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ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI)

A Comprehensive Training Manual for Pediatric Residents, Emergency Medicine Residents, ICU Nurses & Vaccination Officers

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CHAPTER 1: DEFINITION OF AEFI

"Any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavorable or unintended sign, abnormal laboratory finding, symptom or disease."

• "Following" does NOT mean "caused by"
• Temporal association is necessary but not sufficient for causality
• Every AEFI must be investigated to determine the true relationship
• Both UIP (Government) and non-UIP (private sector) vaccine reactions must be reported

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CHAPTER 2: CLASSIFICATION OF AEFI

WHO 2013 Classification (Used in India's 2024 Guidelines)

Classification by Severity

Classification by Causality (Brighton Collaboration)

1. Consistent causal association - evidence clearly supports
2. Indeterminate - evidence is insufficient or conflicting
3. Inconsistent causal association (coincidental) - evidence supports unrelated event
4. Unclassifiable - insufficient information

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CHAPTER 3: EPIDEMIOLOGY AND INCIDENCE OF SERIOUS AEFI

Global Rates (Park's PSM / WHO data)

• India's National AEFI Surveillance system (under MoHFW) tracks events through a network from PHC to National level
• Serious AEFIs must be reported within 24-48 hours to the DIO (District Immunization Officer)
• AEFI rates in India through HMIS reporting are generally lower than expected (under-reporting is a known issue)

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CHAPTER 4: PATHOPHYSIOLOGY OF VACCINE REACTIONS

Mechanism by Type

VACCINE ADMINISTERED
        |
  ┌─────┴─────┐
  |           |
LOCAL      SYSTEMIC
REACTION    REACTION
  |           |
Pain/swelling  ┌───────────────┬──────────────┐
redness        |               |              |
               Immune-mediated  Direct        Anxiety
               (IgE, T-cell)   toxicity      mediated
               |               |
         Anaphylaxis     Fever via
         (Type I HSR)    IL-1, IL-6
         Serum sickness  (cytokines)
         (Type III)      Endotoxin
                         (whole-cell pertussis)

Pathophysiology by Reaction Type

• Adjuvants (aluminum salts in DTP, HepB, PCV) cause local inflammatory response
• Mast cell activation, release of histamine, prostaglandins
• Typically appears within hours, resolves in 1-3 days
• DTwP causes more local reactions than DTaP

• Vaccine antigens or adjuvants stimulate macrophages and dendritic cells
• Release of IL-1, IL-6, TNF-alpha
• These act on hypothalamus via prostaglandin E2 pathway
• Fever after inactivated vaccines: within 24 hours, brief
• Fever after live vaccines (MMR): 6-12 days post-vaccination (viral replication phase)

• Prior sensitization to vaccine component (gelatin, egg protein, latex, neomycin, yeast protein)
• IgE-mediated mast cell and basophil degranulation
• Release of histamine, tryptase, leukotrienes, prostaglandins
• Results in: vasodilation, capillary leak, bronchospasm, urticaria, angioedema
• Can be FATAL within minutes if untreated

• Pathophysiology not fully understood
• Hypotheses: vagal response, endotoxin-mediated, cerebral hypoperfusion
• Occurs within 48 hours of DTwP
• Self-limiting, not a contraindication to future vaccines (controversial)

• Post-measles vaccine: demyelination, immune-mediated (very rare)
• ADEM (Acute Disseminated Encephalomyelitis) - rare, immune-mediated
• Must differentiate from coincidental viral encephalitis

• OPV contains attenuated poliovirus
• In immunocompromised recipients or contacts: virus reverts to neurovirulence
• Anterior horn cell destruction causes flaccid paralysis
• Rate: 2-4 cases per million first doses; 0.2 per million subsequent doses

• Immune-mediated platelet destruction
• Molecular mimicry between measles/rubella antigens and platelet glycoproteins
• Usually transient (6-8 weeks), rarely severe

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CHAPTER 5: RISK FACTORS FOR AEFI

• Previous anaphylaxis to any vaccine component
• Severe egg allergy (for influenza, yellow fever vaccines)
• Immunocompromised (avoid live vaccines)
• Active moderate-to-severe illness (defer vaccination)
• Bleeding disorders (use fine needle, apply pressure)

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CHAPTER 6: COMMON ADVERSE EFFECTS BY VACCINE

Routine Childhood Vaccines - Complete Reference Table

• BCG ulcer is EXPECTED and NORMAL. Do NOT apply antibiotics or cover. Parents must be counselled.
• MMR fever and rash at days 6-12 is expected (viral replication phase). It is NOT contagious.
• DTwP local reactions are more common than DTaP. Do not switch brands mid-series without reason.
• Hepatitis B birth dose must be given within 24 hours for MTCT (mother-to-child transmission) prevention.

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CHAPTER 7: EXPECTED MINOR REACTIONS vs. WARNING SIGNS

Traffic Light System

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CHAPTER 8: DIFFERENTIAL DIAGNOSIS

Fever After Vaccination

Post-Vaccination Rash

Post-Vaccination Seizures

Excessive Crying After Vaccination

Hypotension/Shock After Vaccination

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CHAPTER 9: INITIAL ASSESSMENT - THE ABCDE APPROACH

A - AIRWAY
    Is the airway PATENT?
    Listen: stridor, hoarseness = upper airway swelling (ANAPHYLAXIS)
    Look: tongue swelling, drooling, uvula edema
    Action: Position (sniffing position), jaw thrust if unconscious

B - BREATHING
    Rate (normal: <1 yr = 30-60, 1-5 yr = 20-40, 5-12 yr = 15-30, adult = 12-20)
    Effort: intercostal recession, use of accessory muscles
    Sounds: wheeze (lower airway), stridor (upper airway)
    SpO2 on pulse oximetry - target >95%
    Action: O2 via face mask; nebulized salbutamol if wheeze

