Adacel TDAP

Adacel®, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration. After shaking, the vaccine is a white, homogenous, cloudy suspension.

Each dose of Adacel vaccine (0.5 mL) contains the following active ingredients:

Acellular Pertussis
Detoxified Pertussis Toxin (PT)	2.5 µg
Filamentous Hemagglutinin (FHA)	5 µg
Pertactin (PRN)	3 µg
Fimbriae Types 2 and 3 (FIM)	5 µg
Tetanus Toxoid (T)	5 Lf
Diphtheria Toxoid (d)	2 Lf

Other ingredients per dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, ≤5 µg residual formaldehyde, <50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative). The antigens are the same as those in DAPTACEL®, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP); however, Adacel vaccine is formulated with reduced quantities of d and detoxified PT.

The acellular pertussis vaccine components are obtained from Bordetella pertussis cultures grown in Stainer-Scholte medium (1) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and co-purified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde, FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed onto aluminum phosphate.

Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (2) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (3) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate.

The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection.

Tetanus and diphtheria toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The tetanus component induces at least 2 neutralizing units/mL of serum and the diphtheria component induces at least 0.5 neutralizing units/mL of serum. The potency of the acellular pertussis vaccine components is evaluated by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA).

Hepatitis B Vaccine

The concomitant use of Adacel vaccine and hepatitis B (Hep B) vaccine (Recombivax HB®, 10 μg per dose using a two-dose regimen, manufactured by Merck and Co., Inc) was evaluated in a multi-center, open-labeled, randomized, controlled study that enrolled 410 adolescents, 11-14 years of age inclusive. One group received Adacel and Hep B vaccines concurrently (N = 206). The other group (N = 204) received Adacel vaccine at the first visit, then 4-6 weeks later received Hep B vaccine. The second dose of Hep B vaccine was given 4-6 weeks after the first dose. Serum samples were obtained prior to and 4-6 weeks after Adacel vaccine administration, as well as 4-6 weeks after the 2nd dose of Hep B for all participants. No interference was observed in the immune responses to any of the vaccine antigens when Adacel and Hep B vaccines were given concurrently or separately. (9) (See DOSAGE AND ADMINISTRATION, Concomitant Vaccine Administration.)

Trivalent Inactivated Influenza Vaccine

The concomitant use of Adacel vaccine and trivalent inactivated influenza vaccine (TIV, Fluzone®, manufactured by Sanofi Pasteur Inc., Swiftwater, PA) was evaluated in a multi-center, open-labeled, randomized, controlled study conducted in 720 adults, 19-64 years of age inclusive. In one group, participants received Adacel and TIV vaccines concurrently (N = 359). The other group received TIV at the first visit, then 4-6 weeks later received Adacel vaccine (N = 361). Sera were obtained prior to and 4-6 weeks after Adacel vaccine, as well as 4-6 weeks after the TIV. The immune responses were comparable for concurrent and separate administration of Adacel and TIV vaccines for diphtheria (percent of participants with seroprotective concentration ≥0.10 IU/mL and booster responses), tetanus (percent of participants with seroprotective concentration ≥0.10 IU/mL), pertussis antigens (booster responses and GMCs except lower PRN GMC in the concomitant group, lower bound of the 90% CI was 0.61 and the pre-specified criterion was ≥0.67) and influenza antigens (percent of participants with hemagglutination-inhibition [HI] antibody titer ≥1:40 IU/mL and ≥4-fold rise in HI titer). Although tetanus booster response rates were significantly lower in the group receiving the vaccines concurrently versus separately, greater than 98% of participants in both groups achieved seroprotective levels of ≥0.1 IU/mL. (9) (See DOSAGE AND ADMINISTRATION, Concomitant Vaccine Administration.)

A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Adacel vaccine or any other tetanus toxoid, diphtheria toxoid or pertussis containing vaccine or any other component of this vaccine is a contraindication to vaccination with Adacel vaccine. Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered. (10) (11)

Encephalopathy within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause is a contraindication to vaccination with Adacel vaccine.(5) (10) (11)

General

Before administration of Adacel vaccine, the patient's current health status and medical history should be reviewed in order to determine whether any contraindications exist and to assess the benefits and risks of vaccination. (See CONTRAINDICATIONS and WARNINGS.)

