chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Lethargy, Post herpetic neuralgia, Pruritus
Clinical narrative: Information has been received from a 74 year old male with a history of shingles in JAN-2005 and an allergic reaction to tetracycline (he breaks out in a rash) who on 25-OCT-2007 was vaccinated with a "single dose" of ZOSTAVAX.  Concomitant therapy included influenza virus vaccine (unspecified) administered on 25-OCT-2007 and 11 other prescription medications "therapy unspecified".  On approximately 27-OCT-2007 a "couple of days after shot" (also reported as "sometime during the second week in NOV-2007") the patient reported feeling lethargic, tired and the back of his head itched really bad.  The itch started in his scalp and then went all the way down his back.  "He did not have any type of outbreak or rash in either area".  The patient stated that he went to the physician and they said he has post herpetic neuralgia.  No diagnostic labs were performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a female who on 05-NOV-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  The physician reported that on 12-NOV-2007, the patient presented to the office with shingles and pain.  The patient was informed she had a "bad case" of shingles and was placed on prednisone.  At the time of this report, the patient's shingles persisted as she remained uncomfortable.  Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Headache, Nausea, Rash
Clinical narrative: Information has been received from a 76 year old female, with no medical history and no allergies , who on 31-OCT-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). There was no concomitant medication. On 01-NOV-2007 the patient developed a rash under her breast, arms, legs, and on her stomach. "After a few days", on approximately 03-NOV-2007, her blood pressure was increased, she had a mild headache and nausea. At the time of the report the patient has not recovered. There were no laboratory or diagnostic tests performed. Medical at attention was not sought. No product quality was involved. No other information was provided. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Post herpetic neuralgia
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old male with no history of drug reaction or allergies, and a history of post herpetic neuralgia (PHN) and shingles, diagnosed in 2006 who on 02-NOV-2007 was vaccinated subcutaneously with 0.65 ml into the left arm with ZOSTAVAX (Lot # 658602/1080U).  On 01 OCT 2007, approximately four weeks prior to the administration of ZOSTAVAX, the patient was administered an influenza virus vaccine (unspecified) (manufacturer unknown).  Two to three days post ZOSTAVAX vaccination, on approximately 04-NOV-2007; the patient had a "possible slight increase in redness at the original site of his shingles lesion", along with an increase in PHN to a level of 8-9.  Prior to his vaccination with ZOSTAVAX; the patient rated his PHN as a 4, on a scale of 1-10.  At the time of reporting the patient was not recovered.  No lab diagnostic studies were performed.  There was no product quality complaint.  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site erythema, Injection site rash, Rash vesicular
Clinical narrative: Information has been received from a certified medical assistant concerning a 74 year old female with no pertinent medical history, drug reactions or allergies who on 30-NOV-2007 was vaccinated into the left tricep with 0.5ml of Zostavax (Oka/Merck).  Concomitant therapy included alendronate sodium (MSD), atenolol, losartan potassium-HCTZ (MSD) and NORVASC.  On 30-NOV-2007 the patient developed an erythematous, zoster like rash at the injection site.  Medical attention was sought.  At the time of reporting the patient was recovering.  There were no diagnostic studies performed.  There was no product quality complaint.  Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a consumer concerning a 77-year-old female, with no pertinent medical history, who on 03-DEC-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX.  Concomitant therapy included diltiazem hydrochloride (TAZTIA XT), valsartan (DIOVAN), fluticasone propionate (+) salmeterol xinafoate (ADVAIR), "provanto", oxybutynin01 (OXYBUTIN) and pantoprazole sodium (PROTONIX).  On 05-DEC-2007 the patient experienced swelling at injection site.  The patient did not seek medical attention.  No diagnostic labs were performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her 75 to 80 year old male friend who on an unspecified date, received a one time subcutaneous dose of 0.65ml ZOSTAVAX (OKA/Merck). The consumer stated that "even though he was vaccinated", within the last six months (approx.July 2007), the patient developed shingles. Current patient status was not reported. A product quality complaint was not reported. Follow up information provided no additional information. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Paraesthesia
