Side Effects of mRNA-Based and Viral Vector-Based COVID-19 Vaccines among German Healthcare Workers

Background: the increasing number of COVID-19 vaccines available to the public may trigger hesitancy or selectivity towards vaccination. This study aimed to evaluate the post-vaccination side effects of the different vaccines approved in Germany; Methods: a cross-sectional survey-based study was carried out using an online questionnaire validated and tested for a priori reliability. The questionnaire inquired about demographic data, medical and COVID-19-related anamneses, and local, systemic, oral, and skin-related side effects following COVID-19 vaccination; Results: out of the 599 participating healthcare workers, 72.3% were females, and 79.1% received mRNA-based vaccines, while 20.9% received a viral vector-based vaccine. 88.1% of the participants reported at least one side effect. Injection site pain (75.6%) was the most common local side effect, and headache/fatigue (53.6%), muscle pain (33.2%), malaise (25%), chills (23%), and joint pain (21.2%) were the most common systemic side effects. The vast majority (84.9%) of side effects resolved within 1–3 days post-vaccination; Conclusions: the mRNA-based vaccines were associated with a higher prevalence of local side effects (78.3% vs. 70.4%; Sig. = 0.064), while the viral vector-based vaccine was associated with a higher prevalence of systemic side effects (87.2% vs. 61%; Sig. < 0.001). Females and the younger age group were associated with an increased risk of side effects either after mRNA-based or viral vector-based vaccines. The gender- and age-based differences warrant further rigorous investigation and standardized methodology.

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Side Effects of mRNA-Based COVID-19 Vaccine: Nationwide Phase IV Study among Healthcare Workers in Slovakia

Pharmaceuticals ◽

10.3390/ph14090873 ◽

2021 ◽

Vol 14 (9) ◽

pp. 873

Author(s):

Abanoub Riad ◽

Barbora Hocková ◽

Lucia Kantorová ◽

Rastislav Slávik ◽

Lucia Spurná ◽

...

Keyword(s):

Side Effects ◽

Side Effect ◽

Healthcare Workers ◽

Large Scale ◽

Large Population ◽

Medical Attention ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Post Vaccination ◽

Phase Iv

mRNA-based COVID-19 vaccines such as BNT162b2 have recently been a target of anti-vaccination campaigns due to their novelty in the healthcare industry; nevertheless, these vaccines have exhibited excellent results in terms of efficacy and safety. As a consequence, they acquired the first approvals from drug regulators and were deployed at a large scale among priority groups, including healthcare workers. This phase IV study was designed as a nationwide cross-sectional survey to evaluate the post-vaccination side effects among healthcare workers in Slovakia. The study used a validated self-administered questionnaire that inquired about participants’ demographic information, medical anamneses, COVID-19-related anamnesis, and local, systemic, oral, and skin-related side effects following receiving the BNT162b2 vaccine. A total of 522 participants were included in this study, of whom 77% were females, 55.7% were aged between 31 and 54 years, and 41.6% were from Banska Bystrica. Most of the participants (91.6%) reported at least one side effect. Injection site pain (85.2%) was the most common local side effect, while fatigue (54.2%), headache (34.3%), muscle pain (28.4%), and chills (26.4%) were the most common systemic side effects. The reported side effects were of a mild nature (99.6%) that did not require medical attention and a short duration, as most of them (90.4%) were resolved within three days. Females and young adults were more likely to report post-vaccination side effects; such a finding is also consistent with what was previously reported by other phase IV studies worldwide. The role of chronic illnesses and medical treatments in post-vaccination side effect incidence and intensity requires further robust investigation among large population groups.

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Self-reported real-world safety and reactogenicity of COVID-19 vaccines: An international vaccine-recipient survey

10.1101/2021.02.26.21252096 ◽

2021 ◽

Author(s):

Alexander G. Mathioudakis ◽

Murad Ghrew ◽

Andrew Ustianowski ◽

Shazaad Ahmad ◽

Ray Borrow ◽

...

