chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal chest pain, Pain
Clinical narrative: Information has been received from a pharmacist and an 80 year old female with sulfonamide and codeine allergy who on 07-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Merck)(LOT #659326/1824U). Concomitant therapy included hydroxyzine hydrochloride. The pharmacist reported that on 14-JUN-2008, he phoned the patient for a follow up check and the patient said she was fine after the vaccination. On 17-JUN-2008, the patient called the pharmacy stating her rib cage was on fire and she had a burning sensation on both sides of her trunk, no difficulty breathing, no rash, afebrile. The patient reported that she had a horrible burning sensation all over her body, and that she had to cover herself in wash cloths for 9 days. The patient stated she currently had a "brown stain" at the injection site and a "big knot" where the injection was given. On 11-JUN-2008, the patient's physician stated that she was allergic to the vaccine prescribed. The patient took CLARITIN, 2 in 48 hours and TYLENOL 500mg, every other day. The patient reported that as of 12-JUL-2008, there had not been a day, in which she didn't have hot flashes, and a very sore aching arm where the vaccine was injected. On 06-AUG-2008, the patient called to state that "she is still experiencing the same conditions after receiving ZOSTAVAX vaccine (Merck) and that she experienced pain and suffering. At the time of the report the patient had not recovered. The patient sought medical attention visiting her physician two times. Additional information has been requested as the consumer requested to contact her physician.  This is in follow-up to report (s) previously submitted on 9/24/2008; 12/23/2008. On 25-FEB-2009 the patient called and reported that she was still experiencing pain in her arm. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthropod bite
Clinical narrative: Information has been received from a 61 year old male pharmacist with no known allergies, with a history of Atrial ablation, who on MAY-2008 was vaccinated SQ in the left  with a dose of ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included hydrochlorothiazide (manufacturer unknown), LISINOPRIL (manufacturer unknown), ATENOLOL and SIMVATATIN (manufacturer unknown). The pharmacist mentioned there are marks on both his legs that appear to be bug bites that are very itchy, red, raised and 1 cm round. The pharmacist was at a baseball game this past weekend on approximately 14-JUN-2008 and noticed these bug bites just after the game that evening. He believes these are just bug bites. At the time of the report the bug bites persisted. There was no product quality complaint. The patient did not seek medical attention. The patient's grandson also had an adverse experience after VARIVAX vaccine (Oka/Merck). (WAES0806USA07716) On23-JUN-2008 information was received from the pharmacist. He discussed his experience after vaccination with ZOSTAVAX vaccine (Oka/Merck) and he was quite sure he had bug bites on his legs. No rash was note on his trunk. No further information is available.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning her father who is around 70 years old and on 15-JUN-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included (FLOMAX). The physician reported that her father received zoster vaccine live and on 17-JUN-2008, developed a red and swollen area at the injection site that was the size of his palm. The physician told her father to put on unspecified corticosteroid on it. The patient sought medical attention by phone. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning an 82 year old female with hypothyroidism, hypertension, osteoarthritis and renal insufficiency and a history of hyperlipidaemia and asthma who on 28-OCT-2006 was vaccinated with 0.65 ml ZOSTAVAX vaccine (Oka/Merck) (lot number 652946/1012F) by subcutaneous injection (injection site not reported). Concomitant therapy included LISINOPROL (manufacturer unknown), FELOPIDINE, DICLOFENAC, ALENDRONATE SODIUM D, MSD, and  SYNTHOROID. On 16-JUN-2008 the patient developed a shingles outbreak. At the time of reporting, the patient was experiencing an erythematous rash with vesicios which extends from her abdomen to back on her right side. Unspecified medical attention was sought. The patient's shingles outbreak persisted. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a 77 year old female consumer with no allergies and with medical history of asthma, depression and gastrointestinal problems who on 17-JUN-2008 was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (Oka/Merck) (Lot # 658395/0966U) in the left thigh. Concomitant therapy included NEXIUM, albuterol, ibuprofen, PROZAC, trazodone HCl, carbidopa/levodopa and MIRAPEX. The patient stated that shortly after received ZOSTAVAX (Oka/Merck) (Lot # 0966U), she developed redness, heat, bump and rash 3 inches in diameter at injection site on her left thigh. The patient had not reported this to physician, thus far. At the time of the report, the patient had not recovered from the AEs. There was no product quality complaint. Follow-up information was received concerning a 77 year old male with 122 pounds of weight and 5' tall, who on 17-JUN-2008 at 9:00 am was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 658395/0966U) in the left leg. On 19-JUN-2008 at 10:00 am, the patient experienced local erythema without sequelae. At the time of reporting the patient recovered. No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Stomach discomfort
