chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female patient with no pertinent medical history and no allergies who on 05-MAY-2008 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck) (Lot# 658861/1822U). There was no concomitant medication. On 05-MAY-2008, the injection site was slightly red after administration of the zoster vaccine live (Oka/Merck). Unspecified medical attention was sought. The patient recovered on 06-MAY-08. No diagnostic labs were performed. No product quality complaint was involved. No further information is available.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Dry skin, Rash pruritic, Skin discolouration
Clinical narrative: Information has been received from a 74 year old female patient with no allergies and high blood pressure who on 07-FEB-2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant medications included "other medications, nothing new" (not further specified). In approximately the end of April 2007 the patient experienced an itchy rash that lasted for about 5 to 6 months. A biopsy "showed something but the dermatologist could not determine what it was." The patient's skin still dry and itching and the "the rash seems to be coming back (flat red bumps) again." The patient also mentioned that she visited the dermatologist and her physician and they both said "it does not seem that the zoster vaccine live (Oka/Merck) vaccination could have caused it" but the patient had not been on any new medication, other than the zoster vaccine live (Oka/Merck). The rash is on the patient's upper legs, trunk, and arms, and where the old rash was she now has purple patches (skin discoloration). No product quality complaint was involved. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Rash
Clinical narrative: Information has been received from a Registered Nurse concerning her 64 year old husband with no allergies and a history of shingles, a high and bad fall in December 2004, and a collapsed lung and pain as a result of the fall, who on approximately 01-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included methadone HCl and atorvastatin calcium (LIPITOR). It was reported that the patient was having some pain and discomfort within his chest wall below the left armpit. On the night of 05-MAY-2008 the patient had about 4 to 5 raised areas that were not itchy and looked like poison ivy. It might be the beginning of a rash and it is at the same area as the discomfort. At the time of this report, the patient had not recovered. It was noted that the patient's collapsed lung from the fall was "around the same location as the discomfort area and rash area." VZV was offered and the nurse will inform the physician that this program is available. Currently the nurse does not think it is necessary. No diagnostic labs were performed. No product quality complaints were involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female patient with a history of sulfonamide allergy who on 30-APR-2008 was vaccinated SC in the left upper arm with a dose of zoster vaccine live (Oka/Merck). The pharmacist reported that the patient developed an injection site reaction. On the evening of 30-APR-2008 the patient's arm became very red and itchy. The left arm at the injection site "became very warm and slightly swollen" and "kept getting bigger and bigger." The adverse experience began to subside on 04-MAY-2008. At the time of this report, the patient is recovering. No diagnostic labs were performed. No product quality complaint was involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Herpes zoster, Incorrect dose administered, Malaise
Clinical narrative: Information has been received from a physician and the husband of a 70 year old female with no allergies, blood pressure increased, a history of chickenpox as a child and hysterectomy on 11-APR-2008 was vaccinated with 0.5 cc zoster vaccine live (Oka/Merck) in the left shoulder. Concomitant therapy included unspecified high blood pressure medication, LIPITOR, amlodipine, and ALLEGRA. On 14-APR-2007, the patient experienced severe pains in her head. Lumps and spots developed on the left side of her head. On 17-APR-2008, the patient was seen by the physician. Blister formations were noted on the left head. She was diagnosed with shingles/herpes zoster in the occipital division of the 5th nerve on left side of the head with a 3-4 out of 10 level of pain and malaise. The number of lesions were not counted by the physician. It was noted she had no recent exposure to chickenpox. No fluorescent antibody or PCR was collected. Subsequently, the patient recovered. The reporting physician advised that the hospital pharmacy who dispensed the zoster vaccine be contacted for the vaccine's lot#. The hospital pharmacy provided lot # of 658861/1822U. However, the hospital pharmacy was unable to verify that this (lot#) was what the patient received, as the physician was responsible for lot # documentation. