Age: 56.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Anaphylactic reaction, Angioedema, Dyspnoea, Fatigue, Vomiting
Clinical narrative: Initial unsolicited report received from the literature on 21 June 2016. This case was linked to 2016SA117942, 2016SA117944, 2016SA117945, 2016SA117946, 2016SA117947, 2016SA117948, 2016SA117959, 2016SA117950, 2016SA117951, 2016SA117952, 2016SA117953, 2016SA117954, 2016SA117955, 2016SA117956, 2016SA117957, 2016SA117958, 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 56-year-old male patient who was vaccinated with a dose Trivalent Influenza Vaccine (manufacture unknown) and with a dose of TDAP (manufacture unknown) (batch number, dose, route and site of administration was not reported) on an unspecified date. Medical history reported as other (amoxicillin allergy) and concomitant medications were not reported. On an unspecified date, 60 to less than 90 minutes following the vaccination, the patient had experienced angioedema, Shortness of breath (SOB), vomiting, fatigue and anaphylaxis. The patient required doctor visit and went to clinic. Laboratory data were not reported. The patient received corrective treatment with Oral antihistamine. 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. The patient had an allergic history to Amoxicillin. Additional information including but not limited to the patient's previous immunization history (i.e., previous immunizations and any adverse events following immunizations), medical history, concomitant medications, vaccine details, and allergy testing to identify the culprit allergen are needed to further assess this case. Moreover, the patient received 2 vaccines concomitantly, making it difficult to assess the role of one vaccine in particular.