Clinical narrative: Information has been received from a consumer, who was allergic to dairy, with no previous medical history reported, who on 16-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Merck) 0.65mL. Concomitant therapy included montelukast sodium (MSD). On 17-JUN-2008, the patient experienced dizziness and an upset stomach. No lot number was provided, at the time of the report, the patient had not recovered. The patient did not seek medical attention. There was no product quality complaint. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist, concerning a patient, with no previous medical history reported who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot # 659406/0298X) subcutaneously on 16-Jun-2008. On 16-JUN-2008, in the evening her arm became red and swollen to the "size of a softball" at the injection site. The pharmacist suggested that the patient see her physician. Sought medical attention: spoke with pharmacist. At the time at the report, the patient had not recovered. There was no product quality complaint. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from  physician concerning a female in her mid 60's who on approximately 09-JUN-2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck). The physician reported that 3 or 4 days after the vaccination was given, the patient experienced an injection site reaction that required her going to urgent care. The patient had swelling and pain at the injection site. At the time of the report, the patient had recovered. The patient sought medical attention visiting the physician. No further  information is available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old female with no known allergies who on 18-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot no. 659406/0298X) via subcutaneous route. Site of injection was not reported. There was no concomitant medication. On 19-JUN-2008 the patient developed swelling and tingling of her upper lip. The patient took OTC BENADRYL for her symptoms. At the time of report, the patient was recovering from the symptoms. The patient sought unspecified medial attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a female consumer who on an unspecified date was vaccinated with ZOSTAVAX (Oka/Merck) (lot no., route and site of administration were not reported). On an unknown date the patient developed redness at the injection site. It was unknown if the patient sought medial attention or not. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a female in her late 70's who in December 2006, was vaccinated with ZOSTAVAX (Oka/Merck) (lot no., route and site of administration were not reported). On 16-JUN-2008 the patient had Shingles; back of neck, rash, no pain. It was reported in follow-up that on 18-JUN-2008 the patient developed rash. The patient did not experience pain or tingling prior to the onset of her rash. On 19-JUN-2008 the physician saw the patient and diagnosed her with Shingles in the C3 dermatome on the right. The patient was not having any pain and was treated with VALTREX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 27-MAY-2008 was vaccinated subcutaneously with a 0.5 ml dose of ZOSTAVAX vaccine (Oka/Merck) (MSD) due to medical error. The patient was not experiencing any known symptoms. The nurse stated that the error was her fault. It had nothing to do with packaging  or anything else. The nurse was disturbed several times while dispensing the medication and she didn't even realize that she grabbed the wrong one until later that evening when she doing the chart. She has since separated the two products in their freezer. In the hopes of preventing others in the office from doing it again. She also stated that the patient was in the office of 30-MAY-2008 and the patient looked and acted fine The patient's siblings also had an adverse experience with ZOSTAVAX vaccine (Oka/Merck) (WAES0805USA05808 & WAES0806USA07719). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 27-MAY-2008 was vaccinated subcutaneously with a 0.5 ml dose of ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) due to a medical error. The patient was not experiencing any known symptoms. The nurse stated that the error was her fault. It had nothing to do with packing or anything else. The nurse was disturbed several times while dispensing the medication and she didn't even realize that she grabbed the wrong one until later that evening when she was doing the charts. She has since separated the two products in their freezer, in the hopes of preventing others in the office from doing it again. She also stated that the patient was in the office on 30-MAY-2008 and the patient looked and acted fine. The patient's siblings also had an adverse experience with ZOSTAVAX (Oka/Merck) (WAES# 0805USA05808 & 0806USA07718). Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 77 year old female with impaired fasting glucose and cholesterol high and a history of chickenpox as a child who on 15-JAN-2008 was vaccinated in the right upper arm with a 0. 65 ml (also reported 0.5 ml) dose of ZOSTAVAX (Oka/Merck) (Lot# 658867/1413U). Concomitant therapy included ACTONEL, CRESTOR, aspirin, calcium (unspecified) and vitamins (unspecified). On 12-JUN-2008 the patient experienced Shingles. The rash was vesicular with 30 lesions under her right breast to axilla. The pain was quantified as 4 as a scale from 0 (least) to 10 (most). The patient's temperature was normal. The patient did not has exposure to chickenpox or herpes zoster recently. The patient was recovering from  Shingles. 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 vaccine VZV strain. The sample of the lesions was collected on 23-JUN-2008. The sample was taken from a vesicular lesion. The specimen was inadequate, negative for B-Globin and no strain was identified. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old patient who on 20-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number, injection site and route not reported) instead of a second dose of VARIVAX (Oka/Merck). No adverse effect reported. This was due to a nursing staff error. The two vaccines were next to each other and the wrong medicine was obtained and administered by accident. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female with diabetes and seasonal allergy who on 20-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) 0.65 ml by subcutaneous injection (lot number and injection site not reported). Concomitant therapy included insulin, unnamed thyroid medication and unnamed estrogens. On hour after the vaccination the patient called the reporter stating that her blood sugar was 400. This was tested on her home glucose monitor. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old female with no relevant medical history or allergies who on 18-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number, injection site and route not reported). There was no concomitant medication. On 20-JUN-2008 the patient experienced injection site reaction. The nurse stated that the patient had "erythema, swelling and felt warmth at the injection site." The patient was treated with compresses. The patient's events persisted. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Constipation
Clinical narrative: Initial and follow-up information has been received from a 71 year old female consumer and a nurse practitioner concerning the consumer herself with no known allergies and a history of breast cancer who on 11-JUN-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Oka/Merck) (lot no. 659409/0409X) into the left upper arm. Concomitant therapy included LEVOXYL, Delaval XY, aspirin, metformin, simvastatin (manufacturer unknown) and Lisinopril (manufacturer unknown). The patient experienced severe constipation five days after vaccination. At the time of report, the patient's constipation persisted. The patient did not seek medical attention. In follow up the nurse practitioner reported that the office was never notified of any adverse reaction to "this immunization". Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician and a consumer concerning herself, a 75 year old white female with diabetes, hypertension, asthma, penicillin allergy, sulfa allergy, arteriosclerotic heart disease, hyperthyroidism and colitis ulcerative who on 29-MAY-2008 was vaccinated subcutaneously in her left deltoid with the first dose of zoster vaccine live (Oka/Merck) (LOT# 659409/0409X). Concomitant therapy included GLIPIZIDE, insulin. Additional information has been requested. This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Contusion, Erythema, Eyelid oedema, Oral herpes
