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ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI)

A Comprehensive Clinical Guide for Pediatric & Emergency Medicine Residents

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PART 1: FOUNDATIONS

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CHAPTER 1: DEFINITION OF AEFI

• Truly caused by the vaccine
• Caused by the injection procedure
• Coincidental - would have happened regardless of vaccination
• A stress/anxiety response

Clinical Pearl: Most AEFIs are minor, self-limiting, and expected. Serious AEFIs are rare. Never let fear of AEFI prevent a child from being vaccinated - the risk of the disease almost always outweighs the risk of the vaccine.

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CHAPTER 2: WHO CLASSIFICATION OF AEFI (Brighton Collaboration / WHO 2013)

• Product-related
• Quality defect
• Error-related (immunization Error)
• Anxiety-related
• Coincidental

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CHAPTER 3: EPIDEMIOLOGY AND INCIDENCE OF SERIOUS AEFI

• Serious AEFIs are rare. The benefits of immunization vastly outweigh the risks.
• Estimated incidence: 10-20 serious AEFI cases per 100,000 doses administered (WHO)
• Anaphylaxis: 1-2 per million doses (most vaccines)
• Fatal AEFI: Extremely rare - <1 per million doses

• All serious AEFIs are notifiable
• SAFE-VAC system used for electronic reporting
• India gives approximately 9.2 lakh vaccine doses to children from birth to 16 years, plus 10 lakh doses to antenatal mothers annually

Key point for India: India uses DTwP (whole-cell pertussis) in the Pentavalent vaccine, which causes MORE local reactions, fever, and HHE than acellular DTaP used in developed countries. Counsel parents accordingly.

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CHAPTER 4: PATHOPHYSIOLOGY OF VACCINE REACTIONS

• Sensitization phase: prior exposure to antigen (vaccine protein, excipient like gelatin, neomycin, yeast protein in HepB)
• Challenge phase: re-exposure triggers mast cell/basophil degranulation
• Mediators released: histamine, tryptase, leukotrienes, prostaglandins
• Effect: vasodilation + increased vascular permeability + bronchospasm + urticaria
• Onset: within minutes (typically 15-30 minutes)

• Non-IgE mediated
• Direct complement activation by vaccine components (adjuvants, polysorbate 80)
• Clinically indistinguishable from true anaphylaxis
• Treat identically

• Killed/inactivated vaccines (DTP, Pentavalent) trigger innate immune cytokine release
• IL-1, IL-6, TNF-alpha cause: fever, malaise, local inflammation, crying, HHE
• This is EXPECTED and peaks at 12-24 hours after injection

• Febrile seizure: fever-lowering threshold + genetic susceptibility
• HHE: likely vasovagal + autonomic dysfunction. Brief, self-limiting
• Encephalopathy: extremely rare; mechanism unclear, may be coincidental in many cases

• OPV: Poliovirus replicates in gut - VAPP risk with first dose
• MMR measles component: replicates, causing fever + rash at 7-12 days
• BCG: local replication in skin causing papule/ulcer

• Contamination (error) or adjuvant precipitation (aluminum salts)
• Alum adjuvant in DTwP/Pentavalent can precipitate if injected too superficially

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CHAPTER 5: RISK FACTORS FOR AEFI

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CHAPTER 6: COMMON ADVERSE EFFECTS BY VACCINE

India Universal Immunization Programme (UIP) Vaccines

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• Site: Left upper arm, intradermal
• Schedule: At birth

Red Flag: BCG at birth + child later found to have severe combined immunodeficiency (SCID) = disseminated fatal BCG disease. Never give BCG to known immunocompromised.

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• Minor reactions: <1% - diarrhea, headache, muscle pain
• VAPP (Vaccine-Associated Paralytic Poliomyelitis): 1:750,000 first doses
  • Only with live OPV, not IPV
  • Caused by reversion of attenuated strain to neurovirulent form
  • Usually in first dose recipients; rarely in contacts (1:6.7 million doses)
  • Risk higher in immunocompromised

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• Generally very safe
• Local pain/redness: up to 10%
• No VAPP risk (killed vaccine)
• Anaphylaxis: rare (contains neomycin, streptomycin, polymyxin B - screen for antibiotic allergy)

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Note: Contains yeast protein. Contraindicated only if prior anaphylaxis to yeast.

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Pearl: Because India uses DTwP (whole-cell) rather than DTaP (acellular), the rate of HHE and prolonged crying is significantly higher. This should be explained to parents in advance.

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Critical: If a child presents with bilious vomiting + abdominal distension + blood in stools within 7 days of rotavirus vaccine, rule out intussusception (USG abdomen) before attributing to AEFI.

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Pearl: MMR fever and rash at 7-12 days is EXPECTED and non-contagious. Do NOT alarm the parent - counsel them in advance.

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• Arthus reaction: severe local reaction with intense swelling, pain, redness in persons with high tetanus antibody levels from multiple prior boosters
• GBS (Guillain-Barre): 1 case per million doses (tetanus-containing vaccine); risk window 2-28 days
• Brachial neuritis: rare, 2-28 days post tetanus-containing vaccine

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Pearl: HPV vaccine is strongly associated with vasovagal syncope. Have all adolescents sit/lie down for 15 minutes after injection to prevent injury from fainting.

