Age: 41.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Malaise, Myalgia, Nausea, Neuropathy, Oral mucosal blistering
Clinical narrative: Report described erectile dysfunction in a 41 year old male who received hep B vaccine recombinant (Engerix B) for the prophylaxis of hep B. The pt was allergic to penicillin. He reportedly had no pre-existing medical condition and was taking no concomitant medications. On 25Apr01, the vaccinee received his first doses of Engerix B and hep A vaccine (Havrix). The vaccinating physician reported that the pt experienced chills and did not feel well the evening of 25Apr01. Three days post immunization, on 28Apr01, the pt reported general achiness, numbness and tingling of his genitals, urethral burning and impotence. He was seen by the physician, who obtained urine and urethral cultures; these cultures did not reveal any pathogens. The physician prescribed methylprednisolone (Medrol Dosepak). On 16May01, the pt was seen by an associate of the vaccinating physician. At that time, the pt reported a recurrence of chills, tingling sensation of the face, a rash and a small perioral ulcer. Viral and bacterial cultures of the ulcer were obtained, and complete blood count, erythrocyte sedimentation rate, and assay for C-reactive protein were performed (results of all evaluations performed 16May01 were not provided). The physician prescribed acyclovir and referred the pt to an infectious disease specialist. On 16May01, the pt's father reported that his son developed a generalized, red, raised rash; itching; flushed face; nausea; fever; and mouth blisters within four hours of immunization on 25Apr01. Several days later, the pt experienced numbness and tingling of the lower extremities and penis. He was reportedly seen by an urologist. The pt's father stated that the urologist's diagnosis was urinary tract infection and possible nerve damage (NOS). The urologist reportedly prescribed phenazopyridine 200mg and levofloxacin (Levaquin). On 18may01, the pt's father reported that his son's condition has worsened. He stated that his son had sexual dysfunction due to numbness in his penis. He also reported that the pt's facial hives were worse. He stated that the pt's work trip was cancelled, and that the pt now will suffer with a lose of income too.  On 18May01, the pt stated I'm having a reaction to one or both of your vaccines. I'm having erectile dysfunction. No other symptoms reported. On 18May01, the infectious disease specialist stated that the pt reported tingling of the face, vague malaise, a macular rash on the face and anterior chest, arthralgias, and inability to have an erection. As of 18May01, all adverse events were unresolved, and the pt's condition had worsened per the pt's father. On 31May01, the internist found the condition of the pt to be normal other than the subjective complaint of erectile impotence. The physician recommend prednisone as treatment. The pt was previously seen by a urologist who prescribed methylprednisolone (Medrol Dose Pak); the pt subsequently felt better for a while. When he stopped taking Medrol Dosepak, his symptoms returned. A legal complaint received by manf on 03Mar05 alleged that the pt developed symptoms of fever, chills, and disorientation approx 2 hours after vaccination with Engerix B. The complaint noted that over the next two days, the symptoms intensified, causing him skin outbreaks, constipation, fever and complete sexual dysfunction, which included but was not limited to: pain and burning in the genital area generally and in the penis specifically, erectile dysfunction, decreased libido, insensitivity of genitals/testicles. By 14May01 the pt was still experiencing symptoms indicating sexual dysfunction as well as rash, chills and mouth sores. The complaint further alleged that on 17May01, the pt c/o feeling no sensation in the pubic area and pelvic area. During Jul01 as a result of extreme pain caused by his vaccine related injury the pt supposedly made two visits to the hospital and a visit to the clinic. On 09Jan01, as a result of injuries related to the vaccine (Engerix B), the pt was taken to the hospital in an unconscious state and was treated in the ICU. On or about 11Mar02, the pt underwent a urinalysis, the results of which showed abnormal metallic levels, which could have resulted after a hep vaccination. On 21Mar02 the pt underwent a hair test for mercury which demonstrated that his urine mercury equals or exceeds twice the maximum expected level. On 03Apr02, the results of a urine metal test showed that the pt's urine mercury equaled twice the maximum expected level. Since April 2002, the pt has been taking DMSA a mercury chelator, as a treatment to remove mercury from his blood, body, organs and brain. It was noted that due to the severe risks associated with mercury poisoning, the pt will have to continue DMSA treatment for several years. The pt (plaintiff) contended that he suffered and continues to suffer severe pain from his physical injuries, primarily in regard to sexual dysfunction, and psychological injuries such as severe depression, suicidal thinking, extreme anger, violent rages, loss of life's pleasures, panic attacks, and severe anxiety, allegedly all as a direct and proximate result of being inoculated with Engerix B vaccine.