Introduction: Hypertension is a serious disease that occurs when blood pressure is persistently elevated over time1. During the COVID- 19 vaccination campaign, several reports of hypertension occurred in plausible temporal relationship with immunization have been reported. Objective: To explore a possible signal of risk of hypertension associated with COVID-19 immunization using VigiBase the World Health Organization (WHO) pharmacovigilance database and to review the evidence available from real world. Methods: We performed a disproportionality analysis using data on spontaneous reports recorded in VigiBase . Data have been extract on May 8th, 2022. We calculated reporting odds ratio (ROR) as a measure of disproportionality for hypertension defined by the Standardized Medical Dictionary for Regulatory Activities (MedDRA) query (SMQ) narrow. ROR was estimated for all reports including the MedDRA preferred term (PT) ‘‘hypertension’’, ‘‘blood pressure increased’’ and ‘‘hypertensive crisis’’ (cases). All other reports have been defined as non-cases. All reports in which the suspected causative agent was a COVID-19 vaccine were used as index reports and all other reports as reference. A signal was defined by at least three reports of the PT of interest and ROR025[1. We reviewed the medical literature using MEDLINE from January 2021 to May 2022 using ‘‘COVID-19 vaccines’’ AND ‘‘hypertension’’ as a search terms to check for evidence from observational studies. Results: As of May 8th, 2022, VigiBase included 3,746,090 reports of adverse events following immunization for COVID-19 vaccines and 87,653 de-duplicated reports of hypertension define by the SMQ. We identified 34,955 reports of ‘‘hypertension’’ (ROR:1.3; ROR025:1.2), 47,733 reports of ‘‘blood pressure increased’’ (ROR:2.6; ROR025:2.6) and 3,741 reports of ‘‘hypertensive crisis’’ (ROR:4.0; ROR025:3.8) in which a COVID-19 vaccine was indicated as suspected causative agent. Most frequently co-reported symptoms ([9%) included headache (n = 16.817; 19.2%), dizziness (n = 12,892; 14.7%), fatigue (n = 8,406; 9.6%). Overall, 75% of cases (n = 65,761) have been classified as not serious. A meta-analysis of observational studies that includes 357,387 individuals reported 13,444 events of blood pressure abnormal or increased2. These events have been often described as short periods of hypertensive response and often observed in patients with risk factors. Conclusion: Our results confirmed a signal of risk of events of elevated blood pressure following immunization with COVID-19 vaccines. However, there is no evidence that these episodes could result in serious complication typically associated with hypertension, such as stroke, aneurysms, heart failure, myocardial infarction and chronic kidney disease.
Oral Presentation: Signal of Hypertension Associated with COVID-19 Vaccination: VigiBase (R) Data and Evidence from Real World
Bonaso, M.;Valdiserra, G.;Cappello, E.;Convertino, I.;Ferraro, S.;Tuccori, M.
2022-01-01
Abstract
Introduction: Hypertension is a serious disease that occurs when blood pressure is persistently elevated over time1. During the COVID- 19 vaccination campaign, several reports of hypertension occurred in plausible temporal relationship with immunization have been reported. Objective: To explore a possible signal of risk of hypertension associated with COVID-19 immunization using VigiBase the World Health Organization (WHO) pharmacovigilance database and to review the evidence available from real world. Methods: We performed a disproportionality analysis using data on spontaneous reports recorded in VigiBase . Data have been extract on May 8th, 2022. We calculated reporting odds ratio (ROR) as a measure of disproportionality for hypertension defined by the Standardized Medical Dictionary for Regulatory Activities (MedDRA) query (SMQ) narrow. ROR was estimated for all reports including the MedDRA preferred term (PT) ‘‘hypertension’’, ‘‘blood pressure increased’’ and ‘‘hypertensive crisis’’ (cases). All other reports have been defined as non-cases. All reports in which the suspected causative agent was a COVID-19 vaccine were used as index reports and all other reports as reference. A signal was defined by at least three reports of the PT of interest and ROR025[1. We reviewed the medical literature using MEDLINE from January 2021 to May 2022 using ‘‘COVID-19 vaccines’’ AND ‘‘hypertension’’ as a search terms to check for evidence from observational studies. Results: As of May 8th, 2022, VigiBase included 3,746,090 reports of adverse events following immunization for COVID-19 vaccines and 87,653 de-duplicated reports of hypertension define by the SMQ. We identified 34,955 reports of ‘‘hypertension’’ (ROR:1.3; ROR025:1.2), 47,733 reports of ‘‘blood pressure increased’’ (ROR:2.6; ROR025:2.6) and 3,741 reports of ‘‘hypertensive crisis’’ (ROR:4.0; ROR025:3.8) in which a COVID-19 vaccine was indicated as suspected causative agent. Most frequently co-reported symptoms ([9%) included headache (n = 16.817; 19.2%), dizziness (n = 12,892; 14.7%), fatigue (n = 8,406; 9.6%). Overall, 75% of cases (n = 65,761) have been classified as not serious. A meta-analysis of observational studies that includes 357,387 individuals reported 13,444 events of blood pressure abnormal or increased2. These events have been often described as short periods of hypertensive response and often observed in patients with risk factors. Conclusion: Our results confirmed a signal of risk of events of elevated blood pressure following immunization with COVID-19 vaccines. However, there is no evidence that these episodes could result in serious complication typically associated with hypertension, such as stroke, aneurysms, heart failure, myocardial infarction and chronic kidney disease.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
