Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination.
Vaccine Safety Datalink System
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The Centers for Disease Control and Prevention (CDC) says that a preliminary COVID-19 vaccine “safety signal” has been identified and is investigating whether the Bivalent Pfizer-BioNTech vaccine creates an increased risk of ischemic stroke in people 65 and older.
In the Friday statement, the CDC said that the preliminary signal hasn’t been identified with the Bivalent Moderna COVID-19 vaccine.
From 14 December 2020 through 31 May 2022 (persons 18–39 years) and 20 August 2022 (persons 5–17 years), 320 potential cases of myocarditis/pericarditis were identified 1 to 98 days after 6 992 340 vaccine doses as part of primary series COVID-19 vaccination, with 224 (70%) verified. Of these, 137 (61%) occurred 0 to 7 days after vaccination; 18 were after the first dose (of 3 562 311 doses administered) and 119 were after the second dose (of 3 430 029 doses administered).
In all age groups, incidence per million doses 0 to 7 days after vaccination was numerically higher in male than in female persons and after dose 2, although confidence intervals were wide and overlapped across sex for some age groups. Incidence was highest for male adolescents ages 12 to 15 years and 16 to 17 years following dose 2.
From 24 September 2021 through 20 August 2022, 101 potential cases of myocarditis/pericarditis were identified 1 to 98 days after 1 848 723 first booster doses, with 77 (76%) verified with a median onset of 4.5 days after vaccination; 39 cases (51%) were verified in the first week versus 38 during the subsequent 13 weeks.
In all age groups, incidence 0 to 7 days after first booster was higher for male compared to female persons, with adolescent males having the highest incidence in 16- to 17-year-olds and in 12- to 15-year-olds. In adults for whom both vaccine products were available, post-booster incidence was higher in male than in female adults and higher in males aged 18 to 29 compared to males aged 30 to 39.
http://archive.today/2022.10.06-094825/https://www.acpjournals.org/doi/10.7326/M22-2274
Thousands of American teenagers may have suffered heart inflammation after getting a Covid jab, a study suggests.
Researchers found up to one in 7,000 boys aged 12 to 15 years old developed myocarditis after receiving the Pfizer vaccine.
The condition — which is mild for most but can cause a recurrent heart palpitation in rare cases — was most common after the second dose.
http://archive.today/2022.10.03-220645/https://www.dailymail.co.uk/health/article-11275889/Up-one-7-000-American-teens-suffered-heart-inflammation-Covid-vaccine.html