chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 61-year-old female, with no pertinent medical history or allergies, who on 28-JAN-2008 was vaccinated intramuscular with a 0.65 mL does of zoster vaccine live (Oka/Merck). There was no concomitant medication. On 28-JAN-2008, the patient experienced injection site redness, swelling and warmth. The patient sought unspecified medical attention. At the time of the report the patient status was not reported. No diagnostic labs were performed. A product quality complaint was not involved. Follow-up information received via medical records indicated the following: A 61-year-old female, with no pertinent medical history or allergies, on 28-JAN2008 was vaccinated subcutaneous with a first 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot # 658085/0882). On 14-APR-2008, the patient was seen by the physician complaining of persistent left arm tenderness at the injection site in January. Initially the patient noticed bruising as well as redness and warmth. Those symptoms resolved within a week or so. Although the tenderness improved the patient continued to experience tenderness when she laid on her left side or when she abducted her shoulder. An exam of the left shoulder showed no swelling or deformity. No erythema. There was fairly localized tenderness over the deltoid muscle about 3 or cm distal to the shoulder joint. The shoulder itself was non-tender to palpation. Full range of motion of the left shoulder with discomfort with internal rotation. Muscle strength was normal in upper extremity. Deep tendon reflexes were 2 plus and symmetrical in upper extremities. Assessment: Tenderness, left upper arm. The physician noted she could not be absolutely sure this is related to the injection. The patient seems to feel the two are related. The physician also noted she was not sure why the patient would be having tenderness at this point, but assured the patient that there was no sign of infection or any swelling to suggest calcification or scar tissue. If the shoulder pain does not continue to improve over the next month the patient was instructed to call back for a referral. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 74 year old male consumer who on 21-JAN-2008 was vaccinated SQ with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 659325/1823U). Subsequently, on an unspecified date the patient developed shingles after receiving the vaccination. Medical attention was sought in the office. It was unspecified if lab studies were performed. The patient was treated with unspecified antiviral medication. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information indicated no new information. Additional information has been requested. This is one of several reports from the same source.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Oropharyngeal blistering, Sebaceous gland disorder
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 72 year old female consumer who on 09-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the day after receiving zoster vaccine live (Oka/Merck), on 10-MAR-2008 the patient experienced discomfort on the right side of her cheek and blisters on the inside of the right cheek. The patient reported "rinsing mouth with peroxide on a daily basis." Unspecified medical attention was sought. The patient was diagnosed with ectopic sebaceous glands. There was no relationship to the vaccine or shingles. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: Information has been received from a physician concerning his female nurse who on approximately 07-MAR-2008 or 08-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 10-MAR-2008 the patient experienced an outbreak of herpes simplex virus (HSV-1). At the time of the report the patient's status was unknown. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Pain
Clinical narrative: Information has been received from a male consumer with no reported pertinent medical history, drug reactions or allergies who "9 months ago" in approximately June 2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included COUMADIN, statin (unspecified), blood pressure medication and "elcarnatine." The patient reported that his waist area became painful and sensitive to touch shortly after receiving zoster vaccine live (Oka/Merck). The patient also noted that the pain began two days after starting therapy with elcarnatine (manufacturer unknown). The lot number was not available. Unspecified medical attention was sought. At the time of reporting the patient had not yet recovered. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck), approximately one week later he developed shingles. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information indicated no new information. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Arthritis
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with 0.65mL of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced "joint inflammation." Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of drug administration, Incorrect dose administered, Malaise, Nausea
