Anaphylaxis, sometimes referred to as anaphylactic shock, is a severe, potentially life-threatening reaction to an allergen. It affects the entire body, and its symptoms include skin rash, shortness of breath, nausea, vomiting, and anxiety, among others. A recent report describes the incidence of anaphylactic shock following immunization with the Pfizer-BioNTech coronavirus vaccine.
The Pfizer-BioNTech vaccine, also known by its generic name tozinameran or its brand name Comirnaty, induces an immune response against SARS-CoV-2, the virus responsible for COVID-19. A clinical trial involving more than 43,000 people demonstrated that the vaccine has an efficacy rate of 95 percent in preventing the disease. The most common reactions to the vaccine were injection site reactions, fatigue, headache, muscle pain, chills, joint pain, and fever.
The Centers for Disease Control and Prevention (CDC) report that some severe reactions have occurred. As of December 23, 2020, nearly 1.9 million people in the United States had received their first dose of Pfizer-BioNTech vaccine. Of these, 21 experienced anaphylaxis (a rate of 11.1 people per one million doses), including 17 in people with a documented history of allergies or allergic reactions, seven of whom had a history of anaphylaxis. The onset of anaphylactic symptoms in most of the people was 13 minutes (with a range of two to 150 minutes). The CDC reported that of the 20 people for whom follow-up information was available, all had recovered.
The findings presented in this report suggest that the Pfizer-BioNTech vaccine has an excellent safety profile and is safe for most people. However, the CDC recommends that vaccination locations should take the following precautions: ensure that necessary supplies are available to manage anaphylaxis; screen potential vaccine recipients to identify those who require extra precautions; establish post-vaccine observation periods (15 to 30 minutes, depending on patient history); ensure that healthcare providers can recognize the signs and symptoms of anaphylaxis early; and immediately treat suspected anaphylaxis with epinephrine.
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