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influenza vaccine; focusing on side effects/adverse effects

https://www.uptodate.com/contents/seasonal-influenza-vaccination-in-adults?search=influenza%20vaccine&source=search_result&selectedTitle=4~148&usage_type=default&display_rank=4

ADVERSE REACTIONS

Inactivated vaccines — The inactivated influenza vaccines are generally well tolerated, with the most common side effect being arm soreness at the injection site (in 64 percent of vaccine recipients) [146]. In clinical trials, serious adverse events have been reported rarely. A slightly increased risk of Guillain-Barré syndrome has been associated with the inactivated influenza vaccine during certain influenza seasons, but this added risk appears to be substantially less than the overall health risk posed by naturally occurring influenza. This topic is discussed in greater detail separately. (See "Guillain-Barré syndrome: Pathogenesis", section on 'Influenza vaccination'.)

Immediate immunoglobulin (Ig)E-mediated hypersensitivity reactions have been reported rarely following influenza vaccination [4]. Oculorespiratory syndrome, an acute self-limited reaction, was first described during the 2000 to 2001 influenza season in Canada and has been reported occasionally within 24 hours of administration of the inactivated influenza vaccine [147]. It is typically mild and is characterized by bilateral conjunctivitis, facial edema, and/or respiratory symptoms (eg, cough, wheezing). It is not thought to be IgE mediated, and a causal link to influenza vaccination has not been established. However, after changes to the manufacturing process to the vaccine formulation associated with oculorespiratory syndrome, the incidence dropped substantially.

Mild to moderate local reactions are more common with the high-dose inactivated influenza vaccine (Fluzone High-Dose) than the standard-dose vaccine [123]. During the first year of postmarketing surveillance of the high-dose vaccine, a greater proportion of gastrointestinal complaints (especially vomiting) was reported to the Vaccine Adverse Event Reporting System (VAERS) among recipients of the high-dose vaccine than among recipients of the standard-dose vaccine [148].

The intradermal inactivated influenza vaccine has been associated with higher rates of injection site reactions (erythema, induration, swelling, and pruritus, but not pain) than the intramuscular inactivated influenza vaccines [149,150].

In a trial that included 50 individuals who were vaccinated using a microneedle patch, the patch was associated with significant rates of pruritus (82 percent), tenderness (66 percent), and erythema (40 percent) [83].

Needle-free intramuscular administration — Use of a trivalent inactivated influenza vaccine (Afluria) with a jet injector device is associated with a higher frequency of local injection site reactions than the use of needle and syringe [84]. These include pain, tenderness, itching, redness, swelling, and bruising.

Live attenuated vaccine — As noted above, the Advisory Committee on Immunization Practices recommends that the live attenuated influenza vaccine (LAIV) not be used during the 2017 to 2018 influenza season [4]. (See 'Comparisons of inactivated and live attenuated vaccines' above.)

LAIV is generally well tolerated, with the most common side effects in adults being rhinorrhea, nasal congestion, headache, and sore throat [151].

Out of 2.5 million people who received LAIV, the following serious adverse events have been reported to VAERS: possible anaphylaxis (seven), Guillain-Barré syndrome (two), Bell's palsy (one), and asthma exacerbation among individuals with a history of asthma (eight) [152].

Sources

= Medline ® Abstract for Reference 146 of 'Seasonal influenza vaccination in adults' =
 * 146
 * PubMed


 * TI
 * Side effects associated with influenza vaccination in healthy working adults. A randomized, placebo-controlled trial.


 * AU
 * Nichol KL, Margolis KL, Lind A, Murdoch M, McFadden R, Hauge M, Magnan S, Drake M


 * SO
 * Arch Intern Med. 1996;156(14):1546.


 * BACKGROUNDConcern about side effects is a barrier to influenza vaccination. This randomized, double-blind, placebo-controlled trial assessed side effects following vaccination among healthy working adults.
 * BACKGROUNDConcern about side effects is a barrier to influenza vaccination. This randomized, double-blind, placebo-controlled trial assessed side effects following vaccination among healthy working adults.


 * METHODSHealthy working adults were recruited during October and November 1994 and were randomized to receive influenza vaccine or placebo injections. Local and systemic symptoms during the week following the injection were evaluated through structured telephone interviews.
 * METHODSHealthy working adults were recruited during October and November 1994 and were randomized to receive influenza vaccine or placebo injections. Local and systemic symptoms during the week following the injection were evaluated through structured telephone interviews.


