Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: A self-controlled case series study

Rahman, Norazida Ab; Lim, Ming Tsuey; Lee, Fei Yee; Lee, Sing Chet; Ramli, Azuana; Saharudin, Siti Nurhafizah; King, Teck Long; Jam, Emelyne Bani Anak; Ayub, Nor Aliya; Sivalingam, Raj Kumar; Bahari, Rashidah; Bahari, Nor Nadziroh.; Mahmud, Farid H; Sivasampu, Sheamini; Peariasamy, Kalaiarasu M

doi:10.1016/j.vaccine.2022.05.075

Cited by 28 publications

(33 citation statements)

References 27 publications

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“…Twenty-three studies reported on 830,585,553 doses of COVID-19 vaccines, 3,23-44 3 studies reported on 154,220,042 doses of HPV vaccines, 6,45,46 5 studies on 513,115,509 doses of influenza vaccines, 25,47-50 2 studies on 4,952,349 doses of acellular pertussis vaccines, 51,52 3 studies on 1,386,209 doses of smallpox vaccines, 50,53,54 and 2 studies on 24,200,000 doses of mixed vaccines (epidemic cerebrospinal meningitis and pneumococcal conjugate vaccine). 55 In the 23 studies involving COVID-19 vaccination, 647,308,174 doses of mRNA vaccines and 183,238,205 doses of non-mRNA vaccines were administered.…”

Section: Resultsmentioning

confidence: 99%

Cardiac Arrhythmia after COVID-19 Vaccination versus Non–COVID-19 Vaccination: A Systematic Review and Meta-Analysis

Shi

Tang

Xia

et al. 2022

Preprint

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Aims: Cardiac arrhythmia is a rare complication after vaccination. Recently, reports of arrhythmia after COVID-19 vaccination have increased. Whether the risk for cardiac arrhythmia is higher with COVID-19 vaccines than with non-COVID-19 vaccines remains controversial. This meta-analysis explored the incidence of arrhythmia after COVID-19 vaccination and compared it with the incidence of arrhythmia after non-COVID-19 vaccination. Methods: We searched the MEDLINE, Scopus, Cochrane Library, and Embase databases for English-language studies reporting the incidence of arrhythmia (the primary endpoint) after vaccination from January 1, 1947 to October 28, 2022. Secondary endpoints included incidence of tachyarrhythmia and all-cause mortality. Subgroup analyses were conducted to evaluate the incidence of arrhythmia by age (children [<18 years] versus adults [≥18 years]), vaccine type (mRNA COVID-19 vaccine versus non-mRNA COVID-19 vaccine; individual non-COVID-19 vaccines versus COVID-19 vaccine), and COVID-19 vaccine dose (first versus second versus third). Random-effects meta-analyses were performed, and the intrastudy risk for bias and the certainty of evidence were evaluated. This study was registered with PROSPERO (CRD42022365912). Results: The overall incidence of arrhythmia from 36 studies (1,528,459,662 vaccine doses) was 291.8 (95% CI 111.6-762.7) cases per million doses. The incidence of arrhythmia was significantly higher after COVID-19 vaccination (2263.4 [875.4-5839.2] cases per million doses; 830,585,553 doses, 23 studies) than after non-COVID-19 vaccination (9.9 [1.3-75.5] cases per million doses; 697,874,109 doses, 14 studies; P<0.01). Compared with COVID-19 vaccines, the influenza, pertussis, human papillomavirus, and acellular pertussis vaccines were associated with a significantly lower incidence of arrhythmia. The incidence of tachyarrhythmia was significantly higher after COVID-19 vaccination (4367.5 [1535.2-12,360.8] cases per million doses; 1,208,656 doses, 15 studies) than after non-COVID-19 vaccination (25.8 [4.5-149.4] cases per million doses; 179,822,553 doses, 11 studies; P<0.01). Arrhythmia was also more frequent after the third dose of COVID-19 vaccine (19,064.3 [5775.5-61,051.2] cases per million doses; 7968 doses, 3 studies) than after the first dose (3450.9 [988.2-11,977.6] cases per million doses; 41,714,762 doses, 12 studies; P=0.05) or second dose (2262.5 [2205.9-2320.7] cases per million doses; 34,540,749 doses, 10 studies; P<0.01). All-cause mortality was comparable between the COVID-19 and non-COVID-19 vaccination groups. Conclusions: The overall risk for arrhythmia after COVID-19 vaccination was relatively low, although it was higher in COVID-19 vaccine recipients than in non-COVID-19 vaccine recipients. This increased risk should be evaluated along with other important factors, such as the incidence of local outbreaks and the risk for arrhythmia due to COVID infection itself, when weighing the safety and efficacy of COVID-19 vaccines.