C - CIRCULATION
    HR, BP, capillary refill time (CRT) - normal <2 seconds
    Pulse volume (bounding = anaphylaxis; thready = shock)
    Skin: urticaria/flushing (anaphylaxis) vs. pallor (HHE/shock) vs. cyanosis
    Action: IV/IO access; fluid bolus if shocked

D - DISABILITY (Neurological)
    Level of consciousness: AVPU scale (Alert / Voice / Pain / Unresponsive)
    Pupils: equal, reactive
    Posture: normal vs. floppy (HHE) vs. rigid/convulsing (seizure)
    Blood glucose (ALWAYS check in altered consciousness)

E - EXPOSURE
    Full skin exam: rash, urticaria, swelling, injection site
    Temperature
    Look for: angioedema (face, lips), petechiae/purpura
    Weigh the child (for drug dosing)

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CHAPTER 10: TRIAGE ACCORDING TO SEVERITY

Three-Level AEFI Triage

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CHAPTER 11: EMERGENCY MANAGEMENT ALGORITHMS

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11A. ANAPHYLAXIS - COMPLETE MANAGEMENT PROTOCOL

Recognition Criteria (Brighton Collaboration / WAO)

• Respiratory compromise (dyspnea, wheeze, stridor, hypoxia)
• Reduced BP or symptoms of end-organ dysfunction (collapse, syncope, incontinence)

• Skin/mucosal symptoms
• Respiratory compromise
• Reduced BP or collapse
• Gastrointestinal symptoms (vomiting, abdominal cramps)

Fainting vs. Anaphylaxis (Exam Favourite)

ANAPHYLAXIS MANAGEMENT ALGORITHM

STEP 1: RECOGNIZE - Any of the criteria above? → YES → ACT IMMEDIATELY
             ↓
STEP 2: CALL FOR HELP - Alert the team; do not leave the patient alone
             ↓
STEP 3: POSITION
    - Conscious, no respiratory distress: LAY FLAT, raise legs 30°
    - Unconscious but breathing: Recovery position (left lateral)
    - Respiratory distress: Semi-recumbent (sitting up)
    - Pregnant: Left lateral tilt
    - NEVER allow to stand/sit up suddenly (can cause cardiac arrest)
             ↓
STEP 4: ADRENALINE (EPINEPHRINE) IM - FIRST AND MOST IMPORTANT DRUG
    Use 1:1000 solution (1 mg/mL)
    Dose: 0.01 mL/kg IM (max 0.5 mL in adults)
    Site: Anterolateral OUTER THIGH (preferred) - better absorption than deltoid
    ─────────────────────────────────────────────────────
    DOSE CHART (1:1000 Adrenaline) - Memorize this!
    ─────────────────────────────────────────────────────
    Age           Weight      Volume (1:1000)
    < 1 year      < 7.5 kg    0.1 mL
    1-2 years     ~10 kg      0.1 mL
    2-3 years     ~15 kg      0.15 mL
    4-5 years     ~20 kg      0.2 mL
    5-10 years    ~30 kg      0.3 mL
    10-12 years   ~40 kg      0.4 mL
    > 12 years    > 50 kg     0.5 mL
    Adult                     0.5 mL (0.3-0.5 mL)
    ─────────────────────────────────────────────────────
    ROUTE: INTRAMUSCULAR (IM) into anterolateral thigh - NEVER IV as first dose
    REPEAT: Every 5-10 minutes if no improvement; up to 2 more doses (total 3 doses)
             ↓
STEP 5: OXYGEN
    - High-flow O2 via face mask (15 L/min) - target SpO2 > 94%
    - If respiratory failure: bag-mask ventilation, prepare for intubation
             ↓
STEP 6: IV ACCESS
    - Insert 2 large-bore IV cannulas
    - Take blood for serum tryptase (within 1-2 hours of onset - RESEARCH USE)
    - Blood glucose
             ↓
STEP 7: IV FLUIDS (if cardiovascular compromise/hypotension)
    - Normal saline (0.9% NaCl) or Ringer's Lactate
    - Pediatric: 10-20 mL/kg IV bolus over 5-10 minutes
    - Adult: 500-1000 mL rapid infusion
    - Repeat as needed; reassess after each bolus
             ↓
STEP 8: NEBULIZED BRONCHODILATOR (if wheeze persists)
    - Salbutamol 2.5 mg (children <5 yr) or 5 mg (>5 yr) nebulized
    - Repeat every 20 minutes if needed
    - NOTE: This is ADJUNCTIVE - adrenaline remains the primary drug
             ↓
STEP 9: ANTIHISTAMINES (ADJUNCTIVE - NOT for shock/respiratory distress)
    - H1 blocker: Chlorpheniramine maleate (CPM)
      - Pediatric: 0.2 mg/kg IM or slow IV (max 10 mg/dose)
      - Adult: 10 mg IM or slow IV
    - H2 blocker (optional): Ranitidine 1 mg/kg IV
    - NOT a substitute for adrenaline; given after patient is stable
             ↓
STEP 10: CORTICOSTEROIDS (ADJUNCTIVE - prevent biphasic reaction)
    - Hydrocortisone: Child 4 mg/kg IV; Adult 200 mg IV
    - OR Methylprednisolone: Child 1-2 mg/kg IV; Adult 125 mg IV
    - Onset: 4-6 hours (NOT for acute management)
    - Purpose: Prevent biphasic anaphylaxis (occurs 1-72h later in 1-20% cases)
             ↓
STEP 11: REFRACTORY ANAPHYLAXIS (no improvement after 2-3 doses of IM adrenaline)
    - IV adrenaline infusion: 0.1-1 mcg/kg/min (ICU setting)
    - Glucagon: 1-5 mg IV (especially in beta-blocker users)
    - Vasopressors (dopamine, noradrenaline) for refractory hypotension
             ↓
STEP 12: MONITOR
    - Continuous cardiac monitoring, pulse oximetry
    - BP every 5 minutes
    - Watch for BIPHASIC reaction (6-72 hours after initial event)
    - Watch for adrenaline overdose: agitation, hypertension, severe tachycardia, irregular heartbeat
             ↓
STEP 13: OBSERVATION PERIOD
    - Minimum 4-6 hours after anaphylaxis
    - 24 hours if severe or biphasic risk
    - Patient must be observed before discharge
             ↓
STEP 14: DISCHARGE CRITERIA
    - Hemodynamically stable >4 hours
    - No respiratory distress
    - No urticaria/angioedema
    - Counseled about biphasic reaction
    - Prescribed take-home antihistamines
    - Written action plan given
    - Referral to allergist/immunologist arranged

