chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Furuncle, Pruritus
Clinical narrative: Information has been received from a female patient with no medical history or allergies who in approximately October or November 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included LIPITOR, esomeprazole magnesium (MSD) and unspecified thyroid medication. In November 2007, after vaccination, the patient began itching uncontrollably. She then developed boils that never erupted and some of the boils looked like chickenpox on her groin area, buttocks, and chest. Unspecified medical attention was sought. Unspecified blood work was performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash macular
Clinical narrative: Information has been received from a licensed Practical Nurse concerning an 84 year old female with sulfonamide allergy who on 15-FEB-2008 at 12:15 was vaccinated SQ in the right arm with a second dose of zoster vaccine live (Oka/Merck) (lot # 658861/1822U). There was no illness at the time of vaccination. On 17-FEB-2008, the patient experienced itching at the injection site and a red blotchy rash on the back of her right arm, at the injection site. There were no lab studies performed. At the time of the report the patient's rash continued and is still slightly itchy, patient had no pain, and the rash did not spread anywhere else. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache
Clinical narrative: Information has been received from a physician concerning a 72 year old female who on 06-DEC-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included multiple unspecified medications. On 10-DEC-2007, the patient developed a headache and blisters on her forehead and eyelid. The patient went to the emergency room but was not hospitalized. A product quality complaint was not involved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a mother concerning her 16 year son who on 18-FEB-2008 at 19:00 was vaccinated in the deltoid with a 0.65 mL first dose of zoster vaccine live (Oka/Merck) instead of dose of varicella virus vaccine live (Oka/Merck) (MSD). No further information was provided. Additional information has been received from a health professional. It was reported that the patient had no reaction and "recovered." Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test, Discomfort, Herpes zoster, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 71 year old female with high blood pressure, hypercholesterolaemia and hypersensitivity to codeine who on 15-NOV-2007 was vaccinated subcutaneously with "one dose" of zoster vaccine live (Oka/Merck) (lot # 658604/1088U). Concomitant therapy included TOPROL XL TABLETS, PLAVIX, DETROL LA, VALIUM, AMBIEN AND ADVAIR. On 22-FEB-2008, the patient developed discomfort on or around her ear and face, followed by a rash the next day. The patient was diagnosed with herpes zoster on 25 FEB 2008. A VZV titer was performed (on an unspecified date) the results of which were not reported. At the time of reporting the patient had not yet recovered. The NP was not interested in getting a VZV analysis. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a nurse practitioner concerning a 71 year old female who on 11-MAR-2008 at 15:30 was vaccinated SC in the arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck). The patient phoned the physician's office stating that on 11-MAR-2008, she developed a large, red, hard area at the injection site on the arm. She was treated with BENADRYL and recovered on an unspecified date. A product quality complaint was not involved. Additional information has been received from the nurse who reported that the redness and firmness at the injection site started on 12-MAR-2008. The area was approximately 12 cm by 7 cm. The redness resolved on its own. The patient recovered on 13-MAR-2008. No further information is expected.
