chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Angiomyolipoma, Blood alkaline phosphatase increased, Body temperature increased, Chest X-ray normal
Clinical narrative: Information has been received from a nurse concerning a 62 year old female with an allergy to BENADRYL who on 16-JUL-2007 was vaccinated intramuscularly in the right deltoid, with a first dose of Zostavax (Oka/Merck) (Lot#657765/0585U). The patient developed a "fever of 101 degrees" days after receiving the vaccination. Unspecified medical attention was sought. There was no other information provided. There was no product quality complaint involved. Follow up information indicated that the patient began running a low grade fever on the night of vaccination. (previously reported as days after vaccination) the patient had a maximum fever of 101.9 degrees Fahrenheit. The fever persisted for several days until the patient was seen in the office on 26-JUL-2007. Her temperature was 101.2 degrees that morning, but after being treated with TYLENOL in the office her temperature dropped to 98.6 degrees. Urinalysis, unspecified labs and chest x-ray taken in the emergency room were all negative. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow up information received from the nurse indicated that Epstein Barr IGG and IGM studies were positive, but there was the possibility of cross-reactivity with the varicella zoster antibodies. Other lab studies of alkaline phosphatase, ALT< and AST were improving. The transaminitis was normalizing. The patient had a liver sonogram which was consistent with steatosis. Also noted in the study was a 2.2x2.2x2.3 cm right renal nodule. The patient had a CAT scan of the right kidney which revealed a 2-cm apparent angiomyolipoma. There was no illness at the time of vaccination. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Epstein-Barr virus antibody positive, Hepatic steatosis, Incorrect route of drug administration, Laboratory test normal, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 62 year old female with an allergy to BENADRYL who on 16-JUL-2007 was vaccinated intramuscularly in the right deltoid, with a first dose of Zostavax (Oka/Merck) (Lot#657765/0585U). The patient developed a "fever of 101 degrees" days after receiving the vaccination. Unspecified medical attention was sought. There was no other information provided. There was no product quality complaint involved. Follow up information indicated that the patient began running a low grade fever on the night of vaccination. (previously reported as days after vaccination) the patient had a maximum fever of 101.9 degrees Fahrenheit. The fever persisted for several days until the patient was seen in the office on 26-JUL-2007. Her temperature was 101.2 degrees that morning, but after being treated with TYLENOL in the office her temperature dropped to 98.6 degrees. Urinalysis, unspecified labs and chest x-ray taken in the emergency room were all negative. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow up information received from the nurse indicated that Epstein Barr IGG and IGM studies were positive, but there was the possibility of cross-reactivity with the varicella zoster antibodies. Other lab studies of alkaline phosphatase, ALT< and AST were improving. The transaminitis was normalizing. The patient had a liver sonogram which was consistent with steatosis. Also noted in the study was a 2.2x2.2x2.3 cm right renal nodule. The patient had a CAT scan of the right kidney which revealed a 2-cm apparent angiomyolipoma. There was no illness at the time of vaccination. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound scan abnormal, Urine analysis normal
Clinical narrative: Information has been received from a nurse concerning a 62 year old female with an allergy to BENADRYL who on 16-JUL-2007 was vaccinated intramuscularly in the right deltoid, with a first dose of Zostavax (Oka/Merck) (Lot#657765/0585U). The patient developed a "fever of 101 degrees" days after receiving the vaccination. Unspecified medical attention was sought. There was no other information provided. There was no product quality complaint involved. Follow up information indicated that the patient began running a low grade fever on the night of vaccination. (previously reported as days after vaccination) the patient had a maximum fever of 101.9 degrees Fahrenheit. The fever persisted for several days until the patient was seen in the office on 26-JUL-2007. Her temperature was 101.2 degrees that morning, but after being treated with TYLENOL in the office her temperature dropped to 98.6 degrees. Urinalysis, unspecified labs and chest x-ray taken in the emergency room were all negative. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow up information received from the nurse indicated that Epstein Barr IGG and IGM studies were positive, but there was the possibility of cross-reactivity with the varicella zoster antibodies. Other lab studies of alkaline phosphatase, ALT< and AST were improving. The transaminitis was normalizing. The patient had a liver sonogram which was consistent with steatosis. Also noted in the study was a 2.2x2.2x2.3 cm right renal nodule. The patient had a CAT scan of the right kidney which revealed a 2-cm apparent angiomyolipoma. There was no illness at the time of vaccination. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Skin warm