Keyword(s):

Side Effects ◽

Side Effect ◽

Hospital Care ◽

Online Survey ◽

Viral Vector ◽

Vaccine Dose ◽

List Type ◽

Increased Risk ◽

Systemic Side Effects ◽

Local Reactions

AbstractBackgroundThe safety of COVID-19 vaccines has been demonstrated in selected populations in recent studies, but more data in specific groups is needed to inform vaccine choice and health policy.ObjectivesAn international, online survey was conducted to compare the safety, tolerability and reactogenicity of available COVID-19 vaccines in different recipient groups.MethodsThis survey was launched in February 2021, for 11 days. Recipients of a first COVID-19 vaccine dose ≥7 days prior to survey completion were eligible. The incidence and severity of vaccination side effects were assessed.ResultsSurvey was completed by 2,002 respondents, of whom 26.6% had prior COVID-19 infection (68.8% laboratory confirmed). Prior COVID-19 infection was associated with increased risk of any side effect (risk ratio 1.08, 95% confidence intervals [1.05-1.11]), fever (2.24 [1.86-2.70]), breathlessness (2.05 [1.28-3.29]), flu-like illness (1.78 [1.51-2.10]), fatigue (1.34 [1.20-1.49]) and local reactions (1.10 [1.06-1.15]). It was also associated with increased risk of severe side effects, leading to hospital care (1.56 [1.14-2.12]).While mRNA vaccines were associated with a higher incidence of any side effect (1.06 [1.01-1.11]) compared to viral vector-based vaccines, these were generally milder (p<0.001), mostly local reactions. Importantly, mRNA vaccine-recipients reported considerably lower incidence of systemic reactions (RR<0.6) including anaphylaxis, swelling, flu-like illness, breathlessness and fatigue, and of side effects requiring hospital care (0.42 [0.31-0.58]).ConclusionFor the first time, our study links prior COVID-19 illness with increased incidence of vaccination side effects and demonstrates that mRNA vaccines cause milder, less frequent systemic side effects, but more local reactions.Key messages–People with prior COVID-19 illness appear to experience significantly increased incidence and severity of side effects after receiving the COVID-19 vaccine.–In this first head-to-head comparison of the safety and reactogenicity of different types of vaccines, it was demonstrated that mRNA vaccines cause milder, less frequent systemic side effects, compared to viral vector vaccines, but more local reactions.Tweetable SummaryA survey of >2000 COVID-19 vaccine-recipients links prior COVID-19 illness with increased incidence of vaccination side effects; mRNA vaccines cause milder, less frequent systemic side effects, but more local reactions.

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Use of information sources regarding medicine side effects among the general population: a cross-sectional survey

Primary Health Care Research & Development ◽

10.1017/s1463423619000574 ◽

2019 ◽

Vol 20 ◽

Cited By ~ 1

Author(s):

Bernadine O’Donovan ◽

Ruth M. Rodgers ◽

Anthony R. Cox ◽

Janet Krska

Keyword(s):

Side Effects ◽

Information Seeking ◽

Side Effect ◽

Information Sources ◽

Negative Impact ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Information Leaflets ◽

