chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 62 year old male, with no history of drug allergies or reactions, who on approximately 29-OCT-2007 or 30-Oct-2007 was vaccinated with a dose of ZOSTAVAX (lot #658604/1088U).  Concomitant therapy included CADUET.  On approximately 29-OCT-2007 the patient experienced burning, swelling, and warmth at the injection site.  The patient's burning, swelling, and warmth at the injection site persisted.  Unspecified medical attention was sought.  No labs were performed.  No product quality complaint.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Follow-up information from the physician indicated that the 62 year old males with penicillin allergy who on 29-OCT-2007 was vaccinated with a dose of ZOSTAVAX vaccine (Merck) (lot#658604/1088U) in the left arm. There was no illness at the time of vaccination. On that same day immediately after the shot, the patient also developed a sore and red arm at the injection site. The patient did not seek medical attention. On 05-NOV-2007 the patient recovered. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a 63 year old male with hypertension who on 25-OCT-2007, was vaccinated with zoster vaccine live (Oka/Merck). Concomitant vaccines included influenza virus vaccine (unspecified). On 26-OCT-2007, the patient developed shingles. He was seen in the physician's office and therapy was initiated with acyclovir. It was reported that the health care provider was not interested in varicella zoster virus analysis. Current patient status was not reported. A product quality complaint was not reported. Additional information was not available. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a pharmacist concerning a female registered nurse who vaccinated a patient with a dose of ZOSTAVAX (Oka/Merck) contracted shingles.  It was reported that this was not the first time this nurse administered ZOSTAVAX (Oka/Merck) to a patient.  The nurse did received unspecified medical attention.  The has not yet recovered.  No product quality complaint.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling, Musculoskeletal pain, X-ray
Clinical narrative: Information has been received from a female with no pertinent medical history or allergies who on 19-OCT-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included amitriptyline hydrochloride (MSD), KLONOPIN and NORVASC.  On approximately 29-OCT-2007 (one week post vaccination) the patient developed swelling in both knees.  "The swelling continued down into both ankles before it began to resolve".  "Currently only one ankle remains swollen".  The patient sought unspecified medical attention.  On an unspecified date the patient had x-rays taken with pending results.  A product quality complaint was not involved.  Follow-up information was received on 13-NOV-2007 indicating the patient thinks the dose of ZOSTAVAX (Oka/Merck) was administered intramuscularly instead of subcutaneous.  This has not been confirmed by the nurse who administered the vaccine.  The patient stated that she experienced pain and swelling of her shoulder, knees, and ankles that lasted 2 weeks.  Patient also reported that she is almost recovered completely (minimal swelling remains in one ankle).  Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Rash, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning an 81 year old female with sulfonamide allergy and a history of glaucoma and gastroesophageal reflux disease, who on 07-NOV-2007 was vaccinated SC on right the right shoulder with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included Aciphex and timolol eye drops. On 08-NOV-2007, the patient developed a rash that was described a foot below the injection site near the elbow. The rash was described as a 3 X 3 inch square rash that is hard, red, hot and painful. The reaction has stayed "about" the same since 08-NOV-2007. No diagnostic laboratory tests were undertaken. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 28-year-old female who was vaccinated with a single dose of ZOSTAVAX (lot # "0426U") and was supposed to be given VARIVAX.  The patient did not have any adverse side effects.  A product quality complaint was not involved.  Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Ocular hyperaemia
Clinical narrative: Information has been received from a health professional concerning a 33 year old female who on 09-NOV-2007 while preparing a dose of ZOSTAVAX (Oka/Merck) (lot# 658209/1085U), she pulled back on the syringe and the solution splashed in her eyes.  It was reported that she flushed her eyes for ten minutes.  It was reported that she sought medical attention in the physician's office.  As of this report it was reported that her eyes are less red than they had been and that she feels fine.  At the time of this report the patient was recovering.  There were no laboratory or diagnostic tests performed.  A product quality complaint was not reported.  Additional information was not available.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a female who in August 2007, was vaccinated with a single dose of zoster vaccine live (Oka/Merck). In October 2007 (about 11 weeks post vaccination), the patient developed a chick pox like rash. The patient sought medical attention thru a physician. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old female with no pertinent medical history or drug allergies who on 01-OCT-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot# 658085/0882U).  There was no concomitant medication.  On 09-NOV-2007 the patient experienced shingles.  Medical attention was sought through the pharmacist.  No labs or diagnostic studies were performed.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 month old patient who on 02-NOV-2007 was vaccinated with zoster vaccine live (Oka/Merck) rather than varicella virus vaccine live (Oka/Merck). The nurse practitioner reports she was not aware of any product confusion. No problems were reported. There was no product quality complaint. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Skin lesion, Virus culture
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old male with hypertension and hypercholesterolaemia and no known drug allergies who on 23-OCT-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot# 658083/0885U) in the left arm.  Concomitant drug therapy included aspirin daily, NIASPAN ("NIASTAN"), simvastatin (MSD), INDERAL ("INDEROL"), lisinopril and hydrochlorothiazide.  On approximately 12-NOV-2007 the patient developed shingles on right posterior scalp and the neck at hairline.  Medical attention was sought in the physician's office on 12-NOV-2007.  A viral culture test was performed.  The patient was treated with VALTREX and prednisone.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested. 03/26/2008 Follow-up information received from the reporting registered nurse indicated that a 61 year old male developed shingles on 09-NOV-2007 characterized by a rash with 8-13 lesions to the right posterior scalp/upper neck extending behind the ear lasting 2 weeks. No other systemic symptoms were noted. There was no recent exposure to chickenpox or herpes zoster. A viral culture test was performed, but no photos, PCR or DFA were done. Additional follow-up information from a physician and medical records indicated there was no illness at the time of vaccination. The final result of the virus culture test collected on 12-NOV-2007 froma rash on the posterior scalp showed no virus isolated on 29-NOV-2007. On 30-NOV-2007 the patient recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Pharyngeal oedema, Rash, Stomatitis
Clinical narrative: Information has been received from an approximately 60 year old female consumer with allergies to penicillin and shellfish (crab meat), who on 17-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant drug therapy included other unspecified medications, but no new medications. Subsequently, the patient developed lip swelling, throat swelling, a rash on her chin and irritation in her mouth. Medical attention was sought in the physician's office on 12-NOV-2007. The patient was treated with Valtrex. The patient was not recovered at the time of this report. There was no product quality complaint. It was noted that the patient was scheduled for a follow-up visit with her health care provider on 14-NOV-2007. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Heat rash, Milk allergy, Rash erythematous, Rash pustular
Clinical narrative: Information has been received from an 84 year old female consumer with congestive heart failure, high blood pressure, diabetes and a penicillin allergy who on approximately 31-OCT-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  In November 2007, "a couple of days after getting ZOSTAVAX (Oka/Merck)" the patient developed a red rash under and on the front of her arms, on her face, stomach and rear-end.  The patient contacted the physician by phone for medical attention.  No labs or diagnostic studies were performed.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested. 03/26/2008 Folow-up information has been received from a physician, dermatologist and medical records indicating that the 84 year old female nursing home patient had a drug hypersensitivity to simvastatin (MSD), who on 25-OCT-2007 was vaccinated IM with a dose of ZOSTAVAX (Oka/Merck) in the deltoid. There was no illness at the time of vaccination. Concomitant drug therapy included famotidine, ZRYTEC, LOTENSIN, ZOLOFT, LIPITOR, LASIX, trazodone HCl, EFFEXOR and potassium chloride. In November 2007, a couple of days after vaccine, the patient developed a red rash. At the doctor visit the physician described the patient's event as a macular eruption in heat areas (concentrated in the arms, lower back, axillary, intra-mammary and neck). On 15-NOV-2007 the dermatologist described the rash as scattered non-blanchable macules on arms, chest with minimal itch for the past month. The dermatologist also observed a cayenne pepper staining on the chest, upper back, with no scaling or palpable lesions. On the left proximal forearm the patient developed a 1 mm pustule. The physician's assessment was a combination of capilaritis and miliaria. Lab diagnostic studies included a CBC, UA, and an ASO titer. The patient was treated with SARNA OTC PRN, CETAPHIL cleanser. The patient was recovered. It was also noted that the dermatologist doubted that the events were correlation to vaccination with ZOSTAVAX (Oka/Merck). