Dtp Side Effects Center

SIDE EFFECTS

Adverse reactions associated with the use of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) include local redness, warmth, edema, induration with or without tenderness, as well as urticaria and rash. Some data suggest that febrile reactions are more likely to occur in those who have experienced such responses after prior doses. ⁶

The frequency of local reactions and fever following DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccination is significantly higher with increasing numbers of doses of D.P. while other mild to moderate systemic reactions (e. g., fretfulness, vomiting) are significantly less frequent. ¹⁹ If local redness 2.5 cm occurs, the likelihood of recurrence after another DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) dose increases significantly. ⁶

Evidence does not indicate a causal relation between DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine and SIDS. Studies showing a temporal relation between these events are consistent with the expected occurrence of SIDS over the age range in which DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) immunization typically occurs. ¹³

Deaths due to causes other than SIDS, including deaths due to serious infections, have occurred in infants following the administration of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) . No association has been shown for hospitalizations due to infectious disease and receipt of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) . ²⁰

Approximate rates for adverse events following receipt of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine (regardless of dose number in the series) are indicated in TABLE 1. ²

*Rate per total number of doses regardless of dose number in DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) series.

Body System as a Whole

Mild systemic reactions such as fever, drowsiness, fretfulness, and anorexia, occur quite frequently. These reactions are significantly more common following administration of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) than following DT, are usually self-limited, and need no therapy other than symptomatic treatment such as acetaminophen. ²

Rarely, an anaphylactic reaction (i. e., hives, swelling of the mouth, difficulty breathing, hypotension, or shock) and death have been reported after receiving preparations containing diphtheria, tetanus, and/or pertussis antigens. ²

Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8 hours after an injection), may follow receipt of tetanus toxoid. ²

Moderate to severe systemic events, include high fever (i. e., temperature of >40.5° C [> 105° F]) and persistent, inconsolable crying lasting > 3 hours. These events occur infrequently and appear to be without sequelae. ² Occasionally, a nodule may be palpable at the injection site of adsorbed products for several weeks. Sterile abscesses at the site of injection have been reported (6 to 10 per million doses). ²

Nervous System

The following neurologic illnesses have been reported as temporally associated with vaccine containing tetanus toxoid: neurological complications ^21,22 including cochlear lesion, ²³ brachial plexus neuropathies, ^23,24 paralysis of the radial nerve, ²⁵ paralysis of the recurrent nerve, ²³ accommodation paresis, and EEG disturbances with encephalopathy. ¹⁹ The report from the IOM suggests that there is a causal relation between Guillain-Barré syndrome (GBS) and vaccines containing tetanus toxoid. ²⁶ In the differential diagnosis of polyradiculoneuropathies following administration of a vaccine containing tetanus toxoid should be considered as a possible etiology. ^19,27

Short-lived convulsions (usually febrile), or collapse (hypotonic-hyporesponsive episode) occur infrequently and appear to be without sequelae. ²

More severe neurologic events, such as a prolonged convulsion, or encephalopathy, although rare, have been reported in temporal association with DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) administration. An analysis of these data failed to show any cause and effect association. ²

In the National Childhood Encephalopathy Study (NCES), a large, case-control study in England, children 2 to 35 months of age with serious, acute neurologic disorders such as encephalopathy or complicated convulsion( s), were more likely to have received DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) in the 7 days preceding onset than their age-, sex-, and neighborhood-matched controls. Among children known to be neurologically normal before entering the study, the relative risk (estimated by odds ratio) of a neurologic illness occurring within the 7-day period following receipt of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) dose, compared to children not receiving DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) in the 7-day period before onset of their illness, was 3.3 (p < 0.001). ²

