Ipol Side Effects

Generic Name: poliovirus vaccine inactivated

Please note - some side effects for Ipol 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 Ipol - for the Consumer

Ipol

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 Ipol:

Crying; decreased appetite; drowsiness; fever, pain, redness, tenderness, or a raised area at the injection site; fussiness; spitting up feedings; tiredness; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); paralysis.

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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Ipol Side Effects - for the Professional

IPOL

BODY SYSTEM AS A WHOLE

In earlier studies with the vaccine grown in primary monkey kidney cells, transient local reactions at the site of injection were observed.3 Erythema, induration and pain occurred in 3.2%, 1% and 13%, respectively, of vaccinees within 48 hours post-vaccination. Temperatures of ≥39°C (≥102°F) were reported in 38% of vaccinees. Other symptoms included irritability, sleepiness, fussiness, and crying. Because IPV was given in a different site but concurrently with Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP), these systemic reactions could not be attributed to a specific vaccine. However, these systemic reactions were comparable in frequency and severity to that reported for DTP given alone without IPV.12 Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants with IPV.37

Four additional US studies using IPOL vaccine in more than 1,300 infants,12 between 2 to 18 months of age administered with DTP at the same time at separate sites or combined have demonstrated that local and systemic reactions were similar when DTP was given alone.

TABLE 212 PERCENTAGE OF INFANTS PRESENTING WITH LOCAL OR SYSTEMIC REACTIONS AT 6, 24, AND 48 HOURS OF IMMUNIZATION WITH IPOL VACCINE ADMINISTERED INTRAMUSCULARLY CONCOMITANTLY AT SEPARATE SITES WITH SANOFI* WHOLE-CELL DTP VACCINE AT 2 AND 4 MONTHS OF AGE AND WITH SANOFI ACELLULAR PERTUSSIS VACCINE (TRIPEDIA®) AT 18 MONTHS OF AGE

	AGE AT IMMUNIZATION
REACTION	2 Months (n=211)			4 Months (n=206)			18 Months† (n=74)
	6 Hrs.	24 Hrs.	48 Hrs.	6 Hrs.	24 Hrs.	48 Hrs.	6 Hrs.	24 Hrs.	48 Hrs.
* Sanofi Pasteur Inc. formerly known as Aventis Pasteur Inc. † Children who have been vaccinated with Tripedia vaccine. ‡ Data are from the IPOL vaccine administration site, given intramuscularly. § The adverse reaction profile includes the concomitant use of Sanofi whole-cell DTP vaccine or Tripedia vaccine with IPOL vaccine. Rates are comparable in frequency and severity to that reported for whole-cell DTP given alone.
Local, IPOL vaccine alone‡
Erythema >1"	0.5%	0.5%	0.5%	1.0%	0.0%	0.0%	1.4%	0.0%	0.0%
Swelling	11.4%	5.7%	0.9%	11.2%	4.9%	1.9%	2.7%	0.0%	0.0%
Tenderness	29.4%	8.5%	2.8%	22.8%	4.4%	1.0%	13.5%	4.1%	0.0%
Systemic§
Fever >102.2°F	1.0%	0.5%	0.5%	2.0%	0.5%	0.0%	0.0%	0.0%	4.2%
Irritability	64.5%	24.6%	17.5%	49.5%	25.7%	11.7%	14.7%	6.7%	8.0%
Tiredness	60.7%	31.8%	7.1%	38.8%	18.4%	6.3%	9.3%	5.3%	4.0%
Anorexia	16.6%	8.1%	4.3%	6.3%	4.4%	2.4%	2.7%	1.3%	2.7%
Vomiting	1.9%	2.8%	2.8%	1.9%	1.5%	1.0%	1.3%	1.3%	0.0%
Persistent Crying	Percentage of infants within 72 hours after immunization was 0.0% after dose one, 1.4% after dose two, and 0.0% after dose three.

DIGESTIVE SYSTEM

Anorexia and vomiting occurred with frequencies not significantly different as reported when DTP was given alone without IPV or OPV.12

NERVOUS SYSTEM

Although no causal relationship between IPOL vaccine and GBS has been established,28 GBS has been temporally related to administration of another inactivated poliovirus vaccine.

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 and to report occurrences of certain adverse events to the US Department of Health and Human Services. Reportable events include those listed in the Act for each vaccine and events specified in the package insert as contraindications to further doses of that vaccine.38,39,40

Reporting by parents or guardians of all adverse events after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by health-care providers to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967.38,39,40

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

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Side Effects by Body System - for Healthcare Professionals

Local

Local side effects associated with intramuscular administration have included erythema, swelling, and tenderness at the injection site.

Other

Other side effects have included fever >102.2 degrees F, irritability, tiredness, and persistent crying in infants following concomitant vaccination with poliovirus and DTP vaccine. The frequency and severity were similar to adverse effects for DTP vaccine alone.

Gastrointestinal

Gastrointestinal side effects have included anorexia and vomiting in infants, following concomitant vaccination with poliovirus and DTP vaccine. The frequency and severity were similar to adverse effects for DTP vaccine alone.

Nervous system

Nervous system side effects temporally associated with a different inactivated poliovirus vaccine have included Guillain-Barre Barre syndrome.

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