chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered pharmacist concerning a 60 year old male patient with no drug reactions or allergies who on 19-OCT-2010, was vaccinated in the left arm with 0.65 ml dose of ZOSTAVAX (Merck) (Lot# 664636/0874Y). It was reported that on 19-OCT-2010, the patient experienced stinging at the injection site. At the time of report, the patient's outcome was unknown. The patient sought unspecified medical attention. No further information is available.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a Registered Pharmacist concerning a current 61 year old patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). The pharmacist reported that on an unspecified date, the patient experienced injection site reactions. At the time of the report, the outcome of the patient was unknown. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain of skin
Clinical narrative: Information has been received from a licensed practical nurse concerning a male patient "in his 80's" who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (lot # and expire date not reported), 0.65 ml, subcutaneously. On an unspecified date, the patient developed shingles on the face and in the scalp area. The patient sought medical attention by a dermatology visit. At the time of the report, the outcome of the patient was unknown. Follow up information received from the licensed practical nurse indicated that the patient was a 78 years old retired male, who on 26-MAR-2007 was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 ml, subcutaneously. The nurse reported that the vaccine was not given at her office. The patient had a visit to the nurse's office on 23-SEP-2010 for pain on his scalp. On an unspecified date the patient saw a dermatologist; the dermatologist reported that the patient had an atypical shingles episode. On an unspecified date the patient recovered from pain. It was reported that "he did not have an adverse reaction to the vaccine; It's just that he probably got shingles despite it". The patient felt that "his illness was much less severe than it could have been without the vaccine". The patient's outcome was unknown. Follow-up information received from a completed questionnaire indicated that a rash did not occurred at the site of injection or elsewhere within 42 days of the vaccination. The onset date of the herpes zoster was reported as September 2010. Follow-up has been received from a licensed practitioner nurse who stated that there was no true adverse reaction. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician assistant's nurse concerning a 73 year old male who on 17-MAR-2009 was vaccinated with the first 0.65 ml dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). Concomitant therapy included a statin and Angiotensin Converting Enzyme (ACE) inhibitor. On 27-SEP-2010 the patient presented with shingles with severe pain even though he was given ZOSTAVAX (Merck). The patient was given VALTREX (GSK) for this AE. The patient sought unspecified medical attention. At the time of report, the patient's present status was not recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal chest pain, Neuralgia
Clinical narrative: Information has been received from a nurse concerning her 63 year old mother with no pertinent medical history who on 05-NOV-2008 was vaccinated with the first 0.65ml dose of ZOSTAVAX (Merck) (lot# not reported). There was no concomitant medication. On 29-SEP-2010 the patient "came back complaining of rib pain and ended up developing a full blown case of shingles. The patient was given acyclovir (manufacturer/description unspecified) to treat the AE. The patient was still experiencing nerve pain. At the time of this report, the patient was recovering. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Oedema peripheral, Skin discolouration, Skin warm
Clinical narrative: Information has been received from a 60 year old female with scopolamine allergy and no pertinent medical history who on 13-DEC-2010 was vaccinated with ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included rizatriptan benzoate. On 14-DEC-2010 the patient had some swelling and warmth as well as some bruising and redness about the size of a baseball. The swelling, warmth, bruising and redness were located below the injection site, closer to the elbow. The patient received no treatment. The outcome of the events was not reported. No lab diagnostics studies performed. The patient did not seek medical attention. Follow up information has been received from the patient who reported that she received ZOSTAVAX (Merck) from a pharmacist. Her arm was swollen, hot and discolored. She returned to the pharmacist but the pharmacist was off till next day. By then (day 3) her arm was much better. The patient did not see her physician for the injection. The patient was fine at the time of this report. No further information is expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old male patient who on 19-DEC-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# 669589/1453Z. Exp date, 28-JAN-2012), may be by the intradermal route. Pharmacist reported that on 19-DEC-2010 the patient had developed a red, warm lump the size of a quarter at the injection site. It was also