chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 12 month old patient who in April 2007, was inadvertently vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) (MSD).  This was reported to be "totally human error" and the nurse did not read the vial.  The patient tolerated ZOSTAVAX (Oka/Merck) "fine".  It was unspecified if medical attention was sought.  There was no product quality complaint involved.  No further information was provided.  Follow up information indicated that the event was human error, the there were not any labeling errors or storage issues.  The office uses a computerized system to distribute vaccines, however, the nurse just administered the wrong vaccine.  There was no any adverse event to report.  No additional information is expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Myasthenia gravis
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old female with myasthenia gravis who on 26-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). The reporter indicated that the PI was reviewed, but "this" was not mentioned (?myasthenia gravis). The patient has been evaluated by a doctor. No further information was provided. Additional information has been requested. Attempts are being made to obtain additional information regarding the extent of the patient's myasthenia gravis and treatment at the time of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental overdose, Incorrect dose administered, Seroconversion test negative
Clinical narrative: Information has been received from a pharmacy student concerning a patient who on 13-AUG-2007 was vaccinated with 0.65 ml of ZOSTAVAX (Oka/Merck).  On 01-OCT-2007 the patient was administered a second dose, 0.65 ml, of ZOSTAVAX (Oka/Merck).  The reporter indicated that the patient received two separate doses, 0.65ml, of ZOSTAVAX (Oka/Merck) and it was believed that the patient failed to seroconvert.  The patient was not experiencing any known symptoms.  There was no product quality complaint.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: Information has been received from a consumer reporting on his 75-year-old female wife, with no pertinent medical history or allergies, who on approximately 15-AUG-2007 (2 1/2 months ago) was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On approximately 31-AUG-2007 (2 weeks after vaccination) the patient experienced "pain that is radiating from front to back".  "Sometimes the pain stays in the front or back area".  There is no other symptoms and no rash".  The consumer is concerned this is shingles related.  The patient sought medical attention by seeing different physicians.  On an unspecified date the patient had a MRI and other unspecified tests that were all negative.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a consumer reporting on her male husband who on 17-SEP-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 18-SEP-2007 ("the next day") the patient "broke out with a bad rash and has been having outbreaks ever since". The patient sought medical attention via an office visit. At the time of the report the patient's status was not recovered. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician assistant concerning a 12-month-old female who was vaccinated with 0.65 ml dose of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck). No adverse experience reported. A product quality complaint was not involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician assistant concerning a 69 or 70 year old female who in October 2007, was vaccinated SC with a dose of zoster vaccine  live (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unspecified) given in "the other arm". Subsequently in October 2007 the patient experienced a rash at the injection site that went down her arm. Unspecified medical attention was sought. The physician assistant described the rash as "looking like a severe case of cellulitis". There was no product quality complaint involved. The patient's outcome was not reported. No further information was provided. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male who on 31-OCT-2007 was vaccinated with ZOSTAVAX (Lot #658086/0761U) instead of VARIVAX.  The nurse indicated that he grabbed the wrong vial in the freezer.  The patient will be re-vaccinated in 30 days with VARIVAX.  It was further reported that ZOSTAVAX and VARIVAX are no longer stored near each other in the freezer, and the labels were made more visible to prevent any reoccurrences.  Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning an 10 year old male who on 31-OCT-2007 was vaccinated with ZOSTAVAX.  The nurse indicated that he grabbed the wrong vial in the freezer.  The patient will be re-vaccinated in 30 days with VARIVAX.  It was further reported that ZOSTAVAX and VARIVAX are no longer stored near each other in the freezer, and the labels were made more visible to prevent any reoccurrences.  Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a pharmacist, (who was told by the sister of a patient) concerning a female patient who was vaccinated on an unspecified date with a dose of zoster vaccine live (Oka/Merck) (dosage and route unspecified). Subsequently, on an unspecified date, the patient experienced redness and induration at the site. There were no other symptoms reported, although the patient's sister stated that the patient was bothered so much that she left church early on Sunday, 28-OCT-2007. The patient took an unspecified antihistamine for the reaction and called her physician. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Ear pain, Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a 66-year-old female with no pertinent medical history or allergies who on 30-OCT-2007 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included vitamins (unspecified).  On 02-NOV-2007 the patient experienced full blown rhinitis, upset stomach, mild diarrhea and flu like symptoms.  On 04-NOV-2007 the patient experienced a fever, earache and weakness.  The patient sought unspecified medical attention.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinitis, Stomach discomfort
Clinical narrative: Information has been received from a 66-year-old female with no pertinent medical history or allergies who on 30-OCT-2007 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included vitamins (unspecified).  On 02-NOV-2007 the patient experienced full blown rhinitis, upset stomach, mild diarrhea and flu like symptoms.  On 04-NOV-2007 the patient experienced a fever, earache and weakness.  The patient sought unspecified medical attention.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 12 month old female who was vaccinated with a dose of ZOSTAVAX instead of a dose of VARIVAX.  No adverse reactions were reported.  There was no product quality complaint involved.  Additional information could not be obtained from the reporting nurse.  She indicated that she reported all the information about the patient via online and she refuse to provide any more information to us.  Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 72-year-old retired male pediatrician with type 2 diabetes mellitus, hypertension, gout, chronic renal insufficiency, rhinitis allergic, allergies to salicylates and sulfonamide (which caused hives and rash) who on 25-JAN-2007 was vaccinated one time with a 0.5 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included Amaryl, ezetimibe (+) simvastatin (MSD), losartan potassium (MSD), allopurinol, Plavix, Claritin and montelukast sodium (MSD). In July 2007, the patient experienced left back and subscapular pain and then went to see a dermatologist who diagnosed him with active shingles lesions. No laboratory or diagnostic tests were performed. He was prescribed Valtrex and the last of the lesions were seen in early August. The patient still has pain and was reported to be recovering at the time of this report. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of ZOSTAVAX.  Subsequently, following the vaccination, the patient had an injection site reaction.  It was reported that the patient had a "red and swollen arm more extensive than other administrations".  It was unspecified if medical attention was sought.  At the time of this report there was no additional information at the time of the report.  No product quality complaint was involved.  Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular, Secondary transmission, Varicella
Clinical narrative: Information has been received from a physician concerning patient about 6 weeks old who on approximately September 2007 (reported as two months ago) was exposed to the grandmother who was vaccinated SC with a 0.65 mL dose of ZOSTAVAX (Oka/Merck) on September 2007 (reported as two months ago).  A day later after the grandmother was vaccinated, the patient "came down with chickenpox/"varicella" like rash."  The patient's status was not reported.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 75-year-old female on 01-NOV-2007 was vaccinated intramuscularly instead of subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot# 658398/1087U).  On 04-NOV-2007 the patient experienced warmth and pain at the injection site.  It was reported that the patient contacted the pharmacist.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 75-year-old female with a history of shingles on her mid-back in 2004, who on 18-OCT-2007 was vaccinated subcutaneously with a first dose of ZOSTAVAX (lot# 658604/1088U).  On 01-NOV-2007 the patient visited the physicians office with a shingles-type rash about the size of a quarter on her chin.  The outcome was reported as not recovered.  No product quality complaint was 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 75-year-old female with a history of shingles on her mid-back in 2004, who on 18-OCT-2007 was vaccinated subcutaneoulsy with a first dose of ZOSTAVAX (Merck) (lot# 658604/1088U).  On 02-NOV-2007 the patient visited the physicians office with a shingles-type rash about the size of a quarter on her chin.  The outcome was reported as not recovered.  No product quality complaint was involved.  