VACCINE SIDE EFFECT REPORTING FORM

Patient details
Patient name:		Gender:		Age:
Health information
Reason of the taking Drug/Vaccine (disease/symptoms):
Drug/ Vaccine advised by :	Doctor	Pharmacist	Friend	Self
Details of the Person reporting the Side Effects
Name :		Address :
Telephone :		Email :
Dosage form :	Liquid	Oral Liquid			Other
About the side effect
When did the Side Effect start ?		When did the Side Effect stop ?		Side effect is still continuing (Yes/No)

Relationship to Drug/Vaccine: 1 = Not related, 2 = Unlikely, 3 = Possible, 4 = Probably, 5 = Definitely, 6 = Not Assessable.

Other Drug/Vaccine administered at the same time?

if yes, specify below.

Vaccine	Manufacturer	Batch No.	Route/Site	No. of previous Doses

Kindly mark all the side effects in appropriate boxes .Please use this form for the side effects occurred from the date of administration /vaccination.
S. No	Parameter	Grade	DAY Details after administration/vaccination of Drug/vaccine							Date of resolution & Relationship to drug/vaccine
			D-	D-	D-	D-	D-	D-	D-
Local adverse events (at the injection site)
1	Pain	None
		Mild
		Moderate
		Severe
None: Absent; Mild: Minor reaction to touch; Moderate: Painful to touch; Severe: Spontaneously painful
2	Pruritus/Itching	None
		Mild
		Moderate
		Severe
None: Absent; Mild: Itching localized to injection site and relieved spontaneously or within <48 hours of treatment; Moderate: Itching beyond injection site, not generalized or localized and requiring >48 hours of treatment; Severe: itching causing inability to perform usual social & functional activities
3	Fever	None
		Mild
		Moderate
		Severe
		Life Threatening
None: Absent; Mild:38.0 – 38.4°C (100.4 – 101.1°F); Moderate: 38.5 -38.9°C (101.2 – 102.0°F); Severe: 39 - 40°C (102.1 - 104°F); Life Threatening: >40°C (>104°F)
4	Redness	None
		Mild
		Moderate
		Severe
None: Absent; Mild: Localized skin erruption; Moderate: Diffuse skin eruption from body surface area ; Severe: Generalized skin erruption involving >50% from the body surface area.
5	Headache	None
		Mild
		Moderate
		Severe

None: Absent; Mild: No interference with daily activity; Moderate: Some interference with daily activity; Severe: Significant interference and prevents daily activity (Non Bearable).

Other than mentioned above (Please specify)
Describe treatment used (if any) for any of the above reported events (brand/ generic name of medications and the course of treatments):
Outcome measures: 1 = Recovered, 2 = Recovered with sequelae, 3 = Event continuing without treatment, 4 = Event continuing and controlled with treatment, 5 = Event continuing and not controlled with treatment, 6 = Unknown ,7 =Death
Reporter Name:- Signature and date
Reviewed by :- Signature and date (Pharmacovigilance Department)
Remarks :