Safety evaluation of SPF66 malaria vaccine in Brazil

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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Epidemiological and clinical profile of dog bitten children and side effects of anti rabies vaccine

International Journal of Contemporary Pediatrics ◽

10.18203/2349-3291.ijcp20192167 ◽

2019 ◽

Vol 6 (4) ◽

pp. 1491

Author(s):

P. Ramkumar ◽

S. Balamurugan

Keyword(s):

Side Effects ◽

Rabies Vaccine ◽

Clinical Profile ◽

Post Exposure Prophylaxis ◽

Dog Bite ◽

Stray Dogs ◽

Post Exposure ◽

Systemic Side Effects ◽

Local Side ◽

Rabies Vaccination

Background: Rabies is one of the commonest zoonotic diseases due to Lyssa virus. Rabies is a 100% fatal disease. Understanding the epidemiological and clinical profile of the victims helps in the prevention of dog bite. But rabies is 100% preventable by pre and post exposure prophylaxis vaccination. Evaluation of side effects of anti-rabies vaccine (ARV) is helpful in the pre and post exposure prophylaxis.Methods: Authors did a descriptive study of 1450 dog-bitten children. Using the pro-forma, authors interviewed the parents, examined the children. Using W.H.O classification, authors classified the dog bite wounds. Anti-rabies vaccination was administered to category 2 dog bite wounded children. Side effects of vaccination are recorded.Results: Out of 1450 children, significantly more number of boys (67%) in the age group of 10-12 years (31%), from class IV socioeconomic category (52%), nuclear families (80%), sustained category III dog bite (52%) in the lower limb (48%) by unvaccinated (82%) stray dogs (60%) while playing or walking (52%) in the street (60%) during night (72%). Purified Vero cell culture rabies vaccine is having rare mild local side effects (2%), rare mild systemic side effects (4.16%) and very rare systemic allergic reaction (0.14%) but no major side effects.Conclusions: Dog bites can be prevented by not allowing the children to play or walk alone in the street especially during night. The severity of wound can be minimized by wearing fully covered extremities. Vaccination of dogs and population control of stray dogs will reduce rabies. There were no major side-effects or adverse events following vaccination (AEFI) with anti-rabies vaccination. Rare mild local side effects and very rare mild systemic side effects may happen.

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Successful Treatment of Intralesional Bleomycin in Keloids of Vietnamese Population

Open Access Macedonian Journal of Medical Sciences ◽

10.3889/oamjms.2019.099 ◽

2019 ◽

Vol 7 (2) ◽

pp. 298-299 ◽

Cited By ~ 2

Author(s):

Nghi Dinh Huu ◽

Sau Nguyen Huu ◽

Xuan Le Thi ◽

Thuong Nguyen Van ◽

Phuong Pham Thi Minh ◽

...

Keyword(s):

Side Effects ◽

High Risk ◽

Successful Treatment ◽

Response Rate ◽

Poor Response ◽

The Poor ◽

Vietnamese Population ◽

Systemic Side Effects ◽

Lesion Treatment ◽

Local Side

BACKGROUND: Keloid is an overactive condition of the skin tissue to early lesions characterised by proliferation of fibroblasts, excessive collagen production in the lesion. Treatment of keloids is a big challenge because of the poor response rate and high risk of recurrence after treatment. We found that bleomycin offers promise in the treatment of keloids. AIM: To evaluate the efficacy of bleomycin injected in the injury for keloids treatment. METHODS: The treatment was carried out in 55 patients having 120 keloids of different sizes and locations. Average treatments were 4 times. RESULTS: Complete flattening was 70.8%, highly significant flattening was 8.3%, no patient of minimal flattening. Systemic side-effects of bleomycin were not evaluated, but local side-effects were mainly pains (100%), blisters (78.3%), ulceration (5.8%), and hyperpigmentation (56.7%). CONCLUSION: The percentage of patients recurring 6, 12, 15, 18 months after the last treatment were 3.8, 15.4, 45.5, 50%, respectively.