Clinical narrative: Information has been received from a consumer concerning her 71-year-old male husband who on 29-NOV-2007 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck).  On 02-DEC-2007 (three days post vaccination) the patient experienced tingling in his right arm.  Approximately two more days later the patient developed blisters on his right arm which were diagnosed as shingles.  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  No further information is available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a 69 year old female with no pertinent medical history and no known drug allergies, who on 29-NOV-2007 was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included vitamins (unspecified), flaxseed oil, ESTROVEN (NEW FORMULA). A day after getting the vaccine, (30-NOV-2007) the patient reported that she felt "a little bit itchy" at the injection site. It was indicated that there were no blisters, "just a little red". The patient reported that her physician recommended that she wash the area with hydrogen peroxide. There were no laboratory or diagnostic studies performed. On an unspecified date, the patient recovered. A product quality complaint was not requested. Additional information has been requested. Follow-up information from the patient indicated she requested to have ZOSTAVAX (Oka/Merck).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Pain in extremity
Clinical narrative: Information has been received from a 71 year old female consumer with allergies to penicillin and Phenobarbital, and Grave's disease who "at the end of September" 2007, was vaccinated with ZOSTAVAX.  Concomitant therapy included candesartan cilexetil (ATACAND), "metlazone", potassium chloride, magnesium (unspecified), finasteride, "amiptrylin" and diazepam.  It was reported that on the same day as she received the vaccination she developed headache, and, raised redness at injection site.  The patient also reported that a week to ten days after receiving the vaccine she developed pain that started mainly in her left leg and now is in both legs.  The patient sought unspecified medical attention.  It was reported that she recovered from the headache, and raised redness at the injection site a couple of weeks after receiving the vaccination (date not reported).  The patient's current status was not reported.  A product quality complaint was not reported.  Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Herpes virus infection, Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 84 year old female with sulfonamide allergy, penicillin allergy and allergy to MACROBID and a history of getting hives every year who on 14-NOV-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included atenolol, LIPITOR and ACTONEL.  On 15-NOV-2007, The consumer reported that her arm got red and itchy at the injection site.  She also had a high fever and diarrhea.  On 01-DEC-2007 the patient broke out with herpes on her buttocks but " " this happens about once a year when I am under stress"  It was reported that the patient recovered about three days after it started."  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Blood pressure, Body temperature, Culture, Facial pain
Clinical narrative: Information has been received from a health professional concerning a 92 year old female with arthritis, glaucoma, macular degeneration and allergies to chocolate and "DAMRON" and hypertension and a history of hysterectomy who on 01-NOV-2007 was vaccinated with ZOSTAVAX (Lot # 658604/1088U) at 10:20 am first dose.  Concomitant medication included aspirin, amlodipine besylate (+) benazepril hydrochloride (LOTREL) esomeprazole magnesium (NEXIUM) and montelukast sodium (MSD).  On 12 NOV-2007 the patient was seen by the physician for a watery draining left eye.  It was reported that the patient had macular degeneration and extremely poor vision at which time she was diagnosed with a bacterial infection and prescribed erythromycin opthalmic ointment.  The patient used this ointment for a few days and then she developed facial pain and a rash.  The patient contacted the office and they presumed it was a reaction to the erythromycin and she was told to stop it.  