chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old white female who on 20-AUG-2007 was vaccinated subcutaneously in the right arm with a dose of zoster vaccine live (Oka/Merck) (lot# 658207/0883U). On 28-SEP-2007 the patient developed a lump on her right arm (unknown location of the lump on the arm). On 28-SEP-2007 the patient sought medical attention at the pharmacy. The patient's outcome is unknown. Follow up information received from the pharmacist indicated that the lump has persisted. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Secondary transmission
Clinical narrative: Information has been received from a pharmacist concerning a male physician's assistant with history of chickenpox who was in next room where a dose of zoster vaccine live (Oka/Merck) was administered. It was reported that he never administered the vaccine. On 8-SEP-2007 the patient developed about a dozen clusters of lesions in the S1 dermatome (right side). The patient self-diagnosed himself and also went to the local clinic and the ER physician confirmed it was herpes zoster. The patient was treated with valacyclovir hydrochloride (VALTREX). The patient complained about small amount of pain. At the time of report the patient had not recovered. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 76 old male patient with controlled type II diabetes mellitus and hypertension who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Eight days after vaccination the patient developed shingles. The shingles was described as a mild case (lesions were unilateral on the chest). Medical attention was sought. The patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a pharmacist concerning an approximately 40 years old female physician who was exposed to zoster vaccine live (Oka/Merck). It was reported that the physician was in close contact with the registered nurse who administered zoster vaccine live (Oka/Merck) and developed shingles. It was reported that the patient was originally thought to have shingles but was not diagnosed with it. The patient may have sumac poisoning. At the time of report the patient had not recovered. Unspecified medical attention was sought. A product quality complaint was not involved. This one several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with zoster vaccine live (Oka/Merck). Subsequently the patient developed an injection site reaction and erythema at the injection site. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye inflammation, Herpes simplex serology negative, Laboratory test, Necrotising retinitis, Polymerase chain reaction
Clinical narrative: Information has been received from a physician concerning a 67 year old male who on 31-JUL-2007 was vaccinated with zoster vaccine live (Oka/Merck). On approximately 27-SEP-2007 the patient experienced right eye inflammation and has not received any treatment yet. The patient sought unspecified medical attention in the physician's office. Physician is sending out fluid from the eye area to identify any virus causing the inflammation. The patient's right eye inflammation persisted. Additional information has been requested. Information has been received from a physician concerning a 67 year old male who in 11-JUL-2007 was vaccinated with ZOSTER vaccine live (Oka/Merck). On approximately 27-SEP-2007 the patient experienced right eye inflammation and has not received any treatment yet. The patient sought unspecified medical attention in the physician's office. Physician is sending out fluid from the eye to identify any virus causing the inflammation. The patient's right eye inflammatin persisted. Additional information was received on 28-NOV-2007. The reporting physician reported that they previously suspected the patient had acute retinal necrosis after vaccination. However, currently they do not think so, on the PCR of the vitreous fluid showed positive HSV,, not VZV. His infection was not related to vaccination.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Virus culture
Clinical narrative: Information has been received from a physician concerning a 67 year old male who on 31-JUL-2007 was vaccinated with zoster vaccine live (Oka/Merck). On approximately 27-SEP-2007 the patient experienced right eye inflammation and has not received any treatment yet. The patient sought unspecified medical attention in the physician's office. Physician is sending out fluid from the eye area to identify any virus causing the inflammation. The patient's right eye inflammation persisted. Additional information has been requested. Information has been received from a physician concerning a 67 year old male who in 11-JUL-2007 was vaccinated with ZOSTER vaccine live (Oka/Merck). On approximately 27-SEP-2007 the patient experienced right eye inflammation and has not received any treatment yet. The patient sought unspecified medical attention in the physician's office. Physician is sending out fluid from the eye to identify any virus causing the inflammation. The patient's right eye inflammatin persisted. Additional information was received on 28-NOV-2007. The reporting physician reported that they previously suspected the patient had acute retinal necrosis after vaccination. However, currently they do not think so, on the PCR of the vitreous fluid showed positive HSV,, not VZV. His infection was not related to vaccination.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash, Skin lesion