Clinical narrative: Information has been received from a female licensed practical nurse concerning another female nurse with an unspecified autoimmune disorder who on an unspecified date splashed zoster vaccine live (Oka/Merck) on her lip by accident and developed a cold sore on her lip the next day. At the time of the event the patient's status was unknown. (LANTUS), (AVALIDE), (DIPENTUM), (CRESTOR), (ZYRTEC) and (SYNTHROID). On 07-JUN-2008 (previously reported as 08-JUN-2008) the patient reported that she broke out in a rash. The physician said that it was not chickenpox or the shingles. It was a varicella like rash. The vesicular rash was over the patient's face and neck. Her arm was red and bruised. The patient's eyelids were swollen on her left eye. Subsequently, the patient recovered from the symptoms. The doctor visit was required. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a female licensed practical nurse concerning another female nurse with an unspecified autoimmune disorder who on an unspecified date splashed zoster vaccine live (Oka/Merck) on her lip by accident and developed a cold sore on her lip the next day. At the time of the event the patient's status was unknown. (LANTUS), (AVALIDE), (DIPENTUM), (CRESTOR), (ZYRTEC) and (SYNTHROID). On 07-JUN-2008 (previously reported as 08-JUN-2008) the patient reported that she broke out in a rash. The physician said that it was not chickenpox or the shingles. It was a varicella like rash. The vesicular rash was over the patient's face and neck. Her arm was red and bruised. The patient's eyelids were swollen on her left eye. Subsequently, the patient recovered from the symptoms. The doctor visit was required. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a nurse/medical assistant concerning a 68 year old female with diabetes and vaginal yeast infection and no allergies who on 28-MAY-2008 was vaccinated with a dose of 0.5 ml zoster vaccine live (Oka/Merck) (lot number 659615/0162X) subcutaneously in the left deltoid. Concomitant therapy included (MSD), (GLUCOPHAGE XR), (BUSPAR) and (LAMISIL). On 28-MAY-2008 the patient developed rash under the neck and on both sides the breast. The rash is symmetric and looks like a V shape. The patient used cool compress and was treated with LIDOCAINE cream and (ATARAX). On 18-JUN-2008, the patient recovered from rash. Additional information is not expected. The physician had nothing further to add since the patient recovered from localized rash on chest.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning a 64 year old female with environmental allergy, asthma, hypertension, diverticulosis and goiter who on 30-MAY-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (lot number 659409/0409X) subcutaneously (injection site not reported). Concomitant therapy included LISINOPRIL (manufacture unknown), (ALLERGA), (PULMICORT), (XOPENEX), (EVISTA) and (VAGIFEM). On 14-JUN-2008 the patient developed 3 lesions (1 vesicular). The lesions were itchy and located on the right shoulder, the ventral side of the left forearm and the lateral side of the left upper arm. Unspecified medical attention was sought. At the time of reporting, the patient was recovering from the lesions. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Computerised tomogram, Inappropriate schedule of drug administration, Lymphadenitis, Pain
Clinical narrative: Information has been received from a 57 year old female with high blood pressure and sulfa allergy who in May 2008, was vaccinated with zoster vaccine live 0.65 mg (Oka/Merck) in her right arm (lot number and injection route not reported). Concomitant therapy included (VIVELLE-DOT), LISINOPRIL-HCTZ (manufacture unknown), (ZYRTEC), (NEXIUM), (AMBIEN) and MOBIC. In May 2008, a week or two after the vaccination the patient experienced right ear burning. She was seen by the doctor and was treated with an unnamed antibiotic for 10 days. On 28-MAY-2008, she saw doctor for some symptoms and was diagnosed an inflamed lymph node and possible shingles. She was treated with famciclovir for 10 days. On 20-JUN-2008 pain returned off and on and continued until the day reporting. The patient was taking (PERCOCET) for pain. Follow-up information was received from a physician stated that he was not sure if the patient has shingles or not. The patient still has burning in the area where this occurred. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated subcutaneously with a 0.65 dose of ZOSTAVAX vaccine (Oka/Merck) (lot no. and site of injection were not reported). The reporter reported that she heard the patient of their clinic, developed a mild rash, shortly after being vaccinated with ZOSTAVAX vaccine (Oka/Merck). The patient did not seek medical attention. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration, Injection site pain, Pain, Rash
Clinical narrative: Information has been received from a medical assistant concerning a 68 year old female with iodine and rofecoxib (MSD, WAES#0807USA02273) allergy, Barrett's esophagus and GERD who on 18-JUN-2008 was vaccinated with zoster vaccine live (Oka/Merck) (LOT #659409/0409X) 0.65 ml, intramuscularly in the right arm. Concomitant therapy included (CELEBREX) and (FLOMAX). The medical assistant reported that on 19-JUN-2008, the patient developed pain at the injection site. On 21-JUN-2008, the patient experienced pain. She had multiple vesicular lesions on her left T6-T9 dermatomes. Her temperature was 97.5. It was unknown if the patient had a recent exposure to chickenpox and there was no recent exposure to shingles. On 23-JUN-2008, the patient was diagnosed with shingles. The patient's symptoms were pain and an unspecified rash on the left chest under the left breast. The patient was prescribed (VALTREX) and (LORTAB) for symptom relief. No other symptoms or treatment reported. At the time of reporting the patient was recovering. As of 30-JUN-2008, the patient still had shingles on the abdomen. The patient sought medical attention. Additional information is not expected. This is in follow-up to report(s) previously submitted on 9/24/2008. 