Safety Profile

Made Differently, Similar Safety Profile1

The safety profile of FLUCELVAX® (Influenza Vaccine) was similar to traditionally made flu vaccines across clinical trials1

The rate of serious adverse events among adults aged 18 through 64 years was 1%

The rate of serious adverse events among adults aged 65 years and older was 4%1

  Adults aged 18 through 64 years Adults aged 65 years and older
Local Adverse Reactions FLUCELVAX® (n=821) (%) Comparator (n=841) (%) FLUCELVAX® (n=509) (%) Comparator (n=483) (%)
Injection site pain 20 15 8 4
Erythema 14 15 10 11
Induration 6 6 5 4
Swelling 4 4 4 2
Ecchymosis 3 3 4 4
  Adults aged 18 through 64 years Adults aged 65 years and older
Systemic Adverse Reactions FLUCELVAX® (n=821) (%) Comparator (n=841) (%) FLUCELVAX® (n=509) (%) Comparator (n=483) (%)
Headache 12 11 10 11
Fatigue 11 11 11 13
Myalgia 7 8 6 8
Malaise 11 11 10 11
Chills 4 4 3 4
Arthralgia 5 5 6 7
Sweating 5 4 7 8
Fever (≥38°C) 1 1 < 1 1

Important Safety Information

Contraindication

Warnings & Precautions

Most Common Adverse Reactions

Please see accompanying US Full Prescribing Information for FLUCELVAX®.


References:

  1. FLUCELVAX® (package insert). Cambridge, MA.