chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash macular
Clinical narrative: Information has been received from a male consumer who "a couple of months ago" in 2007, received  a dose of zoster vaccine live (Oka/Merck). He reported that 4 or 5 days after he got the shot he developed pink spots on his stomach, hands and face. He reported that one spot got big enough where he drained it (blister), and still had a few spots left on his face. The patient was part of a shingles prevention study and spoke with a physician that had been monitoring his reaction from the vaccine. Specific medical treatment and further current patient status was not reported. A product quality complaint was not reported. Further information was not available. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Viral DNA test positive
Clinical narrative: Initial and follow up information has been received from a physician concerning a 66 year old female with a hypersensitivity to ezetimibe (MSD) who on 19-OCT-2007 was vaccinated into the left arm with a single dose of zoster vaccine live (Oka/Merck) (Lot # 658602/1080U). Concomitant therapy included Ambien, potassium chloride, Nexium, Lisinopril Comp, Norvasc, Toprol XL, Benicar HCT and Tekturna. Five days post vaccination, on 25-OCT-2007, the patient developed a vesicular rash, with 10 to 11 lesions, on the right side of her mid back. The patient was diagnosed with herpes zoster. The patient reported pain at a level of five on a scale of one to ten. The patient denied any any history of chickenpox or recent exposure of chickenpox. There was no lab diagnostic studies performed, and no lesion specimens submitted for analysis. The physicians reported that the patient was not immunocompromised in any way. At the time of reporting the patient "still had a rash." Unspecified medical attention was sought. There was no product quality complaint. It has been determined that WAES0710USA5849 is a duplicate of WAES710USA05579. Therefore, WAES # 0710USA05849 is being deleted from our files and the reports consolidated into WAES # 0710USA05579. 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. The PCR results for the specimen from vesicular rash identified the presence of WT VZV.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an approximate 70-year-old female with allergies to BENGAY and opsite topical dressing who on 18-OCT-2007 was vaccinates subcutaneous with a dose of ZOSTAVAX (lot # 657559/0462U). Concomitant therapy included IMODIUM, omeprazole (MSD), TRIAMTEREN COMP), atenolol (MSD) and influenza virus vaccine (unspecified) administered on 23-OCT-2997. On an unspecified date (after administration of vaccine) the patient experienced injection site erythema and swelling. The patient sought medical attention via a telephone call. On an unspecified date a hemogram diagnostic lab was performed. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect dose administered, Inflammation, Malaise, Musculoskeletal pain
Clinical narrative: Information has been received from a 76 year old female with a history of shingles who in December 2006, was vaccinated with a 0.5 ml zoster vaccine live (Oka/Merck). Concomitant therapy included hypertension and glaucoma medications. On approximately 15-SEP-2007 the patient developed "worst case" of shingles that she ever had. The patient stated that she had shingles outbreak every couple years since 1979. The patient experienced fever, whole body aches, illness, larger lesions than before and a painful inflamed shoulder. No diagnostic laboratory tests were undertaken. Unspecified medical attention was sought. At the time of report the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Skin lesion
Clinical narrative: Information has been received from a 76 year old female with a history of shingles who in December 2006, was vaccinated with a 0.5 ml zoster vaccine live (Oka/Merck). Concomitant therapy included hypertension and glaucoma medications. On approximately 15-SEP-2007 the patient developed "worst case" of shingles that she ever had. The patient stated that she had shingles outbreak every couple years since 1979. The patient experienced fever, whole body aches, illness, larger lesions than before and a painful inflamed shoulder. No diagnostic laboratory tests were undertaken. Unspecified medical attention was sought. At the time of report the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently the patient developed a rash. It was unknown whether medical attention was sought. There was no product quality complaint. No other information was available. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immunodeficiency, Pain, Rash, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning a 78 year old female with a history of chickenpox as a child, rheumatoid arthritis, diabetes, hypertension and no drug reactions/allergies, who on 15-OCT-2007 (also reported as 09-OCT-2007) was vaccinated SC in the left deltoid with a first 0.65 mL (also reported as 0.5CC) dose of zoster vaccine live (Oka/Merck). Concomitant therapy included: prednisone 10 mg daily; methotrexate 10 mg weekly; lisinopril; Ditropan; Chromagen; aspirin;folic acid; Darvocet-N; Aleve; Prilosec; insulin. On 16-OCT-2007 (also reported as 10-OCT-2007), the following day the patient experienced a diffuse rash on the left anterior chest, left neck and left occiput. The rash did not occur at the site of the injection or elsewhere within 42 days of vaccination. The patient's maximum temperature was 99 degrees. The patient quantified her pain as a 10/10. A direct fluorescent antibody was not done. The patient was diagnosed with shingles. She was treated with Valtrex and Neurontin. The physician stated that the patient has typical shingles, localized and not disseminated at the time. No additional information was available. No lab diagnostics studies were performed. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested. Follow-up information has been received from the physician stating that his patient has been on methotrexate for about 10 years and was stable, so he did not think of her as an immunocompromised patient. However since she is immunocompromised, he was worrier that she might progress to a disseminated case and wanted to know how he should treat her. He asked if he was treating her effectively with Valtrex and Neurontin or should he be treating her as if she had a disseminated case. The physician stressed his concern for the patient. On 02-NOV-2007, the physician collected health Zoster lesions from the left side of the neck for PCR. The specimen arrived in the laboratory on 07-NOV-2007. The results indicated the VZV DNA was amplified. The VZV strain identification showed a Wild-type. The B-globin DNA was amplified. The interpretation was adequate specimen, wild type strain. A direct fluorescent antibody was not done.  A photo was not taken. The patient did not have a recent exposure to chickenpox or shingles. The patient's maximum pain level was a ten. The outcome was reported as recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Nausea, Urine analysis normal, Vomiting
Clinical narrative: Information has been received from a 63 year old female with Osteopenia and drug allergies to penicillin and sulfonamide who in September 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant drug therapy included alendroanate sodium (MSD) and atorvastatin calcium (LIPITOR). On approximately 18-SEP-2007 the patient experienced nausea and vomiting. The patient stated the symptoms were noted to come and go and on 05-OCT-2007 the patient went to the emergency room. Blood tests and urine tests were performed and the results came back fine. The patient stated she went home the same day she went to the ER. The patient's outcome was not recovered. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation, Wrong technique in drug usage process
Clinical narrative: Information has been received from a medical assistant concerning a female who on 25-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). The patient, along with her husband (WAES# 0711USA01697) were scheduled to receive zoster vaccine live (Oka/Merck) 25 OCT 2007. The medical assistant reported that during charting documentation, that same day, it was noted that only diluent was given to one of the patients, and the other patient received zoster vaccine live (Oka/Merck). The medical assistant did not know which of the patient's received zoster vaccine live (Oka/Merck). It was noted that the female patient did experience burning at the injection site. The patients were contacted, and both patients returned that same day and were re-vaccinated with zoster vaccine live (Oka/Merck) (lot# 658209/1085U). The records were not available from the first Lot number. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician who was vaccinated with a dose of zoster vaccine live (Oka/Merck) and he stated that he experienced shingles a couple of weeks after receiving the vaccination. No further information was provided. It is unknown if medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated subcutaneously with 0.65 mL of zoster vaccine live (Oka/Merck) ("lot # 0829U"). On 21-OCT-2007, the patient developed vesicles. At the time of reporting the patient was recovering. Medical attention was sought, the patient was seen at the physician's office. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer with a history of chickenpox who in September 2006, was vaccinated with a dose of zoster vaccine live (Oka/Merck). In October 2007, the patient developed shingles. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. Information has been received from a consumer with a history of chickenpox who in September 2006, was vaccinated with adose of ZOSTER vaccine live (oka/Merck). In October 2007, the patient developed shingles. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information was received from someone in the physician's office. It was noted that this 83 year old retired female was  on 12-SEP-2006 in the right arm with a first dose of ZOSTER vaccine live (Oka/Merck) (lot # 652965/0622F). Subsequently, on approximately 20-SEP-2007 the patient developed shingles. No further information was reported.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician and a registered nurse (R.N.) concerning a 75-year-old female who during the week of 22-OCT-2007 was vaccinated subcutaneously with a dose of zoster vaccine live (Oka/Merck) (lot# 658604/1088U). During the week of 22-OCT-2007 the patient experienced a 2 inch round, red swelling at the injection site. It was unspecified if medical attention was sought. No outcome was reported for the patient. No quality quality complaint was involved. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein, Full blood count, Hyperaesthesia, Musculoskeletal pain, Red blood cell sedimentation rate