Clinical narrative: Information has been received from a healthcare worker concerning a 36 year old female employee who 2 weeks ago on approximately 27-FEB-2008 was vaccinated SQ with 0.65 "mg" of zoster vaccine live (Oka/Merck). Subsequently, on approximately 27-FEB-2008 (th past two weeks) the patient experienced a red, itchy rash over her whole body with no lesions. She also had a headache, nausea and vomiting. Medical attention was sought in the office on 12-MAR-2008, the patient was seen by the nurse practitioner. She was treated with ATARAX for itching. The nurse practitioner did not feel this was related to the vaccine. The rash did not resemble chickenpox or shingles. At the time of the report the patient had not recovered. VZVIP offered but there was no lesion, the rash had no opened areas.   Follow-up information from the nurse practitioner indicated that the patient was evaluated in a local emergency room and was diagnosed with chickenpox. The nurse practitioner stated lab testing was not involved in the diagnosis of this varicella rash. The diagnosis was based upon the patient's symptoms which were described as a rash which was "macular, papular and vesicular" associated with itching.   Follow-up information received has been form a nurse practitioner concerning this 36 year old female registered nurse who on 26-FEB-2008 was vaccinated in the left arm with zoster vaccine live (Oka/Merck) (lot # "10794"). Subsequently, on 12-MAR-2008 the patient developed itching, a rash and headache. The patient also felt nauseated and had general malaise. Medical attention was sought in the emergency room. According to the ER report the patient had macular papular vesicular lesions on her trunk and chest. At the time of the report the patient's status was unknown.  Follow-up information from the nurse practitioner indicated that she was not seeing this patient. She did not know if the patient had recovered.   Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash maculo-papular, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a healthcare worker concerning a 36 year old female employee who 2 weeks ago on approximately 27-FEB-2008 was vaccinated SQ with 0.65 "mg" of zoster vaccine live (Oka/Merck). Subsequently, on approximately 27-FEB-2008 (th past two weeks) the patient experienced a red, itchy rash over her whole body with no lesions. She also had a headache, nausea and vomiting. Medical attention was sought in the office on 12-MAR-2008, the patient was seen by the nurse practitioner. She was treated with ATARAX for itching. The nurse practitioner did not feel this was related to the vaccine. The rash did not resemble chickenpox or shingles. At the time of the report the patient had not recovered. VZVIP offered but there was no lesion, the rash had no opened areas.   Follow-up information from the nurse practitioner indicated that the patient was evaluated in a local emergency room and was diagnosed with chickenpox. The nurse practitioner stated lab testing was not involved in the diagnosis of this varicella rash. The diagnosis was based upon the patient's symptoms which were described as a rash which was "macular, papular and vesicular" associated with itching.   Follow-up information received has been form a nurse practitioner concerning this 36 year old female registered nurse who on 26-FEB-2008 was vaccinated in the left arm with zoster vaccine live (Oka/Merck) (lot # "10794"). Subsequently, on 12-MAR-2008 the patient developed itching, a rash and headache. The patient also felt nauseated and had general malaise. Medical attention was sought in the emergency room. According to the ER report the patient had macular papular vesicular lesions on her trunk and chest. At the time of the report the patient's status was unknown.  Follow-up information from the nurse practitioner indicated that she was not seeing this patient. She did not know if the patient had recovered.   Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella, Vomiting
Clinical narrative: Information has been received from a healthcare worker concerning a 36 year old female employee who 2 weeks ago on approximately 27-FEB-2008 was vaccinated SQ with 0.65 "mg" of zoster vaccine live (Oka/Merck). Subsequently, on approximately 27-FEB-2008 (th past two weeks) the patient experienced a red, itchy rash over her whole body with no lesions. She also had a headache, nausea and vomiting. Medical attention was sought in the office on 12-MAR-2008, the patient was seen by the nurse practitioner. She was treated with ATARAX for itching. The nurse practitioner did not feel this was related to the vaccine. The rash did not resemble chickenpox or shingles. At the time of the report the patient had not recovered. VZVIP offered but there was no lesion, the rash had no opened areas.   Follow-up information from the nurse practitioner indicated that the patient was evaluated in a local emergency room and was diagnosed with chickenpox. The nurse practitioner stated lab testing was not involved in the diagnosis of this varicella rash. The diagnosis was based upon the patient's symptoms which were described as a rash which was "macular, papular and vesicular" associated with itching.   