Follow-up information has been received from a physician concerning a , retired, female with sulfonamide allergy who on 18-OCT-2007 was vaccinated in the left deltoid with a dose of ZOSTAVAX (Merck) (lot# 658604/1088U, dilutent vial # "3091U").  Concomitant therapy included TOPROL XL tablets, PREVACID, DIAZEPAN, ACTONEL, hydrocodone bitartrate, nortriptyline, iron (unspecified).  "CA", "vitotuss", montelukast sodium (MSD), PRAVACHOL, EVISTA, FLOWASE, MOBIC, MUCINEX.  On 02-Oct-2007, the patient was vaccinated in the left deltoid with pneumococcal (lot# 657525/0554U (WAES# 077USA08187).  The patient was given FAMVIR 500 tid and LORTAN PRN.  The patient developed a rash that was painful  had vesicles.  There were no pictures taken.  On 01-Nov-2007, the patient's blood pressure was 120/80, pulse 80 respirations 14 and temperature 97.3.  On an unspecified date the patient recovered.  No further information is expected.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 83-year-old female who during the week of 22-OCT-2007 was vaccinated subcutaneously with a dose of zoster vaccine live (Oka/Merck) (lot# 658604/1088U). During the week of 22-OCT-2007, the patient experienced a 2 inch round, red swelling at the injection site. It was unspecified if medical attention was sought. No outcome was reported for the patient. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: MNQ, VARZOS
Symptoms: Injection site pain, Nasopharyngitis, Pain, Pyrexia, Sinusitis
Clinical narrative: Information has been received from a health professional concerning a 13 year old female who on 05-NOV-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Other concomitant therapy included Menactra. On 05-NOV-2007, the patient experienced receiving zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live. No adverse effect was reported. The caller reports it was just human error and there was no product confusion. Unspecified medical attention was sought. No product quality complaint. Follow-up information received from the Nurse indicating that the child was vaccinated with zoster vaccine live (Oka/Merck) (lot# 658603/1081U) via IM in the right deltoid and Menactra (lot# U23928A-Sanofi) via IM in the left deltoid on 05-Nov-2007. On 05-Nov-2007, the child experienced tenderness and pain in the right arm at the injection site. Two days after the injection, she experienced body aches, fever, a "cold" and sinus infection for 2 weeks after the injection. The child recovered approximately 2 weeks after the injection. No further information is expected.
Age: 13.0
Sex: F
Vaccine: MNQ, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 13 year old female who on 05-NOV-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Other concomitant therapy included Menactra. On 05-NOV-2007, the patient experienced receiving zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live. No adverse effect was reported. The caller reports it was just human error and there was no product confusion. Unspecified medical attention was sought. No product quality complaint. Follow-up information received from the Nurse indicating that the child was vaccinated with zoster vaccine live (Oka/Merck) (lot# 658603/1081U) via IM in the right deltoid and Menactra (lot# U23928A-Sanofi) via IM in the left deltoid on 05-Nov-2007. On 05-Nov-2007, the child experienced tenderness and pain in the right arm at the injection site. Two days after the injection, she experienced body aches, fever, a "cold" and sinus infection for 2 weeks after the injection. The child recovered approximately 2 weeks after the injection. No further information is expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: Information has been received from a physician concerning a 76 year old female with cholesterol high, gastrooeseophageal reflux disease, degenerative joint disease, neuropathy peripheral and drug hypersensitivity and a history of coronary stent placement who on 16-OCT-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included LANOXIN, PLAVIX, aspirin, PREVACID, NIASPAN, COZAAR, folic acid, OXYCONTIN, LASIX, spironolactone, VICODIN, PAXIL, ZOCOR, amitriptyline hydrochloride, SENOKOT-S TABLETS, METAMUCIL and calcium (unspecified).  In October 2007, the patient experienced red spot on forehead and tenderness on the head.  The tenderness on the head is mainly the area surrounding the forehead.  The patient was sent to urgent care and received unspecified antibiotics.  The patient called on 05-Nov-2007 to report the red spot near the left eye.  The medical assistant could not determine if the red spot is a rash.  The patient's red spot on forehead and eye, and tenderness on the head persisted.  Unspecified medical attention was sought on 02-Nov-2007.  No product quality complaint.  Additional information has been requested. This is infollow-up to report (s) previously submitted on 12/21/2007. Follow-up information received from the healthcare professional indicating that the patient has an allergy to "TOPROL". The  patient received the vaccination subscutaneous in the left arm. On 11-OCT-2007, the patient experienced inflammation of the forehead. Patient went urgently to care facility and was given "cephalexin" 500 mg. The patient later experienced another area of inflammation. Both have resolved. No further information is expected.