Mild side effects such as redness, warmth, or swelling where the shot was given have been reported in connection with administration of Hib vaccines. Fever over 101 degrees F may occur, and can last two to three days. Sysemic reactions include irritability and lethargy. However, more severe reactions have also been reported in both clinical trials with all of the vaccines as well as to the Vaccine Adverse Events Reporting System (VAERS).
According to MedAlerts.org (a searchable VAERS database) as of June 2012, there have been 12,140 serious adverse events reported to VAERS in connection with all Hib vaccines combined. Most of this number were children under age 3 (11,278). Serious reactions included deaths (471) and such things as anaphylactic reaction, asthma, pneumonia, convulsions, noninfectious encephalitis, acute pancreatitis, peripheral neuropathy, Guillain-Barre syndrome, sepsis, seizures, cerebral edema.
In clinical trials the severity of adverse reactions varied depending on which vaccine was given, and which other vaccines were given with them at the same time. Some of the events reported by the manufacturers included:
- ActHIB — tenderness, erythema, induration, fever, irritability, drowsiness, anorexia, diarrhea, vomiting; when combined with DTP vaccine by reconstitution, adverse reactions included: tenderness, erythema, induration, fever, irritability, drowsiness, anorexia, diarrhea, persistent crying, and one hypotonic/hypresponsive episode (which is consistent with the HHE rate observed with DTP vaccination alone)
- Hiberix — when co-administered with DTaP-HBV-IPV: redness, pain and swelling at injection site, fever, fussiness, loss of appetite, restlessness, sleepiness, diarrhea, vomiting; post-marketing reported adverse events included extensive swelling of the vaccinated limb, anaphylactic reactions, angioedema, convulsions, hypotonic-hyporesponsive episode, syncope, apnea, rash, urticarial, somnolence.
- PedvaxHIB — adverse events during clinical trials included irritability, sleepiness, injection siter pain/soreness, erythema, swelling induration, unusual high-pitched crying, prolonged crying (more than 4 hours), diarrhea, vomiting, crying, pain, otitis media, rash, and upper respiratory infection; potential adverse events may include early onset of Hib disease and Guillain-Barre syndrome; in post-marketing, reported adverse events included lymphadenopathy, angioedema, febrile seizures and injection site abscess.
- Comvax — (children in clinical trials were monitored five days) with the most frequently cited events being mild, transient signs and symptoms of inflammation at the injection site, pain/soreness, erythema, swelling, induration, somnolence, irritability, anorexia, vomiting, otitis media, fever, diarrhea, upper respiratory infection, rash, rhinorrhea, respiratory congestion, cough, candidiasis; in post-marketing: anaplylaxis, angioedema, urticarial, erythema multiforme, thrombocytopenia, seizure, febrile seizures, lymphadenopathy, pruritus, arthralgia, dyspnea, tachycardia, syncope, elevation of liver enzymes, increased erythrocyte sedimentation rate, arthritis, Bell’s Palsy, Guillain-Barre syndrome, agitation, Stevens-Johnson syndrome, alopecia, conjunctivitis, visual disturbances.
- Pentacel — redness, swelling, tenderness at injection site, increase in arm circumference (dose 4), fever, lethargy, inconsolable crying, fussiness, irritability, hypotonic hyporesponsive episodes, seizures, febrile seizures, bronchiolitis, dehydration, pneumonia, gastroenteritis, asthma, pneumonia, encephalopathy, and four deaths attributed to asphyxia due to suffocation, head trauma, Sudden Infant Death syndrome (SIDS), and neuroblastoma; in post-marketing, reported adverse events included cyanosis, vomiting, diarrhea, extensive swelling of injected limb including swelling that involved adjacent joints, invasive Hib disease (classified as vaccine failure), rash, urticarial, meningitis, rhinitis, viral infection, decreased appetitie, somnolence, HHE, depressed level of consciousness, screaming, apnea, cough, erythema, skin discoloroation, and pallor.