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) ZVZ strain or with the OKA/Merck vaccine VZV strain. Follow up information was received from the VZV identification program which reported that the sample of the lesion was collected on 25-JUN-2008. The sample was taken from a vaccine. The VZV DNA was amplified, the VZV strain identification was wild type. The interpretation of the result was adequate specimen, wile type strain. This is an amended report. Information regarding results of the VZV identification program were added to the laboratory field and narrative. No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a medical assistant concerning a 68 year old female with iodine and rofecoxib (MSD, WAES#0807USA02273) allergy, Barrett's esophagus and GERD who on 18-JUN-2008 was vaccinated with zoster vaccine live (Oka/Merck) (LOT #659409/0409X) 0.65 ml, intramuscularly in the right arm. Concomitant therapy included (CELEBREX) and (FLOMAX). The medical assistant reported that on 19-JUN-2008, the patient developed pain at the injection site. On 21-JUN-2008, the patient experienced pain. She had multiple vesicular lesions on her left T6-T9 dermatomes. Her temperature was 97.5. It was unknown if the patient had a recent exposure to chickenpox and there was no recent exposure to shingles. On 23-JUN-2008, the patient was diagnosed with shingles. The patient's symptoms were pain and an unspecified rash on the left chest under the left breast. The patient was prescribed (VALTREX) and (LORTAB) for symptom relief. No other symptoms or treatment reported. At the time of reporting the patient was recovering. As of 30-JUN-2008, the patient still had shingles on the abdomen. The patient sought medical attention. Additional information is not expected. This is in follow-up to report(s) previously submitted on 9/24/2008. 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) ZVZ strain or with the OKA/Merck vaccine VZV strain. Follow up information was received from the VZV identification program which reported that the sample of the lesion was collected on 25-JUN-2008. The sample was taken from a vaccine. The VZV DNA was amplified, the VZV strain identification was wild type. The interpretation of the result was adequate specimen, wile type strain. This is an amended report. Information regarding results of the VZV identification program were added to the laboratory field and narrative. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a female who on 16-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot no., route and site of injection were not reported). On an unspecified date following the vaccination the patient developed redness at injection site. The patient sought unspecified medical attention.  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 unspecified date was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot no., route and site of administration were not reported). On an unspecified date the patient experienced what was assumed to be shingles rash. It was unknown if the patient sought medical attention or not. The patient's outcome was unknown at the time of reporting. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a 66 year old female consumer with no known allergies who on 05-JUN-2008 was vaccinated with one 0.65 ml dose of zoster vaccine live (Oka/Merck) (lot no. not reported) via subcutaneous route. Site of injection was not reported. Concomitant therapy included alendronate sodium (MSD). On 07-JUN-2008 the patient developed flu like symptoms, itchy red spots on her back. As of 25-JUN-2008, the patient's flu like symptoms and itchy red spots on her back persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Nodule, Varicella zoster serology negative
