chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female with PENICILLIN allergy who on 05-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # not reported). On 05-JAN-2009 the patient developed redness at the injection site. The next day (Tuesday), on 06-JAN-2009 the patient had swelling and the reaction was "the size of an egg with tenderness in the area". On Wednesday (07-JAN-2009), "the swelling went down but the area was still tender & red". Today (09-JAN-2009) the area is itchy and swelling is gone." At the time of the report, on 09-JAN-2009, the patient was recovering from the redness and tenderness. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female who on 06-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck) in her left arm (lot# not reported) and experienced an injection site reaction. In the evening of 06-JAN-2009 the patient's injection site was red and warm. The pharmacist instructed the patient to take BENADRYL which she did. On 07-JAN-2009 the patient woke up and had redness and swelling down to her elbow and up to her neck. She saw her physician on 07-JAN-2009 who prescribed LEVAQUIN and FLAGYL. On 09-JAN-2009 the patient called the pharmacist to say her arm was blistered around the injection site and she was still taking LEVAQUIN and FLAGYL. She reported her arm felt better. The outcomes of the redness, warmth, swelling and blisters were unknown. Follow-up information from a physician who reported he had no information on this case because the patient was not given vaccine or seen in his office for treatment following vaccination of ZOSTAVAX. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a nurse concerning a male who on an unknown date, was vaccinated with ZOSTAVAX (Oka/Merck) (lot# not provided). Subsequently the patient broke out with cold sores on his lips. He had never had cold sores before. The patient's symptoms persisted. Unspecified medical attention was sought. This is one of several reports received from the same source. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Flank pain, Herpes zoster, Rash
Clinical narrative: Information has been received from an 82 year old female patient with no known drug reactions-allergies and medical history, who on 16-DEC-2008 were vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included TOPROL XL tablets and SYNTHROID. On 28-DEC-2008 the patient started feeling back pain. Later her right side (arm, hip and stomach) started hurting and a couple of days ago she started experiencing the rash on her right side that looked like measles. Her physician determined it was shingles. There were not laboratory studies performed. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. Follow-up information has been received from a physician who reported that the patient was vaccinated into the right arm with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (Lot #663196/1417X). Two weeks post vaccination on 30-DEC-2008 the patient developed right abdominal/flank shingles. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site pain
Clinical narrative: Information has been received from a 75 year old female with allergic to sulfa who was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # not reported) for prevention of shingles about 4 days ago, on approximately 29-DEC-2008. Concomitant therapy included LIPITOR. On 02-JAN-2009 the patient experienced pain at injection site and had an upset stomach. "Routine labs" were performed. The patient was not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Burning sensation
Clinical narrative: Information has been received from an office manager concerning a female nurse with a history of shingles who on 31-DEC-2008 was reconstituting ZOSTAVAX (Oka/Merck) to give to a patient. When she was injected the diluent into the vial, the pressure was so much that the vaccine sprayed back into face and eyes. Her face feels like it was burning but her eyes have no issues. It was reported that the nurse flushed her eyes and face with water. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who on approximately 24-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck). On an unknown date after vaccination, the patient developed shingles. The physician may be interested in VZV analysis by PCR and wanted to send viral isolates. Follow up information was received from a physician, he reported that the patient had a dose of ZOSTAVAX "one week ago" on his right arm. It was reported that the patient had developed topical vesicles in his right shoulder, arm and right upper chest. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dental operation, Injection site mass
