chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Syncope
Clinical narrative: Pt had syncopal episode after GARDASIL.  Did not fall, guided to chair by me & aroused with ammonia & cold wet cloth.  No seizure act.  Pulse always present.  Given water & granola bars
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 77 year old female with SULFONAMIDE allergy and no known medical history who on 01-MAR-2007 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck) (lot # 656412/1476F) subcutaneous.  Concomitant therapy included SYNTHROID, calcium (unspecified), COUMADIN and estrogens (unspecified).  On 22-JAN-2009 the patient developed shingles.  The patient developed painful red raised blisters on her shoulder blades on her back.  The patient was given DARVOCET, VALTREX, and a cream for the treatment.  No laboratories studies performed.  The patient sought medical attention with the nurse.  At the time of this report the patient was recovering.  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a 74 year old female with no known medical history and drug allergies, who two weeks ago was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included XANAX. For the past 2-3 days her back had been very itchy but she cannot determine if there was a rash present. No laboratories studies were performed. The patient did nit seek medical attention. At the time of this report the patient had not recovered. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 77 year old female patient with no known allergies and no pertinent medical history, who on 27-SEP-2007 was vaccinated with ZOSTAVAX (Lot not provided). There was no concomitant medication. The patient developed (on an unspecified date) painful shingles around face, scalp and forehead. She also experienced shooting pain, chills and fever. She was prescribed VALTREX for the treatment. As of 26-JAN-2009 the patient hadn't recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.   Follow up information has been received from a registered nurse and a completed questionnaire, concerning a 78 year old female patient with a history of chickenpox in 1938, who on 27-SEP-2007 was vaccinated with 0.5 mL the first dose of ZOSTAVAX (Merck) (Lot 658084/0888U) subcutaneously in the left arm at 2:15 pm.  It was reported the patient had no illness at time of vaccination.  The reporter stated a failure in the ZOSTAVAX (Merck) vaccine.  On 26-Jan-2009, the patient developed shingles.  The patient had a maximum of body temperature of 91.8 degrees F, with a pain degree of 5 (0 lest to 10 most), she also had trouble with vision and went to see the ophthalmologist.  The nurse reported the patient had had no recent exposure to chicken pox or herpes zoster.  A direct fluorescent antibody test was not done and no specimen was collected for PCR.  On an unspecified date the patient recovered.  Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a registered nurse (also reported as certified medical assistant) concerning a 71 year old female patient with hiatus hernia, seasonal allergy, ibuprofen causes shortness of breath, glaucoma, arthritis and hyperlipidaemia and a history of helicobacter pylori infection that had been corrected who on 20-JAN-2009 was vaccinated intramuscularly into the right arm with a 0.65ml dose of ZOSTER vaccine live (Oka/Merck) (Lot #663196/1417X).  Concomitant therapy included ACTONEL, aspirin, calcium (unspecified) (+) vitamin D (unspecified), chondroitin sulfate sodium (+) glucosamine sulfate, vitamins (unspecified), NEURONTIN, NEXIUM and simvastatin (MSD).  The medical assistant reported that after vaccination (on unspecified date) the patient experienced a local reaction to the right arm.  The area was red, warm and slightly raised area that was 2 by 1 and 1/2 inches.  The patient was told to apply a cool compress to this area.  The patient sought medical attention by phone on 23-JAN-2009.  At the time of reporting the patient was recovering  This is one of two cases from the same source.  This is a consolidation of two reports concerning the same patient.  Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pustule, Injection site vesicles
Clinical narrative: Information has been received from a licensed practical nurse concerning a 55 year old female paraeducator (weight 242 pounds, height unknown) with penicillin allergy who on 2-JAN-2009 was vaccinated with a first dose of ZOSTAVAX subcutaneous, lot # 663177/1413X. The nurse stated that the patient called on 5-JAN-2009 and reported she developed blister filled pustules where the vaccine was given, denied any pain at injection site, only developed pustules. Patient recovered. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a female patient who on 23-JAN-2009 was vaccinated with a 0.65 ml dose of ZOSTER vaccine live (Oka/Merck).  The physician reported that on 23-JAN-2009 after the vaccination the patient experienced pain and erythema at the injection site.  The patient sought unspecific medical attention.  The patient recovered on 25-JAN-2009.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Varicella virus test positive