Clinical narrative: Initial and follow-up information has been received from a pharmacy student and a pharmacist concerning a 72 year old male with hypertension and leukemia and a history of chickenpox who on 10-JUN-2008 was vaccinated subcutaneously into left deltoid with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (lot no. 659408/0300X). Concomitant therapy included MAVIK, MSD, omega - marine triglycerides and vitamins (unspecified). Rash did not occur at the site of injection post-vaccination. On 16-JUN-2008 the patient experienced fluid filled nodule, similar to a boil, on his leg after receiving ZOSTAVAX vaccine (Oka/Merck). The nodule was drained by the patient's physician and the patient was placed on antibiotic therapy. The patient experienced two additional nodules in the same area after the initial nodule was drained. At the time of this report, the patient's symptoms persisted. On26-JAN-2008 a specimen on the patient was sent to the laboratory. Final Varicella zoster virus identification polymerase chain reaction test result was negative. Follow-up information from a nurse stating the physician had seen the patient and cultured a blister sent to the laboratory and did not have any additional information to provide. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Initial information has been received from a 65 year old female with allergies to grass and mold and no known drug allergies. Follow-up information was received from a registered nurse. On 13-JUN-2008 the patient was vaccinated  subcutaneously with a 0.65 ml dose of zoster vaccine live (Oka/Merck) (lot no. 659406/0298X). Concomitant therapy included (LOTREL) and (ZYRTEC). On 19-JUN-2008 (also reported as 16-JUN-2008) the patient experienced back pain, rash, burning sensation in the left posterior thorax and then shingles. On 21-JUN-2008 the patient went to the emergency room and her condition was diagnosed as shingles. The patient was started on (VALTREX) and (VICODIN). As of 25-JUN-2008, the patient was recovering from these events. On 27-JUN-2008 the patient was re-evaluated and diagnosed as post-herpetic neuralgia. The patient was treated with lidocaine (LIDODERM) patches and (LYRICA). Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received fro a physician concerning a 75 year old female who on 21-AUG-2007 was vaccinated with a dose of 0.65 ml ZOSTAVAX vaccine (Oka/Merck). On 03-JUN-2008 the patient experienced shingles rash. The patient was seen by the physician. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 72 female who on 04-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) at her pharmacy. On 05-JUN-2008 the patient went to see physician and was found there were 2 zoster-like blisters at the injection site with erythema, but the physician was not interested in VZV analysis by Polymerases Chain Reaction. At the time of report, the patient's 2 zoster-like blisters at the injection with erythema persisted. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX vaccine (Merck). Subsequently the patient experienced shingles. At the time of the report, no outcome was reported. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Follow up information was received from the physician who reported that the 62 year old female patient on 15-JUN-2007 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). On 16-APR-2008 the patient developed a shingles on "one side of the trunk". On 30-SEP-2008 the patient developed her second case of shingles on "the other side of the trunk". The patient contacted the physician for medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/24/2008; 12/23/2008. Follow-up information received from a physician via a HZ questionnaire concerning a 62-year-old female patient with an allergy to lisinopril and a past medical history of chickenpox at age 3. On 15-JUN-2007 she was vaccinated in the left arm with a dose of ZOSTAVAX vaccine (Merck) (lot# 6576/0618U). Concomitant medication included amlodipine. On 16-APR-2008 the patient developed herpes zoster in the right thoracic dermatome, the patient reported pain of an 8-9. The lesions were reportedly papular and vesicular. It was reported that there was no recent exposure to chickenpox or herpes zoster. Unspecified medical attention was sought, no specimen was submitted. The patient recovered. Then on 30-SEPT-2008, the patient developed lesions in the left lumbosacral dermatome. She reported pain of a 5 out of 10 for this episode. The patient sough medical attention. It was reported that the patient recovered. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Subsequently the patient experienced abdominal pain and recovered.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Rash
Clinical narrative: Information has been received from a physician concerning a 62 year old female who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently the patient experienced rash and bad neuralgia. It is unknown if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site urticaria
Clinical narrative: Information has been received from a physician concerning a female who on 06-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Subsequently the patient experienced a 3 cm triangular wheal with induration at the site of injection. The physician did not have the patient's information available. Medical attention was sought via office visit. No product quality complaint was involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fibromyalgia, Myalgia