Clinical narrative: Information has been received from a 60 year old female who was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient received vaccine for shingles and arm got very hot and bruised.  No medical attention was sought.  No further information is available.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Information has been received from a 71-year-old male consumer with hypertension and no allergies, who on 23-JUL-2007 was vaccinated with a 0.65 milliliter dose of Zostavax (Oka/Merck).  Concomitant therapy included unspecified hypertension medication.  On 24-JUL-2007 the patient experienced hives on his right side above his waist and total body itchiness.  It is reported that the patient is not sure if he ever had chickenpox.  No medical attention was sought.  There were no laboratory or diagnostic tests performed.  The outcome is reported as not recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 40.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered pharmacist concerning a 40-year-old male with a history of recurrent shingles and no known allergies or drug reactions who was vaccinated on an unspecified date with a dose of Zostavax (Oka/Merck). Subsequently, the patient experienced an outbreak of shingles 6 weeks after receiving the vaccination. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. On an unspecified date the patient recovered from shingles. No product quality complaint was involved. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Information has been received from a 68-year-old female consumer with thyroid disorder, a history of shingles and no known allergies or drug reaction who "last Monday, 23-JUL-2007" was vaccinated in the left arm with a dose of Zostavax (Merck). Concomitant therapy included hormones (unspecified), CELEBREX and PROTONIX. On approximately 23-JUL-2007, "2 days ago," the patient noticed a red spot on her left arm about 1 centimeter in diameter and there was pain associated with it, "the pain had increased gradually until today" (approximately 25-Jul-2007). Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. The outcome was reported as not recovered. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacy nurse concerning a female who on 20-JUL-2007 was vaccinated with a dose of ZOSTAVAX. On 25-JUL-2007 the patient notified the nurse about a rash on her abdomen. The patient was instructed to follow-up with her primary doctor. Unspecified medical attention was sought. The outcome is unknown. No product quality complaint was involved. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia, Sensory loss
Clinical narrative: Information has been received from a physician concerning a 61 year old female with psoriatic arthritis who on 10-JUL-2007 at 11:30 was vaccinated SC on the left with a first dose of ZOSTAVAX (lot # 657559/0462U). Concomitant therapy included ENBREL. On 11-JUL-2007 in the morning the patient experienced parathesias of the legs and arms and numbness or buzzing of the scalp. There was "-NVF", sensation was not ascending, loss of sensation in the right lower extremity and numbness. The sought unspecified medical attention in the emergency room and a doctor's visit. The patient was scheduled to see Neuro on 23-JUL-2007. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with an injection of ZOSTAVAX. Subsequently the patient experienced redness around the injections site. No other information was available. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a certified medical assistant concerning a female (age not reported) who was vaccinated with a dose of ZOSTAVAX and experienced redness about the size of a quarter at the injection site. No treatment was given. No other complications were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a female consumer who on 17-JUL-2007 (reported as last Tuesday) was vaccinated with a dose of ZOSTAVAX. on approximately 17-JUL-2007 the patient developed a rash. At the time of this report the patient had not spoken with her physician. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a male consumer with a history of shingles who "a couple of months ago" in approximately May 2007, was vaccinated with a dose of ZOSTAVAX. Subsequently the patient developed shingles on his eyeball. No other information was provided. There was not product quality complaint involved. No further information is available.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a 61 year old male consumer with diabetes and a prostaglandin inhibitor allergy who on 24-JUL-2007 was vaccinated intramuscularly with a single 0.65 ml dose of ZOSTAVAX. Concomitant therapy included lisinopril (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), dorzolamide HCL (+)/ timolol maleate (MSD), ALPHAGAN and glipizide. On 24-JUL-2007 the patient developed "a little pain" at the injection site. No lab studies were performed, and no medical attention was sought. At the time of this report the patient had not recovered. There was no further information provided. There was no product quality complaint involved. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial information has been received from a 61 year old male with diabetes and a prostaglandin inhibitor allergy who on 24-JUL-2007 was vaccinated IM in the left arm with a single first 0.65 ml dose of ZOSTAVAX (Oka/Merck) (Lot#656858/0356U). Concomitant therapy included lisinopril (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), dorzolamide HCl (+)/ timolol maleate (MSD), ALPHAGAN and glipizide. There was no illness at the time of vaccination. On 24-JUL-2007 the patient developed "a little pain" at the injection site. No lab studies were performed, and no medical attention was sought. At the time of this report the patient had not recovered. No adverse event occurred. Follow up information from a licensed practical nurse indicated that the nurse recorded in the chart that the vaccine was given SC in the left arm. The patient came in later saying it was given IM and wanted to know if it would still work. The patient's outcome was not reported. There was no further information provided. There was no product quality complaint involved. Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Incorrect route of drug administration, Skin lesion
Clinical narrative: Information has been received from a physician concerning a female retired volunteer who on 19-APR-2007 was vaccinated IM with a 0.65 ml dose of ZOSTAVAX (Lot#656606/0033U). On 18-JUN-2007, "three weeks after" vaccination, the patient developed a mild case of shingles. Unspecified medical attention was sought. At the time of this report the patient's status was unspecified. No further information was provided. there was no product quality complaint involved. Follow up information received from the nurse said that the patient has had 2 outbreaks of zoster on unknown dates since the vaccination on 19-APR-2007 (onset date of 18-JUN-2007 also provided). It was noted that a rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. At the time of the outbreaks there was 1 lesion on the right gluteal region which was red with blisters and 2 smaller lesions lateral. There was an exposure to chickenpox or herpes zoster on 16-JUL-2007. There was no direct fluorescent antibody done, nor was a specimen collected for PCR. No photo was taken. Additional information received indicated that no additional information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a patient who on 31-MAY-2007 was vaccinated with a dose of ZOSTAVAX. In approximately July 2007, the patient developed a rash. There was no other information provided. There was no product quality complaint in involved. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 77 year old female who on 22-JUL-2007 was vaccinated with a dose of ZOSTAVAX. On approximately 28-JUL-2007 the patient developed an erythematous rash and swelling around the injection site the size of a pancake. No further information was provided. No further information is available.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning an 83 year old male with no pertinent medical history who on 03-JUL-2007 was vaccinated with a 0.65ml SC dose of ZOSTAVAX. On 14-JUL-2007 the patient developed shingles. Patient was sent to urgent care. The patient was prescribed VALTREX (manufacturer unknown). No labs were performed. The patient was noted to be recovering. No product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with a dose of ZOSTAVAX. It was reported that the patient experienced itching after vaccination. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood calcium increased, Blood parathyroid hormone increased, Glomerular filtration rate decreased, Hyperhidrosis, Insomnia
Clinical narrative: Information has been received from a 63 year old female consumer with no known allergies or pertinent medical history who, "three weeks ago", on approximately 28-JUN-2007, was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included furosemide, metoprolol, ELMIRON, PROTONIX, simvastatin (manufacturer unknown), etodolac and DEMEROL.  Subsequently the patient reported "becoming very itchy all over her body" a few days after receiving the vaccination.  There was no visible rash.  Unspecified medical attention was sought.  The patient reported ineffective therapy to ease the itching with hydroxyzine HCl and hydrocortisone cream.  There were no lab studies performed.  No further information was provided.  There was no product quality complaint involved.  Follow up Information from the patient indicated that she was still in "excruciating pain" and has severe itching and severe "needle-like" pain all over her body, from her head to her toes.  She said she has a history of rheumatoid arthritis and fibromyalgia.  She tried taking prednisone, but it did not help at all.  No further information was provided.  