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a child who in November 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck) instead of a dose of varicella virus vaccine live (Oka//Merck). It was reported as a medical error administered by the nurse. A product quality complaint was not involved. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a male patient who was vaccinated several months ago with zoster vaccine live (Oka/Merck). The nurse reported that another nurse and her husband were " indeed vaccinated with zoster vaccine live (Oka/Merck) IM instead of SQ". The nurse reported that the patient had a sore arm (unspecified) for a day or two after the vaccination was given. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old male with arrhythmia and bipolar disorder and a history of myocardial infarction and no allergies who on approximately 29-OCT-2007 was vaccinated with a dose of zoster vaccine live(Oka/Merck). Concomitant therapy included cyclophosphamide (+) doxorubicin, blood pressure medication, stomach medication and bipolar medication. On 09-NOV-2007 the patient developed shingles. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Acrochordon, Anaemia, Blood cholesterol increased, Body temperature increased, Diverticulum
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old female with high cholesterol, hypertension, osteoarthritis, gastroesophageal reflux disease, prednisone allergy, Terramycin allergy and penicillin allergy, who on 09-NOV-2007 was vaccinated SC on the right deltoid with a single 0.65 mL dose of zoster vaccine live (Oka/Merck) (Lot # 658602/1080U). Concomitant therapy included Diovan HCT, Norvasc, Daypro and a dose of influenza virus vaccine (unspecified). On 12-NOV-2007, the patient developed an injection site reaction. The reaction was described as 2X4 cm raised rash at the injection site area. The area of rash was described as warm, tender and itchy. Unspecified medical attention was sought. No diagnostic laboratory test were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. Additional information has been received from the licensed practical nurse concerning this 65 year old white female with cholesterol high, hypertension, osteoarthritis, gastroesophageal reflux disease, prednisone allergy, penicillin allergy, seborrhoeic keratosis, skin tags, acute gastritis, hypertriglyceridaemia, anaemia, diverticular disease and a terramycin allergy who on 09-NOV-2007 at 11:52 was vaccinated SC in the right deltoid with a first dose of zoster vaccine live (Oka/Merck) (lot # 658602/1080U). Concomitant vaccination included a second dose of FLUZONE (lot # U2489AA) given IM in the left deltoid at 11:50. Additional concomitant therapy included DIOVAN HCT, NORVASC, DAYPRO, XALATAN and omega-3 marine triglycerides. Illness at the time of vaccination included a sore throat and post nasal drip. On 12-NOV-2007 the patient experienced injection site warmth, tenderness and pruritis. Below the injection site there was an erythematous pruritic rash. The patient was seen in the office on 12-NOV-2007. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Drug hypersensitivity, Gastritis, Hypertriglyceridaemia, Injection site pain, Injection site papule
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old female with high cholesterol, hypertension, osteoarthritis, gastroesophageal reflux disease, prednisone allergy, Terramycin allergy and penicillin allergy, who on 09-NOV-2007 was vaccinated SC on the right deltoid with a single 0.65 mL dose of zoster vaccine live (Oka/Merck) (Lot # 658602/1080U). Concomitant therapy included Diovan HCT, Norvasc, Daypro and a dose of influenza virus vaccine (unspecified). On 12-NOV-2007, the patient developed an injection site reaction. The reaction was described as 2X4 cm raised rash at the injection site area. The area of rash was described as warm, tender and itchy. Unspecified medical attention was sought. No diagnostic laboratory test were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. Additional information has been received from the licensed practical nurse concerning this 65 year old white female with cholesterol high, hypertension, osteoarthritis, gastroesophageal reflux disease, prednisone allergy, penicillin allergy, seborrhoeic keratosis, skin tags, acute gastritis, hypertriglyceridaemia, anaemia, diverticular disease and a terramycin allergy who on 09-NOV-2007 at 11:52 was vaccinated SC in the right deltoid with a first dose of zoster vaccine live (Oka/Merck) (lot # 658602/1080U). Concomitant vaccination included a second dose of FLUZONE (lot # U2489AA) given IM in the left deltoid at 11:50. Additional concomitant therapy included DIOVAN HCT, NORVASC, DAYPRO, XALATAN and omega-3 marine triglycerides. Illness at the time of vaccination included a sore throat and post nasal drip. On 12-NOV-2007 the patient experienced injection site warmth, tenderness and pruritis. Below the injection site there was an erythematous pruritic rash. The patient was seen in the office on 12-NOV-2007. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Oropharyngeal pain, Postnasal drip