Follow-up information received has been form a nurse practitioner concerning this 36 year old female registered nurse who on 26-FEB-2008 was vaccinated in the left arm with zoster vaccine live (Oka/Merck) (lot # "10794"). Subsequently, on 12-MAR-2008 the patient developed itching, a rash and headache. The patient also felt nauseated and had general malaise. Medical attention was sought in the emergency room. According to the ER report the patient had macular papular vesicular lesions on her trunk and chest. At the time of the report the patient's status was unknown.  Follow-up information from the nurse practitioner indicated that she was not seeing this patient. She did not know if the patient had recovered.   Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Nuclear magnetic resonance imaging normal, Post herpetic neuralgia, Ultrasound scan normal
Clinical narrative: Information has been received from a medical assistant and a physician who "last year" in 2007 vaccinated himself with zoster vaccine live (Oka/Merck). Subsequently, in 2008 he came down with a case of shingles. The physician stated he was without a rash, but has experienced post herpetic neuralgia. Medical attention was sought with another physician who diagnosed him with a case of herpes zoster. The physician had numerous ultrasounds and a MRI which were negative for anything. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information form the physician indicated that there were no side effects experienced. Additional information is not expected. This is one of several reports from the same source.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 13 year old female consumer who on 10-MAR-2008 was inadvertently vaccinated SQ with 0.65mL of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). Concomitant vaccinations included MENACTRA and GARDASIL (MSD). Subsequently, the nursing error was discovered the next day on 11-MAR-2008. Medical attention was sought in the office. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow up information from the medical assistant indicated she inadvertently picked up the wrong bottle as both the zoster vaccine live (Oka/Merck) and the varicella virus vaccine live (Oka/Merck) (MSD) were in the same location in the freezer. The medical assistant indicated that both are labeled clearly, it was human error. Follow-up information has been received from the medical assistant concerning this 13 year old white female with rhinitis allergy who on 10-MAR-2008 was inadvertently vaccinated SQ with 0.65mL of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). The medical assistant indicated that the patient has not experienced an adverse event thus far. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Paraesthesia, Pruritus, Urticaria
Clinical narrative: Information has been received from a female consumer who on 10-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 10-MAR-2008 the patient developed "a hive" that was 3X4, red, itching, tingling and hurting. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Viral DNA test positive
Clinical narrative: Information has been received from a physician and a pharmacist concerning a 63 year old female consumer with no known drug allergies, diabetes, hypertension, Gastrooesophageal reflux disease and hyperlipidaemia who on 07-MAR-2008 was vaccinated SQ in the left deltoid with 0.65mL (also reported as 0.5mL) of zoster vaccine live (Oka/Merck) (lot # "01429U"). Concomitant therapy included PREVACID, AVAPRO, TOPROL XL TABLETS, ezetimibe (MSD), alendronate sodium (MSD), CRESTOR, ACTONEL, metformin, flaxseed, fish oil and aspirin. Subsequently, on 11-MAR-2008 the patient had shingles symptoms. She had a shingles-like rash with no vesicles. There are 3 patches which were red and raised on her left, mid-lower back near T-11. It was also reported as "the patient developed shingles." Medical attention was sought in the office. There were no lab studies performed. At the time of the report 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 strain. Follow-up information indicated that the patient developed 3 lesions along the T12 dermatome. The patient also developed pain (rated 3 on a scale of 0 to 10). It was also noted that there was no recent exposure to chickenpox or herpes zoster. The sample of the lesion was collected and sent to the laboratory on 13-MAR-2008. The sample was taken from a lesion along the T12 dermatome location. The PCR results for the specimen taken from a lesion along the T12 dermatome location was an ADEQUATE SPECIMEN and identified the presence of WT VZV. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Information has been received from a physician's wife concerning a 64 year old female consumer who on 16-JAN-2008 was vaccinated SQ with 0.65 of zoster vaccine live (Oka/Merck). Three days after she was vaccinated with zoster vaccine live (Oka/Merck), on 19-JAN-2008 the patient developed a water blister on her foot. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient was recovering. There was no product
Age: 1.06
