PedvaxHIB Side Effects

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

PedvaxHIB

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 PedvaxHIB:

Fever; irritability; redness, tenderness, pain, swelling, or a lump at the injection site; sleepiness.

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

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

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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PedvaxHIB Side Effects - for the Professional

PedvaxHIB

Liquid PedvaxHIB

In a multicenter clinical study (n=903) comparing the effects of Liquid PedvaxHIB with those of lyophilized PedvaxHIB, 1,699 doses of Liquid PedvaxHIB were administered to 678 healthy infants 2 to 6 months of age from the general U.S. population. DTP and OPV were administered concomitantly to most subjects. Both formulations of PedvaxHIB were generally well tolerated and no serious vaccine-related adverse reactions were reported.

During a three-day period following primary vaccination with Liquid PedvaxHIB in these infants, the most frequently reported (>1%) adverse reactions, without regard to causality, excluding those shown in TABLE 5, in decreasing order of frequency, were: irritability, sleepiness, injection site pain/soreness, injection site erythema (≤2.5 cm diameter, see also TABLE 5), injection site swelling/induration (≤2.5 cm diameter, see also TABLE 5), unusual high-pitched crying, prolonged crying (>4 hr), diarrhea, vomiting, crying, pain, otitis media, rash, and upper respiratory infection.

Selected objective observations reported by parents over a 48-hour period in these infants following primary vaccination with Liquid PedvaxHIB are summarized in TABLE 5.

TABLE 5: Fever or Local Reactions in Subjects First Vaccinated at 2 to 6 Months of Age with Liquid PedvaxHIB*

		Post-Dose 1 (hr)				Post-Dose 2 (hr)
Reaction	No. of Subjects Evaluated	6	24	48	No. of Subjects Evaluated	6	24	48
* DTP and OPV were administered concomitantly to most subjects. † Fever was also measured by another method or reported as normal for an additional 345 infants after dose 1 and for an additional 249 infants after dose 2; however, these data are not included in this table.
		Percentage				Percentage
Fever† >38.3°C (≥101°F) Rectal	222	18.1	4.4	0.5	206	14.1	9.4	2.8
Erythema >2.5 cm diameter	674	2.2	1.0	0.5	562	1.6	1.1	0.4
Swelling >2.5 cm diameter	674	2.5	1.9	0.9	562	0.9	0.9	1.3

Adverse reactions during a three-day period following administration of the booster dose were generally similar in type and frequency to those seen following primary vaccination.

Lyophilized PedvaxHIB

In The Protective Efficacy Study, 4,459 healthy Navajo infants 6 to 12 weeks of age received lyophilized PedvaxHIB or placebo. Most of these infants received DTP/OPV concomitantly. No differences were seen in the type and frequency of serious health problems expected in this Navajo population or in serious adverse experiences reported among those who received lyophilized PedvaxHIB and those who received placebo, and none was reported to be related to lyophilized PedvaxHIB. Only one serious reaction (tracheitis) was reported as possibly related to lyophilized PedvaxHIB and only one (diarrhea) as possibly related to placebo. Seizures occurred infrequently in both groups (9 occurred in vaccine recipients, 8 of whom also received DTP; 8 occurred in placebo recipients, 7 of whom also received DTP) and were not reported to be related to lyophilized PedvaxHIB.

In early clinical studies involving the administration of 8,086 doses of lyophilized PedvaxHIB alone to 5,027 healthy infants and children 2 months to 71 months of age, lyophilized PedvaxHIB was generally well tolerated. No serious adverse reactions were reported. In a subset of these infants, urticaria was reported in two children, and thrombocytopenia was seen in one child. A cause and effect relationship between these side effects and the vaccination has not been established.

Potential Adverse Reactions

The use of Haemophilus b Polysaccharide Vaccines and another Haemophilus b Conjugate Vaccine has been associated with the following additional adverse effects: early onset Hib disease and Guillain-Barré syndrome. A cause and effect relationship between these side effects and the vaccination was not established.{36,37,39,40,41,49}

Post-Marketing Adverse Reactions

The following additional adverse reactions have been reported with the use of the lyophilized and liquid formulations of PedvaxHIB:

Hemic and Lymphatic System

Lymphadenopathy

Hypersensitivity

Rarely, angioedema

Nervous System

Febrile seizures

Skin

Sterile injection site abscess 

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Side Effects by Body System - for Healthcare Professionals

Local

Local side effects have included local pain, redness, swelling, tenderness at the injection site.

Nervous system

Nervous system side effects have included irritability, drowsiness, and lethargy.

Gastrointestinal

Gastrointestinal side effects have included anorexia, vomiting, and diarrhea.

General

General side effects have included fever greater than 100.8°F, persistent crying, and unusual crying.

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