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was received from the physician concerning a 70 year old female with no known allergies and a history of chicken pox as a child, who on 11-APR-2008, in the morning, was vaccinated with a second dose of ZOSTAVAX (Merck) subcutaneously in the left shoulder. Concomitant medications included LIPITOR, NORVASC, ALLEGRA and LOXOL. On 17-APR-2008, the patient experienced a rash. Distribution of Herpes zoster lesions were found in the occipital division of V cranial nerve (left). At the time of reporting the patient had recovered. There was no recent exposure to chicken pox. There was no illness at the time of vaccination. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if is associated with the wild-type (WT) VZV strain with the Oka/merck vaccine VZV strain. The sample of the lesion was collected on an unspecified date. The sample was taken from vesicle and papule lesions on the left occipital divisions of V cranial nerve. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Information has been received from a physician and the husband of a 70 year old female with no allergies, blood pressure increased, a history of chickenpox as a child and hysterectomy on 11-APR-2008 was vaccinated with 0.5 cc zoster vaccine live (Oka/Merck) in the left shoulder. Concomitant therapy included unspecified high blood pressure medication, LIPITOR, amlodipine, and ALLEGRA. On 14-APR-2007, the patient experienced severe pains in her head. Lumps and spots developed on the left side of her head. On 17-APR-2008, the patient was seen by the physician. Blister formations were noted on the left head. She was diagnosed with shingles/herpes zoster in the occipital division of the 5th nerve on left side of the head with a 3-4 out of 10 level of pain and malaise. The number of lesions were not counted by the physician. It was noted she had no recent exposure to chickenpox. No fluorescent antibody or PCR was collected. Subsequently, the patient recovered. The reporting physician advised that the hospital pharmacy who dispensed the zoster vaccine be contacted for the vaccine's lot#. The hospital pharmacy provided lot # of 658861/1822U. However, the hospital pharmacy was unable to verify that this (lot#) was what the patient received, as the physician was responsible for lot # documentation. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was received from the physician concerning a 70 year old female with no known allergies and a history of chicken pox as a child, who on 11-APR-2008, in the morning, was vaccinated with a second dose of ZOSTAVAX (Merck) subcutaneously in the left shoulder. Concomitant medications included LIPITOR, NORVASC, ALLEGRA and LOXOL. On 17-APR-2008, the patient experienced a rash. Distribution of Herpes zoster lesions were found in the occipital division of V cranial nerve (left). At the time of reporting the patient had recovered. There was no recent exposure to chicken pox. There was no illness at the time of vaccination. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if is associated with the wild-type (WT) VZV strain with the Oka/merck vaccine VZV strain. The sample of the lesion was collected on an unspecified date. The sample was taken from vesicle and papule lesions on the left occipital divisions of V cranial nerve. No further information is available.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Occipital neuralgia
Clinical narrative: Information has been received from a physician concerning an 80 year old female patient with no allergies and a history of shingles on her right buttocks and thigh on 07-FEB-2007 who on 03-JAN-2008 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck). On 05-MAR-2008, the patient experienced occipital neuralgia and stabbing and lacerating pain on the left side of face. The patient has been prescribed NEURONTIN for the treatment. No diagnostic laboratory tests were performed. At the time of this report, the patient was recovering. No product quality complaints were involved. Further information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 61 year old female consumer with codeine, bee stings, and "spring" allergies who on 09-MAY-2008 was vaccinated IM with zoster vaccine live (Oka/Merck). Concomitant therapy included amtriptyline hydrochloride (MSD), calcium (unspecified) and IMITREX. Subsequently, on the 09-MAY-2008 the patient developed swelling in her left arm. It was noted that the patient had redness which seemed to appear on 13-MAY-2008. It was also noted that the patient's arm was sore down to her elbow. Medical attention was not sought and there were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information is available.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an "over 80" year old female consumer who on an unspecified date was vaccinated with a single dose vial of 0.65 mL of zoster vaccine live (Oka/Merck). It was not noted whether or not the patient had a history of shingles prior to the vaccination. Subsequently, about a month after receiving the vaccine the patient developed a rash. It was noted that upon visual examination by the physician that the patient developed a mild case of shingles. There was no pain associated with it. The patient was treated with VALTREX. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Body temperature, Chest pain, Herpes zoster, Pain
