Gardasil Side Effects

Generic Name: human papillomavirus vaccine

Please note - some side effects for Gardasil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Gardasil - for the Consumer

Gardasil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Gardasil:

Dizziness; headache; mild fever; mild pain, redness, itching, bruising, or swelling at the injection site; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Gardasil:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); calf or leg pain or tenderness; chest pain; chills; confusion; fainting with or without jerking movements or seizure-like activity; general feeling of being unwell; joint pain; muscle pain or weakness; seizures; severe or persistent pain, redness, swelling, or warmth at the injection site; severe stomach pain; shortness of breath; swollen glands (eg, in the neck, armpit, or groin); unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Gardasil Side Effects - for the Professional

Gardasil

Overall Summary of Adverse Reactions

Headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising) occurred after administration with Gardasil.

Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with Gardasil and may result in falling with injury; observation for 15 minutes after administration is recommended. [See Warnings and Precautions (5.1).] 

Anaphylaxis has been reported following vaccination with Gardasil.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

Studies in Girls, Women, Boys, and Men 9 Through 26 Years of Age

In 6 clinical trials (4 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]-controlled, 1 saline placebo-controlled, and 1 uncontrolled), 14,273 individuals were administered Gardasil or AAHS control or saline placebo on the day of enrollment, and approximately 2 and 6 months thereafter, and safety was evaluated using vaccination report cards (VRC)-aided surveillance for 14 days after each injection of Gardasil or AAHS control or saline placebo in these individuals. The individuals who were monitored using VRC-aided surveillance included 8180 individuals 9 through 26 years of age at enrollment who received Gardasil and 6093 individuals who received AAHS control or saline placebo. Few individuals (0.2%) discontinued due to adverse reactions. The race distribution of the girls and women in the safety population was as follows: 62.3% White; 17.6% Hispanic (Black and White); 6.8% Asian; 6.7% Other; 6.4% Black; and 0.3% American Indian. The race distribution of the boys and men in the safety population was as follows: 42.0% White; 19.7% Hispanic (Black and White); 11.0% Asian; 11.2% Other; 15.9% Black; and 0.1% American Indian.

Common Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age

The injection site adverse reactions that were observed among recipients of Gardasil at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients are shown in Table 1.

Table 1: Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age*

Adverse Reaction (1 to 5 Days Postvaccination)	Gardasil (N = 5088) %	AAHS Control† (N = 3470) %	Saline Placebo (N = 320) %
* The injection-site adverse reactions that were observed among recipients of Gardasil were at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients. † AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
Injection Site     Pain     Swelling     Erythema     Pruritus     Bruising	83.9 25.4 24.7 3.2 2.8	75.4 15.8 18.4 2.8 3.2	48.6 7.3 12.1 0.6 1.6

Common Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age

The injection site adverse reactions that were observed among recipients of Gardasil at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients are shown in Table 2.

Table 2: Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age*

Adverse Reaction (1 to 5 Days Postvaccination)	Gardasil (N = 3093) %	AAHS Control† (N = 2029) %	Saline Placebo (N = 274) %
* The injection-site adverse reactions that were observed among recipients of Gardasil were at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients. † AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
Injection Site     Pain     Erythema     Swelling     Hematoma	61.4 16.7 13.9 1.0	50.8 14.1 9.6 0.3	41.6 14.5 8.2 3.3

Evaluation of Injection-Site Adverse Reactions by Dose in Girls and Women 9 Through 26 Years of Age

An analysis of injection-site adverse reactions in girls and women by dose is shown in Table 3. Of those girls and women who reported an injection-site reaction, 94.3% judged their injection-site adverse reaction to be mild or moderate in intensity.

