Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Skin test negative, Skin test positive, Swelling face, Urticaria
Clinical narrative: Upon re-evaluation of the case on 10 February 2015, the case was upgraded to serious from non-serious. Based on the follow-up information received on 19 Dec 2014, this case initially considered as serious was downgraded to non-serious. Initial unsolicited report received on 02 December 2014 from a nurse practitioner.  An 8 year-old female patient, with no reported medical history, had received an intramuscular dose of FLUZONE QIV (batch number and site of administration not reported), on an unspecified date. Four hours post vaccination, the patient developed a large red area at the injection site. She also experienced vomiting, facial and lip swelling as well as SOB. She was taken to the ER. Concomitant therapies, corrective treatment and complementary investigations were not reported. The patient recovered from the events on an unspecified date. Document held by senders: none. Based on the follow-up information received on 19 Dec 2014 and upon medical review the case is downgrade serious to non-serious due to other medically important condition. Follow-up information received from healthcare professional on 19 Dec 2014. Patient was vaccinated at 4 PM and experienced hives at 8 PM and eye swelling, facial swelling, lip swelling, hypersensitivity to FLUZONE vaccine, SOB which required emergency doctor visit. Patient concomitantly received Flintstones vitamins and Benadryl as needed. Skin test was positive for vaccination and formaldehyde test was performed and result awaited. Skin test was positive for vaccination and formaldehyde test was performed and result awaited. Patient was treated with Benadryl, Steroid (oral) and prednisolone. Follow-up information was received from this unsolicited case on 10 February 2015 from a healthcare professional. Upon medical review of the case, the case was upgraded to serious due to seriousness criteria other: important medical event. Patch testing to formaldehyde was also negative. The reporter was unable to determine what part of the vaccine she was sensitive to based on ingredient list online and would like a more comprehensive list for evaluation. Follow-up information received for this unsolicited case on 23 March 2015 from a healthcare professional. The patient was seen on 18 November 2014 and had recovered from the events (exact date of recovery was not provided). He had received the vaccine in October (no details). Results from allergy testing came back negative for formaldehyde and for FLUVIRIN. The patient was still continuing his treatment for Flintstones multiple vitamins and Benadryl without difficulty. Documents held by sender: none. Follow-up information received from a Physician on 7-May-2015. There was no other vaccination 4 weeks prior to the vaccination date. It was reported that the patient was tested negative for FLUVIRIN so the allergen was assumed to be in FLUZONE and FLUVIRIN. The formaldehyde test was negative. She continued to take the test without difficulty. She continued to take Benadryl and multivitamins as corrective treatment without difficulty. The patient had recovered from the events on 18-Nov-2014.