Sex: M
Vaccine: MMR, PNC, VARZOS
Symptoms: Blood immunoglobulin G normal, Feeling abnormal, No adverse event, Pyrexia, Restlessness
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 1 year old male baby who on 11-MAR-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. Follow-up information indicated that the new person pulled out zoster vaccine live (Oka/Merck) by accident and the CMA did not check it close enough to see it was the wrong vaccine. No problems have been reported. This is in follow-up to report(s) previously submitted on 6/24/2006. Follow-up information was received which reported that the 12 month old male patient with no illnesses at time of vaccination who was vaccinated SC into right thigh with a first dose of ZOSTAVAX (Merck) (lot # 659325/1823U) on 11-MAR-2008. Concomitant vaccinations included a first dose of MMR II (lot # 657357/1670U) SC into left thigh on 11-MAR-2008 and a fourth dose of PREVNAR (lot# reported as C57539) IM into left thigh on 11-MAR-2008. On 20-MAR-2008 the patient experienced fever 100 C, fussiness and restless sleep. The patient was seen for appointment on 21-MAR-2008. TYLENOL and ADVIL were prescribed for treatment. It was reported that the patient was 16.93 lbs weight and 29 inches height, and has 3 siblings. Laboratory tests included varicella-zoster titer which indicated that the injection was immune. At the time of reporting, patient's outcome was unknown. Follow-up information was received which reported that on 19-MAR-2008 the patient developed a fever, 100 C that lasted for 2 days. On 21-MAR-2009 the patient was seen in office and was afebrile in office. On an unspecified date the patient recovered, it was reported that "no symptoms occurred". On 30-MAY-2008, the titer of varicella-zoster virus (VZV) IgG antibody was 1.61. No further information is available.
Age: 1.06
Sex: M
Vaccine: MMR, PNC, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 1 year old male baby who on 11-MAR-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. Follow-up information indicated that the new person pulled out zoster vaccine live (Oka/Merck) by accident and the CMA did not check it close enough to see it was the wrong vaccine. No problems have been reported. This is in follow-up to report(s) previously submitted on 6/24/2006. Follow-up information was received which reported that the 12 month old male patient with no illnesses at time of vaccination who was vaccinated SC into right thigh with a first dose of ZOSTAVAX (Merck) (lot # 659325/1823U) on 11-MAR-2008. Concomitant vaccinations included a first dose of MMR II (lot # 657357/1670U) SC into left thigh on 11-MAR-2008 and a fourth dose of PREVNAR (lot# reported as C57539) IM into left thigh on 11-MAR-2008. On 20-MAR-2008 the patient experienced fever 100 C, fussiness and restless sleep. The patient was seen for appointment on 21-MAR-2008. TYLENOL and ADVIL were prescribed for treatment. It was reported that the patient was 16.93 lbs weight and 29 inches height, and has 3 siblings. Laboratory tests included varicella-zoster titer which indicated that the injection was immune. At the time of reporting, patient's outcome was unknown. Follow-up information was received which reported that on 19-MAR-2008 the patient developed a fever, 100 C that lasted for 2 days. On 21-MAR-2009 the patient was seen in office and was afebrile in office. On an unspecified date the patient recovered, it was reported that "no symptoms occurred". On 30-MAY-2008, the titer of varicella-zoster virus (VZV) IgG antibody was 1.61. No further information is available.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning his 55 year old wife with no known drug allergies and a history of cold sores who on 07-MAR-2008 or 08-MAR-2008 was vaccinated SQ with one dose of 0.65mL of zoster vaccine live (Oka/Merck). Concomitant therapy included hormone replacement therapy (unspecified manufacturer/brand). Subsequently, on 11-MAR-2008 the patient experienced an outbreak of herpes simplex virus (HSV-1). The physician does not think the vaccine is related to her symptoms. Medical attention was sought, the physician was called. There were no lab studies performed. At the time of the report the patient was not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Pruritus
Clinical narrative: Information has been received from a physician concerning a 65 year old male consumer with CELEBREX allergy who 6 weeks ago on approximately 29-JAN-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included lovastatin (manufacturer unknown). The physician reported 3-4 weeks post vaccination approximately 26-FEB-2008 the patient developed erythema multiform after receiving zoster vaccine live (Oka/Merck). The physician stated he is sure it is erythema multiform because of the "characteristic target rash." The patient reported mild itching. Medical attention was sought in the office, there were no lab studies performed. The patient was treated with topical creams with no success. The patient was recently switched from LIPITOR to lovastatin (manufacturer unknown) shortly before the rash appeared. He was switched back to LIPITOR 2 weeks ago but the rash has not resolved. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with zoster vaccine live (Oka/Merck). The patient experienced a varicella like rash and pain at the injection site of the arm after he received zoster vaccine live (Oka/Merck). The patient sought medical attention. The outcome was not reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial and follow-up information has been received from a registered pharmacist concerning an 80-year-old female, with no pertinent medical history or allergies, who on 15-MAR-2008 at 09:30 was vaccinated subcutaneous in the left arm with a first 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot # 659404/1826U). There were no illness at the time of vaccination. There was no concomitant medication. On 15-MAR-2008 (previously reported as the 16-MAR-2008), the patient experienced injection site redness, warmth and swelling. No other symptoms were noted. The patient sought unspecified medical attention. No diagnostic labs were performed. The symptoms resolved a "few days later" without treatment or medication. A product quality complaint was not involved. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Incorrect route of drug administration, Injection site movement impairment, Injection site pain, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old male with no drug allergies who on 15-FEB-2008 was vaccinated IM with a dose of zoster vaccine live (Oka/Merck) (lot# 658861/1822U). On that same day after administration, the patient experienced soreness and swelling in his injection arm. The patient sought medical attention through the pharmacist. The pharmacist stated that the patient's pain at the injection site traveled down to his elbow and radiated to his hand. Ever since the vaccination, he was not able to lift his arm and his arm felt numb. On 28-MAR-2008, the patient was seen by the physician who suspected that the vaccine had been given into the muscle. The physician prescribed physical therapy for treatment. No labs or diagnostic studies were performed. The patient was not recovered from the symptoms experienced after vaccination. There was no product quality complaint. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old male with no drug allergies who on 15-FEB-2008 was vaccinated IM with a dose of zoster vaccine live (Oka/Merck) (lot# 658861/1822U). On that same day after administration, the patient experienced soreness and swelling in his injection arm. The patient sought medical attention through the pharmacist. The pharmacist stated that the patient's pain at the injection site traveled down to his elbow and radiated to his hand. Ever since the vaccination, he was not able to lift his arm and his arm felt numb. On 28-MAR-2008, the patient was seen by the physician who suspected that the vaccine had been given into the muscle. The physician prescribed physical therapy for treatment. No labs or diagnostic studies were performed. The patient was not recovered from the symptoms experienced after vaccination. There was no product quality complaint. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 62 year old female consumer with penicillin allergy who on 10-MAR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (lot # not available) that was "injected in the arm." Concomitant therapy included ACTONEL and XALATAN. On that same day"after receiving the vaccination the injection site became red, itchy warm, painful and swollen." The patient sought unspecified medical attention. No labs or diagnostic studies were performed. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Information has been received from a licensed practical nurse concerning a 68 year old female with no pertinent medical history, drug reactions or allergies who on 14-JAN-2008 was vaccinated subcutaneously with 0.65 mL of zoster vaccine live (Oka/Merck) (Lot # 659403/1825U). There was no concomitant medication. On 28-FEB-2008, the patient broke out in shingles. On 17-MAR-2008, the patient contacted the nurse and reported that she had shingles blisters on her face. The patient was seen by a dermatologist and was being treated with an antiviral. The nurse was not interested in VZV ID program. At the time of reporting the patient's present status was unknown. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on an unknown date in December 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 13-MAR-2008, the patient was seen by the nurse practitioner for a very mild case of shingles. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Infection, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a female (age unknown) with a history of mastectomy who in December 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). In December 2007, the patient developed an infection in arm opposite of vaccination. The patient developed redness, swelling and pain in the unvaccinated arm and sought unspecified treatment in the emergency room on the day after the patient received the vaccination. The patient had a history of a mastectomy on the same side as the infected arm. No product quality complaint. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Oral disorder