Additional information from the physician indicated that the patient has also had sweats and insomnia for weeks. The patient was given ZYRTEC, DECADRON, MEDROL, TAGAMET, SARNA, TOPICORT, hydrocortisone cream 2.5%, CETAPHIL and calamine (+) camphor (+) diphonhydramine hydrochloride as well as ice packs and vinegar. The patient was seen by urgent care, dermatology and internal medicine physicians. Multiple lab studies were performaed. Abnormal labs included RDW was 15.3%, calcium was 10.6 mg/dl, parathyroid hormone 86 pg/ml, and estimated CPR of 53 ml/min. All other labs performed were within normal limits. There was no illness at the time of vaccination. At the time of this report the patient had not recovered. The patient had no adverse events following prior vaccination . No further information was provided. Follow-up information was received from the physician which indicated that the patient had been seen in the doctors office on 29-AUG-2007 when symptoms has subsided. The physician reported that there were no significant signs on exam. No additional information is expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus generalised, Red cell distribution width increased
Clinical narrative: Information has been received from a 63 year old female consumer with no known allergies or pertinent medical history who, "three weeks ago", on approximately 28-JUN-2007, was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included furosemide, metoprolol, ELMIRON, PROTONIX, simvastatin (manufacturer unknown), etodolac and DEMEROL.  Subsequently the patient reported "becoming very itchy all over her body" a few days after receiving the vaccination.  There was no visible rash.  Unspecified medical attention was sought.  The patient reported ineffective therapy to ease the itching with hydroxyzine HCl and hydrocortisone cream.  There were no lab studies performed.  No further information was provided.  There was no product quality complaint involved.  Follow up Information from the patient indicated that she was still in "excruciating pain" and has severe itching and severe "needle-like" pain all over her body, from her head to her toes.  She said she has a history of rheumatoid arthritis and fibromyalgia.  She tried taking prednisone, but it did not help at all.  No further information was provided.  Additional information from the physician indicated that the patient has also had sweats and insomnia for weeks. The patient was given ZYRTEC, DECADRON, MEDROL, TAGAMET, SARNA, TOPICORT, hydrocortisone cream 2.5%, CETAPHIL and calamine (+) camphor (+) diphonhydramine hydrochloride as well as ice packs and vinegar. The patient was seen by urgent care, dermatology and internal medicine physicians. Multiple lab studies were performaed. Abnormal labs included RDW was 15.3%, calcium was 10.6 mg/dl, parathyroid hormone 86 pg/ml, and estimated CPR of 53 ml/min. All other labs performed were within normal limits. There was no illness at the time of vaccination. At the time of this report the patient had not recovered. The patient had no adverse events following prior vaccination . No further information was provided. Follow-up information was received from the physician which indicated that the patient had been seen in the doctors office on 29-AUG-2007 when symptoms has subsided. The physician reported that there were no significant signs on exam. No additional information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of ZOSTAVAX. Subsequently the patient "got all kinds of side effects." No further information was provided. No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an approximately 73-year-old female who on an unspecified date was vaccinated with a dose of ZOSTAVAX. The patient broke out in shingles five weeks later. Unspecified medical treatment was sought. The outcome in not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash papular
Clinical narrative: Information has been received from a 72 year old female consumer, with no known allergies, and a history of chicken pox as a child, who on 20-FEB-2007 was vaccinated with a single dose of ZOSTAVAX (lot#652947/1411F). On 12-JUL-2007 the patient developed a sharp pain in her front and back. Medical attention was sought and shingles was diagnosed on 14-JUL-2007 by an emergency care physician. At the time of this report the patient had not recovered. There was no product quality complaint involved. Follow up information has been received from the physician. on 14-JUL-2007 the patient went to the emergency room for a rash on her left thorax. It was noted that this was a papular rash without vesicles. the rash was painful and in a distribution commonly seen with herpes zoster. The patient was diagnosed with herpes zoster. The patient was diagnosed with herpes zoster. The patient was prescribed FAMVIR 500mg two tablets a day and the rash subsequently resolved completely. She did not have any sequelae from this rash and was otherwise doing well. No further information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently "a few days after" vaccination, she developed a headache and became lightheaded after drinking a glass of wine. There was no product quality complaint involved. No additional information is available
