Side effects of COVID-19 vaccines: a systematic review and meta-analysis protocol of randomised trials

Medeiros, Kleyton Santos de; Costa, Ana Paula Ferreira; Sarmento, Ayane Cristine Alves; Freitas, Cijara Leonice de; Gonçalves, Ana Katherine

doi:10.1136/bmjopen-2021-050278

Cited by 26 publications

(25 citation statements)

References 34 publications

(32 reference statements)

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“…Indeed, this study emphasizes the importance patient-centered care and the employment of technology in telemedicine which can facilitate health-care providers and patients alike. Notably, the results of this study align with the low occurrence of major AEs after COVID-19 vaccination (18)(19)(20)(21)(22)(23). The reported AEs in relation to vaccine doses were 53,910 (75.42%), 17,369 (24.30%), and 201 (0.28%) after the first, second, and third vaccine dose, respectively.…”

Section: Discussionsupporting

confidence: 83%

Pattern of self-reported adverse events related to COVID-19 vaccines in Saudi Arabia: A nationwide study

Alkhalifah

Seraihi

Al‐Tawfiq

et al. 2023

Front. Public Health

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BackgroundVaccination against coronavirus disease 2019 (COVID-19) is the most effective way to end the pandemic. Any development of adverse events (AEs) from various vaccines should be reported. We therefore aimed to explore major and minor AEs among vaccinated individuals in Saudi Arabia.MethodsThis is a nationwide report based on the Saudi Arabian Ministry of Health (MOH) registry. It included those who received COVID-19 vaccines from 17th December 2020 to 31st December 2021. The study included spontaneous self-reported adverse effects to COVID-19 vaccines where the study participants used a governmental mobile app (Sehhaty) to report their AEs following vaccination using a checklist option that included a selection of side-effects. The primary outcome was to determine AEs reported within 14 days of vaccination which included injection site itching, pain, reaction, redness, swelling, anxiety, dizziness, fever, headache, hoarseness, itchiness, loss of consciousness, nausea, heartburn, sleep disruption, fatigue, seizures, anaphylaxis, shortness of breath, wheezing, swelling of lips, face, and throat, loss of consciousness, and admissions into the intensive care unit (ICU).ResultsThe study included a total number of 28,031 individuals who reported 71,480 adverse events (AEs); which were further classified into minor and major adverse events including ICU admissions post vaccination. Of the reported AEs, 38,309 (53. 6%) side-effects were reported following Pfizer-BioNTech, 32,223 (45%) following Oxford-AstraZeneca, and 948 (1.3%) following Moderna. The following reported AEs were statistically significant between the different vaccine types: shortness of breath\difficulty of breathing, dizziness, fever above 39°C, headache, hoarseness, injection site reactions, itchiness, nausea, sleep disruption, fatigue, wheezing, swelling of lips/face and\or throat, and loss of consciousness (p-value < 0.05). Fever and seizure were the only statistically significant AEs amongst the number of vaccine doses received (p-value < 0.05). Ten ICU admissions were reported in the 14 days observation period post-COVID-19 vaccination with the following diagnoses: acute myocardial infarction, pneumonia, atherosclerosis, acute respiratory failure, intracranial hemorrhage, grand mal seizure, Guillain-Barré syndrome, abnormal blood gas levels, and septic shock.ConclusionThis study demonstrated that the most prevalent SARS-CoV-2 vaccine side-effects among adults in Saudi Arabia were mild in nature. This information will help reduce vaccine hesitancy and encourage further mass vaccination to combat the COVID-19 pandemic, especially as booster doses are now available. Further studies are warranted to obtain a better understanding of the association between risk factors and the experiencing of side-effects post vaccination.

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Section: Discussionsupporting

confidence: 83%

Pattern of self-reported adverse events related to COVID-19 vaccines in Saudi Arabia: A nationwide study

Alkhalifah

Seraihi

Al‐Tawfiq

et al. 2023

Front. Public Health

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“…The World Healthcare Organization (WHO) approved the first vaccine (Pfizer/BioNTech) through emergency validation on 31 December 2020. Currently, around 200 COVID-19 vaccines are at various stages of pre-clinical and clinical trials [25]. Since vaccines were produced in a record time, various researchers have prioritized the investigations of their safety profile.…”

Section: Discussionmentioning

confidence: 99%

Surveillance of Post-Vaccination Side Effects of COVID-19 Vaccines among Saudi Population: A Real-World Estimation of Safety Profile

