What should be documented if a vaccine is given off-label?

When a vaccine is administered off-label, it is essential to document the rationale for the off-label use along with any relevant patient information. This is critical for several reasons.

Firstly, the documentation serves to explain the clinical reasoning behind the decision to use the vaccine outside of its approved indications, which could be important for the health care team's understanding and continuity of care. It also provides a clear record that can be vital for any future health care needs of the patient or in the event of an adverse reaction.

Additionally, including relevant patient information, such as contraindications, allergies, or other medical history, supports the clinical decision-making process and ensures safe and appropriate care. This thorough documentation is especially important in the context of off-label use, as it highlights the specific considerations that were taken into account when deciding to administer the vaccine in this manner. Ultimately, maintaining accurate and comprehensive records contributes to patient safety and quality of care.