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: Information has been received from a 60 year old registered nurse with no known allergies who on an unspecified date was vaccinated intramuscularly, instead of subcutaneously, with a dose of ZOSTAVAX. The patient was not experiencing any known symptoms. There was no further information provided. There was no product quality complaint involved. Follow up information from a registered nurse about the patient states that the patient developed an arm that was sore for a day or two after receiving the vaccination. The patient has recovered from the sore arm. Additional information is not expected. This is one of several reports from the same source.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Herpes zoster
Clinical narrative: Information has been received from a physician concerning an approximately 70 year old female with a history of strokes and no known allergies who during the week of 16-JUL-2007 was vaccinated subcutaneously with a 0.5 ml dose of Zostavax (Oka/Merck). Concomitant therapy included COUMADIN. On 20-JUL-2007 the patient returned to the office with a characteristic shingles rash with pain on her left breast. No labs were performed. At the time of this report the patient had not recovered. No additional information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 70-year-old female patient with a history of shingles "15 months earlier" who on 03-JUL-2007 was vaccinated subcutaneously with a 0.65 milliliter dose of ZOSTAVAX. on an unspecified date after the vaccination, the patient developed shingles. medical attention was not sought. There were no diagnostic laboratory studies performed. The outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture urine negative, Rash, Rash papular, Skin lesion, Urinary tract disorder
Clinical narrative: Information has been received from a physician concerning a 62-year-old female who on 13-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 657764/0854U).  Four weeks later, on approximately 10-JUL-2007, the patient broke out in a rash on the trunk and then it spread to her lower extremities.  Unspecified medical attention was sought.  The outcome is reported as recovered.  No product quality complaint was involved. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow-up information received concerning a female with C5-6 spinal cord injury with remittent neurogenic bladder, spasticity, hypoaesthesia of trunk and extremities, osteopenia, and a history of adenoidal radiation, tubal ligation, tonsillectomy. Concomitant therapy included amitriptyline hydrochloride (MSD) 25 milligrams HS for insomia, NEURONTIN 150 (units not indicated) PRN for neuropathy and DITROPAN XL for incontinence. On 09-JUL-2007, (previously reported as approximately 10-Jul-2007) the patient developed an erythematous papular rash with questionable umbilicated vesicles. It started in her groin and developed scattered lesions on trunk and proximal extremities. It was also reported that the patient had mild irritative urinary tract symptoms, a urine culture was negative. There were no lesions in the scalp, face, palms and soles. There was no pruritus, no fever, no headaches, no myalgia and no arterial "gear". Varicella antibody titers on 30-May-2007 were positive for the varicella antibody. The rash resolved over a 2 to 3 week period. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella virus test positive
Clinical narrative: Information has been received from a physician concerning a 62-year-old female who on 13-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 657764/0854U).  Four weeks later, on approximately 10-JUL-2007, the patient broke out in a rash on the trunk and then it spread to her lower extremities.  Unspecified medical attention was sought.  The outcome is reported as recovered.  No product quality complaint was involved. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow-up information received concerning a female with C5-6 spinal cord injury with remittent neurogenic bladder, spasticity, hypoaesthesia of trunk and extremities, osteopenia, and a history of adenoidal radiation, tubal ligation, tonsillectomy. Concomitant therapy included amitriptyline hydrochloride (MSD) 25 milligrams HS for insomia, NEURONTIN 150 (units not indicated) PRN for neuropathy and DITROPAN XL for incontinence. On 09-JUL-2007, (previously reported as approximately 10-Jul-2007) the patient developed an erythematous papular rash with questionable umbilicated vesicles. It started in her groin and developed scattered lesions on trunk and proximal extremities. It was also reported that the patient had mild irritative urinary tract symptoms, a urine culture was negative. There were no lesions in the scalp, face, palms and soles. There was no pruritus, no fever, no headaches, no myalgia and no arterial "gear". Varicella antibody titers on 30-May-2007 were positive for the varicella antibody. The rash resolved over a 2 to 3 week period. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 71-year-old female who was vaccinated with a dose of ZOSTAVAX (lot# 657558/0461U). On an unspecified date the patient developed an injection site welt with no rash. Unspecified medical attention was sought. The outcome is not reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Information has been received from a health professional (pharmacy student) concerning a female (age unknown) who on approximately 13-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On approximately 13-JUL-2007, the patient developed painful rash below breast and persisted.  The pharmacy student stated that this may be shingles because the patient was asking about reactivation of shingles after receiving Zostavax (Oka/Merck).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with Zostavax (Oka/Merck) (lot#658082/0744U).  On the second day after vaccination, the patient developed a dark red, hot to touch and itchy 3 inch injection site reaction.  On day 3 the redness decreased but the site became lumpy.  Patients were treated with TYLENOL and cool compresses.  This is one report of several reports received from the same source.  Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 41 year old female who on 17-JUL-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck) instead of a dose of Varivax (Oka/Merck) due to medical error.  The patient sought unspecified medical attention.  The patient did not experience any known symptoms.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 09/24/07. Follow up information from the nurse indicated that on 17-JUL-2007 the patient also received an IM second dose of diphtheria toxoid + tetanus toxoid (manufacturer unknown) (Lot#U1704BA) in the left deltoid. On 19-JUL-2007 the patient developed soreness at the injection site and joint pain. On 23-JUL-2007 the patient had recovered. No further information was provided. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling, Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a physician concerning a 60 year old female who had a reaction to flu vaccine one year ago, and with codeine, sulfonamide and tetracycline allergies, and a history of hypertension, irritable bowel and rosacea who on 18-JUL-2007 was vaccinated intramuscularly in the left arm, with a single dose of Zostavax (Oka/Merck) (Lot#652966/0623F).  Concomitant therapy included amitriptyline hydrochloride (MSD), NEXIUM, COLESTID and ZIAC.  On 18-JUL-2007 the patient experienced injection site erythema, swelling and pain.  Medical attention was sought, and antihistamines (unspecified name) were ordered.  There were no labs performed.  As of 25-Jul-2007 the patient recovered.  There was no product quality complaint involved.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old female with no allergies who on 16-JUL-2007 was vaccinated SC in the left upper arm with a dose of Zostavax (Oka/Merck) (lot # 657764/0584U). On 17-JUL-2007, one day after administration, the patient developed redness, warmth, soreness, and swelling at the injection site. The pharmacist suggested the use of ibuprofen and the application of ice compresses to the affected area. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. No further information is available.
Age: 85.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning an 85-year-old male retired physician with no known allergies who on 20-FEB-2007 was vaccinated subcutaneously in the left deltoid with a first dose of 0.65 milliliters (and reported as 0.5 milliliters) of ZOSTAVAX (lot# 656606/0033U). Concomitant vaccination included an intramuscular first dose of PNEUMOVAX (lot# 655591/0886F) in the right arm. The patient had chronic ischemic disease at the time of vaccination. On 01-Jul-2007 the patient called the office and was seen on 11-JUL-2007 and diagnosed with shingles on the right side of his abdomen at the umbilical level. It is unknown if the patient had a fever, or had any laboratory or diagnostic tests performed. It is unknown if the patient had chickenpox in the past, however there was not a recent exposure to chicken pox or herpes zoster. The patient was treated VALTREX. On 11-Jul-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 74 year old female who on 20-JUL-2007 was inadvertently vaccinated with a dose of Zostavax (Oka/Merck) instead of her second dose of Varivax (Oka/Merck).  The patient received a first dose of Varivax (Oka/Merck) on 21-JUN-2007, and was due for the second dose on 20-JUL-2007.  Unspecified medical attention was sought.  There was no additional information provided. There was no product quality complaint involved.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a pharmacist concerning an approximately 60 year old female who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient developed cold sores in and around the mouth. Unspecified medical attention was sought. No other information was provided. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash pruritic
