chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Inappropriate schedule of drug administration, Migraine, Nausea
Clinical narrative: Information has been received from a health professional concerning a 58 year old Caucasian male patient with penicillin allergy who on 12-NOV-2007 was vaccinated with the first dose of ZOSTAVAX, subcutaneously in left arm, 0.65 ml (lot number "10874").  There was no concomitant medication.  On 15-NOV-2007 the patient experienced nausea, stomach cramps, diarrhea and the onset of a migraine.  The patient's nausea and stomach cramps and diarrhea and onset of migraine persisted.  It was reported that the patient did not seek medical attention.  There was no product quality complaint.  Additional information has been requested.  Follow up information has been received from a physician concerning a 58 year old male patient with a penicillin allergy who on 12-NOV-2007 was vaccinated with the first dose of ZOSTAVAX, SQ, left arm, 0.65 ml (lot number "10874").  On 18-NOV-2007, the patient experienced acute amount of nausea, vomiting, headache, and diarrhea following ZOSTAVAX.  He was treated with phenergan 25 mg IM x 1 dose, an unspecified therapy prn, and bismuth subsalicylate (PEPTO-BISMOL) prn.  It was reported that the patient's symptoms gradually resolved after 2 weeks on approximately 02-DEC-2007.  No further information is available.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Information has been received from a health professional concerning a 58 year old Caucasian male patient with penicillin allergy who on 12-NOV-2007 was vaccinated with the first dose of ZOSTAVAX, subcutaneously in left arm, 0.65 ml (lot number "10874").  There was no concomitant medication.  On 15-NOV-2007 the patient experienced nausea, stomach cramps, diarrhea and the onset of a migraine.  The patient's nausea and stomach cramps and diarrhea and onset of migraine persisted.  It was reported that the patient did not seek medical attention.  There was no product quality complaint.  Additional information has been requested.  Follow up information has been received from a physician concerning a 58 year old male patient with a penicillin allergy who on 12-NOV-2007 was vaccinated with the first dose of ZOSTAVAX, SQ, left arm, 0.65 ml (lot number "10874").  On 18-NOV-2007, the patient experienced acute amount of nausea, vomiting, headache, and diarrhea following ZOSTAVAX.  He was treated with phenergan 25 mg IM x 1 dose, an unspecified therapy prn, and bismuth subsalicylate (PEPTO-BISMOL) prn.  It was reported that the patient's symptoms gradually resolved after 2 weeks on approximately 02-DEC-2007.  No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: Information has been received from a 61 year old female with a history of "more sinus infections than usual this year" who on 19-FEB-2008 was vaccinated with a dose of ZOSTAVAX.  Concomitant therapy included enalapril maleate (VASOTEC).  On approximately 21-FEB-2008, 2 days after the vaccination the patient experienced sinus infection.  The patient's sinus infection persisted.  No product quality complaint.  Additional information has been requested. 02/17/2010 Follow-up information received by the patient indicating that she was received the vaccination on 13-Feb-2008. She went to the MD office on 27-Feb-2008 because she had tenderness at the injection site and her allergies were bothering her for a few days after the injection and that she "felt that she was developing a sinus infection". (Since she takes allergy shots once a week, she could not take her allergy injection the week of vaccination). On 22-Feb-2008, the patient went to see her ENT specialist and at the time her thought she had just chronic sinusitis. On 27-Feb-2008, the MD prescribed her an antibiotic, because she was still had muscus. On 27-Feb-2008, she was treated with "Paeudovent" 120-200mg BID for 14 days. On 27-FEb-2008 she received Aug,emtom 375mg BID for 14 days. My March 13, 2008 all medication  was completed and she was "feeling good". The patient doesn't think it had anything to do with zoster vaccine live (Oka/Merck). She has been having a roght winter (since early December 2007) with sinus problems and infections. She asked her MD if she could have zoster vaccine live (Oka/Merck) vaccination and he said "Yes",  he believes in the vaccine. The patient has no regrets receiving the vaccination and wanted to be protected from from Shingles.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a 62 year old female consumer who reported that her mother developed a headache after receiving Zostavax (Oka/Merck) on 31 DEC 2007.  This is one of several reports from the same source.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with ZOSTAVAX.  The physician reported that she vaccinated the patient and three weeks after the vaccination the patient presented with a severe case of shingles.  The case was severe but the pain was limited.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning their sister's friend who on an unspecified date was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient developed shingles.  At the time of the report the patient's status was unknown.  There was no product quality complaint involved.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood lactate dehydrogenase increased, Blood pressure increased, C-reactive protein increased, Dysstasia, Feeling hot