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Information has been received from a registered nurse concerning a male who was vaccinated (on an undisclosed date) with zoster vaccine live (Oka/Merck), and about "three months ago," in approximately 2007, the patient developed neuralgia after receiving zoster vaccine live (Oka/Merck). The patient was seen by his physician for the pain, and treated with unspecified pain medication. At the time of reporting the patients current status was unknown. There was no product quality complaint.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning an 86 year old female consumer with no pertinent medical history who on an unspecified date was vaccinated with 1 dose of zoster vaccine live (Oka/Merck). Concomitant therapy included alendronate sodium (MSD) and VALTREX. Subsequently, on 17-SEP-2007 the patient developed a rash on "her lower buttocks." Medical attention was sought in the emergency room. On an unspecified date the patient recovered. There was no product quality complaint involved. Follow-up information has been received from a health professional concerning this 86 year old female with osteoporosis, increased lipids, sulfonamide and CIPRO allergies and a history of a motor vehicle accident, cerebrovascular accident, RAYNAUDS and diverticulosis who on 28-AUG-2007 was vaccinated SQ in the left arm with a first dose of zoster vaccine live (Oka/Merck) (lot # 658085/0882U). The patient was recovering from a rib fracture due to a motor vehicle accident at the time of vaccination. Additional concomitant therapy included minerals (unspecified) (+) CENTRUM SILVER, LIPITOR, aspirin and folic acid. Subsequently, on 17-SEP-2007 at 2:45 PM the patient had a painful rash on her left buttocks and leg. The patient was diagnosed with shingles. The patient was given VALTREX 1 gm three times a day X 1 week and VICODIN as needed for pain. On 26-Sep-2007, the patient had an office visit and was improved (recovered). Additional information is not expected.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning an 80 year old male who on approximately 14-FEB-2008 was vaccinated with zoster vaccine live (Oka/Merck). The physician reported that "the patient received zoster vaccine live (Oka/Merck) at a pharmacy around 2/14/2008, (the pharmacy information was unspecified by the reporter), and that the patient had broke out in hives about 24 hours after receiving zoster vaccine live (Oka/Merck). The physician reported that the patient come into the office on 2/19/2008 which was five days after receiving zoster vaccine live (Oka/Merck) with hives still on his body." The patients status was unknown at the time of reporting. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Injection site swelling, Pain, Pyrexia
Clinical narrative: Information has been received from a female immunization coordinator who "about 2 months ago" in approximately January 2008, was vaccine with .65mL of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced severe injection site swelling, fever of 100.6, aches and headaches for 4 days after receiving the vaccine. It was unspecified if medical attention was sought. At the time of the report the patient had recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck) (lot # 658861/1822U). Subsequently, the patient developed an erythematous injection site rash. It was unspecified if medical attention was sought. The patient recovered on an unspecified date. There was no product quality complaint involved. Follow-up information from the pharmacist indicated she did not have the names of the patients involved in the event. Follow-up information has been received from the pharmacist concerning this 65 year old female consumer who on 13-FEB-2008 was vaccinated SQ with a first dose of zoster vaccine live (Oka/Merck) (lot # 658861/1822U). Subsequently on 14-FEB-2008 the patient developed a rash about 2 inches in diameter around the injection site. There was no medical attention sought. The patient recovered on 15-FEB-2008. This is one of several reports from the same source. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a license practical nurse concerning a 3 year old female consumer who in August 2007 was inadvertently vaccinated in the right deltoid with zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). The LPN indicated this was a staff error only. No adverse events reported post vaccination. Medical attention was sought in the office. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old female consumer who on 24-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck) subcutaneouly. On 26-MAR-2008 the patient presented with a red, warm and hard area at the injection site. Medical attention was sought, the patient spoke to the pharmacist. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/24/2008. Subsequently the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old female who on 22-FEB-2008 was vaccinated subcutaneously with "one dose", 0.65 ml of zoster vaccine live (Oka/Merck) (Lot #659326/1824U). On 24-FEB-2008 the patient developed a red round rash about 3 inches in diameter at the injection site. The patient placed a phone call to the pharmacist. At the time of reporting the patient was recovering. There was no product complaint. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pain, Injection site reaction, Muscle spasms