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CHAPTER 7: EXPECTED MINOR REACTIONS vs. WARNING SIGNS

Expected Minor Reactions (Reassure and Send Home)

WARNING SIGNS - Evaluate Urgently

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PART 2: CLINICAL ASSESSMENT

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CHAPTER 8: DIFFERENTIAL DIAGNOSIS

Post-Vaccination Fever

Key point: In a child <3 months with post-vaccination fever, you CANNOT attribute fever to vaccine alone. Full sepsis evaluation (CBC, blood culture, urinalysis, LP if <8 weeks) is standard.

Post-Vaccination Seizure

Post-Vaccination Rash

Post-Vaccination Hypotonia / Collapse

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CHAPTER 9: INITIAL ASSESSMENT - THE ABCDE APPROACH

ABCDE APPROACH TO SERIOUS AEFI

A - AIRWAY
   Is the airway patent?
   Stridor? Drooling? Swelling of lips/tongue/uvula?
   [Angioedema = potential airway emergency]
   → Position, jaw thrust, airway adjunct if needed

B - BREATHING
   Respiratory rate (normal for age?)
   SpO2 (target >95%)
   Wheeze? (bronchospasm)
   Cyanosis?
   Retractions?
   → Oxygen 10-15 L/min via non-rebreather mask

C - CIRCULATION
   Heart rate, blood pressure, capillary refill time
   Pulse quality (bounding vs. weak/thready)
   Skin color, temperature, mottling
   → IV access; if hypotensive: 20 mL/kg NS bolus

D - DISABILITY
   Level of consciousness: AVPU or GCS
   Posture (normal vs. hypertonic/hypotonic)
   Pupils
   Blood glucose (check ALWAYS in any altered consciousness)
   → If unconscious: recovery position; if seizure: benzodiazepine

E - EXPOSURE
   Full skin examination: urticaria, rash, petechiae, swelling
   Temperature
   Injection site: local reaction, abscess
   → Remove clothing, look everywhere

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CHAPTER 10: TRIAGE BY SEVERITY

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PART 3: EMERGENCY MANAGEMENT ALGORITHMS

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CHAPTER 11A: ANAPHYLAXIS

This is the most important emergency in vaccination. Every vaccination provider must be able to recognize and treat anaphylaxis.

Recognition - Brighton Collaboration Criteria

• Sudden urticaria/angioedema + respiratory compromise OR hypotension

• Sudden urticaria/angioedema + stridor OR wheeze OR hypotension (without respiratory symptoms)

• Sudden hypotension alone after vaccine

Anaphylaxis Management Algorithm

ANAPHYLAXIS RECOGNITION
         ↓
1. CALL FOR HELP - activate emergency response
   Position: SUPINE with legs elevated (if not in respiratory distress)
   If respiratory distress or stridor: sitting up
   Pregnant: left lateral decubitus
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2. ADRENALINE (EPINEPHRINE) - GIVE IMMEDIATELY
   IM into LATERAL THIGH (vastus lateralis)
   [NOT subcutaneous, NOT IV initially]
   
   Dose by weight:
   < 10 kg:  0.01 mg/kg of 1:1000 (1 mg/mL) = 0.1 mL/10 kg
   10-25 kg: 0.15 mg (use 0.15 mg auto-injector or draw 0.15 mL of 1:1000)
   25-50 kg: 0.3 mg (draw 0.3 mL of 1:1000)
   > 50 kg / Adult: 0.5 mg (draw 0.5 mL of 1:1000)
   
   Simplified Weight-Based Table:
   Weight    Dose      Volume (1:1000 solution)
   5 kg    = 0.05 mg = 0.05 mL
   10 kg   = 0.10 mg = 0.10 mL
   15 kg   = 0.15 mg = 0.15 mL
   20 kg   = 0.20 mg = 0.20 mL
   25 kg   = 0.25 mg = 0.25 mL
   30 kg   = 0.30 mg = 0.30 mL
   Adult   = 0.50 mg = 0.50 mL
   
