Impact of age, sex and medical history on adverse reactions to the first and second dose of BNT162b2 mRNA COVID-19 vaccine in Japan: a cross-sectional study

Abstract

Background Vaccines for coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are being promoted worldwide. In this study, we analyzed the relationship between adverse reactions and the profile of vaccinated recipients. Methods Vaccinated subjects who received two doses of BNT162b2 between May 17 and June 11, 2021, at Osaka University Dental Hospital were included in this study. Adverse reactions and profiles were collected by questionnaires, and the relationship between the presence of adverse reactions and the profiles of the vaccinated persons was analyzed by logistic regression analysis. The correlation between the severity of adverse reactions and age was analyzed by Spearman’s rank correlation. Results Logistic regression analysis showed that, for many kinds of adverse reactions, the incidence was significantly higher in females than in males and in younger than in older people. There was a very weak but significant negative correlation between age and the severity of many kinds of adverse reactions. The relationship between sex and the incidence of each adverse reaction was significant for injection site reactions and fatigue in the first vaccination, whereas significant relationships were found for fatigue, chills, fever, arthralgia, myalgia and headache in the second vaccination, all of which were clearly more likely to occur in females. Conclusion Adverse reactions to BNT162b2 were found to be more frequent and more intense in females and younger people in Japan, especially after the second vaccination.

Common adverse events following immunization with the COVID-19 comirnaty vaccine (Pfizer-BioNTech) among adult population in Hanoi, Vietnam, 2021

“…In the current study, the association between AEFI and medical history was not statistically significant. This result was similar to the study conducted by Ryuta Urakawa and colleagues in Japan in 2022, indicating that there was no evidence of the relationship between comorbidities and AEFI (24).…”

Adverse events after administration of the first and second doses of messenger RNA-based COVID-19 vaccines in Japanese subjects aged 12–18 years

“…This result is consistent with those of previous reports. 5 – 8 However, the frequency of fever of >38°C was significantly higher in females than in males after both the first and second doses. In general, fever of >38°C to 39°C is classified as grade 1 in the Common Terminology Criteria for AEs (CTCAE) and is considered a “mild” AE.…”

“…Data on the types of adverse events (AEs) occurring in adults after administration of COVID-19 vaccines are gradually being accumulated. 5 , 6 …”

“…Data on the types of adverse events (AEs) occurring in adults after administration of COVID-19 vaccines are gradually being accumulated. 5,6 It should be noted that there is insufficient knowledge available on the characteristics of AEs in adolescent vaccinees. We thus collected data on AEs following COVID-19 vaccination in children aged 12 to 18 years.…”

Evaluasi Kejadian Ikutan Pasca Imunisasi pada Peserta Vaksinasi di Puskesmas Teluk Dalam, Tenggarong Seberang

“…Hal ini selaras dengan penilitian sebelumnya yang dilakukan oleh Urakawa dkk. mengenai vaksin Pfizer dimana perbedaan jenis kelamin tidak mempengaruhi efek samping yang terjadi pada pemberian vaksin Pfizer dosis pertama, tetapi tingkat kejadiannya lebih tinggi pada kelompok usia yang lebih muda dan juga pada dosis kedua lebih tinggi pada perempuan dan tingkat kejadianya lebih rendah pada kelompok usia yang lebih tua [7]. Berdasarkan dari Gambar 1 pada pemberian vaksin dosis pertama efek samping terbanyak adalah nyeri di daerah suntikan dengan 26,31%, diikuti dengan demam 17,89% dan mengantuk 14,73%.…”