Clinical narrative: Information has been received from a registered pharmacist, "who administers vaccines", concerning a 67 year old female with no pertinent medical history, drug reactions or allergies noted on her pharmacy forms, who on 28-JAN-2008 was vaccinated  subcutaneously into the left upper arm with "one single dose" of zoster vaccine live (Oka/Merck) (lot# 658324/1821U) at the pharmacy. Concomitant therapy included celecoxib (CELEBREX), citalopram hydrobromide (CELEXA), vitamin D (unspecified), calcium (unspecified), magnesium (unspecified), amlodipine besylate (NORVASC), hydrochlorothiazide, aspirin and unspecified natural remedies. On 10-FEB-2008 (previously reported as approximately 11-FEB-2008), 14 days after the vaccination, the patient reported an injection site reaction. The patient called the pharmacy to report that she developed a "white or light colored circle area about 1/2 inch in diameter at the injection site." The patient stated that "it is not as pink as normal skin." The pharmacist noted that the area was not warm, raised, or red. The area was painful to touch and the pharmacist mentioned that the patient was having "spasms at the injection site and around the arm in that area." At the time of reporting the events had not resolved and the patient was trying to get an appointment with her physician. There was no product quality complaint. The patient was reported to be recovering at the time of reporting. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning an approximately 70 year old male consumer who in  approximately December 2007, was vaccinated with zoster vaccine live (Oka/Merck). On 25-MAR-2008 or 26-MAR-2008 the patient had a full case of zoster. Medical attention was sought in the office. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dry skin, Hot flush, Pruritus, Rash macular
Clinical narrative: This is in follow-up to report (s) previously submitted on 6/24/2008. Information has been received from a physician concerning an 87-year-old female with reactions to all other medications the physician prescribed (specifics were not known; "can not tolerate any medication that had been prescribed")and a history of artiral fibrillation who on 06-NOV-2007 was vaccinated subcutaneously in left arm with her first dose of ZOSTAVAX (Oka/Merck) (Lot# 0966). On an unspecified date the patient experienced hot flashes and upset stomach. On 11-NOV-2007, the patient experienced blurred vision, dizziness, skin blotchs, skin itches and dry skin. At the time of the report the patient's status was unknown. The patient sought unspecified medical attention. A product quality complaint was not involved. Additional information is not expected.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Stomach discomfort, Vision blurred
Clinical narrative: This is in follow-up to report (s) previously submitted on 6/24/2008. Information has been received from a physician concerning an 87-year-old female with reactions to all other medications the physician prescribed (specifics were not known; "can not tolerate any medication that had been prescribed")and a history of artiral fibrillation who on 06-NOV-2007 was vaccinated subcutaneously in left arm with her first dose of ZOSTAVAX (Oka/Merck) (Lot# 0966). On an unspecified date the patient experienced hot flashes and upset stomach. On 11-NOV-2007, the patient experienced blurred vision, dizziness, skin blotchs, skin itches and dry skin. At the time of the report the patient's status was unknown. The patient sought unspecified medical attention. A product quality complaint was not involved. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: Information has been received from a 66-year-old female with asthma and "can not take anti-inflammatories" who on 22-FEB-2008 was vaccinated in the arm with her first dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. On 25-FEB-2008, the patient experienced a severe migraine. The patient did not seek medical attention and no diagnostic labs were performed. At the time of the report the patient's status was recovering. A product quality complaint was not involved. No further information is available.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 60 year old female friend with no pertinent medical history who on 24-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Additional suspect vaccination administered at the same time included pneumococcal 23v polysaccharide vaccine (MSD). The patient had a respiratory illness the day she received the vaccines. Subsequently, on 25-MAR-2008 the day after vaccination the patient became very sick with a fever, malaise and soreness in her arm. It was unspecified if medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Headache
Clinical narrative: Information has been received from a physician concerning an 86-year-old female with hypertension, cardiac dysrhythmias and osteoporosis who on 06-FEB-2008 was vaccinated subcutaneous with her first dose of zoster vaccine live (Oka/Merck). Concomitant therapy included losartan potassium-HCTZ (MSD) alendronate sodium (MSD) and propranolol HCL. On an unspecified date the patient experienced fullness in the head. The patient sought unspecified medical attention. The patient had a CT scan and blood work performed on an unspecified date. 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.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Injection site pain