The patient had pain so she went to the emergency department.  The patient reported that she had macular degeneration and could only see a shadow and movement.  The patient had left sided facial pain forehead.  Vital signs were temperature 96, BP 164/62, pulse 108, respiratory rate 17 and pulse oximetry 98%.  The emergency room summary noted that the patient had a vesicular rash on her forehead and around the eye.  Corneal staining was negative.  The clinical impression was herpes zoster without current evidence of hutchinsons sign.  The patient had a vesicle broken and the fluid sent for smear.  The patient was managed as an outpatient with acyclovir 800mg five times a day and PERCOCET one q 4-5 hours prn pain.  The patient recovered.  Additional information is not expected.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate, Herpes zoster, Laboratory test, Lacrimation increased, Oxygen saturation
Clinical narrative: Information has been received from a health professional concerning a 92 year old female with arthritis, glaucoma, macular degeneration and allergies to chocolate and "DAMRON" and hypertension and a history of hysterectomy who on 01-NOV-2007 was vaccinated with ZOSTAVAX (Lot # 658604/1088U) at 10:20 am first dose.  Concomitant medication included aspirin, amlodipine besylate (+) benazepril hydrochloride (LOTREL) esomeprazole magnesium (NEXIUM) and montelukast sodium (MSD).  On 12 NOV-2007 the patient was seen by the physician for a watery draining left eye.  It was reported that the patient had macular degeneration and extremely poor vision at which time she was diagnosed with a bacterial infection and prescribed erythromycin opthalmic ointment.  The patient used this ointment for a few days and then she developed facial pain and a rash.  The patient contacted the office and they presumed it was a reaction to the erythromycin and she was told to stop it.  The patient had pain so she went to the emergency department.  The patient reported that she had macular degeneration and could only see a shadow and movement.  The patient had left sided facial pain forehead.  Vital signs were temperature 96, BP 164/62, pulse 108, respiratory rate 17 and pulse oximetry 98%.  The emergency room summary noted that the patient had a vesicular rash on her forehead and around the eye.  Corneal staining was negative.  The clinical impression was herpes zoster without current evidence of hutchinsons sign.  The patient had a vesicle broken and the fluid sent for smear.  The patient was managed as an outpatient with acyclovir 800mg five times a day and PERCOCET one q 4-5 hours prn pain.  The patient recovered.  Additional information is not expected.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Respiratory rate
Clinical narrative: Information has been received from a health professional concerning a 92 year old female with arthritis, glaucoma, macular degeneration and allergies to chocolate and "DAMRON" and hypertension and a history of hysterectomy who on 01-NOV-2007 was vaccinated with ZOSTAVAX (Lot # 658604/1088U) at 10:20 am first dose.  Concomitant medication included aspirin, amlodipine besylate (+) benazepril hydrochloride (LOTREL) esomeprazole magnesium (NEXIUM) and montelukast sodium (MSD).  On 12 NOV-2007 the patient was seen by the physician for a watery draining left eye.  It was reported that the patient had macular degeneration and extremely poor vision at which time she was diagnosed with a bacterial infection and prescribed erythromycin opthalmic ointment.  The patient used this ointment for a few days and then she developed facial pain and a rash.  The patient contacted the office and they presumed it was a reaction to the erythromycin and she was told to stop it.  The patient had pain so she went to the emergency department.  The patient reported that she had macular degeneration and could only see a shadow and movement.  The patient had left sided facial pain forehead.  Vital signs were temperature 96, BP 164/62, pulse 108, respiratory rate 17 and pulse oximetry 98%.  The emergency room summary noted that the patient had a vesicular rash on her forehead and around the eye.  Corneal staining was negative.  The clinical impression was herpes zoster without current evidence of hutchinsons sign.  The patient had a vesicle broken and the fluid sent for smear.  The patient was managed as an outpatient with acyclovir 800mg five times a day and PERCOCET one q 4-5 hours prn pain.  The patient recovered.  Additional information is not expected.