   MAXIMUM single dose: 0.5 mg (adult)
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3. OXYGEN
   High-flow oxygen: 10-15 L/min via non-rebreather mask
   Target SpO2 >95%
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4. IV ACCESS
   Two large-bore IV lines
   IO access if IV fails (especially in children)
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5. REPEAT ADRENALINE if no improvement in 5-10 minutes
   Same dose, same route
   Up to 30% of patients require more than one dose
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6. IV FLUIDS if hypotensive
   Normal saline: 10-20 mL/kg bolus over 5-10 minutes
   Repeat as needed
   May require up to 1-2 L in adults
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7. BRONCHOSPASM (persistent wheeze after adrenaline)
   Salbutamol (albuterol) nebulization:
   Child <20 kg: 2.5 mg (0.5 mL of 0.5% solution) in 2.5 mL NS
   Child >20 kg: 5 mg (1 mL of 0.5% solution) in 2.5 mL NS
   Adult: 5-10 mg nebulized
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8. ANTIHISTAMINES (ADJUNCTIVE ONLY - not first-line, do not delay adrenaline)
   Chlorpheniramine (IV):
   Children 1-5y: 2.5 mg slow IV
   Children 6-12y: 5 mg slow IV
   Adult: 10 mg slow IV
   OR Diphenhydramine: 1 mg/kg IV (max 50 mg)
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9. CORTICOSTEROIDS (ADJUNCTIVE - prevent biphasic reaction)
   Hydrocortisone IV:
   Child: 4-8 mg/kg (max 200 mg) IV
   Adult: 200-300 mg IV
   OR Dexamethasone 0.6 mg/kg IV (max 10 mg)
   OR Prednisolone oral 1-2 mg/kg (max 50 mg) if mild and oral route available
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10. REFRACTORY ANAPHYLAXIS (no response to 2+ doses IM adrenaline)
    IV Adrenaline infusion:
    Dilute: 1 mg in 100 mL NS = 10 mcg/mL
    Child: 0.1-1.5 mcg/kg/min IV (titrate)
    Adult: 1-10 mcg/min IV (titrate)
    REQUIRES cardiac monitoring, ICU
    Consider glucagon 1-5 mg IV if on beta-blockers
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11. TRANSFER TO HOSPITAL / ICU
    All anaphylaxis cases require monitoring for biphasic reaction

Observation Period

• Mild-Moderate Anaphylaxis: Observe minimum 4-6 hours after last dose of adrenaline
• Severe Anaphylaxis (required ICU/IV adrenaline): Observe 12-24 hours
• Biphasic reaction occurs in 1-20% of cases, up to 72 hours after initial event

Discharge Criteria

• Hemodynamically stable for >4 hours without further treatment
• SpO2 >95% on room air
• No urticaria, angioedema, or bronchospasm
• No renal, cardiac, or neurological compromise
• Prescribe adrenaline auto-injector (EpiPen) on discharge if available
• Written action plan
• Follow up with allergist/immunologist
• Document the AEFI and notify

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CHAPTER 11B: FEBRILE SEIZURE

Definition

• Seizure with fever >38°C (rectal) in child age 6 months to 6 years
• NOT caused by CNS infection
• Simple febrile seizure: single episode, generalized, <15 minutes, full recovery
• Complex febrile seizure: >15 min, focal features, multiple episodes in 24h, or incomplete recovery

Post-Vaccination Timing

• DTP/Pentavalent: Day 0-2 (febrile, from cytokine release)
• MMR: Day 6-12 (febrile, from viral replication)
• PCV13 + Influenza vaccine together: small increased risk

Management Algorithm

FEBRILE SEIZURE POST-VACCINATION

Is the child convulsing NOW?
YES:
  → Place in recovery position (left lateral)
  → Time the seizure
  → Do NOT restrain; protect from injury
  → Oxygen by mask
  → Check blood glucose
  → DO NOT put anything in mouth
  
  Seizure > 5 minutes = STATUS EPILEPTICUS
  → Benzodiazepine:
     Midazolam buccal: 0.2-0.3 mg/kg (max 10 mg)
     OR Diazepam rectal: 0.5 mg/kg (max 10 mg)
     OR Lorazepam IV/IO: 0.1 mg/kg (max 4 mg)
  
  → If still seizing after 5-10 more minutes:
     Repeat benzodiazepine OR
     Phenobarbitone IV: 20 mg/kg over 20 min
     (Fosphenytoin is alternative; avoid dilantin IV in children if possible)

AFTER SEIZURE STOPS:
  → ABCDE assessment
  → Temperature management: Paracetamol 15 mg/kg oral/rectal
  → Blood glucose
  → Assess for features of meningitis (neck stiffness, Kernig's, bulging fontanelle)
  
  IF SIMPLE FEBRILE SEIZURE (age 6m-6y, generalized, <15 min, fully recovered):
  → Reassure parents
  → No LP required unless <18 months (clinical judgment) or post-MMR (consider meningitis)
  → No long-term anticonvulsants needed
  → Discharge with fever management instructions
  → Report as AEFI
  
  IF COMPLEX / FOCAL / PROLONGED / AGE <6 MONTHS OR >6 YEARS:
  → Hospital admission
  → LP, EEG, neuroimaging
  → Neurology consult
  → IV access, monitoring

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CHAPTER 11C: HYPOTONIC-HYPORESPONSIVE EPISODE (HHE)

Definition (Brighton Collaboration)

• Sudden onset of hypotonia (limpness, floppiness)
• AND hyporesponsiveness (reduced or absent reactivity)
• AND pallor or cyanosis
• Occurring within 48 hours of immunization
• Duration: minutes to hours
• NOT a seizure - no convulsive movements

Pathophysiology

Management Algorithm

HHE RECOGNITION
(Limp + Pale/Cyanotic + Unresponsive within 48h of vaccine)
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IMMEDIATE ASSESSMENT - ABCDE
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A: Is the airway patent? Position (lateral) to prevent aspiration
B: Is the child breathing? Check SpO2 - apply oxygen
C: Pulse present? Check BP
D: AVPU - Alert/Voice/Pain/Unresponsive
   Check blood glucose (ALWAYS - to exclude hypoglycemia)
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MOST CASES: Self-limiting, resolves in minutes-hours
   → Supportive care
   → Oxygen if SpO2 <95%
   → Maintain warmth
   → Monitor vital signs
   → IV access (in case of deterioration)
   
