The labeling for Gardasil has been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the Food & Drug Administration (FDA), some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries.
According to a posting yesterday on the FDA website, roughly 13% of Gardasil side effects reported to VAERS describe fainting. In some instances, Gardasil fainting has resulted in serious injuries from falling. Such injuries often occurred while still in the healthcare provider’s office, and other fainting episodes resulted in motor vehicle accidents. Fainting has been listed as a possible side effect on the Gardasil label since 2007, but because of continued reports of this occurrence, the FDA has decided to raise the prominence of this information.
The FDA has asked Merck & Co. to move information on fainting risks to the “Warnings and Precautions” section of the Gardasil label. The revised label reminds healthcare providers that recipients of Gardasil should be closely observed for 15 minutes after vaccination. Gardasil recipients should be encouraged to remain seated or lying down for this length of time and be alert to the following warning signs and symptoms that may happen before a person faints: paleness, sweating, dizziness, ringing in ears or vision changes.