Increased Risk ◽

Use Of Information Sources

Abstract Aim: To determine the use and perceived value of different information sources that patients may use to support identification of medicine side effects; to explore associations between coping styles and use of information sources. Background: Side effects from medicines can have considerable negative impact on peoples’ daily lives. As a result of an ageing UK population and attendant multi-morbidity, an increasing number of medicines are being prescribed for patients, leading to increased risk of unintended side effects. Methods: A cross-sectional survey of patients who use medicine, recruited from community pharmacies. The survey sought views on attributes of various information sources, their predicted and actual use, incorporating a shortened Side Effects Coping Questionnaire (SECope) scale and the abbreviated Miller Behavioural Style Scale (MBSS). Findings: Of 935 questionnaires distributed, 230 (25.0%) were returned, 61.3% from females; 44.7% were retired and 84.6% used at least one medicine regularly. 69.6% had experienced a side effect, resulting in 57.5% of these stopping the medicine. Patient information leaflets (PILs) and GPs were both predicted and actually most widely used sources, despite GPs being judged as relatively less accessible and PILs less trustworthy, particularly by regular medicine users. Pharmacists, considered both easy to access and trustworthy, were used by few in practice, while the internet was considered easy to access, but less trustworthy and was also little used. SECope sub-scales for non-adherence and information seeking showed positive associations with stopping a medicine and seeking information from a health professional. More high monitors than low monitors stopped a medicine themselves, but there were no differences in use of information sources. Information seeking following a side effect is a common strategy, potentially predicted by the SECope, but not the MBSS. Limited GP accessibility could contribute to high internet use. Further research could determine how the trustworthiness of PILs can be improved.

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Side Effects of mRNA-Based COVID-19 Vaccines among Young Adults (18–30 Years Old): An Independent Post-Marketing Study

Pharmaceuticals ◽

10.3390/ph14101049 ◽

2021 ◽

Vol 14 (10) ◽

pp. 1049

Author(s):

Abanoub Riad ◽

Andrea Pokorná ◽

Jitka Klugarová ◽

Natália Antalová ◽

Lucia Kantorová ◽

...

Keyword(s):

Young Adults ◽

Side Effects ◽

Side Effect ◽

Demographic Data ◽

Herd Immunity ◽

Age Groups ◽

Common Side Effect ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Validated Questionnaire

Young adults had been widely perceived as a low-risk group for COVID-19 severity; therefore, they were deprioritised within the mass vaccination strategies as their prognosis of COVID-19 infection is relatively more favourable than older age groups. On the other hand, vaccination of this demographic group is indispensable to achieve herd immunity. A cross-sectional survey-based study was used to evaluate the side effects of mRNA-based COVID-19 vaccines among university students in the Czech Republic. The validated questionnaire was delivered in a digital form, and it consisted of demographic data; COVID-19 vaccine-related anamnesis; and local, systemic, orofacial, and skin-related side effects’ prevalence, onset, and duration. Out of the 539 included participants, 70.1% were females and 45.8% were <23 years old. The vast majority (95.2%) reported at least one side effect. The most common side effect was injection site pain (91.8%), followed by fatigue (62.5%), headache (36.4%), and muscle pain (34.9%). The majority of local side effects occurred after both doses (74.4%), while most systemic side effects occurred after the second dose only (56.2%). Most local (94.2%) and systemic (93.3%) side effects resolved within three days after vaccination. Females participants’ adjusted odds ratio (AOR) showed they were 2.566 (CI 95%: 1.103–5.970) times more likely to experience post-vaccination side effects, and the participants who received two doses reported an increased AOR of 1.896 (0.708–5.077) for experiencing side effects. The results of this study imply that mRNA-based COVID-19 vaccines are highly probably safe for young adults, and further studies are required to investigate the role of medical anamnesis, prior COVID-19 infection, and gender in side effects incidence.

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Side Effects Reported by Jordanian Healthcare Workers Who Received COVID-19 Vaccines

Vaccines ◽

10.3390/vaccines9060577 ◽

2021 ◽

Vol 9 (6) ◽

pp. 577

Author(s):

Osama Abu-Hammad ◽

Hamza Alduraidi ◽

Shaden Abu-Hammad ◽

Ahmed Alnazzawi ◽

Hamzah Babkair ◽

...