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DOES NOT RESOLVE or CARDIAC/RESPIRATORY COMPROMISE:
   → Hospital admission
   → IV access + monitoring
   → Seek and treat other causes (hypoglycemia, sepsis, meningitis, ALTE)
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OUTCOME: Vast majority recover completely
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FUTURE VACCINATION:
   HHE after DTwP is NOT a contraindication to subsequent doses
   (unlike encephalopathy, which is a contraindication)
   → Consider switching to DTaP if available
   → Observe longer (30-60 min) after future doses
   → Pre-medicate with paracetamol
   → Report as AEFI

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CHAPTER 11D: SYNCOPE (VASOVAGAL)

• Most common in adolescents after HPV, Td, Tdap
• Triggered by anxiety, pain, sight of needle
• Can occur before, during, or immediately after injection

• Lie flat, elevate legs
• Loosen clothing
• Cool environment
• Recovery in seconds-minutes
• Monitor SpO2 and HR
• If not recovering as expected → consider anaphylaxis and treat accordingly

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CHAPTER 11E: BREATH-HOLDING EPISODE

• Young children (6 months to 6 years); triggered by pain of injection
• Child cries, holds breath, turns blue (cyanotic) or pale, then loses consciousness briefly
• Lasts seconds to <1 minute
• Self-resolves when child breathes again

• Remain calm; reassure parents
• Place child in recovery position
• Stimulate child (call name, firm sternal rub)
• NEVER shake the child
• Recovery is spontaneous
• No medications needed
• Distinguish from seizure: no tonic-clonic movements typically; child is not post-ictal
• No AEFI reporting required (anxiety/procedural reaction)

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CHAPTER 11F: PERSISTENT INCONSOLABLE CRYING

• Associated with local pain from injection + cytokine-mediated neurological effect
• More common with DTwP than DTaP
• Self-limiting: settles within 24 hours

1. Assess for other causes: otitis media, intussusception, fracture (NAI), UTI
2. Paracetamol 15 mg/kg/dose every 4-6h (oral or rectal)
3. Ibuprofen 10 mg/kg/dose in children >3 months
4. Topical anesthetics at injection site (EMLA)
5. Skin-to-skin comfort, breastfeeding
6. Rule out HHE if child becomes limp
7. Report as AEFI if lasts >3 hours

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CHAPTER 11G: INJECTION SITE ABSCESS

• Signs: fluctuant, tender, warm, red; may have draining sinus; fever
• Cause: Staphylococcus aureus (most common), usually from contaminated needle/vial or poor skin preparation
• Treatment:
  • Incision and drainage (I&D) - primary treatment
  • Oral antibiotics: cloxacillin/flucloxacillin 25 mg/kg/dose QID x 7 days
  • IV antibiotics (cefazolin/clindamycin) if systemic sepsis
  • Culture drainage material
  • Report as AEFI (program error investigation)

• Signs: soft fluctuant swelling, NO fever, NOT warm, NOT red
• Cause: Aluminum adjuvant precipitation from improper injection technique (too superficial) or incorrect needle length
• Treatment:
  • Aspiration if large and painful
  • Usually resolves spontaneously
  • No antibiotics needed
  • Report as AEFI + investigate cold chain and injection technique

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CHAPTER 11H: CELLULITIS

• Red, warm, tender, spreading erythema at injection site
• Not fluctuant (vs. abscess)
• May have systemic features (fever, elevated WBC)
• Most common organisms: Staph aureus, Group A Strep

• Mark the border of erythema with a pen to track spread
• Mild: oral cloxacillin/amoxicillin-clavulanate 7-10 days
• Severe/spreading/systemic: IV antibiotics (cefazolin 25 mg/kg/dose TID, or clindamycin if MRSA suspected)
• Elevate limb
• Analgesia
• Report as AEFI

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CHAPTER 11I: TOXIC SHOCK SYNDROME (TSS) AFTER VACCINATION

• High fever (>38.9°C)
• Vomiting and profuse watery diarrhea
• Sunburn-like diffuse rash
• Rapid cardiovascular collapse
• Often fatal within 24-48 hours if untreated

Immediate hospital transfer
Resuscitation:
  → IV NS 20 mL/kg bolus; repeat PRN
  → O2 high flow
  → Blood cultures BEFORE antibiotics
  → IV antibiotics:
     Cloxacillin 50 mg/kg/dose IV 6-hourly + Gentamicin 7.5 mg/kg/day
     OR Vancomycin 15 mg/kg/dose IV 6-hourly (if MRSA suspected)
  → IVIG 1g/kg/day x 2 days (for streptococcal TSS)
  → ICU management: vasopressors if refractory shock
  → Corticosteroids: controversial but used in severe cases
Public health action:
  → Immediate reporting
  → Quarantine the entire vaccine batch
  → Investigate cold chain and preparation procedures

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CHAPTER 11J: HIGH FEVER POST-VACCINATION

• Fever >38.5°C: Very common with Pentavalent, PCV, DTP
• Fever >40.5°C: Uncommon but occurs; requires evaluation

• Paracetamol 15 mg/kg/dose every 4-6h (maximum 60 mg/kg/day)
• Ibuprofen 10 mg/kg/dose every 6-8h (children >3 months, NOT in dengue fever)
• Physical cooling: undress, tepid sponging
• Ensure hydration (oral fluids, breastfeeding)
• Assess for serious bacterial infection especially in infants <3 months
• Febrile seizure precautions counseling

Avoid aspirin in children - risk of Reye's syndrome. No role of prophylactic antihistamines or steroids.