Clinical narrative: Information has been received from a 68 year old female lab technician at the doctor's office who reported that she was vaccinated with a dose of ZOSTAVAX (Oka/Merck), 0.65ml (lot number 654603/1405F) on 15-DEC-2006. Concomitant therapy included EVISTA. In JAN-2007, she experienced a whooshing warm sensation on the same side as the injection in upper left chest quadrant for 10 days to 2 weeks. That subsided. On 14-JUN-2007 she was taking a bath and could not get out of the tub without assistance. She was taken to the clinic where her blood pressure was 200/115. Her bloodwork showed a high C-reactive protein at 8.3, lactate dehydrogenase was 280, and a positive RA, full test name not identified. She had a negative doppler of all extremities and she was also negative for renal impairment. Seen by a rheumatologist who ruled out rheumatoid arthritis. She was seen by a cardiologist and heart conditions were ruled out. She was given 3 different medications to try to control the blood pressure but it was still elevated. In mid JUL-2007, everything returned to normal and she has had not had additional experiences. There was no product quality complaint. The patient sought medical assistance in the physician's office. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Renal function test normal, Rheumatoid factor positive, Ultrasound Doppler normal
Clinical narrative: Information has been received from a 68 year old female lab technician at the doctor's office who reported that she was vaccinated with a dose of ZOSTAVAX (Oka/Merck), 0.65ml (lot number 654603/1405F) on 15-DEC-2006. Concomitant therapy included EVISTA. In JAN-2007, she experienced a whooshing warm sensation on the same side as the injection in upper left chest quadrant for 10 days to 2 weeks. That subsided. On 14-JUN-2007 she was taking a bath and could not get out of the tub without assistance. She was taken to the clinic where her blood pressure was 200/115. Her bloodwork showed a high C-reactive protein at 8.3, lactate dehydrogenase was 280, and a positive RA, full test name not identified. She had a negative doppler of all extremities and she was also negative for renal impairment. Seen by a rheumatologist who ruled out rheumatoid arthritis. She was seen by a cardiologist and heart conditions were ruled out. She was given 3 different medications to try to control the blood pressure but it was still elevated. In mid JUL-2007, everything returned to normal and she has had not had additional experiences. There was no product quality complaint. The patient sought medical assistance in the physician's office. Additional information has been requested.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Borrelia burgdorferi serology negative, Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning an approximately 93 year old female with cardiac failure congestive, drug hypersensitivity to narcotics, codeine and shellfish allergy who on 07-DEC-2007 (reported as 6 days ago), was vaccinated with a dose of Zostavax (Oka/Merck) subcutaneously.  Concomitant therapy included alendronate sodium (MSD) and aspirin.  Subsequently the patient developed a 2 inch wide erythema at the injection site.  The patient saw a physician on 05-DEC-2007.  The outcome was reported as not recovered.  There was no product quality complaint.  Further Information has been received from the physician concerning this retired 93 year old female with allergy to DEMEROL.  The physician reported that the patient developed an expanding erythema for one week following injection.  The patients Lyme titer was negative.  The physician reported that the patient recovered on 21-DEC-2007.  Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient who, on an unspecified date, was vaccinated with a dose of ZOSTAVAX.  Subsequently the patient experienced herpes zoster at the injection site following the dermatome.  Medical attention was sought through a phone call.  The outcome is unknown.  No product quality complaint was involved.  This is one of several reports from the same reporter.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a 63 year old female consumer with sulfonamide allergy (chodroitin sulfate) and drug hypersensitivity (novacine, xylocaine, and cetirizine) who on 29-NOV-2007 was vaccinated with a dose of ZOSTAVAX.  Concomitant therapy included irbesartan (AVAPRO), levothyroxine Na, estrogens, conjugated (CENESTIN), "Promethium" (therapy unspecified), fenofibrate (TRICOR) and fexofenadine hydrochloride.  The patient developed fatigue and malaise followed by an injection site reaction following the vaccination with ZOSTAVAX on 29-Nov-2007.  The caller reported that the fatigue and general malaise started on 30-Nov-2007 and that the injection site was red, swollen, warm, and itchy which started on 02-Dec-2007.  The injection site reaction was still present on 13-Dec-2007 and described as itchy, red, "2 C2BD" inch oval area at the injection site.  The swelling and warmth are no longer present as of 13-Dec-2007.  The patient received the vaccination at the pharmacy.  Unspecified medical attention was sought.  No product quality complaint.  Follow-up information received from the physician indicating that she is not aware of any adverse events or the patient.  No further information is expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise
Clinical narrative: Information has been received from a 63 year old female consumer with sulfonamide allergy (chodroitin sulfate) and drug hypersensitivity (novacine, xylocaine, and cetirizine) who on 29-NOV-2007 was vaccinated with a dose of ZOSTAVAX.  Concomitant therapy included irbesartan (AVAPRO), levothyroxine Na, estrogens, conjugated (CENESTIN), "Promethium" (therapy unspecified), fenofibrate (TRICOR) and fexofenadine hydrochloride.  The patient developed fatigue and malaise followed by an injection site reaction following the vaccination with ZOSTAVAX on 29-Nov-2007.  The caller reported that the fatigue and general malaise started on 30-Nov-2007 and that the injection site was red, swollen, warm, and itchy which started on 02-Dec-2007.  The injection site reaction was still present on 13-Dec-2007 and described as itchy, red, "2 C2BD" inch oval area at the injection site.  The swelling and warmth are no longer present as of 13-Dec-2007.  The patient received the vaccination at the pharmacy.  Unspecified medical attention was sought.  No product quality complaint.  Follow-up information received from the physician indicating that she is not aware of any adverse events or the patient.  No further information is expected.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a health professional concerning a 40 year old female employee, with no history of shingles, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006.  It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck).  Subsequently the patient was diagnosed with shingles by her physician and treated.  No product quality complaint was involved.  No other information was provided.  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission, Viral DNA test negative
Clinical narrative: Information has been received from a health professional concerning a female employee in her 60's, with no history of shingles, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006.  It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck).  Subsequently the patient was diagnosed with shingles by her physician and treated.  No product quality complaint was involved.  No other information was provided.  Follow-up information indicated that the patient had a VZV PCR test and no VZV DNA was amplified.  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Scab, Secondary transmission, Viral DNA test negative
Clinical narrative: Information has been received from a health professional concerning a female employee in her late 30's or early 40's, with chronic Epstein-Barr virus (EBV) and recurrent herpes simplex outbreaks, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006.  It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck).  Subsequently the patient was diagnosed with shingles by her physician and treated.  It was noted that the patient had blisters and scabs and was currently experiencing her second episode of shingles since November 2007, which started on 11-DEC-2007.  No product quality complaint was involved.  No other information was provided.  Follow-up information from a health professional indicated that the patient has had 3 cases of shingles since November 2007.  The shingles was diagnosed by a nurse practitioner in a nearby urgent care facility.  Subsequently the patient had either recovered or was recovering.  All lesions were either gone or almost completely dried up.  VZV PCR results showed that all four samples were either inadequate or negative.  This is one of several reports from the same source.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 64 year old female with a history of hyperlipidaemia, allergic rhinitis, osteoarthritis, irritable bowel syndrome, cervical disc degeneration disease, glucose intolerance and drug reactions/allergies to anesthetics, who on 17-OCT-2007 was vaccinated with a dose of ZOSTAVAX (lot number: 658085/0882U).  Concomitant therapy included multi-vitamins daily, calcium 600mg twice daily, vitamin D 400 IU daily, cyanocobalamin 500mg daily, ibuprofen as needed and "amitriptyline" 10mg daily.  On 24-OCT-2007 the patient developed varicella lesions on both her thighs and legs after receiving the vaccine.  No further information was available.  There were no lab diagnostic studies performed.  Unspecified medical attention was sought via the telephone.  The outcome was reported as recovering.  There was no product quality complaint.  The physician is not interested in the VZV analysis by PCR (Polymerase Chain Reaction).  Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Epidermal necrosis, Headache, Nausea, Rash generalised, Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 72 year old male who on 05-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On approximately 08-NOV-2007 the patient experienced hives on neck, back and scalp 3 or four days after receiving the vaccination.  Per the nurse, "the patient looks like he got chicken pox".  