Table 3: Postdose Evaluation of Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

	Gardasil (% occurrence)			AAHS Control* (% occurrence)			Saline Placebo (% occurrence)
* AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † N = Number of individuals with follow-up ‡ Intensity of swelling and erythema was measured by size (inches): Mild = 0 to ≤1; Moderate = >1 to ≤2; Severe = >2.
Adverse Reaction	Post- dose 1 N† = 5011	Post- dose 2 N = 4924	Post- dose 3 N = 4818	Post- dose 1 N = 3410	Post- dose 2 N = 3351	Post- dose 3 N = 3295	Post- dose 1 N = 315	Post- dose 2 N = 301	Post- dose 3 N = 300
Pain Mild/Moderate Severe	63.4 62.5 0.9	60.7 59.7 1.0	62.7 61.2 1.5	57.0 56.6 0.4	47.8 47.3 0.5	49.6 48.9 0.6	33.7 33.3 0.3	20.3 20.3 0.0	27.3 27.0 0.3
Swelling‡ Mild/Moderate Severe	10.2 9.6 0.6	12.8 11.9 0.8	15.1 14.2 0.9	8.2 8.1 0.2	7.5 7.2 0.2	7.6 7.3 0.2	4.4 4.4 0.0	3.0 3.0 0.0	3.3 3.3 0.0
Erythema‡ Mild/Moderate Severe	9.2 9.0 0.2	12.1 11.7 0.3	14.7 14.3 0.4	9.8 9.5 0.3	8.4 8.4 0.1	8.9 8.8 0.1	7.3 7.3 0.0	5.3 5.3 0.0	5.7 5.7 0.0

Evaluation of Injection-Site Adverse Reactions by Dose in Boys and Men 9 Through 26 Years of Age

An analysis of injection-site adverse reactions in boys and men by dose is shown in Table 4. Of those boys and men who reported an injection-site reaction, 96.4% judged their injection-site adverse reaction to be mild or moderate in intensity.

Table 4: Postdose Evaluation of Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

	Gardasil (% occurrence)			AAHS Control* (% occurrence)			Saline Placebo (% occurrence)
Adverse Reaction	Post- dose 1 N† = 3003	Post- dose 2 N = 2898	Post- dose 3 N = 2826	Post- dose 1 N = 1950	Post- dose 2 N = 1854	Post- dose 3 N = 1799	Post- dose 1 N = 269	Post- dose 2 N = 263	Post- dose 3 N = 259
* AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † N = Number of individuals with follow-up ‡ Intensity of swelling and erythema was measured by size (inches): Mild = 0 to ≤1; Moderate = >1 to ≤2; Severe = >2.
Pain Mild/Moderate Severe	44.7 44.5 0.2	36.9 36.4 0.5	34.4 34.1 0.3	38.4 37.9 0.4	28.2 28.2 0.1	25.8 25.5 0.3	27.5 27.5 0.0	20.5 20.2 0.4	16.2 16.2 0.0
Swelling‡ Mild/Moderate Severe	5.6 5.3 0.2	6.6 6.2 0.3	7.7 7.1 0.5	5.6 5.4 0.2	4.5 4.5 0.0	4.1 4.0 0.1	4.8 4.8 0.0	1.5 1.5 0.0	3.5 3.1 0.4
Erythema‡ Mild/Moderate Severe	7.2 6.8 0.3	8.0 7.7 0.2	8.7 8.3 0.3	8.3 8.0 0.2	6.3 6.2 0.1	5.7 5.6 0.1	7.1 7.1 0.0	5.7 5.7 0.0	5.0 5.0 0.0

Common Systemic Adverse Reactions in Girls and Women 9 Through 26 Years of Age

Headache was the most commonly reported systemic adverse reaction in both treatment groups (Gardasil = 28.2% and AAHS control or saline placebo = 28.4%). Fever was the next most commonly reported systemic adverse reaction in both treatment groups (Gardasil = 13.0% and AAHS control or saline placebo = 11.2%).

Adverse reactions that were observed among recipients of Gardasil, at a frequency of greater than or equal to 1.0% where the incidence in the Gardasil group was greater than or equal to the incidence in the AAHS control or saline placebo group, are shown in Table 5.

