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Update: Vaccine Side Effects, Adverse Reactions, Contraindications, and Precautions Recommendations of the Advisory Committee on Immunization Practices (ACIP) part-2

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DTP The following recommendations concerning adverse events associated with DTP vaccination update those applicable sections in "Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures -- Recommendations of the Immunization Practices Advisory Committee (ACIP)" (MMWR 1991;40{No. RR-10}).

Side Effects and Adverse Reactions Following DTP Vaccination

Local reactions (generally erythema and induration with or without tenderness) are common after the administration of vaccines containing diphtheria, tetanus, or pertussis antigens. Occasionally, a nodule may be palpable at the injection site of adsorbed products for several weeks. Sterile abscesses at the injection site have been reported rarely (6-10 events per million doses of DTP). Mild systemic reactions such as fever, drowsiness, fretfulness, and anorexia occur frequently. These reactions are substantially more common following the administration of DTP than of DT, but they are self-limited and can be safely managed with symptomatic treatment.

Acetaminophen is frequently given by physicians to lessen fever and irritability associated with DTP vaccination, and it may be useful in preventing seizures among febrile-convulsion-prone children. However, fever that does not begin until greater than or equal to 24 hours after vaccination or persists for more than 24 hours after vaccination should not be assumed to be due to DTP vaccination. These new or persistent fevers should be evaluated for other causes so that treatment is not delayed for serious conditions such as otitis media or meningitis. Moderate-to-severe systemic events include high fever (i.e., temperature of greater than or equal to 40.5 C {greater than or equal to 105 F}); persistent, inconsolable crying lasting greater than or equal to 3 hours; collapse (hypotonic-hyporesponsive episode); or short-lived convulsions (usually febrile). These events occur infrequently. These events appear to be without sequelae (57-59). Other more severe neurologic events, such as a prolonged convulsion or encephalopathy, although rare, have been reported in temporal association with DTP administration.

Approximate rates for the occurrence of adverse events following receipt of DTP (regardless of dose number in the series or age of the child) are shown in (Table_6) (60,61). The frequencies of local reactions and fever are substantially higher with increasing numbers of doses of DTP, while other mild-to-moderate systemic reactions (e.g., fretfulness, vomiting) are substantially less frequent (59-61).

Concern about the possible role of pertussis vaccine in causing neurologic reactions has been present since the earliest days of vaccine use. Rare but serious acute neurologic illnesses, including encephalitis/encephalopathy and prolonged convulsions, have been anecdotally reported following receipt of whole-cell pertussis vaccine given as DTP (62,63). Whether pertussis vaccine causes or is only coincidentally related to such illnesses or reveals an inevitable event has been difficult to determine conclusively for the following reasons: a) serious acute neurologic illnesses often occur or become manifest among children during the first year of life irrespective of vaccination; b) there is no specific clinical sign, pathologic finding, or laboratory test which can determine whether the illness is caused by the DTP; c) it may be difficult to determine with certainty whether infants less than 6 months of age are neurologically normal, which complicates assessment of whether vaccinees were already neurologically impaired before receiving DTP; and d) because these events are exceedingly rare, appropriately designed large studies are needed to address the question.

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