Clinical narrative: Information has been received from a Master of Science in Dentistry and a Physician concerning herself, a 61 year old female patient with pre-osteoporosis and no know drug allergies, who on 09-JAN-2009 was vaccinated with a "single dose" of ZOSTER vaccine live (Oka/Merck) (lot # not provided).  Concomitant therapy included, vitamins (unspecified) and EVISTA.  On 24-JAN-2009 the patient developed a "shingles rash that is about 2 inches by 4 inches in the left hand side of the belly".  It was reported that the patient had received in November 2008 a shot of influenza virus vaccine (unspecified).  Patient sought medical attention by seeing her physician.  No lab diagnostic studies were performed.  At the time of this report the patient had not yet recovered.  Follow up information received on 29-JAN-2009.  Patient called back and reported that the "rash never developed into fluid-filled blisters but rather pimple-like".  The rash is improving and she is not experiencing severe pain or pruritis.  Follow up information was received from a physician who reported that the patient had a history of cholesterol and chickenpox when she was a child.  The patient had no recent exposure to chickenpox or herpes ZOSTER.  The patient was vaccinated with ZOSTER vaccine live (Oka/Merck) (Lot no. 663673/1710X) SC, 0.65 mL into the right arm.  The physician stated that the patient did not develop the event (shingles) at the site of the injection.  The patient had pain quantified as 0 in a 0-10 scale and did not present other systemic symptoms.  The patient recovered from the event.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  On 30-JAN-2009 the lesion sample was collected.  On 04-FEB-2009 the sample arrived to the laboratory and the DNA was amplified.  The PCR results confirmed that the VZV strain was related to a wild-type.  The specimen was adequate.  It is unknown the specific site where the sample was collected from.  A photo of the lesion was taken.  No further information is available.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning an 87 year old female patient with recurrent shingles (about every two months) who on 09-JAN-2009 was vaccinated with one dose of ZOSTER vaccine live (Oka/Merck) SQ.  Since receiving the vaccine, the patient continued to develop shingles about every three months.  The patient had contacted the pharmacist for medical attention.  Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count, Pruritus, Rash generalised, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old male patient with no pertinent medical history and no known drug allergies/drug reactions who on 12-JAN-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneously. Concomitant therapy included niacin. It was reported that on 15-JAN-2009 the patient experienced a generalized rash on his torso after being vaccinated with ZOSTAVAX. It was reported that the rash was described as itchy and raised. The patient was seen at the practice. The lot # 662389/1325X was previously reported as a lot # for ZOSTAVAX. This lot # has been validated and it was a lot # for VARIVAX. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Injection site rash, Malaise, Musculoskeletal discomfort
Clinical narrative: Information has been received from a physician concerning a 65 year old male patient who on 21-JAN-2009 was vaccinated with ZOSTAVAX. On 23-JAN-2009, the patient began having discomfort around the neck. On 26-JAN-2009, the patient presented with a "typical" shingles rash. The patient's discomfort around the neck and "typical" shingles rash persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information has been received from physician that the patient still had the shingles.  The patient had improved but not recovered.  The patient was given VALTREX 3 grams per day starting on 30-JAN-2009.  Stop date of VALTREX was unknown.  Follow-up information has been from a completed questionnaire by a physician on 30-MAR-2009.  It was reported that the patient with a history of chickenpox in his childhood, kidney stone and knee replacement, was vaccinated on 21-JAN-2009 with one dose of ZOSTER vaccine live (MERCK) in the left deltoid.  On 24-JAN-2009, the patient developed absolutely typical case of herpes in right occipital and neck in dermatomal rash (but discomfort without rash on 23-JAN-2009).  Distribution was trigeminal nerve.  Eye not involved.  The rash did occur at the site of injection or elsewhere within 42 days of the vaccination.  Patient said this pain was worse than knee replacement or kidney stone (pain scale 10).  Other systemic symptoms were fatigue and malaise.  There was not a direct fluorescence antibody done and the specimen was not collected for Polymerase Chain Reaction (patient refused).  There was no a photo taken.  As of 23-MAR-2009, the patient was just getting back to normal.  Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a 65 year old male patient who on 21-JAN-2009 was vaccinated with ZOSTAVAX. On 23-JAN-2009, the patient began having discomfort around the neck. On 26-JAN-2009, the patient presented with a "typical" shingles rash. The patient's discomfort around the neck and "typical" shingles rash persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information has been received from physician that the patient still had the shingles.  