chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: Initial and follow up information has been received from a physician concerning a 42 year old white female with fibromyalgia, sjogren's syndrome and systemic lupus erythematosus who on approximately 12-DEC-2007 was vaccinated into the right deltoid with a first dose of ZOSTAVAX (Lot "14114").  Concomitant therapy included hydroxychloroquineS04 (PLAQUENIL), alprazolam (XANAX), duloxetine hydrochloride (CYMBALTA), acetaminophen/hydrocodone bitartrate (LORTAB), pramipexole dihydrochloride (MIRAPEX) and "xanaflex".  Subsequently the patient developed a shingles outbreak after being given ZOSTAVAX.  The patient had contacted the physician and sought medical attention.  The physician also noted "questionable neurontin and hydrocodone reactions".  The patient was reported to be recovered on 21 DEC 2007.  It was noted that the patient had not yet returned to the clinic despite repeated requests.  There was no product quality complaint.  No further information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a female with a history of shingles who was vaccinated with a dose of ZOSTAVAX.  On an unspecified date the patient developed shingles.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  No further information is available.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Blister, Culture negative, Dermatitis bullous, Erythema
Clinical narrative: Information has been received from a 79 year old female consumer with no pertinent medical history and no drug reactions/allergies, who on 24-OCT-2007 was vaccinated SC with a 0.65 mL dose of ZOSTAVAX.  Concomitant therapy included "avadone", "rely" and "topral".  On 03-NOV-2007 the patient was seen in the office with bullous rash on the right thigh.  On 07-NOV-2007 the patient had a tooth removed.  On 09-NOV-2007 the patient stated that she developed approximately 12 lesions after receiving the vaccine.  Lab diagnostic studies performed included a biopsy which the patient indicated was inconclusive.  Wound culture was negative.  Applied topical antibiotic and it eventually resolved.  No additional information was available.  Unspecified medical attention was sought, patient was seen in the office.  The outcome was reported as recovered.  There was no product quality complaint.  Follow-up information has been received from a pharmacist indicating that the patient was experiencing a reoccurrence of the symptoms that she experienced on 09-NOV-2007.  On 28-FEB0-2008 the patient began to experience redness and rash in the exact area where she first experienced the symptoms on 09-NOV-2007.  On 29-FEB-2008 the patient noticed a blister on one of the rashes and also noticed that the rash was spreading.  No further information was available.  Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin lesion, Tooth extraction
Clinical narrative: Information has been received from a 79 year old female consumer with no pertinent medical history and no drug reactions/allergies, who on 24-OCT-2007 was vaccinated SC with a 0.65 mL dose of ZOSTAVAX.  Concomitant therapy included "avadone", "rely" and "topral".  On 03-NOV-2007 the patient was seen in the office with bullous rash on the right thigh.  On 07-NOV-2007 the patient had a tooth removed.  On 09-NOV-2007 the patient stated that she developed approximately 12 lesions after receiving the vaccine.  Lab diagnostic studies performed included a biopsy which the patient indicated was inconclusive.  Wound culture was negative.  Applied topical antibiotic and it eventually resolved.  No additional information was available.  Unspecified medical attention was sought, patient was seen in the office.  The outcome was reported as recovered.  There was no product quality complaint.  Follow-up information has been received from a pharmacist indicating that the patient was experiencing a reoccurrence of the symptoms that she experienced on 09-NOV-2007.  On 28-FEB0-2008 the patient began to experience redness and rash in the exact area where she first experienced the symptoms on 09-NOV-2007.  On 29-FEB-2008 the patient noticed a blister on one of the rashes and also noticed that the rash was spreading.  No further information was available.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a dose of ZOSTAVAX.  On approximately 01-DEC-2007 "4-6 weeks after vaccination", the patient developed a mild case of shingles.  Unspecified medical attention was sought.  No additional information was provided.  There was no product quality complaint.  Additional information is expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a 71-year-old female who on 17-DEC-2007 at 10:00 was vaccinated subcutaneous in the left arm with a dose of ZOSTAVAX.  On 18-DEC-2007 the patient had "redness at site" and "presently increasing area is painful".  "Presently redness and pain increasing".  The patient also reported that she had not expected the redness and tender area to develop.  At the time of the report the patient's status was unknown.  Additional information has been requested. 