The Canadian Press

Evan Tordorf, 4, cries as he gets his flu shot as his mother and Karen Joly looks on at a H1N1 vaccination centre Friday, November 6, 2009 in Montreal. (THE CANADIAN PRESS/Ryan Remiorz)

TORONTO — The Public Health Agency of Canada says there have been 48 cases of a severe allergic reaction reported in people who have had H1N1 shots.

The agency says that was as of the week of Nov. 20, when nearly 12.3 million doses of vaccine had been distributed across the country.

The rate of anaphylactic reactions is 0.39 per 100,000 doses, which the agency says doesn't exceed the normal rate seen for the administration of vaccines.

Anaphylaxis is the type of severe allergic reaction seen in people with severe food or insect sting allergies and must be treated quickly with adrenaline.

The Public Health Agency says one of the cases of anaphylaxis was fatal and is being investigated.

One lot of GlaxoSmithKline's pandemic vaccine was put on hold because it was linked to a higher-than-normal number of cases of anaphylaxis.

The agency says seven of the cases of anaphylaxis were in people who received shots from that batch of vaccine.

The agency says the investigation into whether there was a problem with that lot is still ongoing.