Keyword(s):

Side Effects ◽

Healthcare Workers ◽

Healthcare Professionals ◽

The Public ◽

Systemic Side Effects ◽

The Common ◽

Larger Sample ◽

Local Side

Background Distribution of COVID-19 vaccines has been surrounded by suspicions and rumors making it necessary to provide the public with accurate reports from trustworthy experts such as healthcare professionals. Methods We distributed a questionnaire in Jordan among physicians, dentists and nurses who received a COVID-19 vaccine to explore the side effects (SE) they encountered after the first or the second dose of one of three vaccines namely: AstraZeneca Vaxzevria (AZ), Pfizer-BioNTeck (PB), and SinoPharm (SP) vaccines. Results A total of 409 professionals participated. Approximately 18% and 31% of participants reported no SE after the first dose and second dose, respectively. The remainder had mostly local side effects related to injection site (74%). Systemic side effects in the form of fatigue (52%), myalgia (44%), headache (42%), and fever (35%) prevailed mainly after the first dose. These were significantly associated with AZ vaccine, and age ≤ 45 years (p = 0.000 and 0.01, respectively). No serious SE were reported. Conclusions We can conclude that SE of COVID-19 vaccines distributed in Jordan are within the common range known so far for these vaccines. Further studies are needed to include larger sample size and longer follow-up period to monitor possible serious and long-term SE of the vaccines.

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Self-Reported Real-World Safety and Reactogenicity of COVID-19 Vaccines: A Vaccine Recipient Survey

Life ◽

10.3390/life11030249 ◽

2021 ◽

Vol 11 (3) ◽

pp. 249

Author(s):

Alexander G. Mathioudakis ◽

Murad Ghrew ◽

Andrew Ustianowski ◽

Shazaad Ahmad ◽

Ray Borrow ◽

...

Keyword(s):

Side Effects ◽

Side Effect ◽

Hospital Care ◽

Online Survey ◽

Viral Vector ◽

Vaccine Dose ◽

Vaccine Recipient ◽

Increased Risk ◽

Local Reactions ◽

Randomised Controlled

An online survey was conducted to compare the safety, tolerability and reactogenicity of available COVID-19 vaccines in different recipient groups. This survey was launched in February 2021 and ran for 11 days. Recipients of a first COVID-19 vaccine dose ≥ 7 days prior to survey completion were eligible. The incidence and severity of vaccination side effects were assessed. The survey was completed by 2002 respondents of whom 26.6% had a prior COVID-19 infection. A prior COVID-19 infection was associated with an increased risk of any side effect (risk ratio 1.08, 95% confidence intervals (1.05–1.11)), fever (2.24 (1.86–2.70)), breathlessness (2.05 (1.28–3.29)), flu-like illness (1.78 (1.51–2.10)), fatigue (1.34 (1.20–1.49)) and local reactions (1.10 (1.06–1.15)). It was also associated with an increased risk of severe side effects leading to hospital care (1.56 (1.14–2.12)). While mRNA vaccines were associated with a higher incidence of any side effect (1.06 (1.01–1.11)) compared with viral vector-based vaccines, these were generally milder (p < 0.001), mostly local reactions. Importantly, mRNA vaccine recipients reported a considerably lower incidence of systemic reactions (RR < 0.6) including anaphylaxis, swelling, flu-like illness, breathlessness and fatigue and of side effects requiring hospital care (0.42 (0.31–0.58)). Our study confirms the findings of recent randomised controlled trials (RCTs) demonstrating that COVID-19 vaccines are generally safe with limited severe side effects. For the first time, our study links prior COVID-19 illness with an increased incidence of vaccination side effects and demonstrates that mRNA vaccines cause milder, less frequent systemic side effects but more local reactions.

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Prevalence of COVID-19 Vaccine Side Effects among Healthcare Workers in the Czech Republic

Journal of Clinical Medicine ◽

10.3390/jcm10071428 ◽

2021 ◽

Vol 10 (7) ◽

pp. 1428

Author(s):

Abanoub Riad ◽

Andrea Pokorná ◽

Sameh Attia ◽

Jitka Klugarová ◽

Michal Koščík ◽

...