Clinical narrative: Information has been received from a physician's assistant concerning a 67 year old white female with high blood pressure who on 04-OCT-2007 at 12:45 PM was vaccinated on left arm with a first dose of zoster vaccine live (Oka/Merck) (lot # 658081/0743U). Concomitant therapy included hydrochlorothiazide. There was no illness at the time of vaccination. On 06-OCT-2007 in morning the patient developed rash on her side torso. It was not specified whether the rash was shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from physician's assistant who stated that the patient had 6 small blister like lesions on abdomen that were itchy. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. No further information is expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Glossodynia, Headache, Injection site rash, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 75 year old white female with sulfonamide allergy, allergic reaction to antibiotics, vitamin b12 deficiency, hypertension, gastrooesophageal reflux disease, osteoporosis and asthma and a history of chickenpox, irritable bowel syndrome and depression history of chickenpox who on 27-SEP-2007 at 9:30 AM was vaccinated SC on left upper extremity with a first 0.5 ml dose of zoster vaccine live (Oka/Merck) (Lot # 658081/0743U). Concomitant therapy included aspirin, cyanocobalamin, lubiprostone (AMITIZA), gabapentin, verapamil, HCTZ/triamterene (MAXZIDE), paroxetine HCl (PAXIL), loratadine (CLARITIN), clonazepam (KLONOPIN), acetaminophen (+) tramadol hydrochloride (ULTRACET) and levothyroxine Na (LEVOXYL). Concomitant therapy on 12-OCT-2007 included a IM dose on right upper extremity of influenza virus split viron 3v vaccine inactivated (FLUZONE) (Lot # U2448ABB). There was no illness at the time of vaccination. On 29-SEP-2007 (previously reported 01-OCT-2007) the patient experienced headache, general malaise, and developed small, red "shingles like" bumps at injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of the report the patient was recovering. A product quality complaint was not involved. Additional information has been received from a physician who stated that on 29-SEP-2007 had red arm with central smaller area of vesicular lesions at the injection site. The patient was afebrile and rated the pain as 3 on the 0 to 10 scale where in 10 being the highest. Other systemic symptoms included itching, malaise, fatigue and headache. The patient had no recent exposure to chickenpox  or herpes zoster. The patient had multiple vesicular rashes in one area on the left upper arm only. At the time of the report the patient had recovered. Additional information has been received from the registered nurse who stated that the patient experienced headache, developed a large hot itchy vesicular and macular rash. The patient also experienced malaise, fatigue and tongue discomfort. On approximately 7-OCT-2007 the patient recovered. There was no adverse event following prior vaccination for the patient and patient's sibling. No further information is expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pruritus, Rash macular, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 75 year old white female with sulfonamide allergy, allergic reaction to antibiotics, vitamin b12 deficiency, hypertension, gastrooesophageal reflux disease, osteoporosis and asthma and a history of chickenpox, irritable bowel syndrome and depression history of chickenpox who on 27-SEP-2007 at 9:30 AM was vaccinated SC on left upper extremity with a first 0.5 ml dose of zoster vaccine live (Oka/Merck) (Lot # 658081/0743U). Concomitant therapy included aspirin, cyanocobalamin, lubiprostone (AMITIZA), gabapentin, verapamil, HCTZ/triamterene (MAXZIDE), paroxetine HCl (PAXIL), loratadine (CLARITIN), clonazepam (KLONOPIN), acetaminophen (+) tramadol hydrochloride (ULTRACET) and levothyroxine Na (LEVOXYL). Concomitant therapy on 12-OCT-2007 included a IM dose on right upper extremity of influenza virus split viron 3v vaccine inactivated (FLUZONE) (Lot # U2448ABB). There was no illness at the time of vaccination. On 29-SEP-2007 (previously reported 01-OCT-2007) the patient experienced headache, general malaise, and developed small, red "shingles like" bumps at injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of the report the patient was recovering. A product quality complaint was not involved. Additional information has been received from a physician who stated that on 29-SEP-2007 had red arm with central smaller area of vesicular lesions at the injection site. The patient was afebrile and rated the pain as 3 on the 0 to 10 scale where in 10 being the highest. Other systemic symptoms included itching, malaise, fatigue and headache. The patient had no recent exposure to chickenpox  or herpes zoster. The patient had multiple vesicular rashes in one area on the left upper arm only. At the time of the report the patient had recovered. Additional information has been received from the registered nurse who stated that the patient experienced headache, developed a large hot itchy vesicular and macular