Age: 12.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Heart rate increased, Pruritus, Radioallergosorbent test negative, Rash
Clinical narrative: Initial unsolicited report received from the literature on 21 June 2016. This case was linked to 2016SA117942, 2016SA117944, 2016SA117945, 2016SA117946, 2016SA117948, 2016SA117949, 2016SA117950, 2016SA117951, 2016SA117952, 2016SA117953, 2016SA117954, 2016SA117955, 2016SA117956, 2016SA117957, 2016SA117958, 2016SA117959, 2016SA117960, 2016SA117961, 2016SA117962, 2016SA117963, 2016SA117964, 2016SA117965, 2016SA117966, 2016SA117967, 2016SA117968, 2016SA117969. (Same literature). The following is verbatim from the article: Background: Anaphylaxis is a potentially life-threatening allergic reaction. The risk of anaphylaxis after vaccination has not been well described in adults or with newer vaccines in children. Objective: We sought to estimate the incidence of anaphylaxis after vaccines and describe the demographic and clinical characteristics of confirmed cases of anaphylaxis. Methods: Using health care data from the Vaccine Safety Datalink, we determined rates of anaphylaxis after vaccination in children and adults. We first identified all patients with a vaccination record from January 2009 through December 2011 and used diagnostic and procedure codes to identify potential anaphylaxis cases. Medical records of potential cases were reviewed. Confirmed cases met the Brighton Collaboration definition for anaphylaxis and had to be determined to be vaccine triggered. We calculated the incidence of anaphylaxis after all vaccines combined and for selected individual vaccines. Results: We identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after 25,173,965 vaccine doses. The rate of anaphylaxis was 1.31 (95 percent CI, 0.90-1.84) per million vaccine doses. The incidence did not vary significantly by age, and there was a non-significant female predominance. Vaccine-specific rates included 1.35 (95 percent CI, 0.65-2.47) per million doses for inactivated trivalent influenza vaccine (10 cases, 7,434,628 doses given alone) and 1.83 (95 percent CI, 0.22-6.63) per million doses for inactivated monovalent influenza vaccine (2 cases, 1,090,279 doses given alone). The onset of symptoms among cases was within 30 minutes (8 cases), 30 to less than 120 minutes (8 cases), 2 to less than 4 hours (10 cases), 4 to 8 hours (2 cases), the next day (1 case), and not documented (4 cases). Conclusion: Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case involves a 12-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (TRIVALENT INFLUENZA VACCINE) (batch number, dose, route and site of administration was not reported) on an unspecified date. Medical history medical history was reported as Allergy to penicillin and concomitant medications were not reported. On unspecified date, 1 day following the vaccination, the patient had experienced Generalized urticaria, pruritus and rash, increased HR, syncope, BP 117/72 mm Hg, ''lump in throat'' and anaphylaxis. On an unknown date, the patient went to ED doctor (allergist, inpatient for overnight). Laboratory data included the patient's skin test and RAST results both negative for latex). The patient received corrective treatment with epinephrine autoinjector, parenteral antihistamine, parenteral H2-blocker, oral steroid, O2, other (antiemetic, lidocaine cream). On an unspecified date, patient was recovered from all the events. Upon internal review the case was considered as serious because of important medical event: Anaphylaxis. List of documents held by sender: none. Sender's Comments: The reported symptoms and time to onset are consistent with the diagnosis of anaphylactic reaction. Time to onset of 1 day is compatible with the role of vaccine. Patient had a history of allergy to penicillin. Based on the available information, there is a positive temporal relationship between suspect vaccine and anaphylaxis, hence the contributory role of INFLUENZA VACCINE cannot be excluded.