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Te Anatoxal Berna Side Effects

Generic name: tetanus toxoid

Note: This document contains side effect information about tetanus toxoid. Some dosage forms listed on this page may not apply to the brand name Te Anatoxal Berna.

Applies to tetanus toxoid: intramuscular solution, intramuscular suspension.

Cardiovascular

Cardiovascular side effects have included hypotension.[Ref]

Dermatologic

Dermatologic side effects have included redness, warmth, edema, induration with or without tenderness as well as urticaria, and rash.[Ref]

Hypersensitivity

Hypersensitivity side effects have rarely included an anaphylactic reaction (i.e., hives, swelling of the mouth, difficulty breathing, hypotension, or shock) following administration of products containing tetanus toxoid (the active ingredient contained in Te Anatoxal Berna) Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8 hours after injection) may occur, particularly in persons who have received multiple prior boosters. Deaths have been reported in temporal association with the administration of tetanus toxoid containing vaccines.[Ref]

General

General side effects have included malaise, transient fever, pain, hypotension, nausea and arthralgia in some patients following an injection.[Ref]

Side effects observed following immunization with vaccines should be reported by healthcare providers to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967.

Healthcare providers also should report these events to the Pharmacovigilance Department, Aventis Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.[Ref]

Nervous system

Nervous system side effects have included neurological complications including cochlear lesion, brachial plexus neuropathies, paralysis of the radial nerve, paralysis of the recurrent nerve, accommodation paresis, Guillain-Barre syndrome, and EEG disturbances with encephalopathy.[Ref]

References

1. Product Information. Tetanus Toxoid Adsorbed (tetanus vaccine). Aventis Pharmaceuticals. 2001;PROD.

2. Product Information. Tetanus Toxoid (tetanus vaccine). Aventis Pharmaceuticals. 2005.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.