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Mini-Review Discussing the Reliability and Efficiency of COVID-19 Vaccines

Diagnostics ◽

10.3390/diagnostics11040579 ◽

2021 ◽

Vol 11 (4) ◽

pp. 579

Author(s):

Bogdan Doroftei ◽

Alin Ciobica ◽

Ovidiu-Dumitru Ilie ◽

Radu Maftei ◽

Ciprian Ilea

Keyword(s):

Side Effects ◽

Severe Acute Respiratory Syndrome ◽

Adverse Events ◽

Adverse Reactions ◽

Age Group ◽

Efficacy And Safety ◽

Short Time ◽

Dose Dependent ◽

Severe Adverse Reactions ◽

Age And Sex

Severe Acute Respiratory Syndrome Coronavirus 2 is a novel strain of human beta-coronavirus that has produced over two million deaths and affected one hundred million individuals worldwide. As all the proposed drugs proved to be unstable, inducing side effects, the need to develop a vaccine crystallized in a short time. As a result, we searched the databases for articles in which the authors reported the efficacy and safety of the use of several vaccines vaccines by sex, age group, and frequency of adverse reactions. We identified a total of 19 relevant articles that were discussed throughout this manuscript. We concluded that from all eleven vaccines, three had an efficacy >90% (Pfizer–BioNTech (~95%), Moderna (~94%), and Sputnik V (~92%)) except for Oxford–AstraZeneca (~81%). However, Moderna, Sputnik V, and Oxford–AstraZeneca also alleviate severe adverse reactions, whereas in Pfizer–BioNTech this was not revealed. The remaining five (Convidicea (AD5-nCOV); Johnson & Johnson (Ad26.COV2.S); Sinopharm (BBIBP-CorV); Covaxin (BBV152), and Sinovac (CoronaVac)) were discussed based on their immunogenicity, and safety reported by the recipients since only phases 1 and 2 were conducted without clear evidence published regarding their efficacy. CoviVac and EpiVacCorona have just been approved, which is why no published article could be found. All adverse events reported following the administration of one of the four vaccines ranged from mild to moderate; limited exceptions in which the patients either developed severe forms or died, because most effects were dose-dependent. It can be concluded that aforementioned vaccines are efficient and safe, regardless of age and sex, being well-tolerated by the recipients.

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SIDE-EFFECTS AND PATIENTS COMPLIANCE OF SUBCUTANEOUS ALLERGEN-SPECIFIC IMMUNOTHERAPY WITH BIRCHPOLLEN EXTRACT ABSORBED ON CALCIUM PHOSPHAT

Rossiiskii Allergologicheskii ZHurnal ◽

10.36691/rja707 ◽

2012 ◽

Vol 9 (6) ◽

pp. 44-48

Author(s):

N V Shakhova ◽

V V Gordeev ◽

N K Bishevskaya ◽

T S Ardatova ◽

V P Tokarev ◽

...

Keyword(s):