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a 58 year old male consumer with a history of shingles two weeks before vaccination, high cholesterol, hypertension, heart attacks with stent placement in 2004 who on 30-OCT-2007 was vaccinated with a dose of ZOSTAVAX.  Concomitant therapy included VALTREX which was completed a week before vaccination, LIPITOR, and RESTORIL.  On 30-OCT-2007 the patient experienced a "bad, bad headache" for 2 days where he could not hold his head up after receiving vaccination with ZOSTAVAX.  The patient took Tylenol which did not help.  The headache resolved after 2 days.  The patient did not seek medical attention.  No product quality complaint was involved.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster
Clinical narrative: Information has been received from a physician's assistant concerning a 67 year old retired white female patient weighing 143 lbs. who on 04-OCT-2007 was vaccinated subcutaneously with the first dose of zoster vaccine live (Oka/Merck) (Lot # 657675/0618U). On 26-OCT-2007 the patient developed severe right facial pain and went to the emergency room on 29-Oct-2007. The patient was diagnosed with shingles however had no rash. The patient was called to come in for a visit on 01-Nov-2007 if there was no rash. The reporter indicated that they considered trigeminal neuralgia. Patient outcome is unknown. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a nurse concerning a 65 year old white male patient with no known drug allergies or illnesses at the time of vaccination who on 17-OCT-2007 was vaccinated subcutaneously in the left deltoid with the first dose of ZOSTAVAX (Oka/Merck) (Lot # 657766/0620U). Concomitant vaccination included sterile diluent (Lot #3035U). The reporter indicated that the patient complained of rash on legs beginning on 27-Oct-2007. The rash was mildly itchy, non-tender, but the patient knew they were there. There was no rash at the site of injection. There were four scattered light erythematous papules on his leg. There was no discharge or vesicles noted. No laboratory diagnostic tests were performed. The patient outcome is recovered. It was noted that on 18-SEP-2007, the patient was vaccinated with the first dose of Pneumovax (Lot # 657526/0555U). No reaction was attributed to any of the vaccines. Follow-up information has been received from a registered nurse indicating that the patient only received one dose of Pneumovax (MSD) (lot # 657526/0555U) on 18-SEP-2007 and no previous vaccinations were given of this vaccine as previously reported. The adverse events resolved (no dates provided). The treating physician did not consider the events to be related to any of the therapies (zoster vaccine live (Oka/Merck), sterile diluent or Pneumovax). No further information is available. This is in follow-up to report previously submitted on 12/21/2007. This is an amended report. One dose of pneumococcal 14v polysaccharide vaccine now reads pneumococcal 23v polysaccharide vaccine (MSD) (lot # 657526/0555U) instead of pneumococcal 14v polysaccharide vaccine (MSD). No further information is available.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaesthesia, Chest pain, Headache, Sensory loss
Clinical narrative: Information has been received from a physician concerning a 77-year-old female who in October 2007, was vaccinated in the right arm with a dose of ZOSTAVAX (Oka/Merck).  In October 2007, a few days after vaccination, the patient experienced an area of loss of sensation over the right lateral hip.  The patient also experienced some transient headaches and possibly some left sided chest pain but, otherwise, had no additional side effects and developed no skin rash.  On 10-OCT-2007, physical examination revealed complete anesthesia over a 6 cm area of the lateral right hip.  On 26-OCT-2007, the patient's numbness seemed to be recovering and she had some light touch sensation in the area.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 72-year-old female retired nurse with high cholesterol, hypothyroidism, glaucoma, osteopenia and a dust allergy who "one year ago" in approximately November 2006, was vaccinated with a first dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included LIPITOR, SYNTHROID, XALATAN and ACTONEL.  In approximately November 2006, "one year ago", the patient experienced a red, hot, hard swollen area at the injection site.  No treatment was required.  No medical attention was sought.  No laboratory test were performed.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested. 03/26/2008 Follow-up information has been received from the physician's office indicating that the patient is a 71-year-old (previously reported as a 72-year-old) with an allergy to indomethacin sodium (manufacturer unknown) (WAES# 0712USA02496) who was vaccinated on 25-AUG-2006 at 10:30 AM in the right deltoid with ZOSTAVAX (Oka/Merck) (lot# 652966/0722F). There was no illness at the time of  vaccination. On 25-AUG-2006 the patient's arm became swollen, hot, hard and red which locally lasted about 1 week. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster, Rash, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 66 year old male with glaucoma, hypertension and dyslipidaemia who on 31-OCT-2007 was vaccinated with 0.65 ml of zoster vaccine live (Oka/Merck) (Lot# 658602/1080U). Concomitant vaccine therapy that same day included influenza virus vaccine (unspecified)(manufacturer unknown). The physician reports that the patient had no prior history of shingles, and on 06-NOV-2007 the patient developed zoster. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Follow up information was received from a physician through the Merck VZV identification program M-15786098391, who reported that on 31-OCT-2007 the patient was vaccinated with 0.5 ml (previously reported 0.65ml) of zoster vaccine live (Oka/Merck) (Lot# 658602/1080U) into the right arm, also reported as "Zoster right hip". On 10 NOV 2007 (previously reported as 06 NOV 2007) the patient developed a rash with 8-10 lesions distributed on the right upper extremities, which was diagnosed as herpes zoster. The patient had no recent exposure to chickenpox or shingles. Concomitant medication included HCTZ, and FAMVIR 500 mg TID "2 weeks". At the time of reporting it was unknown if the patient recovered. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a male who on 25-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). The patient, along with his wife (WAES# 0710USA05662) were scheduled to received zoster vaccine live (Oka/Merck) 25 Oct 2007. The medical assistant reported that during charting documentation, that same day, it was noted that only diluent was given to one of the patients, and the other patient received zoster vaccine live (Oka/Merck). The patient returned that same day and was re-vaccinated with zoster vaccine live (Oka/Merck) (lot 658209/1085U). The records were not available from the first lot number. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a female consumer who was vaccinated in her arm on an unspecified date with a 0.65 milliliter dose of ZOSTAVAX (Oka/Merck).  Subsequently the patient developed a "red mark" on her arm at the injection site.  It was unspecified if medical attention was sought.  No outcome was reported.  No product quality complaint was involved.  Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a receptionist in a physician's office concerning a 48-year-old female who on 05-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) at a local pharmacy.  Subsequently the patient developed a large soft ball-like size spot on the injection site that was red and warm.  Medical attention was sought by calling the office.  Per the receptionist, based on the patient's description over the phone, their office thinks that the patient might have developed "cellulitis" but it has not yet been confirmed because the patient has to come to the office for a check-up.  Lot number was unavailable.  The outcome was reported as unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Herpes zoster, Pain, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a health professional and a physician concerning a 72-year-old female with hypothyroidism, hypertension, no known drug allergies and a history of endometrial and breast cancer and childhood chickenpox who on 30-OCT-2007 (also reported as 29-Oct-2007) was vaccinated subcutaneously in the right deltoid with a 0.5 milliliter dose of ZOSTAVAX (lot# 658395/0966U).  Concomitant therapy included LANOXIN, CARDIZEM, SYNTHROID, NEXIUM and EVISTA.  On 07-NOV-2007 the patient developed a vesicular rash with lesions too numerous to count scattered on the right side of her face, hairline and right eyelid and was diagnosed with shingles.  The patient had "stinging pain" that was rated a 4 on a scale of 1 to 10, 10 being the most painful.  There were no other systemic symptoms.  Medical attention was sought at the doctor's office and the patient was prescribed VALTREX and prednisone.  The maximum body temperature was 98.6.  Photos were taken.  The outcome was reported as not recovered.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it associated with the wild-type VZV strain or with the OKA/MERCK vaccine VZV strain.  The sample of the lesion was collected on 09-Nov-2007.  The sample was taken from lesion fluid from the forehead.  The PCR results for the specimen from the lesion fluid from the forehead identified the presence of WT VZV.  Additional information has been requested. 03/26/2008 Additional follow-up indicates that the patient developed shingles on the right side of the face one week after vaccination. On an unspecified date the patient recovered. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Viral test