• Giving antihistamine INSTEAD of adrenaline
• Using subcutaneous adrenaline (poor absorption in shock)
• Using IV adrenaline as first dose (high risk of cardiac arrhythmia)
• Allowing patient to sit up/stand (can cause cardiac arrest)
• Failing to repeat adrenaline if no improvement in 5-10 minutes
• Discharging without adequate observation period

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11B. FEBRILE SEIZURE - MANAGEMENT

Types

Algorithm

FEBRILE SEIZURE AFTER VACCINATION
         ↓
Protect airway → Position: left lateral (recovery position)
         ↓
DO NOT restrain limbs forcefully; remove harmful objects
         ↓
High-flow O2 via face mask
         ↓
Check blood glucose (Dextrostix) - treat hypoglycemia if present
         ↓
If seizure continues >5 minutes:
  → Diazepam:
     - Rectal: 0.5 mg/kg (max 10 mg)
     - IV: 0.3 mg/kg (max 10 mg) slowly over 2-3 minutes
     - Buccal midazolam: 0.2-0.3 mg/kg (max 10 mg)
         ↓
If seizure continues after 2 doses of benzodiazepine:
  → Phenobarbital IV: 20 mg/kg loading dose (max 1 g) at 1 mg/kg/min
  → Or Phenytoin/Fosphenytoin IV: 20 mg/kg
         ↓
Treat the FEVER:
  → Paracetamol: 15 mg/kg oral or PR (max 1 g/dose)
  → Tepid sponging (NOT cold water or ice)
  → Remove excess clothing
         ↓
After seizure stops:
  → Full neurological assessment
  → Look for focus of fever (otitis media, URTI, UTI)
  → For SIMPLE febrile seizure: observe 2-4 hours; discharge if well
  → For COMPLEX: admit, LP if indicated, EEG if focal

• 30-40% risk of recurrence with future febrile illnesses
• Does NOT cause brain damage if managed correctly
• Return immediately if: seizure >15 min, focal, occurs in afebrile state, <12 months old
• Long-term prophylaxis NOT routinely recommended for simple febrile seizures

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11C. HYPOTONIC-HYPORESPONSIVE EPISODE (HHE)

• Decreased or absent muscle tone (limpness)
• Decreased or absent responsiveness
• Pallor or cyanosis
• Onset within 48 hours of vaccination

Management Algorithm

RECOGNIZE HHE: Limpness + pallor + unresponsiveness after DTwP
         ↓
Call for help; place in recovery position
         ↓
ABCDE assessment immediately
  - Airway patent? → Ensure airway open
  - Breathing adequate? → O2 if SpO2 <94%
  - Circulation? → HR, BP, CRT
  - BGL check (rule out hypoglycemia)
         ↓
Most HHE episodes are SELF-LIMITING (resolve within minutes)
         ↓
DO NOT give adrenaline (this is NOT anaphylaxis)
DO NOT give anticonvulsants (this is NOT a seizure)
         ↓
If episode persists >15 minutes or SpO2 low: TRANSFER to hospital
         ↓
Observe in hospital for 4-6 hours
         ↓
DOCUMENT and REPORT as serious AEFI
         ↓
DISCHARGE: Counsel family - prognosis is EXCELLENT
         ↓
FUTURE VACCINATION: Switch to DTaP (acellular pertussis)
  - HHE is a PRECAUTION (not absolute contraindication) for future DTwP
  - DTaP has lower risk of HHE

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11D. SYNCOPE (VASOVAGAL)

RECOGNITION: Dizziness/lightheadedness → brief loss of consciousness
  - During or immediately after injection
  - Bradycardia (slow pulse)
  - Pale, cold, clammy skin (NO urticaria)
  - Usually resolves spontaneously within 1-2 minutes
         ↓
POSITION: Lay FLAT, raise legs above heart level
         ↓
RECOVERY: Most recover within minutes
         ↓
If no recovery within 2-3 minutes: Rule out anaphylaxis
  → Check: urticaria? wheeze? tachycardia? → if yes → treat as ANAPHYLAXIS
         ↓
Post-recovery: Keep supine for 15-30 minutes before sitting up
         ↓
Prevention: Have patient sitting/lying during all injections
  - Vaccine in sitting or supine position reduces syncope risk

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11E. BREATH-HOLDING SPELL

TRIGGER: Pain of injection → crying → breath-holding → cyanosis → brief loss of consciousness
         ↓
Occurs in children 6 months - 6 years
         ↓
CYANOTIC type: More common; cry → hold breath at end of expiration → cyanosis → limp/faint
PALLID type: Less common; minimal cry → sudden pallor → faint (vagal)
         ↓
MANAGEMENT:
  - No specific treatment required
  - Position flat or recovery position
  - Usually resolves spontaneously within 1 minute
  - Cold cloth on face may terminate spell
         ↓
KEY TEACHING: Differentiate from seizure (no post-ictal phase in breath-holding)
         ↓
COUNSEL PARENTS: Benign, self-limiting; minimize injection pain
  (EMLA cream, oral sucrose, distraction techniques)