Clinical narrative: Information has been received from a certified medical assistant concerning an approximately 75 year old female consumer who on 06-JUL-2007 was vaccinated with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 657765/0585U). Concomitant therapy included ALLEGRA, aspirin, FLONASE, and METROGEL. It was reported that in April 2008, the patient felt a shocking and burning pain under her left breast. The pain continued and developed into shingles lesions within two weeks. Unspecified medical attention was sought and it was unspecified if lab studies were performed. The patient was treated with NEURONTIN. At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information has been received from the physician concerning this 75 year old female consumer with no known allergies and a history of chickenpox years ago who on 06-JUL-2007 was vaccinated in the left arm with 0.65 mL of zoster vaccine live (Oka/Merck) (lot # 657765/0585U). Concomitant therapy included ALLEGRA, aspirin, FLONASE, and minocycline. Subsequently, on 08-MAY-2008 the patient developed left sided chest pain and clusters of vesicles on the left side of her chest and back. The patient did not developed a rash at the site of injection or elsewhere within 42 days of vaccination. The patient's temperature was 98.3. It was noted that there was no recent exposure to chickenpox or herpes zoster. The physician also reported that the patient's treatment was changed from NEURONTIN to LYRICA. The patient recovered on an unspecified date. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female with leukemia and an allergy to heparin who on 08-MAY-2008 was vaccinated with zoster vaccine live (Oka/Merck) 0.65 mL subcutaneously (Lot 659760/0159X). Concomitant therapy included lisinopril (MSD), iron (unspecified) and PROTONIX. On 10-MAY-2008, the patient developed an injection site reaction approximately 2 X 2 inches in area after receiving zoster vaccine live (Oka/Merck). There was redness and hardness underneath the injection site. The patient was told to take BENARYL. The patient had a complete blood count on 08-May-2008; the results were normal. The pharmacist did not know if the patient's leukemia was in remission. The patient will be having a follow-up appointment with her physician for the injection site reaction. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Anaemia, Dizziness, Fatigue, Pain in extremity
Clinical narrative: Information has been received from a 65-year-old male consumer who on 18-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) 0.65 mL injection (Lot # not provided). Concomitant therapy included losartan potassium-HCTZ (MSD), AMARYL, simvastatin (MSD), GLUCOPHAGE and EFFEXOR. The consumer reported that on 18-APR-2008 he experienced dizziness, tiredness, anemia and leg pain. The consumer also reported that he drinks one glass of alcohol per day. At the time of this report, the consumer was recovering from these events. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information was received from a physician which reported that there was no documentation or phone call from patient concerning adverse reaction to zoster vaccine live (Oka/Merck). No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Medication error
Clinical narrative: Information has been received from a physician concerning a 64 year old female with chronic lymphocytic leukaemia who on 08-MAY-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) (Dose, route, and Lot # not reported). The physician reported that post vaccination, the patient had a mild topical reaction at the injection site. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested. No further information is available.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 62-year-old male with a history of splenectomy who on 08-MAY-2008 was vaccinated with zoster vaccine live (Oka/Merck) (Dose, route, and Lot # not reported). On an unspecified date following the vaccination, the patient experienced a zoster type reaction. The patient contacted the physician for medical attention. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Ultrasound kidney normal
Clinical narrative: Information has been received from a 72-year-old female with hypercholesterolaemia and an allergy to LIPITOR (muscles aches all over body, the muscle aches resolved when the medication was discontinued-years ago) who in April 2007, was vaccinated with a single dose of zoster vaccine live (Oka/Merck). In July 2007, the patient developed pain in her right side. The distribution of the pain was from the right side of the torso, at waist level, radiating round to the middle of her back. The patient's physician suspected a possible case of shingles. No rash developed. The patient was referred for a renal ultrasound, which was negative. The pain resolved 6-7 weeks after onset with treatment. A product quality complaint was not involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 71-year-old female