Within this 7-day period, the risk was significantly increased for immunized children only within 3 days of vaccination (relative risk 4.2, p < 0.001). The relative risk for illnesses occurring 4 to 7 days after vaccination was 2.1 (p < 0.1). Serious neurologic illnesses requiring hospitalization attributable to pertussis vaccine are rare. Final analysis of a comprehensive case-control study has estimated that the attributable risk of such illnesses is 1 in 140,000 doses administered. An earlier analysis had estimated this risk at 1/110,000 doses. In contrast, final analysis of the case-control study found that the risk of serious neurologic illness following pertussis disease was 1/11,000 pertussis cases. Repeated evaluations have shown that the benefits of vaccine outweigh the risks. ^2,9

The methods and results of the NCES have been thoroughly scrutinized since publication of the study. This reassessment by multiple groups has determined that the number of patients was too small and their classification subject to enough uncertainty to preclude drawing valid conclusions about whether a causal relation exists between pertussis vaccine and permanent neurologic damage. Preliminary data from a 10-year follow-up study of some of the children studied in the original NCES study also suggested a relation between symptoms following DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccination and permanent neurologic disability. However, details are not available to evaluate this study adequately, and the same concerns remain about DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine precipitating initial manifestations of pre-existing neurologic disorders. ²

An IOM report by the Committee to review the adverse consequences of pertussis and rubella vaccines concluded that evidence is consistent with a causal relation between DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine and acute encephalopathy, defined in the controlled studies reviewed as encephalopathy, encephalitis, or encephalomyelitis. On the basis of a review of the evidence bearing on this relation, the Committee concludes that the range of excess risk of acute encephalopathy following DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) immunization is consistent with that estimated for the NCES: 0.0 to 10.5 per million immunizations. The report also states that there is insufficient evidence to indicate a causal relation between DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine and permanent neurologic damage. ¹³

Onset of infantile spasms has occurred in infants who have recently received DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or DT. Analysis of data from the NCES on children with infantile spasms showed that receipt of DT or DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) was not causally related to infantile spasms. ²⁸ The incidence of onset of infantile spasms increases at 3 to 9 months of age, the time period in which the second and third doses of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) are generally given. Therefore, some cases of infantile spasms can be expected to be related by chance alone to recent receipt of D.P. ²

A bulging fontanelle associated with increased intracranial pressure which occurred within 24 hours following DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) immunization has been reported. A causal relationship has not been established. ^29,30,31

Cardiovascular System

An infant who developed myocarditis several hours after immunization has been reported. ³²

Respiratory System

Respiratory difficulties, including apnea, have been observed.

Local

Rash and allergic reactions have been observed. Sudden Infant Death Syndrome (SIDS) has temporally occurred in infants following administration of D.P. A large case-control study of SIDE in the United States showed that receipt of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) was not causally related to SIDS. ^33,34,35 It should be recognized that the first three primary immunizing doses of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) are usually administered to infants 2 to 6 months of age and that approximately 85% of SIDS cases occur at ages 1 to 6 months, with the peak incidence occurring at 6 weeks to 4 months of age. By chance alone, some SIDE victims can be expected to have recently received D.P. ^33,34,35

When CLI whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) was administered concomitantly (at separate sites with separate syringes) with ActHIB ^® or OmniHIB, the systemic adverse experience profile was not different from that seen when CLI whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine was administered alone. ^10,11 (Refer to ActHIB ^® package insert.)

In general, the rates of minor systemic reactions after DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) was used to reconstitute ActHIB ^® or OmniHIB were comparable to those usually reported after DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine alone. ^6,19,36

When CLI whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) was used to reconstitute ActHIB ^® or OmniHIB and administered to infants at 2, 4, and 6 months of age, the systemic adverse experience profile was comparable to that observed when the two vaccines were given separately. An increase in the rate of local reactions was observed in some instances within the 24- hour period after immunization. ^10,11 (Refer to ActHIB ^® package insert.)

Reporting of Adverse Events

Reporting by parents or guardians of all adverse events occurring 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. ^16,17,18

Health-care providers also should report these events to the Director of Medical Affairs, Connaught Laboratories, Inc., a Pasteur Mérieux Connaught Company, Route 611, PO Box 187, Swiftwater, PA 18370 or call 1-800-822-2463.

Read the entire FDA prescribing information for Dtp (Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed USP)