Special Investigation of COMIRNATY in the Population With Underlying Diseases

Primary outcomes

1. Proportion of Participants With Adverse Reactions

   Time frame: From the date of the first dose to 28 days after the second dose, up to approximately 49 days.

   An adverse reaction was any untoward medical occurrence attributed to COMIRNATY in a participant who was vaccinated with COMIRNATY. Relatedness to COMIRNATY was assessed by the physician. The proportion of adverse reactions was presented for the overall observation period, the observation period from the date of the first dose of Comirnaty up to 28 days after the second dose, and the observation period from the date of Dose 1 up to 28 days after Dose 2.

2. Proportion of Participants With Serious Adverse Reactions

   Time frame: From the date of the first dose to 28 days after the second dose, up to approximately 49 days.

   A serious adverse reaction was any untoward medical occurrence attributed to COMIRNATY resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician. The proportion of serious adverse reactions was presented for the overall observation period, the observation period from the first to the second vaccination, and the observation period from the date of Dose 1 up to 28 days after Dose 2.

3. Proportion of Participants With Local Reactions and Systemic Reactions (The First Vaccination)

   Time frame: Within 8 days after the date of the first dose.

   Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the first vaccination was collected from 1035 participants of the 1038 safety analysis set participants.

4. Proportion of Participants With Local Reactions and Systemic Reactions (The Second Vaccination)

   Time frame: Within 8 days after the date of the second dose.

   Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the second vaccination was collected from 1026 participants of the 1032 participants who received the second vaccination with Comirnaty.