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old female with high cholesterol, hypertension, osteoarthritis, gastroesophageal reflux disease, prednisone allergy, Terramycin allergy and penicillin allergy, who on 09-NOV-2007 was vaccinated SC on the right deltoid with a single 0.65 mL dose of zoster vaccine live (Oka/Merck) (Lot # 658602/1080U). Concomitant therapy included Diovan HCT, Norvasc, Daypro and a dose of influenza virus vaccine (unspecified). On 12-NOV-2007, the patient developed an injection site reaction. The reaction was described as 2X4 cm raised rash at the injection site area. The area of rash was described as warm, tender and itchy. Unspecified medical attention was sought. No diagnostic laboratory test were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. Additional information has been received from the licensed practical nurse concerning this 65 year old white female with cholesterol high, hypertension, osteoarthritis, gastroesophageal reflux disease, prednisone allergy, penicillin allergy, seborrhoeic keratosis, skin tags, acute gastritis, hypertriglyceridaemia, anaemia, diverticular disease and a terramycin allergy who on 09-NOV-2007 at 11:52 was vaccinated SC in the right deltoid with a first dose of zoster vaccine live (Oka/Merck) (lot # 658602/1080U). Concomitant vaccination included a second dose of FLUZONE (lot # U2489AA) given IM in the left deltoid at 11:50. Additional concomitant therapy included DIOVAN HCT, NORVASC, DAYPRO, XALATAN and omega-3 marine triglycerides. Illness at the time of vaccination included a sore throat and post nasal drip. On 12-NOV-2007 the patient experienced injection site warmth, tenderness and pruritis. Below the injection site there was an erythematous pruritic rash. The patient was seen in the office on 12-NOV-2007. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Seborrhoeic keratosis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old female with high cholesterol, hypertension, osteoarthritis, gastroesophageal reflux disease, prednisone allergy, Terramycin allergy and penicillin allergy, who on 09-NOV-2007 was vaccinated SC on the right deltoid with a single 0.65 mL dose of zoster vaccine live (Oka/Merck) (Lot # 658602/1080U). Concomitant therapy included Diovan HCT, Norvasc, Daypro and a dose of influenza virus vaccine (unspecified). On 12-NOV-2007, the patient developed an injection site reaction. The reaction was described as 2X4 cm raised rash at the injection site area. The area of rash was described as warm, tender and itchy. Unspecified medical attention was sought. No diagnostic laboratory test were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. Additional information has been received from the licensed practical nurse concerning this 65 year old white female with cholesterol high, hypertension, osteoarthritis, gastroesophageal reflux disease, prednisone allergy, penicillin allergy, seborrhoeic keratosis, skin tags, acute gastritis, hypertriglyceridaemia, anaemia, diverticular disease and a terramycin allergy who on 09-NOV-2007 at 11:52 was vaccinated SC in the right deltoid with a first dose of zoster vaccine live (Oka/Merck) (lot # 658602/1080U). Concomitant vaccination included a second dose of FLUZONE (lot # U2489AA) given IM in the left deltoid at 11:50. Additional concomitant therapy included DIOVAN HCT, NORVASC, DAYPRO, XALATAN and omega-3 marine triglycerides. Illness at the time of vaccination included a sore throat and post nasal drip. On 12-NOV-2007 the patient experienced injection site warmth, tenderness and pruritis. Below the injection site there was an erythematous pruritic rash. The patient was seen in the office on 12-NOV-2007. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Information has been received from a 64 year old female with codeine allergy and no medical history who on 08-NOV-2007 was vaccinated SC with first dose of zoster vaccine live (Oka/Merck). Concomitant therapy on same day but opposite arm included a dose of influenza virus vaccine (unspecified). Concomitant medications included (NASACORT), (ADVAIR), (MSD), (XANAX) and anti-depressant (unspecified). On 10-NOV-2007 the patient developed 3 X 1 inch red blotch near injection site. It was reported that the blotch was red, but there was no pain. The patient reported that the red blotch only itched when it was exposed to heat for example when taking a shower. No medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient  had not recovered. A product quality was not involved. Additional information  has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007.  Information has been received from a 64 year old female with codeine allergy and no medical history who on 08-NOV-2007 was vaccinated SC with first dose of ZOSTAVAX (Merck) (lot# "0966").  Concomitant therapy on same day but opposite arm included a dose of influenza virus vaccine (unspecified).  