06/24/2008 This is in follow-up to report(s) previously submitted on 3/26/2008. Additional information has been received from the responsible physician. The physician indicated the patient picked up the dose at the pharmacy with prescription and had a coworker (registered nurse) give it; therefore, details of the injection were not known. However, the physician did indicate the patient recovered from the events. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who was on an unspecified date was vaccinated subcutaneously with 0.65 ml of ZOSTAVAX.  The physician reported that "the patient developed a rash after receiving ZOSTAVAX".  Unspecified medical attention was sought.  It was noted that the patient was due to return to the office for follow-up after which any additional information would be reported.  There was no product quality complaint.  There were no lab diagnostic studies performed.  At the time of reporting the patient's status was unknown.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Information has been received from a 71 year old female with no pertinent medical history and allergies to sulfonamide and silver nitrate who on 14-DEC-2007 was vaccinated with ZOSTAVAX.  Concomitant therapy included alendronate sodium (FOSAMAX) and an unspecified "acid inhibitor".  On 16-DEC-2007 the patient developed muscle aches on her legs.  At the time of reporting the patient had not yet recovered.  There were no lab diagnostic studies performed.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 69 year old female with hypertension and increased high density lipoprotein and drug hypersensitivity to lisinopril (ZESTRIL) and valdecoxib (BEXTRA) who on 13-DEC-2007 was vaccinated with ZOSTAVAX 0.65mL SQ (Lot #658396/0967U).  Concomitant therapy included atenolol, hydrochlorothiazide, losartan potassium (MSD) and lovastatin (MSD).  On 14-DEC-2007 the patient developed a warm and itchy rash at the injection site.  The patient sought medical attention and contacted the physician's office.  The medical assistant reported the "rash started out small and progressed to the size of a golf ball."  The patient's warm and itchy rash at the injection site persisted.  Additional information received from the physician confirmed that the patient developed redness and itching to the right triceps area after receiving ZOSTAVAX on 13-DEC-2007.  The physician advised the patient to treat the symptoms with diphenhydramine (BENADRYL) PRN.  The symptoms persisted for two weeks.  Subsequently, the patient recovered from the redness and itching to right triceps area.  Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a pharmacist and a 58 year old female with penicillin allergy and "recurrent shingles for thirty seven years" who on 18-JUN-2007 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy unspecified by patient who stated "I take lots of medication". The patient reported that within a month after receiving the vaccine (approx) 18-JUL-2007 she developed shingles. Unspecified medical attention was sought. The patient reported that just a week ago (12-DEC-2007) she developed shingles. A product quality complaint was not reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pain
Clinical narrative: Information has been received from a health professional concerning a 67 year old male with no known allergies or medical history who on 30-NOV-2007, was vaccinated with a 0.65 ml subcutaneous dose of Zostavax (Oka/Merck) (lot# /658867/1413U). There was no concomitant medication. On 14-DEC-2007, the patient was seen by a physician. It was reported that the patient developed a mild case of shingles beginning on 11-DEC-2007, and presented with five lesions with pain and discomfort on his right rib cage. The patient was prescribed VALTREX, one gram every 8 hours for 7 days. On 20-DEC-2007, the patient via phone reported to the nurse that he had been taking 2 ibuprofens (strength unspecified) with meals for pain. As of this report, the patient was reported to have been recovering. A product quality complaint was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with Zostavax (Oka/Merck). Subsequently the patient developed chicken pox. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a physician concerning a 64 year old male with no pertinent medical history, drug reactions or allergies who on 05-FEB-2008 was vaccinated with 0.65 ml of ZOSTAVAX.  There was no concomitant medication.  Ten days post vaccination, on approximately 15-FEB-2008, the patient developed shingles.  At the time of reporting the patient had not yet recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  No further information was provided.  The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR 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.  