Clinical narrative: Information has been received from a physician concerning an 80 year old female with a history of herpes simplex who on 11-MAR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On approximately 11-MAR-2008 the patient experienced herpes simplex outbreak and lesions around her mouth. The patient called the office today and said that it occurred within the last 24 hours. The patient's herpes simplex outbreak and lesions around her mouth persisted. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Rash
Clinical narrative: Information has been received from a 73 year old male who on 12-OCT-2007 was vaccinated subcutaneously with 065 mL of zoster vaccine live (Oka/Merck). Concomitant therapy included digoxin and "an Ace inhibitor." It was reported that "within twenty-four hours of the vaccination," approximately 13-OCT-2007, the patient developed a rash from his lower back to his left knee. The patient reported that his doctor diagnosed the rash as shingles. At the time of reporting the rash was gone, but his leg was still "touch sensitive." Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 71 year old male who on 01-FEB-2008 was vaccinated SC with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ARICEPT, LEXAPRO, FLOMAX and digoxin. Seven to ten days after vaccination, on approximately 08-FEB-2008 the patient developed shingles. The patient was advised to and did visit a dermatologist. There were no lab studies performed. Subsequently, the patient recovered after visiting the dermatologist. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Headache, Vertigo
Clinical narrative: Information has been received from an 80 year old male consumer with degenerative neurological problems diagnosed three years ago and gemfibrozil allergy who on 06-MAR-2008 was vaccinated with a single dose of series of zoster vaccine live (Oka/Merck). Concomitant therapy included fish oil, aspirin, vitamins (unspecified), lisinopril, FELODIPIN and NITRO which he stated he does not use. Subsequently, around 10-MAR-2008 the patient started to get dizzy, have a headache and vertigo to the point where when he got up from his chair he could not tell if he was standing upright and fell over. The patient stated he fell the other day. Medical attention was sought, there were no lab studies performed. The patient stated he went to see his family physician. The family physician told him to get a MRI and a "cat scan" to see what is going on with his head. The patient stated he has not gotten the MRI or "cat scan" as of yet. At the time of the report the patient stated the experiences he is having are reoccurring and have not gone away yet. There was no product quality complaint involved. Follow-up information from the physician's office indicated the patient the patient ended up having a subdural hematoma from a fall that happened on an unspecified date before the vaccination. He has had surgery. No further information was provided. Follow-up information from the physician's office indicated that the subdural hematoma did not come from the zoster vaccine live (Oka/Merck) vaccination. It came from a fall prior to receiving the vaccination. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration, Pain, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 57 year old female consumer with a history of shingles who in October 2007, was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 13-MAR-2008 the patient presented with a shingles outbreak. Medical attention was sought, the patient contacted the physician. At the time of the report the patient had not recovered. There was no product quality complaint involved.  This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information has been received from the physician's office concerning this 57 year old female consumer with DARVON, DEMEROL, penicillin, erythromycin and aspirin allergies and a history of shingles and chickenpox (at age 10) who on 01-NOV-2007 (also reported in October 2007) was vaccinated in the left arm with 0.65ml of ZOSTAVAX (Merck) (lot # 657766/0620U). There was no concomitant medication. There was no rash at the site of injection or elsewhere within 42 days of vaccination. Subsequently, on 28-APR-2008 the patient developed pain, rated 7 on a scale of 0 to 10. It was reported that the patient developed pruritis and felt hot (her body temperature was not measured). On 29-APR-2008 (also reported as 13-MAR-2008) the patient developed a painful, pruritic papular rash on her back. The papular lesions developed on the right side of the L3 vertebral area. It was reported that there was no recent exposure to chickenpox or herpes zoster. At the time of report the patient's status was unknown. The patient was currently on VALTREX. 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 strain. The sample of the lesions was collected on 10-APR-2008, and sent to the laboratory on 01-MAY-2008. The sample was taken from a papular lesion. The PCR results for the specimen from the papular lesion was an inadequate swab - capillary tube- negative. Follow-up information indicated that the PCR results from the specimen from the papular lesion was an adequate specimen. No VZV identified-negative. There was B-globin DNA amplified. On 16-JUN-2008, the physician indicated that the patient developed another rash. However, he did not see the patient and couldn't confirm anything. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella zoster serology negative
