Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Based on data from spontaneous reports, the following events have been reported after Imovax dT was marketed. However, the exact incidence cannot be calculated precisely.

Blood and lymphatic system disorders
Lymphadenopathy.
Immune system disorders
Immediate hypersensitivity reactions such as face oedema, angio-oedema, Quincke’s oedema and anaphylactic reactions.
Nervous system disorders
Headache, feeling of, malaise
Vascular disorders
Hypotension
Skin and subcutaneous tissue disorders
Pruritus, generalised urticaria
Erythema or oedema
Musculoskeletal and connective tissue disorders
Myalgia, arthralgia
General disorders and administration site conditions
Injection site reactions such as pain, rash, induration or oedema mayoccur within 48 hours and lastfor 1 or 2 days. These reactions can sometimes be accompanied by a subcutaneous nodule. Cases of aseptic abscesses have been exceptionally reported.
Temporaryfever.
Malaise.
The majority of allthese reactions were observed in hyperimmunized subjects, particularly when boosters were given too frequently.
Potential undesirable effects
(That is, they have not been reported directly with Imovax dT but with other vaccines containing one or more of the antigenic constituents of Imovax dT): Guillain-Barré syndrome and neuritis after administration of a tetanus toxoid containing vaccine.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health (www.health.gov.il) according to the National Regulation by using an online form https://sideeffects.health.gov.il