Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Initial case was retrieved from the scientific literature on 02 April 2012. The following is verbatim from the report: "Abstract Background. In December 2009, a new high-dose, trivalent, inactivated influenza vaccine (TIV-HD) was licensed for adults aged greater than or equal to 65 years. We characterized clinical patterns of reports to the Vaccine Adverse Event Reporting System (VAERS) among older adults who received TIV-HD. Methods. We searched VAERS for reports involving persons aged greater than or equal to 65 years who received TIV-HD or TIV (standard dose) from 1 July 2010 through 31 December 2010. Medical records were requested for serious reports (ie, those associated with death, hospitalization or prolonged hospitalization, life-threatening illness, or disability). Clinicians reviewed information and assigned a diagnostic category to each report. Empirical Bayesian data mining was used to identify disproportional reporting following TIV-HD in VAERS. Reporting rates were calculated for reports of Guillain-Barre syndrome and anaphylaxis. Results. VAERS received 605 reports after TIV-HD in persons aged greater than or equal to 65 years (8.2% of reports involved serious events). The number of reports yielded by searches using the terms "ocular hyperemia" and "vomiting" exceeded the data mining threshold; >80% of these reports were nonserious. Clinical review of serious reports found that a greater proportion involving gastrointestinal events were made after TIV-HD receipt (5 of 51 [9.8%]) than after TIV receipt (1 of 123 [0.8%]). Four persons who received TIV-HD had gastroenteritis, and 1 had multiple gastrointestinal symptoms; all recovered. A higher proportion of cardiac events were noted after receipt of TIV-HD (9 of 51 [17.6%]) than after receipt of TIV (6 of 123 [4.9%]). No concerning clinical pattern was apparent. The reporting rates of Guillain-Barre syndrome and anaphylaxis after TIV-HD receipt were 1.4 and 1.0 reports per million doses distributed, respectively. Conclusions. During the first year after licensure of TIV-HD, no new serious safety concerns were identified in VAERS. Our analyses suggested a clinically important imbalance between the reported and expected number of gastrointestinal events after TID-HD receipt. Future studies should assess this potential association." The following is selective verbatim from the report: Materials and Methods Medical officers reviewed the VAERS reports, and on the basis of the primary event (ie, the event that appeared to trigger the reporter to report to VAERS), categorized reports into one of the following diagnostic categories modified from a system previously described: allergic (including anaphylaxis); cardiovascular (including cerebrovascular accident); ear, nose, throat, gastrointestinal; local reaction at the injection site; muscloskeletal; neurologic (including GBS); psychiatric; respiratory (including influenza-like illness, pneumonia, and noninfectious upper/lower respiratory tract conditions); other infectious; other noninfectious (eg, syncope and diabetes); and death." "Results VAERS received 622 reports after TIV-HD receipt; 606 (97.4%) involved persons aged greater than or equal to 65 years. Fifty-one (8%) of 622 reports were coded as serious, which included 3 deaths. The most frequent MedDRA-preferred terms associated with persons aged greater than or equal to 65 years were vomiting and dyspnea, occurring in 37% and 35% of serious reports, respectively, and chills and fever, occurring in 25.4% and 25.2% of nonserious reports, respectively. Among the 3 deaths that occurred after TIV-HD receipt, the reported cause of death was sepsis in 1 and coronary artery disease in 2. All 9 patients for whom the serious report contained a cardiac diagnosis had preexisting cardiac conditions. For TIV-HD, the predominant diagnostic categories were other noninfectious (eg, syncope and diabetes), local reactions, allergic, and respiratory, which together made up 86% of all reports. The main diagnosis in 55 reports (75.3%) was influenza-like illness. In the data mining analysis, only the MedDRA-preferred terms "ocular hyperemia" and "vomiting" exceeded the EB05 threshold in reports made after TIV-HD receipt. Among the 34 reports of ocular hyperemia, 32 (94%) were nonserious. Twenty-eight of these 32 persons (88%) recovered by the time the VAERS form was submitted; cases in 17 of 32 were categorized as nonanaphylaxis allergic reactions. The 2 serious reports with the preferred term "ocular hyperemia" involved one patient who was hospitalized for experiencing syncope and subsequently recovered and another who had exacerbation of chronic obstructive pulmonary disease and an unknown recovery status. Sixteen reports were found to meet this definition of oculorespiratory syndrome. Of the 99 VAERS reports made after TIV-HD receipt that contained the preferred term "vomiting," 83 (84%) were nonserious. Sixty-two of these 83 persons (75%) recovered by the time the VAERS form was submitted. The primary diagnosis included gastroenteritis in 4 cases, nonanaphylaxis allergic reactions in 2, sepsis in 2, and chest pain, seizures, conjunctivitis, urinary tract infection, renal insufficiency, reactive airway disease, respiratory insufficiency, and anaphylaxis in 1 each. Discussion As of 28 February 2011, VAERS had received 622 reports following TIV-HD receipt. Most reports (91.8%) were coded as nonserious, generally self-limited events. Consistent with prelicensure experience, fever, pain, and headache were among the most frequent adverse events reported after TIV-HD receipt [5]. Postmarketing surveillance done by the manufacturer revealed that nausea, vomiting, and diarrhea were among the top 10 most frequently observed adverse events after TIV-HD receipt, which is consistent with some of our observations [16]; however, there may be some overlap in the cases appearing in the VAERS and manufacturer databases. Fifteen TIV-HD nonserious reports occurred in subjects aged greater than or equal to 65 years. Although some of these reports may represent true medication errors (eg, inappropriate schedule of drug administration), it is possible the reporter may have mistakenly reported TIV-HD when in fact TIV was really administered. It is also possible the vaccine manufacturer may have chosen to give TIV-HD to someone aged greater than or equal to 65 years. Vaccine records were only available for 1 of the 15 reports (which involved a 61-year-old woman who mistakenly received TIV-HD), and therefore it is difficult to assess whether these were true medication errors." Documents held by sender: None.