The patient had improved but not recovered.  The patient was given VALTREX 3 grams per day starting on 30-JAN-2009.  Stop date of VALTREX was unknown.  Follow-up information has been from a completed questionnaire by a physician on 30-MAR-2009.  It was reported that the patient with a history of chickenpox in his childhood, kidney stone and knee replacement, was vaccinated on 21-JAN-2009 with one dose of ZOSTER vaccine live (MERCK) in the left deltoid.  On 24-JAN-2009, the patient developed absolutely typical case of herpes in right occipital and neck in dermatomal rash (but discomfort without rash on 23-JAN-2009).  Distribution was trigeminal nerve.  Eye not involved.  The rash did occur at the site of injection or elsewhere within 42 days of the vaccination.  Patient said this pain was worse than knee replacement or kidney stone (pain scale 10).  Other systemic symptoms were fatigue and malaise.  There was not a direct fluorescence antibody done and the specimen was not collected for Polymerase Chain Reaction (patient refused).  There was no a photo taken.  As of 23-MAR-2009, the patient was just getting back to normal.  Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration
Clinical narrative: Information has been received from a physician concerning a 68 year old female patient who on 21-JAN-2009 was vaccinated with 0.65 ml of a dose of ZOSTAVAX (Lot not reported) in her left arm but very near to elbow. the patient developed golf ball size induration at the injection site after vaccination. As of 28-JAN-2009 the outcome of the patient was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes simplex
Clinical narrative: Information has been received from a registered pharmacist concerning a 69 year old female patient with herpes simplex and penicillin allergy who on 5-MAR-2008 was vaccinated with ZOSTAVAX SQ. On 26-JAN-2009, the patient had experienced increased severity in the presentation of herpes simplex lesions after receiving her ZOSTAVAX vaccination. The patient had spoken to a registered pharmacist for medical attention. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 74 year old male physician with prostate cancer that was treated with radiation who in approximately December 2007, "winter 2007", was vaccinated with a dose of ZOSTAVAX. In January 2009, the patient experienced shingles outbreak "now". The patient spoke to his physician. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: Information has been received from a pharmacy student concerning an over 65 year old female who on 28-JAN-2009 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck) (lot number, injection site and route not reported).  On 29-JAN-2009 the patient had a blood sugar level of 400.  The patient was treated at an unspecified emergency room but not admitted.  The patient was released from the emergency room on an unknown data.  The outcome of the patient's experience was unknown.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician's assistant concerning a roughly 60 year old female who on 20-JAN-2009 was vaccinated with a dose of ZOSTAVAX (lot number, injection site and route not reported). On 20-JAN-2009, after the vaccination, the patient developed a shingles-like rashes. The physician assistant looked at the rashes and it looks like it was a bad case of shingles. The outcome of the patient's experience was like unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a physician's assistant concerning a roughly 60 year old female who on 20-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, injection site and route not reported).  On 20-JAN-2009, after the vaccination, the patient developed a shingles-like rashes.  The physician assistant looked at the rashes and it looked like it was a bad case of shingles.  The outcome of the patient's experience was unknown.  Follow-up information was received which reported that the patient was not seen in their clinic.  Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Pain
Clinical narrative: Information has been received from a physician's assistant concerning a 59 year old female with no drug reactions or allergies and a history of breast cancer who on 2-JAN-2008 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX. There was no concomitant medication. On approximately 22-JAN-2009, about a week ago, the patient experienced mild pain at the T3 dermatome. The patient did not have a rash. Comprehensive metabolic panel was performed (result not reported). At the time of this report, the patient was not recovered. The patient was seen for medical attention. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 79 year old male who on 6-JAN-2009 was vaccinated injection with ZOSTAVAX (LOT # not provided) 0.65ml. On 20-JAN-2009, the patient developed chickenpox after getting ZOSTAVAX. The patient's chickenpox persisted. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 3 year old patient who on 19-JAN-2009 was vaccinated with a dose of ZOSTAVAX instead of a dose of VARIVAX by a human error. No adverse effect reported. Follow-up information was received from the RN. It was reported that "the person giving the vaccine to the patient was new to immunizations and they grabbed the wrong vaccine". The physician has talked to the patient's mother and the patient is doing fine. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia facial