Clinical narrative: Information has been received from a 60 year old nurse practitioner with no pertinent medical history reported and no drug reaction/allergies, reporting that she received ZOSTAVAX (Oka/Merck) on 03-DEC-2008 subcutaneously. Concomitant therapy included vitamin D (unspecified) and calcium (unspecified). On 11-DEC-2008 she had dental surgery. By 14-DEC-2008, she noticed that there were a cluster of vesicles on the roof of her mouth on her hard palate. She went back to the dentist who thought that it might be herpes simplex-1. The nurse practitioner was prescribed an unspecified pain pill. She also mentioned that she developed a small lump at the injection site. By 25-DEC-2008, the patient recovered from the event. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of ZOSTAVAX (lot # not reported) by the intramuscular route. No adverse effect reported. Follow-up information was received from a registered nurse which reported that the 67 year old patient was a male who was vaccinated IM into the left deltoid with a first dose of ZOSTAVAX (Oka/Merck) (lot # 662859/1561X) at 10:15 am on 23-DEC-2008. There was on illness at the time of vaccination. It was reported that on an unspecified date the patient developed a sore arm that last for 3-4 days. No other symptoms. No relevant lab tests were performed. At the time of reporting, the patient's outcome was unknown. Follow-up information was received from the R.N. on 19-FEB-2009 which reported that the patient was a female. Her vaccine was given at 10:00 am, 23-DEC-2008. The patient had a joint problem in shoulder prior to the injection. The reporter stated that on 19-FEB-2009, "talked to the patient today and muscle was fine, no redness and soreness". The patient recovered on an unspecified date. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Information has been received from a 63 year old female consumer with penicillin allergy who reported that she received a single dose of ZOSTAVAX (Oka/Merck) in April 2008. Concomitant therapy included NEXIUM. The patient recently went on a trip and started experiencing an itchy patch on her upper back. The patch was on her left side, and a week later she had another itchy patch on her lower back. She went to the hospital for check up and the Physician's Assistant there stated that if it was painful he would have said it was shingles. The patches were extremely itchy and hot but not painful at all. The patches started spreading and were mostly confined to her left side. The patches were around her ankles and knees, buttocks and back. There was patch on her right side on her collar bone. The areas were itchy and developed round, red welts that were different sizes and hard to touch. The welts seem to only come out at night. She came back from the trip about a week ago and went to see her physician and a dermatologist. The patient also mentioned that 12 years ago she took prednisone (manufacturer unspecified) and experienced gastroesophageal reflux disease. She was prescribed prednisone for the welts as well as other medication; however the welts were getting worse. Lab diagnostics Studies Performed include a biopsy, the outcomes unknown yet. At the time of reporting the patient was not recovered. No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 66 year old female patient with no known drug reactions/allergies and asthma who on 15-DEC-2008 was vaccinated subcutaneously into the left deltoid with a 0.65ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ADVAIR. The nurse reported that on 22-DEC-2008 the patient experienced injection site pain, redness, tenderness and swelling. The patient sought unspecified medical attention by phone. At the time of reporting the patient was not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a female who on 19-DEC-2009 was vaccinated with "one dose" of ZOSTAVAX (Oka/Merck) (lot # not reported). It was reported that the patient visited the clinic yesterday, 22-DEC-2008, because her arm got swollen and she was experiencing pain and itching on her neck. The patient experienced upper arm swollen, pain in neck and itching in neck. Patient's outcome was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Body temperature increased, Chest pain, Herpes zoster, Rash macular
Clinical narrative: Information has been received from a nurse concerning a 68 year old female patient with hypertension who on 08-FEB-2008 was vaccinated in her left arm with a 0.65 mL dose of ZOSTAVAX (Oka/Merck) (LOT # 658398/1087U). "Approximately 10 days ago" the patient developed shingles upon her return home from a vacation. The nurse reported that the patient started with back pain and was put on VALTREX to treat her symptoms. The patient went back to her physician's office due to "being in a lot of pain". She was treated with a combination therapy of VICODIN, LYRICA and ULTRACET. At the time of reporting it is unknown if the patient recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. Follow-up information has been received from a physician concerning the patient with a history of chickenpox and no known allergies. Concomitant therapy included hydrochlorothiazide (manufacturer unknown), aspirin (manufacturer unknown), and lisinopril (manufacturer unknown). The rash was on her right lateral chest wall. It was an erythematous macular rash with vesiculation. Number of lesions was unknown but there were 3 scattered areas. Other systemic symptoms included pain in the right side of her chest. Her maximum temperature was 97.5 F. No specimen was taken because the vesicles healed. At the time of reporting the patient had recovered. No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash maculovesicular