Concomitant medications included NASACORT, ADVAIN, OMEPROZOLE (MSD), XANAX and anti-depressant (unspecified).  On 10-NOV-2007 the patient developed 3 x 1 inch red blotch near injection site.  It was reported that the blotch was red, but there was no pain.  The patient reported that the red blotch only itched when it was exposed to heat for example when taking shower.  No medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report the patient had not recovered.  A product quality was not involved.  Additional information from the physician indicated that the patient did not inform him about any reaction but after receiving correspondence from us he called the patient and asked about the reaciton.  The patient stated that she had a red streak on her arm that lasted for one week, she had no further problems and did not received treatment for it.  Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Skin lesion
Clinical narrative: Information has been received from a advanced practiced registered nurse concerning a 66-year-old female with herpes simplex type II, hyperparathyroidism and breast cancer who on 14-AUG-2007 at 14:50 hours was vaccinated subcutaneous in the left upper upper arm with her first dose of zoster vaccine live (Oka/Merck) (lot # 657767/0740U). There were no illnesses at the time of vaccination. Concomitant vaccine administered on 14-AUG-2007 included her first intramuscular dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) administered in the left deltoid (lot # U2155CA). Concomitant therapy included (MSD), (DIOVAN), vitamin D (unspecified), calcium (unspecified), and vitamins (unspecified). On 20-AUG-2007 the patient thought they had "mosquito bites" five to six days after vaccination the patient developed an itchy rash over trunk rapidly spreading with about 30 lesions on their trunk with less central papules on a 2 cm erythematous base. The patient started acyclovir on 21-AUG-2007. No diagnostic labs were performed. At the time of the report the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with zoster vaccine live (Oka/Merck). On 01-NOV-2007 (less than 2 weeks after vaccination) the patient called the office to report that her acupuncturist thought she may have developed shingles because of a feeling of "something squirming" under the skin on her back. No further information was available. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Herpes zoster, Infection, Skin lesion
Clinical narrative: Information has been received from a Pharmacist concerning a 77-year-old male who on 05-OCT-2007 was vaccinated subcutaneous with a 0.65 mL dose of zoster vaccine live (Oka/Merck). On 24-OCT-2007, the patient developed pimples on his neck, and secondary infections. The patient was treated with Valtrex for the latter event. Pharmacist stated the patient informed her that a physician diagnosed him with shingles "per he latter event". At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has been received from a Pharm D. concerning a 70-year-old female (previously reported as 77-year-old male) with no pertinent medical history of allergies who on 05-OCT-2007 (also reported as "10-10-08") was vaccinated subcutaneous in the right arm with her first 0.65 ml dose of ZOSTAVAX (Merck) (lot # 658208/0886U). There were no illness at the time of vaccination. Concomitant therapy included clonazepam, gabapentin, tramadol HCL and TAZORAC 1% cream. It was also reported the patient broke out in painful lesions, saw a dermatologist and was diagnosed with shingles. The patient was treated with VALTREX 1 gm on 01-NOV-2007 for the latter event.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Hypotension, Immediate post-injection reaction, Malaise
Clinical narrative: Information has been received from a pharmacist concerning a 60 to 70 year old female with a history of anxiety attacks who during a routine visit with her physician was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included aspirin. It was reported that within thirty seconds of receiving the vaccine she developed a vasovagal response that included weakness and hypotension and recovered a half hour later (treatment not reported). The reporter indicated that the patient did not experience angioedema or anaphylaxis. It was reported that forty-eight hours later, the patient was on the internet and read that there was an interaction between aspirin and zoster vaccine live (Oka/Merck), she then suddenly felt gastrointestinal distress and malaise. It was reported that she visited a nurse practitioner and was ordered a gastrointestinal ultrasound that revealed the study was the same as her baseline (specifics not reported). At the time of this report it was indicated by the reporter that the patient was 90 percent recovered. A product quality complaint was not reported. Additional information was not available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007.  Information has been received from a pharmacist concerning a 60 to 70 year old female with a history of anxiety attacks who during a routine visit with her physician was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included ASPIRIN.  