with hypertension, hyperthyroidism, Hyperlipidaemia, migraine and an allergy to pneumococcal vaccine polyvalent (MSD) (WAES # 0806USA00185) and naproxen (ALEVE) who on 02-APR-2008 was vaccinated subcutaneous in the left arm with 0.65 ml dose of zoster vaccine live (Oka/Merck) (lot # 659267/1836U). On 07-APR-2008 the patient developed shingles. The patient had pain and broke out in painful shingles on the left side, T1 dermatome. The patient was seen at her physician's office the same day and was prescribed valacyclovir (VALTREX) and lidocaine transdermal (LIDODERM). At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on 06-MAY-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 09-MAY-2008 the patient developed a zoster-like rash. The patient sought medical attention via a phone call. At the time of the report the patient's status was unknown. A product quality complaint was not involved. No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Vomiting
Clinical narrative: Information has been received from a 73 year old female consumer with no known allergies or pertinent medical history who on 06-MAY-2008 was vaccinated with zoster vaccine live (Oka/Merck). There was no concomitant medication. It was reported that the night of vaccination the patient woke up with vomiting, diarrhea and a headache. Medical attention was not sought, and there were 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. This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician (follow-up) and a 73 year old female consumer with no known allergies or pertinent medical history who on 06-MAY-2008 at 08:53 am was vaccinatedSQ with zoster vaccine live (Oka/Merck) (Lot #458844/0204X). There was no concomitant medication. There was no illness at the time of vaccination. It was reported that the night of vaccination at 22:00 pm the patient woke up with vomiting, diarrhea and a headache. Medical attention was not sought, and there were no lab studies performed. On approximately 10/11-MAY-2008 the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling abnormal, Lethargy, Nasopharyngitis
Clinical narrative: Information has been received from a licensed practical nurse, concerning a 60 year old female patient with high blood pressure and an allergic reaction to antibiotics (tetracycline, manufacturer not specified), who on 05-MAY-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (lot # 659759/1873U) (dose, site and route not reported). On approximately 07-MAY-2008 ("past couple days"), the patient reported she "feels lethargic and like she is catching something." The patient called the physician's office (treatment not specified). At the time of this report, the patient had not recovered. Additional information has been requested. Follow up information was received from the LPN concerning a 61 (previously reported as 60) year old Caucasian female who at 10:30 AM on 06-MAY-2008 (previously reported as 05-MAY-2008) was vaccinated with a first dose of zoster vaccine live (Oka/Merck) (lot #659410/0412X, previously reported as lot # 659759/1973U) in her left upper extremity. There was no illness at the time of vaccination. On 07-MAY-2008 the patient complained of cold-like symptoms (weakness, body aches, chills). Symptoms were mild. On approximately 10-MAY-2008, the patient recovered. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a licensed practical nurse, concerning a 60 year old female patient with high blood pressure and an allergic reaction to antibiotics (tetracycline, manufacturer not specified), who on 05-MAY-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (lot # 659759/1873U) (dose, site and route not reported). On approximately 07-MAY-2008 ("past couple days"), the patient reported she "feels lethargic and like she is catching something." The patient called the physician's office (treatment not specified). At the time of this report, the patient had not recovered. Additional information has been requested. Follow up information was received from the LPN concerning a 61 (previously reported as 60) year old Caucasian female who at 10:30 AM on 06-MAY-2008 (previously reported as 05-MAY-2008) was vaccinated with a first dose of zoster vaccine live (Oka/Merck) (lot #659410/0412X, previously reported as lot # 659759/1973U) in her left upper extremity. There was no illness at the time of vaccination. On 07-MAY-2008 the patient complained of cold-like symptoms (weakness, body aches, chills). Symptoms were mild. On approximately 10-MAY-2008, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female who in March 2008, was vaccinated with zoster vaccine live (Oka/Merck) (lot# 659268/1430U). Concomitant therapy included amitriptyline hydrochloride (MSD) and rosuvastatin calcium (CRESTOR). In April 2008, the patient developed shingles. As of 08-MAY-2008, the patient was recovering. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a pharmacist concerning a 64 year old female patient with no known drug allergies and a medical history of left knee replacement who was vaccinated SC with a 0.65 ml dose of zoster vaccine live (Oka/Merck) on 27-DEC-2007. It was reported that the patient also had a "flu shot (unspecified therapy)" on an unspecified date close to the time of the zoster vaccine live
