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Contraindications and Adverse Events for Infant Vaccines
Part 1: General Principles
A contraindication is a condition that increases the chance of a serious adverse reaction - when one is present, the vaccine should not be given. A precaution is a situation where risks and benefits must be weighed; vaccination may still proceed if benefits outweigh risks.
"A contraindication increases the chance of a serious adverse reaction. Therefore, a vaccine should not be administered when a contraindication is present." - Textbook of Family Medicine, 9e
Part 2: Contraindications by Vaccine
Universal Contraindication (ALL Vaccines)
- Anaphylaxis or severe allergic reaction to a previous dose of the same vaccine
- Anaphylaxis to any vaccine component (e.g., egg protein, neomycin, gelatin, latex, yeast)
Vaccine-Specific Contraindications
| Vaccine | Contraindications | Precautions |
|---|
| BCG | Immunocompromised infants (HIV with severe immunosuppression, primary immunodeficiency, malignancy, high-dose steroids) | Eczema/skin disease at injection site |
| OPV | Immunodeficiency states (primary or secondary); household contacts of immunodeficient persons | Diarrhea at time of vaccination (may reduce efficacy) |
| IPV | Anaphylaxis to previous dose or components (neomycin, streptomycin, polymyxin B) | Moderate/severe acute illness |
| DTP/DTaP | Anaphylaxis to prior dose; encephalopathy within 7 days of prior DTP dose not attributable to another cause | - Fever ≥40.5°C within 48 hrs of prior dose - Hypotonic-hyporesponsive episode (HHE) - Seizure within 3 days of prior dose - Persistent, inconsolable crying >3 hrs - Progressive or unstable neurological disorder |
| Hepatitis B | Anaphylaxis to yeast or prior dose | - Moderate/severe illness - Defer in preterm infants <2000 g if mother is HBsAg-negative (give at 1 month or discharge) |
| Rotavirus | Anaphylaxis to prior dose; Severe Combined Immunodeficiency (SCID); history of intussusception | - Altered immunocompetence (other than SCID) - Acute gastroenteritis - Do NOT give after 8 months 0 days of age |
| PCV (Pneumococcal) | Anaphylaxis to prior dose or components | Moderate/severe illness |
| Hib | Anaphylaxis to prior dose or components; age <6 weeks | Moderate/severe illness |
| Measles/MMR | Anaphylaxis to prior dose or gelatin/neomycin; severe immunodeficiency; pregnancy | - Recent IG or blood product administration - Thrombocytopenia - Tuberculin testing pending (defer TST 4-6 weeks) - High-dose steroids ≥14 days |
| Influenza (IIV) | Anaphylaxis to prior dose or egg protein | Moderate/severe illness; Guillain-Barré within 6 weeks of previous flu vaccine |
Special note - Hepatitis B in low birth weight: Hepatitis B vaccine should be deferred for preterm infants weighing less than 2000 g if the mother is HBsAg-negative. For infants born to HBsAg-positive mothers, Hep B vaccine + HBIG must be given within 12 hours of birth regardless of weight. - Textbook of Family Medicine, 9e
HIV exception: MMR can be given to HIV-infected infants unless there is evidence of severe immunosuppression (CD4 <15% in children 1-13 years). MMRV should NOT be given to any HIV-infected infant regardless of CD4 count (insufficient safety data). - Red Book 2021
Corticosteroids: Delay live vaccines (BCG, MMR, OPV, varicella) for at least 4 weeks after stopping high-dose steroids (≥2 mg/kg/day or ≥20 mg/day prednisone for ≥14 days). - Red Book 2021
Part 3: Adverse Events Following Immunization (AEFI)
Classification
AEFIs are classified as:
- Vaccine product-related - due to inherent properties of the vaccine
- Vaccine quality defect-related - due to manufacturing defects (now rare with modern GMP)
- Immunization error-related - improper preparation, handling, or administration
- Immunization anxiety-related - stress/anxiety response to the procedure
Common Minor Reactions
"Local reaction, fever and systemic symptoms can result as part of the immune response... Most vaccine reactions are minor and settle on their own." - Park's Textbook of Preventive and Social Medicine