Additional information is not expected. This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a physician concerning a 64 year old male with no pertinent medical history, drug reactions or allergies who on 05-FEB-2008 was vaccinated with0.65 ml of ZOSTAVAX (Merck). There was no concomitant medication. Two days post vaccination, on approximately 15-FEB-2008, the patient developed shingles. At the time of reporting the patient had not yet recovered. Unspecified medical attention was sought. There was no product quality complaint. No further information was provided. The patient was enroled in teh VZVIP program, the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to indetify if VZV is present and if it is present and if it is present to identify if it is associated with the wild-type VZV strain or with the the Merck vaccine VZV strain. Follow up information was received from the consumer who reported that he still had shingles and that neither LYRICA nor VALTREX helped get rid of his shingles pain. The consumer also reported that his wife was vaccinated on 05-FEB-2008 with ZOSTAVAX (Merck), and has had itchiness and a burning sensation at the injections site ever since she was vaccinated (WAES # 0804USA01392). Additional information has been requested. Product quality complaint, No further information was provided. The patient was enrolled in the VZVIP program the VARICELLA ZOSTER Virs Identification program enables biological samples to be analyzed by PCR the identify if VZV is present and if it is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Merck vaccine VZV strain. Additional informationis not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Information has been received from a physician concerning a 70 year old female with hypersensitivity to "scolaxin" who on 06-NOV-2007 was vaccinated subcutaneously with 0.65 ml of ZOSTAVAX.  There was no concomitant medication.  On approximately 16-NOV-2007, "ten days to one week after receiving the vaccine" (ZOSTAVAX), the patient developed several lesions on her extremities.  At the time of reporting the patient had not yet recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  There were no lab diagnostic studies performed.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a male who, on an unspecified date, was vaccinated with 0.65 ml of ZOSTAVAX.  It was reported that the patient developed shingles (date unspecified) after receiving ZOSTAVAX.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a physician concerning a 70 year old male with no pertinent medical history, drug reactions, or allergies who in 2007 was vaccinated with a first dose, into the right deltoid, with a 0.65 ml of ZOSTAVAX (Merck) (lot # 652966/0722F). There was no illness at the time of vaccination. It was reported that in February 2008 the patient developed Herpes Zoster (date unspecified). Unspecified medical attention was sought. At the time of reporting the patient was recovered (date unspecified). There was no product quality complaint. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 74 year old female with hypertension and hypercholesterolaemia who on 08-FEB-2008 was vaccinated with a dose of ZOSTAVAX (Merck).  Concomitant therapy included losartan potassium-HCTZ (MSD).  In February 2008, the patient experienced rash on her leg and thigh.  The patient has not yet been in to see the physician.  The patient called the physician.  Outcome of the rash was unknown.  No product quality complaint.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Lichen planus, Pruritus
Clinical narrative: Information has been received from a physician concerning a 69 year old female with no known allergies or pertinent medical history who "in the first week of October 2007" on approximately 01-OCT-2007 was vaccinated SQ with Zostavax (Oka/Merck). There was no concomitant medication. On 17-NOV-2007 the patient developed blisters on the injection arm that quickly spread to her entire upper body. The patient did not have pain, but reported itching. The patient was diagnosed by a dermatologist on 04-Jan-2008 with lichen planus. There was no product quality complaint involved. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an "over 80-year-old female who "a few months ago," approximately January 2008, was vaccinated with a first dose of of Zostavax (Oka/Merck). No lot number was provided. On 19-FEB-2008 the patient "developed shingles". A "shingles-type rash was located on her forehead, above her eye, and also near her hairline on one side." Unspecified medical attention was sought. The outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Viral DNA test positive, Virus culture
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 74-year-old male with a history of childhood chickenpox who on 12-DEC-2007 was vaccinated subsequently with a 0.65 ml dose of Zostavax (Oka/Merck). There was no concomitant medication. On 09-FEB-2008 the patient developed herpes zoster lesions on left side of face. The patient was seen at a physician's office and a viral culture of the lesions was performed and was positive for varicella zoster virus. This event was reported to be non-serious. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information was received from a physician on 21-FEB-2008. The 74-year-old male patient was vaccinated on 18-DEC-2007 [previously reported as 12-DEC-2007]. It was reported that no rash occurred at the site of the injection site or elsewhere within 42 days of the vaccination 18-FEB-2008 (previously reported as 09-FEB-2008). A herpes zoster vesicular eruption with distribution of the first division of the trigeminal, approximately 60 days following Zostavax (Oka/Merck) vaccination. The eruption was described as a VI dermatome classic eruption on the trunk and the patient's pain on a scale of 0-10 was rated as a 1. A giant cell culture was pending at the time of this report, no direct flourescent antibody was done and no specimen was collected for PCR. It was reported that the patient recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning a friend who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient developed a case of shingles. It was unspecified if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Rash
Clinical narrative: Information has been received from a 61 year old female consumer with a drug reaction to Compazine who on 02-JUL-2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck) (lot # 657676/0619U). Concomitant therapy included PLAVIX, losartan potassium (MSD) and "Lavistatin". On 03-JUL-2007 the patient experienced cold sore and rash on her body. Unspecified medical 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. No further information was provided. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with Zostavax (Oka/Merck). It was reported that the patient developed shingles after receiving Zostavax (Oka/Merck). It is unknown if medical attention was sought. There was no product quality complaint. This is one of several reports received from the same source. The nurse mentioned that some of the cases were reported to VAERS. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Cellulitis, Injection site reaction, Injection site vesicles
Clinical narrative: Information has been received from a healthcare worker concerning a 79 year old female with no drug reaction/allergies, who on 15-FEB-2008 was vaccinated SC with a 0.65 mL dose of Zostavax (Oka/Merck) (lot number: 659324/1835U). On 15-FEB-2008 the patient had an injection site reaction after receiving the vaccine. The patient developed blisters the size of "the palm of the hand" at the injection site. The patient was given a diagnosis of cellulitis. The patient also had an elevated temperature of 103 degrees F and was treated with unspecified antibiotics and corticosteroids. No other information was available at the time. There were no lab diagnostic studies performed. Unspecified medical attention was sought. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested. Follow up information has been received indicating there was no additional information at this time. This is a consolidated report of two reports (WAES# 04913) for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a pharmacist concerning a female who on 12-FEB-2008 was vaccinated with Zostavax (Oka/Merck). On an unspecified date, the patient developed an erythematous rash on her face and neck. The reporter indicated that there were no pustules and that the rash did not resemble shingles or chicken pox. The patient was seen in the physician's office, treatment was not reported. At the time of this report, it was indicated that the patient had not recovered. A product quality complaint was not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Inappropriate schedule of drug administration, Injection site reaction, Injection site vesicles
Clinical narrative: Information has been received from a health professional concerning a 59 year old female who on 18-FEB-2008 was vaccinated with a 0.65 ml. subcutaneous dose of Zostavax (Oka/Merck) (lot# 659324/1835U). After receiving the vaccine (approximately 18-FEB-2008), the patient experienced injection site reaction, and blisters the size of a palm of a hand on the arm. The patient was seen in the office by the physician and was given a diagnosis of cellulitis. No laboratory or diagnostic studies were performed. Treatment was not reported. At the time of this report, it was indicated that the patient was recovering. A product quality complaint was not reported. A lot check was requested. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a female with unspecified drug allergies and pertinent medical history who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient experienced warmth at the injection site and felt "under the weather". The patient called the physician but it was unspecified if medical attention was sought. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old female with thyroid disorder, no drug reaction or allergies who on 11-FEB-2008 was vaccinated subcutaneously into the right arm with Zostavax (Oka/Merck) 658862/1415U. Concomitant therapy included levothyroxine Na and vitamins (unspecified). On 12-FEB-2008 the patient developed injection site swelling and redness. The patient presented to the pharmacy on 13 FEB 2008 with a red swollen broad rash that was warm to touch at the injection site. The pharmacist did not identify the rash as either chicken pox or zoster. At the time of reporting the patient had not yet recovered. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 17 year old patient who on 13-FEB-2008 was vaccinated with Zostavax (Oka/Merck) instead of Gardasil.  It was reported that this was due to human error and did not involve product confusion.  At the time of reporting the patient was not experiencing any known symptoms.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/26/2008.  Information has been received from a physician concerning a 17 year old patient with no pertinent medical history, or pre-existing allergies who on 13-FEB-2008 at 15:00, was vaccinated into the right arm with a first dose of ZOSTAVAX (Lot # 658863/1414U) instead of GARDASIL.  It was reported that this was due to human error and did not involve product confusion.  The patient had no illness at the time of vaccination.  On 28 FEB 2008, at 16:30, the patient received a second dose of GARDASIL (Lot # 659180/1758U), into left deltoid.  At the time of reporting the patient was not experiencing any known symptoms.  Results of diagnostic lab studies performed on an unspecified date, included the following varicella titer 1:160 and HCP negative.  There was no product quality complaint.  Further information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who on 12-DEC-2007 was vaccinated with a first dose of Zostavax (Oka/Merck) (Lot # 658398/1087U).  Five weeks post vaccination, in approximately February 2007, the patient developed skin eruptions, with clusters along 6-7 rib line.  At the time of reporting the patient was still being treated.  No further information provided.  Additional information has been requested. 02/17/2010 Information has been received from a physician concerning a 74 year  old female with osteoporosis and hypertension at the time of vaccination and no known drug allergies who on 12-DEC-2007 was vaccinated into the left deltoid with a first dose of ZOSTAVAX (Lot # 658398/1087U). Five weeks post vaccination in approximately February 2007, the patient developed skin eruptions, with clusters along 6-7 rib line. At the time of reporting the patient was still being treated, and the final outcome was unknown. There was no lab diagnostic studies performed. No further information was provided. Additional information has been been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Rash pruritic
Clinical narrative: Information has been received from a health professional concerning a 66 year old female with allergic reaction to "a lot of antibiotics" who on 06-FEB-2008 was vaccinated subcutaneously into the left arm with a first dose of Zostavax (Oka/Merck) (Lot # 659403/1825U).  Concomitant therapy included LIPITOR.  On 09-FEB-2008 the patient developed a rash around injection site, inside the left arm, upper chest, and at the bend of the elbow.  There was no illness at the time of vaccination.  It was reported that the rash "itched a little" and that the patient took BENADRYL.  It was also reported that the patient had a quarter size knot at the injection site.  On 11 FEB 2008 the patient's rash was going and it was "just red at the site".  The patient was reportedly recovered on 11 FEB 2008.  Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Laboratory test, Pain, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 61 year old male with an unspecified cardiac disorder and diabetes who on 09-JAN-2008 was vaccinated with a "single dose" of Zostavax (Oka/Merck) (Lot # "1131U"), site of administration unspecified.  It was reported that on 15 JAN 2008 the patient developed herpes zoster, with dermatome C2-3 involvement.  Vesicular lesions were present on the patient's head and neck.  It was also reported that on 15 JAN 2008 the patient developed a shingles like rash on the forehead.  On a pain scale of one to ten, the patient's pain was assessed at three.  The patient "was given some topical cream and acyclovir".  Unspecified medical attention was sought.  There was no product quality complaint.  A direct fluorescent antibody was not collected.  It was reported that the specimen for the VZV identification program was obtained from a vesicular area (site unspecified).  At the time of reporting the patient had recovered (date unspecified).  Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Information has been received from a physician concerning a 61 year old male with an unspecified cardiac disorder and diabetes who on 09-JAN-2008 was vaccinated with a "single dose" of Zostavax (Oka/Merck) (Lot # "1131U"), site of administration unspecified.  It was reported that on 15 JAN 2008 the patient developed herpes zoster, with dermatome C2-3 involvement.  Vesicular lesions were present on the patient's head and neck.  It was also reported that on 15 JAN 2008 the patient developed a shingles like rash on the forehead.  On a pain scale of one to ten, the patient's pain was assessed at three.  The patient "was given some topical cream and acyclovir".  Unspecified medical attention was sought.  There was no product quality complaint.  A direct fluorescent antibody was not collected.  It was reported that the specimen for the VZV identification program was obtained from a vesicular area (site unspecified).  At the time of reporting the patient had recovered (date unspecified).  Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus
Clinical narrative: Information has been received from an 88 year old female with shingles, post herpetic neuralgia, osteoporosis and no known allergies who in July 2007, was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included EVISTA.  The patient's physician told her to get the vaccine to help with her burning and itching.  The caller stated that she has shingles on her left side on her back around to under her bust.  She stated the itchiness and burning has gotten worse in the last couple of days.  Unspecified medical attention was sought.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a "teenager" patient who on an unspecified date was inadvertently vaccinated with Zostavax (Oka/Merck), instead of receiving a 2nd dose of Varivax (Oka/Merck) (MSD).  There was no AE reported.  There is no product quality complaint involved.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female with diabetes and penicillin allergy who on 09-FEB-2008 was vaccinated with 0.5ml Zostavax (Oka/Merck) (lot # 658861/1822U).  On 12-FEB-2008 the patient experienced fever, and an injection site reaction that was a half dollar size swollen area with a hard center.  Unspecified medical attention was sought in the pharmacy.  There was no lab studies performed.  At the time of the report the patient's status was unknown.  There is not product quality complaint involved.  Additional information has been requested.  This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a female with allergy to several antibiotics including CIPRO and a history of shingles who on 14-FEB-2008 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included TOPAMAX, PREMARIN, NEXIUM, simvastatin (MSD), acyclovir and aspirin.  On 15-FEB-2008, the patient removed a ring she was wearing since being vaccinated and found a slight red rash where the Onyx stone in the ring was against her skin.  She applied NEOSPORIN ointment and the area has improved.  No other symptoms were noted.  The patient did not seek medical attention.  There was no product quality complaint.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning a female who on 07-FEB-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck), subcutaneously.  Subsequently the patient experienced red, raised area at the injection site of the left upper arm after receiving ZOSATAVAX (Oka/Merck) on 07-FEB-2008.  The interval between the vaccination and the onset of symptoms was unknown.  The patient sought medical attention: exam.  No treatment had been initiated at the time of the report and at the time of the report, the patient had not recovered.  The lot number was not provided.  There was no product quality complaint.  Additional information has been requested. Follow up information indicated that on 08-FEB-2008 (also reported as 07-FEB-2008), the patient developed a 1 inch wide redness following the vaccination. Slight edma was noted. The outcome was recovered on 09-FEB-2008. No additional information is expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old male with coronary artery disease, cardiac failure congestive, cholesterol high, cardiac defibrillator, hypertension and allergy to propoxyphene, and lisinopril (WAES# 0802USA04233) and a history of coronary artery bypass, low back pain and upper respiratory tract infection who on 07-FEB-2007 was vaccinated with a 0.65 cc dose of Zostavax (Oka/Merck) (658867/1413U) subcutaneously in the "deltoid upper region left arm".  Concomitant therapy included thiamine, nitroglycerin, TYLENOL WITH CODEINE, aspirin, COMBIVENT, WELLBUTRIN, digoxin, furosemide, isosorbide, metoprolol, omeprazole, simvastatin (MSD) and spironolactone.  On 08-FEB-2008 the patient experienced horrible pain in left arm.  The patient stated that he had a heart attack in the past and never experienced pain like the one he experienced with Zostavax (Oka/Merck).  The patient had pain go from the left shoulder to wrist and lasted 10 minutes.  The patient called the clinic.  The patient recovered on 08-FEB-2008.  There was no product quality complaint.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Purulence, Rash pruritic, Scab, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 60 year old female who on 27-NOV-2007 at 11:19 AM was vaccinated with the first dose of Zostavax (Oka/Merck) (658361/1090U) in the left upper extremity.  It was reported that within 2 weeks, the patient developed a rash with welts.  It was itchy and crusty with drainage, not painful.  The rash resolved after six weeks.  There was no illness at the time of vaccination. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pyrexia, Rash
