Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood thyroid stimulating hormone normal, Blood urea normal, Body temperature, Burning sensation, Cellulitis
Clinical narrative: Information has been received from a legal firm regarding a case in litigation concerning a 74 year old male with a history of coronary artery disease, hyperlipidaemia and percutaneous coronary intervention (approximately 1994) who on 30-JUL-2007 was vaccinated with ZOSTAVAX (Lot # 656395/0290U) in the left arm. On 15-Aug-2007, the patient presented to the physicians office with suspected shingles, burning severe pain in the left ankle area; red, large weeping yellow serous fluid and left lower extremity red patch and vesicles, weeping yellow fluid, not ____. The patient complained of pain being severe and is moderate with ambulation. The left leg/ankle extreme pain for one day and redness for ten days (approximately 05-AUG-2007). The physicians assessment included shingles and cellulitis (approximately 05-AUG-2007). Vital signs included blood pressure 129/80, temperature 97.6, and pulse 116. The patient was prescribed LEVAQUIN 500 mg, daily for 10 days, ZOVIRAX 500 mg, one, 5 times daily and a left leg/ankle x-ray. On 17-AUG-2007, the patient was admitted to the hospital with complaints of chest pain and rash. Vital signs were: temperature normal, pulse 72, blood pressure 106/56 and respiratory rate 20. He described the chest pain as a burning sensation along his chest, and also on the left lower leg. The rash over the chest area, most likely herpetic shingles versus an allergic reaction or urticaria. The chest burning sensation was secondary to the rash. Upon examination, there was redness, erythema and warmth on the right side of the chest, also on the mid left and epigastric region all over. Extremities showed left mid leg to ankle where there was a herpetic lesion, yellow and with minimal discharge present; also on bilateral inner thighs there were herpetic lesions. Lab results included white count 4.0, hemoglobin 10.8 MCV 32, platelets (results not reported), BUN 11, creatinine 0.9, sodium 134, potassium 3.0, chloride 108, BNP 5, myoglobin 230, troponin X4 were negative, TSH within normal limits, urine culture, blood culture and wound culture were negative. The patient was admitted as chest pain, rule out MI, but after physical examination, most likely pain secondary to this allergic reaction and the rash. The patient was ruled out for acute MI. The next day, the patient was feeling much better. The patient's itchiness, redness was reduced; and no pain. The patient was discharged to the nursing home on 19-AUG-2007 with a diagnosis of herpetic shingles on the left lower leg and also on the bilateral thighs and possible allergic reaction to the patient taking herpes zoster vaccine. Discharge medications included nitroglycerin 0.4 mg, PRN, docusate 100 mg, at bedtime, aspirin 325 mg, PO, once daily, nifedipine 30 mg, PO, BID, lovastatin 20 mg, PO, once daily, RESTORIL 30 mg, at bedtime PRN, hydrocodone (+) acetaminophen 1 tablet for pain, morphine 4 mg every 3 hours PRN for pain, valavyclovir 1000 mg, TID for actually a total of 10 days, NEURONTIN 100 mg, every 8 hours, PROTONIX 40 mg, PO, once daily, prednisone 10 mg for 10 days then discontinue, ROCEPHIN 1 g, IVPB, and ZITHROMAX 500 mg for rule out any cellulitis. On 26-OCT-2007 called KEFLEX 500 mg, 1, QID, ZOVIRAX 800 mg, 1, 5 times daily, and ULTRAM 50 mg, 1, BID. The patient continued to experience painful skin outbreaks, including rashes. He followed up with the physician on 29-OCT-2007 who noted left ankle shingles/herpes zoster. A skin infection with fresh red blisters was observed. The skin on the left ankle was exfoliated, and the patient had a poor appetite. The patient was treated with herpes zoster, prescribed medications and advised to follow up in three months. On 15-NOV-2007, the patient was seen for abdominal lesions with erythema for two months. There was an irregular finding of dermatitis unspecified on right arm with a plan for biopsy. The patient received triamcinolin 1% cream BID, and KENALOG 40 mg/mL total of 1.5 mL injected intramuscular. On 26-NOV-2007 biopsy of right arm showed interface dermatitis, favor drug reaction. Microscopic diagnosis showed vacuolar change involving the basal keratinocytes associated with few to many necrotic/apoptoptic keratinocytes and accompanied by superficial perivascular predominantly hymphocytic inflammation and few eosinophils was noted. On 10-DEC-2007 the patient was seen for follow up of dermatitis. Irregular findings included chest, back and abdomen. Some improvement was noted. The patient started prednisone 60 mg X 3 days, then 50 mg daily for 3 days, then 40 mg for 3 days, then 30 mg for 3 days, then 30 mg for 3 days, then 10 mg for 3 days and "cont tac" 1% cream BID. The patient was prescribed triamcinolone 0.1% cream, BID. On 27-DEC-2007 biopsy of the left upper neck showed interface dermatitis, favor drug eruption. The patient consulted with the physician again on 18-FEB-2008 who indicated that the rash and pain problems were a severe reaction to the vaccine. On 27-FEB-2008, the patient saw a dermatologist who diagnosed a probable drug eruption vs. eczema vs. psoriasis. The dermatologists prescribed narrow band UVB, which was continued on a three times per week basis through 10-SEP-2008. On 11-AUG-2008, the patient was seen for complaints of an itchy rash. Physical exam included groups of vesicles of the right upper inner ankle. Impression was herpes zoster. The patient was prescribed acyclovir 800 mg, one, PO, five times daily. Information received on 27-JAN-2009 contained the following adverse experiences: hypertension (17-AUG-2007), generalized weakness (17-AUG-2007), not feeling well (17-AUG-2007), low hemoglobin (approximately 17-AUG-2007) and poor appetite (approximately 29-OCT-2007). Additional information has been requested. All available medical records will be provided upon request.    Follow-up: I am still broken out with the after rash all over my body. There is no cure. This after effects of the shot is very painful and break out from the blisters and bleed almost everyday. This is awful. I don't know why released the use of this shot without any antidote. If there was an antidote maybe the doctors could find a way to help me. A year and eleven months is too long a time to suffer. Why can't someone find out what all was in this shot. Every day is the same. I no longer look for tomorrow as it will be the same as today. I don't want to live like this but don't know how or what to do. I am sorry for this, can anymore help me before its too late. Why can't Merck & Co. do something? Don't they have some responsibility?