376 A Pilot Study: Trivalent Inactivated Influenza Vaccine (TIV)and Myopericarditis

M. I. Slingluff1, M. M. Klote1, B. A. Hemann1, M. R. Nelson1, M. A. Ya-

cavone1, J. E. Atwood1, S. Black2, R. J. M. Engler1; 1Walter Reed Army

Medical Center, Washington, DC, 2Kaiser Permanente Vaccine Study

Center, Oakland, CA.

RATIONALE: Rare cases of myopericarditis have been reported retro-

spectively after inactivated influenza vaccination and chest pain is a side

effect reported by some vaccinees.

METHODS: Prospective study of adults presenting for influenza immuni-

zation in 2004-2006; enrolled to complete a 30 day diary card including

chest symptoms; subjects were evaluated before, 6-8, and 9-14 days after

vaccination with electrocardiograms (ECG), interviews, and serum tropo-

nin levels. All subjects with abnormalities were adjudicated by the study

team of cardiologists and immunologists.

RESULTS: 200 adults (21-72 years, mean 37 years) were enrolled in

2004-2006 influenza seasons. Prior to vaccination, 67/197 (34%) had nor-

mal variant ECG findings. After vaccination, ECG changes from baseline

were noted in 21/186 (11.3%). All were considered normal variants, in-

cluding ST elevation consistent with early repolarization (57%), rhythm

changes such as sinus bradycardia (38%) and non-specific T wave abnor-

malities (5%). Of 134 subjects (67%) with available troponin levels,

none were significantly elevated before or after immunization. Four pa-

tients (2%) reported chest pain within 14 days after vaccination. All

were atypical on review; three were associated with cough and upper res-

piratory symptoms and one had a prior history of atypical chest pain. None

sought medical treatment; ECG or troponin levels were unchanged on their

follow up visit.

CONCLUSIONS: Atypical chest pain following inactivated influenza im-

munization was an uncommon event in this study. The atypical pain did not

correlate with diagnostic ECG or troponin changes and did not support a

diagnosis of myopericarditis.

Funding: CDC-CISA, Walter Reed National Vaccine Healthcare Center

and Immunology Department

377 Headache After Trivalent Inactivated Influenza Vaccine (TIV):Gender Differences and Severity

S. Kim-Delio1, M. M. Klote1, M. R. Nelson1, W. W. Carr2, R. D. Deguz-

man1, C. P. Mikita1, B. L. Martin1, R. J. M. Engler1; 1Walter Reed Army

Medical Center, Washington, DC, 2Walter Reed Army Medical Ctr-

WRAIR, Washington, DC.

RATIONALE: Headache is a frequently reported side effect of vaccines

generally considered acceptable with minimal impact on quality of life.

There are limited data about TIV associated headache severity (using a

quantitative pain scale) nor gender differences in rates of occurrence and

severity.

METHODS: In the context of a single-blinded, half versus full dose TIV

trial in the 2004-5 season, 1258 healthy adults (ages 18-64 years, 552-

women/706-males) completed a detailed daily side effect diary for the first

96 hours following immunization. All symptoms were graded by subjects

using the Wong-Baker FACES pain rating scale (0-5). The focus of this

analysis was a frequency comparison of post-TIV new onset headache

stratified on gender as well as dose.

RESULTS: The frequency of any headache for one or more days was sig-

nificantly greater in women (25.7%) versus men (18.6%) at p < 0.01 re-

gardless of dose. Headache for more than one day with a peak severity

�2/5 was also significantly greater in women (13.9%) versus men

(7.2%) at p<0.0001. For headache lasting 2 or more days with peak sever-

ity �2/5, the gender difference trended towards significance (p50.07).

There was no significant difference in headache frequency based on

dose. A small percentage (1.7%) of vaccinees experienced headache for

2 or more days with maximum severity 3-5/5.

CONCLUSIONS: Headache with pain severity meriting analgesic ther-

apy following influenza vaccine is not a rare event and appears to occur

more frequently in women than men. Studies are needed to define the im-

pact of headache on future vaccine acceptability and possible prevention.