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CHAPTER 11K: ENCEPHALOPATHY / ENCEPHALITIS

• Coma, seizures, or severe alteration of consciousness lasting >24 hours
• Without other identifiable cause

The causal link between DTP and encephalopathy is unproven in modern literature. Most cases are likely coincidental or represent an underlying undiagnosed epileptic encephalopathy (e.g., Dravet syndrome) that was unmasked by fever.

• CT/MRI brain
• LP: CSF analysis (cell count, protein, glucose, PCR for HSV/enteroviruses/JEV)
• EEG
• Metabolic workup (electrolytes, glucose, ammonia, organic acids)
• Genetics workup (SCN1A gene for Dravet syndrome in DTP-associated cases)

• Acute seizure management (as above)
• Treat for viral encephalitis empirically if cannot be excluded: Acyclovir IV 10-15 mg/kg/dose 8-hourly for 14-21 days
• Dexamethasone 0.15 mg/kg/dose 6-hourly x 4 days if bacterial meningitis not excluded
• ICU monitoring
• Neurology consult

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CHAPTER 11L: GUILLAIN-BARRE SYNDROME (GBS)

• Rare: 1-2:1,000,000 doses of tetanus-containing vaccine
• Also linked to influenza vaccine (historical)
• Temporal window: 2-6 weeks post-vaccination

• Ascending flaccid paralysis
• Areflexia
• Sensory symptoms (tingling, pain)
• Autonomic dysfunction (BP instability, bradycardia)
• Respiratory failure in 25-30% (most dangerous complication)

• Admit to hospital immediately
• Monitor respiratory function (FVC, NIF) every 4-6 hours
• Intubation if FVC <20 mL/kg or NIF > -25 cm H2O or rapid deterioration
• IVIG 2g/kg IV over 2-5 days (first-line treatment)
• OR Plasmapheresis (plasma exchange)
• NOT corticosteroids alone (ineffective or harmful in GBS)
• DVT prophylaxis, pain management, physiotherapy
• Neurology consult

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CHAPTER 11M: THROMBOCYTOPENIA (ITP) AFTER MMR

• Immune thrombocytopenic purpura (ITP)
• Occurs 15-35 days after MMR
• Incidence: 1:30,000-40,000 MMR doses
• Usually mild and self-limiting (immune-mediated platelet destruction)

• Bruising, petechiae
• Mucosal bleeding (nosebleeds, oral petechiae)
• Platelet count <50,000/mL

• CBC + platelet count
• Peripheral blood smear (to exclude TTP, hemolytic-uremic syndrome)
• PDNS/IVIG if platelet count <20,000 or bleeding:
  • IVIG 1g/kg/day x 2 days
  • OR Prednisolone 2 mg/kg/day x 14 days then taper
• Platelet transfusion only for life-threatening bleeding (intracranial hemorrhage)
• Most recover spontaneously in 6-8 weeks

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CHAPTER 11N: MYOCARDITIS (mRNA COVID-19 Vaccines)

• Primarily with mRNA COVID vaccines (Pfizer/Moderna), NOT routinely seen with UIP vaccines
• Males, adolescents 12-17 years, after second dose, within 3-7 days
• Usually mild, self-limiting

• Chest pain (sharp, pleuritic)
• Shortness of breath
• Palpitations
• Fever
• Elevated troponin, ECG changes (ST elevation, T-wave changes)

• 12-lead ECG
• Troponin I/T, CK-MB
• Echocardiogram
• Cardiology consult
• NSAIDs + colchicine for mild cases
• ICU for severe (LV dysfunction, arrhythmia)
• Restrict activity for 3-6 months

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PART 4: DRUG MANAGEMENT

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CHAPTER 12: CRITICAL DRUGS WITH PEDIATRIC AND ADULT DOSES

ADRENALINE (EPINEPHRINE) - THE MOST IMPORTANT DRUG

COMPLETE EMERGENCY DRUG CHART

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PART 5: EQUIPMENT, OBSERVATION, AND REPORTING

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CHAPTER 14: AEFI EMERGENCY KIT

Medications (Minimum)

Equipment (Minimum)

Advanced Centers (AEFI Management Centers)

• Endotracheal tubes (3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 uncuffed/cuffed)
• Laryngoscope with pediatric and adult blades
• Intraosseous (IO) needles
• Defibrillator/AED
• Cardiac monitor + SpO2
• Mechanical ventilator

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CHAPTER 15: OBSERVATION AND DISCHARGE

Standard Post-Vaccination Observation

Discharge Instructions for Parents (Minor Reactions)

1. Mild fever: Paracetamol 15 mg/kg/dose every 6 hours as needed
2. Injection site: Cold compress, do not rub
3. Fussiness: Comfort feeding, skin-to-skin
4. BCG: Do not cover the site; it will ulcerate and heal naturally over 3 months
5. MMR: Expect mild rash and fever at 7-12 days - normal reaction
6. Return immediately if: High fever >40°C, seizure, persistent crying >3 hours, difficulty breathing, swelling of face/lips, child becomes limp or unresponsive

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CHAPTER 16: FUTURE VACCINATION AFTER AEFI

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CHAPTER 17: AEFI REPORTING - INDIA UIP

Who Reports?