rash. The patient also experienced malaise, fatigue and tongue discomfort. On approximately 7-OCT-2007 the patient recovered. There was no adverse event following prior vaccination for the patient and patient's sibling. No further information is expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Information has been received from a physician concerning a 75 year old white female with sulfonamide allergy, allergic reaction to antibiotics, vitamin b12 deficiency, hypertension, gastrooesophageal reflux disease, osteoporosis and asthma and a history of chickenpox, irritable bowel syndrome and depression history of chickenpox who on 27-SEP-2007 at 9:30 AM was vaccinated SC on left upper extremity with a first 0.5 ml dose of zoster vaccine live (Oka/Merck) (Lot # 658081/0743U). Concomitant therapy included aspirin, cyanocobalamin, lubiprostone (AMITIZA), gabapentin, verapamil, HCTZ/triamterene (MAXZIDE), paroxetine HCl (PAXIL), loratadine (CLARITIN), clonazepam (KLONOPIN), acetaminophen (+) tramadol hydrochloride (ULTRACET) and levothyroxine Na (LEVOXYL). Concomitant therapy on 12-OCT-2007 included a IM dose on right upper extremity of influenza virus split viron 3v vaccine inactivated (FLUZONE) (Lot # U2448ABB). There was no illness at the time of vaccination. On 29-SEP-2007 (previously reported 01-OCT-2007) the patient experienced headache, general malaise, and developed small, red "shingles like" bumps at injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of the report the patient was recovering. A product quality complaint was not involved. Additional information has been received from a physician who stated that on 29-SEP-2007 had red arm with central smaller area of vesicular lesions at the injection site. The patient was afebrile and rated the pain as 3 on the 0 to 10 scale where in 10 being the highest. Other systemic symptoms included itching, malaise, fatigue and headache. The patient had no recent exposure to chickenpox  or herpes zoster. The patient had multiple vesicular rashes in one area on the left upper arm only. At the time of the report the patient had recovered. Additional information has been received from the registered nurse who stated that the patient experienced headache, developed a large hot itchy vesicular and macular rash. The patient also experienced malaise, fatigue and tongue discomfort. On approximately 7-OCT-2007 the patient recovered. There was no adverse event following prior vaccination for the patient and patient's sibling. No further information is expected.
Age: 94.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 94 year old husband who on 20-SEP-2007 was vaccinated subcutaneously with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included amlodipine besylate, atenolol, lisinopril, hydrochlorothiazide and prednisone. On approximately 06-OCT-2007, "16 days after the shot" the patient developed a rash on his chest and back that "came and went". On approximately 09-OCT-2007 the rash on chest and back were gone but he developed a rash on his right leg. The patient's status was reported as recovering. There was no product quality complaint. No further information is available.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient (gender and age not reported) who was vaccinated in error with a dose of zoster vaccine live (Oka/Merck) instead of a dose of varicella virus vaccine live (Oka/Merck). No adverse events were reported. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. All attempts to obtain follow up information have been unsuccesful. No further information available.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a male (age not reported) who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently the patient experienced fever of 103.4 F, body aches, stiff neck and nausea approximately 2 - 3 hours after vaccination The patient sought unspecified medical attention. The patient's status was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with diabetes and allergy to "lots of medication, cholesterol and high blood pressure medications" who on approximately 26-SEP-2007 "about two weeks ago" was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX. Concomitant therapy included therapy unspecified (insulin "an antibiotic"). On approximately 28-SEP-2007, "2-3 days after vaccination", the patient experienced pain in her left arm that are 'similar to the pains from a heart attack" and a "heaviness" in her chest. The patient reported that "it comes and goes" and "it has been getting less severe." The patient did not seek medical attention. No laboratory diagnostic tests were performed. The patient's status was reported as recovering. There was no product quality complaint involved. Follow up information was received from a health care professional who noted that as of the time of reporting the patient had not notified them of any reaction or symptoms. No further information is available.