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The goal of this study is to confirm the onset status of hypersensitivity reactions including shock and anaphylaxis observed after vaccination with this drug in persons with underlying diseases who are considered to have a high risk of severe exacerbation of COVID-19 and explore risk factors.
Data collected from the JDMC Claims Database between May 2021 to November 2021.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants received 2 doses of mRNA-1273 vaccine approximately 4 weeks apart. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Either Dose 1 and Dose 2 | Up to 2 days post vaccination after either the first or second vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 1 | Up to 2 days post vaccination | |
| Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 2 | Up to 2 days post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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The study population was selected from participants who were registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database whose start date of observation in the claim database was within 6 months or more before vaccination with mRNA-1273 vaccine, and those who met the definition of underlying disease based on the claim data for 6 months.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMIC Co., Ltd. | Tokyo | Japan |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D014777 | Virus Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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