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11F. PERSISTENT INCONSOLABLE CRYING

ASSESSMENT:
  - Duration of crying (>3 hours = diagnostic criterion for AEFI)
  - Check injection site: redness, swelling, firmness
  - Temperature: fever >38.5°C?
  - Neurological: is child responsive, able to be partially comforted?
  - Rule out: intussusception (after rotavirus), incarcerated hernia
         ↓
MANAGEMENT:
  - Antipyretic: Paracetamol 15 mg/kg for pain/fever
  - Cold compress to injection site
  - Comfort measures (feeding, holding, rocking)
         ↓
CAUTION if:
  - Cry changes from high-pitched to weak (rule out more serious pathology)
  - Associated with bilious vomiting, blood in stool (consider intussusception)
  - >24 hours duration (investigate further)
         ↓
DOCUMENT and REPORT if >3 hours
         ↓
FUTURE VACCINATION: Switch to DTaP recommended

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11G. INJECTION-SITE ABSCESS

MANAGEMENT:
  Mild/early (cellulitis): Oral antibiotics - Amoxicillin-clavulanate or Cephalexin
    Pediatric: Amoxicillin-clavulanate 40 mg/kg/day in 3 divided doses x 7 days
    Adult: 625 mg TDS x 7 days
         ↓
  Fluctuant (abscess): INCISION AND DRAINAGE
    + Send pus for C&S
    + Wound care
    + Antibiotics if systemic features
         ↓
  Serious/septic: IV antibiotics (Cloxacillin/Flucloxacillin)
         ↓
  INVESTIGATE: Check vaccination records, cold chain, sterility
  REPORT: Immunization error-related AEFI

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11H. CELLULITIS

Features: Warmth, redness, pain, swelling extending beyond injection site;
          may have AESL (extensive limb swelling)
         ↓
AESL (Adverse Event - Swelling of the Limb): Extensive swelling of entire limb
  after Pentavalent/DTP - recognized AEFI; self-limiting; monitor
         ↓
MANAGEMENT:
  - Mild: Oral amoxicillin-clavulanate or cephalexin
  - Moderate-severe: IV cloxacillin/cefazolin
  - Mark margins with pen to monitor progression
  - Elevate limb
  - Analgesics/antipyretics
         ↓
RED FLAGS requiring hospitalization:
  - Spreading rapidly despite antibiotics
  - Systemic toxicity
  - Immunocompromised child
  - Facial cellulitis

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11I. TOXIC SHOCK SYNDROME (TSS) AFTER VACCINATION

• Rapid onset high fever (>38.9°C) within 2-24 hours
• Vomiting, diarrhea
• Diffuse sunburn-like erythematous rash
• Hypotension, shock
• Multiorgan dysfunction (renal failure, liver failure, DIC)
• NOT localized to injection site

MANAGEMENT (EMERGENCY):
  - ABC resuscitation
  - IV fluids: 20 mL/kg bolus NS/RL; repeat if needed
  - IV antibiotics: Cefotaxime 200 mg/kg/day + Cloxacillin 200 mg/kg/day
  - ICU admission
  - Monitor: renal function, LFTs, coagulation, CBC
         ↓
REPORT as SERIOUS AEFI - likely immunization error
  - Quarantine suspected vaccine batch
  - Investigate cold chain and preparation technique

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11J. HIGH FEVER (>39°C)

MANAGEMENT:
  - Paracetamol: 15 mg/kg/dose oral (max 1 g); repeat every 4-6 hours PRN
  - Adequate oral fluids
  - Remove excess clothing; tepid sponge if >40°C
  - DO NOT use aspirin in children <12 years (Reye's syndrome risk)
  - Ibuprofen: 5-10 mg/kg/dose every 6-8 hours (alternate with paracetamol)
         ↓
If fever >40°C or not responding to antipyretics:
  - Investigate: CBC, blood culture, CRP
  - Consider IV fluids if not taking orals
  - Rule out meningitis, sepsis
         ↓
Vaccine-induced fever usually resolves within 48 hours
If fever persists >48 hours: Look for other cause (infection)

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11K. ENCEPHALOPATHY

MANAGEMENT:
  - Airway protection (most important)
  - Seizure control: Benzodiazepines → Phenobarbital/Phenytoin
  - IV fluids (restrict if SIADH suspected)
  - Raised ICP management: Head 30° elevation, avoid hypoxia
         ↓
INVESTIGATIONS:
  - CBC, LFTs, RFTs, electrolytes, blood glucose
  - CSF analysis (LP): to rule out viral encephalitis
  - MRI brain (CT first if raised ICP suspected)
  - EEG
         ↓
DIFFERENTIATE: Viral encephalitis (fever + CSF pleocytosis) vs.
  Post-vaccine immune-mediated ADEM (subacute onset, MRI white matter changes)
         ↓
TREATMENT:
  - If ADEM suspected: IV methylprednisolone 30 mg/kg/day x 5 days
  - If viral: Acyclovir (for HSV encephalitis) empirically
         ↓
REPORT: Serious AEFI; notify state and national AEFI committee

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11L. GUILLAIN-BARRE SYNDROME (GBS)

• Ascending flaccid paralysis
• Onset: 2-4 weeks after vaccination
• Areflexia
• CSF: Albuminocytologic dissociation (high protein, normal cells)
• NCS: Demyelinating pattern