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old male who on 21-SEP-2007 was vaccinated SC with a dose of ZOSTAVAX (Lot # 656395/0290U). Concomitant therapy included 10 mg HYTRIN and 100 mcg SYNTHROID. In October 2007, the patient developed pruritis on left side and his back. The patient was examined by his physician and was told treat symptoms with ibuprofen. A product quality complaint was not involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Information has been received from a nurse practitioner concerning a 67 year old female with no pre-existing allergies, birth defects, medical conditions, who on 09-OCT-2007 was vaccinated SC with a first dose of ZOSTAVAX (Lot # 658209/1085U). On 10-OCT-2007 the patient called the office stating that she woke up with red puffy eyes. The patient was scheduled to be seen in the office. There were no lab diagnostic studies performed. There was no illness at the time of vaccination. There was no adverse events following prior vaccinations. No medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. This is a consolidation of two reports concerning the same patient. Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old patient who on 08-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck). It was reported due to human error. The patient had no symptoms. A product quality complaint was not involved. Additional information has been received from a nurse practitioner who stated that the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (MSD) on a different day. There were no adverse effects and the mistake was primarily because by product placement in the refrigerator. A wrong vial was grabbed and was reported as a human error. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a 73 year old white female with breast cancer, renal failure acute, renal insufficiency, hypertension, degenerative joint disease, hypercholesterolaemia and cardiac disorder and a history of rib fracture who on 10-OCT-2006 was vaccinated with a dose of ZOSTAVAX (lot number reported: "70089"), subcutaneously in the left arm. On 01-OCT-2007, the patient developed zoster lesions on scalp, face, eye (right). There was no illness at the time of vaccination. Additional information has been requested.  2/26/08 Reviewed pcp medical records which reveal patient experienced fall from ladder & seen in hospital.  Seen in office 10/2/07 in f/u & had rash suddenly 4 days prior to office visit starting as hypersensitivity on scalp.  Now had extensive raised red crops of painful skin lesions & fatigue.  Right eyelid was puffy w/non-purulent drainage.  Tx w/antiviral meds, pain med & referred to ophthalmologist.  Returned to office 10/8/07.  Rash improved.  Returned to office 11/8/07 for continued right eye & rib pain. FINAL DX: Rib fractures; herpes zoster w/ophthalmic complications.  Follow-up received 04/16/2008 from a healthcare professional. It was reported that the patient with hypertension, coronary artery disease, breast cancer, degenerative joint disease, allergic rhinitis and allergy to hydrochlorothiazide (manufacturer unknown) (WAES# 0801USA00056) and lisinopril (manufacturer unknown) (WAES# 0801USA00055), and hypercholesterolemia and a history of rib fractures developed hypersentivity in the right scalp and around the right eye and then broke out in a papular/vesicular rash in the same area. Very painful zoster lesions (onset date reported as 29-SEP-2007, previously reported as 01-OCT-2007). The patient was prescribed VALTREX and NEURONTIN and the patient was referred to ophthalmology due to eye involvement. The patient required a doctor's office visit. The patient was recovering. It was reported that the rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. Pain was reported as "10". It was reported that the patient had a history of chickenpox in childhood and had not had recent exposure to chickenpox or herpes zoster. A direct fluorescent antibody was not done and a specimen was not collected for PCR. No further information is available.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 65 year old female who was vaccinated with ZOSTAVAX. It was reported that 2 weeks after vaccination, the patient developed shingles. The shingles covered 3 dermatones and 1 lasted for about 1 month. The patient had recovered at the time of report. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is in follow-up submitted on 12/21/2007.  Information has been received from a physician concerning a 79 year old female who on 21-JUL-2007 was vaccinated in the right arm with a first dose ZOSTAVAX (Merck) (given by her daughter).  On 27-JUL-2007 in the AM, (previously reported as 2 weeks after vaccination), the patient developed shingles.  The shingles covered 3 dermatones and 1 lasted for about 1 month.  Relevant diagnostic test and laboratory data included:  varicella-zoster Ab, IgG, S-positive;  varicella-zoster Ab, IgM, S-negative;  varicella positive;  skin culture- no growth after 3 days;  white blood  count-6.8 10E3/MM3;  red blood count-5.58 10M3/MM3;  platelet count-179 10E3/MM3;  herpes simplex virus/rapid PCR (HERP)-negative;   hemoglobin-14.2 g/dL;  hematocrit-41.38;  mean corpuscular volume 90.1FL;  mean corpuscular hemoglobin 31.0 pg;  mean corpuscular hgb conc 34.5%; red cell distribution width-12.7%;  mean platelet volume 12.0 FL;  granulocytes-86.7%;  lymphocytes-9.6%;  monocytes-3.5% eosinophils-0.0%;  basophils-0.2%; granulocytes absolute number-5.9;  lymphocytes absolute number -0.7;  monocytes absolute number 0.2;  eosionophils absolute number-0.00 10FL/mml;  basophils absolute number-0;  erythrocyte sedimentation rate-8 mm/hr.  