Clinical narrative: Information has been received from a health professional concerning a 78 year old female with allergies to Ancef, "decongestant", Talwin and Lomotil and no pertinent medical history who, "2 1/2 weeks ago", on approximately 09-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included Lescol XL, Lanoxin, Boniva, Coumadin, Bumex, enalapril malate MSD, Caltrate, vitamins (unspecified) milk of magnesia, chondroitin sulfate sodium (+) glucosamine sulfate and potassium (unspecified). "About 3-4 days ago", on approximately 23-OCT-2007 the patient began to experience hyperpathia. The patient developed pain and sensitivity in the left shoulder area, only on the left side (does not cross midline). The patient was very sensitive to any type of touch. Medical attention was sought. The following labs were performed: complete blood count, C-Reactive protein and sedimentation rate (results not provided). The patient was prescribed Lortab and Lyrica. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Culture, Full blood count, Herpes simplex, Herpes simplex serology positive
Clinical narrative: Information has been received from a physician concerning a 64 year old female with asthma, hypertension, arthritis, "common variable hypogammaglobunemia" and mycotic allergy and a history of chickenpox and rotator cuff tear who on 16-JAN-2007 was vaccinated subcutaneously into the left deltoid with 0.65 ml of zoster vaccine live (Oka/Merck) (lot# 654604/1406F). Concomitant therapy included NORVASC, MOBIC, ZOLOFT, ADVAIR, NEXIUM, globulin, immune, aspirin and allergenic extract. The physician reported that the patient had received zoster vaccine live (Oka/Merck) and developed a recurrent HSV lesion that was more vigorous than usual. The patient was originally seen by a dermatologist who did not culture the lesion on the lips which was improving without treatment. However some of the lesions got worse and the dermatologist cultured group b strep and it was found to be cellulitis. The vesicular lesions of HSV were improving while the patient was on FAMVIR. When the physician spoke to the patient in MAY 2007 her symptoms had resolved and the physician had recommended that the patient continually take acyclovir. On 24 JUN 2007 the patient informed the physician, via telephone contact, that she was asymptomatic and wanted to stop the acyclovir. The physician advised the patient to continue therapy. It was unknown if the patient continued therapy. On 20 SEP 2007 the patient contacted the physician, via telephone, and reported that her lesions were "as bad as in March" and wanted to increase the acyclovir to therapeutic levels and treat strep with amoxicillin (+) clavulanate potassium (AUGMENTIN). On 16 OCT 2007 a dermatologist wanted to have the patient stop acyclovir and do a biopsy to have lesions cultured. The dermatologist mentioned a "diagnosis of keratosis". An infectious disease physician saw the patient on "the same day" and advised the patient to stop the amoxicillin (+) clavulanate potassium. The patient continued to take acyclovir. The patient had HSV-1 antibodies and high titer, but her culture was negative for HSV-a. Lab diagnostic studies performed included cultures of lesions, "t-subset was found normal at testing for AIDS done at Harvard", on "02 OCT 2007 CBC, CMP, HSV antibody screen type 1 was over 5.0". The physician wanted it to be known that he does not feel this is an AE because many people have HSV outbreaks. There was no product quality complaint. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperkeratosis, Laboratory test normal, Metabolic function test, Skin lesion, Viral test
Clinical narrative: Information has been received from a physician concerning a 64 year old female with asthma, hypertension, arthritis, "common variable hypogammaglobunemia" and mycotic allergy and a history of chickenpox and rotator cuff tear who on 16-JAN-2007 was vaccinated subcutaneously into the left deltoid with 0.65 ml of zoster vaccine live (Oka/Merck) (lot# 654604/1406F). Concomitant therapy included NORVASC, MOBIC, ZOLOFT, ADVAIR, NEXIUM, globulin, immune, aspirin and allergenic extract. The physician reported that the patient had received zoster vaccine live (Oka/Merck) and developed a recurrent HSV lesion that was more vigorous than usual. The patient was originally seen by a dermatologist who did not culture the lesion on the lips which was improving without treatment. However some of the lesions got worse and the dermatologist cultured group b strep and it was found to be cellulitis. The vesicular lesions of HSV were improving while the patient was on FAMVIR. When the physician spoke to the patient in MAY 2007 her symptoms had