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Section: Resultsmentioning

confidence: 99%

Cardiac Arrhythmia after COVID-19 Vaccination versus Non–COVID-19 Vaccination: A Systematic Review and Meta-Analysis

Shi

Tang

Xia

et al. 2022

Preprint

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“…The literature search screened 1296 studies of which 102 were reviewed in full text (Figure 1). A total of 43 studies were included in the meta-analyses, of which reported 16,978 cases of myocarditis [7,8, , 28,451 cases of myocardial infarction [8,19,20,43,47,50,[52][53][54][55][56][57][58] and 96,269 cases of cardiac arrhythmia [8,19,21,22,24,43,44] (Table S1). Overall risk of bias in these studies were rated as moderate to high quality (Tables S2 and S3).…”

Section: Search Results and Characteristics Of Included Studiesmentioning

confidence: 99%

“…Such as, a cohort study from the United States [66] concluded that among young men, the pooled incidence rate was highest after the second dose for BNT162b2 and mRNA-1273. However, only a few studies [43,44] reported statistically insignificant risk for myocarditis and the second dose vaccine, especially CoronaVac and ChAdOx1-S vaccine. Most of the studies included in our review did not report on cardiovascular outcomes after receiving the third dose.…”

Section: Discussionmentioning

confidence: 99%

cardiovascular safety of COVID-19 vaccines in real-world studies: a systematic review and meta-analysis

Chang

Liu

et al. 2022

Preprint

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AimsTo assess the association between COVID-19 vaccines and the risk of major adverse cardiovascular events (MACE) in the real world and to provide a reliable evidence-based basis for the cardiovascular safety of COVID-19 vaccines.MethodsWe conducted a comprehensive search in databases from January 1, 2020 to June 15, 2022 for observational studies, that included reporting of MACE and COVID-19 vaccines were included. Random-effects or fixed-effects models were used to estimate the pooled incidence rate and risk ratio of MACE after vaccination. Meta-regression, subgroup analyses, publication bias, sensitivity analyses were performed to evaluate the process and quality of meta-analysis.ResultsThe analyses included data from 43 studies reporting of 16,978 cases, 28,451 cases, and 96,269 cases of myocarditis, myocardial infarction, and cardiac arrhythmia, respectively. The overall incidence rate was 14.8 events per million persons of myocarditis, and 1.73 and 9.6 events per 10,000 persons of myocardial infarction and cardiac arrhythmia after COVID-19 vaccination, respectively. Overall and subgroup analyses showed the increased risks of myocarditis associated with second dose (RR, 2.09; 95%CI: 1.59-2.58), third dose (RR, 2.02; 95%CI: 1.40-2.91), mRNA-1273 (RR, 3.13; 95%CI: 2.11-4.14), or BNT162b2 (RR, 1.57; 95%CI: 1.30-1.85) vaccination. The risk ratios of myocarditis events were more frequently in males than in females (3.44, 2.61-4.54), in younger than in older (2.20, 1.06-4.55). No significant increase risk of myocardial infarction (RR, 0.96; 95%CI: 0.84-1.08) or cardiac arrhythmia (RR, 0.98; 95%CI: 0.84-1.12) events was observed following vaccination. The risk of cardiovascular events (myocarditis, RR, 8.53; myocardial infarction, RR, 2.59; cardiac arrhythmia, RR, 4.47) after SARS-CoV-2 infection was much higher than after vaccination.ConclusionAlthough there is a risk of cardiovascular events following vaccination, the risk was much lower than that following SARS-CoV-2 infection. The benefits of COVID-19 vaccination to the population outweigh the risks in terms of cardiovascular safety assessment.