| Vaccine | Local Reactions | Systemic Reactions | Frequency |
|---|
| BCG | Pain, swelling, redness; papule → ulcer → scar (2+ weeks); keloid in Asian/African populations | Rare | Common |
| DTP/DTaP | Pain, swelling, redness | Fever, irritability, malaise, loss of appetite | Up to 50% each |
| Hepatitis B | Pain, swelling, redness | Fever | Children: <5% local; 1-6% fever |
| Hib | Pain, swelling, redness | Fever | 5-15% local; 2-10% fever |
| Measles/MMR | Mild local | Fever, rash, conjunctivitis (5-15%); joint pains (rubella, <1% children); parotid swelling (mumps, <1%) | Up to 10% |
| OPV | None | Diarrhea, headache, muscle pain | <1% |
| IPV | None | None significant | - |
| Pneumococcal (PCV) | Pain, swelling, redness | Low-grade fever | 30-50% local |
| Tetanus (TT/Td) | Pain, swelling, redness (up to 50% with boosters) | Malaise | Up to 25% |
Rare, Serious Vaccine Reactions
An AEFI is considered serious if it results in death, is life-threatening, requires hospitalization, results in persistent disability, or requires intervention to prevent permanent damage. - Park's Textbook
| Adverse Event | Definition | Treatment | Associated Vaccine(s) |
|---|
| Anaphylaxis | Severe immediate allergic reaction (within 1 hour), circulatory failure ± bronchospasm/laryngospasm | Adrenaline (epinephrine) injection - emergency | All vaccines |
| Anaphylactoid reaction | Exaggerated allergic reaction within 2 hours - bronchospasm, laryngeal edema, hives, facial edema | Antihistamines; self-limiting | All vaccines |
| Vaccine-Associated Paralytic Poliomyelitis (VAPP) | Acute flaccid paralysis within 4-30 days of OPV receipt; neurological deficits remaining at 60 days | Supportive care only | OPV |
| Febrile seizures | Seizures with fever; mostly febrile (not epileptic) | Supportive; antipyretics | DTP, Measles/MMR |
| Hypotonic-Hyporesponsive Episode (HHE) | Sudden onset of hypotonia, reduced responsiveness, pallor/cyanosis within 48 hrs | Usually self-limiting | DTP/DTaP |
| Intussusception | ~1-2 cases per 100,000 infants vaccinated; shortly after 1st dose | Surgical/radiological reduction | Rotavirus vaccine |
| Disseminated BCG infection | Disseminated BCG disease in immunocompromised infants | Anti-TB therapy | BCG |
| Brachial neuritis | Deep aching pain + weakness in shoulder/arm | Analgesics; symptomatic | Tetanus |
| Thrombocytopenia | Platelet count drop | Monitoring; supportive | MMR |
| Arthralgia/Arthritis | Joint pain (persistent >10 days or transient ≤10 days) | Analgesics; self-limiting | Rubella, MMR |
VAPP risk: Higher after the first dose of OPV (1 in 750,000) compared to subsequent doses (1 in 5.1 million). Risk is higher in adults and immunocompromised persons. - Park's Textbook
Encephalopathy: Although listed as a rare possible reaction to measles, JE, or DTP vaccines, it is not certain these vaccines actually cause encephalopathy - further scientific evaluation is needed. - Park's Textbook
Part 4: False Contraindications ("Do NOT withhold vaccine for these")
These are not contraindications to vaccination:
- Mild illness (cold, mild diarrhea) with low-grade fever
- Current antibiotic therapy
- Prematurity (except HepB in <2000 g if mother HBsAg-negative)
- Breastfeeding
- Family history of adverse vaccine reactions
- Malnutrition (mild-moderate)
- Stable neurological conditions (cerebral palsy, Down syndrome)
- Known exposure to infectious disease
- Convalescent phase of illness
Part 5: Post-Vaccination Observation
- Observe all infants for at least 15-30 minutes after vaccination to detect anaphylaxis
- Adrenaline (epinephrine 1:1000) should always be immediately available at vaccination sites
- All serious AEFIs should be reported to the national surveillance system (VAERS in USA; AEFI reporting in India)
Key Sources:
- Park's Textbook of Preventive and Social Medicine (Table 36, 37)
- Red Book 2021 - Report of the Committee on Infectious Diseases (AAP)
- Textbook of Family Medicine, 9e