 * RESULTSOf 849 subjects enrolled in the study, 425 received a placebo and 424 received influenza vaccine. Baseline characteristics were similar between the groups, and 99% of subjects completed interviews to assess side effects after the study injection. No differences were seen between the 2 groups for the systemic symptoms of fever, myalgias, fatigue, malaise, or headaches. Overall, 35.2% of placebo and 34.1% of vaccine recipients reported at least 1 of these systemic symptoms (P = .78, chi 2). Vaccine recipients reported a higher rate of arm soreness at the injection site than did placebo recipients (63.8% vs 24.1%, P<.001). Local reactions were mild in both groups and infrequently resulted in decreased use of the arm. After logistic regression, female sex (odds ratio [OR], 1.5;95% confidence interval [CI], 1.1-2.1), age younger than 40 years (OR, 1.6;95% CI, 1.2-2.2), and coincidental upper respiratory tract illness (OR, 4.6; 95% CI, 3.2-6.6) were independently associated with higher rates of systemic symptoms. In the multivariate model, vaccine again was not associated with systemic symptoms (OR, 0.9; 95% CI, 0.7-1.2).
 * RESULTSOf 849 subjects enrolled in the study, 425 received a placebo and 424 received influenza vaccine. Baseline characteristics were similar between the groups, and 99% of subjects completed interviews to assess side effects after the study injection. No differences were seen between the 2 groups for the systemic symptoms of fever, myalgias, fatigue, malaise, or headaches. Overall, 35.2% of placebo and 34.1% of vaccine recipients reported at least 1 of these systemic symptoms (P = .78, chi 2). Vaccine recipients reported a higher rate of arm soreness at the injection site than did placebo recipients (63.8% vs 24.1%, P<.001). Local reactions were mild in both groups and infrequently resulted in decreased use of the arm. After logistic regression, female sex (odds ratio [OR], 1.5;95% confidence interval [CI], 1.1-2.1), age younger than 40 years (OR, 1.6;95% CI, 1.2-2.2), and coincidental upper respiratory tract illness (OR, 4.6; 95% CI, 3.2-6.6) were independently associated with higher rates of systemic symptoms. In the multivariate model, vaccine again was not associated with systemic symptoms (OR, 0.9; 95% CI, 0.7-1.2).


 * CONCLUSIONSInfluenza vaccination of healthy working adults is not associated with higher rates of systemic symptoms when compared with placebo injection. These findings should be useful to physicians and other health care providers as they counsel patients to take advantage of an important opportunity for disease prevention and health protection.
 * CONCLUSIONSInfluenza vaccination of healthy working adults is not associated with higher rates of systemic symptoms when compared with placebo injection. These findings should be useful to physicians and other health care providers as they counsel patients to take advantage of an important opportunity for disease prevention and health protection.


 * AD
 * Veterans Affairs Medical Center, Minneapolis, USA.


 * PMID
 * 8687262

= Medline ® Abstract for Reference 147 of 'Seasonal influenza vaccination in adults' =
 * 147
 * PubMed


 * TI
 * Oculo-respiratory syndrome: a new influenza vaccine-associated adverse event?


 * AU
 * Skowronski DM, Strauss B, De Serres G, MacDonald D, Marion SA, Naus M, Patrick DM, Kendall P


 * SO
 * Clin Infect Dis. 2003 Mar;36(6):705-13. Epub 2003 Mar 5.


 * During the 2000-2001 influenza immunization campaign in Canada, a new adverse event, oculo-respiratory syndrome (ORS), was noted in association with administration of vaccine supplied by one manufacturer. The original case definition for ORS specified bilateral conjunctivitis, facial edema, or respiratory symptoms beginning 2-24 h after influenza vaccination and resolving within 48 h after onset. To characterize the spectrum, severity, and impact of ORS, we contacted persons who had reported any influenza vaccine-associated adverse event in British Columbia, Canada, during the 2000-2001 vaccination campaign. With use of a standardized telephone interview, we collected information from 609 (79%) of 769 eligible persons. Thirteen percent of ORS-affected persons reported onset48 h, and 42% considered the symptoms to be severe. The surveillance case definition for ORS for 2001-2002 was revised to include onset<or=24 h after vaccination, with no restriction on duration. ORS should be incorporated into annual influenza vaccine safety monitoring.
 * During the 2000-2001 influenza immunization campaign in Canada, a new adverse event, oculo-respiratory syndrome (ORS), was noted in association with administration of vaccine supplied by one manufacturer. The original case definition for ORS specified bilateral conjunctivitis, facial edema, or respiratory symptoms beginning 2-24 h after influenza vaccination and resolving within 48 h after onset. To characterize the spectrum, severity, and impact of ORS, we contacted persons who had reported any influenza vaccine-associated adverse event in British Columbia, Canada, during the 2000-2001 vaccination campaign. With use of a standardized telephone interview, we collected information from 609 (79%) of 769 eligible persons. Thirteen percent of ORS-affected persons reported onset48 h, and 42% considered the symptoms to be severe. The surveillance case definition for ORS for 2001-2002 was revised to include onset<or=24 h after vaccination, with no restriction on duration. ORS should be incorporated into annual influenza vaccine safety monitoring.