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female patient with an allergy to something the dentist gave her (not further specified) and a history of thyroid removal who on 22-JAN-2009 was vaccinated with a dose of ZOSTAVAX (lot # 663175/1553X) subcutaneously. There was no concomitant medication. On 22-JAN-2009 the patient experienced numbness around her lips extending into her right cheek 15 minutes after receiving the dose. The patient's numbness around her lips extending into her right cheek persisted. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 80 year old female patient with no known allergies who on 19-JAN-2009 was vaccinated with a dose of ZOSTAVAX (lot # 663673/1710X). The patient had completed a 16 day course of VALTREX seven days before receiving ZOSTAVAX. On 21-JAN-2009 the patient experienced an outbreak of shingles after receiving ZOSTAVAX. The lesions were located on her waist and down buttocks. The patient had not contacted her physician at the time. The patient's outbreak of her shingles persisted. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient who was over 65 year old, who beginning November 2008, was vaccinated with a dose of ZOSTAVAX. In approximately December 2008, the patient developed mild case of shingles in her right chest wall. No treatment required. The patient's mild case of shingles in her right chest wall persisted. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a female in her 70's who on an unknown date was vaccinated with ZOSTER vaccine, 0.65 mL, lot # not reported.  It was reported that the patient developed a case of shingles after receiving the vaccine.  The patient sought unspecified medical attention.  Her outcome is unknown.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow up information has been received concerning a 76 year old female patient with a medical history of immunisation who on 28-FEB-2008 was vaccinated with ZOSTAVAX (Merck), (lot # 658082/0744U) 0.65 mL, intramuscular route.  In November 2008, the patient developed shingles described as a rash, distributed on mouth, 2 patchy areas.  Photos were not taken and the patient was not evaluated in the office.  On an unspecified date the patient had recovered.  Prior vaccinations included a dose of pneumococcal 23v polysaccharide (MSD) (lot #660718/0551X) on 22-OCT-2008, and a dose of pneumococcal 23v polysaccharide (manufacturer unknown) in 1999; influenza virus vaccine (unspecified) on 15-OCT-2007; a dose of FLUZONE (lot #U2847AA) on 22-OCT-2008 and a dose of diphtheria toxoid (+) tetanus toxoid on 19-MAY-2005.  Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 67 year old female who was vaccinated with ZOSTER vaccine live (Oka/Merck), lot # not reported.  The physician stated that the patient experienced an injection site reaction within a few hours of receiving the vaccine.  The patient's injection site reaction included tenderness for about 5 days.  Also was reported that the patient experienced flu-like symptoms for about five days after receiving the vaccine.  The physician reported that the patient "is fine now".  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a 63 year old male patient with headaches caused from some food products (unspecified) and no known drug allergy, who in approximately September 2008 was vaccinated with a dose of ZOSTAVAX 0.65ml. Concomitant therapy included PRILOSEC. The patient experienced headaches after receiving ZOSTAVAX, the patient reported "the intensity changed but they were pretty much there all the time". The patient's headache persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 4 year old female who on 23-JAN-2009 was vaccinated with ZOSTAVAX SQ, 0.65ml (lot # 663195/1416X) instead of VARIVAX due to human error. This was to be the second dose of VARIVAX. No adverse effects noted. Unspecified medical attention was sought. Additional information has been received from a nurse who verified that a 4 year old female patient received ZOSTAVAX instead of VARIVAX. It was a case of human error and not product confusion. The floating nursed who was unfamiliar with the placement of vaccines in the freezer, picked up the wrong vaccine. Both were kept on the same, but opposite, sides of a shelf in the same freezer. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a female patient with diabetes who in February 2007, was vaccinated with a 0.65 ml dose of ZOSTAVAX. The patient developed herpes zoster after getting ZOSTAVAX. At the time of reporting the patient had not recovered. The patient sought unspecified medical attention. The patient was enrolled on the program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the vaccine VZV strain. Follow-up information has been received from a physician concerning a 68 year old female with diabetes and multiple sclerosis and a history of chicken pox and no known allergies, who on 5-FEB-2007 was vaccinated in her right upper arm with 0.65 ml dose of ZOSTAVAX (lot # 656606/0033U). Concomitant therapy included SANTURA, TOPROL XL tablets, ACTONEL, losartan potassium, interferon (unspecified) and insulin (unspecified). In January 2009 the patient developed herpes zoster on the injection site. She had no recent exposure to chicken pox or shingles. It was reported that  the patient was seen by her dermatologist. At the time of reporting the patient was recovering. A direct fluorescent antibody was not performed. No photo was taken by the physician. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Herpes zoster