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician concerning a 67 year old male with no known drug reactions/allergies and no pertinent medical history (including no history of chickenpox) who was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included aspirin and NIRVAN. "One month ago", in 15-APR-2008, the patient developed a mild shingles outbreak. Additional systemic symptoms included fatigue. The patient also experienced pain rated 8 on a scale of 0 (least) to 10 (most). The patient was seen by a physician. He was treated with LYRICA. It was noted that the patient had no recent exposure to chickenpox or herpes zoster. Subsequently, the patient recovered from mild shingles outbreak. The product quality complaint unit was not involved. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a licensed nurse concerning a 69 year old white female who on 21-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) injection (lot# 659763/1875U). On 25-APR-2008, the patient experienced a rash under her right breast spreading to the right side and right back. The patient was being treated by a physician at the time of reporting. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008.  Information has been received from a licensed practical nurse concerning a 69 year old female with no drug allergies who on 21-APR-2008 was subcutaneously vaccinated into left arm with ZOSTAVAX (Merck) injection (lot# 659761/1875U).  On 25-APR-2008, the patient experienced a rash under her right breast spreading to the right side and rigth back.  The patient was being treated by a physician.  The physician did diagnose with shingles when the patient was seen.  As the time of report the patient didn't recover.  No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female consumer who on 13-MAY-2008 was vaccinated SQ with 0.65ml of zoster vaccine live (Oka/Merck) (lot # 659411/0293X). Subsequently, the next day the patient developed redness at the injection site that was about 3-4 inches in diameter, and also warm to touch. Unspecified medical attention was sought. It was unspecified if lab studies were performed. The patient took over the counter diphenhydramine HCl (BENADRYL) and naproxen sodium (ALEVE). No other symptoms were noted. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report previously submitted on 6/24/2008. Information has been received from a pharmacist concerning a 63 year old female with sensitivity to neomycin who on 13-May-2008 was vaccinated subcutaneously with a 0.65 ml first dose of ZOSTAVAX (Merck) (Lot # 6659411/0293X). The next day the patient developed redness at the injection site that was about 3-4 inches in diameter, and also warm to touch which was continued 3 days post vaccination. No other symptoms were noted. The patient took a couple of doses of over the counter BENADRYL and ALEVE. On 16-MAY-2008, the patient was referred to the physician for evaluation. The physician prescribed DORICEF 500g twice a day for 5 days "just in case". On 19-MAY 2008, the patient recovered from the events. There was no product quality complaint involved. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse at a physician's office concerning a female who was vaccinated with a single dose of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced shingles. The patient's shingles persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008.  Initial information has been received from a nurse at the physician's office and follow up information was received from the physician concerning an 83 year old female with allergic to SEPTRA who on 02-APR-2007 was vaccinated in her upper arm with the first dose of ZOSTAVAX (Merck). On 15-OCT-2007, the patient was vaccinated with a dose of influenza virus vaccine (unspecified) (manufacturer unknown). There was no illness at time of vaccination. On 21-APR-2009 the patient developed a herpes zoster outbreak on the left lower thoracic dermatome. Subsequently, on 06-JUN-2008 the patient recovered from herpes zoster outbreak. A doctor visit was required. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse in a physician's office concerning a 61 year old female with no allergies and no medical history who on 14-MAY-2008 was vaccinated with zoster vaccine live (Oka/Merck) (lot 659615/0162X). There was no concomitant medication. On 15-MAY-2008, after the patient received zoster vaccine live (Oka/Merck) a rash appeared on the area of the patient's wrist to the elbow of the vaccinated right arm and also some on her left arm. No lab test were performed. The patient called the physician's office to report her experience. As of 16-MAY-2008 the shingles type rash persisted. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Erythema, Pruritus, Skin lesion, Urticaria