Epinephrine Hydrochloride Solution (1:1,000) and other appropriate agents and equipment should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

If Adacel vaccine is administered to immunocompromised persons, including persons receiving immunosupressive therapy, the expected immune response may not be obtained.

Information for Vaccine Recipients and/or Parent or Guardian

Before administration of Adacel vaccine, health-care providers should inform the vaccine recipient and/or parent or guardian of the benefits and risks.

The health-care provider should inform the vaccine recipient and/or parent or guardian about the potential for adverse reactions that have been temporally associated with Adacel vaccine or other vaccines containing similar components. The health-care provider should provide the Vaccine Information Statements (VISs) that are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization.

The vaccine recipient and/or parent or guardian should be instructed to report any serious adverse reactions to their health-care provider. Females of child-bearing potential should be informed that Sanofi Pasteur Inc. maintains a pregnancy surveillance system to collect data on pregnancy outcomes and newborn health status outcomes following vaccination with Adacel vaccine during pregnancy. If they are pregnant or become aware they were pregnant at the time of Adacel vaccine immunization, they are encouraged to contact directly or have their health-care professional contact Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE).

Reporting adverse events after vaccination to VAERS (Vaccine Adverse Event Reporting System) by recipients and/or parents/or guardian should be encouraged. The toll-free number for VAERS forms and information is 1-800-822-7967. Reporting forms may also be obtained at the VAERS website at www.vaers.hhs.gov

Drug Interactions

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines. (See PRECAUTIONS, General.)

For information regarding simultaneous administration with other vaccines refer to the CLINICAL PHARMACOLOGY, CONCURRENTLY ADMINISTERED VACCINES, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been performed with Adacel vaccine to evaluate carcinogenicity, mutagenic potential, or impairment of fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with Adacel vaccine. It is also not known whether Adacel vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Adacel vaccine should be given to a pregnant woman only if clearly needed. Animal fertility studies have not been conducted with Adacel vaccine. The effect of Adacel vaccine on embryo-fetal and pre-weaning development was evaluated in two developmental toxicity studies using pregnant rabbits. Animals were administered Adacel vaccine twice prior to gestation, during the period of organogenesis (gestation day 6) and later during pregnancy on gestation day 29, 0.5 mL/rabbit/occasion (a 17-fold increase compared to the human dose of Adacel vaccine on a body weight basis), by intramuscular injection. No adverse effects on pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There were no vaccine related fetal malformations or other evidence of teratogenesis noted in this study. (9)

Nursing Mothers

It is not known whether Adacel vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Adacel vaccine is given to a nursing woman.

Pediatric Use

Adacel vaccine is not indicated for individuals less than 11 years of age. (See INDICATIONS AND USAGE.) For immunization of persons 6 weeks through 6 years of age against diphtheria, tetanus and pertussis refer to manufacturers' package inserts for DTaP vaccines.

Geriatric Use

Adacel vaccine is not indicated for individuals 65 years of age and older. No data are available regarding the safety and effectiveness of Adacel vaccine in individuals 65 years of age and older as clinical studies of Adacel vaccine did not include participants in the geriatric population.

The safety of Adacel vaccine was evaluated in 4 clinical studies. A total of 5,841 individuals 11-64 years of age inclusive (3,393 adolescents 11-17 years of age and 2,448 adults 18-64 years) received a single dose of Adacel vaccine.