Clinical narrative: Information has been received from a nurse concerning a 68 year old female patient with hypertension who on 08-FEB-2008 was vaccinated in her left arm with a 0.65 mL dose of ZOSTAVAX (Oka/Merck) (LOT # 658398/1087U). "Approximately 10 days ago" the patient developed shingles upon her return home from a vacation. The nurse reported that the patient started with back pain and was put on VALTREX to treat her symptoms. The patient went back to her physician's office due to "being in a lot of pain". She was treated with a combination therapy of VICODIN, LYRICA and ULTRACET. At the time of reporting it is unknown if the patient recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. Follow-up information has been received from a physician concerning the patient with a history of chickenpox and no known allergies. Concomitant therapy included hydrochlorothiazide (manufacturer unknown), aspirin (manufacturer unknown), and lisinopril (manufacturer unknown). The rash was on her right lateral chest wall. It was an erythematous macular rash with vesiculation. Number of lesions was unknown but there were 3 scattered areas. Other systemic symptoms included pain in the right side of her chest. Her maximum temperature was 97.5 F. No specimen was taken because the vesicles healed. At the time of reporting the patient had recovered. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a 61 year old female with an allergy to penicillin and no pertinent medical history who on 19-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (dose, route not reported) in the arm. Concomitant therapy included LIPITOR. On 19-DEC-2008 the patient developed an itchy rash all over her body shortly after vaccination. The patient was not hospitalized. As of 23-DEC-2008 the patient's itchy rash persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a 61 year old female with an allergy to penicillin and no pertinent medical history who on 19-DEC-2008 was vaccinated with ZOSTAVAX (Merck) (dose, route not reported) in the arm.  Concomitant therapy included LIPITOR.  On 19-DEC-2008 the patient developed an itchy rash all over her body shortly after vaccination.  The patient was not hospitalized.  As of 23-DEC-2008 the patient's itchy rash persisted.  Follow-up information was received from a physician who indicated that on 19-DEC-2008 the patient with hyperlipidaemia was vaccinated with her first dose of ZOSTAVAX (Merck) (lot number 662860/1617X) IM.  On 22-DEC-2008 3 days post vaccination the patient developed a purpuric "bury" rash on neck.  Concomitant therapy included LIPITOR 20mg and aspirin 81mg.  The rash was a bilateral dermatitic, nonvessicular errythematic on neck approximately 4X4 cm each.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female patient, with no pertinent medical history and no known drug reactions/allergies, who on 23-DEC-2008, was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 663199/1557X). There was no concomitant medication. The pharmacist reported that on 23-DEC-2008, the patient developed pain and erythema at the injection site. She had been treated it with ice. The patient stated to the pharmacist that she had always developed injection site pain and erythema after vaccinations, but this was worse than usual. At the time of the report, the patient had not recovered. The patient sought medical attention and was seen by the pharmacist. Additional information has been received from a Registered Pharmacist who reported that a patient received first dose of ZOSTAVAX (Oka/Merck) (Lot # 663199/1557X) intramuscularly on 23-DEC-2008 at 14:40 hours. On 23-DEC-2008 at 18:00 hours patient experienced red, hot, swollen at injection site. Also she experienced itching for 3 or more weeks. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck) about two weeks ago, and then within two weeks of receiving ZOSTAVAX (Oka/Merck) the patient had chickenpox like rash and it was itchy. No further information is available.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 81 year old female who in October 2008 was vaccinated with ZOSTAVAX (Oka/Merck), 0.65ml/once, SC Subsequently the patient developed shingles since vaccination. The patient sought medical attention. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Headache, Oral herpes
Clinical narrative: Information has been received from a pharmacist concerning a 74 year old male with a history of cold sores, who one year ago was diagnosed with Non-Hodgkin lymphoma (reported to be in complete remission for several moths) who on 20-Dec-2008 was vaccinated with ZOSTAVAX. The patient developed headache and cold sore the next day. The patient self medicated with 3 doses of Acyclovir 800mg on 21-Dec-2008 to treat the cold sore. It was reported that the patient's immune system was treated 3 days prior to vaccination and was reported to be completely normal. The patient called the pharmacist. No further information is available.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: Information has been received from a 62 year old male who "about 8 weeks ago" was vaccinated with single dose of series of ZOSTAVAX (Oka/Merck) and now the patient has genital herpes. At time of the report the patient's genital herpes outcome was unknown. The patient sought unspecified medical attention. Additional information has requested.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Fatigue, Headache, Herpes simplex
Clinical narrative: Information has been received from a male with a history of herpes simplex who was vaccinated with a single dose of ZOSTAVAX (Oka/Merck) (lot # not reported) on Saturday, 20-DEC-2008 and experienced a little headache and tiredness. The caller mentioned that he took a nap and when he woke up he noticed a herpes simplex on his chin. The caller took 3 doses of acyclovir (manufacturer unspecified) an wanted to know if that would interfere with the vaccine virus. Patient's outcome was not recovered. No further information is available.