• Any healthcare worker who vaccinates or manages a post-vaccination reaction
• Community health workers (ASHA, ANM) for events in the field

What to Report?

• Death following immunization
• Hospitalization following immunization
• Life-threatening illness (anaphylaxis, encephalopathy, TSS, VAPP)
• Cluster of 2+ cases at same session or from same vaccine lot
• Persistent/significant disability following immunization

How to Report (India UIP)?

1. Immediate notification: Call Medical Officer / District Immunization Officer (DIO)
2. AEFI Form 1: Filled by vaccinator within 24h (for serious AEFI); submitted to PHC/CHC MO
3. AEFI Form 2: Detailed investigation form - MO submits to DIO within 7 days
4. SAFE-VAC platform: Electronic reporting system
5. Investigation: District AEFI Committee reviews all serious AEFIs
6. Causality assessment: Using WHO causality assessment tool

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CHAPTER 18: PARENT COUNSELING

After Minor Reactions

• Use simple, reassuring language: "This is a normal response showing your child's immune system is working"
• Explain expected timeline and resolution
• Provide written instructions for home management
• Give specific warning signs to watch for
• Confirm next vaccine appointment date

After Major Reactions

• Honest, empathetic explanation of what happened
• Avoid blame language
• Explain what treatment was given and why
• Explain what will be done next (reporting, investigation, future vaccination plan)
• If future doses are safe: reassure and commit to a plan
• If future doses are contraindicated: explain clearly which vaccines are affected, which are safe alternatives
• Provide written summary of the event and the management plan
• Offer follow-up appointment

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CHAPTER 19: PREVENTION OF IMMUNIZATION ERRORS

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CHAPTER 20: COLD CHAIN AND STORAGE

• Use the Shake Test to detect freeze damage

• Color indicator on vial changes from light to dark when cumulative heat damage occurs
• If inner square is darker than outer circle = DO NOT USE

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PART 6: EXAM PREP

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CHAPTER 22 & 24: HIGH-YIELD POINTS AND VIVA

KEY FACTS FOR NEET-PG / INI-CET / AIIMS / UPSC CMS

1. Adrenaline dose for anaphylaxis = 0.01 mg/kg IM (1:1000 solution), max 0.5 mg, in lateral thigh
2. HHE = NOT a contraindication to future DTP doses
3. Encephalopathy within 7 days of DTP = CONTRAINDICATION to pertussis component
4. VAPP occurs with OPV, NOT IPV; risk 1:750,000 first doses
5. ITP after MMR occurs at 15-35 days post-vaccination; treated with IVIG or steroids
6. GBS associated with tetanus-containing vaccine; risk window 6 weeks
7. TSS after vaccination = program error; quarantine entire batch
8. Biphasic anaphylaxis occurs in 1-20%; observe minimum 4-6 hours
9. Syncope after HPV = vasovagal; bradycardia, pale, cold; corrects in supine position
10. BCG lymphadenitis = spontaneous resolution; DO NOT give systemic anti-TB drugs
11. MMR rash at 7-12 days is NON-CONTAGIOUS and expected
12. Do NOT give antipyretics prophylactically before vaccination (may reduce immune response)
13. Minimum observation after all vaccines = 15-30 minutes
14. SAFE-VAC = India's electronic AEFI reporting platform
15. Rotavirus vaccine + intussusception: suspect if bilious vomiting + blood in stool within 7 days

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CHAPTER 23: CLINICAL CASE SCENARIOS

Case 1 (Simple)

• Diagnosis: Expected vaccine reaction (product-related)
• Management: Paracetamol 15 mg/kg; reassure mother; advise to return if fever >40°C or child becomes limp

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Case 2 (Moderate)

• Diagnosis: Mild-moderate anaphylaxis
• Management:
  1. Call for help; lay supine with legs elevated
  2. Weight ~10 kg: Adrenaline 0.1 mg IM lateral thigh (0.1 mL of 1:1000)
  3. O2 via mask
  4. IV access; monitor vitals
  5. If improved: antihistamine + hydrocortisone
  6. Observe 6 hours; discharge with AEFI report

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Case 3 (Critical)

• Diagnosis: Hypotonic-Hyporesponsive Episode (HHE)
• Management:
  1. Position lateral; open airway
  2. ABCDE; check blood glucose (must exclude hypoglycemia)
  3. O2 by mask; monitor SpO2 and HR
  4. IV access; observe
  5. Resolves spontaneously in 30-60 minutes in most cases
  6. Document and report as serious AEFI
  7. NOT a contraindication to future Pentavalent doses; consider DTaP if available

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Case 4 (Critical)