The principal safety study was a randomized, observer-blind, active controlled trial that enrolled participants 11-17 years of age (Adacel vaccine N = 1,184; Td vaccine N = 792) and 18-64 years of age (Adacel vaccine N = 1,752; Td vaccine N = 573). Study participants had not received tetanus or diphtheria containing vaccines within the previous 5 years. Solicited local and systemic reactions and unsolicited adverse events were monitored daily for 14 days post-vaccination using a diary card. From days 14-28 post-vaccination, information on adverse events necessitating a medical contact, such as a telephone call, visit to an emergency room, physician's office or hospitalization, was obtained via telephone interview or at an interim clinic visit. From days 28 to 6 months post-vaccination, participants were monitored for unexpected visits to a physician's office or to an emergency room, onset of serious illness and hospitalizations. Information regarding adverse events that occurred in the 6 month post-vaccination time period was obtained from the participant via telephone. Approximately 96% of participants completed the 6-month follow-up evaluation.

In the concomitant vaccination study with Adacel and Hepatitis B vaccines (see Clinical Studies for description of study design and number of participants), local and systemic adverse events were monitored daily for 14 days post-vaccination using a diary card. Local adverse events were only monitored at site/arm of Adacel vaccine administration. Unsolicited reactions (including immediate reactions, serious adverse events and events that elicited seeking medical attention) were collected at a clinic visit or via telephone interview for the duration of the trial, i.e., up to six months post-vaccination.

In the concomitant vaccination study with Adacel vaccine and trivalent inactivated influenza vaccine (see Clinical Studies for description of study design and number of participants), local and systemic adverse events were monitored for 14 days post-vaccination using a diary card. All unsolicited reactions occurring through day 14 were collected. From day 14 to the end of the trial, i.e., up to 84 days, only events that elicited seeking medical attention were collected.

In all the studies, participants were monitored for serious adverse events throughout the duration of the study.

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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.

Serious Adverse Events in All Safety Studies

Throughout the 6-month follow-up period in the principal safety study, serious adverse events were reported in 1.5% of Adacel vaccine recipients and 1.4% in Td vaccine recipients. Two serious adverse events in adults were neuropathic events that occurred within 28 days of Adacel vaccine administration; one severe migraine with unilateral facial paralysis and one diagnosis of nerve compression in neck and left arm. Similar or lower rates of serious adverse events were reported in the other trials and there were no additional neuropathic events reported.

Solicited Adverse Events in the Principal Safety Study

The frequency of selected solicited adverse events (erythema, swelling, pain and fever) occurring during Days 0-14 following one dose of Adacel vaccine or Td vaccine are presented in Table 5. Most of these events were reported at a similar frequency in recipients of both Adacel vaccine and Td vaccine. Few participants (<1%) sought medical attention for these reactions. Pain at the injection site was the most common adverse reaction occurring in 63 to 78% of all vaccinees. In addition, overall rates of pain were higher in adolescent recipients of Adacel vaccine compared to Td vaccine recipients. Rates of moderate and severe pain in adolescents did not significantly differ between the Adacel vaccine and Td vaccine groups. Among adults the rates of pain, after receipt of Adacel vaccine or Td vaccine, did not significantly differ. Fever of 38°C and higher was uncommon, although in the adolescent age group, it occurred significantly more frequently in Adacel vaccine recipients than Td vaccine recipients. (9)

Table 5: Frequencies of Solicited Injection Site Reactions and Fever for Adolescents and Adults, Days 0-14, Following a Single Dose of Adacel Vaccine or Td Vaccine