The patient had recovered at the time of report.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 76-year-old white retired male with hypertension and hyperglycemia who on 21-AUG-2007 was vaccinated subcutaneously in the left arm with a dose of ZOSTAVAX (lot# 658207/0883U). There was no illness at the time of vaccination. On 24-AUG-2007 the patient developed herpes zoster on right side of his neck three days after vaccination. There were no laboratory tests or diagnostic procedures performed. No medical attention was sought. The outcome was reported as still recuperating. It was reported that the patient did not have any adverse events following previous vaccinations. Follow-up information received indicates that the patient had a history of childhood chickenpox. There was no recent exposure to chickenpox or herpes zoster. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. It was reported that approximately dermatome C2 was involved, however it was not measured. The patient rated the pain as moderate. Additional information has been requested. There is in follow-up to report (s) previously submitted on 12/21/2007. Follow-up informaiton received indicates that there has been no new contact with the patient since the last report. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a consumer, a 74-year-old female, registered nurse with penicillin allergy, who in August of 2007 was vaccinated subcutaneously with a dose of ZOSTAVAX. Concomitant therapy included estrogens, PREMPRO. On approximately 20-SEP-2007, "3 weeks ago", the patient broke out in shingles. She stated that it was very painful. Medical treatment was sought and she was treated with steroids. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a medical assistant concerning a 61 year old female who on 18-SEP-2007 was vaccinated subcutaneously into the right arm with ZOSTAVAX (Lot #658083/0885U). Concomitant therapy that same day included a tetanus toxoid injection. Concomitant therapy included amoxicillin and "sulfa", for unspecified indications. On 22-SEP-2007 or 23-SEP-2007 the medical assistant reported that the patient "developed shingles after she was given ZOSTAVAX". The patient contacted the doctor's office. Medical attention was sought. She was treated with an unspecified anti-viral medication. At the time of reporting the patient was recovered, date unknown. There was no product quality complaint. Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 74 year old male with diabetes, cardiac disorder, hypertension, peripheral vascular disorder and Alzheimer's disease who in approximately October 2006, was vaccinated with a 0.65 ml dose of zoster vaccine live (Oka/Merck). In approximately September 2007, the patient developed a shingles outbreak. The patient's shingles outbreak persisted. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Information has been received from a pharmacist concerning a 77 year old female with sulfonamide allergy who on 12-OCT-2007 was vaccinated SC with a dose of ZOSTAVAX (Lot # 657766/0620U). On 12-OCT-2007, 10 minutes after vaccination the patient developed metallic taste. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Blood testosterone normal, Blood thyroid stimulating hormone normal, Chest X-ray normal, Computerised tomogram normal
Clinical narrative: Information has been received from a 66 year old female with a history of herpes zoster prior to 2005 and with no allergies who on 18-APR-2007 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included vitamins (unspecified), omega-3 fish oil and 81 mg aspirin. On 29-APR-2007, 10 days after vaccination the patient had hair loss and most of her hair were lost over the next 2 months. At present her hair is "mostly gone with a few spots of fuzz". It was reported that the patient had her hair permed on 28-APR-2007 and the hair loss started on 29-APR-2007. The patient had picked up the vaccine and transported to the physician's office for administration. On 09-AUG-2007 the patient underwent thyroid stimulating hormone (TSH) test-normal, testosterone level test-elevated, mammogram-normal, CAT scan of the abdomen-normal and chest x-ray-normal. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Mammogram normal
Clinical narrative: Information has been received from a 66 year old female with a history of herpes zoster prior to 2005 and with no allergies who on 18-APR-2007 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included vitamins (unspecified), omega-3 fish oil and 81 mg aspirin. On 29-APR-2007, 10 days after vaccination the patient had hair loss and most of her hair were lost over the next 2 months. At present her hair is "mostly gone with a few spots of fuzz". It was reported that the patient had her hair permed on 28-APR-2007 and the hair loss started on 29-APR-2007. The patient had picked up the vaccine and transported to the physician's office for administration. On 09-AUG-2007 the patient underwent thyroid stimulating hormone (TSH) test-normal, testosterone level test-elevated, mammogram-normal, CAT scan of the abdomen-normal and chest x-ray-normal. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration, Injection site bruising, Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 58 year old female who on 09-OCT-2007 was vaccinated SC on upper right arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included a dose of influenza virus vaccine (unspecified) on left arm. On approximately 11-OCT-2007, 48 hours after vaccination the patient complained of pain and bruising at the injection site of the right arm. The patient was seen in the office on 12-OCT-2007 and in addition the patient also had burning and vesicles at the injection site of the right arm which the physician thought as shingles. The patient was treated with famciclovir. At the time of report the patient had not recovered. No diagnostic laboratory tests were undertaken. A product quality test was not involved. Additional information has been requested. Initial and follow-up information has been received from a physician concerning a 58 year old female who on 09-OCT-2007 was vaccinated SC in the upper right arm with a 0.65 ml first dose of ZOSTAVAX (lot # 658084/0888U). Concomitant vaccination included a first dose of influenza virus vaccine (unspecified) (U2440AA) given IM in the left deltoid. There was no illness at the time of vaccination. On 10-OCT-2007 (also reported as 48 hours after vaccination) the patient complained of pain and bruising at the injection site of the right arm. The patient was seen in the office on 12-OCT-2007 and in addition the patient also had burning and vesicles at the injection site of right arm which the physician thought was shingles. The patient was treated with fameiclovir. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date within one week. There was no product quality complaint involved. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 58 year old female who on 09-OCT-2007 was vaccinated SC on upper right arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included a dose of influenza virus vaccine (unspecified) on left arm. On approximately 11-OCT-2007, 48 hours after vaccination the patient complained of pain and bruising at the injection site of the right arm. The patient was seen in the office on 12-OCT-2007 and in addition the patient also had burning and vesicles at the injection site of the right arm which the physician thought as shingles. The patient was treated with famciclovir. At the time of report the patient had not recovered. No diagnostic laboratory tests were undertaken. A product quality test was not involved. Additional information has been requested. Initial and follow-up information has been received from a physician concerning a 58 year old female who on 09-OCT-2007 was vaccinated SC in the upper right arm with a 0.65 ml first dose of ZOSTAVAX (lot # 658084/0888U). Concomitant vaccination included a first dose of influenza virus vaccine (unspecified) (U2440AA) given IM in the left deltoid. There was no illness at the time of vaccination. On 10-OCT-2007 (also reported as 48 hours after vaccination) the patient complained of pain and bruising at the injection site of the right arm. The patient was seen in the office on 12-OCT-2007 and in addition the patient also had burning and vesicles at the injection site of right arm which the physician thought was shingles. The patient was treated with fameiclovir. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date within one week. There was no product quality complaint involved. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 63 year old female who in November 2006, was vaccinated with a single dose of zoster vaccine live (Oka/Merck). Concomitant therapy included famciclovir (FAMVIR). On 12-OCT-2007 the patient was diagnosed with acute case of shingles. Unspecified medical attention was sought. A product quality complaint was not involved. At the time of report the patient had not recovered. Additional information has been requested. 03/26/2008 This is one of several reports from the same source. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a 62 year old female consumer with no known allergies who on 29-JAN-2007 was vaccinated with 0.65 ml dose of ZOSTAVAX. On 29-JAN-2007 the patient experienced "mirror ache" on her upper left arm after vaccination. Unspecified medical attention was sought. Lab studies were not performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Inappropriate schedule of drug administration, Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a 57 year old female consumer with a history of osteopenia and no drug reactions/allergies, who on 11-OCT-2007 was vaccinated SC in the  abdomen with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included alendronate sodium (+) cholecalciferol (MDS), tablet (duration, dose and indication nor reported). Other concomitant therapy included Requip (manufacturer unknown). On 12-OCT-2007, the patient developed a red circle and itchiness at injection site. The patient was concerned that the effectiveness of the vaccine would have been compromised because the vaccine was not administered in the deltoid region of the upper arm as recommended. The patient was considering suing her physician for the latter reason. There were no lab diagnostics studies performed. Medical attention was not sought. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an approximately 85 year old female with no reported pertinent medical history, and an "allergy to penicillin years ago" who "sometime in February, March or April 2007", was vaccinated with 0.65ml of ZOSTAVAX. Concomitant therapy included LINSINOPRIL-HCTZ, NORVASC, baby aspirin and calcium (unspecified). "In the late part of August into September 2007" the patient developed shingles under her right breast and down towards the hip bone after receiving ZOSTAVAX. At the time of reporting the patient was recovering, and only had pink spots left from the rash. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostics studies performed. No further information is available.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 82-year-old female who "6 or 7 years ago" while enrolled in a clinical trail, in approximately 2000, was vaccinated with a 0.65 ml dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. On 12-OCT-2007 the patient experienced shingles. No medical attention was sought. At the time of this report the patient had not recovered. No product quality complaint was involved. No further information is available.
Age: 28.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 29 year old female (also reported as a 6-year-old) with an amoxicillin allergy and no pertinent medical history who on 13-AUG-2007 (also reported as 01-AUG-2007) was vaccinated intramuscularly in the left deltoid (arm) with a dose of ZOSTAVAX (Lot#657675/0618U). This was due to nursing error. There was no concomitant medication. On 13-AUG-2007 the patient developed injection site warmth, tenderness and redness. The patient took ADVIL and/or TYLENOL for the injection site reaction. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been received from the physician who stated that the patient was vaccinated with a dose of ZOSTAVAX instead of a dose of VARIVAX. The patient reported redness, mild pain at the injection site after vaccination. The physician stated that it was an error by the medical assistant (also reported as a new nurse). The error was found when the patient came in June 2007 for her second dose of VARIVAX. No diagnostic laboratory tests were undertaken. This is a consolidation of two reports concerning the same patient. No further information is expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture, Fatigue, Headache, Herpes zoster, Myalgia
Clinical narrative: Information has been received from a physician, and the patient's husband, concerning a 62 year old female consumer with hypothyroidism and osteoporosis and a history of allergy to cats and chickenpox as a child who on 01-OCT-2007 was vaccinated SC in the left deltoid with a first 0.65 ml dose of ZOSTAVAX (Lot#658085/0882U). Concomitant therapy included SYNTHROID. There was no illness at the time of vaccination. On 10-OCT-2007 (previously reported as 06-OCT-2007) the patient developed shingles. The patient had muscle pain and a red rash on the right flank, back and waist with vesicles and lesions. Medical attention was sought. A viral swab culture specimen was performed. The patient was prescribed VALTREX and LYRICA. No further information was provided. At the time of reporting the patient had not recovered. There was no product quality complaint involved. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 16-OCT-2007. The patient had multiple lesions on right T8 dermatome. The patient had no recent exposure to chickenpox or shingles. The patient's rash occurred 12 days after vaccination. The patient rated her pain 8 on a scale from 0 to 10 with 10 being the highest. Other systemic symptom was fatigue and headache. The patient recovered on an unspecified date. A direct fluorescent antibody test was done which was positive for zoster. The strain was identified as a wild-type. No further information is expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Viral DNA test positive
Clinical narrative: Information has been received from a physician, and the patient's husband, concerning a 62 year old female consumer with hypothyroidism and osteoporosis and a history of allergy to cats and chickenpox as a child who on 01-OCT-2007 was vaccinated SC in the left deltoid with a first 0.65 ml dose of ZOSTAVAX (Lot#658085/0882U). Concomitant therapy included SYNTHROID. There was no illness at the time of vaccination. On 10-OCT-2007 (previously reported as 06-OCT-2007) the patient developed shingles. The patient had muscle pain and a red rash on the right flank, back and waist with vesicles and lesions. Medical attention was sought. A viral swab culture specimen was performed. The patient was prescribed VALTREX and LYRICA. No further information was provided. At the time of reporting the patient had not recovered. There was no product quality complaint involved. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 16-OCT-2007. The patient had multiple lesions on right T8 dermatome. The patient had no recent exposure to chickenpox or shingles. The patient's rash occurred 12 days after vaccination. The patient rated her pain 8 on a scale from 0 to 10 with 10 being the highest. Other systemic symptom was fatigue and headache. The patient recovered on an unspecified date. A direct fluorescent antibody test was done which was positive for zoster. The strain was identified as a wild-type. No further information is expected.