Clinical narrative: Information has been received from a health professional and a physician concerning a 72-year-old female with hypothyroidism, hypertension, no known drug allergies and a history of endometrial and breast cancer and childhood chickenpox who on 30-OCT-2007 (also reported as 29-Oct-2007) was vaccinated subcutaneously in the right deltoid with a 0.5 milliliter dose of ZOSTAVAX (lot# 658395/0966U).  Concomitant therapy included LANOXIN, CARDIZEM, SYNTHROID, NEXIUM and EVISTA.  On 07-NOV-2007 the patient developed a vesicular rash with lesions too numerous to count scattered on the right side of her face, hairline and right eyelid and was diagnosed with shingles.  The patient had "stinging pain" that was rated a 4 on a scale of 1 to 10, 10 being the most painful.  There were no other systemic symptoms.  Medical attention was sought at the doctor's office and the patient was prescribed VALTREX and prednisone.  The maximum body temperature was 98.6.  Photos were taken.  The outcome was reported as not recovered.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it associated with the wild-type VZV strain or with the OKA/MERCK vaccine VZV strain.  The sample of the lesion was collected on 09-Nov-2007.  The sample was taken from lesion fluid from the forehead.  The PCR results for the specimen from the lesion fluid from the forehead identified the presence of WT VZV.  Additional information has been requested. 03/26/2008 Additional follow-up indicates that the patient developed shingles on the right side of the face one week after vaccination. On an unspecified date the patient recovered. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Information has been received from a female consumer who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced swelling and bruising at the injection site. It was unspecified if medical attention was sought. No outcome was reported. No product quality complaint was involved. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a consumer who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) and his wife experienced shingles.  On 17-OCT-2007 at 14:41 the patient's wife received a response about transmission of the vaccine to another.  The caller does not think an adverse event was filed at that time.  The caller did not want to be identified or get further involved.  It was unknown whether medical attention was sought.  The outcome was unknown at the time of this report.  There was no product quality complaint.  No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a female (age unknown) who on 05-NOV-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On approximately 05-NOV-2007, the patient experienced 3 inch long injection site reaction. Injection site is red, tender and warm. The injection site reaction persisted. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus, Skin lesion, Swelling
Clinical narrative: Information has been received from a physician concerning his wife, a 76 year old female patient, with a history of questionable penicillin allergy who on 02-AUG-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included MAVIK, LEVOXYL and vitamins (unspecified).  On 30-OCT-2007 the patient experienced zoster.  The physician indicated that his wife developed zoster after administration of ZOSTAVAX (Oka/Merck).  Initially the area under her left arm was pruritic.  Then she developed slightly raised, red, pruritic lesions on the dermatomes: d7 and d8.  She had a cluster of two lesions and another cluster of 3 lesions on her lateral chest wall.  She also had 1 lesion by her sternum and another lesion 1 to 2 inches to the right of her sternum.  The physician's diagnosis was zoster.  She also was examined by a dermatologist who confirmed the diagnosis of zoster.  The dermatologist prescribed topical cortisone.  Within 3 to 4 days she improved significantly.  The dermatologist's name was not provided.  At the time of reported she was about 75 to 85 % recovered.  She did not have any pain.  The lesions never became blisters or formed scabs.  He stated on a scale of severity of 1 to 10 this was a 1.5.  He was interested in the VZV analysis.  No laboratory diagnostic tests were performed.  Patient's outcome was reported as recovering.  No product quality complaint was involved.  Additional information has been requested. 03/26/2008 Additional information was received from the physician concerning his retired wife with hypothyroidism, high blood pressure, a penicillin allergy and a history of chicken pox as a child who on 21-AUG-2007 (previously reported as 02-AUG-2007) was vaccinated IM in the left deltoid with a dose of ZOSTAVAX (lot # *08846*). Concomitant therapy included MAVIK, LEVOXYL and vitamins (unspecified). In early October 2007 the patient noticed an itching lateral to her left breast (at D6-8). Exam disclosed a cluster of 3 flat, red spots at that spot, another two red spots 2 inches posteriorly and slightly superiorly removed, and one other red spot between her breasts at about the same level. She was seen 2 days later by a dermatologist who concurred in the diagnosis of herpes zoster. On an unspecified date the patient fully recovered. It was noted that the patient's husband had herpes zoster of left V-1 seventeen months prior to the patient. A direct fluorescent antibody was not performed and a specimen was not collected for PCR. No further information was provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 60-year-old female, "vascular patient", consumer with diabetes, who on an unspecified date was vaccinated with a "single dose" of zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles. No further information was available. No product quality complaint was involved. