PMID- 36217268
OWN - NLM
STAT- MEDLINE
DCOM- 20221012
LR  - 20221015
IS  - 1473-2300 (Electronic)
IS  - 0300-0605 (Print)
IS  - 0300-0605 (Linking)
VI  - 50
IP  - 10
DP  - 2022 Oct
TI  - Adverse events after administration of the first and second doses of messenger 
      RNA-based COVID-19 vaccines in Japanese subjects aged 12-18 years.
PG  - 3000605221127518
LID - 10.1177/03000605221127518 [doi]
LID - 03000605221127518
AB  - OBJECTIVE: Using a prospective observational design, we assessed adverse events 
      (AEs) after COVID-19 vaccination in Japanese patients. METHODS: Two doses of the 
      mRNA-1273 (SPIKEVAX(R)) or BNT162b2 (COMIRNATY(R)) vaccine were administered to 
      participants aged 12 to 18 years, and AEs after each dose were recorded for 14 
      days. Data on the duration and nature (local vs. systemic) of AEs were collected 
      using a questionnaire. Sex-based differences in AE frequency were also analyzed. 
      RESULTS: After the first and second doses, 152 and 135 vaccinees were enrolled, 
      respectively. After the first dose, fever (>37.1 degrees C) occurred in 38.9% of males 
      and 50.0% of females, whereas local pain occurred in 89.8% and 97.7% of males and 
      females, respectively (only SPIKEVAX(R) was used as the first dose). After the 
      second dose, fever (>37.1 degrees C) occurred in 77.8% and 82.6% of males vaccinated with 
      COMIRNATY(R) and SPIKEVAX(R), respectively, and 82.6% of females (all received 
      SPIKEVAX(R)). The local pain rates in these groups were 80.6%, 76.3%, and 100%, 
      respectively. After the second dose, local pain, fever (>38.1 degrees C) and headache 
      were significantly more common in female participants, and the median symptom 
      duration was 3 days. CONCLUSIONS: AEs were more frequent after the second dose 
      and in females.
FAU - Ogawa, Taku
AU  - Ogawa T
AUID- ORCID: 0000-0003-1569-4642
AD  - Department of Microbiology and Infection Control, Osaka Medical and 
      Pharmaceutical University, Osaka, Japan.
AD  - Infection Control Center, Osaka Medical and pharmaceutical University Hospital, 
      Osaka, Japan.
FAU - Yamada, Tomoyuki
AU  - Yamada T
AD  - Infection Control Center, Osaka Medical and pharmaceutical University Hospital, 
      Osaka, Japan.
FAU - Matsumoto, Yuki
AU  - Matsumoto Y
AD  - Infection Control Center, Osaka Medical and pharmaceutical University Hospital, 
      Osaka, Japan.
FAU - Minami, Kenta
AU  - Minami K
AD  - Infection Control Center, Osaka Medical and pharmaceutical University Hospital, 
      Osaka, Japan.
FAU - Kawanishi, Fumiko
AU  - Kawanishi F
AD  - Infection Control Center, Osaka Medical and pharmaceutical University Hospital, 
      Osaka, Japan.
FAU - Nakano, Takashi
AU  - Nakano T
AD  - Department of Microbiology and Infection Control, Osaka Medical and 
      Pharmaceutical University, Osaka, Japan.
FAU - Ukimura, Akira
AU  - Ukimura A
AD  - Infection Control Center, Osaka Medical and pharmaceutical University Hospital, 
      Osaka, Japan.
AD  - Department of Internal Medicine III, Osaka Medical and pharmaceutical University, 
      Osaka, Japan.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PL  - England
TA  - J Int Med Res
JT  - The Journal of international medical research
JID - 0346411
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (RNA, Messenger)
RN  - 0 (mRNA Vaccines)
RN  - N38TVC63NU (BNT162 Vaccine)
SB  - IM
MH  - BNT162 Vaccine
MH  - *COVID-19/prevention & control
MH  - *COVID-19 Vaccines/adverse effects
MH  - Female
MH  - Fever/epidemiology/etiology
MH  - Humans
MH  - Japan/epidemiology
MH  - Male
MH  - Pain/etiology
MH  - RNA, Messenger
MH  - mRNA Vaccines
PMC - PMC9558881
OTO - NOTNLM
OT  - Adolescent
OT  - COVID-19
OT  - Japanese
OT  - adverse event
OT  - fever
OT  - headache
OT  - local pain
OT  - messenger RNA
OT  - vaccine
COIS- The authors declare that there is no conflict of interest.
EDAT- 2022/10/12 06:00
MHDA- 2022/10/13 06:00
PMCR- 2022/10/10
CRDT- 2022/10/11 00:43
PHST- 2022/10/11 00:43 [entrez]
PHST- 2022/10/12 06:00 [pubmed]
PHST- 2022/10/13 06:00 [medline]
PHST- 2022/10/10 00:00 [pmc-release]
AID - 10.1177_03000605221127518 [pii]
AID - 10.1177/03000605221127518 [doi]
PST - ppublish
SO  - J Int Med Res. 2022 Oct;50(10):3000605221127518. doi: 10.1177/03000605221127518.