Age: 62.0
Sex: F
Vaccine: PPV, TTOX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a 62 old female who on 10-OCT-2007 was vaccinated with ZOSTAVAX. Concomitant vaccination included PNEUMOVAX 23 and tetanus toxoid. On 11-OCT-2007, it was reported that she developed shingles on her face. It was reported that the patient was seen by a physician. Current patient status was not reported. No product quality complaint was reported. No further information was available. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: Information has been received from a 66-year-old female with a history of genital herpes and no known drug allergies who on 12-OCT-2007 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included CYMBALTA and hormone replacement therapy (unspecified). On approximately 12-OCT-2007 (after vaccination) the patient experienced numerous outbreaks of genital herpes. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient with a history of chickenpox who was vaccinated subcutaneous with a dose of zoster vaccine live (Oka/Merck). On an unspecified date the patient developed shingles. The patient sought unspecified medical attention. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning an approximately 63 year old female with no drug allergies who on 12-OCT-2007 was vaccinated with and IM 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot# 656395/0290U). On approximately 12-OCT-2007 the patient developed a 10 cm raised red area at the injection site. On 15-OCT-2007, the patient was seen in the physician's office. No labs or diagnostic studies were performed. The patient was not recovered. There was no product quality complaint. Additional information has been requested. 03/26/2008 Follow-up information from the medical assistant indicated that a 63 year old female with no pre-existing medical conditions or allergies who on 12-OCT-2007 at 11:30 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 656395/0290U) in the right upper extremity. There was no illness at the time of vaccination. On 13-OCT-2007 less than 24 hours after vaccination, the patient developed diffuse erythema with mild induration and mild warmth at the right upper extremity (upper arm posterior aspect). There was no vesicle formation. On 03-OCT-2007 the patient was also vaccinated with a dose of influenza virus vaccine (unspecified) (lot# AFLLA036AA) in the right arm. Subsequently, the patient recovered. No follow-up was necessary. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site oedema, Injection site reaction, Injection site urticaria, Local reaction
Clinical narrative: Information has been received from a physician concerning a 74 year old female who on 24-SEP-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot# 657765/0585U). On 25-SEP-2007 the patient experienced a localized allergic reaction on the left arm at the injection site with a 5 inch induration, urticarial wheal without systemic urticaria and edema. The patient was treated with oral BENADRYL. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 78 year old female who in June 2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 652936/0981F). In October 2007, the patient hand an outbreak of shingles. The physician believed that the patient did not have shingles but had a semi circular rash. Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. The nurse is not interested inthe VZV by PCR analysis program. Follow-up information has been received from the L.P.N. who reiterated that the reported episode of shingles was not diagnosed as shingles whom evaluated by the physician on 16-Oct-2007. Follow-up information has been received from the L.P.N. who reiterated that the reported episode of shingles was not diagnosed when evaluated on 16-Oct-2007. Follow-up information has been received from the L.P.N. that stated the patient did not have shingles. No other information is available.