reported that the lump began shortly after vaccination. At the time of the report the patient had not recovered from these symptoms. The patient sought medical attention by calling pharmacy. Follow-up information has been received from the Registered Pharmacist, who reported that the male patient with no illness at the time of vaccination and no pre-existing allergies, birth defects, medical conditions, was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot# 669589/1453Z. Exp date. 28-JAN-2012), SQ, Right arm, at 16:00 on 19-DEC-2010. The pharmacist stated that on 19-DEC-2010 the patient experienced a red lump immediately formed post injection. The pharmacist also stated that the lump was red and warm to the touch and became itchy after 1 day on 20-DEC-2010. The pharmacist mentioned that the patient had seen a Doctor who stated that these events were a slight reaction and did not prescribe anything. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). The physician stated that the patient developed herpes simplex in her genitalia. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Follow-up information has been received from a physician who reported that he had received that stated, the case and there was no relationship to the vaccine and the incident. No further information is available.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site rash, Nausea, Pruritus, Rash erythematous
Clinical narrative: Information has been received from a registered pharmacist concerning an 85 year old female patient with no known allergies who on 13-DEC-2010, was vaccinated SQ with a single 0.65 ml dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included SYNTHROID, ACIPHEX, LUNESTA, ATIVAN and aspirin. Pharmacist reported that on 20-DEC-2010, the patient returned to the pharmacy complaining of chills, nausea, itching on two locations on the back, between the shoulder blades and on the back at the waistline; as well as a rash at the injection site, described as raised, red and approximately 2x2 inches in size. There were not lab diagnostics studies performed. The patient sought unspecified medical attention. At the time of the report, the patient's outcome is unknown. Follow-up information has been received from the pharmacist who reported that the retired female patient was vaccinated with SQ with a 0.65 ml first dose of ZOSTAVAX (Merck) (Lot# 669408/1384Z), arm, on 13-DEC-2010, at 13:00. Pharmacist reported that unknown time on 14-DEC-2010 the patient experienced rash at the injection site with some itching, chills, nausea, rash on waist (Very light). In December 2010 the patient had recovered from these symptoms. No further information is available.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 75 year old male patient who on 16-DEC-2010 was vaccinated with ZOSTAVAX (Merck) (lot # not reported) by another pharmacy. In December 2010 (also reported as on an unspecified date), the patient started to experience right leg pain from his hip to his shin. The patient was given PERCOCET for pain at night. At the time of reporting, the patient's right leg pain from his hip to his shin persisted. The patient had sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on 15-DEC-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, expire date and route not reported). After ZOSTAVAX (Merck) was administered, the patient told pharmacist she had shingles and had been having some achy back pain. The patient sought unspecified medical attention. The pharmacist stated that he did not see signs or symptoms of shingles. At the time of the report, the outcome of the patient was unknown. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Information has been received from a female patient who on an unspecified date was vaccinated with ZOSTAVAX (Merck). The patient developed several blisters after receiving her injection of ZOSTAVAX (Merck). The patient wanted to know if there was a possibility of the vaccine virus spreading to several of her pregnant co-workers and was referred to her physician. The status of the patient was unknown. No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old female who on 17-DEC-2010 was vaccinated with one dose of 0.65ml ZOSTAVAX (Merck) through subcutaneous. On 19-DEC-2010 the patient experienced pain in arm at the injection site especially when moving her arm, with redness and warmth to below the elbow. Unspecified medical attention had been sought. The patient was given BENADRYL and ADVIL for treatment. No laboratory diagnostics studies were performed. At the time of reporting, the patient was not recovered. Follow-up information was received from the pharmacist who reported that the patient with no illness at time of vaccination or pre-existing allergies, birth defects, medical conditions on 17-DEC-2010 was vaccinated with the first dose of ZOSTAVAX (Merck) (lot number 669533/1383Z) through subcutaneous. On 19-DEC-2010, the patient experienced redness, tenderness and warmth at injection site which spread towards shoulder and elbow and was treated with BENADRYL and ibuprofen and symptoms resolved by 23-DEC-2010 (also reported on 20-DEC-2010). There was no illness at time of vaccination. There was no pre-existing allergies, birth defects, medical