378 Adverse Reactions To Pneumovax Pneumococcal Vaccine-cases Of Hyperimmunization?

S. E. Mannan, E. Yousef; A. I. duPont Hospital for Children/Thomas Jef-

ferson University Hospital, Wilmington, DE.

RATIONALE: The purpose of our study was to determine identifiable risk

factors for adverse reactions to Pneumovax, the 23-serotype pneumococcal

vaccine.

METHODS: Medical records of 173 patients who received Pneumovax

between January 2004 and December 2005 were reviewed for evaluation

of risk factors. Variables considered included age, gender, indication for

Pneumovax, and prior pneumococcal vaccines.

RESULTS: 4/173 patients were identified with adverse reactions Two of

them developed local cellulitis and fever and two had local cellulitis, fever

and vomiting. The mean age of the study subjects was 8.6 years, 68% were

male. The most common indication for vaccination was recurrent upper

respiratory infections. Other indications included recent pneumonia,

chronic lung disease and asplenia. Of the patients who had a reaction to

the vaccine, the mean age was 6.5 years old and all were male. The indica-

tion for 3/4 was evaluation of suspected immunodeficiency. The fourth had

received the vaccine because of asplenia. The previous vaccination records

were available for 1/4 patients. He had had 4 PCV vaccinations, with the

most recent being about 18 months prior to the pneumovax administration.

CONCLUSION: Although rare, adverse reactions do occur after vaccina-

tion with pneumoccocal vaccines. Local and systemic reactions to the vac-

cine may be greater when revaccination is done within 3 years after the

previous dose; this reactivity appears to be due to an Arthus-like response

that results from local formation of antigen-antibody complexes. Further

studies are indicated to determine if adverse reactions may be avoided

by observing defined time frames between subsequent doses of pneumo-

coccal vaccines.

379 Knowledge, Attitudes and Beliefs (KAB) Regarding Reportingof Adverse Events Following Immunizations (AEFI)

P. A. Hutchinson1, M. R. Nelson1, S. L. Hill1, L. L. Duran2, R. J. M. Eng-

ler1; 1Walter Reed Army Medical Center, Washington, DC, 2Walter Reed

Army Medical Center-VHC, Washington, DC.

RATIONALE: KAB about the Vaccine Adverse Event Reporting System

(VAERS) among health care workers (HCW) within the Military Health

System (MHS) continues to be of increasing interest because of the man-

datory biodefense vaccines for anthrax and smallpox.

METHODS: Survey tools developed for the project focused on questions

related to KAB surrounding VAERS. Surveys were distributed to a conve-

nience sample of HCW through clinics within the MHS. An anonymous

survey collection procedure was utilized for survey retrieval.

RESULTS: Of 547 distributed surveys and 512 returned, 487 (89%) were

included for analyses. Demographics of participants: 67% active duty

(62%-Army, 21%-Air Force); 16% providers and 76% medics/nurses/tech-

nicians. Overall, 54% reported familiarity with VAERS: providers 72%

(p<0.01 providers versus other HCW). Respondents acknowledged report-

ing in some fashion the last identified AEFI (74%), but only 45% identified

VAERS as the method of reporting. The top three factors that over 90 per-

cent of respondents identified to facilitate VAERS reporting included

more: training in identifying AEFI; information on when to report AEFI;

information on how to report to VAERS.

CONCLUSIONS: Familiarity with VAERS and how to use this reporting

system depends on training. Even in an environment actively supporting

VAERS awareness, less than half of the respondents reported using this

system when an adverse event was identified. Among HCW, providers re-

ported higher levels of understanding and reporting but this was associated

with more training and involvement in the anthrax/smallpox vaccination

program. Ongoing need exists for training in the identification and report-

ing of vaccine adverse events.

Funding: Centers for Disease Control and Prevention

J ALLERGY CLIN IMMUNOL

JANUARY 2007

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