Table 5: Common Systemic Adverse Reactions in Girls and Women 9 Through 26 Years of Age (Gardasil ≥Control)*

Adverse Reactions (1 to 15 Days Postvaccination)	Gardasil (N = 5088) %	AAHS Control† or Saline Placebo (N = 3790) %
* The adverse reactions in this table are those that were observed among recipients of Gardasil at a frequency of at least 1.0% and greater than or equal to those observed among AAHS control or saline placebo recipients. † AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
Pyrexia	13.0	11.2
Nausea	6.7	6.5
Dizziness	4.0	3.7
Diarrhea	3.6	3.5
Vomiting	2.4	1.9
Cough	2.0	1.5
Toothache	1.5	1.4
Upper respiratory tract infection	1.5	1.5
Malaise	1.4	1.2
Arthralgia	1.2	0.9
Insomnia	1.2	0.9
Nasal congestion	1.1	0.9

Common Systemic Adverse Reactions in Boys and Men 9 Through 26 Years of Age

Headache was the most commonly reported systemic adverse reaction in both treatment groups (Gardasil = 12.3% and AAHS control or saline placebo = 11.2%). Fever was the next most commonly reported systemic adverse reaction in both treatment groups (Gardasil = 8.3% and AAHS control or saline placebo = 6.5%).

Adverse reactions that were observed among recipients of Gardasil, at a frequency of greater than or equal to 1.0% where the incidence in the group that received Gardasil was greater than or equal to the incidence in the AAHS control or saline placebo group, are shown in Table 6.

Table 6: Common Systemic Adverse Reactions in Boys and Men 9 Through 26 Years of Age (Gardasil ≥Control)*

Adverse Reactions (1 to 15 Days Postvaccination)	Gardasil (N = 3093) %	AAHS Control† or Saline Placebo (N = 2303) %
* The adverse reactions in this table are those that were observed among recipients of Gardasil at a frequency of at least 1.0% and greater than or equal to those observed among AAHS control or saline placebo recipients. † AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
Headache	12.3	11.2
Pyrexia	8.3	6.5
Oropharyngeal pain	2.8	2.1
Diarrhea	2.7	2.2
Nasopharyngitis	2.6	2.6
Nausea	2.0	1.0
Upper respiratory tract infection	1.5	1.0
Abdominal pain upper	1.4	1.4
Myalgia	1.3	0.7
Dizziness	1.2	0.9
Vomiting	1.0	0.8

Evaluation of Fever by Dose in Girls and Women 9 Through 26 Years of Age

An analysis of fever in girls and women by dose is shown in Table 7.

Table 7: Postdose Evaluation of Fever in Girls and Women 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

	Gardasil (% occurrence)			AAHS Control* or Saline Placebo (% occurrence)
* AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † N = Number of subjects with follow-up
Temperature (°F)	Postdose 1 N† = 4945	Postdose 2 N = 4804	Postdose 3 N = 4671	Postdose 1 N = 3681	Postdose 2 N = 3564	Postdose 3 N = 3467
≥100 to <102	3.7	4.1	4.4	3.1	3.8	3.6
≥102	0.3	0.5	0.5	0.2	0.4	0.5

Evaluation of Fever by Dose in Boys and Men 9 Through 26 Years of Age

An analysis of fever in boys and men by dose is shown in Table 8.

Table 8: Postdose Evaluation of Fever in Boys and Men 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

	Gardasil (% occurrence)			AAHS Control* or Saline Placebo (% occurrence)
Temperature (°F)	Postdose 1 N† = 2972	Postdose 2 N = 2849	Postdose 3 N = 2792	Postdose 1 N = 2194	Postdose 2 N = 2079	Postdose 3 N = 2046
* AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † N = Number of individuals with follow-up
≥100 to <102	2.4	2.5	2.3	2.1	2.2	1.6
≥102	0.6	0.5	0.5	0.5	0.3	0.3

Serious Adverse Reactions in the Entire Study Population

Across the clinical studies, 258 individuals (Gardasil N = 128 or 0.8%; placebo N = 130 or 1.0%) out of 29,323 (Gardasil N = 15,706; AAHS control N = 13,023; or saline placebo N = 594) individuals (9- through 45-year-old girls and women; and 9- through 26-year-old boys and men) reported a serious systemic adverse reaction.