Age: 96.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 96 year old female who on 15-NOV-2007 was vaccinated with a 0.65 ml subcutaneous dose of Zostavax (Oka/Merck). Concomitant therapy included KLONOPIN and LEXAPRO. "About 13 days later", on 27-NOV-2007, the patient experienced a severe case of shingles around the eyes. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 10-SEP-2007 was vaccinated with a single dose of Zostavax (Oka/Merck). On 02-OCT-2007 the patient experienced "dry zoster-like rash" on the buttocks, legs and scapula. There was itching associated with the rash but no "oozing." The patient sought unspecified medical attention. No labs or diagnostic studies were performed. As of 07-NOV-2007 the rash was cleared up however; the patient still experienced slight itching on her left interior thigh and scapula and was noted to be recovering. There was no product quality complaint. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site scab
Clinical narrative: Initial and follow-up information has been received from a physician and nurse concerning an approximately 67 year old female who in approximately November 2007, "within the last month" was vaccinated SC with a dose of ZOSTAVAX (lot# 658395/0966U).  In approximately November 2007, the patient developed a localized injection site reaction with redness and yellow crust around the area.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  There was no product quality complaint.  This is one of several reports from the same source.  Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 76 year old female who on 06-DEC-2007, was vaccinated with ZOSTAVAX.  On 06-DEC-2007, the patient developed soreness, swelling, and erythema at the injection site.  The patient described it as "a knot" at the injection site and reported that it "was starting to spread to surrounding areas".  She sought medical attention via the phone.  Laboratory and diagnostic studies were not performed.  Current patient status was not reported.  A product quality complaint was not reported.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 60 year old female who on 05-DEC-2007 was vaccinated with a dose of Zostavax (Oka/Merck) and "had lots of swelling at the injection site, with bumpy rash in the middle of it".  The patient sought medical attention (office visit on 07-DEC-2007).  The patient had not recovered.  Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration, Pain, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 59 year old female with hypertension, hypercholesterolaemia, and allergies to penicillin and aspirin who on 27-NOV-2007 was vaccinated SC with a single dose of Zostavax (Oka/Merck).  Concomitant therapy included LIPITOR and AVAPRO.  On 05-DEC-2007 the patient experienced onset of a painful, pruritic rash on her left mid-thoracic region which extended to the left mid-back.  The patient was examined in the office on 07-DEC-2007 and was diagnosed with suspected herpes zoster.  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.  Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site atrophy, Injection site induration, Injection site pruritus
Clinical narrative: Information has been received from a physician concerning a female "in her 50's" with multiple sclerosis and rheumatoid arthritis who "5 or 6 months ago" (approximately September 2007), was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included an unspecified therapy (Ariva), HUMIRA and methotrexate. On an unspecified date, the patient developed atrophy of the muscles at the injection site as well as itching. It was also indicated that the patient, on an unspecified date, developed "a dimple at the injection site". The physician reported that at "check-ups" the "dimple is gradually getting bigger" (specific dates 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.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed a "herpes like rash".  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 was provided.  No further information is available.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Benign prostatic hyperplasia, Drug hypersensitivity, Headache, Hyperlipidaemia, Radiculopathy
Clinical narrative: Information has been received from a 76 year old male consumer who is a physician, with benign prostatic hyperplasia, hyperlipidaemia, radiculopathy and an allergy to cephalosporins who "about a year ago" (December 2006) was vaccinated with ZOSTAVAX and developed intermittent headaches after receiving the vaccine.  Concomitant therapy included dutasteride (AVODART), simvastatin (MSD) and clonazepam.  It was also reported that the headache onset was three days ago (approx 07-DEC-2007).  Medical attention sought was not specified.  There were no laboratory or diagnostics studies performed.  At the time of this report, it was reported that the patient had not recovered.  A product quality complaint was not reported.  This is one of two reports from the same source.  