Report Adverse Reactions to Medicines, Vaccines, Med Devices to FDA

Posted by jabrown0407 @jabrown0407, Apr 5 5:14pm

If you have had an adverse reaction to a medication, even if it is a known side effect, you can self-report it to the FDA. It is also possible for your provider to report the problems as well. So ask them if they could do it as well, especially if it is an unusual reaction or a very serious one.
The FDA maintains a data base of reactions for post release of drugs, vaccines, medical devices, etc to maintain information on frequency, trends. differences from the drug trials, etc.
To report this type information, please follow the link below for online submission.
https://www.safetyreporting.hhs.gov/smarthub
I have used it in the past and will be using it to report that my Tyenne injectables resulted in several side effect including having an episode of diverticulitis. This has resulted in me having to quit taking Tyenne as well as any other IL-6 inhibitor for my GCA.

Interested in more discussions like this? Go to the Polymyalgia Rheumatica (PMR) Support Group.

susanlf | @susanlf | Apr 6 8:50am

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.

susanlf | @susanlf | Apr 9 9:47am

My Mayo rheumatologist told me yesterday that he did not and would not get in touch with GSK. I will see my local rheumatologist on 4/20. Hopefully he will have honored my request.

Colleen Young, Connect Director | @colleenyoung | Apr 9 11:15am

In reply to @susanlf "Hi! I reported my adverse reaction to Glaxo Smith Klein’ s ShingrixShot as well as FDA...." + (show)

@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?

jabrown0407 | @jabrown0407 | Apr 9 11:24am

Before a medical provider will contact a manufacturer or report it to the FDA they most often need independent medically creditable evidence that they can report as supporting facts. Unlike you, they cannot often report an opinion. In my case with the vaccination, one of my doctor's knew the doctor who managed the vaccine drug trial. That drug trial doctor wrote a letter stating that my reaction was highly possible.
I recently had my first ever episode of diverticulitis while on Tyenne, Tyenne has a label warning on this. I had a CT scan where the radiologist Dx a mild case. This too is independent medically creditable evidence. Please know that a doctor is putting their credentials at risk every time they report something. You and I can report based on opinions and assumptions, doctors are much more limited.
If your doctor said they did not/will not you might ask if they could explain why they are reluctant.

jabrown0407 | @jabrown0407 | 5 days ago

In reply to @susanlf "Hi! I reported my adverse reaction to Glaxo Smith Klein’ s ShingrixShot as well as FDA...." + (show)

@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.