Clinical narrative: Information has been received from a 62 year old female registered nurse with no known drug allergy and hypercholesterolaemia who on 13-JAN-2009 vaccinated a patient with a dose of ZOSTAVAX (lot #: 663199/1557X). Concomitant therapy included FLAGYL, ezetimibe (+) simvastatin (MSD), estrogens, conjugated (+) PEMPRO and calcium. On 20-JAN-2009, a week after the vaccination, the nurse developed shingles. She developed about 12 lesions under her left breast and upper left back next to her spinal column. She was experiencing some pruritis. She was being treated with VALTREX and ibuprofen. At the time of this report, the nurse was not recovered from shingles. The nurse sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received form a consumer concerning his son in law who on unspecified date was vaccinated with a dose of ZOSTAVAX. Five days after receiving ZOSTAVAX the patient experienced a severe case of shingles around his waist. This is one of two reports from the same source. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female who on 23-DEC-2008 was vaccinated with a 0.65 ml dose of ZOSTER vaccine live (Oka/Merck) (lot # 663199/1557X).  The patient's relevant medical history and relevant past drug history are unknown.  The patient's relevant concomitant therapy included CIPRO that was started on 29-DEC-2008 for an unknown indication.  On 17-JAN-2009 this consumer reported to the pharmacist that she experienced redness and itching around the injection site.  The pharmacist described the ZOSTER vaccine live (Oka/Merck) injection as a slightly reddened, circular area without any bumps, which is kind of "patchy" looking.  The consumer did not see her doctor regarding the ZOSTER vaccine live (Oka/Merck) injection site.  It was unknown if any laboratory testing had been performed.  As of 17-JAN-2009, it was unknown if the patient continued to use the ZOSTER vaccine live (Oka/Merck) and the outcomes of the redness and itchiness around the ZOSTER vaccine live (Oka/Merck) injection site were unknown.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 67 year old female with drug hypersensitivity to codeine, PPD and ZYBAN who on 14-JAN-2009 was vaccinated with ZOSTAVAX (LOT # 662757/1622X). 3 days later, on 17-JAN-2009 the. The patient came into the office to report the shingles, but was not seen by a HCP. The shingles had not been confirmed. Office might be interested in PCR identification. The patient's shingles was not recovered. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Rash generalised
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 60 year old male with cholesterol and hypertension who on 8-JAN-2009 was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously, lot # 663638/1706X. Concomitant therapy included amlodipine, methotrexate, ezetimibe (+) simvastatin and lisinopril-HCTZ. The patient received the vaccine and on 18-JAN-2009 developed a rash on the body. Pharmacist indicated that the rash started as a quarter on the back. As of 19-JAN-2009 the rash spread to the abdomen and to the chest. The rash was not painful but sensitive to touch. Lying back on rash or putting pressure on the back area was sensitive. It was not reported that a physician friend of the patient looked at the rash and believed it was not shingles. The patient had not recovered. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Joint swelling, Scab
Clinical narrative: Information was received from a 80 year old male patient with allergies to tetracycline; CIPRO; penicillin; clindamycin; erythromycin; tramadol; metoprolol; KEFLEX; MEDROL and sulfanomide and a history of skin reaction (not specified) from eating spicy foods who on 5-NOV-2008 was vaccinated with ZOSTAVAX (lot number was not available). Concomitant therapy included lisinopril (manufacturer unspecified), PRAVACHOL and FLOMAX. On 10-NOV-2008 the patient developed a severe case of shingles all over his body five days after vaccination, he ha blisters all over his chest, back, feet and head. He also developed water blisters and fluid build up in his elbows and feet. The patient sought medical attention. He was prescribed a prescription topical cream (unspecified) which did not help. He reported he had shingles twice before receiving the vaccine. As of 20-JAN-2009 he had a few scabs and was recovering. This is one of two reports from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 74 year old female patient with a history of splenectomy who on approximately 6-JAN-2009 was vaccinated with a dose of ZOSTAVAX. On approximately 20-JAN-2009 the patient developed shingles and pain. The patient's outcome was not reported. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Eye inflammation, Eye irritation