Clinical narrative: Information has been received from a physician concerning a 57 year old female consumer with a history of shingles who in October 2007, was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 13-MAR-2008 the patient presented with a shingles outbreak. Medical attention was sought, the patient contacted the physician. At the time of the report the patient had not recovered. There was no product quality complaint involved.  This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information has been received from the physician's office concerning this 57 year old female consumer with DARVON, DEMEROL, penicillin, erythromycin and aspirin allergies and a history of shingles and chickenpox (at age 10) who on 01-NOV-2007 (also reported in October 2007) was vaccinated in the left arm with 0.65ml of ZOSTAVAX (Merck) (lot # 657766/0620U). There was no concomitant medication. There was no rash at the site of injection or elsewhere within 42 days of vaccination. Subsequently, on 28-APR-2008 the patient developed pain, rated 7 on a scale of 0 to 10. It was reported that the patient developed pruritis and felt hot (her body temperature was not measured). On 29-APR-2008 (also reported as 13-MAR-2008) the patient developed a painful, pruritic papular rash on her back. The papular lesions developed on the right side of the L3 vertebral area. It was reported that there was no recent exposure to chickenpox or herpes zoster. At the time of report the patient's status was unknown. The patient was currently on VALTREX. 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 strain. The sample of the lesions was collected on 10-APR-2008, and sent to the laboratory on 01-MAY-2008. The sample was taken from a papular lesion. The PCR results for the specimen from the papular lesion was an inadequate swab - capillary tube- negative. Follow-up information indicated that the PCR results from the specimen from the papular lesion was an adequate specimen. No VZV identified-negative. There was B-globin DNA amplified. On 16-JUN-2008, the physician indicated that the patient developed another rash. However, he did not see the patient and couldn't confirm anything. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female consumer who approximately a year ago in approximately March 2007 was vaccinated SQ with 0.65 mL of zoster vaccine live (Oka/Merck). Subsequently, within the last month (approximately February 2008) the patient developed shingles. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There were no lab studies performed. There was no product quality complaint involved. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an office manager concerning a 63 year old male consumer who in July 2007, was vaccinated SQ with a single dose vial of zoster vaccine live (Oka/Merck). Subsequently, in August 2007 the patient developed shingles. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Limb discomfort, Pain in extremity
Clinical narrative: Information has been received from a medical student concerning a 60 year old male consumer with a history of hypertension, and no known allergies who on 06-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). The patient had flu-like symptoms at the time of vaccination. Subsequently, on 12-MAR-2008 the patient developed severe anterior pressure in his right leg after the administration of zoster vaccine live (Oka/Merck). The patient experienced difficulty walking and had sharp pain in his right leg. The medical student felt that it may be zoster although no rash developed as of yet. Medical attention was sought via a telephone call. There were no lab studies performed. At the time of the report that patient had not recovered. The medical student was not interested in VZV Analysis by PCR but may be interested in the future if a rash develops. She has already received information through email. There was no product quality complaint involved. No further information is available.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral pain, Oropharyngeal blistering, Stomatitis
Clinical narrative: Information has been received from a 71 year old female consumer with codeine allergy and pain since 01-FEB-2008 when she opened her mouth really wide who on 14-FEB-2008 was vaccinated with a single dose of zoster vaccine live (Oka/Merck). Concomitant therapy included PREMARIN, atenolol and clonidine. On 15-FEB-2008, the patient developed redness, pain and blisters in her mouth and on her tongue. Unspecified attention was sought. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 60 year old female consumer who on 19-MAR-2008 was vaccinated IM with zoster vaccine live (Oka/Merck) (lot # 658861/1822U). No adverse reaction reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information has been received from a health professional concerning this 60 year old with female consumer who on 19-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (lot # 658861/1822U). Subsequently, on 19-MAR-2008 the patient complained of hurting upon administration of the injection which was given IM, and soreness at the injection site for a couple of days. At the time of the report the patient's status was unknown. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Eczema, Rash pruritic