Unknown if the patient recovered.  No product quality complaint.  Additional information has been requested. Follow-up information received from the physician indicating Information has been received from a physician via a medical record concerning a 72 year old male who on 05-NOV-2007 was vaccinated with ZOSTAVAX (lot# 658082/0744U) via the right upper arm. Concomitant therapy included BENADRYL, DIOVAN, LIPITOR, metoprolol tartrate, ORABASE-B, triamcinolone and triamcinolone acetonide. On approximately 20-NOV-2007 the patient experienced headaches and nausea. On approximately 22-NOV-2007 the patient experineced " the patient looks like he got chicken pox" and hives on neck, back and scalp. It was reported that the patient was a 72-year-old gentleman who is referred in for evaluation of possible varicella. The patient recalls no history of chickenpos or shingles, and on 11/5/2007 received the ZOSTAVAX vaccine. Fifteen days later, he reports headaches and nausea. and then 17 days after the original vaccine a rash erupted. He describes it as being on the neck with water blisters and then spreading to all parts of the body, healing with hemorrhagic crusts. He denies current symptomatology including fevers, chills, sweats, headach, shortness of breath, or cough. Physical examination revealed multiple erythematous papules and a few pustules on an erythelnatous base, some with hemorrhagic crusts diffusely. Clinical impression was that of varicella secondary to the ZOSTAVAX vaccine. It does appear that varioliform eruptions are well describes in the setting of vaccination, independent of previous immune status. A shave bisosy from the right forearm was obtained to confirm the diagnosis. Results of dermatologist review are as follows: Clinical impressions was Varicella. Diagnosis Epidermal necrosis, ulceration and re-epithelialization. There are no specific cytopathic features of herpes virus infection, although this pattern of ulceration and vascular congestioncould have been produced by a virus. Biopsy of a leasion earlier inits evolution would be diagnostic. Gross view: Specimen was received fixed in formation consisting of tissue measuring 9X6X1 cm, submitted after bisection. Microscopic evaluation as follows: There is evidence of re-epitheliazation and a difuse dermal infiltrate which is heterogenous in composition. There was marked congestion of blood vessels. There is a small focus of abcess formation with degenerated collagen. There are clumpsof subcorneal neutrophils and eveidence of necrosis belistering which was replaced by re-epithelializaiton. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin ulcer, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 72 year old male who on 05-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On approximately 08-NOV-2007 the patient experienced hives on neck, back and scalp 3 or four days after receiving the vaccination.  Per the nurse, "the patient looks like he got chicken pox".  Unknown if the patient recovered.  No product quality complaint.  Additional information has been requested. Follow-up information received from the physician indicating Information has been received from a physician via a medical record concerning a 72 year old male who on 05-NOV-2007 was vaccinated with ZOSTAVAX (lot# 658082/0744U) via the right upper arm. Concomitant therapy included BENADRYL, DIOVAN, LIPITOR, metoprolol tartrate, ORABASE-B, triamcinolone and triamcinolone acetonide. On approximately 20-NOV-2007 the patient experienced headaches and nausea. On approximately 22-NOV-2007 the patient experineced " the patient looks like he got chicken pox" and hives on neck, back and scalp. It was reported that the patient was a 72-year-old gentleman who is referred in for evaluation of possible varicella. The patient recalls no history of chickenpos or shingles, and on 11/5/2007 received the ZOSTAVAX vaccine. Fifteen days later, he reports headaches and nausea. and then 17 days after the original vaccine a rash erupted. He describes it as being on the neck with water blisters and then spreading to all parts of the body, healing with hemorrhagic crusts. He denies current symptomatology including fevers, chills, sweats, headach, shortness of breath, or cough. Physical examination revealed multiple erythematous papules and a few pustules on an erythelnatous base, some with hemorrhagic crusts diffusely. Clinical impression was that of varicella secondary to the ZOSTAVAX vaccine. It does appear that varioliform eruptions are well describes in the setting of vaccination, independent of previous immune status. A shave bisosy from the right forearm was obtained to confirm the diagnosis. Results of dermatologist review are as follows: Clinical impressions was Varicella. Diagnosis Epidermal necrosis, ulceration and re-epithelialization. There are no specific cytopathic features of herpes virus infection, although this pattern of ulceration and vascular congestioncould have been produced by a virus. Biopsy of a leasion earlier inits evolution would be diagnostic. Gross view: Specimen was received fixed in formation consisting of tissue measuring 9X6X1 cm, submitted after bisection. Microscopic evaluation as follows: There is evidence of re-epitheliazation and a difuse dermal infiltrate which is heterogenous in composition. There was marked congestion of blood vessels. There is a small focus of abcess formation with degenerated collagen. There are clumpsof subcorneal neutrophils and eveidence of necrosis belistering which was replaced by re-epithelializaiton. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional who is the office manager concerning a 45 year old female who in October 2007, was vaccinated with Zostavax (Oka/Merck).  Secondary suspect therapy included Varivax (OKA/Merck) MSD.  The office manager reported that a patient was inadvertently given Zostavax instead of Varivax.  This was reported as a nursing error.  Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella zoster virus serology positive, Virus culture positive
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Zostavax .65 mL injection (Oka/Merck).  Subsequently, 48 hours after receiving on 06-DEC-2007 the vaccine the patient developed a mild case of shingles.  The patient sought unspecified medical attention.  Further information has been received regarding this 84 year old retired male who was vaccinated on 03-DEC-2007 with Zostavax (Oka/Merck) ( Lot # 658602/1080U) sc in the right arm.  The physician reported that on 06-DEC-2007 the patient developed shingles involving the left C2-3 dermatome.  Culture was positive for varicella zoster detected by immunofluorescent monoclonal antibody.  The physician did not report the outcome of the patients experience.  Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Pain, Pruritus, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning an 88 year old male with a history of atrial fibrillation, coronary artery disease, hyperlipidaemia and no drug reactions/allergies, who on 15-OCT-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included influenza virus vaccine (unspecified), "topral" (therapy unspecified), COUMADIN, ALTACE, LIPITOR, FLOMAX, OCUVITE and aspirin 81 once daily.  On 11-DEC-2007 the patient developed zoster.  On 14-DEC-2007 a specimen was obtained.  On 17-DEC-2007 the specimen was sent to the laboratory.  The adverse experience was herpes zoster.  The zoster was described as unilateral, T10 distribution on the right side.  The patient complained of itching for the first two days followed by pain.  The patient was treated for a mild respiratory viral infection on the day of vaccination, which was treated with NASACORT.  The physician was not interested in the VZV Analysis by PCR at the time.  On 17-DEC-2007 the physician stated that he was interested in VZV analysis by PCR and that he collected a specimen on 14-DEC-2007 that he would like to submit.  The VZV DNA was amplified.  The B-globulin DNA was amplified.  The VZV strain identification showed wild-type.  The interpretation was adequate specimen, wild strain.  No other information to report.  There were no lab diagnostic studies performed.  Unspecified medical attention was sought.  The patient contacted the physician.  The outcome was reported as not recovered.  The was no product quality complaint.  Follow-up information received from the physician indicated that the patient had severe shingles.  He did not have a recent exposure to chickenpox or shingles.  The source of specimen was lesion type, vesicle.  No other information was available.  Additional follow-up information indicated that on the morning of 06-FEB-2008, the wife of the patient left another message for the doctor requesting a call back explaining that she wanted more information about the strain and someone to contact her.  She was concerned that the vaccine might have lowered the patient's immune system causing his shingles.  The HCP was contacted and indicated that he informed the patient of the PCR results on 30-JAN-2008 and reiterated the information on 31-JAN-2008 when the patient was seen in the office.  The HCP confirmed that the patient was a dentist and that the patient had a "bad outbreak".  The HCP stated that he was willing to contact the patient to further answer any additional questions.  The patient was doing fine when he was seen for an unrelated issue.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Burning sensation, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a nurse practitioner concerning a 66 year old female with a history of chickenpox, AODM, HTN, HLP, and insomnia and drug reactions/allergies to NKDA, who on 26-JUN-2007 was vaccinated SC in the left side with a 0.64 mL dose of ZOSTAVAX (lot number: 657764/0584U).  On 16-OCT-2007 the patient developed a shingles rash after receiving the vaccine.  She experienced intense burning in the right thoracic area.  There was an impression post herpetic neuralgia T7 dermatome.  The patient's maximum temperature was 97.8 and pain was 9.  There was no presence of rash.  There was no recent exposure to chickenpox or shingles.  There was no photo taken.  The patient was being treated with pregabalin (LYRICA), lidocaine (LIDODERM PATCH) and unspecified steroids.  The patient had not fully recovered at the time.  No further information was provided.  There was no product quality complaint.  Additional information has been requested.