Keyword(s):

Czech Republic ◽

Side Effects ◽

Healthcare Workers ◽

Demographic Data ◽

Vaccine Safety ◽

Public Confidence ◽

Cross Sectional Survey ◽

Independent Evidence ◽

The Czech Republic ◽

Validated Questionnaire

Background: COVID-19 vaccine side effects have a fundamental role in public confidence in the vaccine and its uptake process. Thus far, the evidence on vaccine safety has exclusively been obtained from the manufacturer-sponsored studies; therefore, this study was designed to provide independent evidence on Pfizer–BioNTech COVID-19 vaccine side effects. Methods: A cross-sectional survey-based study was carried out between January and February 2021 to collect data on the side effects following the COVID-19 vaccine among healthcare workers in the Czech Republic. The study used a validated questionnaire with twenty-eight multiple-choice items covering the participants’ demographic data, medical anamneses, COVID-19-related anamneses, general, oral, and skin-related side effects. Results: Injection site pain (89.8%), fatigue (62.2%), headache (45.6%), muscle pain (37.1%), and chills (33.9%) were the most commonly reported side effects. All the general side effects were more prevalent among the ≤43-year-old group, and their duration was mainly one day (45.1%) or three days (35.8%) following the vaccine. Antihistamines were the most common drugs associated with side effects, thus requiring further investigation. The people with two doses were generally associated with a higher frequency of side effects. Conclusions: The distribution of side effects among Czech healthcare workers was highly consistent with the manufacturer’s data, especially in terms of their association with the younger age group and the second dose. The overall prevalence of some local and systemic side effects was higher than the manufacturer’s report. Further independent studies on vaccine safety are strongly required to strengthen public confidence in the vaccine.

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Medicinal plants’ use among patients with dyslipidemia: an Iranian cross-sectional survey

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2018-0101 ◽

2018 ◽

Vol 16 (3) ◽

Cited By ~ 1

Author(s):

Mohammad Hashem Hashempur ◽

Seyed Hamdollah Mosavat ◽

Mojtaba Heydari ◽

Mesbah Shams

Keyword(s):

Side Effects ◽

Medicinal Plants ◽

Demographic Data ◽

Zingiber Officinale ◽

Cross Sectional Study ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Herbal Preparations ◽

Positive Effects ◽

High Prevalence

Abstract Background Despite growing demand for medicinal plants, there is little data about their use by patients with dyslipidemia. We aimed to determine the prevalence, pattern, and associated factors for the use of medicinal plants among patients with dyslipidemia. Methods A 17-item semi-structured questionnaire was filled out by 195 patients with dyslipidemia in a cross-sectional study carried out in two academic endocrinology clinics in Shiraz, Iran. The questionnaire comprised of three main domains of demographic data (6 questions), clinical data (2 of them), and data related to the use of medicinal plants (totally 9 questions). Results A total of 77.4% of patients took medicinal plants. The most common medicinal herbs used by dyslipidemic patients were Zataria multiflora, Cinnamomum zeylanicum, and Zingiber officinale. Duration of dyslipidemia was significantly longer in herbal users than non-herbal users (p=0.04). Patients believing that concomitant use of conventional drugs and herbal preparations had synergic positive effects in addition to those persuaded that herbal preparations possessed less side effects, were significantly more likely to use medicinal plants (p=0.008 and 0.005, respectively). Additionally, most of the medicinal herb users (87.4%) changed neither the pattern nor the dosage of their medications all during herbal preparations use. Conclusions This study demonstrated a high prevalence of medicinal plants’ use among patients with dyslipidemia, which was associated with the duration of dyslipidemia, patients’ viewpoints about herbal preparations’ synergic positive effects, and their fewer side effects.

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Safety evaluation of SPF66 malaria vaccine in Brazil

Revista da Sociedade Brasileira de Medicina Tropical ◽

10.1590/s0037-86821996000500014 ◽

1996 ◽

Vol 29 (5) ◽

pp. 497-501 ◽

Cited By ~ 6

Author(s):

LM. Urdaneta ◽

A. Prata ◽

C.J. Struchiner ◽

C.E. Tosta ◽

P. Tauil ◽

...