Clinical narrative: Information has been received from a 66 year old white female consumer (62 in 174 lb) with asthma and allergies to mold who on 25-FEB-2008 was vaccinated subcutaneously with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included montelukast sodium (MSD) and mometasone furoate (NASONEX). On 25-FEB-2008 the patient developed pain (also reported as soreness) at the injection site with no redness and a mild headache that was different from usual. She also felt tired and had no energy for about 24 hours. (previously reported as no other symptoms noted). The patient did not seek medical attention and no diagnostic labs were performed. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Information has been received from a female consumer indicating that someone told her that their brother was vaccinated on an unspecified date with zoster vaccine live (Oka/Merck). Subsequently, he got really sick after vaccination. At the time of the report the patient's status was unknown. It was unspecified if medical attention was sought. There was no product quality complaint involved. Additional information is unavailable.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female who on 24-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included Metformin, glipizide (GLUCOTROL XL), hydrochlorothiazide, diltiazem HCL, propranolol Hcl, aspirin, lorazepam (ATIVAN), omega-3 marine triglycerides, vitamins (unspecified), albuterol, acetaminophen/hydrocodone bitartrate (LORTAB), hyoscyamineSO4, lovastatin, lisinopril, rabeprazole sodium (ACTPHEX), nitrofurantoin, fluconazole (DIPLUCAN), fluoxitene, naproxen (NAPROSYN) and nystatin (MYCOSTATIN). On 22-FEB-2008 the patient developed herpes zoster. Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient's status was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was exposed to her grandmother who on 08-FEB-2008 was vaccinated SQ in the right arm with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 659325/1823U). Medical attention was sought on 24-MAR-2008 in the clinic. The patient had shingles. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the patient was treated with acyclovir 400mg. The patient's outcome was not reported. Follow-up information indicated no new information. Additional information is not expected. This is one of several reports from the same source.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash papular, Skin warm
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 62 year old male consumer who has not had chickenpox in the past who on 21-MAR-2008 was vaccinated SQ with zoster vaccine live (Oka/Merck) (lot # 659324/1835U). There was no illness at the time of vaccination. Subsequently, on 22-MAR-2008 the patient noticed a local rash 3 inches in diameter consisting of small pimple-like bumps near the injection site surrounded by a dark red ring. The area also appeared to be warm. Medical attention was sought, the patient called the pharmacist. There were no lab studies performed. On 26-MAR-2008, the patient recovered. There was no product complaint involved. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac flutter, Feeling hot, Influenza like illness, Palpitations, Peripheral coldness
Clinical narrative: Information has been received from a female consumer with no pertinent medial history or allergies who on 28-FEB-2008, at 9:15 AM was vaccinated with a first dose of zoster vaccine live (Oka/Merck). Concomitant therapy included ascorbic acid and vitamin D (unspecified). On 28-FEB-2008, after running some errands and returning home at an unspecified time, the consumer noticed that her feet were cold, head was hot, and heart was racing and fluttering. She commented these symptoms resembled flu-like symptoms. As she was reporting this, at 12:40 PM, she reported that itching was developing. Medical attention was not sought. There were no laboratory tests or diagnostic studies performed. The outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a female consumer with no pertinent medial history or allergies who on 28-FEB-2008, at 9:15 AM was vaccinated with a first dose of zoster vaccine live (Oka/Merck). Concomitant therapy included ascorbic acid and vitamin D (unspecified). On 28-FEB-2008, after running some errands and returning home at an unspecified time, the consumer noticed that her feet were cold, head was hot, and heart was racing and fluttering. She commented these symptoms resembled flu-like symptoms. As she was reporting this, at 12:40 PM, she reported that itching was developing. Medical attention was not sought. There were no laboratory tests or diagnostic studies performed. The outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a Nurse Practitioner and a 70 year old male with no known allergies and an "unremarkable" medical history who on 02-NOV-2007 was vaccinated SQ in the right arm with 0.65mL first dose of zoster vaccine live (Oka/Merck) (Lot # 658395/0966U). There was no concomitant therapy. On 04-FEB-2008, the patient went to the doctor's office for a pruritic and painful rash on his back that started on 02-FEB-2008. The patient was seen by the physician and diagnosed with shingles, described as vesicular lesions on his back. The patient was treated with VALTREX. On 14-FEB-2008, the patient called the office complaining of pain (post herpetic neuralgia) so he was started on LYRICA 75mg bid. There were no lab studies performed. The patient recovered on 29-FEB-2008. There was no product quality complaint involved. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Herpes zoster, Pain, Rash, Underdose
