A vaccine safety monitoring system in late November picked up a signal that the updated Pfizer coronavirus vaccine booster was possibly linked to an increased risk of strokes in people 65 and older.
Los Angeles, CA - April 15: Liesl Eibschutz, a medical student from Dartmouth University, loads a syringe with Pfizer COVID-19 vaccine before giving it to people on the first day that people ages 16 and up can receive the vaccine at Kedren Health on Thursday, April 15, 2021 in Los Angeles, CA.
Government vaccine safety experts have combed through databases containing millions of records in the United States and consulted with regulators in other countries but have not found any indication that the statistical signal represents a clinical risk to patients. They said they would continue to analyze the data.
The signal was detected in the Vaccine Safety Datalink, a collaboration involving the CDC and about a dozen health-care organizations with electronic health records on 12 million people. As part of routine monitoring for possible adverse events, officials noticed late last year that they were picking up indications of higher-than-expected stroke risk, officials said.
"Although the totality of the data currently suggests that it is very unlikely that the signal . . . represents a true clinical risk," the statement said, "we believe it is important to share this information with the public."
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