Clinical narrative: Information has been received from a female patient who on 16-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck). It was reported that on 17-JUL-2007 night the patient had an itchy bump on her left shoulder. On 18-JUL-2007 night, the patient developed shingles on left shoulder and left breast. The patient described it as "quite unsightly" and a painful itching mess. On 19-JUL-2007 the patient saw the physician.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a 65 year old female consumer with no known allergies or pertinent medical history who on 20-JUL-2007 was vaccinated subcutaneously with a single dose of ZOSTAVAX (lot#656858/0356U). Concomitant therapy included LIPITOR and omeprazole (MSD). On 21-JUL-2007 the patient developed a swollen lump at the injection site which was red, itchy and painful. She states that it seems to get "bigger and bigger". No medical attention was sought. No lab studies were performed. The patient tried DRIXORAL for the symptoms, but it did not seem to help. At the time of this report the patient had not recovered. No other information was provided. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning an over 60 year old female who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed a "tender but not painful" lesion on her forehead two weeks after receiving vaccination.  Unspecified medical attention was sought.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 20 year old female who on 23-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot#656395/0290U) instead of Varivax (Oka/Merck) (MSD).  Unspecified medical attention was sought.  It was noted that this was due to staff error.  No other information was provided.  There was no product quality complaint involved.  Follow up information indicated that the patient was vaccinated with Zostavax (Oka/Merck) (lot#656395/0290U) instead of Varivax (Oka/Merck) (MSD).  She was later vaccinated with Varivax (Oka/Merck) (MSD) and has had no problems.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an over 60 year old male who in January 2007, was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck). In approximately April 2007 a "few months after being vaccinated," the patient developed shingles. At the time of this report the patient had not recovered. Unspecified medical attention was sought. No other information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 70 year old male consumer with no known allergies or pertinent medical history who on 09-JUL-2007 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck).  Concomitant therapy included verapamil, hydrochlorothiazide (manufacturer unknown), diuretic (unspecified), terazosin hydrochloride, lisoprinil (manufacturer unknown), simvastatin (manufacturer unknown) and finasteride (manufacturer unknown).  "Around 17-JUL-2007" the patient developed a slight case of the shingles.  The breakout was about the size of a silver dollar on his left shoulder.  There was no itching or pain.  Unspecified medical attention was sought.  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. This is in follow-up to report (s) previously submitted on 9/24/2007.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Culture wound negative, Pain, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a 68 year old male with gastroesophageal reflux disease, a history of glaucoma and no allergies who on 25-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included omeprazole (MSD), timolol, LUMIGAN, aspirin. It was reported that the patient was treated in mid June 2007 for a bilateral rash on the patient's buttocks, between the cheeks. The patient was prescribed KETAZONE for the rash. On 03-JUL-2007 the patient's rash worsened after vaccination. It was reported that the rash was not elevated, but reddened. It was reported that the patient experienced burning pain. A wound culture test was undertaken which was reported to be negative for bacteria. At the time of report the patient was not recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Additional information has been received from the physician who stated that the patient developed rash on buttock and in August 2007 the patient recovered. No further information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a female who was vaccinated on an unspecified date with a single dose of Zostavax (Oka/Merck). It was reported that approximately on 11-JUL-2007 she developed hives. No medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Beta globulin increased, Biopsy skin abnormal, Herpes zoster, Pruritus, Rash vesicular
Clinical narrative: Information has been received from a physician and a nurse practitioner concerning a 60 year old female with a history of childhood chickenpox and hives from DEMEROL who on 06-JUL-2007 was vaccinated SQ in her left arm with Zostavax (Oka/Merck) (lot #657767/0740U). There was no illness at the time of vaccination. Concomitant therapy included FLONASE, ZYRTEC, BENADRYL, vitamins (unspecified) and calcium (unspecified). On 17-JUL-2007 the patient developed a varicella-like rash on both arms and legs, worse at left posterior thigh and ankle. The patient was treated with cortisone cream and a gel for the itching. The patient had not had any recent exposure to chickenpox or shingles. On 24-JUL-2007, a specimen was taken from the lesion which were described as vesicles, papules and scabs (results not provided). At the time of this report, the patient had not recovered. There were no reported adverse events following prior vaccination. 