• Diagnosis: Vasovagal syncope (NOT anaphylaxis - bradycardia, pale, no urticaria, corrects in supine)
• Management: Supine position, elevate legs, loosen clothing; recovers in 2-3 minutes
• If uncertain: treat as anaphylaxis (will not harm)

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Case 5 (Emergency)

• Diagnosis: Toxic Shock Syndrome (TSS) - immunization error, cluster
• Management:
  1. EMERGENCY: IV access, O2, immediate resuscitation
  2. IV NS 20 mL/kg bolus
  3. Blood culture, then IV antibiotics: Cloxacillin + Gentamicin
  4. IMMEDIATE public health notification - quarantine entire vaccine batch
  5. Investigate vaccine preparation and storage
  6. Report as cluster AEFI within hours

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OSCE Station Example

1. Remain calm; rush to patient
2. Quick assessment: Is she breathing? Pulse present? SpO2?
3. Distinguish syncope vs. anaphylaxis: Look for urticaria, wheeze, stridor (anaphylaxis) vs. bradycardia, cold, pale, no urticaria (syncope)
4. If syncope: Lay flat, elevate legs, O2, monitor; should recover in <2 minutes
5. If anaphylaxis (or uncertain): Adrenaline 0.3 mg IM lateral thigh (25-50 kg child) + O2 + IV access + call for help
6. Assess ABCDE, check blood glucose
7. Document events with exact timings
8. Complete AEFI reporting form
9. Counsel parents, document plan for future HPV doses

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PART 7: ONE-PAGE RAPID REVISION SHEET

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MEMORY MNEMONICS

• HHE: Pallor, Atony (limpness), Lethargic, Episode resolves
• Anaphylaxis: Hives, IV-line urgently, Vascular collapse, Epinephrine needed, Stridor/wheeze

• Encephalopathy within 7d of DTP → no pertussis
• Anaphylaxis to vaccine → no repeat
• Severe combined immunodeficiency → no live vaccines
• (other indications case-by-case)

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FLOWCHART: APPROACH TO A CHILD WITH POST-VACCINATION COLLAPSE

Child collapses after vaccination
              ↓
        ABCDE Assessment
              ↓
   Is there urticaria / angioedema
   / wheeze / stridor?
         /         \
       YES           NO
        ↓             ↓
  ANAPHYLAXIS      Bradycardia + cold + pale?
  → Adrenaline         /          \
    IM immediately    YES          NO
                       ↓            ↓
                   SYNCOPE      Limp + pale +
                  → Supine,      unresponsive?
                   elevate legs     ↓
                                   YES
                                    ↓
                                   HHE
                               → Supportive
                                  O2, BG check

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ANAPHYLAXIS ADRENALINE DOSE QUICK REFERENCE CARD

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KEY TAKE-HOME POINTS

1. Adrenaline IM is the only first-line treatment for anaphylaxis. Do not delay for antihistamines or steroids. Adrenaline saves lives; antihistamines do not.
2. HHE is terrifying but almost always self-limiting. Maintain airway, give O2, check blood glucose, observe. Do NOT withhold future DTP doses.
3. In infants <3 months with post-vaccination fever, evaluate for sepsis. Never attribute fever solely to the vaccine without ruling out infection.
4. MMR fever and rash at day 7-12 is expected. Counsel parents in advance to prevent panic.
5. Syncope and anaphylaxis look different. Key differentiator: bradycardia + corrects in supine = syncope. Tachycardia + urticaria + does NOT correct in supine = anaphylaxis.
6. Toxic shock after vaccination is a program emergency. Quarantine the batch, treat the patient aggressively, notify public health immediately.
7. Encephalopathy within 7 days of DTP = contraindication to pertussis component (give DT instead).
8. Every vaccination site must have an AEFI kit with adrenaline, O2, BVM, and IV supplies.
9. Observe all vaccinees for at least 15-30 minutes. Anaphylaxis typically occurs within this window.
10. AEFI reporting is not about blame - it is about vaccine safety surveillance. Under-reporting harms public health.

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MCQ BANK (10 Questions with Explanations)

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PREPARATION OF IM ADRENALINE FOR ANAPHYLAXIS

Step-by-Step Clinical Guide

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WHAT YOU NEED TO KNOW FIRST

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STEP-BY-STEP PREPARATION

STEP 1 - CONFIRM THE VIAL

LOOK AT THE LABEL:
✓ Name: Adrenaline (Epinephrine) Injection
✓ Concentration: 1:1000 or 1 mg/mL
✓ Expiry date: not expired
✓ Appearance: clear, colorless solution (DISCARD if brown/discolored/cloudy)
✓ Confirm with a colleague (double-check rule)

⚠ WARNING: 1:10,000 (0.1 mg/mL) is for IV use in cardiac arrest only.
   It looks similar but is 10x more dilute.
   In anaphylaxis, ALWAYS use 1:1000 IM.