Clinical narrative: Information has been received from a 69 year old female with no drug reactions, fibromyalgia, restless legs syndrome, cholesterol high and a history of cardiac pacemaker insertion who at the end of April 2008, was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included DIOVAN, LIPITOR, and DIAZEPAN. The patient reported that she had fibromyalgia where her muscle pain on the scale from one to ten is usually around a three or a four, but after receiving the ZOSTERVAX vaccine (Oka/Merck) her muscle pain intensified to about an eight or a nine in the beginning of May 2008. Since the muscle pain intensified, the patient had been resting more and had been taking a muscle relaxer name and manufacturer of muscle relaxer unspecified by reporter). The patient reported that as of 08-JUN-2008 her pain had subsided a little bit. The patient did not seek medical attention. No product quality complaint was involved. No further information is available.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 84 year old female with hypertension, hyperlipidaemia, hypothyroidism, bundle branch block right and a drug hypersensitivity to (LIPITOR) who on 26-APR-2008 was vaccinated with a 0.65 ml dose of zoster vaccine live (Oka/Merck) (lot # 656861/0329U). Concomitant therapy included (SYNTHROID), calcium (unspecified) and aspirin. On 08-JUN-2008 the patient experienced
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Pruritus
Clinical narrative: Information has been received from a 72 year old female with "blood pressure", Oesophageal acid reflux, arthritis, cholesterol high, sulfonamide allergy and allergic to LYRICA who in February or March 2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included ACIPHEM, piroxicam, Pravastatin Na, AVAPRO, ALLEGRA, AMARYL, AMBIEN, CYMBALTA, ROBAXIN and ZYDONE. three weeks ago, on approximately 19-MAY-2008 the patient experienced shingles on her "rear end". It was only about 3 to 4 itchy blisters. The physician prescribed and antiviral medication and the blisters went away however she was still experiencing itching and burning. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist who stated that a physician's office called her and asked if shingles can be caused by zoster vaccine live (Oka/Merck). She thinks a patient is involved, but was not entirely sure. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning an older male who was vaccinated with ZOSTAVAX (Oka/Merck). The physician reported that the patient experienced rash, no neuralgia. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Red blood cell sedimentation rate increased, Vasculitis
Clinical narrative: Information has been received from a physician concerning a 72 year old male with hypertension and no history of drug reactions or allergies who on 26-FEB-2008 was vaccinated with one dose ZOSTAVAX (Oka/Merck) (lot#: 65210/1079U) SQ. Concomitant therapy included lisinopril (manufacturer unknown), hydroxyzine, vitamin E, warfarin and simvastatin (manufacture unknown). On 23-APR-2008 the patient developed "a head to toe" rash, possible Shingles. The rash began on the back and anterior chest and continued to spread over the body including the scalp. The patient denied pain and fever at this time. On 09-JUN-2008 the patient was going to see the physician. The patient was started on acyclovir and steroids by another physician. Three months later (on approximately July 2008) test results suggested the patient had vasculitis. Subsequently the patient recovered. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pruritus, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 67 year old female, weight 146 lb, with allergies to ANCEF and related antibiotics, and a history of cancer 14 years ago who at 10:30 AM on 05-JUN-2008 was vaccinated with a "regular dose" of ZOSTAVAX (Oka/Merck) (lot#: 659409/0409X) in the left deltoid. Concomitant therapy included VESICARE and unspecified eye drops. At 5 PM on 06-JUN-2008, 30 hours after receiving ZOSTAVAX the patient developed hives on her trunk of body and groin, which were very itchy. The hives went away completely on the morning of 09-JUN-2008. The patient also noted that the injection site was sore and red. Subsequently, the patient recovered. The patient did not seek medical attention. Additional information is not expected.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician who reported that her mother was talking with her friend, a probably 75 year old patient who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently the patient experienced a rash. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source.
Age: 10.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning a 10 year old patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck). This happened within the past 24 hours at a hospital physician unknown. No adverse effects known. The pharmacist was not aware it was product confusion. The grandmother indicated human error. Unspecified medical attention was sought. No product quality complaint was involved. This is one of several reports received from the same source. No further information is available.