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 and a 76 year old 139 lb. 60 in. white male consumer who is a physician, which benign prostatic hyperplasia, hyperlipidaemia, radiculopathy and an allergy to CEPHALOXPORINS who on 11-DEC-2006, was vaccinated with a first dose in the right arm subcutaneously of ZOSTAVAX (Merck) (lot# 652947/1212F) and developed intermittent headaches after receiving the vaccine. Concomitant therapy included AVODART, SIMVASTATIN and CLONAZEPAM. There was no reported illness at the time of vaccination. It was reported that the headache onset was 01-DEC-2007 (also reported as three days ago: approx 07-DEC-2007). It was indicated that the intermittent headaches were daily. generalized, but usually one sided. Medical attention sought was not specified. There were no laboraory or diagnostics studies performed. It was indicated that the headaches lasted for six weeks with no significant reoccurance. The physian reported that as of January 2008, the patient had recovered. A product quality complaint was not reported. This is one of two reports from the same source. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning his 73 year old wife with atrial fibrillation, coronary artery disease, hyperlipidaemia, hypertension, and allergies to penicillin, digoxin, and amiodarone who "about a year ago" (December 2006) was vaccinated with Zostavax (Oka/Merck) and developed intermittent headaches after receiving the vaccine. Concomitant therapy included NORVASC, metoprolol, ezetimibe (+) simvastatin (MSD), COUMADIN and aspirin. It was also reported that the headaches began about three days ago (07-DEC-2007). Medical attention sought was not specified. There were no laboratory or diagnostics studies performed. At the time of this report it was reported that the patient had not recovered. A product quality complaint was not reported. This is one of two reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a nurse concerning a 60-year-old female who on 04-DEC-2007 was vaccinated with one dose of Zostavax (Oka/Merck). On 16-FEB-2008 "last Saturday" the patient returned to the clinic with a rash on her palms and upper left arm. The nurse said it was shingles. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female with a sulfonamide allergy who on 17-FEB-2008 was vaccinated with a 0.65ml dose of ZOSTAVAX (lot# 658605/1089U).  Concomitant therapy included alendronate sodium (MSD).  On an unspecified date, the patient developed an injection site reaction described as a "KNOT" or swelling.  It was indicated that the patient called the pharmacist, and was instructed to apply ice and use diphenhydramine (BENADRYL).  No laboratory or diagnostic studies were performed.  It was indicated that at the time of this report, the symptoms had improved, but not resolved.  A product quality complaint was not reported.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 10-DEC-2007 was vaccinated with a dose of ZOSTAVAX and later that day developed a rash on her neck.  The patient did not have any other symptoms.  No further information was available.  The outcome was reported as not recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 13 year old patient who was vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck). Pharmacist was not aware of product confusion. No further details about the incident was reported. No further information was available. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female who on an unspecified date was vaccinated with ZOSTAVAX.  Subsequently the patient broke out in "shingles like pox" post vaccination.  The reporter is not interested in VZV Analysis by PCR.  The patients "symptoms" resolved.  At the time of reporting the patient was "okay".  No further information is available.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning an approximate 70-year-old female who in approximately February 2008, was vaccinated with a dose of Zostavax (Oka/Merck). In approximately February 2008, it was reported the patient was on vacation and experienced a rash 10 days after vaccination and called the doctors office to let them known about it. The rash was over her entire body and the patient was going to follow-up with a doctor where she was vacationing. 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. Information has been received from a registered nurse concerning an 80 year-old female with no known allergies who on 30-OCT-2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 658602/1080U). Concomitant therapy included an unspecified influenza vaccine "within the last 4 weeks". On 07-NOV-2007, the patient was on vacation and broke out in a rash on 04-NOV-2007 (also reported as 10 days after vaccination) and called the doctors office to let them know about it. The rash was over her entire body but especially on her face and arms. The patient stated that "it looks like chicken pox before it blisters to heads" and "I have shingles". She did not complain of pain or itching. She stated that she felt fine. The patient was going to follow-up with a doctor where she was vacationing the next day. At the time of the report the patient's status was unknown. In follow up the registered nurse indicated that they were unable to follow up with the patient because she did not answer her telephone on vacation for the next 3 days and her other telephone number was disconnected. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a 62-year-old male with high blood pressure, type II diabetes mellitus and no known allergies who on 08-DEC-2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included lisinopril (MSD), GLUCOPHAGE and aspirin.  On 09-DEC-2007 the patient developed a "rash like shingles on chest" post vaccination.  The patient did not seek medical attention and did not have any diagnostic labs performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Guttate psoriasis