		Adolescents 11-17 years		Adults 18-64 years
Adverse Event*		Adacel N† = 1,170-1,175 (%)	Td‡ N† = 783-787 (%)	Adacel N† = 1,688-1,698 (%)	Td‡ N† = 551-561 (%)
* Sample size was designed to detect >10% differences between Adacel and Td vaccines for events of 'Any' intensity. † N = number of participants with available data. ‡ Tetanus and Diphtheria Toxoids Adsorbed For Adult Use manufactured by Sanofi Pasteur Inc., Swiftwater, PA. § Adacel vaccine did not meet the non-inferiority criterion for rates of 'Any' Pain in adolescents compared to Td vaccine rates (upper limit of the 95% CI on the difference for Adacel vaccine minus Td vaccine was 10.7% whereas the criterion was <10%). For 'Any' Fever the non-inferiority criteria was met, however, 'Any' Fever was statistically higher in adolescents receiving Adacel vaccine. ¶ Interfered with activities, but did not necessitate medical care or absenteeism. # Incapacitating, prevented the performance of usual activities, may have/or did necessitate medical care or absenteeism.
Injection Site Pain	Any	77.8§	71.0	65.7	62.9
	Moderate¶	18.0	15.6	15.1	10.2
	Severe#	1.5	0.6	1.1	0.9
Injection Site Swelling	Any	20.9	18.3	21.0	17.3
	Moderate¶
	1.0 to 3.4 cm	6.5	5.7	7.6	5.4
	Severe#
	≥3.5 cm	6.4	5.5	5.8	5.5
	≥5 cm (2 inches)	2.8	3.6	3.2	2.7
Injection Site Erythema	Any	20.8	19.7	24.7	21.6
	Moderate¶
	1.0 to 3.4 cm	5.9	4.6	8.0	8.4
	Severe#
	≥3.5 cm	6.0	5.3	6.2	4.8
	≥5 cm (2 inches)	2.7	2.9	4.0	3.0
Fever	≥38.0°C (≥100.4°F)	5.0§	2.7	1.4	1.1
	≥38.8°C to ≤39.4°C (≥102.0°F to ≤103.0°F)	0.9	0.6	0.4	0.2
	≥39.5°C (≥103.1°F)	0.2	0.1	0.0	0.2

The frequency of other solicited adverse events (Days 0-14) are presented in Table 6. The rates of these events following Adacel vaccine were comparable with those observed with Td vaccine. Headache was the most frequent systemic reaction and was usually of mild to moderate intensity.

Table 6: Frequencies of Other Solicited Adverse Events for Adolescents and Adults, Days 0-14, Following a Single Dose of Adacel Vaccine or Td Vaccine

Adverse Event		Adolescents 11-17 years		Adults 18-64 years
		Adacel N* = 1,174-1,175 (%)	Td† N* = 787 (%)	Adacel N* = 1,697-1,698 (%)	Td† N* = 560-561 (%)
* N = number of participants with available data. † Tetanus and Diphtheria Toxoids Adsorbed For Adult Use manufactured by Sanofi Pasteur Inc., Swiftwater, PA. ‡ Interfered with activities, but did not necessitate medical care or absenteeism. § Incapacitating, prevented the performance of usual activities, may have/or did necessitate medical care or absenteeism.
Headache	Any	43.7	40.4	33.9	34.1
	Moderate‡	14.2	11.1	11.4	10.5
	Severe§	2.0	1.5	2.8	2.1
Body Ache or Muscle Weakness	Any	30.4	29.9	21.9	18.8
	Moderate‡	8.5	6.9	6.1	5.7
	Severe§	1.3	0.9	1.2	0.9
Tiredness	Any	30.2	27.3	24.3	20.7
	Moderate‡	9.8	7.5	6.9	6.1
	Severe§	1.2	1.0	1.3	0.5
Chills	Any	15.1	12.6	8.1	6.6
	Moderate‡	3.2	2.5	1.3	1.6
	Severe§	0.5	0.1	0.7	0.5
Sore and Swollen Joints	Any	11.3	11.7	9.1	7.0
	Moderate‡	2.6	2.5	2.5	2.1
	Severe§	0.3	0.1	0.5	0.5
Nausea	Any	13.3	12.3	9.2	7.9
	Moderate‡	3.2	3.2	2.5	1.8
	Severe§	1.0	0.6	0.8	0.5
Lymph Node Swelling	Any	6.6	5.3	6.5	4.1
	Moderate‡	1.0	0.5	1.2	0.5
	Severe§	0.1	0.0	0.1	0.0
Diarrhea	Any	10.3	10.2	10.3	11.3
	Moderate‡	1.9	2.0	2.2	2.7
	Severe§	0.3	0.0	0.5	0.5
Vomiting	Any	4.6	2.8	3.0	1.8
	Moderate‡	1.2	1.1	1.0	0.9
	Severe§	0.5	0.3	0.5	0.2
Rash	Any	2.7	2.0	2.0	2.3

Local and systemic solicited reactions occurred at similar rates in Adacel vaccine and Td vaccine recipients in the 3 day post-vaccination period. Most local reactions occurred within the first 3 days after vaccination (with a mean duration of less than 3 days).

