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Fluzone

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Just as in 2003, the nasty H3N2 flu bug is causing most cases so far.

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Fluzone

Fluzone

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trial of another vaccine, and may not reflect the rates observed in practice.

Children 6 Months through 8 Years of Age

In a multi-center study conducted in the US, children 6 months through 35 months of age received two 0.25 mL doses of Fluzone, and children 3 years through 8 years of age received two 0.5 mL doses of Fluzone, irrespective of previous influenza vaccination history. The two doses (year 2006-2007 formulation) were administered 26 to 30 days apart. The safety analysis set included 97 children 6 months through 35 months of age and 163 children 3 years through 8 years of age. Table 2 and Table 3 summarize solicited injection site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards.

Table 2: Frequency of Solicited Injection Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone, Children 6 Through 35 Months of Age

  Dose 1
(Na=90-92)
Percentage
Dose 2
(Na=86-87)
Percentage
Any Moderateb Severec Any Moderateb Severec
Injection-Site Tenderness 47.3 8.8 0.0 56.3 3.4 1.1
Injection-Site Erythema 29.3 0.0 0.0 32.2 1.1 0.0
Injection-Site Swelling 16.7 0.0 0.0 14.9 0.0 0.0
Injection-Site Induration 14.4 0.0 0.0 16.1 0.0 0.0
Injection-Site Ecchymosis 14.4 1.1 0.0 14.9 2.3 0.0
Feverd 11.0 4.4 0.0 10.3 3.4 1.1
Vomiting 6.6 1.1 0.0 8.1 5.8 0.0
Crying Abnormal 31.9 11.0 0.0 18.6 7.0 2.3
Drowsiness 26.4 1.1 0.0 26.7 4.7 0.0
Appetite Lost 23.1 8.8 0.0 19.8 5.8 1.2
Irritability 42.9 19.8 1.1 34.9 17.4 4.7
aN is the number of vaccinated subjects with available data for the events listed
b Moderate - Injection-site tenderness: cries and protests when injection site is touched; Injection-site erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 2.5 cm to < 5 cm; Fever: > 101.3°F to ≤ 103.1°F; Vomiting: 2 to 5 episodes per 24 hours; Crying abnormal: 1 to 3 hours; Drowsiness: not interested in surroundings or did not wake up for a meal; Appetite lost: missed 1 or 2 feeds completely; Irritability: requiring increased attention
c Severe - Injection-site tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Injection-site erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 5 cm; Fever: > 103.1°F; Vomiting: ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: > 3 hours; Drowsiness: sleeping most of the time or difficulty to wake up; Appetite lost: refuses ≥ 3 feeds or refuses most feeds; Irritability: inconsolable
d Fever - Any Fever indicates ≥ 100.4°F. The percentage of temperature measurements that were taken by rectal, axillary, or oral routes, or not recorded were 69.2%, 17.6%, 13.2%, and 0.0%, respectively for Dose 1; and 69.0%, 13.8%, 16.1%, and 1.1%, respectively for Dose 2

Table 3: Frequency of Solicited Injection Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone, Children 3 Through 8 Years of Age

  Dose 1
(Na=150-151)
Percentage
Dose 2
(Na=144-145)
Percentage
Any Moderateb Severec Any Moderateb Severec
Injection-Site Pain 59.3 8.0 0.0 62.1 9.7 0.7
Injection-Site Erythema 27.8 3.3 0.7 27.6 2.1 0.7
Injection-Site Swelling 19.9 5.3 0.0 14.5 2.8 0.0
Injection-Site Induration 16.6 2.0 0.0 11.7 1.4 0.0
Injection-Site Ecchymosis 12.6 0.7 0.7 15.2 0.7 0.0
Injection-Site Pruritus 7.3 - - 13.2 - -
Feverd 11.9 2.6 2.0 9.7 1.4 1.4
Headache 16.7 2.0 0.7 11.8 1.4 1.4
Malaise 20.0 2.7 1.3 14.6 4.2 0.7
Myalgia 28.0 5.3 0.0 17.4 4.2 0.0
aN is the number of vaccinated subjects with available data for the events listed
b Moderate - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injectionsite erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 2.5 cm to < 5 cm; Fever: > 100.4°F to ≤ 102.2°F; Headache, Malaise, and Myalgia: interferes with daily activities
c Severe - Injection-site pain: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Injection-site erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 5 cm; Fever: > 102.2°F; Headache, Malaise, and Myalgia: prevents daily activities
d Fever - Any Fever indicates ≥ 99.5°F. The percentage of temperature measurements that were taken by oral or axillary routes, or not recorded were 93.4%, 6.6%, and 0.0%, respectively for Dose 1; and 93.1%, 6.2%, and 0.7%, respectively for Dose 2
“-” indicates information was not collected

During the period from the first vaccination through 6 months following the second vaccination, there were no serious adverse events considered to be caused by vaccination and no deaths reported in this study.

