Sex: U
Vaccine: TDAP, VARZOS
Symptoms: Hypothyroidism
Clinical narrative: Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146044, 2015SA146045, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146052, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background. Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalized clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods. ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the System, an integrated healthcare system. We queried the VAERS database to determine System's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results. In the 8 months following implementation, 91,622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable pre-implementation period. Conclusions. An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. This case involve a patient (age and gender not reported), who was vaccinated with a dose of TDAP (Manufacturer: unknown, batch number, route, dose in series and site of administration were not reported) and a dose of Varicella-Zoster Vaccine Live (Manufacturer: other, batch number, route, dose in series and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient experienced hypothyroidism. Lab tests and corrective treatments were not reported. Outcome of event was not reported. Upon medical review, case was upgraded to serious due to the important medical event: hypothyroidism. Documents held by sender: none.