Incidence of outcomes relevant to vaccine safety monitoring in a US commercially-insured population

Esposito, Daina B.; Titievsky, Lina; Beachler, Daniel C.; Hawes, Jennifer; Istúriz, Raúl; Scott, Daniel A.; Gangemi, Kelsey; Maroko, Robert; Hall-Murray, Cassandra; Lanes, Stephan

doi:10.1016/j.vaccine.2018.10.052

Cited by 9 publications

(8 citation statements)

References 11 publications

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“…In the surveillance system for adverse effects following immunization (AEFI) in Victoria, Australia [18], females accounted for 55% of reports overall, and 80% of adults. Using vaccine safety claim databases, the risk of the 32 outcomes were often highest in females and adults ≥ 65 [19]. In a study of the risk of fever and rash following MMR vaccination in infants, it was higher in females, after controlling for background morbidity [20].…”

Section: Discussionmentioning

confidence: 99%

“…In one study, there were no differences in the frequency and severity of adverse events associated with gender after the first and second doses of the vaccine [12]. In another study of an inactivated virus COVID-19 vaccine (Sinovac COVID- 19), the frequency of adverse events was higher among female medical staff [13]. In a recent study on the 75 clinical trials on different types of COVID-19 vaccines, 24% reported their main results disaggregated by gender, and only 13% mentioned the implications of their study for females and males [14].…”

Section: Introductionmentioning

confidence: 99%

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Gender Differences in Adverse Events Following the Pfizer-BioNTech COVID-19 Vaccine

et al. 2022

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Age and gender disaggregated data on reports of adverse events following two or three doses of the Pfizer-BioNTech COVID-19 vaccine were obtained from four cross-sectional studies. The first was from reports submitted to the Israel Ministry of Health national adverse events database (for ages 16 and above). The second was from a national cross-sectional survey based on an internet panel (for ages 30 and above), and the third and fourth were from cross-sectional surveys among employees of a large company (for ages 20–65) using links to a self-completed questionnaire. Results: In all studies, the risks of adverse events were higher following the second dose and consistently higher in females at all ages. The increased risk among females at all ages included local events such as pain at the injection site, systemic events such as fever, and sensory events such as paresthesia in the hands and face. For the combined adverse reactions, for the panel survey the female-to-male risk ratios (RRs) were 1.89 for the first vaccine dose and 1.82 for the second dose. In the cross-sectional workplace studies, the female-to-male RRs for the first, second and third doses exceeded 3.0 for adverse events, such as shivering, muscle pain, fatigue and headaches. Conclusions: The consistent excess in adverse events among females for the mRNA COVID-19 vaccine indicates the need to assess and report vaccine adverse events by gender. Gender differences in adverse events should be taken into account when determining dosing schedules.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Gender Differences in Adverse Events Following the Pfizer-BioNTech COVID-19 Vaccine

et al. 2022

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“…In claims research, diagnosis, procedure, and prescription dispensing codes are used to reconstruct patients’ medical histories. As such, claims diagnoses are subject to misclassification and incidence estimates can vary widely based on the case definition used – a rate based on a definition that is very sensitive but not specific may be an overestimate, while a rate based on a definition that is specific but poorly sensitive may be an underestimate [ 21 ]. This is particularly relevant given that some of the outcomes used in the current study are based on clinical characteristics that are less likely to be assigned a diagnosis code (e.g., nausea, fatigue), and therefore would be captured in a claims database with poor sensitivity.…”

Section: Discussionmentioning

confidence: 99%

A real-world study on characteristics, treatments and outcomes in US patients with advanced stage ovarian cancer

