Medical Editor: John P. Cunha, DO, FACOEP
Fluzone High-Dose (Influenza Vaccine) Suspension for Intramuscular Injection 2016-2017 Formula is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine, approved for use in persons 65 years of age and older. Common side effects of Fluzone High-Dose include:
The dose of Fluzone High-Dose is a single 0.5 mL dose for intramuscular injection in adults 65 years of age and older. Fluzone High-Dose may interact with other drugs or vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received. Tell your doctor if you are pregnant before receiving Fluzone High-Dose; it is unknown if it would affect a fetus. It is unknown if Fluzone High-Dose passes into breast milk. Consult your doctor before breastfeeding.
Our Fluzone High-Dose (Influenza Vaccine) Suspension for Intramuscular Injection 2016-2017 Formula Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice. Two clinical studies have evaluated the safety of Fluzone High-Dose. Study 1 (NCT00391053, see http://clinicaltrials.gov) was a multi-center, double-blind pre-licensure trial conducted in the US. In this study, adults 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone (2006-2007 formulation). The study compared the safety and immunogenicity of Fluzone High-Dose to those of Fluzone. The safety analysis set included 2573 Fluzone High-Dose recipients and 1260 Fluzone recipients.
Table 1 summarizes solicited injection-site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards. Onset was usually within the first 3 days after vaccination and a majority of the reactions resolved within 3 days. Solicited injection-site reactions and systemic adverse events were more frequent after vaccination with Fluzone High-Dose compared to Fluzone.
Table 1: Study 1a: Frequency of Solicited
Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination
with Fluzone High-Dose or Fluzone, Adults 65 Years of Age and Older
|Fevere( ≥ 99.5°F)||3.6||1.1||0.0||2.3||0.2||0.1|
b N is the number of vaccinated participants with available data for the events listed
c Moderate - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injection-site erythema and Injection-site swelling: ≥ 2.5 cm to < 5 cm; Fever: > 100.4°F to ≤ 102.2°F; Myalgia, Malaise, and Headache: interferes with daily activities
d Severe - Injection-site pain: incapacitating, unable to perform usual activities; Injectionsite erythema and Injection-site swelling: ≥ 5 cm; Fever: > 102.2°F; Myalgia, Malaise, and Headache: prevents daily activities
e Fever - The percentage of temperature measurements that were taken by oral route or not recorded were 97.9% and 2.1%, respectively, for Fluzone High-Dose; and 98.6% and 1.4%, respectively, for Fluzone
Within 6 months post-vaccination, 156 (6.1%) Fluzone High-Dose recipients and 93 (7.4%) Fluzone recipients experienced a serious adverse event (SAE). No deaths were reported within 28 days post-vaccination. A total of 23 deaths were reported during Days 29 - 180 post-vaccination: 16 (0.6%) among Fluzone High-Dose recipients and 7 (0.6%) among Fluzone recipients. The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluzone High-Dose.
Study 2 (NCT01427309, see http://clinicaltrials.gov) was a multi-center, double-blind postlicensure efficacy trial conducted in the US and Canada over two influenza seasons. In this study, adults 65 years of age and older were randomized to receive either Fluzone High- Dose or Fluzone (2011-2012 and 2012-2013 formulations). The study compared the efficacy and safety of Fluzone High-Dose to those of Fluzone. The safety analysis set included 15,992 Fluzone High-Dose recipients and 15,991 Fluzone recipients.
Within the study surveillance period (approximately 6 to 8 months post-vaccination), 1323 (8.3%) Fluzone High-Dose recipients and 1442 (9.0%) Fluzone recipients experienced an SAE. Within 30 days post-vaccination, 204 (1.3%) Fluzone High-Dose recipients and 200 (1.3%) Fluzone recipients experienced an SAE. The majority of these participants had one or more chronic comorbid illnesses. A total of 167 deaths were reported within 6 to 8 months post-vaccination: 83 (0.5%) among Fluzone High-Dose recipients and 84 (0.5%) among Fluzone recipients. A total of 6 deaths were reported within 30 days post-vaccination: 6 (0.04%) among Fluzone High-Dose recipients and 0 (0 %) among Fluzone recipients. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluzone High-Dose.
The following events have been spontaneously reported during the post-approval use of Fluzone or Fluzone High-Dose. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone or Fluzone High-Dose.
Events Reported During Post-Approval Use of Fluzone
- Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy
- Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
- Eye Disorders: Ocular hyperemia
- Nervous System Disorders: Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell's palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia
- Vascular Disorders: Vasculitis, vasodilatation/flushing
- Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pharyngitis, rhinitis, cough, wheezing, throat tightness
- Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome
- General Disorders and Administration Site Conditions: Pruritus, asthenia/fatigue, pain in extremities, chest pain
- Gastrointestinal Disorders: Vomiting
- Other Events Reported During Post-Approval Use of Fluzone High-Dose.
- Gastrointestinal Disorders: Nausea, diarrhea
- General Disorders and Administration Site Conditions: Chills
Read the entire FDA prescribing information for Fluzone Highdose (Flu Vaccine)