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 VZV strain or with the OKA/Merck VZV strain. Follow up information was received from a university associate research scientist, who reported the PCR results on the three specimens collected from the patient on 24 JUL 2007. The PCR results, received on 25 JUL 2007 at the lab, included the following: scab-inadequate (not a scab, but a tiny piece of "something"), swab left shin-inadequate, and swab left ankle-negative. VZV DNA was not amplified. B-globulin DNA was amplified, L ankle only. The reporter noted they were still working on CSF. Additional information had been requested. This is in follow-up to report(s) previously submitted on 9/24/2007. Follow up information was received from a medical assistant who reported on an undisclosed date the patient recovered. No further information is expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a 61 year old female patient who in approximately June 2007, was vaccinated subcutaneously in the right arm with a dose of Zostavax (Oka/Merck).  On approximately 01-JUL-2007, "within the last 3 weeks" the patient developed a VZV like rash after vaccination.  Initially she experienced an injection site reaction with swelling, erythema and pruritus at the injection site.  Later, at an unspecified time interval, she developed spots (about 10-11 spots) on multiple areas of her body."  The patient reported that one of her spots was located on her ankle.  It was described as a red bump, nickel size with scab like center as if a blister had popped.  The patient sought unspecified medical attention.  The patient started treatment with Famvir.  The patient's outcome was reported as recovering.  There was no product quality complaint involved.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: Information has been received from a 61 year old female patient who in approximately June 2007, was vaccinated subcutaneously in the right arm with a dose of Zostavax (Oka/Merck).  On approximately 01-JUL-2007, "within the last 3 weeks" the patient developed a VZV like rash after vaccination.  Initially she experienced an injection site reaction with swelling, erythema and pruritus at the injection site.  Later, at an unspecified time interval, she developed spots (about 10-11 spots) on multiple areas of her body."  The patient reported that one of her spots was located on her ankle.  It was described as a red bump, nickel size with scab like center as if a blister had popped.  The patient sought unspecified medical attention.  The patient started treatment with Famvir.  The patient's outcome was reported as recovering.  There was no product quality complaint involved.  Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature normal, Influenza like illness, Injection site discharge, Injection site erythema, Oedema peripheral
Clinical narrative: Information has been received from a medical assistant concerning a "60+" year old male who "about one month ago" on approximately 18-JUN-2007 was vaccinated SC with a dose of Zostavax (Oka/Merck).  Subsequently the patient experienced arm swelling, flu-like symptoms and "pus" in the deltoid area of the injection site arm.  Unspecified medical attention was sought.  Subsequently the patient recovered.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial and follow-up information has been received from a medical assistant concerning a 75 year old male with no known allergies or pertinent medical history who on approximately 13-JUN-2007 at 9:45 was vaccinated SC in the left arm with a first dose of ZOSTAVAX (Oka/Merck) (lot # 657764/0584U). There was no illness at the time of vaccination. On 15-JUN-2007 at 16:30 the patient experienced arm swelling, localized erythema, flu-like symptoms (including a temperature of 99 degrees) and "pus" (also reported as a "waxy like substance") that was squeezed from the injection site. Unspecified medical attention was sought. On 18-JUN-2007 the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Initial and follow-up information has been received from a physician concerning an 83 year old female with osteoporosis, spinal stenosis, mitral valve prolapse and allergies to CIPRO and IVP dye, who on 16-NOV-2006 was vaccinated in the left deltoid with a dose of Zostavax (Oka/Merck) (lot # 652946/1012F).  "Last week", on approximately 08-JUL-2007 the patient developed moderate-severe (previously reported as a bad case of) shingles involving her breast and right mid/upper back.  Unspecified medical attention was sought.  At the time of follow-up the patient had not recovered.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a who was vaccinated with a single dose of Zostavax (Oka/Merck). It was reported that the patient developed an injection site swelling after vaccination. The swelling resolved with ice. Additional information has been requested. This is one of the several reports received from the same source.