Clinical narrative: Information has been received from a 71 year old female patient with a history of shingles, MRSA, hives from taking CELEBREX and "rashes to other medications," who on 20-MAR-2008 was vaccinated with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included NORVASC, PREMARIN, and ibuprofen. On 15-MAY-2008 the patient experienced hives in about four spots on her body after receiving zoster vaccine live (Oka/Merck). The hives were "very itchy." The patient stated that she had undergone "routine labs." At the time of this report, the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No further information is available. This is in follow-up to report (s) previously submitted on 6/24/2008.  Follow-up information received on 24-MAR-2009 indicated that the patient was a retired nurse.  The patient called back and mentioned that about 58 days after receiving ZOSTAVAX (Merck), she developed a rash on the entire right arm.  The right arm was very itchy.  The ZOSTAVAX (Merck) was given in the right arm.  The caller reported that it took about 1 week to clear up.  The reporter also mentioned that she had a shingles lesion on her temple back in 2002.  The retired nurse reported that on 17-MAR-2009, she experienced a horrible itch on the left rib cage.  She also added that she noticed one large 50 cents piece size very red lesion, not rough but she could feel it.  On the moring of 18-MAR-2009, there was another lesion that was the size of a 50 cent piece that was on the top of the initial lesion so "it looked like a snowman".  The lesions were very red.  The retired nurse went to the physician on the morning of 18-MAR-2009 and the physician prescribed VALTREX.  The nurse did not take the VALTREX because of the cost.  There was not itching in the morning but the retired nurse experienced it later in the day on 18-MAR-2009.  On the morning of 19-MAR-2009, there was no itching but the lesions were black and blue (lost the redness).  By 20-MAR-2009, the lesions are a slight black and blue and very faded.  The lesions are gradually disappearing.  No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash papular
Clinical narrative: Information has been received from a physician concerning a male patient with a history of chilhood chickenpox and no recent history of exposure to chickenpox of herpes zoster,who was vaccinated with the first dose of zoster vaccine live (Oka/Merck) at a local pharmacy 6 months ago, in approximately November 2007. In May 2008, the patient came into the physician's office with a mild case of shingles. There were 3-4 clusters papulovesicular lesions mostly distributed on the right chest (T3-4). The patient rated his pain at 1 on scale of 0 (least) to 10 (most). There were no other systemic symptoms. Subsequently the patient recovered. No fluorescent antibody or specimen were collected. No product quality complaint was involved. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a individual concerning his wife an 83 year old female patient with "heart problems" and allergies to "some types of anesthesia," and a history of cataract operation and "artery circulation surgery" who in the end of December 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included unspecified "heart medication." On approximately 05-MAY-2008, the patient "broke out with shingles," which were "mild and located on her chest between her breast and her waist." Unspecified medical attention was sought. Subsequently, the patient recovered from the shingles. No product quality complaint was involved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 72-year-old male with hypertension, gout, pain, gastrooesophageal reflux disease and no know allergies or drug reactions who on 01-APR-2008 was vaccinated subcutaneous with 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot # 659760/0159X). Concomitant therapy included LOTREL, allopurinol, gabapentin, LIPITOR and PROTONIX. On 09-MAY-2008, the patient experienced a diffuse "classic" vesicular rash on his torso, arms and legs that was described as a " dew drop on a rose bare" vesicular rash. The rash was pruritic and identified by the physician as varicella. The patient was treated VALTREX 500 mg orally three times a day for 7 days and FAMVIR. 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 has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a consumer concerning her 62-year-old husband with high cholesterol and high blood pressure who on 07-MAY-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included unspecified cholesterol and blood pressure medications. On 07-MAY-2008, the patient experienced severe headache. The patient did not seek medical attention. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Laboratory test
Clinical narrative: Information has been received from a pharmacist concerning his 73 year old father with no known allergies or pertinent medical history who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). There was no concomitant medication. Subsequently, 2 days after vaccination the patient developed a severe case of diarrhea. On 14-MAY-2008, medical attention was sought and blood work was performed (results not reported). The patient also contacted his son (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.