MANAGEMENT:
  - ICU monitoring for respiratory failure
  - Respiratory support: Ventilation if FVC <20 mL/kg or NIF < -30 cmH2O
         ↓
  IMMUNOTHERAPY (EQUIVALENT EFFICACY):
    Option A: IVIG 0.4 g/kg/day IV x 5 days
    Option B: Plasmapheresis 200-250 mL/kg in 4-6 sessions
    (Do NOT combine)
         ↓
  Physiotherapy (prevent contractures)
  DVT prophylaxis (heparin) in adults
  Adequate nutrition
         ↓
PROGNOSIS: Most recover; 5-10% have long-term disability
REPORT: Serious AEFI; national investigation

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11M. THROMBOCYTOPENIA

INVESTIGATIONS:
  - CBC with differential
  - Peripheral smear
  - Coagulation profile (PT, aPTT, fibrinogen)
  - Rule out: ITP, TTP, DIC
         ↓
MANAGEMENT:
  - Mild (platelets >30,000; no bleeding): Observation
  - Moderate (platelets 10-30,000; minor bleeding): IVIG or steroids
    IVIG: 1 g/kg/day x 2 days
    Prednisolone: 1-2 mg/kg/day x 14-21 days
  - Severe (platelets <10,000 or significant bleeding):
    IVIG + steroids; consider platelet transfusion if active hemorrhage
         ↓
FUTURE VACCINATION: 2nd dose MMR generally safe in post-vaccine ITP
  (Natural measles infection causes WORSE thrombocytopenia than vaccine)

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11N. MYOCARDITIS (COVID-19 mRNA Vaccines)

• Onset: 1-5 days after 2nd dose (median 2-3 days)
• Chest pain, shortness of breath, palpitations
• Elevated troponin, CRP, BNP
• ECG: ST changes, T-wave inversion
• Echo: LV dysfunction (usually mild)
• Cardiac MRI: myocardial edema/inflammation

MANAGEMENT:
  - Admit to cardiology ward
  - Rest (avoid exercise for at least 3-6 months per guidelines)
  - NSAIDs (ibuprofen) for pain and inflammation
  - Colchicine: 0.5 mg BID (adjunctive)
  - Severe cases: Steroids, IVIG
         ↓
PROGNOSIS: Generally EXCELLENT (>95% full recovery in adolescents/young adults)
  Better prognosis than viral myocarditis
         ↓
NOTE: Myocarditis from COVID-19 DISEASE is far more common and more severe
  than vaccine-related myocarditis

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CHAPTER 12: DRUG MANAGEMENT - COMPLETE REFERENCE

AEFI Emergency Drug Chart

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CHAPTER 13: STEP-BY-STEP ANAPHYLAXIS MANAGEMENT (DETAILED)

Adrenaline IM - Key Points

• Concentration: Use 1:1000 (1 mg/mL) - NOT 1:10,000 (for IV use only)
• Site: Outer anterolateral thigh (vastus lateralis) - better absorption than deltoid
• Through clothing is acceptable in emergency (removes delay)
• Repeat: Every 5-10 minutes, up to 3 total doses (2 additional after first)
• Never: Subcutaneous route (erratic absorption in shock); IV as first dose (cardiac risk)

Biphasic Anaphylaxis

• Occurs in 1-20% of anaphylaxis cases
• Rebound symptoms 1-72 hours after initial resolution
• Risk factors: severe initial reaction, slow response to adrenaline, delayed adrenaline
• Prevention: Corticosteroids (hydrocortisone/methylprednisolone) and 24h observation

Post-Anaphylaxis Discharge Instructions

1. Prescribe oral antihistamines for 3-5 days
2. Written anaphylaxis action plan
3. Referral to allergist for skin testing and allergen identification
4. Medic-alert bracelet recommendation
5. Education on EpiPen use (if available) for future
6. Return precautions: any return of symptoms

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CHAPTER 14: AEFI EMERGENCY KIT

Every Vaccination Center Must Have:

• Endotracheal tubes (sizes 2.5-8.0)
• Laryngoscope with blades
• Pulse oximeter
• BP machine (pediatric + adult cuffs)
• Glucometer with strips
• Nebulizer with salbutamol
• Diazepam ampoules
• Methylprednisolone

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CHAPTER 15: OBSERVATION PERIOD AND DISCHARGE

Standard Observation After Vaccination

Discharge Instructions for Parents (Routine Vaccines)

1. Child may have low-grade fever for 1-2 days - use paracetamol
2. Injection site may be red/sore - cold compress for 10-15 minutes
3. BCG ulcer will form at 2-4 weeks - normal, do not apply antibiotic cream
4. MMR may cause mild fever/rash at days 6-12 - normal
5. Return IMMEDIATELY if: high fever (>40°C), seizure, limpness, difficulty breathing, rash with hives, unusual cry, swelling of face/tongue/throat

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CHAPTER 16: FUTURE VACCINATION AFTER AEFI

Contraindications vs. Precautions

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CHAPTER 17: AEFI REPORTING UNDER INDIA'S UIP

National AEFI Surveillance System (MoHFW Guidelines 2024)

Who Must Report

• All health workers at session sites (ASHA, ANM, LHV)
• Medical Officers at PHC, CHC, DH
• Private practitioners (for all vaccines, not just UIP)
• ADR Monitoring Centres (PvPI network)

What to Report

• ALL vaccines (UIP and non-UIP; government and private sector)
• All serious/severe AEFIs (mandatory within 24-48 hours)
• Routine AEFI (minor reactions) - aggregate monthly reporting in AEFI registers and HMIS

Reporting Hierarchy

AEFI Detected at Session Site
        ↓ Immediate notification (phone/WhatsApp/SMS)
Medical Officer (PHC)
        ↓ 24-48 hours (for serious AEFI)
District Immunization Officer (DIO)
        ↓ 48-72 hours
State Immunization Officer (SIO)
        ↓ 5-7 days
National Immunization Division (MoHFW)
        ↓
WHO (if applicable - large cluster or unusual event)