conditions. No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old female who on 17-DEC-2010 was vaccinated with one dose of 0.65ml ZOSTAVAX (Merck) through subcutaneous. On 19-DEC-2010 the patient experienced pain in arm at the injection site especially when moving her arm, with redness and warmth to below the elbow. Unspecified medical attention had been sought. The patient was given BENADRYL and ADVIL for treatment. No laboratory diagnostics studies were performed. At the time of reporting, the patient was not recovered. Follow-up information was received from the pharmacist who reported that the patient with no illness at time of vaccination or pre-existing allergies, birth defects, medical conditions on 17-DEC-2010 was vaccinated with the first dose of ZOSTAVAX (Merck) (lot number 669533/1383Z) through subcutaneous. On 19-DEC-2010, the patient experienced redness, tenderness and warmth at injection site which spread towards shoulder and elbow and was treated with BENADRYL and ibuprofen and symptoms resolved by 23-DEC-2010 (also reported on 20-DEC-2010). There was no illness at time of vaccination. There was no pre-existing allergies, birth defects, medical conditions. No further information is available.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female patient with no allergies and no medical history who on 14-DEC-2010 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (Lot# 664636/0874Y), SQ. The patient also received on the same date a dose of PNEUMOVAX 23. Concomitant therapy included thyroid and FORTICAL. Pharmacist stated that on 16-DEC-2010 the patient developed "chicken pox like rash". There were no laboratories performed. BENADRYL and hydrocortisone was given, both topically as the treatment. At the time of the report the patient was recovering. The patient sought medical unspecified medical attention. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerumen impaction, Electrocardiogram abnormal, Herpes zoster, Pain, Painful respiration
Clinical narrative: Information has been received from a nurse practitioner concerning a "late 60's" year old female who "16-18 months ago", approximately in September 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not reported). The nurse practitioner reported that "recently" the patient developed a severe case of shingles with Post Herpetic Neuralgia (PHN) after vaccination with ZOSTAVAX (Merck). The patient was given unspecified treatment. It was unspecified if the patient sought medical attention. Upon the time of report, the patient present status was unknown. Additional information was received from medical records regarding a 75 year old obese female (65.5 inches, 180 pounds), non-smoker, non-drinker, with lupus, thyroid disorder, hypertension, back pain, osteoarthrosis (prim lower leg), chronic lymphedema of both legs, varicose veins, keratosis/acquired keratoderma, alopecia/telogen effluvium, "kidney and ureter disorders unspec," palpitations, degenerative joint disease, venous (peripheral) insufficiency, diverticulosis, polyarthritis/osteoarthritis with left knee injections of HYALGAN, and with a history of chicken pox (childhood), hypogastric pain, hysterectomy who on 10AUG09 received a dose of ZOSTAVAX 0.65 mL subcutaneously in the right arm. On 22JAN11, she developed a rash on dermatome T5-6 with numerous lesions to cover from mid back to left breast. Pain was a 9-10 out of 10. There was no recent exposure of chicken pox or herpes zoster. The patient reported that on the evening of 21JAN11, she had pain on her left lateral ribs and left back pain radiating around to the front underneath her breasts. She took some aspirin for it. Subsequently the patient was taken to the ER via ambulance because she thought she was having a myocardial infarction. She reported no high fevers, no chills, no difficulty breathing although it hurt to take a deep breath. Upon examination, the patient did have a red erythematous rash in the dermatomal pattern. It started in the midline of the left back in the T5-6 region which radiates around underneath the left breast typical of a herpes zoster. The patient's pain was limited to this dermatome. Concurrent medications were SYNTHROID, sulindac, MAXIDE, VICODIN, LIDODERM, NEURONTIN, prednisone, and PLAQUENIL. Patient was diagnosed with herpes zoster. Treatment included VICODIN and FAMVIR. Patient instructed to follow-up with her physician if worse. On 02FEB11, rash had begun to dry out but was still painful. There was peeling off of herpes zoster with scarring. On 03MAR11, patient had pain at the site which was significant especially anteriorly and she was wondering if her lupus could be making her pain worse. Patient complained of sleep has been poor because of the pain. BENADRYL apply to affected area for itching. Information received included the following events: abnormal EKG (22JAN11); bilateral ear wax, lost 13 pounds since 28OCT10 (02FEB11). Additional information has been requested. All available medical records will be provided upon request.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep, Post herpetic neuralgia, Rash, Rash erythematous, Scar
