Adverse effects


Last updated: 2022 Jan 25
Total hit(s): 33
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Original Article
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The majority of the solicited adverse effects in participants vaccinated with Sputnik Light were mild (66.4% from all vaccines), with only a few being moderate (5.5%). There were no major side effects reported. A) Mild and transient changes were observed in erythrocyte sedimentation rate, alanine and aspartate aminotransferases, lactate dehydrogenase, leukocyte, lymphocyte and neutrophil counts.
B) Both seronegative and seropositive groups were immunogenic to "Sputnik Light" vaccine producing both binding and neutralising antibody responses. It also ellicited cell - mediated immunity along with IFN- secretion.
34746910
(Lancet Reg Health Eur)
PMID
34746910
Date of Publishing: 2021 Dec
Title An open, non-randomised, phase 1/2 trial on the safety, tolerability, and immunogenicity of single-dose vaccine Sputnik Light for prevention of coronavirus infection in healthy adults
Author(s) nameTukhvatulin AI, Dolzhikova IV et al.
Journal Lancet Reg Health Eur
Impact factor
n/a
Citation count: 2
Date of Entry 2022 Jan 25


Among the adjuvanted vaccine formulations, the number and severity of local and systemic solicited reactions were higher than expected after the second dose, with the highest frequency in the high-dose plus AS03 groups.On an average, reactions were less frequent and milder in participants aged 50 years than younger adults. The unadjuvanted high-dose formulation produced reactogenicity profiles that were identical to placebo. In AS03-adjuvanted vaccine groups, a non-Th2 cell skewed cytokine response was elicited, with constant IFN- production and robust neutralising and binding antibody responses was observed.
33887209
(Lancet Infect Dis)
PMID
33887209
Date of Publishing: 2021 Apr 19
Title Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 12, dose-ranging study
Author(s) nameGoepfert PA, Fu B et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 16
Date of Entry 2022 Jan 25


A higher number of participants exhibited significant reactogenicity after the second dose. The reactogenicity in the 50ug dose cohort after the booster dose was severe that booster dose for 60ug cohort group was dropped. For other doses, there were no significant adverse events or withdrawals due to linked adverse events. This clinical study has several limitations, including a limited sample size and a restriction on people under the age of 55.
32998157
(Nature)
PMID
32998157
Date of Publishing: 2020 Oct
Title COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses
Author(s) nameSahin U, Muik A et al.
Journal Nature
Impact factor
24.36
Citation count: 422
Date of Entry 2022 Jan 25


In the combined phase 1 and phase 2 trial, the KCONVAC vaccine was found to be safe and did not elicit major adverse events. The 5ug dose of vaccine was selected for phase 3 trials. In the combined phase 1 and phase 2 trial, the KCONOVOC vaccine elicited a strong immune response. The vaccine induced good antibody response and a moderately good T-cell response.
33928916
(Chin Med J (Engl))
PMID
33928916
Date of Publishing: 2021 Apr 28
Title Immunogenicity and safety of a severe acute respiratory syndrome coronavirus 2 inactivated vaccine in healthy adults: randomized, double-blind, and placebo-controlled phase 1 and phase 2 clinical trials
Author(s) namePan HX, Liu JK et al.
Journal Chin Med J (Engl)
Impact factor
1.053
Citation count: 5
Date of Entry 2021 Dec 15


In a phase I clinical trial, DNA vaccine ZyCoV-D was found to be safe, well-tolerated, and immunogenic in healthy individuals with no vaccine-related severe or solicited adverse events. The adverse events reported were mild to moderate in severity. 1) Interesting to note that all the study participants were males. 2)Solicited local and systemic adverse symptoms were reported for 7 days post each vaccine dose and any other unsolicited adverse events were reported within 28 days post each dose. 3)No subject was discontinued from the study due to a solicited adverse event. 4) One subject withdrew from the study because of asymptomatic positive COVID-19 test, 27 days after receiving the first dose of the vaccine. 5)ZyCoV-D when administered intradermally induced good humoral and cellular immune responses.
34308319
(EClinicalMedicine)
PMID
34308319
Date of Publishing: 2021 Aug
Title Safety and Immunogenicity of a DNA SARS-CoV-2 vaccine (ZyCoV-D): Results of an open-label, non-randomized phase I part of phase I/II clinical study by intradermal route in healthy subjects in India
Author(s) nameMomin T, Kansagra K et al.
Journal EClinicalMedicine
Impact factor
6.68
Citation count: 13
Date of Entry 2021 Oct 30