resolved and the physician had recommended that the patient continually take acyclovir. On 24 JUN 2007 the patient informed the physician, via telephone contact, that she was asymptomatic and wanted to stop the acyclovir. The physician advised the patient to continue therapy. It was unknown if the patient continued therapy. On 20 SEP 2007 the patient contacted the physician, via telephone, and reported that her lesions were "as bad as in March" and wanted to increase the acyclovir to therapeutic levels and treat strep with amoxicillin (+) clavulanate potassium (AUGMENTIN). On 16 OCT 2007 a dermatologist wanted to have the patient stop acyclovir and do a biopsy to have lesions cultured. The dermatologist mentioned a "diagnosis of keratosis". An infectious disease physician saw the patient on "the same day" and advised the patient to stop the amoxicillin (+) clavulanate potassium. The patient continued to take acyclovir. The patient had HSV-1 antibodies and high titer, but her culture was negative for HSV-a. Lab diagnostic studies performed included cultures of lesions, "t-subset was found normal at testing for AIDS done at Harvard", on "02 OCT 2007 CBC, CMP, HSV antibody screen type 1 was over 5.0". The physician wanted it to be known that he does not feel this is an AE because many people have HSV outbreaks. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old patient who was vaccinated with zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck). The nurse reported she felt "that the vaccination with zoster vaccine live (Oka/Merck) was due to product confusion, but had no specific information to what caused the product confusion". No problems were reported. There was no product quality complaint. Additional information is not expected. This is in follow-up to report(s) previously submitted on 12/21/2007.  Information has been received from a registered nurse concerning a 10 year old patient who was vaccinated with ZOSTAVAX (Merck) instead of VARIVAX (Merck).  The nurse reported that she felt "that the vaccination with ZOSTAVAX (Merck) was due to product confusion, but had no specific information as to what caused the confusion.  Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of zoster vaccine live (Oka/Merck) and a couple of days later he had a small shingles case in his hip area. There was no concomitant medication. No further information provided. It was unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site papule, Injection site rash
Clinical narrative: Information has been received from a 60 year old female nurse practitioner who on 24-OCT-2007 ordered and vaccinated herself with a dose of zoster vaccine live (Oka/Merck). On approximately 26-OCT-2007, the patient experienced sensitivity, rash and redness around area. The patient wanted to know with this going on was she contagious and could she cause harm to a woman who was pregnant. No medical attention was sought. There was no product quality complaint. Additional information has been requested. 06/24/2008 Initial and follow-up information has been received from a 60 year old female nurse practitioner who on 24-OCT-2007 ordered and vaccinated herself in the abdomen with a dose of ZOSTAVAX (Oka/Merck). There was no illness at the time of vaccination. On approximately 26-OCT-2007 the patient experienced a red, raised, painful lesion (also reported as rash) around the injection site. The patient wanted to know with this going on was she contagious and could she cause harm to a woman who was pregnant. No medical attention was sought. On an unspecified date the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Information has been received from a 60 year old female nurse practitioner who on 24-OCT-2007 ordered and vaccinated herself with a dose of zoster vaccine live (Oka/Merck). On approximately 26-OCT-2007, the patient experienced sensitivity, rash and redness around area. The patient wanted to know with this going on was she contagious and could she cause harm to a woman who was pregnant. No medical attention was sought. There was no product quality complaint. Additional information has been requested. 06/24/2008 Initial and follow-up information has been received from a 60 year old female nurse practitioner who on 24-OCT-2007 ordered and vaccinated herself in the abdomen with a dose of ZOSTAVAX (Oka/Merck). There was no illness at the time of vaccination. On approximately 26-OCT-2007 the patient experienced a red, raised, painful lesion (also reported as rash) around the injection site. The patient wanted to know with this going on was she contagious and could she cause harm to a woman who was pregnant. No medical attention was sought. On an unspecified date the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema induratum, No reaction on previous exposure to drug, Skin warm, Tenderness
