Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy skin abnormal, Pemphigoid, Rash, Urticaria
Clinical narrative: Initial report received on 02 February 2010 from a consumer concerning a case of misuse (half dose administered). A 63 year old male patient with allergies to cats, pollen, mold, dust, and roaches received half of a dose (0.25 ml) of FLUZONE SV 2009-2010 on 04 December 2009 and another half of a dose (0.25 ml) on 07 December 2009. Per the reporter, the lot numbers administered were from any of three following vials: U3232AA, U3191AA, and U3394AA. The reporter was unsure which lot numbers were administered on which dates. On 08 December 2009 the patient developed generalized hives. The patient was seen by an allergist and a dermatologist on unspecified dates. The patient had two skin biopsies, results not reported. The patient was treated with steroids for two weeks. Per the patient, when the steroids were decreased, the hives would return. The patient was not recovered at the time of the report. Follow-up information received on 18 March 2010 from a health care professional. The reporter crossed out hives on the VAERS form and reported that the patient had experienced a "rash" 24-36 hours post vaccination. The patient was evaluated by a dermatologist who prescribed topical prescription (prescription not identified), and performed a biopsy. The patient also had a second biopsy performed by a second dermatologist (date not provided). From the two biopsies, the patient was diagnosed with bullous pemphigoid. Recovery status was unknown. Follow-up information received on 07 June 2010 from a health care professional who reported that the FLUZONE SV 2009-2010 was administered at a one half dose (.25 cc) at the patient's request in view of his concerns regarding a prior history of a significant local reaction. The dose was administered by halves because of the patient's concern of an adverse reaction. His first dose was administered on 04 December 2009 in the right deltoid and the remaining one half was administered on 07 December 2009 and there was no adverse event associated with either dose. The lot numbers which the patient recorded can not be confirmed by the provider. No information can be provided in regard to the patient's topical steroid treatment and other treatments provided by various dermatologists. The outcome for the event has not been reported. Follow-up information was received 16 July 2010 from a health care professional. The patient had a history of local reactions with no systemic symptoms following influenza vaccination. The reporter had contact with the patient "some weeks ago" via telephone and the patient was encouraged as his anti-inflammatory treatment was being tapered (name of treatment not reported). The reporter further clarified that the patient was first seen because the patient was concerned the allergic involvement was not "hives", and the patient was advised to see a dermatologist of his choice. The patient had a "fixed belief" that there was a relationship between the flu vaccine and/or the timing of the dosing. The reporter further stated that the medical literature did not provide any evidence for the patient's belief. No additional information was provided at the time of the report. List of documents held by sender: none.