Alzarea

Khan²,

Alatawi³

et al. 2022

Vaccines

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Vaccines are considered to be the most beneficial means for combating the COVID-19 pandemic. Although vaccines against SARS-CoV-2 have demonstrated excellent safety profiles in clinical trials, real-world surveillance of post-vaccination side effects is an impetus. The study investigates the short-term side effects following the administration of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines in Saudi Arabia. A cross-sectional quantitative study was conducted among the general population with age ≥ 18 years, from five regions (Central, Northern, Eastern, Southern, and Western Regions) of Saudi Arabia for a period of 6 months (July to December 2021). A self-administered study instrument was used to record the side effects among the COVID-19 vaccine recipients. Of the total 398 participants (males: 59%), 56.3% received Pfizer and 43.7% were vaccinated with AstraZeneca. Only 22.6% of respondents received the second dose of the COVID-19 vaccines. The most commonly reported side effects were pain at the injection site (85.2%), fatigue (61.8%), bone or joint pain (54.0%), and fever (42.5%). The average side effects score was 3.4 ± 2.2. Females, young people, and Oxford-AstraZeneca recipients had a higher proportion of side effects. The Oxford-AstraZeneca vaccine recipients complained more about fever (p < 0.001), bone and joint pain (p < 0.001), fatigue (p < 0.001), loss of appetite (p = 0.001), headache (p = 0.008), and drowsiness (p = 0.003). The Pfizer-BioNTech vaccinees had more pain and swelling at the injection site (p = 0.001), and sexual disturbance (p = 0.019). The study participants also reported some rare symptoms (<10%) including heaviness, sleep disturbance, fainting, blurred vision, palpitations, osteomalacia, and inability to concentrate. This study revealed that both Pfizer-BioNTech and Oxford-AstraZeneca administration was associated with mild to moderate, transient, short-lived side effects. These symptoms corroborate the results of phase 3 clinical trials of these vaccines. The results could be used to inform people about the likelihood of side effects based on their demographics and the type of vaccine administered. The study reported some rare symptoms that require further validation through more pharmacovigilance or qualitative studies.

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“…[1] As the scope of Covid-19 widens, some post-vaccination side effects have been reported; one of which is menstrual changes. [2] In the largest surveillance system in the United Kingdom, more than 36.000 menstrual changes post-vaccination have been reported. Meanwhile, around the world, there are various results on menstruation changes post-vaccination.…”

Section: Backgroundsmentioning

confidence: 99%

Effect of Covid-19 Vaccination on Menstrual Pattern Changes : a Systematic Review

Muskitta

Siagian

Rumondang

2023

Preprint

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Covid-19 vaccination has proven to be an effective measure to reduce morbidity and mortality. However, some reports have linked Covid-19 vaccination with alterations in menstruation. Considering that menstruation is an important health component for people who menstruate, this information may cause hesitancy to get vaccinated. There are limited systematic reviews regarding the impact of Covid-19 vaccination on changes in menstrual patterns. Therefore, it is necessary to review the available literature on this topic. A systematic review was done in accordance with the PRISMA statement. The literature search was done by hand and on four databases: PubMed, EMBASE, ProQuest, and CENTRAL. All found articles were screened based on predetermined criteria. Articles that meet the requirements were critically appraised and analyzed. Fourteen (14) articles consisting of 11 cross-sectional studies and 3 cohorts were found. The outcomes mentioned in the studies include changes in menstrual cycle range, durations, estimated blood quantities, and menstruation symptoms. There are changes in the menstrual pattern after the administration of the Covid-19 vaccination, in the form of irregular menstruation, menorrhagia, worsening of menstruation symptoms, and intermenstrual bleeding. However, these changes only occur temporarily. Therefore, the administration of the Covid-19 vaccination is beneficial for people who menstruate.

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Side effects of COVID-19 vaccines: a systematic review and meta-analysis protocol of randomised trials

Cited by 26 publications

References 34 publications

Pattern of self-reported adverse events related to COVID-19 vaccines in Saudi Arabia: A nationwide study

Pattern of self-reported adverse events related to COVID-19 vaccines in Saudi Arabia: A nationwide study

Surveillance of Post-Vaccination Side Effects of COVID-19 Vaccines among Saudi Population: A Real-World Estimation of Safety Profile

Effect of Covid-19 Vaccination on Menstrual Pattern Changes : a Systematic Review

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