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 64-year-old female with hypertension, hyperlipidaemia, scoliosis, rhinitis allergic, osteoporosis, gastrooesophageal reflux disease, mitral valve prolapse, depression, left carotid bruit, and penicillin, MACROBID and BACTRIM allergies who on 18-MAR-2008 was vaccinated subcutaneously in the right deltoid with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot# 659759/1873U). Concomitant therapy included hydrochlorothiazide (manufacturer unknown), atenolol, NEXIUM, LIPITOR, ZYRTEC, OMACOR and NASACORT. On 20-MAR-2008, the patient experienced a shingles like rash on the patient's left shoulder. Medical attention was sought at the physician's office. There were no laboratory or diagnostic tests performed. The outcome was reported as not recovered. No product quality complaint was involved. Follow-up has been received from the L.P.N. concerning a patient with a history of chickenpox at the age of 7 who was vaccinated with a 0.6 mL (previously reported as 0.65 mL) dose of zoster vaccine live (Oka/Merck). It was reported that a rash had not occur at the site of injection or elsewhere within 42 days of the vaccination. Date of Herpes Zoster was reported as 20-Mar-2008. The patient rated the pain a 5-6 on a scale of 0-10 (10 being the most). Other symptoms included itching. There was no recent exposure to chickenpox. A direct fluorescent antibody was not done. Follow-up has been received from the L.P.N. and physician who indicated that additional concomitant therapy included cyclobenzaprine hydrochloride (MSD). On 20-Mar-2008, the patient developed a rash on the chest area above the left breast and shoulder. The patient's maximum temperature was 98 degrees. There was no recent history of exposure to chickenpox or shingles. On an unspecified date the patient recovered. The patient was enrolled in the Varicella Zoster Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The samples of the lesion were collected on 26-Mar-2008. The sample of #1 and #2 were taken from fluid from a vesicle (swab of vesicle). The PCR results for the specimen from the vesicle identified the presence of WT VZV. Additional information is not expected. This is in follow-up to report (s) previously submitted on 6/24/2008. A lot check has been iniciated. A standard lot check investigation was performed. All in-process quality checks for the lot# 659759/1873U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release not all specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Viral DNA test positive
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 64-year-old female with hypertension, hyperlipidaemia, scoliosis, rhinitis allergic, osteoporosis, gastrooesophageal reflux disease, mitral valve prolapse, depression, left carotid bruit, and penicillin, MACROBID and BACTRIM allergies who on 18-MAR-2008 was vaccinated subcutaneously in the right deltoid with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot# 659759/1873U). Concomitant therapy included hydrochlorothiazide (manufacturer unknown), atenolol, NEXIUM, LIPITOR, ZYRTEC, OMACOR and NASACORT. On 20-MAR-2008, the patient experienced a shingles like rash on the patient's left shoulder. Medical attention was sought at the physician's office. There were no laboratory or diagnostic tests performed. The outcome was reported as not recovered. No product quality complaint was involved. Follow-up has been received from the L.P.N. concerning a patient with a history of chickenpox at the age of 7 who was vaccinated with a 0.6 mL (previously reported as 0.65 mL) dose of zoster vaccine live (Oka/Merck). It was reported that a rash had not occur at the site of injection or elsewhere within 42 days of the vaccination. Date of Herpes Zoster was reported as 20-Mar-2008. The patient rated the pain a 5-6 on a scale of 0-10 (10 being the most). Other symptoms included itching. There was no recent exposure to chickenpox. A direct fluorescent antibody was not done. Follow-up has been received from the L.P.N. and physician who indicated that additional concomitant therapy included cyclobenzaprine hydrochloride (MSD). On 20-Mar-2008, the patient developed a rash on the chest area above the left breast and shoulder. The patient's maximum temperature was 98 degrees. There was no recent history of exposure to chickenpox or shingles. On an unspecified date the patient recovered. The patient was enrolled in the Varicella Zoster Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The samples of the lesion were collected on 26-Mar-2008. The sample of #1 and #2 were taken from fluid from a vesicle (swab of vesicle). The PCR results for the specimen from the vesicle identified