Adverse reactions to the BNT162b2 and mRNA-1273 mRNA COVID-19 vaccines in Japan

Kitagawa, Hirohisa; Kaiki, Yuki; Sugiyama, Aya; Nagashima, Shintaro; Kurisu, Akemi; Nomura, Toshihito; Omori, Keitaro; Akita, Tomoyuki; Shigemoto, Norifumi; Tanaka, Junko; Ohge, Hiroki

doi:10.1016/j.jiac.2021.12.034

Cited by 39 publications

(47 citation statements)

References 13 publications

(48 reference statements)

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“…However, other studies [ 65 , 66 ] reported a higher incidence of adverse reactions observed after the second dose of mRNA-based vaccine. In contrast with Kitagawa et al [ 68 ] and Saita et al [ 69 ], we showed a significant difference in injection site pain between the first and second dose. The most frequent systemic adverse reaction reported in the literature has been fatigue [ 19 , 65 , 67 , 70 ], but in our study, it was headache and joint pain.…”

Section: Discussioncontrasting

confidence: 99%

Effectiveness of Comirnaty® Vaccine and Correlates of Immunogenicity and Adverse Reactions: A Single-Center Prospective Case Series Study

et al. 2022

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The literature suggests that real-world data on the effectiveness and safety of the BNT162b2 vaccine depend on the characteristics of the vaccinated volunteers. The purpose of this study was to evaluate antibody responses and kinetics, established association with sociodemographic and clinical characteristics, and adverse reactions after complete vaccination with the BNT162b2 vaccine. A single-center prospective case series study was conducted with 112 eligible volunteers who were institutionalized elderly and health care workers with had a negative anti-SARS-CoV-2 IgG test prior to receiving the first dose of vaccine. At least one serological antibody test after each dose of vaccine was performed. Volunteers with a positive SARS-CoV-2 PCR test before vaccination were excluded. A chemiluminescent immunoassay anti-S1 antibody assay performed a serological evaluation. Both vaccine doses elicited positive IgG antibodies 3799.0 ± 2503.0 AU/mL and 8212.0 ± 4731.0 AU/mL after 20 days of the first and second doses of BNT162b2, respectively. Comirnaty® vaccine induced an immune response with antibody production against SARS-CoV-2 in 100% of participants, regardless of age (Spearman rho = −0.10, p-value = 0.312), body mass index (Spearman rho = 0.05, p-value = 0.640), blood group first dose (p-value for Kruskal–Wallis test = 0.093) and second dose (p-value for Kruskal–Wallis test = 0. 268), number of drugs (Spearman rho = −0.07, p-value = 0.490), and number of chronic diseases first dose (p-value for Kruskal–Wallis test = 0.632) and second dose (p-value for Kruskal–Wallis test = 0.510). IgG antibodies to SARS-CoV-2 were intensely elevated after the second administration of the BNT162b2 vaccine. The higher the titer of anti-peptide IgG antibodies generated after the first dose of vaccine, the higher the titer generated by the second dose of vaccine (Spearman rho = 0.86, p-value < 0.001) and the total antibody titer (Spearman rho = 0.93, p-value < 0.001). Furthermore, no serious adverse effects were reported among participants, although mild to moderate adverse effects (local or systemic) were reported after both doses of the BNT162b2 vaccine, being more frequent after the first dose of the vaccine. No participants showed a positive PCR. The BNT162b2 vaccine induces a robust and rapid antibody response regardless of participant characteristics. The second dose might be especially important because of the increased immunogenicity it produces and the possible temporal distancing of the interval between doses. In general, the vaccines were well tolerated.