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, MNQ, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient, who on an unspecified date, was vaccinated with ZOSTAVAX (Oka/Merck).  The physician reported that the patient received ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck0 (MSD).  The outcome is unknown.  Follow-up information from her physician indicated that she was a 15 year old female patient, with no known drug reactions/allergies, who on 19-DEC-2008 at 18:30, the patient was accidentally vaccinated with the first dose of ZOSTAVAX (Oka/Merck) (Lot # 659760/0159X), subcutaneously, instead of VARIVAX (Oka/Merck).  Concomitant therapy included the first dose of GARDASIL (Lot # 661530/0575X), intramuscularly, the first dose of MENACTRA (Lot # U2733AA), intramuscularly and the first dose of ENGERIX B (Lot # AHBUB5E2AA), intramuscularly.  There were no illnesses at the time of vaccination.   Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who was vaccinated with single dose of ZOSTAVAX about 6 months ago, and then within two weeks of receiving ZOSTAVAX the patient had chickenpox like rash and it was itchy. At the time of reporting, the patient outcome was unspecified. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Information has been received from a 62 year old female with "numerous reactions to other unspecified medication" who on 17-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included "many other unspecified medications". "Within 24 hours of vaccination", on approximately 17-DEC-2008 the patient experienced warmth, itching and a swollen band around her left arm near the injection site; the band was about three inches thick and felt like a big hives. No medical attention was sought. The patient planed to follow up with her physician's office later the morning of 19-DEC-2008 to determine what she could do to treat her symptoms. At the time of this report, as 19-DEC-2008, the outcomes were unknown. Follow-up information was received on 05-FEB-2009 from a physician who reported that the patient never reported any "adverse side effect" to the office. Additional information is not expected.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a 85 year old female patient, with codeine and sulfonamide allergy, who on 15-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 16-DEC-2008 the patient experienced injection site reaction, redness, swelling and pain. The patient did not seek medial attention. the patient's injection site reaction, redness, swelling and pain persisted. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash morbilliform, Rash pruritic
Clinical narrative: Information has been received from a 61 year old female patient with allergic reactions to antibiotics (had a reaction once to ERYTHROMYCIN), who on 26-NOV-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). There was no concomitant medication. On approximately 26-NOV-2008, after getting the vaccine, the patient experienced a rash on her abdomen. The rash came and went and it felt itchy. The patient had been taking BENADRYL and it helped a little however recently the rash had gotten worse and spread to the ribcage and back area. The rash looked like measles rash rather than Varicella rash, and it looked like it was under the skin. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. No further information is available.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Diagnostic procedure, Neuropathy peripheral
Clinical narrative: Information has been received from an 86 year old female with blood pressure and a history of shingles in April 2006, who on 07-DEC-2007 was vaccinated with a single dose of series ZOSTAVAX (Oka/Merck) (dose, route and lot # not reported). Concomitant therapy included DIOVAN. On 16-DEC-2008 the patient went to see a neurologist and she thought the test she had was a molecular gram, and from that test she was diagnosed with neuropathy in her legs and feet. The patient was not recovered form the neuropathy in her legs and feet. No further information provided. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Eye swelling, Pruritus, Rash macular, Swelling face
Clinical narrative: Information has been received from a 71 year old female patient with hypertension and no known drug reaction or allergies, who on 20-NOV-2008, was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included lisinopril, EFFEXOR, LEVOXYL, WAL-ITIN. The patient reported that the day after the vaccination, 21-NOV-2008, she developed a pimple below her mouth. Then, she started getting blotches on her face, which lasted on and off for 2 weeks. She reported that her face got swollen and her eyes were completely closed up by 06-DEC-2008. She was seen on 08-DEC-2008 and was given an unspecified shot, Z-PACK and prednisone. She felt like most of the symptoms resolved around 13-DEC-2008. However, about a week before the reporting date, her neck and ears were itchy. On 17-DEC-2008, her eyes were swelling again. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow-up information received on 13-FEB-2009, from her physician's assistant indicated that this patient had been traveling at the time of this adverse experience and had been exposed to many new and different environmental exposures, such as foods and soap. The reporter felt that this may had been the cause of this adverse experience. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Haematoma