It was reported that within thirty seconds of receiving the vaccine she developed a vaso-vagal response that included weakness and hypotension and recovered a half hour hour later (treatment no reported).  The reporter indicated that the patient did not experience angioedema or anaphylaxis.  It was reported that forty-eight hours later, the patient was on the internet and read that there was an interaction between ASPIRIN and ZOSTAVAX.  She then suddenly felt gastrointestinal distress and malaise.  It was reported that she visited a nurse practitioner and was ordered a gastrointestinal ultrasound that revealed the study was the same as her baseline (specifics not reported).  At the time of this report it was ti was indicated by the reported that the patient was 90 percent recovered.  A product quality complaint was not reported.  Additional information was not available.  Follow up information received from the nurse practitioner indicated there was no further information to report.  Current patient status was not reported.  Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope vasovagal, Ultrasound abdomen normal
Clinical narrative: Information has been received from a pharmacist concerning a 60 to 70 year old female with a history of anxiety attacks who during a routine visit with her physician was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included aspirin. It was reported that within thirty seconds of receiving the vaccine she developed a vasovagal response that included weakness and hypotension and recovered a half hour later (treatment not reported). The reporter indicated that the patient did not experience angioedema or anaphylaxis. It was reported that forty-eight hours later, the patient was on the internet and read that there was an interaction between aspirin and zoster vaccine live (Oka/Merck), she then suddenly felt gastrointestinal distress and malaise. It was reported that she visited a nurse practitioner and was ordered a gastrointestinal ultrasound that revealed the study was the same as her baseline (specifics not reported). At the time of this report it was indicated by the reporter that the patient was 90 percent recovered. A product quality complaint was not reported. Additional information was not available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007.  Information has been received from a pharmacist concerning a 60 to 70 year old female with a history of anxiety attacks who during a routine visit with her physician was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included ASPIRIN.  It was reported that within thirty seconds of receiving the vaccine she developed a vaso-vagal response that included weakness and hypotension and recovered a half hour hour later (treatment no reported).  The reporter indicated that the patient did not experience angioedema or anaphylaxis.  It was reported that forty-eight hours later, the patient was on the internet and read that there was an interaction between ASPIRIN and ZOSTAVAX.  She then suddenly felt gastrointestinal distress and malaise.  It was reported that she visited a nurse practitioner and was ordered a gastrointestinal ultrasound that revealed the study was the same as her baseline (specifics not reported).  At the time of this report it was ti was indicated by the reported that the patient was 90 percent recovered.  A product quality complaint was not reported.  Additional information was not available.  Follow up information received from the nurse practitioner indicated there was no further information to report.  Current patient status was not reported.  Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Information has been received from a health professional concerning a 60 year old female with a history of shingles, who in August 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). It was reported that the patient developed an injection site reaction after vaccination and now has shingles. It was reported that the patient complained that it "messed her arm up for weeks". The patient currently has zoster in her ears. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Toothache
Clinical narrative: Information has been received from a female who was vaccinated with a dose of zoster vaccine live (Oka/Merck). It was reported that since she was vaccinated, her nerve in her tooth is bothering her and causing pain. The patient stated that she had the pain since the last 6 weeks. The patient had seen root canal specialist and they could not find anything wrong and stated that the root nerve would get better in a couple of months. At the time of report the patient had not recovered. A product quality complaint was not involved. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus, Pyrexia, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old female who in October 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). In October 2007, 2 days after vaccination the patient developed redness, warmth and swelling on the arm of vaccination. The patient also had a low grade fever. One week after vaccination the patient felt "itchy from the inside". The patient was prescribed Benadryl and  Tylenol. A product quality complaint was not involved. Additional information has been requested. Additional information has been received from the physician's office. They were unable to provide any further information regarding this patient. Further information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning  a patient who was vaccinated with zoster vaccine live (Oka/Merck) ("lot # 0829U") and three weeks later presented with chicken pox. At the time of reporting the patient was still recovering. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes simplex serology positive, Pain, Pruritus, Varicella zoster serology negative