 * AD
 * University of British Columbia Centre for Disease Control, University of British Columbia, Vancouver, Canada. danuta.skowronski@bccdc.ca


 * PMID
 * 12627354

= Medline ® Abstract for Reference 123 of 'Seasonal influenza vaccination in adults' =
 * 123
 * PubMed


 * TI
 * Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older.


 * AU
 * Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ


 * SO
 * J Infect Dis. 2009;200(2):172.


 * BACKGROUNDInfluenza-associated morbidity and mortality has not decreased in the last decade, despite increased receipt of vaccine. To improve the immunogenicity of influenza vaccine, a high-dose (HD) trivalent, inactivated influenza vaccine was developed.
 * BACKGROUNDInfluenza-associated morbidity and mortality has not decreased in the last decade, despite increased receipt of vaccine. To improve the immunogenicity of influenza vaccine, a high-dose (HD) trivalent, inactivated influenza vaccine was developed.


 * METHODSA multicenter, randomized, double-blind controlled study was conducted to compare HD vaccine (which contains 60 microg of hemagglutinin per strain) with the licensed standard-dose (SD) vaccine (which contains 15 microg of hemagglutinin per strain) in adults>or = 65 years of age.
 * METHODSA multicenter, randomized, double-blind controlled study was conducted to compare HD vaccine (which contains 60 microg of hemagglutinin per strain) with the licensed standard-dose (SD) vaccine (which contains 15 microg of hemagglutinin per strain) in adults>or = 65 years of age.


 * RESULTSHD vaccine was administered to 2575 subjects, and SD vaccine was administered to 1262 subjects. There was a statistically significant increase in the rates of seroconversion and mean hemagglutination inhibition titers at day 28 after vaccination among those who received HD vaccine, compared with those who received SD vaccine. Mean postvaccination titers for individuals who received HD vaccine were 116 for H1N1, 609 for H3N2, and 69 for B strain; for those who received SD vaccine, mean postvaccinationtiters were as 67 for H1N1, 333 for H3N2, and 52 for B strain. The HD vaccine met superiority criteria for both A strains, and the responses for B strain met non-inferiority criteria. Seroprotection rates were also higher for those who received HD vaccine than for those who received SD vaccine vaccine, for all strains. Local reactions were more frequent in individuals who received HD vaccine, but the reactions were mild to moderate.
 * RESULTSHD vaccine was administered to 2575 subjects, and SD vaccine was administered to 1262 subjects. There was a statistically significant increase in the rates of seroconversion and mean hemagglutination inhibition titers at day 28 after vaccination among those who received HD vaccine, compared with those who received SD vaccine. Mean postvaccination titers for individuals who received HD vaccine were 116 for H1N1, 609 for H3N2, and 69 for B strain; for those who received SD vaccine, mean postvaccinationtiters were as 67 for H1N1, 333 for H3N2, and 52 for B strain. The HD vaccine met superiority criteria for both A strains, and the responses for B strain met non-inferiority criteria. Seroprotection rates were also higher for those who received HD vaccine than for those who received SD vaccine vaccine, for all strains. Local reactions were more frequent in individuals who received HD vaccine, but the reactions were mild to moderate.


 * CONCLUSIONSThere was a statistically significant increase in the level of antibody response induced by HD influenza vaccine, compared with that induced by SD vaccine, without an attendant increase in the rate or severity of clinically relevant adverse reactions. These results suggest that the high-dose vaccine may provide improved protective benefits for older adults.
 * CONCLUSIONSThere was a statistically significant increase in the level of antibody response induced by HD influenza vaccine, compared with that induced by SD vaccine, without an attendant increase in the rate or severity of clinically relevant adverse reactions. These results suggest that the high-dose vaccine may provide improved protective benefits for older adults.