Clinical narrative: Information has been received from a nurse practitioner concerning a male consumer with diabetes and a history of eczema who"recently" (date unspecified) was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient "recently" experienced eczema in several places. The nurse practitioner was not sure this was caused by the vaccine because the patient has a history of eczema. The nurse practitioner also reported she did not administer the vaccine, it was administered at a pharmacy. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information has been received from a nurse practitioner concerning this 71 year old male consumer with diabetes, hypertension, hyperlipidemia and a history of eczema as a child who on 19-DEC-2007 was vaccinated SQ in the left arm with zoster vaccine live (Oka/Merck) (lot # 654604/1406F) at 2:50 pm. Subsequently, 1 week after vaccination on 26-DEC-2007 the patient reported a rash. It was reported that the rash itched, but there was no pain. It was also reported that there were no changes in his skin products: lotions, soaps, etc. The rash was located on the left antecubital and bilateral forearms. The rash was described as dry and slightly scaly patches. The patient was treated with triamcinolone cream 0.1%. The medicine helped, but the rash progressed to his arms, his back, upper leg and bilateral popliteals. The rashes were circular patches with red raised borders. The patient was also given prednisone dose pack. It was reported that the rash resolved probably on 22-MAR-2008. Additional information is not expected.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash papular
Clinical narrative: Information has been received from a 92 year old female consumer who on 06-DEC-2007 was vaccinated with a single dose of zoster vaccine live (Oka/Merck). Subsequently, in early January 2008 the patient developed an area of intense itching and "pimples" on her left upper thigh. Medical attention was sought, the patient was examined in the office. In early February 2008, her primary physician referred her to a dermatologist for consultation. the dermatologist prescribed betamethasone topical cream. The symptoms resolved initially with use of the cream. At the time of the report the patient had not recovered. She was continuing to experience intermittent episodes of intense itching in the affected area. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning his wife who is a nurse who "last year" in 2007 vaccinated herself with zoster vaccine live (Oka/Merck). Subsequently, in 2008 she came down with a case of shingles. The physician stated she had a rash , but no post herpetic neuralgia. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the physician indicated no adverse effects were experienced. Additional information is not expected. This is one of several reports from the same source.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Hyperaesthesia, Inflammation, Injection site rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 70 year old female who on 26-FEB-2008 at 12:32 PM was vaccinated SC in the left thigh with a dose of zoster vaccine live (Oka/Merck) (lot # 658861/1822U). There was no illness at the time of vaccination. In the AM of 28-FEB-2008, the patient had a rash at the injection site that spread to the neck around 05-MAR-2008 or 06-MAR-2008 and became itchy and inflamed. About a week after vaccination the patient experienced tingling, stinging, and burning on the arms, hands, and legs that felt like very dry skin. On 14-MAR-2008, the patient had a little less redness than the previous day but it was still very sensitive. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Rash pruritic, Skin burning sensation
Clinical narrative: Information has been received from a licensed practical nurse concerning a 70 year old female who on 26-FEB-2008 at 12:32 PM was vaccinated SC in the left thigh with a dose of zoster vaccine live (Oka/Merck) (lot # 658861/1822U). There was no illness at the time of vaccination. In the AM of 28-FEB-2008, the patient had a rash at the injection site that spread to the neck around 05-MAR-2008 or 06-MAR-2008 and became itchy and inflamed. About a week after vaccination the patient experienced tingling, stinging, and burning on the arms, hands, and legs that felt like very dry skin. On 14-MAR-2008, the patient had a little less redness than the previous day but it was still very sensitive. At the time of the report, the patient had not recovered. Additional information has been requested.