Clinical narrative: Information has been received from a doctor of pharmacy concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Subsequently, "over a year ago" the patient had a hematoma from ZOSTAVAX (Oka/Merck). It was unknown if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. This is one of several cases received from the same source.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a doctor of pharmacy concerning a patient on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Subsequently, the patient "had extensive swelling and redness". It was unknown if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a doctor of pharmacy concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX. Subsequently, the patient had a local injection site reaction that was "the size of a silver dollar". It was unknown if the patient sought medical attention. At the time of reporting, the patient 's outcome was unknown. This is one of several cases received from the same source. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Pain in extremity, Pain of skin
Clinical narrative: Information has been received from a registered pharmacist concerning a 77 year old female patient who on 12-DEC-2008 was vaccinated subcutaneously in the left arm with a one dose of ZOSTAVAX (Oka/Merck) (LOT # 662991/1619X). On 15-DEC-2008 the patient developed tenderness to the touch down the injection arm but not at the injection site of the left arm. The patient stated "it feels like I'm going to break out in a cold sore". The pharmacist also reported that the patient had an upset stomach. The tenderness has begun to resolve without sequelae. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: Information has been received from a registered pharmacist concerning an unknown number of patients who were vaccinated with a dose of ZOSTAVAX that was possibly transported and improperly stored. No adverse effects was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients. Follow up information was received from the pharmacist who indicated that on 02-Dec-2008 they transported the vaccine to a clinic packed with cold packs in a cooler without a thermometer. So they have no way of confirming the temperature of the vaccine at the time of transport. They did not know to pack it dry ice. The vaccine was in the cooler for approximately 1 hour. She reported that only one patient received this vaccine. He was a 70 year old male who on an unspecified date received a dose of zoster vaccine live (Oka/Merck), lot # 658861/1822U.  When asked if he had any adverse reaction, the pharmacist reported nothing she could identify. She also reported this patient had left inguinal hernia surgery done 06-Oct-2008, prior to the vaccination, and had his right inguinal hernia surgery on 15-Dec-2008. He was discharged the same day. She did not think the procedure had anything to do with the vaccination as he had prior surgery for the other side before the vaccination. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Pruritus, Rash vesicular
Clinical narrative: Initial information has been received from an office coordinator and follow up information has been received from a physician concerning a 59 year old female patient maintained on unspecified hormone replacement therapy with hypothyroidism and sulfonamide allergy and a history of hormone replacement therapy who on 16-OCT-2007 was vaccinated subcutaneously in her left deltoid area with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified). On an unspecified date the patient experienced shingles on the right trunk section of her body and some itchiness but it was not painful. The patient was prescribed with ZOVIRAX one tablet five times a day to treat her symptoms. It is unknown if the patient recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. Follow-up information has been received from a physician concerning the patient with latex allergy who on "09-OCT-2007" (originally reported as 16-OCT-2007) was vaccinated subcutaneously in her left deltoid area with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included CHANTIX. On 17-DEC-2008 the patient developed herpes zoster with "itching, pain". There was no recent exposure to chickenpox or herpes zoster. The sample of the lesion was collected on 18-DEC-2008. The source of the specimen was vesicular zoster rash, number of lesions was not specified but there were 6 linear patches noted. A photo of the lesions was taken. At the time of reporting the patient had not recovered. Follow-up information has been received from a physician. The sample was taken from a vesicular lesion and there was erythema. Date of PCR analysis was 19-DEC-2008. VZV DNA was amplified and it identified VZV WILD TYPE STRAIN from an adequate specimen. No further information is available.
Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Varicella zoster virus serology positive
Clinical narrative: Initial information has been received from an office coordinator and follow up information has been received from a physician concerning a 59 year old female patient maintained on unspecified hormone replacement therapy with hypothyroidism and sulfonamide allergy and a history of hormone replacement therapy who on 16-OCT-2007 was vaccinated subcutaneously in her left deltoid area with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified). On an unspecified date the patient experienced shingles on the right trunk section of her body and some itchiness but it was not painful. The patient was prescribed with ZOVIRAX one tablet five times a day to treat her symptoms. It is unknown if the patient recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. Follow-up information has been received from a physician concerning the patient with latex allergy who on "09-OCT-2007" (originally reported as 16-OCT-2007) was vaccinated subcutaneously in her left deltoid area with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included CHANTIX. On 17-DEC-2008 the patient developed herpes zoster with "itching, pain". There was no recent exposure to chickenpox or herpes zoster. The sample of the lesion was collected on 18-DEC-2008. The source of the specimen was vesicular zoster rash, number of lesions was not specified but there were 6 linear patches noted. A photo of the lesions was taken. At the time of reporting the patient had not recovered. Follow-up information has been received from a physician. The sample was taken from a vesicular lesion and there was erythema. Date of PCR analysis was 19-DEC-2008. VZV DNA was amplified and it identified VZV WILD TYPE STRAIN from an adequate specimen. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Blister
Clinical narrative: Information has been received from a registered nurse who on unspecified date developed shingles like blisters from giving ZOSTAVAX to patients. She had little blisters on her hands. As of 17-Dec-2008 the outcome was unknown. No further information is available.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning a 75 year old female patient who on 23-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot # 659326/1824U). On 09-DEC-2008 the patient was diagnosed with shingles. The patient developed 4-5 lesions in the right axillary area. No treatment was prescribed. As of 17-DEC-2008 the patient was recovering. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 71 year old male who on 09-DEC-2008 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Oka/Merck) (lot # 662856/1559X). Concomitant therapy included TRICOR, COUMADIN and TOPROL XL TABLETS). On 15-DEC-2008 the patient experienced a fever of 100 degres. Also the patient experienced itching, chills and redness at the injection site.  The patient sought uspecified medical attention.  Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a 56 year old male patient with dialysis and allergy to tetracycline who on 11-DEC-2008 was vaccinated in the arm with a dose of ZOSTAVAX (Oka/Merck) (Lot # is not available). The patient was unsure if he has ever had chickenpox and he had a titer test done but it was inconclusive. Concomitant medication included many unspecified medications. On 12-DEC-2008 the patient experienced itchiness under his belly button. There were no Laboratory Diagnostics Studies performed. At the time of the report on 12-DEC-2008 the patient was not recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness
Clinical narrative: Information has been received from a nurse practitioner concerning a 65 year old female patient with hypertension and osteoporosis, who on 15-DEC-2008 was vaccinated with 0.65 ml of a dose of ZOSTAVAX (Oka/Merck) (Lot not reported). Concomitant therapy included lisinopril-HCTZ, alendronate sodium and CYMBALTA. On 16-DEC-2008 the patient developed headache and flu like symptoms. As of 16-DEC-2008 the patient's symptoms persisted. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Pain, Rash, Rash papular