Clinical narrative: Information has been received from a nurse practitioner concerning a "late 60's" year old female who "16-18 months ago", approximately in September 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not reported). The nurse practitioner reported that "recently" the patient developed a severe case of shingles with Post Herpetic Neuralgia (PHN) after vaccination with ZOSTAVAX (Merck). The patient was given unspecified treatment. It was unspecified if the patient sought medical attention. Upon the time of report, the patient present status was unknown. Additional information was received from medical records regarding a 75 year old obese female (65.5 inches, 180 pounds), non-smoker, non-drinker, with lupus, thyroid disorder, hypertension, back pain, osteoarthrosis (prim lower leg), chronic lymphedema of both legs, varicose veins, keratosis/acquired keratoderma, alopecia/telogen effluvium, "kidney and ureter disorders unspec," palpitations, degenerative joint disease, venous (peripheral) insufficiency, diverticulosis, polyarthritis/osteoarthritis with left knee injections of HYALGAN, and with a history of chicken pox (childhood), hypogastric pain, hysterectomy who on 10AUG09 received a dose of ZOSTAVAX 0.65 mL subcutaneously in the right arm. On 22JAN11, she developed a rash on dermatome T5-6 with numerous lesions to cover from mid back to left breast. Pain was a 9-10 out of 10. There was no recent exposure of chicken pox or herpes zoster. The patient reported that on the evening of 21JAN11, she had pain on her left lateral ribs and left back pain radiating around to the front underneath her breasts. She took some aspirin for it. Subsequently the patient was taken to the ER via ambulance because she thought she was having a myocardial infarction. She reported no high fevers, no chills, no difficulty breathing although it hurt to take a deep breath. Upon examination, the patient did have a red erythematous rash in the dermatomal pattern. It started in the midline of the left back in the T5-6 region which radiates around underneath the left breast typical of a herpes zoster. The patient's pain was limited to this dermatome. Concurrent medications were SYNTHROID, sulindac, MAXIDE, VICODIN, LIDODERM, NEURONTIN, prednisone, and PLAQUENIL. Patient was diagnosed with herpes zoster. Treatment included VICODIN and FAMVIR. Patient instructed to follow-up with her physician if worse. On 02FEB11, rash had begun to dry out but was still painful. There was peeling off of herpes zoster with scarring. On 03MAR11, patient had pain at the site which was significant especially anteriorly and she was wondering if her lupus could be making her pain worse. Patient complained of sleep has been poor because of the pain. BENADRYL apply to affected area for itching. Information received included the following events: abnormal EKG (22JAN11); bilateral ear wax, lost 13 pounds since 28OCT10 (02FEB11). Additional information has been requested. All available medical records will be provided upon request.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation, Skin lesion, Weight decreased
Clinical narrative: Information has been received from a nurse practitioner concerning a "late 60's" year old female who "16-18 months ago", approximately in September 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not reported). The nurse practitioner reported that "recently" the patient developed a severe case of shingles with Post Herpetic Neuralgia (PHN) after vaccination with ZOSTAVAX (Merck). The patient was given unspecified treatment. It was unspecified if the patient sought medical attention. Upon the time of report, the patient present status was unknown. Additional information was received from medical records regarding a 75 year old obese female (65.5 inches, 180 pounds), non-smoker, non-drinker, with lupus, thyroid disorder, hypertension, back pain, osteoarthrosis (prim lower leg), chronic lymphedema of both legs, varicose veins, keratosis/acquired keratoderma, alopecia/telogen effluvium, "kidney and ureter disorders unspec," palpitations, degenerative joint disease, venous (peripheral) insufficiency, diverticulosis, polyarthritis/osteoarthritis with left knee injections of HYALGAN, and with a history of chicken pox (childhood), hypogastric pain, hysterectomy who on 10AUG09 received a dose of ZOSTAVAX 0.65 mL subcutaneously in the right arm. On 22JAN11, she developed a rash on dermatome T5-6 with numerous lesions to cover from mid back to left breast. Pain was a 9-10 out of 10. There was no recent exposure of chicken pox or herpes zoster. The patient reported that on the evening of 21JAN11, she had pain on her left lateral ribs and left back pain radiating around to the front underneath her breasts. She took some aspirin for it. Subsequently the patient was taken to the ER via ambulance because she thought she was having a myocardial infarction. She reported no high fevers, no chills, no difficulty breathing although it hurt to take a deep breath. Upon examination, the patient did have a red erythematous rash in the dermatomal pattern. It started in the midline of the left back in the T5-6 region which radiates around underneath the left breast typical of a herpes zoster. The patient's pain was limited to this dermatome. Concurrent medications were SYNTHROID, sulindac, MAXIDE, VICODIN, LIDODERM, NEURONTIN, prednisone, and PLAQUENIL. Patient was diagnosed with herpes zoster. Treatment included VICODIN and FAMVIR. Patient instructed to follow-up with her physician if worse. On 02FEB11, rash had begun to dry out but was still painful. There was peeling off of herpes zoster with scarring. On 03MAR11, patient had pain at the site which was significant especially anteriorly and she was wondering if her lupus could be making her pain worse. Patient complained of sleep has been poor because of the pain. BENADRYL apply to affected area for itching. Information received included the following events: abnormal EKG (22JAN11); bilateral ear wax, lost 13 pounds since 28OCT10 (02FEB11). Additional information has been requested. All available medical records will be provided upon request.