Reporting Forms

1. Case Notification Form (CNF): First-level report; sent within 24-48 hours of serious AEFI
2. Case Investigation Form (CIF): Detailed clinical/epidemiological investigation; completed within 5-7 days
3. Causality Assessment: Done at district/state level using WHO causality assessment framework

Timelines for India

Cluster Investigation

• ≥2 cases from same batch OR same session = CLUSTER
• Quarantine the suspected batch (do not discard - preserve for testing)
• Investigate: cold chain, preparation technique, administration errors
• Send samples to CDSCO (Central Drugs Standard Control Organisation)

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CHAPTER 18: PARENT COUNSELING

After Minor Reactions

"Your child may have a sore arm, a little fever, or be more fussy than usual for 1-2 days. This is normal and shows the vaccine is working. Give paracetamol syrup (dose by weight) if fever or pain. Put a cool wet cloth on the injection site. Come back to me if your child has very high fever, a fit/seizure, becomes limp or unresponsive, or gets a rash with hives. These are rare but I want you to seek help immediately if they happen."

After BCG Vaccination

"A small red bump will appear at the vaccination site in 2-4 weeks. It will slowly become a small sore (ulcer) and then heal by 2-3 months, leaving a small scar. This is completely normal and shows the vaccine is working. Do NOT put any medicine or bandage on it. Do NOT squeeze it."

After MMR Vaccination

"About 6-12 days from now, your child may develop a mild fever and a faint rash. This is expected and is NOT measles disease. The child is NOT infectious during this time. Paracetamol for the fever. No treatment needed for the rash."

After a Serious AEFI

1. Acknowledge the parents' fear and distress - validate their feelings
2. Give honest, clear information about what happened
3. Explain the investigation process
4. Clarify causality (temporal association vs. proven cause)
5. Discuss implications for future vaccines
6. Never be dismissive of their concerns
7. Provide written information

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CHAPTER 19: PREVENTION OF IMMUNIZATION ERRORS

The "10 Rights" of Safe Vaccine Administration

1. Right patient - verify identity before every dose
2. Right vaccine - check label carefully
3. Right dose - volume, not just number of doses
4. Right route - IM/SC/ID/oral as specified
5. Right site - appropriate anatomical location by age
6. Right time/interval - minimum intervals between doses
7. Right technique - aspiration not required; correct angle
8. Right documentation - record immediately after giving
9. Right counseling - parents informed about reactions and return signs
10. Right storage - vaccine not frozen/overheated; check VVM

Common Immunization Errors (Exam Favourite)

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CHAPTER 20: VACCINE STORAGE AND COLD CHAIN

Temperature Requirements

VVM (Vaccine Vial Monitor)

• Heat-sensitive indicator on vaccine vials
• Shows SQUARE inside a CIRCLE
• If inner square is LIGHTER than outer ring: vaccine is USABLE
• If inner square is SAME or DARKER than outer ring: DISCARD vaccine
• VVM tells you about HEAT damage only; NOT freeze damage

Shake Test (for Freeze-Sensitive Vaccines)

• Compare: suspected frozen vial vs. control vial (same vaccine, properly stored)
• Shake both vigorously
• After shaking: if suspected vial has no/slow sedimentation = FROZEN (discard)
• If sediment appears but clears as quickly as control = safe to use

Cold Chain Equipment (India UIP)

• Walk-in Cooler / Walk-in Freezer: State level
• Deep Freeze: District level (-15 to -25°C for OPV)
• Ice-Lined Refrigerator (ILR): PHC level (+2 to +8°C)
• Cold Box: For transport
• Vaccine Carrier: For session site (4 ice packs, maintains 2-8°C for 4-6 hours)

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CHAPTER 21: RECENT UPDATES IN AEFI GUIDELINES (2023-2026)

Key Updates

1. India National AEFI Operational Guidelines 2024 (MoHFW):
   • Private sector must now report all AEFI (both UIP and non-UIP vaccines)
   • ADR Monitoring Centres (PvPI network) integrated into AEFI reporting
   • Enhanced digital reporting pathways
   • Emphasis on anaphylaxis kit at ALL vaccination session sites
2. WHO 2024 - AEFMI (Adverse Events Following Maternal Immunization):
   • New methodology for causality assessment in pregnant women
   • GAIA (Global Alignment of Immunization Safety Assessment in Pregnancy) Brighton Collaboration definitions integrated
   • New subcategories for pregnancy outcomes as AEFI
3. mRNA COVID-19 Vaccines - Myocarditis Update (2023-2024):
   • CDC/WHO confirmed rare myocarditis signal predominantly in males 12-29 years after 2nd mRNA dose
   • Onset: 1-5 days post-vaccination
   • Most cases self-limiting; excellent prognosis
   • Updated clinical guidance for recognition and management
4. IAP ACVIP Schedule 2023 (Published January 2024):
   • HPV vaccine now recommended for BOYS as well as girls
   • 2-dose schedule of 9vHPV (9-valent) for boys and girls aged 9-14 years
   • Td booster added at 16-18 years
   • IPV guidance: if hexavalent combination unaffordable, refer to government facility for UIP schedule
5. Brighton Collaboration Updates:
   • Revised case definitions for multiple AEFIs including AESL (adverse event: swelling of the limb), injection site reactions
   • International harmonization of AEFI definitions continues
6. COVID-19 AEFI Experience (Globally):
   • Thrombosis with Thrombocytopenia Syndrome (TTS) linked to adenovector COVID vaccines (AstraZeneca/Covishield)
   • Strengthened pharmacovigilance systems globally
   • Real-time safety monitoring through VAERS (US), Yellow Card (UK), CDSCO (India)