the presence of WT VZV. Additional information is not expected. This is in follow-up to report (s) previously submitted on 6/24/2008. A lot check has been iniciated. A standard lot check investigation was performed. All in-process quality checks for the lot# 659759/1873U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release not all specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 73-year-old female with no medical history who on 11-MAR-2008 at 15:34 was vaccinated subcutaneously in the left arm with first dose of zoster vaccine live (Oka/Merck) (lot# 658210/1079U). There was no illness at the time of vaccination. On 11-MAR-2008 at 17:00, the patient experienced 6" welt (red and swollen and warm area) surrounding the injection site. No diagnostic tests were performed. Subsequently, 8 days following the vaccination, on 18-MAR-2008, the patient recovered from 6" welt welt surrounding the injection site. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: Information has been received from a female consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed stabbing pain and itching for months after vaccination. It was unspecified if medical attention was sought. The patient's outcome was not reported. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an "over 70 years old" female who was vaccinated on an unspecified date with zoster vaccine live (Oka/Merck) at the pharmacy. Subsequently, 10 to 12 days later the patient developed shingles. Unspecified medical attention was sought in the Emergency Room. The patient was not admitted. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 71 year old female consumer with no pertinent medical history or allergies who on 26-FEB-2008 was vaccinated with a 0.65mL dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. On 27-FEB-2008, the patient experienced redness, swelling, and warmth in a two inch circle around the injection site. No medical attention was sought. No lab studies were performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall
Clinical narrative: Information has been received from a 79 year old female consumer with Shingles, Post Herpetic Neuralgia, latex allergy and drug hypersensitivity to acetaminophen (TYLENOL), ibuprofen (MOTRIN), and "(VACTRUM)." A history of "surgery because she fell and hit her head" and "shingles in 2006 for an unknown period of time" who "sometime near the end of 2006" was vaccinated with zoster vaccine live (Oka/Merck). Subsequently the patient did not know if after receiving zoster vaccine live (Oka/Merck) her shingles and PHN got better or worse. Unspecified medical attention was sought with a "spinal physician," there were no lab studies performed. The patient was given pregabalin (LYRICA). she had felt dizzy and fell out of her chair about eight times. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is available.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Rash pruritic, Skin burning sensation
Clinical narrative: Information has been received from a 79 year old female consumer with a history of lymphoma and no known allergies who "about five months ago" in approximately October 2007, was vaccinated with a 0.65mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included COUMADIN, BENICAR, SYNTHROID, TAMBOCOR, PROTONIX and vitamins (unspecified). Subsequently, "several months ago" the patient experienced a burning, itchy rash on her breasts and stomach. Unspecified medical attention was sought. There was no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician concerning a 79 year old female consumer with a history of lymphoma and no known allergies who "about five months ago" in approximately October 2007, was vaccinated with a 0.65ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included COUMADIN, BENICAR, SYNTHROID, TAMBOCOR, PROTONIX and vitamins (unspecified). Following some period of time (several months ago) the patient developed a burning, itchy rash on her breasts and stomach. Medical attention was sought. The event persisted and even biopsy was non-diagnostic. The patient was unclear of the time it took after the ZOSTAVAX for the rash to appear. The relationship of the rash to the ZOSTAVAX remained undeterminate. There was no product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Information has been received from a 60 year old Registered Nurse with no known allergies, "osteomylasia" and hypothyroidism who on 19-FEB-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included ezetimibe (+) simvastatin (MDS), SYNTHROID, LEXAPRO, EXCEDRIN and FORTEO. On 23-FEB-2008, the patient experienced a headache that was being treated with EXCEDRIN. The patient also developed a lump, bruise, erythema and pruritus at the site of injection. There was no medical attention sought. At the time of the report the patient was not recovered. There was no product quality complaint involved. Follow-up information from the physician indicated she did not administer the vaccine to the patient nor was she aware of any complaints. Follow-up information from the registered nurse indicated that the headache she experienced after the vaccination was probably not due to the vaccine. It was noted that the headache was thought to be due to environmental consequences. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: FLU3, HIBV, MMRV, PNC