Of the entire study population (29,323 individuals), 0.04% of the reported serious systemic adverse reactions were judged to be vaccine related by the study investigator. The most frequently (frequency of 4 cases or greater with either Gardasil, AAHS control, saline placebo, or the total of all three) reported serious systemic adverse reactions, regardless of causality, were:

Headache [0.02% Gardasil (3 cases) vs. 0.02% AAHS control (2 cases)],
Gastroenteritis [0.02% Gardasil (3 cases) vs. 0.02% AAHS control (2 cases)],
Appendicitis [0.03% Gardasil (5 cases) vs. 0.01% AAHS control (1 case)],
Pelvic inflammatory disease [0.02% Gardasil (3 cases) vs. 0.03% AAHS control (4 cases)],
Urinary tract infection [0.01% Gardasil (2 cases) vs. 0.02% AAHS control (2 cases)],
Pneumonia [0.01% Gardasil (2 cases) vs. 0.02% AAHS control (2 cases)],
Pyelonephritis [0.01% Gardasil (2 cases) vs. 0.02% AAHS control (3 cases)],
Pulmonary embolism [0.01% Gardasil (2 cases) vs. 0.02% AAHS control (2 cases)].

One case (0.006% Gardasil; 0.0% AAHS control or saline placebo) of bronchospasm; and 2 cases (0.01% Gardasil; 0.0% AAHS control or saline placebo) of asthma were reported as serious systemic adverse reactions that occurred following any vaccination visit.

In addition, there was 1 individual in the clinical trials, in the group that received Gardasil, who reported two injection-site serious adverse reactions (injection-site pain and injection-site joint movement impairment).

Deaths in the Entire Study Population

Across the clinical studies, 40 deaths (Gardasil N = 21 or 0.1%; placebo N = 19 or 0.1%) were reported in 29,323 (Gardasil N = 15,706; AAHS control N = 13,023, saline placebo N = 594) individuals (9- through 45-year-old girls and women; and 9- through 26-year-old boys and men). The events reported were consistent with events expected in healthy adolescent and adult populations. The most common cause of death was motor vehicle accident (5 individuals who received Gardasil and 4 individuals who received AAHS control), followed by drug overdose/suicide (2 individuals who received Gardasil and 6 individuals who received AAHS control), gun shot wound (1 individual who received Gardasil and 3 individuals who received AAHS control), and pulmonary embolus/deep vein thrombosis (1 individual who received Gardasil and 1 individual who received AAHS control). In addition, there were 2 cases of sepsis, 1 case of pancreatic cancer, 1 case of arrhythmia, 1 case of pulmonary tuberculosis, 1 case of hyperthyroidism, 1 case of post-operative pulmonary embolism and acute renal failure, 1 case of traumatic brain injury/cardiac arrest, 1 case of systemic lupus erythematosus, 1 case of cerebrovascular accident, 1 case of breast cancer, and 1 case of nasopharyngeal cancer in the group that received Gardasil; 1 case of asphyxia, 1 case of acute lymphocytic leukemia, 1 case of chemical poisoning, and 1 case of myocardial ischemia in the AAHS control group; and 1 case of medulloblastoma in the saline placebo group.

Systemic Autoimmune Disorders in Girls and Women 9 Through 26 Years of Age

In the clinical studies, 9- through 26-year-old girls and women were evaluated for new medical conditions that occurred over the course of follow-up. New medical conditions potentially indicative of a systemic autoimmune disorder seen in the group that received Gardasil or AAHS control or saline placebo are shown in Table 9. This population includes all girls and women who received at least one dose of Gardasil or AAHS control or saline placebo, and had safety data available.