In a phase 2 placebo-controlled clinical trial, the mRNA-1273 vaccine was found to be safe at 50 and 100 g doses given as a 2 dose-regimen. The mRNA-1273 vaccine was found to be safe and immunogenic at both the 50 and 100ug doses. The vaccine induced good titers of neutralsing antibodies.
33707061
(Vaccine)
PMID
33707061
Date of Publishing: 2021 May 12
Title A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine
Author(s) nameChu L, McPhee R et al.
Journal Vaccine
Impact factor
3.31
Citation count: 24
Date of Entry 2021 Oct 30


In the four randomised trials, the ChAdOx1 nCoV-19 (AZD1222) vaccine was found to be safe with low incidence of adverse events. In the participants who received two standard doses, the efficacy after the second dose was higher in those who received the booster dose after 12 weeks when compared to those who received the second dose after 6 weeks.
33617777
(Lancet)
PMID
33617777
Date of Publishing: 2021 Feb 19
Title Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials
Author(s) nameVoysey M, Costa Clemens SA et al.
Journal Lancet
Impact factor
43.38
Citation count: 285
Date of Entry 2021 Oct 30


In a placebo-controlled, phase 1/2 clinical trial, two doses of inactivated virus vaccine CoronaVac was found to be safe with lower adverse effects in healthy adults aged 1859 years. The vaccine was found to be safe and induced good humoral immune response.
33217362
(Lancet Infect Dis)
PMID
33217362
Date of Publishing: 2020 Nov 17
Title Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial
Author(s) nameZhang Y, Zeng G et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 334
Date of Entry 2021 Oct 30


In a multicentre, phase 3 clinical trial, the BBV152 vaccine was found to be safe and immunogenic. The overall efficacy of the vaccine was 77.8%. The overall rate of adverse reactions was lower than that seen with other vaccinations. 15 deaths were reported, of which 6 deaths were related to COVID-19. The cause of death was not related to the vaccine, no analphylatic events were reported.
Pre-print ( medRXiv )
Title Efficacy, safety, and lot to lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): a, double-blind, randomised, controlled phase 3 trial
Impact factor
N/A
Date of Entry 2021 Oct 30


In a randomized, double-blind placebo-controlled phase 3 trial, a single-dose of the Ad26.COV2.S vaccine was safe and efficacious against severe critical Covid 19 disease. The vaccine was found to be more efficacious against critical severe COVID-19 disease than moderate to severe COVID-19 disease. The vaccine showed good efficacy against different variants. The trial showed safety and efficacy of the single dose vaccine for ethinically and geographically diverse population.
33882225
(N Engl J Med)
PMID
33882225
Date of Publishing: 2021 Apr 21
Title Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
Author(s) nameSadoff J, Gray G et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 339
Date of Entry 2021 Sep 27


In a phase 1 trial, the adjuvanted sclamp subunit vaccine was found to be safe and free from severe solicited adverse reactions. Similar frequency of adverse events were observed in the placebo and the vaccine group, irrespective of the vaccine dosage. The data are reported are up unitl day 57. The MF59-adjuvanted vaccine was found to be safe and elicited a good antigen-specific immune response.
33887208
(Lancet Infect Dis)
PMID
33887208
Date of Publishing: 2021 Apr 19
Title Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial
Author(s) nameChappell KJ, Mordant FL et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 15
Date of Entry 2021 Sep 27


