Sex: U
Vaccine: DTAP, FLUX, HEP, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Rubella, Viral rash
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, 2015SA146053, 2015SA146054, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065 and 2015SA146066, 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, generalizable 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 an integrated healthcare system. We queried the VAERS database to determine the 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 preimplementation period. Conclusions: An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. Keywords: Vaccine; immunization; adverse reaction; reporting; adverse event. This case involves patient (age and gender not reported), who was vaccinated with a dose of DTAP (manufacturer: unknown, batch number, expiration date, dose, dose in series, route and site of administration were not reported), a dose of HEPATITIS B (manufacturer: unknown, batch number, expiration date, dose, dose in series, route and site of administration were not reported), dose of IPV (manufacturer: unknown, batch number, expiration date, dose, dose in series, route and site of administration were not reported), a dose HIB (manufacturer: unknown, batch number, expiration date, dose, dose in series, route and site of administration were not reported), a dose of INFLUENZA VACCINE (IIV) (manufacturer: unknown, batch number, expiration date, dose, dose in series, route and site of administration were not reported), a dose of PCV13 (manufacturer: unknown, batch number, expiration date, dose, dose in series, route and site of administration were not reported), a dose of MMR (manufacturer: unknown, batch number, expiration date, dose, dose in series, route and site of administration were not reported), a dose of VARICELLA (manufacturer: unknown, batch number, expiration date, dose, dose in series, route 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 had experienced viral exanthema and rubella symptoms. Laboratory tests and corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none.