Clinical narrative: Information has been received from a physician concerning a female with a history of guttate psoriasis who was vaccinated with a "single dose" of ZOSTAVAX.  On an unspecified date, about a couple of days post vaccination, the patient broke out with a case of "guttate psoriasis".  The physician reported that the patient has not had an outbreak in about 20 years, but the day of receiving ZOSTAVAX the patient may have had an upper respiratory infection.  The patient sought medical attention via her physician.  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: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a 60-year-old female (licensed visiting nurse) who on 08-OCT-2007 in the evening was vaccinated subcutaneous in the left arm with her first dose of Zostavax (Oka/Merck). On 09-OCT-2007 in the morning at the injection site the patient developed welts and had swelling and redness from her elbow to her shoulder that persisted for a week. "It was also warm to the touch". The patient sought unspecified medical attention. The patient took BENADRYL to help her reaction. On 14-OCT-2007 the patient recovered. A product quality complaint was not involved. No further information is available.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a consumer reporting on her 72-year-old husband, with no pertinent medical history or allergies, who on 06-DEC-2007 and 09-DEC-2007 was vaccinated with a first and second dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 09-DEC-2007 the patient "developed a rash, which was itchy, on his left shoulder where he received the vaccine".  The patient sought medical attention via a phone call with his physician.  No diagnostic labs were performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a female who on 03-DEC-2007 was vaccinated with Zostavax (Oka/Merck). On 04-DEC-2007 the patient developed a "mini vzv rash" at the injection site. On 12-DEC-2007 the patient went to the physician's office. The injection site rash was red with induration over "about a 2x3 inch area" which was treated with cold compresses. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old female with peripheral neuropathy and a medical history of an "outbreak of herpes zoster" and no known allergies who in August 2007, was vaccinated with ZOSTAVAX.  Concomitant therapy included carbamazepine and baclofen.  The pharmacist reported the patient "developed a self-diagnosed case of shingles" in December 2007.  The patient's shingles persisted.  Follow-up information received from the LPN indicating that the patient "got shingles again on 04-Nov-2007".  The patient also has a history of trigeminal neuralgia.  No further information is expected.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure, Eye irritation, Ocular hyperaemia
Clinical narrative: Information has been received from a 59-year-old male (also reported as 34-year-old) with glaucoma in both eyes, hypertension, prostatitis, a history of chickenpox, no known allergies and no history of immunosuppressive therapy or immune compromise who on 10-DEC-2007 splashed a few drops of Zostavax (Oka/Merck) (lot # "1141U") into his left eye while administering the vaccine to a 75-year-old woman (she jumped during administration and it squirted into his left eye).  The left eye became red and irritated after flushing with saline.  Concomitant therapy included hydrochlorothiazide, aspirin, metoprolol, DOXASIN and TRAVATAN.  The patient sought unspecified medical attention.  No diagnostic labs were performed.  The patient stated that "his eyes were irritated for a few days but it was probably due to all the water he flushed it out with".  On an unspecified date the patient recovered.  A product quality complaint was not involved.  Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral herpes, Secondary transmission
Clinical narrative: Information has been received from a nurse concerning a female nurse with a history of shingles in the past and herpes simplex who after giving multiple vaccinations of ZOSTAVAX on 14-FEB-2008 developed shingles.  There was no concomitant medication.  It was reported that the nurse noticed a rash on 18-FEB-2008 and also had a cold sore on her lips.  The nurse wore gloves when administering the vaccinations but not when it was being reconstituted.  The nurse is taking acyclovir.  Subsequently, the patient recovered from shingles and cold sore on lips.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Blood pressure decreased, Cough, Dizziness
Clinical narrative: Information has been received from a 64 year old female consumer with no known allergies or pertinent medical history who on 10-DEC-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included DIOVAN and LEVOXYL.  Approximately 15 minutes after vaccination on 10-DEC-2007 the patient felt off balance and experienced dizziness coughing, weakness and a drop in her blood pressure.  Medical attention was sought.  There were no lab studies performed.  The patient was treated with diphenhydramine hydrochloride (manufacturer unknown) which did not help her dizziness and weakness.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a health professional concerning a 22 year old female employee, with no history of shingles, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006.  It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck).  Subsequently the patient was diagnosed with shingles by her physician and treated.  No product quality complaint was involved.  No other information was provided.  Follow-up information from a health professional indicated that the patient had either recovered completely or was recovering.  All lesions were either gone or almost completely dried up.  This is one of several reports from the same source.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Bacterial culture, Erythema, Incorrect route of drug administration, Nodule, Skin lesion