Clinical narrative: Information has been received from a nurse practitioner concerning a 60 year old female with preexisting allergies, birth defects, and medical conditions to sulfonamide allergy, allergic reaction to antibiotics such as Keflex and Terramycin, hypertension, asthma and high cholesterol who on 17-OCT-2007 was vaccinated in the right deltoid with a dose of zoster vaccine live (Oka/Merck) (lot number: 658084/08880). There was no concomitant medication. There was no illness at time of vaccination. There was no adverse events following prior vaccination. There were no relevant diagnostic test and laboratory data. On 19-OCT-2007, the patient experienced circular erythematous induration with vesicular lesions in the center 232 mm in size with mild pink peri-induration, warmth with mild tenderness. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Diarrhoea, Laboratory test, Stool analysis
Clinical narrative: Information has been received from a 78 year old male with blood pressure high, enlarged prostate and glaucoma who on 22-OCT-2007 was vaccinated with ZOSTAVAX. Concomitant vaccine therapy that day included influenza virus vaccine (unspecified) (manufacturer unknown). Concomitant therapy included AVODART, COSOPT and PRILOSEC. At the time of reporting, 29 OCT 2007, the patient was recovering, and due to be seen by his physician that same day. There was no product quality complaint. Follow up information was received from the consumer who reported that he was experiencing "violent diarrhea" for four weeks and is under the care of two physicians. The consumer noted he did not think that this was related to the vaccine. It was also reported that unspecified blood work and a stool test were obtained, of which the results were not provided. The consumer did not provide physician contact information. No further information is expected. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Erythema, Rash pruritic, Skin warm
Clinical narrative: Information has been received from a 69 year old female with pertinent medical history which includes "thyroid surgery about 6 weeks ago (on 17-SEP-2007) and no drug reactions/allergies, who on 23-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included "cholesterol medication". On 25-OCT-2007, the patient experienced an itchy rash on her right upper thigh. On 26-OCT-2007, the patient noticed a bright red, warm and itchy rash which was located on the underside of her arms and torso from her breasts down to buttocks. On 26-OCT-2007, the patient spoke with her pharmacist who instructed to use a cortisone based ointment. The patient had no relief from any of the symptoms. The patient had an appointment with her physician on 29-OCT-2007, for unspecified medical attention. No further information was available. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested. Follow-up received 04/16/2008 indicated that this facility "did not administer vaccine to patient".
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Contusion, Dermatitis contact, Erythema, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old female with no drug reactions/allergies, who on 06-SEP-2007 was vaccinated SC with a 0.65mL dose of ZOSTAVAX (Oka/Merck) (lot number: 658085/0882U).  Concomitant therapy included losartan potassium (MSD) and simvastatin (MSD) and doxycycline (manufacturer unknown).  Subsequently the patient experienced a three inch area of redness and swelling shortly after receiving the vaccination.  When the redness faded the area looked discolored and bruised and then cleared.  Approximately one week ago the patient experienced a red rash with blisters that the patient described as looking like a shingles rash.  The patient also noted that the rash looked like a burn.  The rash had progressively worsened since it started.  The patient was not seen by the physician and the rash had not been confirmed to be a shingles rash.  No lab diagnostics studies were performed.  The outcome was reported as not resolved.  Unspecified medical attention was sought through a telephone call to the office.  No further information was available.  There was no product quality complaint.  On 01-NOV-2007 follow-up information was received from a health professional in the physician office who indicated that the physician did not believe the patient had shingles or any adverse experience related to the vaccination.  The physician felt the patient had a contact dermatitis and referred her to a dermatologist.  Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin discolouration, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old female with no drug reactions/allergies, who on 06-SEP-2007 was vaccinated SC with a 0.65mL dose of ZOSTAVAX (Oka/Merck) (lot number: 658085/0882U).  Concomitant therapy included losartan potassium (MSD) and simvastatin (MSD) and doxycycline (manufacturer unknown).  Subsequently the patient experienced a three inch area of redness and swelling shortly after receiving the vaccination.  When the redness faded the area looked discolored and bruised and then cleared.  Approximately one week ago the patient experienced a red rash with blisters that the patient described as looking like a shingles rash.  The patient also noted that the rash looked like a burn.  The rash had progressively worsened since it started.  The patient was not seen by the physician and the rash had not been confirmed to be a shingles rash.  No lab diagnostics studies were performed.  The outcome was reported as not resolved.  