In two randomised, placebo-controlled, phase1/ 2 trials, RBD dimer-protein subunit vaccine ZF200 was found to be safe and well tolerated. 25g of the vaccine as a 3-dose regimen was selected for phase-3 trials. The two or three dose schedule of ZF2001 vaccine was well tolerated in both phase 1 and phase 2 trials. The adverse events reported were anticipated for alum adjuvanted protein subunit vaccines and were short-lived (resolved within 3 to 4 days after vaccination). The occurence of pain at injected site, fatigue, headache, nausea were lower with ZF2001 when compared with NVX-CoV2373 (where Matrix M1 was used as an adjuvant).
33773111
(Lancet Infect Dis)
PMID
33773111
Date of Publishing: 2021 Mar 24
Title Safety and immunogenicity of a recombinant tandem - repeat dimeric RBD - based protein subunit vaccine (ZF2001) against COVID-19 in adults : two randomised, double - blind, placebo - controlled, phase 1 and 2 trials
Author(s) nameYang S, Li Y et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 72
Date of Entry 2021 Sep 27


In a placebo-controlled, phase 3 clinical trial, rAd26 and rAd5 vaccines were found to be safe with a 91.6 % efficacy. After the first dose and before administration of the second dose, 0.1% of the vaccine recipients and 1.3% of the placebo recipients contracted COVID-19 infection.
33545094
(Lancet)
PMID
33545094
Date of Publishing: 2021 Feb 20
Title Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia
Author(s) nameLogunov DY, Dolzhikova IV et al.
Journal Lancet
Impact factor
43.38
Citation count: 403
Date of Entry 2021 Sep 27


In a placebo-controlled phase1/2 trial, a whole inactivated COVID-19 vaccine was found to be safe with a low rate of adverse reactions. A phase 3 trial would be required to assess the long term safety of the vaccine.
32789505
(JAMA)
PMID
32789505
Date of Publishing: 2020 Sep 8
Title Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials
Author(s) nameXia S, Duan K et al.
Journal JAMA
Impact factor
14.78
Citation count: 242
Date of Entry 2021 Sep 27


In a randomised, placebo-controlled phase 1 trial, protein subunit vaccine SCB-2019 formulated with either AS03 or CpG/Alum adjuvants had a good safety profile and was well-tolerated. The vaccine was considered for further clinical development. The SCB-2019 vaccine, comprising S-Trimer protein formulated with either AS03 or CpG/Alum adjuvants, elicited robust humoral and cellular immune responses against SARS-CoV-2, with high viral neutralising activity.
33524311
(Lancet)
PMID
33524311
Date of Publishing: 2021 Feb 20
Title Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial
Author(s) nameRichmond P, Hatchuel L et al.
Journal Lancet
Impact factor
43.38
Citation count: 66
Date of Entry 2021 Aug 3


In an open, non-randomised, combined phase 1/2 trial, heterologous vector-based vaccine rAd26 and rAd5 COVID vaccines, was found to be safe. The vaccine did not elicit any severe adverse reaction in the recipients. The vaccine was available in two formulations, frozen form (Gam-COVID-Vac) and lyophilised form (Gam-COVID-Vac-Lyo). The frozen form had a volume of 0.5mL and the lyophilised form was reconstituted in 1.0mL of sterile water.
32896291
(Lancet)
PMID
32896291
Date of Publishing: 2020 Sep 26
Title Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia
Author(s) nameLogunov DY, Dolzhikova IV et al.
Journal Lancet
Impact factor
43.38
Citation count: 327
Date of Entry 2021 Aug 3


In a placebo-controlled, randomised, double-blind phase 2 clinical trial, the safety of two dosage groups ( 5*10^10 viral particles and 1*10^11 viral particles) of Ad5 vectored vaccine was evaluated. The safety profile of the 5*10^10 dosage group was better and chosen for phase the 3 trial.
32702299
(Lancet)
PMID
32702299
Date of Publishing: 2020 Aug 15
Title Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial
Author(s) nameZhu FC, Guan XH et al.
Journal Lancet
Impact factor
43.38
Citation count: 440
Date of Entry 2021 Aug 3


In the phase 1/2 trial, the ChAdOx1 nCov-19 vaccine was found to be safe with no severe adverse reactions. The side effects resulted in mild and moderate symptoms but were reduced by taking paracetamol after taking the vaccination. 1. ChAdOx1 nCoV-19 vaccine was found to be safe. Local and sytemic side effects were very minimum after the administeration of prophylactic paracetamol. One severe adverse effect, haemolytic anaemia, was associated with the control group after nine days of administeration. 2. Reactogenicity profile appeared less severe in the participants who received the vaccine booster dose.
32702298
(Lancet)
PMID
32702298
Date of Publishing: 2020 Aug 15
Title Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial
Author(s) nameFolegatti PM, Ewer KJ et al.
Journal Lancet
Impact factor
43.38
Citation count: 825
Date of Entry 2021 Aug 3


