Anaphylaxis following immunization
Case Investigation Form
A. Identification and Related Basic Information
1
2
3
4
5
Name of the patient /guardian
Address of the patient/guardian
Date of Birth
Age on the date of immunization
Hospital (if admitted)
6
RDHS Division
7
Place of
Immunization
Date of immunization
8
9
BHT No:
MOOH Area
10
Time interval between immunization and onset of
reaction
Duration of the reaction
11
Ethnic Group
Time
B. Information on vaccine/cold chain and vaccination technique
Incriminated vaccine/s
1
2
3
4
Expiry Date
Batch No.
Manufacturer
Status of the cold chain of the used vaccines
Temperature Record
VVM
Data logger
5 Anatomical site of immunization
6 Type of AD Syringe Use
7 Expiry date & Batch No:
8 Needle length and gauge
9 Route of Administration and dose
10 number of mothers immunized at same clinic on
same day
11 Similar events with other mothers
B. Clinical description/ detailed history and sequence of the events from the time of
immunization until seeking medical advice the patient/guardian.
C. Clinical description/ sequelae of the event as per medical records/by clinicians
Presence or absence of key anaphylaxis clinical features/laboratory findings
Key Clinical Feature
Yes/ No
1 Presence of features of cardiovascular signs/
symptoms
a. Hypotension
b. Tachycardia
c. Features of Poor peripheral perfusionprolong capillary refilling time>3 sec
d. Decreased level of consciousness/loss of
consciousness
2
Presence of respiratory symptoms
a. Bilateral wheezing
b. Shortness of breath
c. Stridor
d. Upper airway swelling
(lip, tongue, throat, uvula, larynx)
e. Respiratory distress
(tachypnoea, use of accessory muscles,
recessions, cyanosis, grunting)
f. Persistent dry cough
g. Hoarse voice
Remarks
h. Sneezing/ rhinorrhea
3
4
5
Presence of dermatological/ mucosal features
a. Generalized urticaria / erythema
b. Angioedema
c. Generalized pruritus with skin rash
d. Generalized prickle sensation
e. Injection site urticaria
f. Red and itchy eyes
Presence of gastrointestinal symptoms
a. Diarrhea
b. Abdominal pain
c. Nausea
d. Vomiting
Laboratory findings
a. Serum beta tryptase assay
D. Concurrent Sings, Symptoms and Diseases
1
2
3
4
5
Concurrent Sing, Symptom and Disease
Ictal or postictal state
Fever
Any symptoms of concurrent infection
Concurrent /Long term medication
Intoxication
E. Clinical Examination findings:
1
2
3
4
5
6
General examination
Cardiovascular System
BP
Pulse Volume
Highest Heart Rate
Respiratory system
Highest Respiratory Rate Recorded
Abdomen
Central Nervous system
Pulse Oximeter ?
Yes/ No
Remarks/Description
F. Investigations
1. Random Blood Sugar2. CXR
3. Any other investigations
G. Management
a. Immediate resuscitation
b. Subsequent Management
H. Diagnosis on discharge/outcome of the patient
I. Detailed history of this pregnancy (if applicable) /Any identified risk factors
J. Past Obstetric History
K. Past medical problems of the mother (if applicable)
a. History of bronchial asthma/ allergic rhinitis/ eczema
b. Allergic History (foods, drugs)
c. Any other significant medical problems/previous hospitalizations
L. Any adverse events noted following previous immunization with same vaccine/ or
different vaccines
M. Family history of similar events
…………………………………………………………………………………..
Name , Designation, Signature of the investigator and Date of Investigation