Clinical narrative: Information has been received from a medical assistant concerning a 60 year old female patient with drug hypersensitivity to DEMEROL and no pertinent medical history, who on 09-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included calcium (unspecified) and vitamin D (unspecified). On 12-DEC-2008 the patient developed a rash on her chest. The patient was examined in the office on 16-DEC-2008 was diagnosed with possible shingles. The rash was distributed on the mid-anterior chest wall extending to the epigastric area and consisted in non-vesicular, non-pustular, pruritic, mildly painful lesions. The patient was prescribed CLARITIN and topic KENALOG cream. The patient's shingles persisted as of 16-DEC-2008. Follow up information has been received from a nurse practitioner and a physician concerning a 60 year old female patient with drug hypersensitivity to DEMEROL and a history of chickenpox in her childhood, who on 09-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 662856/1559X). Concomitant therapy included calcium (unspecified) and vitamin D (unspecified). On 16-DEC-2008 (previously reported as 12-DEC-2008) the patient developed rash-papules 35+ bilateral lesions mid upper anterior chest and was diagnosed with possible shingles. The affected dermatomes were C4 and T2-T4 with a qualified pain as 3 from 0-10 (Most). A photo of the lesion was taken (16-DEC-2008) showing skin eruptions on chest. On 22-DEC-2008 the patient was "almost completely" recovered. Additional information is not expected.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site irritation, Rash
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 66 year old patient who on 16-Dec-2008 was vaccinated with a dose of ZOSTAVAX (lot# 66856/1559X). While a dose of ZOSTAVAX was being given the patient experienced burning at the site. After 5 minutes ZOSTAVAX was given, the patient also had a "mosquito bite size rash". It was unknown if the patient sought medical attention. As of 16-Dec-2008, the had not recovered. This is one of several cases received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received from a female who on an unknown date, was vaccinated with ZOSTAVAX (Oka/Merck) (lot# not reported). Subsequently the patient reported, "I have a red, itchy outbreak on abdomen" and she wanted to know if it was from the vaccine. It was unspecified if the patient sought medial attention. No further information is available.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her 73 year old male husband with a pacemaker and a defibrillator, and a history of both knees and hips replaced; who on 02-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). It was reported that the patient was on therapy with other unspecified medications. Around the first week of November 2008, the patient experienced pain in his hip and by mid-November developed the shingles. Patient had received two nerve blocks to help with the pain associated with the shingles. The patient sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a female patient who on 26-Nov-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Oka/Merck). On approximately 26-Nov-2008, since received the ZOSTAVAX, the patient developed an intermittent rash on her abdomen. The rash was characterized by flat, red lesions that were itchy. The rash was localized to the abdomen and got worse in dry weather. It is unknown if the patient sought medical attention. At the time of reporting, the patient had not recovered. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female patient with no drug reactions/allergies, who on 12-DEC-2008 was vaccinated subcutaneously on the right arm with a dose of ZOSTAVAX (Oka/Merck) (Lot # 662996/1618X). On 13-DEC-2008 the patient developed an irritating/itchy rash on the right arm at the injection site and on the right shoulder. The patient reported the rash to the pharmacist during a follow-up phone call. VZV analysis offered. Pharmacist said it was not his call and that the rash was not vesicular. It is unknown if the patient sought medical attention.  At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Excoriation, Herpes zoster, Pain
Clinical narrative: Information has been received from a nurse concerning a 75 year old male patient with a history of large cell lymphoma who on 21-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Lot# 658395/0966U). Concomitant therapy included NORVASC, LIPITOR, PAXIL, PRILOSEC and "bysiolene" (Therapy unspecified). On 05-DEC-2008 the patient developed shingles. The patient received treatment with VICODIN. As of 12-DEC-2008 the patient was recovering. Follow up information has been received from a completed Herpes Zoster questionnaire from a registered nurse concerning a 74 year old male with hypertension, gastroesophageal reflux disease, sulfonamide allergy and CELEBREX and a history of disseminated large cell lymphoma and anemia who on 02-NOV-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot #: 658395/0966U) in the left deltoid. Concomitant therapy included NORVASC, LIPITOR, PAXIL, PRILOSEC, MYSOLINE and vitamins (unspecified). On 20-NOV-2008 the patient developed pain and excoriated vesicles in right thorax. On 05-DEC-2008 the patient developed herpes zoster in the 8 right thoracic dermatome, the lesions were grouped and with approximately 7 days of duration. The pain was quantified as 4 from a range 0-10 (Most). At the time of reporting the patient was recovered (2008). Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Oral herpes