Symptoms: Unevaluable event
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 27 month old male with no medical history or allergies who had clear rhinitis and a cough at the time of vaccination, who on 20-NOV-2006 was vaccinated subcutaneously in the left arm with a 0.5 mL first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female who on an unspecified date was vaccinated with a 0.65ml dose of zoster vaccine live (Oka/Merck). Subsequently the patient developed shingles. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Herpes zoster
Clinical narrative: Information has been received from an 85 year old male consumer with no known allergies and a history of shingles and kidney infection who on 03-JAN-2008 was vaccinated with a first dose of zoster vaccine live (Oka/Merck) in the arm. The patient was on unspecified concomitant therapy. "14 days post vaccination", on 17-Jan-2008, the patient developed shingles. Unspecified medical attention was sought and the patient was treated with medication (specifics were not known) from his Physician. The patient also noted "constant misery." There were no lab studies performed. On an unspecified date the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a consumer concerning a 91 year old female consumer with no known allergies and no pertinent medical history who on 05-FEB-2008 was vaccinated IM with 0.65mL of zoster vaccine live (Oka/Merck). There was no concomitant medication. On 05-FEB-2008, the patient experienced injection site pain. On an unspecified date the patient recovered. There was no product quality complaint involved. This is one of several reports from the same source. Follow-up information indicated no further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Initial and follow-up information has been received from a Certified Medical Assistant concerning a 67 year old female with no known drug allergies or pertinent medical history, who on 20-FEB-2008 was vaccinated IM (also reported as SQ) in the left deltoid with a 0.65mL dose of zoster vaccine live (Oka/Merck) (lot # 659324/1835U). Subsequently, a few days after vaccination on 23-FEB-2008 or the 26-FEB-2008 the patient developed a vesicular rash and pain following dermatome distribution at the right scapular area. Unspecified medical attention was sought in the office. There were no lab studies performed. The patient was diagnosed with shingles, with lesions on her right shoulder, chest, and back. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMRV
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male who on 22-MAY-2007 was vaccinated subcutaneously with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (Lot XXXXXXXX). Concomitant vaccine therapy included PREVNAR. The physician noted that the patient was diagnosed with shingles after receiving measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process), dates unspecified. It was noted that the patient improved "after a shot of acyclovir (manufacturer unknown). Unspecified medical attention was sought, which included being seen by the physician on 12 MAR 2008. No lab diagnostic studies were performed. At the time of reporting the patient was recovering. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female friend who apparently had shingles 5 years ago who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient experienced quite a severe reaction to the vaccination by having hives all over, and "had to be treated with corticosteroids (unspecified), etc." At the time of the report the patient's status was unknown. Attempts are being made to obtain additional information. Additional information will be provided if available.
Age: 1.0
Sex: M
Vaccine: DTAPH, FLU3, HEPA, MMRV, PNC
Symptoms: Chest X-ray normal, Febrile convulsion, Influenza serology negative, Respiratory syncytial virus serology negative
Clinical narrative: Initial and follow-up information has been received from a healthcare worker concerning her 12 month old son with a history of hernia surgery on 04-MAR-2008 and no drug allergies who on 14-JAN-2008 at 16:15 was vaccinated subcutaneous in the right thigh with his first 0.5 ml dose of PROQUAD (lot# 656891/0914U).  There were no illnesses at the time of vaccination.  Concomitant vaccines administered on 14-JAN-2008 at 16:15 included a second intramuscular dose of FLUZONE administered in the right leg; an intramuscular "3+2" dose of TRIHIBIT administered in the left leg; an intramuscular fourth dose of PREVNAR administered in the right leg and an intramuscular first dose of VAQTA administered in the left leg.  On 23-JAN-2008, 9 days post vaccination, the patient experienced a febrile seizure that lasted 15 minutes.  The patient was evaluated at a hospital emergency room and transported via ambulance to be admitted to another medical center on that same day.  Lab diagnostic studies included testing for two strains of Influenza and respiratory syncytial virus which were negative and a negative chest x-ray.  The patient was prescribed breathing treatments, TAMIFLU, MOTRIN, TYLENOL, XOPENEX and PULMICORT.  The patient was discharged from the hospital on 24-JAN-2008.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information is not expected.