- MenHibrix — redness, swelling and pain at injection site, irritability, drowsiness, loss of appetitie, fever, and syncope. For more severe reactions such as nervous system disorders and other serious events, the manufacturer referred to reactions reported by the use of Hiberix rather than its own vaccine. It is not known whether MenHibrix can cause fetal harm when administered to a pregnant woman or whether it can affect reproduction capacity. 1
Besides the deaths reported in the clinical trials, deaths have been recorded in post-marketing reports as well. In fact, an open letter to Dr. Margaret Chan, director general of the World Health Organization, in March 2012 calls attention to the deaths the author says are connected with the pentavalent (DPT + Hib + Hepatitis B vaccine in India, Sri Lanka, Bhutan, and Pakistan.2 The authors add that the cause of the problem is unrelated to the brand or manufacturer or lot of the vaccine:
“It appears to be a form of ‘hypersensitivity reaction’ as described in the post mortem report on one of the children in Kerala. The vaccine can be administered to many patients without problems and there is no available method at present to predict which infant will react adversely.”
In a pediatric safety and use review of Pentacel in February 2010 the U.S. FDA discussed reported adverse reactions attributed to the vaccine in post-marketing, noting that Pentacel is now marketed in 11 countries, and there have been no safety-related labeling revisions. At the meeting, the FDA reported that 775 adverse reactions, 177 of which were considered serious including 26 deaths, had been reported to VAERS in connection with Pentacel between June 20, 2008 (when Pentacel was licensed) and October 31, 2009. The deaths were attributed to SIDS (12 cases), congenital/genetic conditions, respiratory infections, positional asphyxia, anoxic encephalopathy, cardiac arrest of undetermined etiology, dilated and hypertrophic cardiomyopathy, two deaths of undetermined cause, one death with no records obtainable, and two deaths with information pending.
The FDA said the SIDS reports “do not raise any concerns about a causal relationship with Pentacel.” The FDA also quoted the Institue of Medicine, which reviewed the data, and the IOM said: “The evidence favors rejection of a causal relationship between exposure to multiple vaccines and SIDS.” The FDA noted that “the sponsor is voluntarily conducting a descriptive, epidemiological safety surveillance study that will include at least 10,000 Pentacel recipients” with comparison groups of infants who receive other DTaP-containing products.3
Antigenuria has been reported after receipt of purified capsular polysaccharide H. influenza b vaccine. In one reported case, a 27-month-old child developed asceptic meningitis two days after getting the vaccine. Tests revealed that antigenuria was secondary to the vaccination.4,5,6None of the vaccines have been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.
IMPORTANT NOTE: NVIC encourages you to become fully informed about Haemophilus Influenza Type B (Hib) and the Hib vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.
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1 FDA.gov. Menhibrix Manufacturer’s Product Insert. June 2012. Online. (Accessed June 2012)
2 Puliyel J, Shiva M, Dabade G, et al. Open Letter to DG, WHO — Pentavalent Vaccine Related Deaths in India. All India Drug Action Network (AIDAN). March 12, 2012. Online. (Accessed June 2012)
3 FDA.gov. Pediatric Safety and Use Review for Pentacel. Advisory Committee. Feb 19, 2010. Online. (Accessed June 2012)
4Scheifelie D, Bjornsen GL, Acand T, Jacobsen K. Antigenuria after Receipt of Haemophilus b Diphtheria Conjugate Vaccine. Pediatr Infect Dis J. Dec 1989. Vol 8 Issue 12 pp 887. Online. (Accessed June 2012)
5Spinola SM, Sheaffer CI, Philbrick KB, Gilligan PH. Antigenuria after Haemophilus Influenzae Type b Polysaccharide Immunization: A Prospective Study. J Pediatr. 1986;109(5):835-838. Online. (Accessed June 2012)
6FDA.gov. Haemophilus b Conjugate Vaccine Manufacturer’s Product Insert. Sanofi Pasteur. May 6, 2009. Online. (Accessed June 2012)