Age: 11.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning a 11 year old patient who was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) instead of VARIVAX vaccine (Oka/Merck) (MSD). This happened within the past 24 hours at a hospital physician unknown. No adverse affects known. The pharmacist was not aware it was product confusion. The grandmother indicated human error. Unspecified medical attention was sought. No product quality complaint was involved. This is one of several reports received from the same source. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning her mother (patient), with cholesterol and high blood pressure, and a medical history of breast cancer more than five years ago and bypass surgery. On 03-JUN-2008 (reported as "last Tuesday") the patient received a dose of ZOSTAVAX (Oka/Merck). There were no illnesses at the time of vaccination. Concomitant therapy included unspecified medication for cholesterol and blood pressure. By Thursday, the patient noticed what looked like a bite on her forehead. At on an unspecified time blisters that were itchy appeared on her chin, cheeks, both arms, back, each thigh and one blister in between her breasts. No blisters at the injection site (which arm unspecified). There was no product quality complaint. The patient sought medical attention: patient called her daughter who is a physician. The patient's experiences persisted. Follow-up information has been received from a physician, who reported that the 70 patient on 03-JUN-2008 in the evening was vaccinated with the first dose of ZOSTAVAX (Oka/Merck) (Lot #659410/0412X) SQ right side. On the same date in the evening, the patient experienced hives on back and legs and was treated with OTC BENADRYL. The patient's final outcome was not reported. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Laboratory test, Rash, Skin burning sensation
Clinical narrative: Information has been received from a 67 year old female with outdoor allergies who on approximately 21-MAY-2008 (reported as 5 weeks ago) was vaccinated with a dose of 0.65 ml of zoster vaccine live (Oka/Merck). Concomitant therapy included (BONIVA), (NEXIUM), calcium (unspecified) and fish oil. The patient reported experience she had about a week after receiving zoster vaccine live (Oka/Merck). Patient had to discontinue deodorant because she developed a painful rash under her arm pits. She tried using different types of deodorants however it burns and the rash will not go away. No lot number was provided. At the time of reporting, the patient had not recovered from the AE. Unspecified medical attention was sought. Unspecified "Labs" were performed. No results provided. There was no product quality complaint. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test
Clinical narrative: Information has been received from a health professional concerning a over 60 year old female who was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot number, injection site and route not reported). Subsequently the patient developed shingles "a couple days post vaccination". The patient sought unspecified medical attention. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and nurse manager concerning an 8 year old female who at 11:30 on 26-JUN-2008 was inadvertently received the first dose of ZOSTAVAX vaccine (Oka/Merck) subcutaneously (lot#: 659615/0162X) in the left arm instead of VARIVAX vaccine(Oka/Merck) (MSD). No adverse events reported. This was a case of human error. The patient sought medical attention with a physician office visit. It was noted that one nurse drew up the vaccine and was suppose to give it when the patient started to "act up". A different nurse stepped in to give the vaccine (and therefore did not see the vial to catch the error). Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist (R. Ph.) concerning a 65 year old female who on 23-JUN-2008 was vaccinated with a dose of ZOSTAVAX (lot # 659409/0299X). Concomitant therapy included lisinopril, hydrochlorothiazide, TRICOR and ezetim (MSD). On an unspecified date the patient experienced an erythematous, raised, itchy area at the injection site. The patient contacted the physician. No product quality complaint was involved. Follow-up information was received from a registered pharmacist (R.Ph.) concerning a 65 year old female who on 23-JUN-2008 was vaccinated with the first dose of ZOSTAVAX in the left arm (lot # 659409/0299X) On 24-JUN-2008 at 1130, the patient developed rash on arm around injection site, itching, erythema. Subsequently, the patient recovered. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist and a patient safety manager concerning an 8 year old female who at 10:45 a.m., on 26-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck). The patient had been seen since then by her primary care physician on 27-JUN-2008 and 01-JUL-2008. She was fine with no adverse experiences. She was scheduled for VARIVAX (Oka/Merck) in 6 months. The patient safety manager felt this was a case of human error. Both vaccines are stored in the same freezer, though on separated shelves. They do a large volume of vaccinations and can be quite busy. The patient safety manager's senior management has issued an alert to other military bases to be careful to avoid such incidences. They have since placed "high alert" tags on the vaccine to remind the staff to be careful not to confuse ZOSTAVAX (Oka/Merck) and VARIVAX (Oka/Merck). This is one of several reports from the same source. The patient's sibling was also vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) (WAES 0807USA00781). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site reaction, Injection site streaking
Clinical narrative: Information has been received from a medical assistant concerning a 72 year old female with allergies to PENICILLIN, SERTRALINE, ZOLOFT, LOVASTATIN and SENTANUL and no pertinent medical history who on 23-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (Lot# 659615/0162X). Concomitant therapy included CRESTOR. The patient developed local injection site reaction after receiving ZOSTAVAX vaccine. The injection site was red and swollen. The redness spread into linear streaks above and below the injection point. The patient had terrible pain on her arm and wasn't able  to sleep. The patient eventually developed a 2 by 5 cm oval erythematous patch on the left posterior upper arm around the injection point. The entire area was tender and had an appearance of severe inflammation, but it didn't appear to be cellulitis. The patient was prescribed BETAMETHASONE CREAM, CLARITIN, and BENADRYL. The patient saw the physician. At the time of the report, the patient was recovering. Additional information has been requested.