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an "over 60-years-old" male who on an unspecified date was vaccinated with a dose of ZOSTAVAX.  Subsequently, two weeks later the patient developed chickenpox.  The physician saw the patient and confirmed the diagnosis of chickenpox.  No additional information was provided.  The outcome was not reported.  No product quality complaint was involved.  Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 74-year-old male with a history of shingles in April 2007, who on 24-OCT-2007 was vaccinated with a dose of ZOSTAVAX.  On 07-Nov-2007 the patient called the clinic stating that he had a very mild case of shingles outbreak, but no pain.  It was unknown where the rash was located.  The outcome was reported as recovering.  It was reported that the VZV ID program information was not discussed with the nurse.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has beenreceived from a registered nurse concerning a 74-year-old male with a history of shingles in April 2007, who on 24-OCT-2007 was vaccinated with a dose of ZOSTAVAX (Merck). On 07-Nov-2007 the patient called the clinic stating that he had a very mild case of shingles outbreak, but no pain. It was unknown where the rash was located. The outcome was reported as recovering. It was reported that the VZV ID program information was not discussed with the nurse. No product quality complaint was involved. Follow-up information has been received from a nurse practitioner indicating that the patient is retired with a history of shingles outbreaks on 26-Apr-2007 and 24-Aug-2007 and allergies to CYCLOBENZAPRINE HYDROCHLORIDE (manufacturer unknown, WAES# 0801USA02777), ASPIRIN and MORPHINE. He was vaccinated in the left upper arm with a first dose of ZOSTAVAX (Merk) (lot#*1406*). There was no illness at the time of vaccination. On 04-Nov-2007 (previously reported as 07-Nov-2007) he had an onset of a rash on his right breast (one vesicle) 11 days after receiving the vaccination. The pain was rated a 0 scale of 1-10 (0 being the least and 10 being the worst). It was reported that there was a "remote" history of chickenpox. It was unknown it there was a recent exposure to chickenpox or herpes zoster. There was no specimen collected for the PCR. There were no photos taken and a direct flourescent antibody was not done. The symptoms have resolved. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a registered pharmacist concerning a 78-year-old with no known allergies who on 05-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On 07-NOV-2007 the patient developed a pruritic and erythemic rash on her arm.  The rash is on the same arm as the injection was administered; however, the rash is "away from the injection site".  On 08-NOV-2007 (the patient stated today) "the rash is no longer pruritic".  At the time of the report the erythemic rash on her arm was recovering.  The patient sought medical attention via a telephone call.  No diagnostic labs were performed.  A product quality complaint was not involved.  Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Pain, Pain in extremity, Rheumatoid arthritis, Vaccination complication
Clinical narrative: Information has been received from a 77 year old female consumer with hypertension, elevated cholesterol, type 2 diabetes, coronary artery disease, allergy to sulfa drugs and central nervous system medications who in June 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included Norvasc, Aspirine, Celexa, folic acid, sitagliptin phosphate (MSD), lorazepam, fish oil, Plavix, omeprazole (MSD), Tricor, Vesicare, unspecified multi-vitamins, calcium (unspecified) and vitamin D (unspecified). On approximately 15-JULY-2007 (report as mid July 2007) the patient developed a severe right hand pain followed by pain in other areas of her body and was diagnosed by her rheumatologist with rheumatoid arthritis after immunization with zoster vaccine live (Oka/Merck). The patient is currently being treated with methotrexate and prednisone. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in jaw, Trigeminal neuralgia
Clinical narrative: Information has been received from a physician assistant concerning a 67-year-old female with a history of shingles who on 08-OCT-2007 was vaccinated with a dose of ZOSTAVAX.  On 26-OCT-2007 the patient experienced pain in her jaw area and went to the local emergency room and was diagnosed with shingles.  The patient sought medical attention via a phone call.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Follow-up information was received on 12-NOV-2007 from a physician assistant.  The PA reported that the patient had trigeminal neuropathy which he felt was related to dental work or dental anesthesia.  He said that he recently saw the patient and she had no rash, just pain.  He felt that it was not appropriate to consider the patient's trigeminal neuropathy an AE.  The PA indicated that should the patient develop a breakthrough rash he would contact us.  He wanted to tentatively close the case and asked that no further correspondence be sent.  Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Lymphadenopathy
