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PedvaxHIB

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Pedvax HIB

Pedvax HIB

PedvaxHIB Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Liquid PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] is used to prevent infection caused by haemophilus b bacteria. The vaccine will not protect against other types of influenza. It is an immunization. Common side effects include pain, swelling, and redness at the injection site. Drowsiness, irritability/crying, loss of appetite, diarrhea, fever, or vomiting may also occur.

Infants 2 to 14 months of age should receive a 0.5 mL dose of Liquid PedvaxHIB vaccine beginning at 2 months of age followed by a 0.5 mL dose 2 months later. When the primary two-dose regimen is completed before 12 months of age, a booster dose is required. Children 15 months of age and older previously unvaccinated should receive a single 0.5 mL dose of vaccine. Liquid PedvaxHIB may interact with steroids, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medicines to treat or prevent organ transplant rejection. Tell your doctor all medications and supplements you use, and all other vaccines you recently received. Liquid PedvaxHIB vaccine is not recommended for use during pregnancy and is not usually used in adults. It is unknown if this drug passes into breast milk. This vaccine is not usually used in adults. Consult your doctor before breastfeeding.

Our Liquid PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

PedvaxHIB in Detail - Patient Information: Side Effects

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives another haemophilus B vaccine in the future, you will need to tell the child's doctor if the first shot caused any side effects.

Becoming infected with haemophilus B is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if your child has any of these serious side effects:

  • pale skin, severe weakness, dizziness, fast heartbeat;
  • extreme drowsiness, fainting;
  • fussiness, irritability, crying for an hour or longer;
  • seizure (black-out or convulsions); or
  • high fever (within a few hours or a few days after the vaccine).

Less serious side effects include:

  • redness, pain, swelling, or a lump where the shot was given;
  • low fever;
  • mild fussiness or crying;
  • joint pain, body aches;
  • drowsiness; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for PedvaxHIB (Haemophilus b Conjugate Vaccine) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

PedvaxHIB FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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*

Reaction No. of
Subjects
Evaluated
Post-Dose 1
(hr)
No. of
Subjects
Evaluated
Post-Dose 2
(hr)
6 24 48 6 24 48
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
* DTP and OPV were administered concomitantly to most subjects.
** Fever was also measured by another method or reported as normal for anadditional 345 infants after dose 1 and for an additional 249 infants after dose 2;however, these data are not included in this table.

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 (see CLINICAL PHARMACOLOGY), 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-Barre 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

Read the entire FDA prescribing information for PedvaxHIB (Haemophilus b Conjugate Vaccine) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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