Clinical narrative: Initial and follow-up information has been received from 62 year old female pharmacist prone to fever blister who on 05-DEC-2008 at 10:00 was vaccinated subcutaneously with a second dose of ZOSTAVAX (Oka/Merk) (lot # not available). Concomitant therapy included COUMADIN, ZOLOFT and LIPITOR. The patient presented with a large fever blister in her lips on 09-DEC-2008 approximately 4 days after receiving the vaccine. Patient gets fever blisters once or twice a year after exposure to sun or from upper respiratory infections. Neither event happened in December. In only unusual event was being immunized. The patient recovered on 12-DEC-2008. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a female physician who on 10-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The physician stated that the night of the vaccination day her arm started to swell at the injection site. At the time of reporting the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain of skin
Clinical narrative: Information has been received from a 65 year old female with diabetes who in July or August 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included LIPITOR and ACTOS. About 10 days ago the patient developed pain under her skin on her right side. The pain extends up to her breast and around her back. There are some red spots. The physician stated that the pain is caused by ZOSTAVAX (Oka/Merck) but it is not shingles. At the time of reporting the patient had not recovered. The patient was seen for an office visit. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a physician concerning a 78 year old male patient with hypertension, artery coronary disease and diabetes and a history of chickenpox and lipids increased who on 05-JAN-2007 (also reported as about a year ago) was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot n 652947/1411F), 0.65 ml. in the left arm. No rash appeared at the site of injection or elsewhere within 42 days of vaccination. On 02-OCT-2008 (also reported as about 4-8 weeks ago), the patient developed shingles which turned into post herpetic neuralgia localized in T3 level, afebrile and pain with the maximum intensity (10). The patient sought unspecified medical attention. The patient did not have any other systemic symptoms. The patient did not have a recent exposure to chickenpox.  At the time of the reporting post herpetic neuralgia persisted. No additional information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a patient who two to three days ago was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (LOT 662860/1617X). On an unknown date the patient developed a rash "the size of a half dollar" at the injection site where ZOSTAVAX vaccine (Oka/Merck) was given. At the time of reporting the patient had not recovered. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Hypoaesthesia oral
Clinical narrative: Information has been received from a health professional concerning a 67 year old female with an allergy to latex, who on 10-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 663198/1419X). On an unspecified date the patient had numbness of her lips and a "weird taste" in her mouth. The patient had not recovered. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood pressure, Dizziness, Heart rate, Immediate post-injection reaction
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old male with hypercholesterolemia who on 10-DEC-2008 was subcutaneously vaccinated with a single dose of ZOSTAVAX (Oka/Merck) (lot #662858/1558X). Concomitant therapy included unspecified cholesterol medication. On 10-DEC-2008 the patient experienced a feeling of generalized weakness immediately after administration of ZOSTAVAX (Oka/Merck). The patient's vital signs were normal and he was being monitored in the office. The patient was administrated orange juice and was recovering at the time of the report. Follow up information was received from a registered nurse who reported the male patient was subcutaneously vaccinated with the first dose of ZOSTAVAX (Oka/Merck) (lot #662858/1558X) into the right deltoid at 11:30 on 10-DEC-2008. On the same day at 11:45 the patient began to experience weakness and light headedness. He performed blood pressure monitor for 1 hour and results included BP 120/80 and 120/82, P 78. In about 1 and 1/2 hours patient recovered completed. No residual problems. Additional information is not expected.