Clinical narrative: Information has been received from a physician concerning a patient who on 16-OCT-2007 received a first subcutaneous dose in the left deltoid of zoster vaccine live (Oka/Merck) (lot # 658211/0884U). On 21-OCT-2007, it was reported that the patient had developed a vulvar crop of vesicles that were round pruritic and mighty painful. It was reported that diagnostics revealed that the varicella titer IgG was positive, and the varicella titer IgM was  negative. Specific sought medical attention and treatment was not reported. A product quality complaint was not reported. Additional information was not available. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a pharmacy technician concerning a 73-year-old female who on 26-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). The patient developed an itchy rash "about 2 to 3 days ago" on approximately 11-NOV-2007. The patient called the pharmacy for medical attention. The outcome was reported as not recovered. No product quality complaint was involved. The VZ VID program was offered but the pharmacy technician did not know if the patient or her physician would be interested. This is on of several reports from the same reporter. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from pharmacy technician concerning a 79 year old male who on 26-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). One week post vaccination, on approximately 07-NOV-2007, the patient developed a "little itchy rash". The location of the rash was not reported. The pharmacy tech also reported this event to the VZVID program. At the time of reporting the patient was recovered from the "little itchy rash". The date of recovery was not reported. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a male twin with no other medical history who was vaccinated SC with a single dose of ZOSTAVAX. The physician reported that the patient subsequently developed a rash. Medical attention was sought via telephone call. No laboratory/diagnostic tests were performed. At the time of this report, the patient's rash persisted. This is one of several reports from the same source. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a consumer concerning his 76 year old wife with severe headaches and no allergies, who on 12-NOV-2007 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included LIPITOR, LOPRESSOR, ZOLOFT and rizatriptan benzoate (MSD). On 12-NOV-2007, later in the evening, the patient experienced headaches later in the evening. The patient took rizatriptan benzoate (MSD) which helped but she still had the headache. At the time of report the patient had not recovered. There were no laboratory or diagnostic tests performed. Medical attention was not sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.65 ml doe of ZOSTAVAX. Subsequently the patient experienced redness at injection site. Unspecified medical attention was sought. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has been received from a physician concerning a female who was vaccinated with a 0.65 ml dose of ZOSTAVAX. Subsequently the patient experienced redness at injection site. Unspecified medical attention was sought. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. No further information is available.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Inappropriate schedule of drug administration, Incorrect route of drug administration
Clinical narrative: Information has been received from a physician concerning a 52 year old female who in June 2007, was vaccinated IM with a dose of ZOSTAVAX. In November 2007, 5 months after vaccination the patient experienced shingles. It was reported that the patient was seen in the office and had vesicles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007.  Information has been received from a physician concerning a 52 year old female who in June 2007, was vaccinated IM with a dose of ZOSTAVAX (Merck). In November 2007, 5 months after vaccination the patient experienced shingles.  It was reported that the patient was seen in the office and had vesicles.  Unspecified medical attention was sought.  A product quality complaint was not involve.  Follow-up information from the physician indicated that this 52 year old female with gastritis, menopause and no known allergies was vaccinated IM in the left deltoid on 20-JUN-2007 with a first dose of ZOSTAVAX (Merck) (lot # 657559/0462U).  There was no illness at the time of vaccination.  On 02-NOV-2007, at that time she had a rash on her back, it was very tender, quite itchy and it had a burning sensation when it was touched.  She was diagnosed with herpes zoster.  There were no lab studies performed.  The patient was treated with oral FAMVIR and recovered on 10-NOV-2007.  No further information was provided.  Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Mass
