Gardasil Adverse Reactions

In 5 clinical trials (4 placebo-controlled), subjects were administered Gardasil or placebo on the day of enrollment and approximately 2 and 6 months thereafter. Few subjects (0.2%) discontinued due to adverse reactions. Safety was evaluated in either the entire study population (4 studies) or in a predefined subset (1 study) of the study population using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Gardasil or placebo. The subjects who were monitored using VRC-aided surveillance included 6160 subjects (5088 females 9-26 years and 1072 males 9-15 years at enrollment) who received Gardasil and 4064 subjects who received placebo.
The following vaccine-related adverse reactions were observed among recipients of Gardasil at a frequency of at least 1% and also at a greater frequency than observed among placebo recipients. They are ranked under headings of frequency using the following convention: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000), including isolated reports.
General Disorders and Administration Site Conditions: Very Common: Pyrexia. At the Injection Site: Erythema, pain, swelling. Common: At the Injection Site: Bleeding, pruritus.
In addition, in clinical trials, adverse reactions that were judged to be vaccine- or placebo-related by the study investigator were observed at frequencies <1%.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Bronchospasm.
Skin and Subcutaneous Tissue Disorder: Rare: Urticaria. Seven cases (0.06%) of urticaria were reported in the Gardasil group and 17 cases (0.18%) were seen in the adjuvant-containing placebo group.
In the clinical studies, subjects in the Safety Population reported any new medical conditions during the follow-up of up to 4 years. Among 11,813 subjects who received Gardasil and 9701 subjects who received placebo, there were 8 cases of nonspecific arthritis reported, 6 in the Gardasil group and 2 in the placebo group.