Table 9: Summary of Girls and Women 9 Through 26 Years of Age Who Reported an Incident Condition Potentially Indicative of a Systemic Autoimmune Disorder After Enrollment in Clinical Trials of Gardasil, Regardless of Causality

Conditions	Gardasil (N = 10,706)	AAHS Control* or Saline Placebo (N = 9412)
	n (%)	n (%)
N = Number of individuals enrolled n = Number of individuals with specific new Medical Conditions NOTE: Although an individual may have had two or more new Medical Conditions, the individual is counted only once within a category. The same individual may appear in different categories.
* AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † Arthralgia/Arthritis/Arthropathy includes the following terms: Arthralgia, Arthritis, Arthritis reactive, and Arthropathy ‡ Hyperthyroidism includes the following terms: Basedow's disease, Goiter, Toxic nodular goiter, and Hyperthyroidism § Hypothyroidism includes the following terms: Hypothyroidism and thyroiditis ¶ Inflammatory bowel disease includes the following terms: Colitis ulcerative, Crohn's disease, and Inflammatory bowel disease # Nephritis includes the following terms: Nephritis, Glomerulonephritis minimal lesion, Glomerulonephritis proliferative Þ Pigmentation disorder includes the following terms: Pigmentation disorder, Skin depigmentation, and Vitiligo ß Psoriasis includes the following terms: Psoriasis, Pustular psoriasis, and Psoriatic arthropathy à Rheumatoid arthritis includes juvenile rheumatoid arthritis. One woman counted in the rheumatoid arthritis group reported rheumatoid arthritis as an adverse experience at Day 130.
Arthralgia/Arthritis/Arthropathy†	120 (1.1)	98 (1.0)
Autoimmune Thyroiditis	4 (0.0)	1 (0.0)
Celiac Disease	10 (0.1)	6 (0.1)
Diabetes Mellitus Insulin-dependent	2 (0.0)	2 (0.0)
Erythema Nodosum	2 (0.0)	4 (0.0)
Hyperthyroidism‡	27 (0.3)	21 (0.2)
Hypothyroidism§	35 (0.3)	38 (0.4)
Inflammatory Bowel Disease¶	7 (0.1)	10 (0.1)
Multiple Sclerosis	2 (0.0)	4 (0.0)
Nephritis#	2 (0.0)	5 (0.1)
Optic Neuritis	2 (0.0)	0 (0.0)
Pigmentation DisorderÞ	4 (0.0)	3 (0.0)
Psoriasisß	13 (0.1)	15 (0.2)
Raynaud's Phenomenon	3 (0.0)	4 (0.0)
Rheumatoid Arthritisà	6 (0.1)	2 (0.0)
Scleroderma/Morphea	2 (0.0)	1 (0.0)
Stevens-Johnson Syndrome	1 (0.0)	0 (0.0)
Systemic Lupus Erythematosus	1 (0.0)	3 (0.0)
Uveitis	3 (0.0)	1 (0.0)
All Conditions	245 (2.3)	218 (2.3)

Systemic Autoimmune Disorders in Boys and Men 9 Through 26 Years of Age

In the clinical studies, 9- through 26-year-old boys and men were evaluated for new medical conditions that occurred over the course of follow-up. New medical conditions potentially indicative of a systemic autoimmune disorder seen in the group that received Gardasil or AAHS control or saline placebo are shown in Table 10. This population includes all boys and men who received at least one dose of Gardasil or AAHS control or saline placebo, and had safety data available.

Table 10: Summary of Boys and Men 9 Through 26 Years of Age Who Reported an Incident Condition Potentially Indicative of a Systemic Autoimmune Disorder After Enrollment in Clinical Trials of Gardasil, Regardless of Causality

