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Product MonographSafety Information
Pfizer Respiratory Vaccine Portfolio
Demonstrated excellent safety profile1Solicited local and systemic adverse reactions (any grade) within 7 days of vaccination in the MATISSE trial (> 20%) among maternal participants
  ABRYSVO
N=3,663a
n (%)		 Placebo
N=3,639a
n (%)
Local adverse reactions
Injection site painb 1,488 (40.6) 369 (10.1)
Rednessb 264 (7.2) 8 (0.2)
Swellingb 227 (6.2) 8 (0.2)
Systemic adverse reactions
Fever (≥ 38.0 °C) 94 (2.6) 107 (2.9)
Fatigueb 1,688 (46.1) 1,594 (43.8)
Headacheb 1,134 (31.0) 1,004 (27.6)
Muscle painb 972 (26.5) 623 (17.1)
Joint painb 424 (11.6) 382 (10.5)
Nauseab 732 (20.0) 700 (19.2)
Vomitingb 287 (7.8) 254 (7.0)
Diarrheab 412 (11.2) 417 (11.5)

Adapted from the ABRYSVO Product Monograph.1

  • Among maternal participants, the majority of reactions were mild to moderate in severity and resolved within 2–3 days of onset.
  • The most frequently reported adverse reactions were vaccination site pain, fatigue, headache, and myalgia.
  • Solicited local and systemic adverse reactions were not studied in infant participants.
aN=number of participants who provided e-diary data for a specific reason after vaccination.
bAny includes all participants who reported a reaction as mild, moderate, or severe during Day 1 to Day 7 after vaccination.Reference:ABRYSVO Product Monograph. Pfizer Canada ULC. May 29, 2024.
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