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with one dose of ZOSTAVAX (Merck) (Lot# unknown). The physician reported that "about a month ago" in approximately July 2010, the patient experienced a case of shingles. The patient's outcome was not reported. The patient sought unspecified medical attention. Follow up information has been received from the physician concerning the 70 year old retired female patient (previously reported as male) who in approximately July 2007 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). The physician reported that the patient developed shingles 3 years after vaccination. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Spinal X-ray, Urine analysis
Clinical narrative: Information has been received from a 67 year old female consumer with high blood pressure, type 2 diabetic, high cholesterol and thyroid disorder and drug reactions or allergies to penicillin who in February 2009, was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (dose, route and lot number not reported) L. Concomitant therapy included metformin, DIOVAN, levothyroxine Na, simvastatin (manufacturer unspecified) and AMITRIPTYLIN. The patient reported that 2 weeks ago, on approximately 13-AUG-2010, was diagnosed with shingles. An urine analysis and a spine x-ray were performed on an unspecified date (results not reported). At the time of the report the patient was recovering. Patient sought unspecified medical attention. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old female patient with arthritis, chronic obstructive pulmonary disease (COPD), osteoporosis, hypertension, hypercholesterolaemia and no known allergies who on 02-AUG-2010 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot# 665307/1171Y). Concomitant therapy included LIPITOR, allopurinol, MOBIC, hydrochlorothiazide and potassium chloride. On 02-AUG-2010, within 24 hours of receiving ZOSTAVAX (Merck), the patient developed an injection site reaction described as "red, raised, the size of a fifty-cent piece". Nurse further reported that the patient called the health department today ("20-AUG-2010") to report that she had developed a single pustule on an unspecified wrist at an unspecified time subsequent to the vaccination. There were no laboratory diagnostics studies performed. At the time of this report, the patient's outcome was not reported. Follow up information has been received from the registered nurse concerning the 67 year old female with arthritis, chronic obstructive pulmonary disease, osteoporosis, hypertension and hypercholesterolaemia and a history of kidney stone, fibromyalgia and chickenpox who on 02-AUG-2010, at 12:30, was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (also reported as VARIVAX (Merck)) (lot# 665307/1171Y) into the right deltoid. Concomitant therapy used at time of illness included tobramycin drops 3% for conjunctivitis. On 12-AUG-2010 the patient developed local reaction of right deltoid of injection, which was the size of egg, red, raised, itchy and warm that lasted for 5 days. She also developed 2 pustules on right wrist, 2-3mm in size with duration of 12 days. The patient had titer drawn prior to administration of vaccine and the titer results were positive. The patient had no recent exposure to chickenpox or shingles. The patient reported her pain to be 7-8 on a scale of 1 to 10. No photos had been taken. No specimen was collected and no direct antibody was done. At the time of this report, the patient had recovered. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from the registered nurse who confirmed that the patient was vaccinated ZOSTAVAX (Merck). Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old female patient with arthritis, chronic obstructive pulmonary disease (COPD), osteoporosis, hypertension, hypercholesterolaemia and no known allergies who on 02-AUG-2010 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot# 665307/1171Y). Concomitant therapy included LIPITOR, allopurinol, MOBIC, hydrochlorothiazide and potassium chloride. On 02-AUG-2010, within 24 hours of receiving ZOSTAVAX (Merck), the patient developed an injection site reaction described as "red, raised, the size of a fifty-cent piece". Nurse further reported that the patient called the health department today ("20-AUG-2010") to report that she had developed a single pustule on an unspecified wrist at an unspecified time subsequent to the vaccination. There were no laboratory diagnostics studies performed. At the time of this report, the patient's