Sex: U
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Information has been received from a consumer concerning a patient with post herpetic neuralgia and a history of shingles who was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed "a few prickles" "a few days." The patient outcome was not reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 74 year old female consumer with sulfonamide, tramadol HCl (ULTRAM), ezetimibe (MSD), and omega-3 acid ethyl esters (LOVAZA) allergies, a pacemaker, depression, recurrent bronchitis, and a history of cardiac ablation, hysterectomy, knee replacement and left breast cancer who on 04-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included calcium (unspecified), antimicrobial (unspecified), clonidine HCl (CATAPRES), celecoxib (CELEBREX), and prednisone. Subsequently, on 04-APR-2008 the patient developed erythema, pain and swelling at the injection site after the administration of the vaccine. Medical attention was sought in the office. There were no lab studies performed. It was noted that the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested. The patient also had an adverse experience after being placed in therapy with ezetimibe (MSD) (WAES # 0805USA03589).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who in the fall of 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). "Very recently," in approximately May 2008, the patient experienced shingles. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 67 year old female with blood pressure high and allergy to ampicillin who on 15-MAY-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included blood pressure medication. The patient reported that after receiving zoster vaccine live (Oka/Merck), she experienced redness, hot feeling, swelling, and itching at the injection site. She said "it felt like a spider bite." At the time of the report, the patient had recovered after applying BENADRYL. The patient did not seek medical attention. No further information is available.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Rhinorrhoea, Stomach discomfort
Clinical narrative: Information has been received from a 68 year old male patient who on 21-MAY-2008 was vaccinated with ZOSTAVAX (Oka/Merck) single dose injection (Lot # not reported). Concomitant therapy included LIPITOR. On 22-MAY-2008, the patient experienced stomach discomfort, cramping, diarrhea, running nose and fatigue. At the time of this report, the patient had not recovered. The patient did not seek medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was received from a physician concerning the patient developed flu like symptoms one day after given ZOSTAVAX. The patient cured in symptoms and notified you. The patient did not come in to office. Additional information has been requested.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash macular, Rash pruritic
Clinical narrative: Information has been received from an 88 year old male with unspecified health issues and no drug reaction/allergies who on 19-MAY-2008 was vaccinated with zoster vaccine live (Oka/Merck) injection. Concomitant therapy included a lot of unspecified medications. That same night, the patient developed a red blotchy rash mostly in the groin and waist area. The rash was a little itchy and seemed to be getting lighter. No lab testing was performed. The patient improved. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a female who "yesterday," on 20-MAY-2008, was vaccinated with zoster vaccine live (Oka/Merck) and stated she experienced one of the common side effects listed in the prescribing information. The patient stated she had headaches and injection site reaction like warmth, redness and swelling. The patient outcome with regard to headache and injection site warmth, redness and swelling was unknown. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 70 year old female who was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient experienced redness, warmth, swelling, and itching at injection site. As of 21-MAY-2008, the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills
Clinical narrative: Information has been received from a Registered Nurse concerning a 65 year old female patient with no allergies and a history of non-Hodgkins lymphoma, which has been in remission for 10 years, who on 19-MAY-2008 was vaccinated SC With a 0.65 mL dose of zoster vaccine live (Oka/Merck) (Lot # 658398/1087U). On 19-MAY-2008, the patient experienced chills and deep bone pain. The symptoms began one hour after the patient received the zoster vaccine live (Oka/Merck). The patient's chills and deep bone pain persisted. No diagnostic laboratory tests were performed. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008.  Information has been received from a Registered Nurse concerning a 65 year old female patient with no allergies and a history of non-Hodgkin's lymphoma with no chemo or radiation, which has been in remission for 10 years, who on 19-MAY-2008 was vaccinated subcutaneously with a first 0.65 mL dose of ZOSTAVAX (Lot# 658398/1087U).  