Unspecified medical attention was sought through a telephone call to the office.  No further information was available.  There was no product quality complaint.  On 01-NOV-2007 follow-up information was received from a health professional in the physician office who indicated that the physician did not believe the patient had shingles or any adverse experience related to the vaccination.  The physician felt the patient had a contact dermatitis and referred her to a dermatologist.  Additional information has been requested.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated SC with a dose of zoster vaccine life (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed painful, itchy, "shingle like blisters and rash" at the injection site after vaccination. No further information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Information has been received from a female consumer who was vaccinated with a dose of ZOSTAVAX on an unspecified date.  Subsequently, the patient experienced a hot, red bump at the injection site.  No medical attention was sought.  The outcome of this event was unspecified.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has been received from a 60-year-old female consumer with hypertension, GERD and sulfa allergy who was vaccianted with a dose of ZOSTAVAX (Oka/Merck) on 18-OCT-2007. At the time of vaccination the patient had an imparied fasting glucose. Subsequently, "two days after vaccination" on 20-OCT-2007, the patient experienced a local injeciton site reaction characterized by redness, swelling, heat, and red bump at the injection site. No medical attention was sought at the office as it was reported that the patient was on vacation; therefore, no laboratory or diagnostic tests were performed. The outcome of this events was reported as recovered as of 28-OCT-2007. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received concerning an "elderly" female who on approximately 08-OCT-2007 was vaccinated IM with a first dose of zoster vaccine live (Oka/Merck). On approximately 08-OCT-2007, the patient experienced "pain at the injection site, redness and soreness". No further information was provided. The outcome was reported as recovering. There was no product quality complaint. It was noted that the above mentioned patient was a "friend" of a patient within the physician's office. It was also noted that the above mentioned patient was not a patient under this specific facility's care and no lot number was given and demographics were unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female with no pertinent medical history and no drug reactions/allergies who on 29-OCT-2007 was vaccinated SC with a 0.5 mL dose of ZOSTAVAX (lot number: 658208/0886U) instead of MMR II.  There was no concomitant therapy.  It was confirmed that this event was a result of human error, not product confusion.  No symptoms were reported.  No further information was available.  No medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female with a history of cancer, who on 24-OCT-2007 was vaccinated SC with a 0.65mL dose of zoster vaccine live (Oka/Merck). Concomitant medication included: an unnamed oral medication for cancer. On 28-OCT-2007, the patient called the physician's office and stated that she experienced rash that looked like tiny ant bites with itching which started on her abdomen and on her back and legs. The patient was taking Benadryl. The patient was seen in the office. VZVID was offered. The nurse stated that she did not feel that it was needed at that time. No lab diagnostics studies were performed. The outcome was reported as not recovered. Unspecified medical attention was sought. No additional information at that time There was no product quality complaint. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a health professional concerning a 60 year old female with pre-existing allergies, birth defects and medical conditions which include: NOTUSS, LOPID, TRICOR, sulfa, CIPRO, KEFLEX, codeine, CLARITIN, AVELOX, CODICLEAR, decongestants, PREVACID, PNC, polylistfote.  Medical diagnosis included: PVD, hyperlipidemia, hypertension, GERD, HA and proteins deficiency as well as insomnia and anxiety, who on 16-OCT-2007 at 2:00 pm was vaccinated SC in the left arm with a first dose of ZOSTAVAX (Oka/Merck) (lot number: 658208/0886U).  On 16-OCT-2007 concomitant therapy included INFLUENZA VIRUS VACCINE (USP) (lot number: U250ZAA) in which she was vaccinated IM at 2:00 pm in the right deltoid.  On 16-OCT-2007 the patient experienced red, raised with heat, local rx around the injection site with no pain or itching.  Treatment included: apply ice as much as possible, take ZYRTEC 1 daily for 10 days and follow-up if symptoms persist.  On 22-OCT-2007 all symptoms were gone except for sore around injection site.  The outcome was reported as recovered.  There was no illness at time of vaccination.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Follow-up information indicated that "all patient's symptoms resolved after 1-4 days of getting vaccine". Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin burning sensation