 * TRIAL REGISTRATIONClinicalTrials.gov identifier: NCT00391053.
 * TRIAL REGISTRATIONClinicalTrials.gov identifier: NCT00391053.


 * AD
 * Department of Medicine, Rochester General Hospital, Rochester, NY, USA. ann.falsey@viahealth.org


 * PMID
 * 19508159

= Medline ® Abstracts for References 149,150 of 'Seasonal influenza vaccination in adults' =
 * 149
 * Sanofi pasteur. Fluzone intradermal. Highlights of prescribing information. http://www.fda.gov/downloads/biologicsbloodvaccines/.../ucm195479.pdf (Accessed on September 30, 2013).
 * Sanofi pasteur. Fluzone intradermal. Highlights of prescribing information. http://www.fda.gov/downloads/biologicsbloodvaccines/.../ucm195479.pdf (Accessed on September 30, 2013).
 * Sanofi pasteur. Fluzone intradermal. Highlights of prescribing information. http://www.fda.gov/downloads/biologicsbloodvaccines/.../ucm195479.pdf (Accessed on September 30, 2013).


 * no abstract available
 * no abstract available


 * 150
 * PubMed


 * TI
 * A systematic review of intradermal influenza vaccines.


 * AU
 * Young F, Marra F


 * SO
 * Vaccine. 2011 Nov;29(48):8788-801. Epub 2011 Oct 1.


 * Influenza infection is associated with many complications, which can lead to hospitalizations and death. This is particularly true for the older adults who are not able to mount as good an immune response as younger adults due to their declining immune function. As such, different strategies are being evaluated to increase immunogenicity in the older adults, including use of adjuvanted vaccines and different delivery techniques, which can enhance immunogenicity as well as potentially be dose-sparing. The objective of this paper was to conduct a systematic review of studies that evaluated the efficacy (in terms of immunogenicity) and safety of intradermal (ID) influenza vaccines compared with traditional methods of administration in the general population and the older adults. Thirteen randomized, controlled, open-label trials were included in this systematic review. Seven trials were conducted in young adults 18-60 years of age, 4 trials were studied in older subjects>60 years, and 2 trials included both young and older adults, of which one did separate analyses for both groups and one did a separate analysis for the older adult population only. We found 7 studies out of 8 for the 18-60-year olds and 4 out of 6 studies in the over 60-year olds showed comparable efficacy between ID and intramuscular (IM) administration. Two out of 6 studies in the over 60-year olds showed superiority of ID administration over IM. Rates of adverse events occurring in the first 3 days were comparable between ID and IM administration of influenza vaccines; however, when assessing adverse events occurring in the first 7 days, rates of local adverse events were consistently higher in the ID group, specifically erythema, swelling, induration, and pruritis. In conclusion, our review shows comparable efficacy between ID and IM administration of influenza vaccine in both the younger and older adults.
 * Influenza infection is associated with many complications, which can lead to hospitalizations and death. This is particularly true for the older adults who are not able to mount as good an immune response as younger adults due to their declining immune function. As such, different strategies are being evaluated to increase immunogenicity in the older adults, including use of adjuvanted vaccines and different delivery techniques, which can enhance immunogenicity as well as potentially be dose-sparing. The objective of this paper was to conduct a systematic review of studies that evaluated the efficacy (in terms of immunogenicity) and safety of intradermal (ID) influenza vaccines compared with traditional methods of administration in the general population and the older adults. Thirteen randomized, controlled, open-label trials were included in this systematic review. Seven trials were conducted in young adults 18-60 years of age, 4 trials were studied in older subjects>60 years, and 2 trials included both young and older adults, of which one did separate analyses for both groups and one did a separate analysis for the older adult population only. We found 7 studies out of 8 for the 18-60-year olds and 4 out of 6 studies in the over 60-year olds showed comparable efficacy between ID and intramuscular (IM) administration. Two out of 6 studies in the over 60-year olds showed superiority of ID administration over IM. Rates of adverse events occurring in the first 3 days were comparable between ID and IM administration of influenza vaccines; however, when assessing adverse events occurring in the first 7 days, rates of local adverse events were consistently higher in the ID group, specifically erythema, swelling, induration, and pruritis. In conclusion, our review shows comparable efficacy between ID and IM administration of influenza vaccine in both the younger and older adults.


 * AD
 * University of British Columbia, Vancouver, BC, Canada.


 * PMID
 * 21968444