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female with high blood pressure and a penicillin allergy who on 19-SEP-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (lot# 658083/0885U).  Concomitant drug therapy included LOTENSIN, hydrochlorothiazide, and PREMARIN.  On 20-SEP-2007 "24 hours after the vaccine," the patient developed a "silver dollar sized red ring at injection site" and swollen lymph nodes of the throat and under arm.  No medical attention was sought.  No labs or diagnostics studies were performed.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female "over 60 years old" who during the week of 22-OCT-2007 was vaccinated subcutaneously with a dose of ZOSTAVAX (Oka/Merck) (lot# 658604/1088U).  During the week of 22-OCT-2007 the patient experienced a 2 inch round, red swelling at the injection site.  It was unspecified if medical attention was sought.  No outcome was reported.  No product quality complaint was involved.  Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from a patient with no pertinent medical history and no drug reactions/allergies who on 30-OCT-2007 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Oka/Merck).  There was no concomitant medication.  On 30-OCT-2007 the patient experienced feeling stronger and more stimulated.  There were no lab diagnostics studies performed.  The outcome is reported as not recovered. No medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning her 14 year old son who on approximately 01-NOV-2007 was inadvertently vaccinated with a dose of ZOSTAVAX instead of VARIVAX, (duration, dose and indication not reported).  There was no Ae.  It was reported that the patient did not seek medical attention.  There was no product quality complaint.  No further information is available.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old female who on 09-Nov-2007 was vaccinated subcutaneously with a single dose of zoster vaccine live (Oka/Merck) (lot # not provided) instead of a dose of varicella virus vaccine live. The medical assistant confirmed that this was not product confusion. No problems were reported. The patient's status was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 62 year old female who on 29-OCT-2007 was vaccinated SC with a dose of ZOSTAVAX (Oka/Merck).  On 29-OCT-2007 the patient experienced redness "that wrapped around her right arm (injection arm) starting from the shoulder and going down to her fingers.  The patient also experienced neck stiffness, pain in the neck, arm and fingers.  The patient also experienced a rash at the waist line and back.  She was itchy around her back and toward her right side with a slight fever and all around flu-like symptoms.  No medical attention was sought.  The outcome was reported as not recovered.  No further information was provided.  There was no product quality complaint.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 62 year old female who on 29-OCT-2007 was vaccinated SC with a dose of ZOSTAVAX (Oka/Merck).  On 29-OCT-2007 the patient experienced redness "that wrapped around her right arm (injection arm) starting from the shoulder and going down to her fingers.  The patient also experienced neck stiffness, pain in the neck, arm and fingers.  The patient also experienced a rash at the waist line and back.  She was itchy around her back and toward her right side with a slight fever and all around flu-like symptoms.  No medical attention was sought.  The outcome was reported as not recovered.  No further information was provided.  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 patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Reported as "single dose of series".  The physician reported that the patient's rash was 2 by 2 on the first day and now it was 4 by 4.  Product lot number was unspecified by the reporter.  The patient sought medical attention from the physician.  Outcome was not reported.  There was no product quality complaint.  The physician also referenced 2 other patients that experienced a rash (WAES# 0711USA01838).  The physician believes that all these vials came in the same package.  No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Vision blurred
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old female with no medical history who on 08-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  There was no concomitant medication.  On 09-NOV-2007 the patient developed a headache and her eyes won't focus.  The patient also had red spots on her body which had gone away.  No treatment was recommended.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested. 02/12/2010 No further information is available.