outcome was not reported. Follow up information has been received from the registered nurse concerning the 67 year old female with arthritis, chronic obstructive pulmonary disease, osteoporosis, hypertension and hypercholesterolaemia and a history of kidney stone, fibromyalgia and chickenpox who on 02-AUG-2010, at 12:30, was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (also reported as VARIVAX (Merck)) (lot# 665307/1171Y) into the right deltoid. Concomitant therapy used at time of illness included tobramycin drops 3% for conjunctivitis. On 12-AUG-2010 the patient developed local reaction of right deltoid of injection, which was the size of egg, red, raised, itchy and warm that lasted for 5 days. She also developed 2 pustules on right wrist, 2-3mm in size with duration of 12 days. The patient had titer drawn prior to administration of vaccine and the titer results were positive. The patient had no recent exposure to chickenpox or shingles. The patient reported her pain to be 7-8 on a scale of 1 to 10. No photos had been taken. No specimen was collected and no direct antibody was done. At the time of this report, the patient had recovered. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from the registered nurse who confirmed that the patient was vaccinated ZOSTAVAX (Merck). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: Information has been received from a physician concerning three patients who on unspecified dates was vaccinated with the dose of ZOSTAVAX (Merck) (LOT# not reported). On unspecified dates, the patients experienced shingles. The physician did not report the patients' outcomes at this time. It was unspecified if the patient sought medical attention. Follow-up information has been received from the physician who stated that he did not consider the adverse experience but considered them part of the 48% of patients who could potentially got shingles after receiving ZOSTAVAX (Merck). He said that no vaccine was 100% and that at least the cases of shingles that patients got after ZOSTAVAX (Merck) were milder. The physician reported that he could only remember one patient's name (had captured in WAES # 1009USA01617), starting the patient for this report and other patient (WAES# 1106USA04323) were not his patients but were patient's of other people in the practice. Follow-up information has been received on 14-SEP-2010 from the physician who on 07-SEP-2010 reported that the occurrence of this episode of shingles occurred 1.5 to 3 years after ZOSTAVAX (Merck) vaccination so the physician did not consider this to be reportable adverse event. Follow-up inconsistently information has been received from the physician who stated that the patient had no adverse reaction. This is one of several reports received from same source. No further information is available.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning an 84 year old female with hypertension and no known allergies who on 05-AUG-2010 was vaccinated subcutaneously with a 0.65 mL single dose of ZOSTAVAX (Merck) (LOT# not reported). Concomitant medication included unspecified blood pressure medication. On 24-AUG-2010, the patient called the pharmacy to report that she had 1.5 x 0.25 rash at the injection site. Pharmacist did not know when the rash started. The pharmacist didn't report the patient's outcome at this time. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Contraindication to vaccination, Neuralgia
Clinical narrative: Information has been received from a 65 year old female patient with Crohn's disease who on 20-AUG-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). Concomitant therapies included: SYNTHROID, NEXIUM and pravastatin sodium (manufacturer unknown). The patient was taking immunosuppressive medication, IMURAN (manufacturer/description unspecified) when she got vaccinated. On 24-AUG-2010 or 25-AUG-2010, after vaccination of ZOSTAVAX (Merck), she developed nerve pain on her left hand and wrist. "The following Friday or Saturday", on 27-AUG-2010 or 28-AUG-2010, she got blisters on her left hand and wrist. The patient sought unspecified medical attention. There was no lab diagnostic test performed. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 65 year old female patient with Crohn's disease who on 20-AUG-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). Concomitant therapies included: SYNTHROID, NEXIUM and pravastatin sodium (manufacturer unknown). The patient was taking immunosuppressive medication, IMURAN (manufacturer/description unspecified) when she got vaccinated. On 24-AUG-2010 or 25-AUG-2010, after vaccination of ZOSTAVAX (Merck), she developed nerve pain on her left hand and wrist. "The following Friday or Saturday", on 27-AUG-2010 or 28-AUG-2010, she got blisters on her left hand and wrist. The patient sought unspecified medical attention. There was no lab diagnostic test performed. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Contraindication to vaccination, Neuralgia
