Reporting side effects following vaccination with Panvax® H1N1
Pandemic (H1N1) 2009 influenza
Updated 16 December 2009
This page links to the form that the Therapeutic Goods Administration (TGA) uses to collect information about adverse reactions (side effects) to Panvax® H1N1 and Panvax H1N1 Junior®.
The TGA is monitoring all adverse reactions following vaccination with Panvax® H1N1 and Panvax H1N1 Junior®. Individuals or health professionals are encouraged to report by:
- Using the online reporting form (link available below), or
- Calling 18 02 007
Reports are welcome from individuals and health professionals.
If you are feeling unwell, or are concerned, you should seek medical advice from your doctor. If you feel it is serious you may need to call an ambulance by dialling '000' or go to your nearest hospital.
Information on Pandemic (H1N1) 2009 Influenza is available at www.healthemergency.gov.au.
Confidentiality
Information identifying the person who has received the vaccine or the person reporting the adverse reaction will not be made available to the public. The TGA is asking for contact information on the reporting form in case we need to contact you for follow-up information after your initial report is received. Please note that your report will be acknowledged if you provide contact information but not all reports will be followed up individually.
If you are reporting a side effect that you or your child has experienced, the TGA reporting form has a field where you can enter your or your child's Medicare number. You do not have to give us your Medicare number but it may help the TGA to analyse the data.
Information supplied in this online form will be securely transmitted to the TGA.
Before you begin
To allow us to effectively monitor the safety of Panvax® H1N1 and Panvax H1N1 Junior® the TGA needs to be able to analyse all reports received. To do this the TGA needs:
- Some basic information about who has experienced the adverse reaction: their age, gender, the State where they live, etc.
- Which vaccine was administered.
- Information about the adverse reaction(s):
- A description of the adverse reaction(s)
- When the vaccine was administered
- When the adverse reaction was first noticed
- Details of any treatment or investigations
General
You should complete a separate form for each person who has experienced an adverse reaction. Please try to provide as much information as you can.
Information to help you complete the form
Items marked with a red star * are essential and must be completed. Dates must be entered in DD/MM/YYYY Format.
Specific instructions
| Section | Sub-section | Information |
|---|---|---|
| Patient details | Please enter the details of the person who has experienced the adverse reaction. | |
| Medicine details | Please choose which vaccine you are reporting an adverse reaction to, Panvax H1N1 or Panvax H1N1 Junior. If you are not sure which vaccine was administered select Panvax H1N1. | |
| Add Additional Medicine Details | Please list any other vaccines that the person received in the two months prior to the onset of the adverse reaction. Also, please list any prescription or non-prescription medicines the person was taking when they received the vaccine. | |
| Reaction Details | Date vaccine received | Please enter the date the vaccine was given (dd/mm/yyyy) |
| Batch # | Information on the Batch number (#) will be available to health professionals. If you are not aware of the Batch # it is not necessary to include it. | |
| Adverse Reaction Description |
If the patient is under 10 years of age, please indicate whether the suspected reaction occurred after the first or second dose of the vaccine. Describe the suspected adverse reaction. Such things as temperature, any symptoms, when you first noticed them and whether they have changed over time should be noted. |
|
| Treatment of Reaction | Describe any treatment you have received, how you have managed the symptoms and whether the symptoms have recovered. Such things as a visit to a healthcare professional, rest, specific medicines taken to relieve fever or discomfort, or applying a cold compress to the injection site should be noted. | |
| Laboratory Notes (if any) | If any laboratory testing has been performed, please note any results here. Leave blank if no laboratory tests were performed. You may also attach test results as a supporting document if you have them in electronic form. | |
| Supporting Documents | This may include a more detailed description of the side effects or any laboratory test results, for example. | |
| Reporter Details | Please enter your details here. The TGA will send you an acknowledgement if you provide your email address. It will not be possible for the TGA to provide personal responses to each adverse event report. The TGA is asking for contact information on the reporting form in case we need to contact you for follow-up information after your initial report is received. | |
About reporting an adverse reaction
The Australian Adverse Drug Reaction Reporting System (ADRS) is a post-marketing safety surveillance program, collecting information about side effects of medicines and vaccines.
When reports of adverse reactions are received, they are entered into a national H1N1 database. The information will be reviewed by professional and medical staff to identify any unusual patterns of adverse reactions. If these are identified, further investigation will be undertaken to determine whether the adverse reaction is related to the vaccine (not all symptoms or conditions occurring around the time of vaccination will be caused by the vaccine itself).
If any concerns about the safety of the vaccine are identified then a decision will be made as to whether any regulatory action is needed.
Link to online reporting form
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