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“…Between 22,760,698 first-dose Pfizer/BioNTech recipients and 22,978,880 first-dose Oxford/AstraZeneca recipients, events of BP in a 21-day interval after the vaccination was compared (74, 91, 92) (Figure 4). For the analysis from the study by Li et al, only the data obtained from the Spanish database of Information System for Research in Primary Care (SIDIAP) were utilized for data pooling, and the data from the UK was excluded due to database overlapping with the study by Patone et al (91, 92).…”

Section: Resultsmentioning

confidence: 99%

“…The 50 included studies comprised 22 case reports and case series (30,, two selfcontrolled case series (SCCS) (74,75), two case controls (76,77), three cross sectionals (78-80), 16 cohorts (48,(81)(82)(83)(84)(85)(86)(87)(88)(89)(90)(91)(92)(93)(94)(95), and five RCTs (96)(97)(98)(99)(100). A summary of the characteristics of the included studies is represented in Table 1 (case reports and case series are summarized in the supplementary Table S9) and detailed in the supplementary Table S8.…”

Section: Study Characteristicsmentioning

confidence: 99%

Bell’s Palsy Following SARS-CoV-2 Vaccines: A Systematic Review and Meta-Analysis

Rafati

Pasebani

Jameie

et al. 2022

Preprint

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Background and Objective Bell's palsy (BP) has been considered as a serious adverse event following the SARS-CoV-2 vaccination. Many studies have reported BP following vaccination, although neither a causative relationship nor a prevalence of the condition higher than the general population has been established. The outcomes of interest were to compare BP incidence among (a) SARS-CoV-2 vaccine recipients, (b) nonrecipients in the placebo or unvaccinated cohorts, (c) different types of SARS-CoV-2 vaccines, and (d) SARS-CoV-2 infected vs. SARS-CoV-2 vaccinated individuals. Methods We performed a systematic search through MEDLINE (via PubMed), Web of Science, Scopus, Cochrane library, and Google Scholar from the inception to August 15, 2022. We included articles reporting individuals receiving any SARS-CoV-2 vaccine in whom BP had occurred. Studies reporting facial paralysis due to etiologies other than BP were excluded. Random- and fixed-effects meta-analyses using the Mantel-Haenszel method were conducted for the quantitative synthesis. Newcastle-Ottawa scale (NOS) was used to assess the quality. The study was conducted in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline, and the protocol was registered with PROSPERO (CRD42022313299). Analyses were carried out using the R, version 4.2.1 (R package 'meta' version 5.2-0). Results Fifty studies were included, of which 17 entered the quantitative synthesis. First, pooling four phase-3 randomized controlled trials (RCT) indicated BP occurrence was significantly higher in SARS-CoV-2 vaccines (77, 525 doses) compared to placebo (66, 682 doses) (OR = 3.00, 95% CI = 1.10 - 8.18, I2 = 0%). Second, pooling nine observational studies of mRNA SARS-CoV-2 vaccine doses (13, 518,026) and matched unvaccinated individuals (13, 510,701) revealed no significant increase in the odds of BP in the vaccinated group compared to the unvaccinated group (OR: 0.70 (95% CI 0.42-1.16), I2=94%). The third meta-analysis suggested that post-vaccination BP among first dose Pfizer/BioNTech recipients (22,760,698) did not significantly differ from that in first dose Oxford/AstraZeneca recipients (22,978,880) (OR = 0.97, 95% CI = 0.82 - 1.15, I2 = 0%). According to the fourth meta-analysis, BP was significantly more commonly reported after SARS-CoV-2 infection (2,641,398) than after SARS-CoV-2 vaccinations (36,988,718) (RR = 4.03, 95% CI = 1.78 - 9.12, I2 = 96%). Conclusion Our meta-analysis suggests a higher incidence of BP among vaccinated vs. placebo groups. BP occurrence did not significantly differ between Pfizer/BioNTech and Oxford/AstraZeneca vaccines. SARS-CoV-2 infection posed a significantly greater risk for BP than SARS-CoV-2 vaccines.

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Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: A self-controlled case series study

Cited by 28 publications

References 27 publications

Cardiac Arrhythmia after COVID-19 Vaccination versus Non–COVID-19 Vaccination: A Systematic Review and Meta-Analysis

Cardiac Arrhythmia after COVID-19 Vaccination versus Non–COVID-19 Vaccination: A Systematic Review and Meta-Analysis

cardiovascular safety of COVID-19 vaccines in real-world studies: a systematic review and meta-analysis

Bell’s Palsy Following SARS-CoV-2 Vaccines: A Systematic Review and Meta-Analysis

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