Clinical narrative: Information has been received from a physician concerning a 65 year old female patient with ulcerative colitis, amitriptyline allergy, amoxicillin allergy, azithromycin allergy and doxycycline allergy who on 20-AUG-2010 was vaccinated IM with a 0.5 ml dose of ZOSTAVAX (Merck) (lot number 665530/0697Z, expiration date 28-APR-2011). The patient was on immunosuppressant therapy, IMURAN. On 22-AUG-2010 the patient experienced swelling of left hand. Patient was seen by emergent care facility on 29-AUG-2010, then seen by physician on an unspecified date (reported as "30-AUG-2011"). Patient complained of pain running up left arm in addition to swelling of the hand. There was no lab diagnostic test performed. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 65 year old female patient with ulcerative colitis, amitriptyline allergy, amoxicillin allergy, azithromycin allergy and doxycycline allergy who on 20-AUG-2010 was vaccinated IM with a 0.5 ml dose of ZOSTAVAX (Merck) (lot number 665530/0697Z, expiration date 28-APR-2011). The patient was on immunosuppressant therapy, IMURAN. On 22-AUG-2010 the patient experienced swelling of left hand. Patient was seen by emergent care facility on 29-AUG-2010, then seen by physician on an unspecified date (reported as "30-AUG-2011"). Patient complained of pain running up left arm in addition to swelling of the hand. There was no lab diagnostic test performed. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Condition aggravated, Herpes zoster, Incorrect route of drug administration
Clinical narrative: Information has been received from a 69 year old female consumer with sulfa allergy concerning herself who on 17-AUG-2010 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included VALTREX, acyclovir and DARVOCET-N. On 24-AUG-2010 the patient was not feeling well. The consumer had joint pain, fever and nausea; now she had Shingles. The consumer also stated, "I have been having outbreaks since the 80's, and those symptoms always proceed before my outbreaks." She stated that she has used VALTREX (manufacturer unspecified) for treatment. The patient also mentioned that she thought the therapy route was done intramuscularly rather than subcutaneously. No medical attention was sought. Blood work was performed with no results reported. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: Information has been received from a 69 year old female consumer with sulfa allergy concerning herself who on 17-AUG-2010 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included VALTREX, acyclovir and DARVOCET-N. On 24-AUG-2010 the patient was not feeling well. The consumer had joint pain, fever and nausea; now she had Shingles. The consumer also stated, "I have been having outbreaks since the 80's, and those symptoms always proceed before my outbreaks." She stated that she has used VALTREX (manufacturer unspecified) for treatment. The patient also mentioned that she thought the therapy route was done intramuscularly rather than subcutaneously. No medical attention was sought. Blood work was performed with no results reported. At the time of this report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis contact
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who "6 days ago" on 19-MAY-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number not reported). The registered pharmacist reported that six days after administration of ZOSTAVAX (Merck), the patient was diagnosed with poison ivy dermatitis. At the time of the report, the patient's outcome was unknown. It was reported that the patient sought medical attention but the method was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 63 year old female without pertinent medical history or drug allergies who on 05-MAY-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 06-MAY-2011 the patient developed shingles. Concomitant therapy included TYLENOL and promethazine. The patient was treated with acyclovir for shingles. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 63 year old female patient with type 2 diabetes mellitus, osteoarthritis, "HT" body mass index increased, "DOD" and LEVAQUIN allergy with a history of recurrent shingles following prior vaccination who on 26-MAR-2010 was vaccinated with a SQ dose of ZOSTAVAX (Merck) (Lot# not reported), into the arm. The physician stated that on 20-APR-2010, the patient experienced acute herpes zoster post vaccination. It was unspecified if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 75 year old female patient with "sulfa", PRISTIQ, codeine and LYRICA allergies, type 2 diabetes mellitus, coronary artery disease and breast cancer and no illness at the time prior vaccination on 08-NOV-2007 at 10:00 am who was vaccinated SQ with the first dose of ZOSTAVAX (Merck) (Lot# not reported), into right arm. The physician stated that on 10-JAN-2011, the patient experienced recurrent shingles post vaccination. The physician reported that on unspecified date the patient experienced increase herpetic rash and neuralgia post vaccination. It was unspecified if the patient sought medical attention. On 21-JAN-2011, the patient had recovered. No further information is available.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: Information has been received from a 54 year old female physician (the current 57 year old) with type 2 diabetes mellitus and "MT" who on 21-MAY-2007 was vaccinated SQ in the left arm with the first dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included BYETTA, ADALAT CC, CIPRO and FLAGYL and "Z-pach". The physician stated that on 30-MAR-2011 (also reported as 02-FEB-2011), she experienced herpes simplex virus around mouth and eyes. The physician also stated that she did not have herpes simplex virus (HSV) symptoms before vaccination. There was no illness at time of vaccination. At the time of the report, the physician's outcome was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Incorrect dose administered