Age: 68.0
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 health professional concerning a 68 year-old White female with hypertension and allergic rhinitis who on 06-DEC-2007 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included BENICAR and allergy shots. On approximately 06-DEC-2007 the patient developed redness and swelling at the injection site and was seen in the physician's office on 10-DEC-2007. No laboratory or diagnostic tests were performed. The physician reported that the reaction appeared to be a "large bull's eye". The patient was treated with BENADRYL, however, at the time of this report the redness and swelling at the injection site persisted. No product quality complaint was involved. Additional information was received. It was reported that approximately 10-12 hours after the injection of ZOSTAVAX (Oka/Merck), on 06-DEC-2007 at 22:00 the patient noticed "hot, red, itching and swelling around the injection site" that progressed to approximately 10 inches in diameter over the next 3 days. BENADRYL and ice packs were used and the reaction subsided after 3 weeks, at the end of December 2007. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Eye swelling, Herpes zoster, Incorrect route of drug administration, Intraocular pressure increased
Clinical narrative: Information has been received from a registered pharmacist concerning a 68-year-old male with allergies to levofloxacin (LEVAQUIN) and perhaps ciprofloxacin hydrochloride (CIPRO) who on 12-DEC-2007 was vaccinated intramuscularly (previously reported as subcutaneously) in the left deltoid with a first 0.65 ml dose of ZOSTAVAX (lot# 658838/1412U).  Concomitant medication included lansoprazole (PREVACID), an unspecified thyroid medication, ezetimibe (+) simvastatin (VYTORIN) and ramipril (ALTACE).  There was no illness at the time of vaccination.  A day after receiving the vaccination, on 13-DEC-2007, the patient developed a red rash on her left upper scalp.  This rash occurred from 13-14-DEC-2007.  On 15-16-DEC-2007 he developed hives and shingles lesions on his left forehead, scalp, nose and around his left eye.  On 17-DEC-2007 he was seen by a physician's assistant who diagnosed him with shingles and prescribed valacyclovir hydrochloride (VALTREX), 1 gm; hydroxzine HCL, 25 mg; and hydrocodone/APAP tab 5-500 mg.  The patient was referred to an optomologist for left eye swelling, he found left 5th nerve opthalmic division with ocular involvement and prescribed prednisolone acetate (PRED FORTE) 1% drops and brimonidine tartrate (ALPHAGAN) 0.1% drops.  On 19-DEC-2007, he returned to the opthomologist and found that the eye pressure was 34.  On 20-DEC-2007, his eye pressure dropped to 25.  Some viral lesions and cell involvement in the left eye.  No outcome was reported.  Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Optic nerve disorder, Rash, Urticaria
Clinical narrative: Information has been received from a registered pharmacist concerning a 68-year-old male with allergies to levofloxacin (LEVAQUIN) and perhaps ciprofloxacin hydrochloride (CIPRO) who on 12-DEC-2007 was vaccinated intramuscularly (previously reported as subcutaneously) in the left deltoid with a first 0.65 ml dose of ZOSTAVAX (lot# 658838/1412U).  Concomitant medication included lansoprazole (PREVACID), an unspecified thyroid medication, ezetimibe (+) simvastatin (VYTORIN) and ramipril (ALTACE).  There was no illness at the time of vaccination.  A day after receiving the vaccination, on 13-DEC-2007, the patient developed a red rash on her left upper scalp.  This rash occurred from 13-14-DEC-2007.  On 15-16-DEC-2007 he developed hives and shingles lesions on his left forehead, scalp, nose and around his left eye.  On 17-DEC-2007 he was seen by a physician's assistant who diagnosed him with shingles and prescribed valacyclovir hydrochloride (VALTREX), 1 gm; hydroxzine HCL, 25 mg; and hydrocodone/APAP tab 5-500 mg.  The patient was referred to an optomologist for left eye swelling, he found left 5th nerve opthalmic division with ocular involvement and prescribed prednisolone acetate (PRED FORTE) 1% drops and brimonidine tartrate (ALPHAGAN) 0.1% drops.  On 19-DEC-2007, he returned to the opthomologist and found that the eye pressure was 34.  On 20-DEC-2007, his eye pressure dropped to 25.  Some viral lesions and cell involvement in the left eye.  No outcome was reported.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her female employee who on an unspecified date was vaccinated with a dose of ZOSTAVAX (manufacturer not specified).  On an unknown date it was reported the patient developed a case of shingles even though she was vaccinated against it.  At the time of the report the patient's status was unknown.  This is one of several reports received from the same source.  Additional information has been requested. 02/17/2010 Information has been received from a Phyiscia Assistant concerning a female cleaning lady with unknown vaccination history. The patient cleans the house of a woman who was vaccinated with a dose of ZOSTAVAX on 13-DEC-2008 and subsequently developed a rash. To this woman's knowledge the patient was not vaccinated with ZOSTAVAX. Subsequently, the patient developed shingles. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 62 year old female consumer with a history of seasonal allergies who on 22-JAN-2008 was vaccinated with .65ml ZOSTAVAX (Oka/Merck). Concomitant therapy included "vipalopran" for blood pressure. On 23-JAN-2008 the patient developed a rash on her stomach. Unspecified medical attention was sought. There was no lab studies performed. Subsequently, the patient stated she recovered "about a week or two afterwards." Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning her daughter, a 38 year old female, who on 31-JUL-2007 was vaccinated with ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck). It was reported to have been a mistake, and not product confusion. There were no adverse reactions reported. It was noted that the patient had previously received VARIVAX (Oka/Merck) in October 2007. There was no product quality complaint; Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Information has been received from a 71-year-old female with a history of anal carcinoma in 1990, a history of "broken bones" and no known allergies who on 06-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 658605/1089U). Concomitant therapy included alendronate sodium (MSD), calcium (unspecified) and multi-vitamins (unspecified). On 06-NOV-2007 the patient experienced "soreness on my right arm where I had ZOSTAVAX (Oka/Merck)". "It has now moved into the shoulder and sometimes up to my neck". "It is hard for me to reach". "It is not excruciating, and I am not on any medications for it". The patient sought medical attention via a phone call to the pharmacist. No diagnostic labs were performed. At the time of reporting the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning a female who's husband was vaccinated with a dose of ZOSTAVAX (Oka/Merck) on 20-NOV-2007. On an unspecified date the patient subsequently developed shingles. The patient sought medical attention via her physician. At the time of the report the patient's status was  unknown. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a registered pharmacist concerning a female (235 lbs., 69 in.) physician who's 66 year old husband was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneous (lot 658395/0966U) on 20-NOV-2007 at 13:00. On 27-NOV-2007, one week later, the patient developed shingles. The patient sought medical attention via her physician and subsequently recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Information has been received from a physician concerning a 68 year old white female who on 03-DEC-2007, at 16:27, was vaccinated subcutaneously with a first dose ZOSTAVAX (Oka/Merck) ( Lot # 658207/0883U). On 05-DEC-2007, in the early AM, the patient developed a painful rash developed at injection site and painful rash developed at injection site. No diagnostic testing was performed. At the time of reporting the outcome was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 69 year old female who on 14-DEC-2007 was vaccinated with ZOSTAVAX (Oka/Merck) ( Lot # 658863/1414U), and subsequently developed a localized rash. No treatment was required. There was no concomitant medication. At the time of reporting the patient was recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a 70 year old female consumer with a history of shingles in 1988 and 2002 and no known allergies who in approximately June 2007, was vaccinated IM with a dose of ZOSTAVAX.  There was no concomitant medication.  "One and a half weeks ago", on approximately 08-DEC-2007 the patient developed shingles.  The patient indicated that the case she has now is not as bad as her previous cases.  Unspecified medical attention was sought.  There were no lab studies performed.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  No further information was provided.  No further information is available.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure
Clinical narrative: Information has been received from a 51 year old registered nurse with a history of hyperthyroidism, asthma and a drug reactions/allergies that include sensitivity to aspirin, who on 20-DEC-2007 felt burning in her eye during an administration of ZOSTAVAX (lot number: 658398/1087U).  Concomitant therapy included albuterol (VENTOLIN) (albuterol), fluticasone propionate (+) salmeterol xinafoate (ADVAIR) and thyroid (ARMOUR THYROID TABLETS).  The patient stated that she usually gets splash backs during reconstitution and withdrawing of ZOSTAVAX and that it was possible that the vaccine may have entered her eyes.  She did not feel any liquid go into her eye but is reporting the event as a precaution.  No other information.  Unspecified medical attention was sought at the office.  There was no product quality complaint.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Information has been received from a consumer concerning a 65 year old female who on 12-DEC-2007 was vaccinated with ZOSTAVAX.  Concomitant therapy included paroxetine HC1 (PAXIL), clonidine and "nerve pills."  The consumer reported that "in the past she has experienced swelling of her arm and pain from receiving a tetanus shot."  On 12-DEC-2007 the patient developed itchiness and swelling.  The patient did not seek medical attention.  No further information is available.
Age: 8.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Anorexia, Fatigue, Herpes zoster, Pain
Clinical narrative: Information has been received from a consumer concerning her 8 year old grandson, with no pertinent medical history, concurrent conditions or drug reactions/allergies, who on 04-DEC-2007 was sitting in the waiting room of his grandparents' physician's office while they were vaccinated with ZOSTAVAX.  The consumer reported that on approximately 11-DEC-2007, the boy felt very tired, complained about abdominal pain, had a lack of appetite, and developed a rash on his left side by the ribs that was painful but not itchy.  The patient was seen by his pediatrician who diagnosed shingles.  The patient's shingles persisted.  Additional information was received from the administering physician who noted that the grandmother was a 67 year old white retired female who was vaccinated on 04-DEC-2007 with ZOSTAVAX subcutaneously.  According to the grandmother, her grandson had chickenpox at a young age.  No further information available.  Follow up information was received from the physician who reported that the patient was diagnosed with shingles on 18 DEC 2007, and that the patient had had natural chickenpox at four months of age.  It was further noted that there was no information available regarding "zoster vaccine live exposure".  No further information is expected.