Clinical narrative: Information has been received from a health professional concerning a 68 year old female who on 24-OCT-2007 was vaccinated with a 0.65 mL dose in her left deltoid of zoster vaccine live (Oka/Merck) (Lot# 658208/0886U). Concomitant therapy included tramadol HC1, diazepam and statin (unspecified). On 26-OCT-2007, the patient began to experience deep burning and sting pain beneath the bra line of her left side. The patient was not experiencing a rash. It was noted that the patient called the office. At the time of the report the patient had not recovered. No other information was provided. No product quality complaint was involved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 73 year old female who on 15-OCT-2007 was vaccinated with ZOSTAVAX.  Four days post vaccination, on 19-OCT-2007; the patient developed a very red, swollen lump at the injection site.  The swelling and redness continued on for the next four weeks.  The patient was prescribed Benadryl and ice; however the patient has continued to contact the physician with the same problem.  At the time of reporting the outcome was unknown.  Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Herpes zoster, Injection site rash, Pain
Clinical narrative: Information has been received from a consumer concerning a 74 year old husband with penicillin allergy, peanut allergy, and allergies to SEPTRA, ENTEX LA, PRILOSEC, and REGLAN and a history of chicken pox (age 8) who on 18-OCT-2007 was probably vaccinated in left arm with a dose of ZOSTAVAX (Oka/Merck) instead of a dose of influenza virus vaccine (unspecified).  Concomitant therapy included primidone, propranolol HCl, PREVACID, finasteride (MSD), "baby" aspirin and vitamin B (unspecified).  On 19-OCT-2007 or 20-OCT-2007, 1 to 2 days after vaccination the patient developed shingles.  It was reported that the patient was there to receive the influenza shot which the office said they gave him but the reporter believed that the patient received ZOSTAVAX (MSD).  It was reported that the office was administering both vaccines at the time of patient's vaccination.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been received from the consumer concerning her husband who stated that the patient was vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of a dose of influenza virus vaccine (unspecified).  She reported that he patient prior to her husband received a dose of ZOSTAVAX (Oka/Merck).  The patient developed rash under his left arm that moved to his back and a little on his chest.  The patient was seen by his physician and subsequently was diagnosed with shingles.  The nurse practitioner stated that the patient was vaccinated with flu vaccine and "they don't make mistakes".  The patient currently had a few large scabs and was starting to have a lot of pain.  Follow up information from a health care professional reported that 1-2 days after vaccination (Oct-19-2007), he developed symptoms of a rash at the injection site, a burning sensation under the arm accompanied by fatigue and pain (site not specified).  On 10-NOV-2007, a specimen was obtained (unspecified source) and sent for varicella zoster identification (results not reported).  It was reported that at the time of this report the patient had recovered.  It was also reported that there was no recent exposure to chickenpox or shingles.  Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Scab, Virus serology test, Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning a 74 year old husband with penicillin allergy, peanut allergy, and allergies to SEPTRA, ENTEX LA, PRILOSEC, and REGLAN and a history of chicken pox (age 8) who on 18-OCT-2007 was probably vaccinated in left arm with a dose of ZOSTAVAX (Oka/Merck) instead of a dose of influenza virus vaccine (unspecified).  Concomitant therapy included primidone, propranolol HCl, PREVACID, finasteride (MSD), "baby" aspirin and vitamin B (unspecified).  On 19-OCT-2007 or 20-OCT-2007, 1 to 2 days after vaccination the patient developed shingles.  It was reported that the patient was there to receive the influenza shot which the office said they gave him but the reporter believed that the patient received ZOSTAVAX (MSD).  It was reported that the office was administering both vaccines at the time of patient's vaccination.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been received from the consumer concerning her husband who stated that the patient was vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of a dose of influenza virus vaccine (unspecified).  She reported that he patient prior to her husband received a dose of ZOSTAVAX (Oka/Merck).  The patient developed rash under his left arm that moved to his back and a little on his chest.  The patient was seen by his physician and subsequently was diagnosed with shingles.  The nurse practitioner stated that the patient was vaccinated with flu vaccine and "they don't make mistakes".  The patient currently had a few large scabs and was starting to have a lot of pain.  Follow up information from a health care professional reported that 1-2 days after vaccination (Oct-19-2007), he developed symptoms of a rash at the injection site, a burning sensation under the arm accompanied by fatigue and pain (site not specified).  On 10-NOV-2007, a specimen was obtained (unspecified source) and sent for varicella zoster identification (results not reported).  It was reported that at the time of this report the patient had recovered.  It was also reported that there was no recent exposure to chickenpox or shingles.  Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaemia, Hypothyroidism, Pyrexia, Renal impairment