Clinical narrative: Information has been received from an office manager related to a female patient in her 60's who was vaccinated with a dose of Zostavax (Oka/Merck) (reported as " vial"/single dose).  Subsequently the patient developed a fever, redness in the injection site that looked like sunburn and swelling on the injection site after receiving Zostavax (Oka/Merck). Lot number was not available.  Subsequently, the patient recovered from fever, redness in the injection site that looked like sunburn and swelling on the injection site.  There was no product quality complaint.  The patient sought unspecified medical attention.  Additional information has been requested. 06/24/2008 This is in follow-up to report(s) previously submitted on 3/26/2008. Additional information has been received from the physician. This 64 year old female was vaccinated in the left arm at 09:00 on 26-MAR-2008 with a first dose of ZOSTAVAX (Oka/Merck). There was no illness at the time of vaccination. At 09:00 on 27-MAR-2008 the patient developed redness, swelling and a rash at the injection site. On 28-MAR-2008 the patient developed a rash around her neck. Medical attention was sought via a doctor visit. On an unspecified date the patient recovered. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Hepatomegaly, Injection site erythema, Injection site warmth, Liver function test abnormal
Clinical narrative: Information has been received from a pharmacist concerning a 44 year old female with bipolar disorder and a history of recurrent herpes zoster who on 19-DEC-2007 was vaccinated with a dose of Zostavax (Oka/Merck) subcutaneously.  Concomitant therapy included gabapentin, LYRICA and DEPAKOTE.  The patient developed a large, red, warm area around the injection site of the right upper arm on 20-DEC-2007, 1 day after receiving Zostavax (Oka/Merck) on 19-DEC-2007.  The patient first contacted the pharmacist by phone at the end of December 2007 and the symptoms were resolving without treatment at that time.  In early February 2008, the patient developed lower right flank pain.  She was examined by her physician on 11-FEB-2008 and was found to have an enlarged liver.  Liver function test results were elevated.  The patient had not recovered.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/26/2008.  Initial and follow-up information has been received from a pharmacist concerning a 44 year old female with bipolar disorder and a history of chronic shingles with no outbreak at the time of vaccination who on 19-DEC-2007 at 11:45 am was vaccinated SC in the left arm (injection site also reported as right arm) with a first dose of ZOSTAVAX (Merck) (lot # 658604/1088u). Concomitant therapy included VALTREX, PROVIGIL, CYMBALTA, estradiol and baclofen. On 20-DEC-2007 the patient developed a large, red, spot covering the under side of the majority of her upper arm, very warm to the touch, which started to decrease. The patient had pain at her liver area and went to see her physician for it on 11-Feb-2008. The patient was examined and found to have an enlarged liver, the physician performed liver function tests, and the patient said the results were elevated since test last performed in SEPT 2007. On 14-FEB-2008 the patient inquired as to if the vaccine caused enlarged live, and increased liver tests/enzymes. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information has been requested. This is in follow-up to report(s) submitted on 1/26/2008, 6/24/2008. Concomitant therapy included gabapentin, LYRICA, DEPAKOTE, VALTREX, PROVIGIL, CYMBALTA, estradiol and baclofen. Follow up information was received from the patient indicated she had a chronic fatigue and shingles recurrent at the time of vaccination. Her liver enzymes became elevated 3 months after vaccination. On approximately 12-OCT-2007 last documented liver function test was done and the result indicated that ALT 49, AST 42 and ALK phosphate 92. Another laboratory test was drawn in March by another physician but no results were provided. Additional information is not
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an office manager concerning a female in her early sixties who on an unspecified date was vaccinated SQ with 1 vial of ZOSTAVAX.  Subsequently 2-3 weeks later the patient developed shingles.  It was unspecified if medical attention was sought.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm skin
Clinical narrative: Information has been received from a consumer regarding her mother with unspecified drug allergies and pertinent medical history who on an unspecified date was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient experienced a growth underneath her eye.  The dermatologist said it was a benign tissue, and it was surgically removed.  Subsequently, the patient recovered.  There was no product quality complaint involved.  No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female consumer concerning herself and her husband, both "in their sixties", who on 18-OCT-2007 were vaccinated with Zostavax (Oka/Merck).  On 17-JAN-2008 the female consumer reported she developed symptoms of shingles.  At the time of reporting the female consumer stated she was" taking VALTREX and pain medication, battling the virus".  It was also noted that her husband showed no symptoms at the time of reporting.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who was vaccinated with a dose of Zostavax (Oka/Merck).  