Age: 8.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Secondary transmission
Clinical narrative: Information has been received from a consumer concerning her 8 year old grandson, with no pertinent medical history, concurrent conditions or drug reactions/allergies, who on 04-DEC-2007 was sitting in the waiting room of his grandparents' physician's office while they were vaccinated with ZOSTAVAX.  The consumer reported that on approximately 11-DEC-2007, the boy felt very tired, complained about abdominal pain, had a lack of appetite, and developed a rash on his left side by the ribs that was painful but not itchy.  The patient was seen by his pediatrician who diagnosed shingles.  The patient's shingles persisted.  Additional information was received from the administering physician who noted that the grandmother was a 67 year old white retired female who was vaccinated on 04-DEC-2007 with ZOSTAVAX subcutaneously.  According to the grandmother, her grandson had chickenpox at a young age.  No further information available.  Follow up information was received from the physician who reported that the patient was diagnosed with shingles on 18 DEC 2007, and that the patient had had natural chickenpox at four months of age.  It was further noted that there was no information available regarding "zoster vaccine live exposure".  No further information is expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received concerning a female in her 60's who was vaccinated with ZOSTAVAX.  Subsequently the patient developed shingles.  It was unspecified if the patient sought medical attention.  Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 63 year old female nurse who on an unspecified date was vaccinated subcutaneously with a first dose of ZOSTAVAX.  Concomitant therapy included "Eleva" and lisinopril.  Within 24 hours of vaccination the patient developed soreness at the injection site as well as redness at the injection site "about as large as a lemon", lasting two weeks.  The patient was recovered at the time of reporting (date unspecified).  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: Discomfort, Exposure to communicable disease, Fatigue, Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 66 year old male with drug hypersensitivity to chloroquine (diploplia) and a history of chickenpox at ten years of age, who on 12-NOV-2007 (also reported as 11-DEC-2007) was vaccinated into the left arm with 0.5 ml ZOSTAVAX (Lot # 658604/1088U).  Concomitant vaccinations included a 0.5 ml. dose of VARIVAX, and MMR II.  Concomitant therapy included ramipril (ALTACE), 2.5 mg daily, and cyanocobalanin (+) folic acid (+) pyridoxine hydrochloride (FOLBEE).  On 15-NOV-2007 (also reported as day three), the patient developed a fine vesicular rash that was wide spread described as a shingles rash.  The patient was reported to have felt poorly (fatigue, achy), and experienced discomfort from the rash, including pain and itching.  Dermatone was T 12 and extremities.  It was also noted that the patient's wife was vaccinated with ZOSTAVAX on the same day, but had no reaction.  The patient had been exposed to his granddaughter on 11 NOV 2007, one day prior to being vaccinated.  The granddaughter, who though not diagnosed at that time, was subsequently diagnosed with chickenpox.  Neither a direct fluorescent antibody nor specimens were obtained.  At the time of reporting it was noted that the rash was resistant with scaring, and the patient had not yet recovered.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  This is a consolidation of two reports concerning the same patient.  Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: Pain, Pruritus, Rash vesicular, Scar
Clinical narrative: Information has been received from a physician concerning a 66 year old male with drug hypersensitivity to chloroquine (diploplia) and a history of chickenpox at ten years of age, who on 12-NOV-2007 (also reported as 11-DEC-2007) was vaccinated into the left arm with 0.5 ml ZOSTAVAX (Lot # 658604/1088U).  Concomitant vaccinations included a 0.5 ml. dose of VARIVAX, and MMR II.  Concomitant therapy included ramipril (ALTACE), 2.5 mg daily, and cyanocobalanin (+) folic acid (+) pyridoxine hydrochloride (FOLBEE).  On 15-NOV-2007 (also reported as day three), the patient developed a fine vesicular rash that was wide spread described as a shingles rash.  The patient was reported to have felt poorly (fatigue, achy), and experienced discomfort from the rash, including pain and itching.  Dermatone was T 12 and extremities.  It was also noted that the patient's wife was vaccinated with ZOSTAVAX on the same day, but had no reaction.  The patient had been exposed to his granddaughter on 11 NOV 2007, one day prior to being vaccinated.  The granddaughter, who though not diagnosed at that time, was subsequently diagnosed with chickenpox.  Neither a direct fluorescent antibody nor specimens were obtained.  At the time of reporting it was noted that the rash was resistant with scaring, and the patient had not yet recovered.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  This is a consolidation of two reports concerning the same patient.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who, on an unspecified date, was vaccinated with a dose of ZOSTAVAX.  Subsequently the patient experienced herpes zoster at the thoracic area and followed a dermatome.  Medical attention was sought through a phone call.  The outcome is unknown.  No product quality complaint was involved.  This is one of several reports from the same reporter.  Additional information has been requested.