STEP 2 - CALCULATE THE DOSE

• Volume to draw = 0.01 mL/kg (i.e., weight in kg ÷ 100)

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WEIGHT-BASED QUICK REFERENCE TABLE

Maximum single dose = 0.5 mg regardless of weight

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STEP-BY-STEP DRAWING UP PROCEDURE

STEP 3 - GATHER EQUIPMENT
   ☐ Adrenaline 1:1000 ampoule or vial
   ☐ 1 mL syringe (for children) or 2 mL syringe (for adults)
   ☐ Drawing-up needle (18G or 21G blunt fill needle if available)
   ☐ Injection needle: 23G x 25 mm (blue) for children
                       21G x 38 mm (green) for adults/obese
   ☐ Alcohol swab
   ☐ Sterile gloves (don gloves)

STEP 4 - OPEN THE AMPOULE / VIAL
   If glass ampoule:
   → Snap the neck away from you (use gauze to protect fingers)
   
   If rubber-capped vial:
   → Wipe the rubber top with alcohol swab; allow to dry

STEP 5 - DRAW UP THE MEDICATION
   → Attach drawing-up needle to syringe
   → If vial: inject air equal to the volume you will withdraw
              (prevents negative pressure)
   → Insert needle into vial/ampoule
   → Pull back plunger to the EXACT required volume
   → Keep needle tip submerged to avoid drawing air

STEP 6 - REMOVE AIR BUBBLES
   → Hold syringe vertically, needle pointing UP
   → Gently tap syringe to bring bubbles to top
   → Slowly depress plunger until a DROP of solution appears at needle tip
   → Confirm correct volume remains in syringe

STEP 7 - CHANGE TO INJECTION NEEDLE
   → Remove drawing-up needle
   → Attach injection needle (23G x 25 mm or 21G x 38 mm)
   → Confirm correct volume again (do not change the volume)
   → Cap the needle until ready to inject

STEP 8 - FINAL CHECK (5 RIGHTS + 1)
   ✓ Right Patient
   ✓ Right Drug (Adrenaline 1:1000)
   ✓ Right Dose (weight-based volume in syringe)
   ✓ Right Route (IM)
   ✓ Right Time (NOW - do not delay)
   ✓ Right Documentation (record time given)

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STEP 9 - ADMINISTRATION TECHNIQUE

INJECTION SITE: ANTEROLATERAL THIGH (VASTUS LATERALIS)
- Best site for ALL ages including neonates
- Fastest absorption; far from major vessels and nerves
- Can inject THROUGH clothing in an emergency

HOW TO LANDMARK THE SITE:
   → Expose or locate the outer mid-thigh
   → Midpoint between hip (greater trochanter) and knee (lateral condyle)
   → Outer, lateral surface - NOT front, NOT back of thigh
   
   Visual: Divide thigh into thirds from groin to knee.
           Inject into the MIDDLE THIRD, on the OUTER side.

       [Hip]
         |
         |  ← Upper third: avoid
         |
    →→→ [MIDDLE THIRD] ← INJECT HERE (outer/lateral aspect)
         |
         |  ← Lower third: avoid
         |
       [Knee]

INJECTION STEPS:
   1. Position patient: supine (lying down)
      - Do NOT sit the patient upright (increases fatality risk)
   2. Expose the site (cut or pull up trouser leg)
   3. Clean with alcohol swab; allow 30 seconds to dry
   4. OPTIONAL: Squeeze/bunch the muscle to increase depth
      (especially in thin patients or small children)
   5. Insert needle at 90° angle (straight in, perpendicular)
      - Smooth, confident, single motion
      - Go all the way to the hub in most patients
   6. Aspirate slightly (pull back plunger) - if blood returns,
      withdraw and choose new site
   7. Inject the full volume smoothly over 10 seconds
   8. Withdraw needle in one smooth motion
   9. Apply gentle pressure with swab; DO NOT rub
      (rubbing disperses adjuvant and increases pain)
   10. Dispose of needle immediately in sharps container
       (do NOT re-cap with two hands)

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STEP 10 - AFTER INJECTION

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SPECIAL SITUATIONS

If Patient is On Beta-Blockers (e.g., propranolol, atenolol)

• Adrenaline may be LESS effective (beta-blockade blunts response)
• Give Glucagon 1-5 mg IV over 5 minutes (bypasses beta-receptors)
• May need IV adrenaline infusion
• Higher volumes of IV fluids required

If No Weight Known (Emergency Estimate)

• Child aged 1-10 years: Weight (kg) ≈ (Age + 4) × 2
• Infant <1 year: approximately 0.5 kg per month up to 10 kg

ANM/Vaccinator at a Rural Session Site (India UIP)

• Give one age-appropriate dose IM as described
• Then immediately transfer to nearest health facility
• Do NOT wait to see if it works before transferring

Auto-Injectors (EpiPen / Emerade) - if available

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COMMON MISTAKES TO AVOID

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QUICK MEMORY AID

"ONE ZERO LATERAL THIGH"

0.01 mg/kg  →  ONE + ZERO (01)
Use 1:1000  →  ONE mg per mL
Outer thigh →  LATERAL THIGH

Volume = Weight (kg) ÷ 100 = mL to draw from 1:1000 vial

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Sources: Resuscitation Council UK Anaphylaxis Guidelines 2021 | Royal Children's Hospital Melbourne IM Injection Guidelines | MoHFW India ANM Adrenaline Guidelines 2018 | Rosen's Emergency Medicine 9e (Chapter 106)