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← Return to Report Adverse Reactions to Medicines, Vaccines, Med Devices to FDA
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Report Adverse Reactions to Medicines, Vaccines, Med Devices to FDA
Polymyalgia Rheumatica (PMR) | Last Active: Apr 13 9:42pm | Replies (5)Comment receiving replies
Hi! I reported my adverse reaction to Glaxo Smith Klein’ s ShingrixShot as well as FDA. First of two. I have a case numbers. Severe reaction to the shot caused possible RA, PMR. Possible because my rheumatologists say Yes I have; No I don’t. Almost two years have passed and I have major bone destruction and had (L) TRSR. I asked my two rheumatologists (semi-local and at Mayo) to contact GSK. I doubt they have consulted with the GSK doctors. Reporting my adverse reaction and experience got me nowhere.
Replies to "Hi! I reported my adverse reaction to Glaxo Smith Klein’ s ShingrixShot as well as FDA...."
@susanlf I am so sorry that you feel that reporting the problem "got you nowhere". What you may not realize is the FDA, manufacturer and researchers use these databases routinely to help people in the future. Without the reports from you, me and others, manufacturers have no idea what happens once their drug, vaccine and/or medical devices are released for general public consumption. I thank you for taking the time to report your events.
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@susanlf, good that you reported the adverse reaction. @jabrown0407, thanks for posting how people can report adverse reactions.
Anyone can (and should) self report vaccine adverse reactions.
- Vaccine Adverse Event Reporting System or VAERS https://vaers.hhs.gov/reportevent.html
Healthcare providers are required by law to report to VAERS:
- Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccinations
- An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine
Healthcare providers are strongly encouraged to report to VAERS:
- Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether it is or is not clear that a vaccine caused the adverse event
- Vaccine administration errors
Vaccine manufacturers are required to report to VAERS all adverse events that come to their attention.
@susanlf, I'm sorry to hear that you are dealing with health issues for 2 years. Do you have underlying autoimmune conditions? Are you being treated for RA and PMR?