Adults

Adults 18 through 64 years of age received Fluzone (year 2008-2009 formulation) in a multicenter trial conducted in the US. The safety analysis set included 1421 Fluzone recipients. Table 4 summarizes solicited injection-site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards.

Table 4: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone, Adults 18 Through 64 Years of Age

  (Na=1392-1394)
Percentage
Any Grade 2b Grade 3c
Injection-Site Erythema 13.2 2.1 0.9
Injection-Site Induration 10.0 2.3 0.5
Injection-Site Swelling 8.4 2.1 0.9
Injection-Site Pain 53.7 5.8 0.8
Injection-Site Pruritus 9.3 0.4 0.0
Injection-Site Ecchymosis 6.2 1.1 0.4
Headache 30.3 6.5 1.6
Myalgia 30.8 5.5 1.4
Malaise 22.2 5.5 1.8
Shivering 6.2 1.1 0.6
Feverd 2.6 0.4 0.2
aN is the number of vaccinated subjects with available data for the events listed
b Grade 2 - Injection-site erythema, Injection-site induration, Injection-site swelling, and Injection-site ecchymosis: ≥ 2.5 cm to < 5 cm; Injection-site pain and Injection-site pruritus: sufficiently discomforting to interfere with normal behavior or activities; Fever: > 100.4°F to ≤ 102.2°F; Headache, Myalgia, Malaise, and Shivering: interferes with daily activities
c Grade 3 - Injection-site erythema, Injection-site induration, Injection-site swelling, and Injection-site ecchymosis: ≥ 5 cm; Injection-site pain: incapacitating, unable to perform usual activities; Injection-site pruritus: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Fever: > 102.2°F; Headache, Myalgia, Malaise, and Shivering: prevents daily activities
d Fever - Any Fever indicates ≥ 99.5°F. The percentage of temperature measurements that were taken by oral or axillary routes, or not recorded were 99.6%, 0.0%, and 0.4%, respectively

Within 28 days and six months post-vaccination, a serious adverse event was reported by 5 (0.4%) and 20 (1.4%) Fluzone recipients, respectively. No serious adverse event was considered to be caused by vaccination. No deaths were reported during the 6 months post-vaccination.

Geriatric Adults

Adults 65 years of age and older received Fluzone (year 2006-2007 formulation) in a multicenter, double-blind trial conducted in the US. The safety analysis set included 1260 Fluzone recipients.

Table 5 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.

Table 5: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone, Adults 65 Years of Age and Older

  Na=1258-1260
Percentage
Any Moderateb Severec
Injection-Site Pain 24.3 1.7 0.2
Injection-Site Erythema 10.8 0.8 0.6
Injection-Site Swelling 5.8 1.3 0.6
Myalgia 18.3 3.2 0.2
Malaise 14.0 3.7 0.6
Headache 14.4 2.5 0.3
Feverd 2.3 0.2 0.1
aN is the number of vaccinated subjects with available data for the events listed
bModerate - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injectionsite 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
cSevere - Injection-site pain: incapacitating, unable to perform usual activities; Injection-site erythema and Injectionsite swelling: ≥ 5 cm; Fever: > 102.2°F; Myalgia, Malaise, and Headache: prevents daily activities
d Fever –Any Fever indicates ≥ 99.5°F. The percentage of temperature measurements that were taken by oral route or not recorded were 98.6% and 1.4%, respectively

Within 6 months post-vaccination, 93 (7.4%) Fluzone recipients experienced a serious adverse event (N=1260). No deaths were reported within 28 days post-vaccination. A total of 7 deaths were reported during the period Day 29-180 post-vaccination: 7 (0.6%) among Fluzone recipients (N=1260). The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. No deaths were considered to be caused by vaccination.

Post-Marketing Experience

The following events have been spontaneously reported during the post-approval use of Fluzone. 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.

Read the Fluzone (influenza virus vaccine) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Data evaluating the concomitant administration of Fluzone with other vaccines are not available.

Last reviewed on RxList: 11/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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