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Section: Discussioncontrasting

confidence: 99%

Effectiveness of Comirnaty® Vaccine and Correlates of Immunogenicity and Adverse Reactions: A Single-Center Prospective Case Series Study

et al. 2022

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“…Not only AGEP but also SARS-CoV-2 vaccine-related dermatological manifestations have been reported in large studies. 44,45 While most are non-threatening skin reactions, a couple of severe cutaneous reactions following several SARS-CoV-2 vaccinations include Steven-Johnson's, 46,47 dermatomyositis, 48 IgA vasculitis, 49 pyoderma gangrenosum, 50 extensive rashes with blisterings, 51 TEM 52 and erythema multiforme, 53,54 and lupus erythematosus. 55 Our patient has developed AGEP probably due to terbinafine, as the skin rash occurred a few days after starting the drug.…”

Section: Discussionmentioning

confidence: 99%

What to expect when AGEP is induced by terbinafine? Case report and critical review of the literature

Oliveira

Maia

Leão

et al. 2022

Mycoses

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Background Acute Generalised Exanthematous Pustulosis (AGEP) is a rash with multiple sterile intraepidermal or subcorneal non‐follicular pustules on edematous papules, with a sudden development and rapid evolution, triggered by drugs, vaccination, insect bites, exposure to mercury, and allergens. Objectives and Methods We describe a female patient who developed extensive and abnormally prolonged AGEP following exposure to terbinafine and SARS‐CoV vaccine. A detailed review of terbinafine‐induced‐AGEP cases was performed, with the aim of evaluating if the AGEP criteria would follow a different pattern when the disease is triggered by this drug. A PubMed search helped retrieve all terbinafine‐induced AGEP case reports. AGEP‐specific Sideroff criteria were analysed in terbinafine‐induced cases and compared to other trigger causes. Conclusions When the AGEP causative drug was terbinafine, a delay in recovery was observed, compared to the existing AGEP criteria when other causes are considered. Terbinafine frequently leads to delayed resolution AGEP probably due to the presence of the drug in the skin for several weeks after exposure, even after discontinuation, and the disease severity may be potentialised by additional factors such as concomitant viral infections or vaccination.

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“…This survey evaluated a toxicity grading scale regarding any adverse events occurring after each vaccine dose. We considered as vaccine-related adverse events those occurring within 7 days after vaccination, according to the literature data [10].…”

Section: Data Collection and Study Instrumentmentioning

confidence: 99%

Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis

et al. 2022

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Background: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients affected by malignancies or on treatment with immunosuppressive drugs were excluded. Patients and methods: A retrospective monocentric study was conducted at Medical Oncological Unit of Santa Chiara Hospital (Pisa, Italy) in this subset of population to investigate safety and tolerability of COVID-19 vaccines; 377 patients with solid tumor on treatment were enrolled. Vaccine-related adverse events were recorded using a face-to-face questionnaire including a toxicity grading scale. Most of the patients (94%) received mRNA vaccine as indicated by Italian health ministry guidelines. Mean age was 66 years (range 27–87), 62% of the patients were older than 65 years and 68% had at least one additional comorbidity. The majority (86%) of patients were in a metastatic setting and 29% received immunotherapy-based treatment. For statistical analysis, multivariate binary logistic regression models were performed and linear regression models were applied. Results: Adverse events were mild and transient and ended in a few days without any sequelae. No severe or uncommon adverse events were recorded. In multivariate analysis, we found that the female sex was associated with a greater risk of more severe and longer lasting adverse events, and a higher risk of adverse events was found for patients treated with immunotherapy. Conclusions: Our results demonstrate that COVID-19 vaccines were safe and well-tolerated in this population of patients being treated for solid tumors.

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Adverse reactions to the BNT162b2 and mRNA-1273 mRNA COVID-19 vaccines in Japan

Cited by 39 publications

References 13 publications

Effectiveness of Comirnaty® Vaccine and Correlates of Immunogenicity and Adverse Reactions: A Single-Center Prospective Case Series Study

Effectiveness of Comirnaty® Vaccine and Correlates of Immunogenicity and Adverse Reactions: A Single-Center Prospective Case Series Study

What to expect when AGEP is induced by terbinafine? Case report and critical review of the literature

Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis

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