On 20-MAY-2008 the patient experienced chills, severe headache and deep bone pain (also reported as 19-MAY-2008, the symptoms began one hour after the patient received ZOSTAVAX (Merck)).  The physician ordered 1500 mg antiviral given x 3 weeks.  Subsequently, the patient recovered from chills, severe headache and deep bone pain.  No diagnostic laboratory tests were performed.  No product quality complaint was involved.  Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Oral herpes, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a 71 year old male who on 12-DEC-2007 was vaccinated with zoster vaccine live (Oka/Merck), 0.65 mL, subcutaneous injection (lot #6597601/0159X). Concomitant therapy included naproxen, ranitidine, gabapentin, hydrocodone bitartrate, simvastatin (MSD), terazosin hydrochloride, finasteride (manufacturer unknown), duloxetine hydrochloride and alendronate sodium (MSD). On Friday, 16-MAY-2008, the patient experienced a sore throat. "The following Sunday," on 18-MAY-2008, he saw blisters on the back of his tongue when he look in a mirror. He was seen by his health care professional and was told it was a herpes rash. As of 20-MAY-2008, the patient was recovering. The product quality complaint unit was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient who on 18-MAY-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). The patient received zoster vaccine live (Oka/Merck) from a provider other than her treating physician because she had been exposed to shingles (time frame unspecified). On 19-MAY-2008 the patient experienced injection site soreness and swelling. The patient was seen in the physician's office and prescribed an unspecified steroid as treatment. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated with a first dose of zoster vaccine live (Oka/Merck). Subsequently, the patient came down with a case of shingles. Unspecified medical attention was sought. The patient's outcome was not provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a 60-year-old female, with no pertinent medical history or allergies, who on 21-APR-2008 was vaccinated in the arm with a "single dose" of zoster vaccine live (Oka/Merck). Concomitant therapy included vitamins (unspecified), "WELCORE' and PAXIL. On approximately 28-APR-2008, "about 3 weeks ago," the patient developed two cold sores on her lip both in different locations. She developed the first cold sore three weeks ago and the second cold sore one week ago. The patient reported she has never had any cold sores in her lifetime until after receiving zoster vaccine live (Oka/Merck). The patient did not seek medical attention. No diagnostic labs or procedures were performed. 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: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Information has been received from an 83 year old female consumer with no pertinent medical history and allergies to NEXIUM, ameprozol, DEMEROL, "statins and other unspecified medications" who on 19-FEB-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included "unspecified blood pressure medication." Subsequently, the patient experienced a burning sensation in her right armpit after receiving the vaccination. Unspecified medical attention was sought and there were 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. This is in follow-up to reprt(s) previously submitted on 6/24/2008. Information has been received from an 83 year old female consumer with no pertinent medical history and allergies to NEXIUM and DEMEROL, "statima and other unspecified medications" who on 19-FEB-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included "unspecified blood pressure medication." Subsquently, the patient experienced a burning sensation in her right armpit receiving the vaccination. Unspecified medical attention was sought and 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 was received on 07-JUL-2008 from a physician. The physician reported that the patient had "no ill effect." Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female consumer who on an unspecified date was vaccinated with 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.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated SC in the arm with a dose of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced pain at site of injection. Six weeks later, the patient developed pain at the site of injection. The patient called the office and was monitored over the phone. No further corrective action was necessary. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated with a first dose of zoster vaccine live (Oka/Merck). Subsequently, the patient came down with a case of shingles. Unspecified medical attention was sought. The patient's outcome was no provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.