Clinical narrative: Information has been received from a registered 35 years old female pharmacist who reported that she thought her right eye could had inadvertently been exposed to ZOSTAVAX (Merck), unknown dose, once, on 14-JAN-2009.  The pharmacist reported no relevant medical history, concomitant medications or past drug history.  On 14-JAN-2009 at around 14:00 while preparing some ZOSTAVAX (Merck) for two of her patients, as she went to inject the air to draw out the reconstituted ZOSTAVAX (Merck) she thought that some of the "back spray" from the vial might had hit her brow, but some of the ZOSTAVAX (Merck) may have inadvertently gotten into her right eye.  She further stated that it was a fluke, and that she could had sworn that something flew up underneath her glasses, but that she did not feel anything go into the eye itself, but then her eye started to bother her.  There was no relevant laboratory data. On 15-JAN-2009, her eye was not red or watering, but it "sort of hurt but not real bad", the inner corner of the eye was a little bit inflamed, but she stated that it could just be irritation from getting something in there, or because the air in the pharmacy had been very dry.  At 8:00 on 15-JAN-2009 she went to see her doctor and he did an eye wash to flush the eye out.  The doctor told her that her eye looked fine, and recommended that she used a moisturizing eye drop for the irritation.  As of 15-JAN-2009, she had no stinging or blurred vision at this time, and was currently using GENTEAL moisturizing eye drops for the irritation.  This was originally reported by a Drug Center.  Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a Physician Assistant concerning an 81 year old female patient with hypertension, hyperlipidaemia, osteoporosis, gastroesophageal reflux disease, coronary artery disease, CLARITIN allergy, BENADRYL allergy and allergic reaction to tetracycline who in approximately 2007 was vaccinated with ZOSTAVAX (Lot # not reported). Concomitant therapy included PRILOSEC (indication not reported), ACCUPRIL, ACTONEL, aspirin, LIPITOR, LOPRESSOR and PLAVIX. On 15-JAN-2009 the patient experienced shingles. She was experiencing a vesicular rash from her mid abdomen to her side which extends around her flank area to her mid- lumbar area. It does not cross the mid- line. She had redness, erythema and severe burning. There was no streaking and no pus. The patient has been prescribed VALTREX and LYRICA. As of today on 19-JAN-2009, the pain was improving but the rash had remained the same. There were no Laboratory Diagnostics Studies performed. The patient sought unspecified medical attention at the office visit. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cough
Clinical narrative: Information has been received form a female patient who was vaccinated with ZOSTAVAX (Lot # not reported). Patient called because she wanted to know if she needed to stay away from her mother for a certain time because her mother had leukemia. Patient had been coughing on the phone. At the time of the report, the patient had not recovered. No further information is available.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a consumer concerning her 60 year old husband with no pertinent medical history and no drug reactions or allergies who on 19-JAN-2009 was vaccinated with ZOSTAVAX (Lot # not reported). There was no concomitant medication. On 19-JAN-2009 after vaccination he experienced dizziness and headache. At the time of the report 19-JAN-2009 patient was not recovered. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient who had an outbreak of shingles in July 2008 and in December 2008 was vaccinated with a dose of ZOSTAVAX (lot # provided). At the time of the vaccination the patient did not have any symptoms of shingles. On approximately 15-JAN-2009, "in mid-January 2009", the patient experienced a recurrence of shingles. Patient sought unspecified medical attention. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Information has been received from a pharmacist concerning a female patient in her 60's who on 2-JAN-2009 was vaccinated with a dose of ZOSTAVAX. The patient's daughter mentioned to the pharmacist that the patient was "sick" after receiving ZOSTAVAX. As of 13-JAN-2009 the outcome of the patient was unknown. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male patient who on 13-JAN-2008 was vaccinated subcutaneously with 0.65 ml of ZOSTAVAX (Merck) (Lot not reported) instead of VARIVAX (Merck). Not noted to be product confusion. No adverse events reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacy tech concerning a female patient in her late 60s who on approximately 01-JAN-2009, "approximately 2 weeks ago", was vaccinated with ZOSTAVAX (Oka/Merck) (lot # not provided). After vaccination, patient experienced excessive pain at injection site. Ibuprofen and ice were suggested as treatment. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # not provided). The physician reported that the patient developed shingles in their mouth after the vaccine. Subsequently the patient experienced shingles in mouth after vaccination. The patient sought unspecific medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a physician concerning a male patient who was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not provided).  