Based on spontaneous reporting, the following adverse events have been reported during the commercial use of TETAVAX. These events have been very rarely (< 0.01%) reported, however exact incidence rates cannot precisely be calculated.
Blood and lymphatic system disorders:
Immune system disorders:
Type I hypersensitivity reactions.
Nervous system disorders:
Hypotension (within a context of reaction of type I hypersensitivity).
Skin and subcutaneous tissue disorders:
Allergic-like symptoms, such as urticaria, generalized pruritus, or erythema.
Musculoskeletal and connective tissue disorders:
General disorders and administration site condition:
Injection site reactions such as pain, rash, induration or oedema, which can occur within 48 hours and persist for one of two days. A subcutaneous nodule can sometimes accompany these reactions. Cases of aseptic abscesses have exceptionally been reported. The incidence and severity of local reactions may be influenced by the site, the method and route of administration as well as by the number of previous doses received.
All these reactions have been observed more frequently in hyper immunized subjects; particularly in the case of over-frequent boosters.
Potential adverse events (i.e., adverse events which have not been reported directly with Tetavax, but with other vaccines containing one or more of the antigenic constituents of TETAVAX): Neurological disorders resulting from a vaccination against diphtheria and/or tetanus are extremely rare and no causal relationship has been clearly demonstrated.
Brachial neuritis and Guillain Barré Syndrome after administration of a tetanus toxoid containing vaccine.
Apnoea in very premature infants (born ≤ 28 weeks of gestation) (see Precautions). As this vaccine contains thiomersal (an organomercuric compound) as preservative, hypersensitivity reactions may occur (Refer to contraindications).