Clinical narrative: Information has been received from a consumer concerning her 85 year old mother with penicillin allergy and a history of lymphoma who in July 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included blood pressure medicines. In July 2007, 2 days after vaccination the patient developed fever and had an on and off temperature for a week after vaccination. The patient "recently" had tests done and it showed her thyroid was not working and her kidney function went down and she became anemic. The patient had lymphoma 10 or 11 years ago. Unspecified medical attention was undertaken. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007.  Information has been received from a consumer concerning her 85 year old mother with penicillin allergy and a history of lymphoma who in July 2007, was vaccinated with a dose of ZOSTAVAX vaccine (Merck). Concomitant therapy included blood pressure medicines. In July 2007, 2 days after vaccination the patient developed fever and had an on and off temperature for a week after vaccination. The patient "recently" had tests done and it showed her thyroid was not working and her kidney function went down and she became anemic. The patient had lymphoma 10 or 11 years ago. Unspecified medical attention was undertaken. A poduct quality complaint was not involved. Additional information was received from the physician. On 08-AUG-2007 the physician was told by the patient's daughter that she wasn't sure was wrong but the patient had been "real sick" for this last few days. She stated that the patient "got the shot, had a med change, got stung by a bee and was at the street fair in the heat all in the same week so it could be any combination of those things". The physician did not feel that ZOSTAVAX vaccine (Merck) was the cause of the patient's symptoms. No further information was provided. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Prostatic specific antigen increased
Clinical narrative: Information has been received from an 81 year old male with a history of prostate cancer and no allergies who on 23-JUL-2007 was vaccinated IM with a first dose of ZOSTAVAX.  Concomitant therapy included hypertension medication (unspecified).  In July 2007, after vaccination the patient had PSA test and reported that it had dropped.  On 30-OCT-2007 it was 0.8 and before vaccination the PSA test value was 2.2.  The patient had contacted his dermatologist and neurologist.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007. Initial and follow up information has been received from a physician concerning an 81 year old male with a history of prostate cancer, hereditary neuropathy. hypertension and no drug reactions or allergies who on 23-JUL-2007 at 10:00, was vaccinated subcutaneously (also reported as IM) into the left arm with a second dose (also reported as first dose) of ZOSTAVAX (Merck) (Lot#656395/0290U). concomitant therapy included hypertension medication (unspecified). The physician reported that two weeks after receiving the ZOSTAVAX (Merck), the PSA levels were elevated. PSA levels are an follows: 01 JAN 2007 (0.2), 07 AUG 2007 (2.1), 29 AUG 2007 (1.4), 04 SEP 2007 (0.6) and 30 OCT 2007 (0.8). The consumer had reported that after receiving ZOSTAVAX (Merk) "his PSA test dropped". There was no illness at the time of vaccination. Medical attention was sought. The patient contacted 4 neurologist and dermatologist. At the time of report the outcome was not reported. A product quality complaint was not involved. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: Information has been received from a 69 year old male with thyroid disorder and blood pressure who on 26-OCT-2007 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included insulin, SYNTHROID, simvastatin (MSD), DIOVAN and NEURONTIN.  On 26-OCT-2007, 8 hours after vaccination the patient took his blood sugar on his meter at home and it was reported that it read extremely high levels.  The patient contacted his physician immediately.  It was reported that the patient had the highest blood sugar level he had ever seen.  The patient stated that he his blood sugar had lowered since then but was still in the 300's.  Unspecified medical attention was sought.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 62 year old female with no pertinent medical history, and an allergy to penicillin who on 30-AUG-2007 was vaccinated subcutaneously with ZOSTAVAX (Lot # 658086/0761U).  There was no concomitant medication.  On 30-AUG-2007 the patient developed redness, itching, swelling and pain at the injection site.  The patient was treated with Benadryl.  The event lasted two weeks, and the patient recovered on an unspecified date (approximately 12-Sep-2007).  There were no lab diagnostic studies performed.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.