Clinical narrative: Information has been received from a biller at a physician's office concerning a 65 year old male with hypertension, coronary artery disease, benign prostatic hyperplasia, hypothyroidism, hyperlipidaemia, gout and no known allergies who on 06-NOV-2007 was vaccinated IM in the left buttock with a dose of ZOSTAVAX (lot # 658395/0966U).  Concomitant therapy included indomethacin (INDOCIN (indomethacin)), allopurinol, atorvastatin calcium (LIPITOR), hydrochlorothiazide (+) valsartan (DIOVAN HCT) and metoprolol.  On 15-NOV-2007 the patient developed an erythematous purulent appearing nodular dermal lesion, a little reminiscent of herpes zoster on the left arm.  The patient had no history of shingles prior to vaccination.  Medical attention was sought, viral and bacterial cultures were performed, results were not reported.  On an unspecified date the patient recovered and was noted to be "fine".  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Virus culture
Clinical narrative: Information has been received from a biller at a physician's office concerning a 65 year old male with hypertension, coronary artery disease, benign prostatic hyperplasia, hypothyroidism, hyperlipidaemia, gout and no known allergies who on 06-NOV-2007 was vaccinated IM in the left buttock with a dose of ZOSTAVAX (lot # 658395/0966U).  Concomitant therapy included indomethacin (INDOCIN (indomethacin)), allopurinol, atorvastatin calcium (LIPITOR), hydrochlorothiazide (+) valsartan (DIOVAN HCT) and metoprolol.  On 15-NOV-2007 the patient developed an erythematous purulent appearing nodular dermal lesion, a little reminiscent of herpes zoster on the left arm.  The patient had no history of shingles prior to vaccination.  Medical attention was sought, viral and bacterial cultures were performed, results were not reported.  On an unspecified date the patient recovered and was noted to be "fine".  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test negative, Serology negative
Clinical narrative: Information has been received from a 64 year old female with no known allergies who in 2007, about a year ago, was vaccinated with Zostavax (Oka/Merck) 0.65 mL.  Concomitant therapy included an unspecified thyroid medication.  The patient reported that she had not developed immunity to shingles.  In addition the consumer reported that the vaccine would have been administered sub q instead of IM, but she is not sure.  The patient sought unspecified medical attention.  There was no product quality complaint.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a male with no allergies and a history of recurrent shingles who in April 2007, was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck).  Since being vaccinated, in 2007, the patient developed two outbreaks of shingles on the same hip.  At the time of this report, 11-DEC-2007, the patient is currently recovering from his second outbreak since his vaccination.  The area is about 2 inches in diameter.  It was unspecified if medical attention was sought and no laboratory or diagnostic tests were performed.  No product quality complaint was involved.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Secondary transmission
Clinical narrative: Information has been received from a 70-year-old female with a sulfonamide allergy whose husband was vaccinated subcutaneously with a 0.65 ml dose of Zostavax (Oka/Merck) on 12-NOV-2007.  On 27-NOV-2007 the 70-year-old female patient experienced pain where she had shingles in the past then on 06-DEC-2007 the patient developed "bumps" but "nothing started to break yet".  Unspecified medical attention was sought.  Concomitant therapy included losartan potassium (MSD) and montelukast sodium (MSD).  It was reported that the patient had not been given the vaccine and her husband showed no signs of a rash or any other adverse event following vaccination.  At the time of the report the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse concerning a female with no known pertinent medical history and no known drug allergies who "about 2 weeks ago" (November 2007), was vaccinated with a single subcutaneous dose of ZOSTAVAX (Merck).  There was no concomitant medication.  It was indicated that "one day after vaccination" (date not reported), the patient developed redness and itching at the site of injection.  It was reported that the patient was examined in the physician's office and was improving without requiring therapy.  Laboratory and diagnostic studies were not performed.  A product quality complaint was not reported.  Additional information has been requested. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Full blood count normal, Injection site pain, Liver function test normal, Rash