On an unspecified date the patient developed a shingles-type rash.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Additional information has been requested. 06/24/2008 This is in follow-up to report(s) previously submitted on 3/26/2008. Additional information is not expected.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning an approximately 90 year old female with hypertension, dementia and osteoporosis who in December 2007, was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included NORVASC and ATENOL.  In December 2007, the patient developed shingles on her leg, "somewhere around L2 or L3" after receiving a single dose of Zostavax (Oka/Merck).  The NP reported that she has not seen the patient since December, and therefore the patient's present status is unknown.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Rash, Scab, Scar
Clinical narrative: Information has been received from a physician concerning an 84 year old female who in 2007 was vaccinated with a dose of ZOSTAVAX.  On 11-FEB-2008 the patient developed a severe case of shingles on thoracic area that traveled around her back.  Visual diagnosis was done.  Unspecified medical attention was sought.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested. Follow up information has been received from a physician concerning an 82 year old female with penicillina and TAMIFLU allergies who on 12-JUN-2007 was vaccinated intramuscularly with ZOSTAVAX (Oka/Merck). There was no illness at the time of vaccination. On 6 FEB 2008 the patient dveleoped a rash. On 11-FEB-2008 the patient was seen in the office at which time there was a rash present in the middle o f the back and left breast area, accompanied by pain in back. On  FEB 2008 the patient was see again in the office, at which time the skin had sacrred/scabbed with no open lesions. At the time of reporting the patient was recovered. No diagnostic or lab testing was performed. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a 76 year old female with a history of breast cancer who on 06-FEB-2008 was vaccinated with a single dose of Zostavax (Oka/Merck).  In February 2008, after vaccination the patient had an outbreak of chickenpox.  It was reported that the patient never had chickenpox in the past.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested. Follow-up information has been received from the physician concerning a white retired female who was vaccinated in the left deltoid with an intramuscular second dose of zoster vaccine live(Oka/Merck) (lot# 659326/1924U).  There was no illness at the time of vaccination.  On 06-Feb-2008 the patient developed skin lesions diffusely consistent with chicken pox which required an emergency room/doctor's visit.  There were no diagnostic or laboratory tests performed.  Follow-up information received indicated that on 18-Feb-2008 the patient recovered from the chickenpox.  Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a 73 year old female with stage three renal disease, and no history of drug reactions or allergies who on 08-FEB-2008 was vaccinated subcutaneously with "a single dose" of ZOSTAVAX.  Concomitant therapy included "calcitrol", amlodipine besylate (NORVASC), furosemide, "nephrocaps" and esomeprazole magnesium (NEXIUM).  On 10-FEB-2008 the patient developed redness, itching and soreness at the injection site.  The patient stated she "has not developed a rash or any lesions at the injection site".  The patient had not contacted her physician, and there had not been any treatment initiated at the time of reporting.  There was no product quality complaint.  There were no lab diagnostic studies performed.  At the time of reporting the patient had not yet recovered.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a 61 year old female consumer with hypertension and no drug reactions or allergies who on 29-SEP-2007 was vaccinated with 0.65 ml Zostavax (Oka/Merck).  Concomitant therapy included PREMARIN and "Catarix".  On 30-SEP-2007 the patient reported developing back pain and "found out that she developed PHN after the Zostavax (Oka/Merck)".  Unspecified medical attention was sought.  There was no product quality complaint.  There were no lab diagnostic studies performed.  At the time of reporting the patient had not yet recovered.  Additional information ahs been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female with no pertinent medical history, drug reactions or allergies who on 08-FEB-2008 was vaccinated subcutaneously into the deltoid with 0.65 ml of ZOSTAVAX (Lot # 658839/1411U).  On 09-FEB-2008 the patient developed redness at the injection site that was reported to have increased in size daily.  It was reported that as of 11-FEB-2008 "the rash" was 4 inches in diameter.  The patient's injection site redness increasing in size daily and rash 4 inches in diameter persisted.  The patient did call the pharmacist, but medical attention was not sought.  There was no product quality complaint.  There were no lab diagnostic studies performed.  At the time of reporting the patient was not yet recovered.  Additional information has been requested.