Adverse Event Reporting

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Report any suspected adverse event to Dano Vaccines & Biologicals Private Limited

What is Adverse Drug Reaction?
A response to a drug which is noxious and unintended and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease or for the modification of physiological function (WHO, 1972).

What to report?
1. Report serious adverse drug reactions. A reaction is serious when the patient outcome is:

Death
Life-threatening
Hospitalization (initial or prolonged)
Disability (significant, persistent or permanent)
Congenital anomaly
Required intervention to prevent permanent impairment or damage

2. Report non-serious, known or unknown, frequent or rare adverse drug reactions due to Medicines, Vaccines and Herbal products.

Who can report an ADR?
All healthcare professionals (Clinicians, Dentists, Pharmacists and Nurses) can report adverse drug reactions.

How to report an ADR?
Duly filled Post Marketing Surveillance Form / Suspected Adverse Drug Reaction Reporting Form can be sent to,
Dano Vaccines & Biologicals Private Limited,
Address: DANO Vaccines & Biologicals Pvt. Ltd.
575, Sivareddyguda, Ghatkesar,
Medchal district, Hyderabad-501301,
Telangana State, India

For ADRs Reporting Call on Helpline
Toll Free No.: 1800 309 6009 (Timings – Monday to Saturday 9:00 AM to 5:30 PM)

Email : [email protected]

Adverse Event Reporting Form

Patient’s Name *

Patient’s Full Address *

Sex *MaleFemale

Telephone No

Ages - In Years/Months

Date of Birth *

Adverse Event *

Severe local reaction >3 days beyond nearest jointSeizures febrile afebrileAbscessSepsisEncephalopathyToxic shock syndromeThrombocytopeniaAnaphylaxisFever ≥38°COther (specify)..

Other (specify).

Date AEFI Started

Time

Describe AEFI

Serious *YesNo

If Yes *

DeathLife threateningPersistent or significant disabilityHospitalizationCongenital anomalyOther important medical event (specify)

Other important medical event

DiedYesNo

If Died, date of death

Outcome *

RecoveringRecoveredRecovered with sequelaeNot RecoveredUnknown

Autopsy doneYesNo

Past medical history (including history of similar reaction or other allergies), concomitant medication and other relevant information

Health facility (place or vaccination centre) name & address:

Vaccine Details

Name of vaccine *

Date of vaccination *

Time of vaccination *

Dose (1st , 2nd ,etc.)

Batch /Lot number *

Expiry date *

Diluent (if applicable)

Name of diluent

Batch /Lot number

Expiry date

Date of reconstitution

Time of reconstitution

Reporter’s Name *

Institution *

Address

Designation & Department

E-mail *

Telephone

Date patient notified event to health system

Today’s date

Click here to download the Adverse Event Reporting form

You may contact to Dano Vaccines & Biologicals Private Limited at:

Toll Free: 1800 309 6009
E-mail: [email protected]
Address: DANO Vaccines & Biologicals Pvt. Ltd.
Sy No. 575, Sivareddyguda,
Ghatkesar, Medchal-Malkajgiri Dist,
Telangana 501301, India

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ADVERSE EVENT REPORTING

Adverse Event Reporting Form

You may contact to Dano Vaccines & Biologicals Private Limited at:

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