Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Respiratory failure, Skin plaque, Swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 67 year old male with non-hodgkin's lymphoma, hyperlipidaemia, skin cancer, benign prostatic hyperplasia and diverticulosis who on 10-MAR-2008 was vaccinated with 0.65 ml ZOSTAVAX (Merck) (lot # 658867/1413U). Concomitant therapy included terazosin hydrochloride. On 12-MAR-2008 the patient experienced alveolitis allergic, arthralgia, cough, dyspnoea, endotracheal intubation, erythema, erythema multiforme, extubation, hyperaesthesia, hypersensitivity, immunisation reaction, pneumonia, pneumonitis, pruritus, rash, rash papular, rash vesicular, respiratory failure, skin plaque and swelling and was hospitalized. 2 days after having received the vaccine, 12-MAR-2008, the patient started developing a rash along with redness and itching on feet. This later progressed to his legs, abdomen and his arms. On 24-MAR-2008, the patient had swelling in right armpit, achiness in joints, short of breath (SOB) but no cough/congestion. On 26-MAR-2008, the patient admitted with cough. All cultures came back was negative. The patient had prolonged hospitalization for respiratory failure secondary hypersensitivity pneumonitis reaction. On 19-SEP-2008 medical record received for DOS from 26-MAR-2008 to 17-APR-2008 with discharge diagnosis: Hypersensitivity rash-resolving, diffuse pulmonary opacities, pneumonia vs hypersensitivity pneumonitis and history of low grade lymphoproliferative d/o, history of non-hodgkins lymphoma, benign prostatic hypertrophy, hyperlipidemia. The patient presented with worsening ascending rash beginning on 12-MAR-2008. 2 days after having received the vaccine, rash was pruritic and started on the dorsum of the feet and progressed upwards to the torso and upper extremities. The vesicular appeared on violaceous papules and plaques. The patient also developed joint pain in the hands, knees and elbows, which were sensitive to touch. The patient further progressed to develop a dry, non-productive cough and short of breath (SOB) at which point he was admitted. Etiology of symptoms unknown. Rheumatologist was consulted for transient arthralgias questionable vasculitis. The dermatologist was consulted with assessment: likely vaccine induced erythema multiforme. The patient's respiratory status declined, and the patient placed on nasal cannula O2, then BiPAP. The patient was transferred to ICU in unstable and guarded condition for possible intubation. Developed a left low lung infiltrate and diagnosed with pneumonia. The patient was treated with abx, antivirals and ultimately steroids. The patient was extubated on 14-APR-2008 and transferred to skilled nursing facility on 17-APR-2008 for further rehab. Lab data include: Skin biopsy on 31-MAR-2008 - cutaneous (+) hypersensitivity; chest X-ray: positive for left low lung infiltrate; CT (computed axial tomography) scan: nodular opacities in left lung with diffuse infiltrates. Echo with normal EF and mild valve insufficiency. Bronchoscopy with non-hodgkin's lymphoma (stable). The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. This was originally reported by a consumer. A standard lot check investigation was performed. All in-process quality checks for the lot number 658867/1413U in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The VAERS ID # is 321179.