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CHAPTER 22: HIGH-YIELD EXAMINATION POINTS

For NEET-PG / AIIMS / INI-CET / MD Pediatrics / MBBS / Nursing Officer / UPSC CMS

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CHAPTER 23: CLINICAL CASE SCENARIOS

Case 1 (Beginner): Expected Reaction

• Paracetamol suspension 15 mg/kg (approximately 60-75 mg for a ~4-5 kg infant) - every 4-6 hours
• Reassure mother: fever will resolve within 24-48 hours
• Continue breastfeeding
• Cold compress to injection sites
• Return if: fever >40°C, seizure, limp baby, difficulty breathing, not feeding

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Case 2 (Intermediate): Anaphylaxis

• Diagnosis: Anaphylaxis following MMR vaccination (vaccine product-related, serious AEFI)
• Immediate Action:
  • Call for help
  • Position: flat with legs raised
  • Adrenaline 1:1000 IM: 0.01 mL/kg × 8 kg = 0.08 mL → 0.1 mL (round to nearest safe dose) into anterolateral thigh
  • High-flow O2 by face mask
  • Establish IV access → 0.9% NS 20 mL/kg (160 mL) IV bolus
  • Chlorpheniramine 0.2 mg/kg = 1.6 mg IM (adjunct, after adrenaline)
  • Hydrocortisone 4 mg/kg = 32 mg IV (adjunct)
  • Monitor continuously for 24 hours (biphasic risk)
  • Report as serious AEFI; complete CNF and send to DIO within 24 hours
  • Contraindication: NO further MMR doses until allergy workup

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Case 3 (Advanced): HHE

• Diagnosis: Hypotonic-Hyporesponsive Episode (HHE) following DTwP - a serious AEFI
• Management:
  • ABCDE assessment: airway clear, SpO2 96% (acceptable), circulation OK
  • Place in recovery position
  • Check blood glucose (to rule out hypoglycemia)
  • Oxygen via nasal prongs if SpO2 drops
  • DO NOT give adrenaline (not anaphylaxis)
  • DO NOT give anticonvulsants (not a seizure)
  • Observe - most HHE resolves within minutes to hours
  • If persists >15 min or deteriorates: Transfer to hospital
  • Admit for 4-6 hours observation
  • Complete neurological exam when she recovers
• Outcome: HHE is self-limiting with excellent prognosis. No brain damage.
• Future vaccination: Switch to DTaP for remaining doses (acellular pertussis is safer)
• Reporting: Serious AEFI - report to DIO within 24-48 hours

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Case 4 (Critical): Toxic Shock Syndrome

• Diagnosis: Toxic Shock Syndrome - an AEFI cluster; likely immunization error-related (contaminated multi-dose vial)
• Immediate Actions:
  • ABC resuscitation for all affected infants
  • IV fluid bolus: 20 mL/kg NS for hypotensive infant
  • IV antibiotics: Cefotaxime 200 mg/kg/day + Cloxacillin 200 mg/kg/day
  • ICU transfer for the hypotensive infant
  • IMMEDIATELY notify: DIO by phone (cluster AEFI)
  • Quarantine the suspect vial (do NOT discard) - seal and send to state health authority and CDSCO
  • Halt vaccination from that vial/batch
  • Document all 4 cases on Case Notification Forms
  • Investigate: Were syringes re-used? Was vial preparation proper? Was cold chain intact?

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Case 5 (Exam Viva): VAPP

• Diagnosis in infant: VAPP (Vaccine-Associated Paralytic Polio) - vaccine product-related AEFI (serious)
• Diagnosis in sibling: Contact VAPP (spread via fecal-oral route from OPV recipient)
• AEFI Classification: Vaccine product-related reaction (OPV contains live attenuated virus that can revert to neurovirulence in susceptible hosts)
• Risk: Highest with FIRST OPV dose (2-4 per million doses)
• Future Vaccination:
  • Switch ENTIRE FAMILY to IPV only
  • Absolute contraindication to further OPV in this child
  • Immunocompromised individuals: Use ONLY IPV (never OPV)
• Why this matters for India: India replaced OPV with IPV as first dose in the UIP schedule to reduce VAPP risk

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CHAPTER 24: OSCE AND VIVA QUESTIONS WITH MODEL ANSWERS

1. Vaccine product-related: DTP causing HHE
2. Quality defect-related: Contaminated batch causing abscess
3. Immunization error-related: BCG given IM instead of ID causing deep abscess
4. Anxiety-related: Vasovagal syncope after injection
5. Coincidental: SIDS occurring within 24h of vaccination (unrelated)

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• Identify: "I will use adrenaline 1:1000 solution"
• Calculate dose: 0.01 mL/kg × 10 kg = 0.1 mL
• Draw up: Use 1 mL syringe; draw 0.1 mL of 1:1000 adrenaline
• Site: Anterolateral outer thigh (can inject through clothing)
• Route: IM (not IV, not SC)
• Inject, note time
• Monitor HR, BP, SpO2
• Prepare to repeat in 5-10 minutes if no improvement

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CHAPTER 25: CONCISE REVISION SHEET

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ONE-PAGE MEMORY AID

AEFI Classification - Mnemonic: "PQE-AC"

• P - Product-related (vaccine itself)
• Q - Quality defect (manufacturing flaw)
• E - Error (immunization error)
• A - Anxiety (vasovagal/psychogenic)
• C - Coincidental (unrelated event)