Keyword(s):

Placebo Group ◽

Side Effects ◽

Malaria Vaccine ◽

Adverse Reactions ◽

Safety Evaluation ◽

Efficacy Trial ◽

Systemic Side Effects ◽

Local Reactions ◽

Severe Adverse Reactions ◽

Local Side

The frequency and description of side effects secondaiy to the subcutaneous application of SPf66 malaria vaccine and placebo are reported for each dose of application in the participants of the vaccine efficacy trial in Brazil. Side effects evaluated two hours after each application were detected in 8.0%, 30.2% and 8.8%, for the Is', and 3"' dose, respectively, in the SPf66group, and in 7.0%, 8.5% and 2.9% in the placebo group. Local reactions such as mild inflammation, nodule and pain or erythema frequently accompanied by pruritus were the most common reactions detected in both groups (3-8%, 29.1% and 8.5% in the SPf66 group and 4.0%, 7.6% and 2.5% in the placebo group). Among vaccinees, local side effects after the 2nd dose were more frequent in females. Systemic side effects were expressed mainly through general symptoms referred by the participants and were most frequent after the 1st dose in both groups (4.3% in the SPf66 group and 3-0% in the placebo group). Muscle aches and fever were refewred by few participants. No severe adverse reactions were detected for either dose of application or group.

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Influenza Vaccination Hesitancy among Healthcare Workers in South Al Batinah Governorate in Oman: A Cross-Sectional Study

Vaccines ◽

10.3390/vaccines8040661 ◽

2020 ◽

Vol 8 (4) ◽

pp. 661

Author(s):

Salah T. Al Awaidy ◽

Zayid K. Al Mayahi ◽

Malak Kaddoura ◽

Ozayr Mahomed ◽

Nathalie Lahoud ◽

...

Keyword(s):

Influenza Vaccine ◽

Influenza Vaccination ◽

Healthcare Workers ◽

Seasonal Influenza ◽

General Medicine ◽

Knowledge Score ◽

Vaccine Uptake ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Increased Risk

Background: Seasonal influenza infections are a major cause of morbidity and mortality worldwide. Healthcare workers (HCWs) are an important target group for vaccination against influenza due to their increased risk of infection and their potential to transmit the infection to their patients, families and communities. The aim of this study was to assess the potential hesitancy and its associated factors towards influenza vaccination amongst HCWs in the South Al Batinah governorate in Oman. Methods: A cross-sectional survey of 390 HCWs with direct or indirect patient contact was conducted in May and June 2019 using a self-administered questionnaire. Associations between HCW characteristics and vaccination status were examined using bivariate and multivariate analyses to identify the likelihood of vaccination against seasonal influenza among HCWs. Results: Overall, 60% of HCWs were vaccinated in the 2018/2019 season; vaccine uptake among nurses was 52% and uptake was higher among women. Self-protection and protection of the community were the most cited reasons for vaccine acceptance, with side effects being the main reason for hesitancy. Vaccinated respondents had a higher mean knowledge score (7.18; standard deviation SD: 2.14) than unvaccinated respondents (6.30; SD: 2.2). Odds of vaccination were highest among respondents who believed influenza vaccine should be mandatory for HCWs (Odds ratio (OR): 2.04 [1.30–3.18]), those working in the general medicine, emergency medicine, or intensive care units (OR: 1.92 [1.20–3.10]), nurses and doctors (OR: 1.75 [1.09–2.79]) and those who believe that HCWs should receive an influenza vaccine (OR: 1.35 [1.07–2.77]). Conclusions: The study provides valuable insights into the enablers and barriers of influenza vaccination practices among HCWs and may inform interventions to increase acceptance of vaccination.

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