The physician reported that the patient developed shingles in their mouth after the vaccine.  Subsequently the patient experienced shingles in mouth after vaccination.  The patient sought unspecific medical attention.  Follow up information was received from an other health professional concerning the 75 year old male who on 28-FEB-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number 658082/0744U).  In July 2008, the patient developed shingles in the back area below shoulder.  The patient gave history but was not evaluated for shingles in reporter's office.  Rash occurred at the site of injection or elsewhere within 42 days of the vaccination.  The patient was not exposed to chickenpox or herpes zoster prior to acquiring herpes zoster.  No photo was taken.  The patient was recovered.  It was also reported that the patient's vaccination history included: a dose of FLUZONE on 22-OCT-2008 given intramuscularly in the right deltoid; a dose of PNEUMOVAX 23 on 13-OCT-1998, and intramuscularly in the right deltoid on 22-OCT-2008; a dose of DECAVAC given on 25-JAN-2008.  No further information is available.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Information has been received from a licensed practical nurse concerning a 76 years old male patient with cardiovascular disorder, hypertension and gout who in August 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included TOPROL XL TABLETS, colchicine, LASIX, simvastatin (manufacturer unknown) and LIPITOR. Within the past few days the patient developed blisters in a band on the right side of his body from front to back. The patient sought medical attention through a physician. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a licensed practical nurse concerning an 87 year old male patient with kidney stone, coronary artery disease, dementia, renal disorder, hypertension, hypercholesterloeaemia, prostate cancer, overactive bladder and impaired fasting glucose who on 15-Jan-2009 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (lot# 662970/1207X) Concomitant therapy included LIPITOR, ECOTRIN, minerals (unspecified) Centrum, NAMENDA, RAZADYNE, K-PHOS ORIGINAL, FOSAMAX, EXELON and NEUROTONIN. The nurse reported that on 16-Jan-2009 the patient diagnosed with shingles. The patient had being treated with VALTREX. VZV analysis refused. The patient sought medical attention. At the time of reporting the patient was not recovered. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, FLUX, HIBV, MMR
Symptoms: Chills, Convulsion, Developmental delay, Febrile convulsion, Lethargy
Clinical narrative: Information has been received from a physician concerning a "young child" who was vaccinated with a dose of PROQUAD (Merck). Subsequently, within 24 hours after receiving the vaccination, the patient experienced a seizure. The outcome was reported as recovered. It was unspecified if medical attention was sought. No product quality complaint was involved. Follow-up information has been received concerning a 27-month-old male who on 17-Oct-2007 was vaccinated with a dose of MMR II (lot # "0867F") previously reported as PROQUAD (Merck). Secondary suspect vaccination included a dose of PEDVAXHIB (lot # 02789, manufacturer unknown). Concomitant medications included a dose of DTAP and INFLUENZA virus vaccine (unspecified). On 18-Oct-2007, the patient had fever, chills, lethargy and a seizure and was sent to the ER. The patient was given two doses of ATIVAN in the ER to stop the seizure. The patient's discharge diagnosis included atypical febrile seizure, upper respiratory seizure, right otitis media, and developmental delay. The patient was given antibiotics for the otitis media. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, FLUX, HIBV, MMR
Symptoms: Otitis media, Pyrexia
Clinical narrative: Information has been received from a physician concerning a "young child" who was vaccinated with a dose of PROQUAD (Merck). Subsequently, within 24 hours after receiving the vaccination, the patient experienced a seizure. The outcome was reported as recovered. It was unspecified if medical attention was sought. No product quality complaint was involved. Follow-up information has been received concerning a 27-month-old male who on 17-Oct-2007 was vaccinated with a dose of MMR II (lot # "0867F") previously reported as PROQUAD (Merck). Secondary suspect vaccination included a dose of PEDVAXHIB (lot # 02789, manufacturer unknown). Concomitant medications included a dose of DTAP and INFLUENZA virus vaccine (unspecified). On 18-Oct-2007, the patient had fever, chills, lethargy and a seizure and was sent to the ER. The patient was given two doses of ATIVAN in the ER to stop the seizure. The patient's discharge diagnosis included atypical febrile seizure, upper respiratory seizure, right otitis media, and developmental delay. The patient was given antibiotics for the otitis media. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 81 year old female with diabetes and a history of nervous breakdown, and no drug reactions who on 22-JAN-2009 was vaccinated with one dose of ZOSTER vaccine live (Oka/Merck) in her arm.  