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Anaphylaxis Quick Card

RECOGNIZE: Urticaria + EITHER respiratory OR cardiovascular compromise
POSITION: Flat + legs raised (NOT sitting)
ADRENALINE 1:1000 IM THIGH: 0.01 mL/kg (max 0.5 mL)
O2: 15 L/min face mask
IVF: 10-20 mL/kg NS bolus
NEBULIZE: Salbutamol if wheeze
ADJUNCTS: Chlorpheniramine + Hydrocortisone (after adrenaline)
REPEAT adrenaline: Every 5-10 min (up to 3 doses total)
OBSERVE: 4-6 hours (24h if severe)
REPORT: Serious AEFI → DIO within 24 hours

Adrenaline Dose Chart (Memorize)

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Vaccine Reactions - Onset Timing Mnemonic: "BCG-2M, MMR-6-12, HHE-48h"

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Absolute Contraindications to Future Vaccination

1. Anaphylaxis to vaccine → No re-administration of same vaccine
2. Encephalopathy within 7 days of DTwP → No further DTwP (use DT/DTaP)
3. VAPP → No further OPV (use IPV only)

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Storage Temperature Summary

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AEFI Emergency Kit - Mnemonic: "ANSI"

• A - Adrenaline 1:1000 (5 ampoules)
• N - Normal Saline 500 mL (2 bottles) + IV set
• S - Steroids (Hydrocortisone) + Syringes + SpO2 probe
• I - IV cannulas + Injectable antihistamine (Chlorpheniramine) + O2

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Reporting Timeline (India)

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Management Algorithm Flowchart

POST-VACCINATION CHILD WITH SYMPTOMS
              ↓
         ABCDE ASSESSMENT
              ↓
    ┌─────────┼─────────┐
Urticaria + Wheeze   Limpness/Pallor    Fever + Seizure
  + Hypotension       Unresponsive        
       ↓                  ↓                   ↓
  ANAPHYLAXIS            HHE           FEBRILE SEIZURE
  Adrenaline IM     Recovery position   Left lateral position
  0.01 mL/kg       Check BGL            O2
  O2, IVF          O2 if needed         Diazepam if >5 min
  Admit 4-6h       Obs 4-6h             Paracetamol
  Report AEFI      Report AEFI          Admit if complex
                   Switch to DTaP
              ↓
         ALL REQUIRE:
     Documentation + AEFI Reporting

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MCQ BANK - CHAPTER-BY-CHAPTER

AEFI Classification (10 MCQs)

• A) Vaccine product-related reaction
• B) Vaccine quality defect-related reaction
• C) Immunization error-related reaction
• D) Coincidental event

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• A) Vaccine product-related reaction
• B) Anaphylaxis
• C) Immunization anxiety-related reaction (vasovagal syncope)
• D) HHE

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• A) Vaccine product-related reaction
• B) Immunization error-related
• C) Coincidental
• D) Quality defect-related

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• A) Vaccine product-related reaction
• B) MMR encephalitis
• C) MMR-induced immunosuppression
• D) Coincidental event

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• A) Vaccine product-related reaction
• B) Immunization error-related
• C) Anxiety-related
• D) Quality defect-related

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Anaphylaxis (5 MCQs)

• A) 0.1 mL
• B) 0.2 mL
• C) 0.3 mL
• D) 0.5 mL

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• A) Hydrocortisone IV
• B) Chlorpheniramine IM
• C) Salbutamol nebulization
• D) Adrenaline 1:1000 IM

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• A) <1%
• B) 1-20%
• C) 20-40%
• D) >50%

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• A) Deltoid muscle
• B) Gluteal muscle
• C) Anterolateral outer thigh (vastus lateralis)
• D) Forearm

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• A) 30 minutes
• B) 1-2 hours
• C) 4-6 hours
• D) 24 hours for all cases

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Emergency Reactions (5 MCQs)

• A) Anaphylaxis
• B) Hypotonic-Hyporesponsive Episode (HHE)
• C) Febrile seizure
• D) VAPP

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• A) HHE after DTwP
• B) Encephalopathy within 7 days of DTwP
• C) Febrile seizure after DTwP
• D) Local swelling >8 cm after DTwP

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• A) Immediately (0-24 hours)
• B) Day 2-5
• C) Day 6-12
• D) Day 15-35

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• A) First dose
• B) Second dose
• C) Third dose
• D) Equal risk with all doses

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• A) Disseminated Intravascular Coagulation
• B) Vaccine-associated immune thrombocytopenic purpura (ITP)
• C) Meningococcemia
• D) Dengue shock syndrome

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Cold Chain / Reporting (5 MCQs)

• A) Hepatitis B
• B) DTP
• C) OPV
• D) PCV

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• A) Use the vaccine - VVM shows it is safe
• B) Shake the vial and use if no aggregation
• C) Discard the vaccine immediately
• D) Report to the DIO and then use

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• A) 6 hours
• B) 24-48 hours
• C) 7 days
• D) Monthly reporting only

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• A) State level
• B) District/PHC level
• C) Session site
• D) National level

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• A) Any two cases of fever after vaccination
• B) One death after vaccination
• C) Two or more similar AEFIs from the same batch at the same session
• D) Three cases of local reaction in one month

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• Park's Textbook of Preventive and Social Medicine (Table 36, Table 37, Table 39; Chapter on Immunization)
• India National AEFI Surveillance and Response Operational Guidelines 2024 (MoHFW, Government of India)
• WHO Anaphylaxis and AEFI Guidelines (WHO GACVS)
• CDC Pink Book Chapter 4: Vaccine Safety (Updated April 2024)
• IAP-ACVIP Recommended Immunization Schedule 2023, Indian Pediatrics (Published January 2024)
• Red Book 2021, American Academy of Pediatrics
• WHO Global Manual on Surveillance of AEFI (ISBN 978-92-4-150776-9)
• Resuscitation Council New Zealand: IM Adrenaline Dose Chart for Anaphylaxis