Side Effects ◽

Calcium Phosphate ◽

Calcium Phosphates ◽

Allergic Rhinoconjunctivitis ◽

Pollen Allergen ◽

Tree Pollen ◽

Allergen Specific Immunotherapy ◽

Local Reactions ◽

High Level ◽

Local Side

Subcutaneous allergenspecific immunotherapy weakens the symptoms of allergic rhinoconjunctivitis and bronchial asthma. However, there exists the risk of local reactions emergence, as well as the threat of the dangerous anaphylactic reactions. Background. The purpose of this work is to evaluate the frequency and severity of the side-effects and to assess the patients’ compliance with subcutaneous allergenspecific immunotherapy, which uses the tree pollen allergen absorbed onto the calcium phosphate suspension. Methods. The study included 21 children at the age from 5 to 17 with allergic rhinoconjunctivitis with the sensibilization to the allergens of the tree pollen (birch, alder, hazel). The patients had been receiving the treatment with the tree pollen allergen absorbed onto the calcium phosphates suspension for 2 years. All cases of systemic and local side-effects, which appeared during the study, have been analised. Results. In 86% of cases (18 out of 21 patients) local reactions were found. During the study, the total number of injections was 740 with 169 cases of local reactions, which constitutes 22,6% of all injections. In 14,3 percent of cases only slight reactions have appeared. However, 8,3% of injections resulted in pronounced reactions. No systemic reactions were observed; neither of patients has refused to get treatment due to the side-effects. Conclusion. The results of the study have shown the high level of compliance and safety of the subcutaneous allergenspecific immunotherapy, which is based on the use of the tree pollen allergen absorbed onto the calcium phosphate suspension.

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Acute Orbital Compromise after Intra-Arterial Chemotherapy in a Complex Retinoblastoma Associated with 13q Deletion Syndrome

Pediatric Neurosurgery ◽

10.1159/000511019 ◽

2020 ◽

Vol 55 (5) ◽

pp. 295-298

Author(s):

Sophia El Hamichi ◽

Dhariana Acon ◽

Veronica Kon Graversen ◽

Aaron S. Gold ◽

Audina M. Berrocal ◽

...

Keyword(s):

Side Effects ◽

Systemic Chemotherapy ◽

Middle Meningeal Artery ◽

Deletion Syndrome ◽

First Line ◽

Case Presentation ◽

First Line Therapy ◽

Line Therapy ◽

Systemic Side Effects ◽

Local Side

Introduction: The intra-arterial chemotherapy (IAC) is increasingly used as a first-line therapy for retinoblastoma. The IAC has proved to be relatively safe. However, many local side effects of IAC have been described. Case Presentation: This case report describes a local side effect presenting as proptosis and myositis with vascular access difficulty of the middle meningeal artery, in a 2-year-old male with left eye diffuse multifocal stage Vb retinoblastoma complicated with retinal detachment. Discussion/Conclusion: IAC is assured to provide as efficient results in eliminating the tumor as the systemic chemotherapy, without causing the systemic side effects. It has become an alternative to systemic chemotherapy. A better understanding of the local side effects is required.

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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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ANALYSIS OF ADVERSE EVENTS AFTER IMMUNIZATION WITH VACCINES AGAINST Sars-Cov-2

World Science ◽

10.31435/rsglobal_ws/30112021/7698 ◽

2021 ◽

Author(s):

Stepanova H. M. ◽

Shevchenko O. T. ◽

Радзієвська Ірина Володимирівна

Keyword(s):

Side Effects ◽

Young People ◽

Adverse Events ◽

Muscle Pain ◽

Adverse Reactions ◽

Healthcare Professionals ◽

Teaching Staff ◽

New Information ◽

Medical Academy ◽

Local Side

Although the WHO-recommended coronavirus vaccines are safe and effective, vaccines provide new information to healthcare professionals about the extent and nature of adverse reactions to these drugs. The aim of the study is supplementing the available data on adverse reactions of vaccines on the example of the experience of vaccination of the teaching staff of the Cherkasy Medical Academy with vaccines COVISHIELD and COMIRNATY. Information for this study was collected retrospectively through a survey of 72 employees of the Cherkasy Medical Academy who were vaccinated with the COVISHIELD vaccine (first dose); 67 workers vaccinated with AstraZeneca (second dose); 54 workers who were vaccinated with COMIRNATY vaccine (first dose); 52 people vaccinated with this vaccine (second dose). The study confirmed that among the local side effects, the most common were pain at the injection site, among the systemic - fever, weakness, fatigue and drowsiness, headache, muscle pain, chills. Most of the side effects were most pronounced in young people, more often in women than in men.

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

Biology ◽

10.3390/biology10080752 ◽

2021 ◽

Vol 10 (8) ◽

pp. 752

Author(s):

Miloslav Klugar ◽

Abanoub Riad ◽

Mohamed Mekhemar ◽

Jonas Conrad ◽

Mayte Buchbender ◽

...