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who was vaccinated with a dose of ZOSTAVAX. Subsequently, the patient experienced 2 bumps on head. At the time of reporting the patient had not recovered. The medical assistant questioned about the bumps being shingles. No product quality complaint was involved. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an 80 year old female relative who on 01-NOV-2007 was vaccinated SC with 0.5 ml dose of ZOSTAVAX. On 02-NOV-2007 the patient developed an erythematous, indurated site that was warm to touch. Medical attention was sought through the physician. The outcome was unknown. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Eye irritation, Paraesthesia
Clinical narrative: Information has been received from a pharmacist concerning a 51 year old female registered nurse with no pertinent medical history or drug allergies who on 05-NOV-2007 was instilling the diluent into vial for 0.65 ml dose of ZOSTAVAX (lot# 658395/0966U) and the entire contents of vial splashed into her left eye, and on her face and neck. There was no concomitant medication. The eye was immediately flushed with water and her face and washed with soap and water. No labs or diagnostic studies were performed. Her face was tingling and the eye was irritated. The patient was not recovered. There was a product quality complaint involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 65-year-old female with codeine, beta blockers, iodine and a sulfa allergy who on 02-NOV-2007 was vaccinated subcutaneous in the left arm with 0.65 ml dose of ZOSTAVAX (658602/1080U). Concomitant therapy included oxybenzone. On 04-NOV-2007 the patient experienced a red, warm, slightly inflamed rash at the site of administration. The patient sought medical attention via a conversation with the pharmacist. At the time of the report patient's status was not recovered. A product quality complaint was not involved. Additional has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hearing impaired, Musculoskeletal stiffness
Clinical narrative: Information has been received from a consumer concerning her aunt who was vaccinated with ZOSTAVAX. Subsequently, it was reported that after the patient received the ZOSTAVAX she developed stiffness in her neck and periods where her hearing goes in and out. It was not reported if the patient sought medical attention. A product quality complaint was not reported. The reporter declined to give any further information. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure diastolic increased, Fatigue
Clinical narrative: Information has been received from a 66 year old female with high blood pressure, high cholesterol and a thyroid problem who on 07-NOV-2007 was vaccinated in the right arm with ZOSTAVAX. Concomitant medication included LIPITOR and THYROXYINE. It was reported by the patient that on the same day (07-NOV-2007), after her blood pressure was taken her physician gave her a prescription for quinapril hydrochloride, 20 mg, once a day because her bottom number was high (values not specified). She reported that on 11-NOV-2007, she started to feel fatigue and thinks it may have been caused by her blood pressure medicine. It was reported that at the time of this report she has not recovered, had called her pharmacist, and will contact her physician in follow up. A product quality complaint was not reported. Additional information was not available. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 68 year old female with hypothyroidism, autoimmune disorder and penicillin allergy who at 19:00 hours on 13-NOV-2007 received a subcutaneous dose in the right upper deltoid of ZOSTAVAX (lot#658862/1415U). It was reported that six hours later (1:00 A.M) on 14-NOV-2007, the patient developed an extreme rash that was very itchy on her back, head, neck, and arm (it was all over). She presented to an urgent care facility and was treated with BENADRYL. On 15-NOV-2007, she was seen in the office by her physician who reported that the rash and itching was gone, only some pink spots remained. A product quality complaint was not reported. Further information was not available. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male who on 06-NOV-2007 was vaccinated with a 0.65 mL dose of ZOSTAVAX. On 09-NOV-2007 the patient developed shingles. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. Additional information is expected. Follow-up information has been received which indicated that the patient is a 70-year-old male who on 07-Nov-2007 (previously reported as 06-Nov-2007) was vaccinated subcutaneously in the upper arm. On 13-Nov-2007, one week after vaccination, (previously reported as 09-Nov-2007) the patient developed shingles. The outcome is reported as unknown. Additional information is expected.