Clinical narrative: Information has been received from a health professional concerning a 64 year old male who on 04-OCT-2007 was vaccinated with a 0.65 ml dose in the left arm of Zostavax (Oka/Merck).  Concomitant therapy included prednisone, BENADRYL, metoprolol, ezetimibe (+) simvastatin (MSD), PLAVIX, aspirin, folic acid, vitamin E, niacin, montelukast sodium (MSD), ranitidine, isosorbide, COMBIVENT and GAS-X.  It was reported that the patient developed a blistering rash after he received the vaccine, and on 19-OCT-2007 was seen by the physician for the rash.  It was reported that the patient was treated with prednisone (also listed as a concomitant medication by the reporter) and as of 29-OCT-2007 had recovered.  A product quality complaint was not reported.  Follow up information received from the reporting nurse.  The nurse reported that she thought the patient might have recovered.  Follow up information received from the physician indicated that on 06-OCT-2007, the patient noticed a blistering rash on his left leg and then it went up to his left arm.  The rash was not painful but was fairly large.  The rash was mainly around his left knee and his forearm.  His vaccination was in the left arm and he did experience pain in that area.  He ultimately developed a little bit of rash on his back, right forearm, but mostly along the left side of his body.  The reporter indicated that the patient had a bit of exposure to some weeds and the rash was initially felt to be contact dermatitis.  He was treated with topical steroids with absolutely no help.  On 15-OCT-2007, he was started on oral prednisone.  Diagnostic studies included a "Sed Rate", blood count, renal function, and liver function tests all reported as normal.  His oral steroid dose was tapered on 19-OCT-2007, and he finally cleared about 10 days later (29-OCT-2007).  Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate normal, Renal function test normal
Clinical narrative: Information has been received from a health professional concerning a 64 year old male who on 04-OCT-2007 was vaccinated with a 0.65 ml dose in the left arm of Zostavax (Oka/Merck).  Concomitant therapy included prednisone, BENADRYL, metoprolol, ezetimibe (+) simvastatin (MSD), PLAVIX, aspirin, folic acid, vitamin E, niacin, montelukast sodium (MSD), ranitidine, isosorbide, COMBIVENT and GAS-X.  It was reported that the patient developed a blistering rash after he received the vaccine, and on 19-OCT-2007 was seen by the physician for the rash.  It was reported that the patient was treated with prednisone (also listed as a concomitant medication by the reporter) and as of 29-OCT-2007 had recovered.  A product quality complaint was not reported.  Follow up information received from the reporting nurse.  The nurse reported that she thought the patient might have recovered.  Follow up information received from the physician indicated that on 06-OCT-2007, the patient noticed a blistering rash on his left leg and then it went up to his left arm.  The rash was not painful but was fairly large.  The rash was mainly around his left knee and his forearm.  His vaccination was in the left arm and he did experience pain in that area.  He ultimately developed a little bit of rash on his back, right forearm, but mostly along the left side of his body.  The reporter indicated that the patient had a bit of exposure to some weeds and the rash was initially felt to be contact dermatitis.  He was treated with topical steroids with absolutely no help.  On 15-OCT-2007, he was started on oral prednisone.  Diagnostic studies included a "Sed Rate", blood count, renal function, and liver function tests all reported as normal.  His oral steroid dose was tapered on 19-OCT-2007, and he finally cleared about 10 days later (29-OCT-2007).  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Discomfort, Incorrect dose administered
Clinical narrative: Information has been received from a health professional concerning a 75 year old female with osteoporosis, rheumatoid arthritis, hypothyroidism, microscopic haematuria and leukopenia with a history of shingles in 1970 and September 2006.  On 10-DEC-2007 she was vaccinated with a 0.7 milliliter dose of ZOSTAVAX (lot# 658398/1087U).  Concomitant therapy included risedronate sodium (ACTONEL) 35 mg, nitrofurantoin (MACRODANTIN) 50 mg once daily, HCTZ/triamterene (DYAZIDE) 25/37.5 mg, levothyroxine sodium (SYNTHROID) 50 mcg, and phentermine 37.5 mg.  On 11-DEC-2007 the patient developed pain on the back, burning sensation on the back and discomfort.  It was reported that the patient called the physician's office and reported that she had been treating herself with gabapentin "that she had" from the September 2006 shingles episode.  At the time of this report, it was reported that the patient had not recovered.  A product quality complaint was not reported.  Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Information has been received from a male consumer with dry skin who in January 2008, "about a month ago", was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included CARDURA, "Azacol" (therapy unspecified) and LUNESTA.  A couple of days ago the patient experienced rash on lower chest and upper stomach.  It looks like a bunch of little dots.  It's hardly itching and feels a little warm.  The patient has been putting cortisone cream on it.  The patient's rash on lower chest and upper stomach persisted.  No product quality complaint.  Additional information is not expected.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: Information has been received concerning a male in his 50's with a history of colon cancer who was vaccinated with ZOSTAVAX.  Subsequently "7-8 days after receiving ZOSTAVAX," the patient developed shingles.  The patient sought unspecified medical attention.  The patient's shingles persisted.  Additional information has been requested.