Conditions	Gardasil (N = 3093)	AAHS Control* or Saline Placebo (N = 2303)
	n (%)	n (%)
N = Number of individuals who received at least one dose of either vaccine or placebo n = Number of individuals with specific new Medical Conditions NOTE: Although an individual may have had two or more new Medical Conditions, the individual is counted only once within a category. The same individual may appear in different categories.
* AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † Hypothyroidism includes the following terms: Hypothyroidism and Autoimmune thyroiditis ‡ Inflammatory bowel disease includes the following terms: Colitis ulcerative and Crohn's disease
Alopecia Areata	2 (0.1)	0 (0.0)
Ankylosing Spondylitis	1 (0.0)	2 (0.1)
Arthralgia/Arthritis/Reactive Arthritis	30 (1.0)	17 (0.7)
Autoimmune Thrombocytopenia	1 (0.0)	0 (0.0)
Diabetes Mellitus Type 1	3 (0.1)	2 (0.1)
Hyperthyroidism	0 (0.0)	1 (0.0)
Hypothyroidism†	3 (0.1)	0 (0.0)
Inflammatory Bowel Disease‡	1 (0.0)	2 (0.1)
Myocarditis	1 (0.0)	1 (0.0)
Proteinuria	1 (0.0)	0 (0.0)
Psoriasis	0 (0.0)	4 (0.2)
Skin Depigmentation	1 (0.0)	0 (0.0)
Vitiligo	2 (0.1)	5 (0.2)
All Conditions	46 (1.5)	34 (1.5)

Safety in Concomitant Use with RECOMBIVAX HB [hepatitis B vaccine (recombinant)] in Girls and Women 16 Through 23 Years of Age

The safety of Gardasil when administered concomitantly with RECOMBIVAX HB®1  [hepatitis B vaccine (recombinant)] was evaluated in an AAHS-controlled study of 1871 girls and women with a mean age of 20.4 years [see Clinical Studies (14.9)]. The race distribution of the study individuals was as follows: 61.6% White; 23.8% Other; 11.9% Black; 1.6% Hispanic (Black and White); 0.8% Asian; and 0.3% American Indian. The rates of systemic and injection-site adverse reactions were similar among girls and women who received concomitant vaccination as compared with those who received Gardasil or RECOMBIVAX HB [hepatitis B vaccine (recombinant)].

Safety in Concomitant Use with Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)]

The safety of Gardasil when administered concomitantly with Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)] was evaluated in a randomized study of 1040 boys and girls with a mean age of 12.6 years [see Clinical Studies (14.10)]. The race distribution of the study subjects was as follows: 77.7% White; 1.4% Multi-racial; 12.3% Black; 6.8% Hispanic (Black and White); 1.2% Asian; 0.4% American Indian, and 0.2% Indian.

There was an increase in injection-site swelling reported at the injection site for Gardasil (concomitant = 10.9%, non-concomitant = 6.9%) when Gardasil was administered concomitantly with Menactra and Adacel as compared to non-concomitant (separated by 1 month) vaccination. The majority of injection-site swelling adverse experiences were reported as being mild to moderate in intensity.

Postmarketing Experience

The following adverse events have been spontaneously reported during post-approval use of Gardasil. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.

Blood and lymphatic system disorders: Autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, lymphadenopathy.

Respiratory, thoracic and mediastinal disorders: Pulmonary embolus.

Gastrointestinal disorders: Nausea, pancreatitis, vomiting.

General disorders and administration site conditions: Asthenia, chills, death, fatigue, malaise.

Immune system disorders: Autoimmune diseases, hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria.

Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.

Nervous system disorders: Acute disseminated encephalomyelitis, dizziness, Guillain-Barré syndrome, headache, motor neuron disease, paralysis, seizures, syncope (including syncope associated with tonic-clonic movements and other seizure-like activity) sometimes resulting in falling with injury, transverse myelitis.

Infections and infestations: cellulitis.

Vascular disorders: Deep venous thrombosis.

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Side Effects by Body System - for Healthcare Professionals

Local

Local side effects have included injection site pain, swelling, erythema, and pruritus.

Gastrointestinal

Gastrointestinal side effects have included nausea, diarrhea, vomiting, and toothache.

General

General side effects have included fever, dizziness, malaise, and insomnia. Postmarketing reports have included asthenia and fatigue.

Respiratory

Respiratory side effects have included cough, nasal congestion, nasopharyngitis, and upper respiratory tract infection.

Musculoskeletal

Musculoskeletal side effects have included myalgia and arthralgia.

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