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Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

When to seek medical advice: Persistent or worsening injection site reactions (increasing redness, warmth, or discharge suggesting infection) Severe or persistent headaches Chest pain or palpitations Unexplained muscle weakness or cramps New or worsening neurological symptoms despite treatment Unexpected bleeding or bruising For non-emergency concerns, contact your GP or NHS 111

doi: 10.1172/jci118639