In phase 2, double-blind, randomised, multicentre clinical trial, BBV152, an inactivated vaccine, elicited mild symptoms in participants and hence was considered to be safe 1. 27 unsolicited adverse events were reported and 9 of them were related to the vaccine.
33705727
(Lancet Infect Dis)
PMID
33705727
Date of Publishing: 2021 Mar 8
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 tria
Author(s) nameElla R, Reddy S et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 76
Date of Entry 2021 Jun 22


In a phase 1 trial with an inactivated viral vaccine, BBV152 elicited mild to moderate adverse effects in a few study participants and hence was declared safe. The overall incidence of solicited local and systemic adverse events in this study was 1421% in all vaccine-treated groups.
33485468
(Lancet Infect Dis)
PMID
33485468
Date of Publishing: 2021 Jan 21
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial
Author(s) nameElla R, Vadrevu KM et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 95
Date of Entry 2021 Jun 22


In phase 1, dose-escalation trial, mRNA vaccine mRNA-1273 was found to be safe with a very low occurrence of adverse side effects. Most of the adverse effects observed were mild to moderate and mostly occurs after the second dose of the vaccine. One participant did not receive second dose of vaccine after experiencing paronychia two days after receiving the first dose of the vaccine. However, the rash was considered to be unrelated to vaccination by the investigators
32991794
(N Engl J Med)
PMID
32991794
Date of Publishing: 2020 Dec 17
Title Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults
Author(s) nameAnderson EJ, Rouphael NG et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 378
Date of Entry 2021 Jun 22


In a phase 1 trial, two types of RNA based vaccines were tested: a) BNT162b2, coding for membrane-bound full-length spike protein; b) BNT162b1 coding secreted domain which is trimerized. Milder systemic events were found with BNT162b2. Hence BNT162b2 was chosen for the next phase of trials. 1. 100ug dose of vaccine was included in the clinical trial study but was discontinued after one dose because of reactogenicity in the participants ( BNT162b1 vaccine and placebo)
33053279
(N Engl J Med)
PMID
33053279
Date of Publishing: 2020 Dec 17
Title Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates
Author(s) nameWalsh EE, Frenck RW Jr et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 690
Date of Entry 2021 Jun 22


In a dose-escalating phase 1 trial, Ad5 vectored COVID-19 vaccine was found to be safe with minimal severe adverse events. Most of the symptoms observed across the three dosage group were mild or moderate in severity.
32450106
(Lancet)
PMID
32450106
Date of Publishing: 2020 Jun 13
Title Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial
Author(s) nameZhu FC, Li YH et al.
Journal Lancet
Impact factor
43.38
Citation count: 522
Date of Entry 2021 Jun 22


A phase2/3 trial of the ChAdOx1 nCoV-19 vaccine shows that it is safe and well-tolerated in older and young adults. Local reactions were more common than systemic reactions. Fewer adverse reactions were reported after the booster dose and reduced with increasing age. The ChAdOx1 nCoV-19 (AZD1222) vaccine was found to be safe and well-tolerated with better reactogenicity profile in older adults than in younger adults.
33220855
(Lancet)
PMID
33220855
Date of Publishing: 2021 Dec 19
Title Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial
Author(s) nameRamasamy MN, Minassian AM et al.
Journal Lancet
Impact factor
43.38
Citation count: 391


Among the 175 adverse events reported during the clinical trial with the Pfizer-BioNTech COVID-19 vaccine, severe allergic reactions including anaphylaxis were reviewed.
33444297
(MMWR Morb Mortal Wkly Rep)
PMID
33444297
Date of Publishing: 2021 Jan 15
Title Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine United States, December 1423, 2020
Author(s) name CDC COVID-19 Response Team; Food and Drug Administration.
Journal MMWR Morb Mortal Wkly Rep
Impact factor
14.4
Citation count: 129