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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

HEPATITIS B VIRUS VACCINE: 212 Adverse Event Reports & Safety Profile

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212
Total FAERS Reports
19 (9.0%)
Deaths Reported
54
Hospitalizations
212
As Primary/Secondary Suspect
8
Life-Threatening
4
Disabilities

First Report: 20010111 · Latest Report: 20250720

What Are the Most Common HEPATITIS B VIRUS VACCINE Side Effects?

#1 Most Reported
Fatigue
43 reports (20.3%)
#2 Most Reported
Drug hypersensitivity
37 reports (17.5%)
#3 Most Reported
Rhinorrhoea
36 reports (17.0%)

All HEPATITIS B VIRUS VACCINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 43 20.3% 0 22
Drug hypersensitivity 37 17.5% 0 18
Rhinorrhoea 36 17.0% 0 19
Diarrhoea 35 16.5% 1 23
Hypoaesthesia 35 16.5% 0 18
Dry skin 34 16.0% 0 16
Vomiting 33 15.6% 1 21
Gait disturbance 32 15.1% 0 20
Arthralgia 31 14.6% 0 19
Headache 31 14.6% 0 21
Nausea 31 14.6% 0 21
Rash 31 14.6% 0 17
Abdominal pain 30 14.2% 0 19
Chills 30 14.2% 0 21
Contusion 30 14.2% 0 22
Dizziness 30 14.2% 0 19
Dyspnoea 30 14.2% 1 22
Anaphylactic reaction 28 13.2% 0 20
Asthenia 28 13.2% 0 19
Dysphagia 28 13.2% 1 19

Who Reports HEPATITIS B VIRUS VACCINE Side Effects? Age & Gender Data

Gender: 59.6% female, 40.4% male. Average age: 36.8 years. Most reports from: US. View detailed demographics →

Is HEPATITIS B VIRUS VACCINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 2 0 2
2002 2 0 2
2005 2 0 0
2009 1 0 0
2010 12 0 11
2011 14 0 6
2012 2 0 0
2013 3 2 1
2014 11 1 3
2015 5 0 2
2016 9 1 5
2017 3 3 1
2018 8 1 4
2019 20 6 0
2020 3 0 0
2021 1 0 1
2022 3 0 0
2023 7 0 2
2024 5 0 1
2025 8 0 4

View full timeline →

What Is HEPATITIS B VIRUS VACCINE Used For?

IndicationReports
Prophylaxis 71
Product used for unknown indication 52
Immunisation 34
Antiviral prophylaxis 14

HEPATITIS B VIRUS VACCINE vs Alternatives: Which Is Safer?

HEPATITIS B VIRUS VACCINE vs HERBALS HEPATITIS B VIRUS VACCINE vs HERBALS\MITRAGYNINE HEPATITIS B VIRUS VACCINE vs HERBALS\PAULLINIA CUPANA SEED HEPATITIS B VIRUS VACCINE vs HERBALS\PLANTAGO INDICA WHOLE HEPATITIS B VIRUS VACCINE vs HERBALS\PLANTAGO OVATA LEAF HEPATITIS B VIRUS VACCINE vs HERBALS\SAW PALMETTO HEPATITIS B VIRUS VACCINE vs HERBALS\SENNA LEAF\SENNOSIDES HEPATITIS B VIRUS VACCINE vs HERBALS\SENNOSIDES HEPATITIS B VIRUS VACCINE vs HERBALS\TETRAHYDROCANNABINOL UNSPECIFIED HEPATITIS B VIRUS VACCINE vs HERBALS\TURMERIC

Official FDA Label for HEPATITIS B VIRUS VACCINE

Official prescribing information from the FDA-approved drug label.