First aid is the assistance given to an injured or sick person in need of urgent medical assistance. First aid applies to a broad range of medical situations and consists both of specific knowledge and skills (for example, what to do for each type of injury or illness) and the ability to assess a situation and make appropriate decisions (such as when to call for emergency medical assistance).
Preparedness is a key element of first aid. While every home, auto, and boat should be equipped with a basic emergency kit that includes first aid supplies and a first aid manual, special circumstances may necessitate more advanced or specific degrees of preparation for an emergency. For example, residents of certain geographic areas where natural disasters (such as hurricanes, earthquakes, tornados, floods, landslides, or tsunamis) may occur should prepare for emergencies by assembling disaster preparedness kits such as earthquake kits, ...
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RECOMBIVAX (hepatitis b vaccine (recombinant)) HB and RECOMBIVAX (hepatitis b vaccine (recombinant)) HB Dialysis Formulation are generally well-tolerated. No adverse experiences were reported during clinical trials which could be related to changes in the titers of antibodies to yeast. As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials.
In three clinical studies, 434 doses of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose. Injection site reactions and systemic complaints were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions ( > 1% injections), in decreasing order of frequency, were irritability, fever ( ≥ 101°F oral equivalent), diarrhea, fatigue/weakness, diminished appetite, and rhinitis.10
In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB in adolescents, the overall frequency of adverse reactions was generally similar.
In a group of studies, 3258 doses of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose. Injection site reactions and systemic complaints were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported:
Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, and nodule formation.
The most frequent systemic complaints include fatigue/weakness; headache; fever ( ≥ 100°F); and malaise.
Nausea; and diarrhea
Pharyngitis; and upper respiratory infection
Sweating; achiness; sensation of warmth; lightheadedness; chills; and flushing
Vomiting; abdominal pains/cramps; dyspepsia; and diminished appetite
Rhinitis; influenza; and cough
Vertigo/dizziness; and paresthesia
Pruritus; rash (non-specified); angioedema; and urticaria
Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; and neck stiffness
Lymphadenopathy
Insomnia/disturbed sleep
The following additional adverse reactions have been reported with use of the marketed vaccine. In many instances, the relationship to the vaccine was unclear.
Anaphylaxis and symptoms of immediate hypersensitivity reactions including rash, pruritus, urticaria, edema, angioedema, dyspnea, chest discomfort, bronchial spasm, palpitation, or symptoms consistent with a hypotensive episode have been reported within the first few hours after vaccination. An apparent hypersensitivity syndrome (serum-sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses and erythema nodosum (see WARNINGS and PRECAUTIONS).
Elevation of liver enzymes; constipation
Guillain-Barré Syndrome; multiple sclerosis; exacerbation of multiple sclerosis; myelitis including transverse myelitis; seizure; febrile seizure; peripheral neuropathy including Bell's Palsy; radiculopathy; herpes zoster; migraine; muscle weakness; hypesthesia; encephalitis
Stevens-Johnson Syndrome; alopecia; petechiae; eczema
Pain in extremity
Increased erythrocyte sedimentation rate; thrombocytopenia
Systemic lupus erythematosus (SLE); lupus-like syndrome; vasculitis; polyarteritis nodosa
Irritability; agitation; somnolence
Optic neuritis; tinnitus; conjunctivitis; visual disturbances
The following adverse reaction has been reported with another Hepatitis B Vaccine (Recombinant) but not with RECOMBIVAX (hepatitis b vaccine (recombinant)) HB: keratitis.
Patients, parents and guardians should be instructed to report any serious adverse reactions to their healthcare provider, who in turn should report such events to the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967.31
There are no known drug interactions. (See INDICATIONS AND USAGE, Use with Other Vaccines.)
Last reviewed on RxList: 9/2/2008
This monograph has been modified to include the generic and brand name in many instances.
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