Age: 47.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 47 year old patient who was to be vaccinated with varicella virus vaccine live (MSD), but inadvertently received zoster vaccine live (Oka/Merck). The patient did not experience any known symptoms. Unspecified medical attention was sought, the patient contacted the Pharmacist. At the time of the report the patient's status was unknown. There was no product quality complaint involved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a Medical Assistant concerning an approximately 66 year old female with no known allergies who on an unspecified date was vaccinated with 0.65mL zoster vaccine live (Oka/Merck). Subsequently, the patient developed redness and soreness at the injection site after receiving the vaccination. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information has been received from a health care professional concerning this 65 year old female consumer who on 21-FEB-2008 was vaccinated SQ in the left arm with zoster vaccine live (Oka/Merck) (lot # 658861/1822U). Subsequently, on 21-FEB-2008 the patient experienced redness and soreness at the injection site after receiving the vaccine. It was to the point that the patient was not able to touch it. This lasted for seven days. The patient recovered on 28-FEB-2008. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 4 year old black female with penicillin allergy who on 15-FEB-2008 was vaccinated intramuscularly into the left thigh with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot #
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Headache, Incorrect route of drug administration, Influenza
Clinical narrative: Information has been received from an unspecified health professional and a 71 year old male consumer with no known allergies or pertinent medical history who on 14-FEB-2008 was vaccinated IM in the left deltoid with a first dose of zoster vaccine live (Oka/Merck) (lot # 658325/1429U). There was no concomitant medication. "13 days post vaccination," on 27-FEB-2008 the patient experienced severe joint pain, cough, flu symptoms, headache, runny nose and also developed pleurisy. No medical attention was sought. The patient called the physician's office on 11-MAR-2008 to complain of flu symptoms. The patient thought it was a side effect of the zoster vaccine live (Oka/Merck). The patient was advised to schedule a follow up appointment. The patient never scheduled an appointment, and per the patient he would schedule if he was worse. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pleurisy, Rhinorrhoea
Clinical narrative: Information has been received from an unspecified health professional and a 71 year old male consumer with no known allergies or pertinent medical history who on 14-FEB-2008 was vaccinated IM in the left deltoid with a first dose of zoster vaccine live (Oka/Merck) (lot # 658325/1429U). There was no concomitant medication. "13 days post vaccination," on 27-FEB-2008 the patient experienced severe joint pain, cough, flu symptoms, headache, runny nose and also developed pleurisy. No medical attention was sought. The patient called the physician's office on 11-MAR-2008 to complain of flu symptoms. The patient thought it was a side effect of the zoster vaccine live (Oka/Merck). The patient was advised to schedule a follow up appointment. The patient never scheduled an appointment, and per the patient he would schedule if he was worse. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Oedema peripheral, Sick relative, Skin warm
Clinical narrative: Information has been received from a consumer concerning her 5 year old white son who was a student with asthma, no known drug allergies and no illness at the time of the vaccine who on 24-JUL-2007 at approximately 10:00 was vaccinated subcutaneously in the right arm with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (Lot number 657780/0617U). Concomitant therapy was not reported. On 24-JUL-2007, by 19:00, the patient experienced a warm, swollen area measuring "11 cm x 5-6 cm" of his "entire upper right arm." Subsequently, on an unspecified date, the patient recovered. It was also reported that the patient's sibling experienced "the same reaction, same day" from varicella virus vaccine live (Oka/Merck) (MSD). (WAES# 0806USA00616). This is one of two reports from the same source. Additional information is not expected.