The rates of unsolicited adverse events reported from days 14-28 post-vaccination were comparable between the two groups, as were the rates of unsolicited adverse events from day 28 through 6 months.

There were no spontaneous reports of whole-arm swelling of the injected limb in this study, nor in the other three studies which contributed to the safety database for Adacel vaccine.

Adverse Events in the Concomitant Vaccine Studies

Local and Systemic Reactions when Given with Hepatitis B Vaccine

The rates reported for fever and injection site pain (at the Adacel vaccine administration site) were similar when Adacel and Hep B vaccines were given concurrently or separately. However, the rates of injection site erythema (23.4% for concomitant vaccination and 21.4% for separate administration) and swelling (23.9% for concomitant vaccination and 17.9% for separate administration) at the Adacel vaccine administration site were increased when co-administered. Swollen and/or sore joints were reported by 22.5% for concomitant vaccination and 17.9% for separate administration. The rates of generalized body aches in the individuals who reported swollen and/or sore joints were 86.7% for concomitant vaccination and 72.2% for separate administration. Most joint complaints were mild in intensity with a mean duration of 1.8 days. The incidence of other solicited and unsolicited adverse events were not different between the 2 study groups. (9)

Local and Systemic Reactions when Given with Trivalent Inactivated Influenza Vaccine

The rates of fever and injection site erythema and swelling were similar for recipients of concurrent and separate administration of Adacel vaccine and TIV. However, pain at the Adacel vaccine injection site occurred at statistically higher rates following concurrent administration (66.6%) versus separate administration (60.8%). The rates of sore and/or swollen joints were 13% for concurrent administration and 9% for separate administration. Most joint complaints were mild in intensity with a mean duration of 2.0 days. The incidence of other solicited and unsolicited adverse events were similar between the 2 study groups. (9)

Additional Studies

An additional 1,806 adolescents received Adacel vaccine as part of the lot consistency study used to support Adacel vaccine licensure. This study was a randomized, double-blind, multi-center trial designed to assess lot consistency as measured by the safety and immunogenicity of 3 lots of Adacel vaccine when given as a booster dose to adolescents 11-17 years of age inclusive. Local and systemic adverse events were monitored for 14 days post-vaccination using a diary card. Unsolicited adverse events and serious adverse events were collected for 28 days post-vaccination. Pain was the most frequently reported local adverse event occurring in approximately 80% of all participants. Headache was the most frequently reported systemic event occurring in approximately 44% of all participants. Sore and/or swollen joints were reported by approximately 14% of participants. Most joint complaints were mild in intensity with a mean duration of 2.0 days. (9)

An additional 962 adolescents and adults received Adacel vaccine in three supportive Canadian studies used as the basis for licensure in other countries. Within these clinical trials, the rates of local and systemic reactions following Adacel vaccine were similar to those reported in the four principal trials in the US with the exception of a higher rate (86%) of adults experiencing 'any' local injection site pain. The rate of severe pain (0.8%), however, was comparable to the rates reported in four principal trials conducted in the US. (9) There was one spontaneous report of whole-arm swelling of the injected limb among the 277 Td vaccine recipients, and two spontaneous reports among the 962 Adacel vaccine recipients in the supportive Canadian studies.

Postmarketing Reports

The following adverse events have been spontaneously reported during the post-marketing use of Adacel vaccine in the US and other countries. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

The following adverse events were included based on severity, frequency of reporting or the strength of causal association to Adacel vaccine.

General disorders and administration site conditions:

   Large injection site reactions (>50 mm), extensive limb swelling from the injection site beyond one or both joints.    Injection site bruising, sterile abscess

Nervous system disorders:

   Paraesthesia, hypoesthesia, Guillain-Barré syndrome, facial palsy, convulsion, syncope, myelitis

Immune system disorders:

   Anaphylactic reaction, hypersensitivity reaction (angioedema, edema, rash, hypotension)

Skin and subcutaneous tissue disorders:

   Pruritus, urticaria

Musculoskeletal and connective tissue disorders:

   Myositis, muscle spasm

Cardiac disorders:

   Myocarditis

Additional Adverse Events

Additional adverse events, included in this section, have been reported in conjunction with receipt of vaccines containing diphtheria, tetanus toxoids and/or pertussis antigens.

Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2-8 hours after an injection), may follow receipt of tetanus toxoid. Such reactions may be associated with high levels of circulating antitoxin in persons who have had overly frequent injections of tetanus toxoid. (14) (See WARNINGS.)

Persistent nodules at the site of injection have been reported following the use of adsorbed products. (12)

Certain neurological conditions have been reported in temporal association with some tetanus toxoid containing vaccines or tetanus and diphtheria toxoid containing vaccines. A review by the Institute of Medicine (IOM) concluded that the evidence favors acceptance of a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. Other neurological conditions that have been reported include: demyelinating diseases of the central nervous system, peripheral mononeuropathies, and cranial mononeuropathies. The IOM has concluded that the evidence is inadequate to accept or reject a causal relation between these conditions and vaccines containing tetanus and/or diphtheria toxoids.

Reporting of Adverse Events

The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records of the manufacturer and lot number of the vaccine administered in the vaccine recipient's permanent medical record along with the date of administration of the vaccine and the name, address and title of the person administering the vaccine. The Act further requires the health-care professional to report to the US Department of Health and Human Services the occurrence following immunization of any event set forth in the Vaccine Injury Table. These include anaphylaxis or anaphylactic shock within 7 days; brachial neuritis within 28 days; an acute complication or sequelae (including death) of an illness, disability, injury, or condition referred to above, or any events that would contraindicate further doses of vaccine, according to this Adacel vaccine package insert. (15) (16) (17)

The US Department of Health and Human Services has established the Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. Reporting of all adverse events occurring after vaccine administration is encouraged from vaccine recipients, parents/guardians and the health-care provider. Adverse events following immunization should be reported to VAERS. Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967 or visit the VAERS website at www.vaers.hhs.gov (15) (16) (17)

Health-care providers should also report these events to Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463 (1-800-VACCINE).

Applies to diphtheria toxoid / pertussis, acellular / tetanus toxoid: intramuscular suspension

Along with its needed effects, diphtheria toxoid / pertussis, acellular / tetanus toxoid may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking diphtheria toxoid / pertussis, acellular / tetanus toxoid:

Less common

• Crying for 3 or more hours
• fainting

Rare

• Confusion
• convulsions (seizures)
• difficulty with breathing or swallowing
• fever of 102.2 degrees F or more
• headache (severe or continuing)
• hives
• itching, especially of the feet or hands
• low blood pressure
• reddening of the skin, especially around the ears
• sleepiness (unusual and continuing)
• swelling of the eyes, face, or inside of the nose
• unusual tiredness or weakness (sudden and severe)
• vomiting (severe or continuing)

Incidence not known

• Blood in the urine
• bloody or black, tarry stools
• blurred vision
• chest pain or discomfort
• chills
• cough
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast heartbeat
• flushed, dry skin
• fruit-like breath odor
• inability to move the arms and legs
• increased hunger
• increased thirst
• increased urination
• large, flat, blue or purplish patches on the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of consciousness
• muscle pain or spasm
• nausea
• painful knees and ankles
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness and swelling on the skin, buttocks, legs, or ankles
• skin rash
• stiff neck
• stomach pain
• sudden numbness and weakness in the arms and legs
• sweating
• tightness in the chest
• trouble breathing
• unexplained weight loss
• unusual tiredness or weakness

Some side effects of diphtheria toxoid / pertussis, acellular / tetanus toxoid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Body aches
• diarrhea
• fever of 99.5 degrees F or more
• headache
• redness, swelling, tenderness, pain, or a lump at the place of injection
• tiredness

Incidence not known

• Back pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• injection site bruising
• muscle or joint pain
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• weakness of the muscles in the face
• welts on the skin