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female with no pertinent medical history and no drug reaction or allergies who on 09-MAY-2011 was vaccinated SC with 2 doses of ZOSTAVAX (Merck) (lot # 669260/0152AA; exp. 01-MAY-2012) at 7:30 pm and 8:45 pm. Concomitant therapy included zolpidem tartrate, VERAMYST, VALTURNA, LIPITOR, XYZAL, PRISTIQ and NAPROSYN. The pharmacist reported that the patient was experiencing severe chest pain on 09-MAY-2011 and she was directed to seek emergency treatment. At the time of the report, the status of the report was not reported. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin lesion
Clinical narrative: Information has been received from a 76 year old male patient with hypercholesterolaemia and a history of shingles and no drug reactions or allergies, who on 03-MAY-2011 was vaccinated with a single dose of ZOSTAVAX (Merck) (lot# not reported) subcutaneously. Concomitant therapy included LIPITOR and VALTREX. On 07-MAY-2011 the patient developed an itchiness in the middle of his back. On 08-MAY-2011 the patient noticed a dime-sized pink area of lesions on his back. The patient self-medicated with VALTREX, 500 mg on 08-MAY-2011 and again on 09-MAY-2011. The patient was evaluated in the physician's office on 10-MAY-2011 and was told to discontinue VALTREX at that time. No additional therapy was prescribed. The patient added that he had a history of getting shingles multiple times over the years and for the last year, he had taken VALTREX daily but he stopped taking it on 02-MAY-2010, the day before receiving ZOSTAVAX (Merck). No labs/diagnostics studies were performed. At the time of reporting, the patient was recovering from the events. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 53 year old female patient in her practice who on 04-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669406/1357Z, Exp 15-JAN-2012). The nurse reported that the patient experienced low grade fever, injection site redness and pain after receipt of ZOSTAVAX (Merck), the patient went to see doctor. At the time of the report, the status of the patient was not reported. This is one of several reports received from the same source. The nurse requested a lot check for the lot number. A lot check has been initiated. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Eye pain, Syringe issue
Clinical narrative: Information has been received from a Registered Pharmacist (RPh) concerning his 29 year old female associate who was accidentally exposed to an unknown amount of ZOSTAVAX (Merck), once, on 09-MAY-2011. Concomitant therapy included hormonal contraceptives (unspecified) (birth control pills). The patient had no relevant medical history or relevant concomitant medication. Her relevant past drug history was unknown. On 09-MAY-2011, about 90 minutes ago, the associate was administered ZOSTAVAX (Merck) to a pharmacy's consumer and accidentally, due to a needle dysfunctioning, she got some of ZOSTAVAX (Merck) into her both eyes. On 09-MAY-2011, she reported to the pharmacist that both of her eyes were hurting and stinging. There was no relevant laboratory data. As of 09-MAY-2011, she was no longer exposed to ZOSTAVAX (Merck) and her eyes continued to hurt and sting. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a doctor of pharmacy reporting that a physician reported to a patient that he had seen an increase trend of patients that were diagnosed with shingles after they had received ZOSTAVAX (Merck) (Lot number not reported). It was reported that shingles was diagnosed "more than two times a week" in a physician's practice. At the time of the report, the patient's outcomes were unknown. Attempts are being made to verify the existence of an identifiable patient. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 68 year old male patient who in 2009 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). Concomitant therapy included CRESTOR and ACTOS. The physician reported that on approximately 02-MAY-2011 ("last week") the patient experienced shingles. The patient sought unspecified medical attention. The therapy with VALTREX and LYRICA were given for the adverse event. At the time of reporting, the patient's status was unknown. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Rash, Rash erythematous
Clinical narrative: Information has been received from an 86 year old female with diabetes and no drug allergies who in "2009 or 2010" was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck). Concomitant therapy included ramipril and GLUCOPHAGE. Approximately one month after the vaccination, the patient experienced a red rash and spots all over her arms and legs and fingers, sometimes her fingers were numb. There was no lab diagnostics performed and the patient did not seek medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.