claims involving significant menstrual changes
(heavy bleeding, amenorrhea, menstrual irregularities) temporally related to vaccination, and, if so, how many and what percentage of such claims have been accepted or declined;
(c) if no such monitoring or claims exist in relation to (b), will the government commit to retrospective review of menstrual and reproductive adverse effects, and include them in an expanded
Vaccine Injury Support Program mandate or bonus coverage;
(d) what medical causality framework is used to adjudicate claims involving reproductive or menstrual injuries (what standard of evidence, what expert review, how is confounding risk handled);
(e) has the government commissioned or examined any internal or external studies (Canadian or international) into vaccine-associated menstrual changes or adverse pregnancy outcomes that might inform eligibility, compensation policy, or claim adjudication guidelines, and, if so, what are the titles, findings, and government responses for each; and (f) does the government claim there is insufficient scientific evidence linking vaccination to menstrual or reproductive harm, and, if so, will it commit to funding a Canadian long-term cohort study or registry to monitor menstrual and reproductive outcomes postvaccination (with transparent periodic reporting)?
Response
This response was tabled in the House of Commons on December 3, 2025, as Sessional Paper 8555-451-459.
Order/Address of the House of Commons
Tabled on
December 3, 2025
Sessional Paper
8555-451-459
House of Commons
Health Canada
Reply by: the Minister of Health
Name of Signatory: Signed by Maggie Chi
Reply
Public Health Agency of Canada
(a) does the Vaccine Injury Support Program, the Public Health Agency of Canada or Health Canada maintain any statistics on claims or medical reports submitted by pregnant persons (either who were pregnant at the time of vaccination or subsequently) whose alleged injury involves obstetric, fetal, neonatal, or reproductive outcomes
(such as miscarriage, stillbirth, preterm birth, congenital anomalies, etc.), and, if so, what are the numbers, broken down by year, and how many such claims have been accepted or rejected?
Canada has a robust vaccine safety system that ensures vaccines are not made available unless they have been demonstrated to be safe and effective.
After vaccines are made available, Health Canada works closely with provincial and territorial health authorities, the Public Health Agency of Canada, healthcare professionals, and vaccine manufacturers to gather and monitor safety data based on real-world use and results.
Health Canada also reviews information from the scientific literature and international regulators.
In the rare case when a safety issue is identified, Health Canada takes all appropriate action to protect the health and safety of Canadians by acting promptly to issue warnings, update the product monograph, change recommended use, or remove a product from the market.
Adverse effects are tracked and published on a number of Government of Canada websites, including the Canada
Vigilance Program, the Canadian Adverse Events Following Immunization Surveillance System, and  Reported side effects following COVID-19 vaccination in Canada.
It is important to note that reports do not imply an established causal
Question number
Q-459
Asked by
Tamara Jansen (Cloverdale—Langley
City)
Date asked
October 16, 2025
Presented by
Kevin Lamoureux
Parliamentary Secretary to the
Leader of the Government in the House of Commons
relationship between a vaccine and an adverse event, only that an event occurred.
This information is provided for the sake of full transparency, out of an abundance of caution.
Any new or unusual adverse events, changes in trends, or changes in the severity of reactions trigger an investigation, including an in-depth medical review and risk assessment.
The evidence reviewed by the National Advisory Committee on Immunization to support public health recommendations for individuals who are pregnant or breastfeeding was presented in a 2022 National Advisory Committee on Immunization
Statement and continues to be maintained in the Canadian Immunization Guide COVID-19 vaccines chapter.
Based on this broader body of evidence, Health Canada and the Public Health Agency of Canada support the use of authorized COVID19 vaccines during pregnancy and lactation.
Observational studies have also shown that vaccination in pregnancy provides protection for infants under six months of age by reducing the risk of COVID-19–related hospitalization.
Since 2020, the
Canadian Adverse Events Following Immunization Surveillance System received only 85 reports of injuries involves obstetric, fetal, neonatal, or reproductive outcomes:
2020: 0
2021: 58
2022: 17
2023: 8
2024: 1
2025: 1
The Public Health Agency of Canada does not have access to data related to claims submitted to the Vaccine Injury
Support Program.
The Vaccine Injury Support Program is currently managed by a third-party administrator, which publishes program statistics at this website.
(b) does the Vaccine Injury Support Program or the Public Health
Agency of Canada collect or monitor claims involving significant menstrual changes (heavy bleeding, amenorrhea, menstrual irregularities) temporally related to vaccination, and, if so, how many and what percentage of such claims have been accepted or declined?
Since 2020, the Canadian Adverse Events Following Immunization Surveillance System received 928 claims of adverse events related to menstrual changes, broken down as follows:
2020: 0
2021: 556
2022: 264
2023: 97
2024: 9
2025: 2
The Public Health Agency of Canada does not have access to data related to claims submitted to the Vaccine Injury
Support Program.
The Vaccine Injury Support Program is currently managed by a third-party administrator, which publishes program statistics at this website.
(c) if no such monitoring or claims exist in relation to (b), will the government commit to retrospective review of menstrual and reproductive adverse effects, and include them in an expanded
Vaccine Injury Support Program mandate or bonus coverage
The Government of Canada monitors vaccine safety through established post-market surveillance systems and reviews all emerging scientific evidence related to vaccine safety, including menstrual and reproductive outcomes.
(d) what medical causality framework is used to adjudicate claims involving reproductive or menstrual injuries (what standard of evidence, what expert review, how is confounding risk handled)?
Claims submitted to the Vaccine Injury Support Program are reviewed and adjudicated by the third-party administrator currently managing the program.
The Public Health Agency of Canada is not involved in the process.
Note that the
Government of Canada will take over management of the Vaccine Injury Support Program as of April 1, 2026.
However, there is no evidence to support any claims of menstrual or reproductive harms suggested in the question.
Available evidence from reputable sources does not demonstrate any increased risks from vaccination such as heavy menstrual bleeding, miscarriage, preterm birth, or other pregnanc