Keyword(s):

Side Effects ◽

Side Effect ◽

Healthcare Workers ◽

Viral Vector ◽

Demographic Data ◽

Cross Sectional Survey ◽

Post Vaccination ◽

Increased Risk ◽

Systemic Side Effects ◽

Local Side

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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Elimination of Ioversol by Hemodialysis

Acta Radiologica ◽

10.1177/02841851960373p278 ◽

1996 ◽

Vol 37 (3P2) ◽

pp. 826-829 ◽

Cited By ~ 10

Author(s):

J. Ueda ◽

T. Furukawa ◽

S. Takahashi ◽

K. Sakaguchi

Keyword(s):

Renal Failure ◽

Chronic Renal Failure ◽

Side Effects ◽

Contrast Medium ◽

Half Life ◽

Adverse Reactions ◽

Elimination Rate ◽

The Body ◽

Contrast Medium Injection ◽

Severe Adverse Reactions

Purpose: The dialysability of ioversol was investigated in 12 patients with chronic renal failure, on 4-h hemodialysis. Material and Methods: One hundred ml of ioversol (320 mg I/ml) was injected in less than 10 min during CT. Hemodialysis was commenced within 30 min of starting the contrast medium injection and was continued for 4 h. Blood was sampled before and at 15 min, 30 min, 1 h, 2 h, and 4 h after the start of hemodialysis. Mean dialysance of ioversol was 114 to 129 ml/min and the elimination rate was 82.5±5.1% 4 h after starting hemodialysis. The half-life of ioversol during hemodialysis was 1.80±0.38 h. The only side effects of the ioversol injection were heat sensations, which were experienced by 3 patients. Results: As ioversol was effectively removed from the body during the 4 h of hemodialysis and no severe adverse reactions were observed, we conclude that ioversol is suitable for use in hemodialyzed patients.

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Safety and Side Effects of COVID-19 Vaccines

Journal of Education, Health and Sport ◽

10.12775/jehs.2021.11.09.039 ◽

2021 ◽

Vol 11 (9) ◽

pp. 315-320

Author(s):

Katarzyna Mielniczek

Keyword(s):

Side Effects ◽

Injection Site ◽

Viral Vectors ◽

Scientific Publications ◽

Subunit Vaccines ◽

Systemic Side Effects ◽

Headache Pain ◽

Scientific Platform ◽

Traditional Approaches ◽

Severe Adverse Reactions

Introduction: COVID-19 is a respiratory disease caused by the SARS-CoV-2 virus. The types of COVID-19 vaccines have been distinguished, ie vector viral vaccines, mRNA, subunit vaccines. These include traditional approaches - inactivated, live-attenuated and protein / adjuvant-based, as well as novel, as yet unlicensed - viral vectors and nucleic acids. There are scientific publications showing the safety and possible side effects of vaccines from various companies. Purpose of the work : Analysis of the safety of COVID-19 vaccines on the basis of scientific publications published on the PubMed scientific platform. Publications have been published in the last 12 months. The safety and adverse effects of vaccines were assessed in the course of clinical trials. Results: Among the main side effects so far were mild / moderate pain at the injection site, redness, hives and rash. Allergic reactions to vaccines are - apart from pronounced local reactions (> 10 cm) at the injection site - very rare and are usually caused by the vaccine's allergy to the components of the vaccine. In addition, there may be swelling or tenderness of the lymph nodes in the armpit, headache, pain in the muscles and joints, nausea and vomiting. Conclusions: Regardless of the concern, these vaccines are characterized by similar mild, systemic side effects, which indicates the similarity in the safety of these vaccines. Severe adverse reactions occur in extreme cases. More patients only experienced side effects after the second dose. Keywords: vaccines; coronavirus; COVID-19; safety of COVID-19 vaccines; side effects

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