et al. 2020

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Background Detailed epidemiologic descriptions of large populations of advanced stage ovarian cancer patients have been lacking to date. This study aimed to describe the patient characteristics, treatment patterns, survival, and incidence rates of health outcomes of interest (HOI) in a large cohort of advanced stage ovarian cancer patients in the United States (US). Methods This cohort study identified incident advanced stage (III/IV) ovarian cancer patients in the US diagnosed from 2010 to 2018 in the HealthCore Integrated Research Database (HIRD) using a validated predictive model algorithm. Descriptive characteristics were presented overall and by treatment line. The incidence rates and 95% confidence intervals for pre-specified HOIs were evaluated after advanced stage diagnosis. Overall survival, time to treatment discontinuation or death (TTD), and time to next treatment or death (TTNT) were defined using treatment information in claims and linkage with the National Death Index. Results We identified 12,659 patients with incident advanced stage ovarian cancer during the study period. Most patients undergoing treatment received platinum agents (75%) and/or taxanes (70%). The most common HOIs (> 24 per 100 person-years) included abdominal pain, nausea and vomiting, anemia, and serious infections. The median overall survival from diagnosis was 4.5 years, while approximately half of the treated cohort had a first-line time to treatment discontinuation or death (TTD) within the first 4 months, and a time to next treatment or death (TTNT) from first to second-line of about 6 months. Conclusions This study describes commercially insured US patients with advanced stage ovarian cancer from 2010 to 2018, and observed diverse treatment patterns, incidence of numerous HOIs, and limited survival in this population.

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“…Claims databases have been used to estimate baseline incidence rates of adverse events of interest that could arise after the introduction of new vaccines [19,20]. How these events are defined within the database has an important impact on the estimates obtained.…”

Section: Plos Onementioning

confidence: 99%

“…On the other hand, ICD-10 codes can lead incomplete capture of diagnoses if they are present in the medical record but not transcribed into an ICD code. A study of potential vaccine-associated adverse events in the United States found that incidence rates of adverse events were higher when more sensitive case definitions were employed compared to more specific definitions [19]. Conditions with a high degree (>90%) of concordance between sensitive and specific conditions included autoimmune hepatitis and cardiac conditions, while <20% concordance was observed for haemolytic anaemia, pancytopenia and acute disseminated encephalitis [19].…”

Section: Plos Onementioning

confidence: 99%

The incidence of thrombosis with co-occurring thrombocytopenia prior to the SARS-CoV2 pandemic: A population-based study

Liu,

Goh,

Shen

et al. 2024

PLoS ONE

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Background Thrombosis with thrombocytopenia syndrome (TTS) is a very rare prothrombotic disorder that is a safety concern for some COVID-19 vaccines. We aimed to devise a case definition to estimate the incidence of thrombosis with thrombocytopenia as a proxy for TTS in a national insurance claims database. Methods We conducted a retrospective observational study using the National Health Insurance Research Database (NHIRD) in Taiwan over the three-year period prior to the SARS-COV-2 pandemic (2017–2019). Our case definition was all patients with newly diagnosed thrombosis co-occurring with a diagnosis of thrombocytopenia within seven days before or after the thrombosis diagnosis. Cases were identified using International Classification of Disease-10 codes. Findings We identified 2010 patients with newly diagnosed thrombosis co-occurring with thrombocytopenia during the study period. The mean age was 64.71 years; female:male ratio 1:1.45. The most frequent thrombotic events were coronary artery disease (18.81%), cerebral infarction (16.87%), and disseminated intravascular coagulation (13.13%). Cerebral venous sinus thrombosis was rare (<0.1%). The average annual incidence rate of co-occurring new diagnoses of thrombosis and thrombocytopenia was 2.84 per 100 000 population. Incidence rates were higher in men than women, except in 20–39 year-olds (higher in females). 20.6% of patients died within the first month after diagnosis. Interpretation We observed that the demographic and clinical characteristics of thrombosis with co-occurring thrombocytopenia using our case definition is different from that of TTS. Further research is needed to refine the case definition of TTS in the post-COVID-19 vaccination period.

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Incidence of outcomes relevant to vaccine safety monitoring in a US commercially-insured population

Cited by 9 publications

References 11 publications

Gender Differences in Adverse Events Following the Pfizer-BioNTech COVID-19 Vaccine

Gender Differences in Adverse Events Following the Pfizer-BioNTech COVID-19 Vaccine

A real-world study on characteristics, treatments and outcomes in US patients with advanced stage ovarian cancer

The incidence of thrombosis with co-occurring thrombocytopenia prior to the SARS-CoV2 pandemic: A population-based study

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