Concomitant therapy included 12 unspecified medications.  The patient has had shingles many times over the past 10 years.  On 28-JAN-2009 she broke out with a recurrence of shingles on her back.  No lab diagnostics study was performed.  The patient's pharmacist told her it would take 3 weeks for ZOSTER vaccine live (Oka/Merck) to start protecting her from shingles.  At the time of reporting, the patient's recurrence of shingles persisted.  No further information is available.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 77 year old female who on 05-JUN-2008 was vaccinated with 0.65 ml dose of ZOSTER vaccine live (Oka/Merck) (lot #659409/0409X).  Concomitant therapy included BONIVA and "NORPROXIN".  On 20-JAN-2009 the patient experienced shingles after receiving ZOSTER vaccine live (Oka/Merck).  She had minimal pain however had a few skin lesions on "one side and back".  Treatment consisted of VALTREX and DARVOCET.  Subsequently, the patient recovered from shingles on an unspecified date.  No further information was provided The patient sought unspecified medical attention.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Rash
Clinical narrative: Information has been received from a medical assistant concerning a 62 year old female patient with no known drug allergies and VARICELLA as a child who on 07-JAN-2009 was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot # 1556X) SQ.  Concomitant therapy included VAGIFEM.  On 27-JAN-2009 the patient developed a ZOSTER rash on her face after administration of ZOSTER vaccine live (Oka/Merck).  The patient had made telephone call for medical attention.  The patient was examined by a dermatologist and was prescribed VALTREX.  The patient was recovering from the ZOSTER rash on her face.  The patient was concerned her grandson would develop HERPES ZOSTER because she held him prior to the rash developing.  The physician may be interested in VZVID analysis.  No lab tests were performed.  Follow-up information has been received from physician via questionnaire that the patient with a history of chickenpox in childhood and no recent exposure to chickenpox or HERPES ZOSTER was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot # 66334/1556X) SQ at the left side.  Nine days post vaccination on 16-JAN-2009 the patient developed ZOSTER rash near right eye on the cheek bone and on the same side of nose.  The patient also felt very tired.  The patient was seen and diagnosed by the physician who reported that she saw the patient for "this ZOSTER outbreak".  A PCR specimen was not collected, and no direct fluorescent antibody was collected.  The physician also reported that a photo was not taken.  At the time of reporting the patient had recovered from the adverse effect.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Limb discomfort, Local reaction, Mass
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old patient who on 20-JAN-2009 was vaccinated with ZOSTER vaccine live (Oka/Merck) (Lot # not reported).  On 21-JAN-2009, the patient had a reaction.  The nurse stated the patient reported a welt that was hot, bright red and very sensitive.  The nurse stated the welt was still present in addition to neck pain that "feels like an electrical impulse".  The patient currently had a "golf ball size bump that is purple, red and painful to touch."  The patient was being treated with ibuprofen.  The patient was not recovered from the adverse events.  It was not reported whether the patients sought medical attention.  Additional information has been received from the licensed practical nurse concerning the now 63 year old patient with allergy to CODEINE, SAR, DAR, ROAD, and a history of cervical cancer in 1980, hepatitis in 1965 and osteopenia who on 20-JAN-2009 3:00 PM was vaccinated SQ with the first dose of ZOSTER vaccine live (Oka/Merck) (Lot # 662757/1622X) in her right arm.  On 21-Jan-2009 9:00 AM, the patient had reaction.  On 26-JAN-2009, the patient's swelling was 5-6 inches long, hot, bright red in middle and faded red around edges, and felt electrical impulse.  Dr.'s recommendation: Call if sighs and symptoms continued.  We would being down swelling with PREDNISONE, but would compromise effectiveness of vaccine.  On 30-JAN-2009, the patient called reaction still very sensitive, stiff neck, shooting pain down her shoulder blade right side arm.  Reaction was getting no better per patient.  Dr recommendation: office visit now, ibuprofen 200mg, 1-2 tabs BID.  Upon observation on 30-JAN-2009, the area on right arm golf ball size red was vague discomfort, the patient's arm was feeling funny with extension and adduction, and hurt to turn head.  On 5-FEB-2009, the patient stated reaction to ZOSTER vaccine live (Oka/Merck) was almost gone, but still had a "strange feeling" in upper back / neck but discomfort diminishing.  On 17-FEB-2009, the patient still got pain when changed position at night, or walked too hard on heels. "Feels strange" in neck arm large local reaction was now gone.  The patient was not completely recovered from adverse events.  No further information is available.