chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Joint swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning a friend who was vaccinated with a dose of ZOSTAVAX. Subsequently, the patient experienced fatigue, knee swollen and pain in arm, shoulder and wrist and knee pain. At the time of report, the outcomes were unknown. There is another patient had similar symptoms after received ZOSTAVAX (WAE #0803USA03918). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 27-JUN-2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (lot # 659672/0294X), subcutaneously. The nurse reported that the patient developed zoster on her face and eye area. Her physician prescribed antivirals. The nurse stated she is interested in VZV analysis by PCR and that the physician reported to the nurse the case was reported to CDC.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old male with no known drug allergies who on 09-JUL-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) in his left arm. Concomitant therapy included testosterone injection. On 10-JUL-2008, the patient developed tenderness, soreness, erythema and swelling at the site of injection. The area was about 2 to 3 inches. The patient made a telephone call to a physician. No laboratory diagnostics studies were performed. The patient's tenderness, soreness, erythema and swelling at the site of injection persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2008. Follow up information was received from the pharmacist who reported that the patient in the morning of 09-JUL-2008 was vaccinated subcutaneously with his first dose of ZOSTAVAX (Merck) (659410/0412X) in her left arm. In the morning of 10-JUL-2008 the patient developed erythema, pain, tenderness and swelling at site which size was 2 to 3 inches. The pain and tenderness increased to the point where the patient was unable to wash with cloth and the size increased. At the time of this report, the outcomes were unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female who "about 3 weeks ago," on approximately 20-JUN-2008 was vaccinated with a dose of ZOSTAVAX. "2 weeks after the dose," on approximately 04-JUL-2008 the patient experienced shingles. The patient went to see a physician. At the time of report, the event's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). The patient got shingles after getting vaccinated with ZOSTAVAX vaccine (Oka/Merck). The outcome was unknown. It was unknown if the patient sought medical attention or not. The pharmacist had no other information. No further information is available.
Age: 11.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial information has been received from a medical assistant and follow-up information was received from the patient's mother concerning a 11 year old white female who on 14-JUL-2008 at 3:30 PM was inadvertently vaccinated subcutaneously with a dose of ZOSTAVAX into the left deltoid instead of VARIVAX because of a medication error. No adverse symptoms were reported. It was unknown if the patient sought medical attention or not. Follow-up information was received from the office manager stating this was a case of human error. Both vaccines were on the same shelf and the nurse accidentally picked up the wrong vial. The office has since started a practice where 2 people will verify the vaccine that is being drawn up and given. There were no suggestions for labeling, storage conditions, etc. She felt it was human error not a problem with the vials themselves. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Local swelling, Lymphadenopathy, Lymphadenopathy
Clinical narrative: This is in follow-up to report (s) previously submitted on 9/24/2008 Information has been received from a registered nurse concerning a 71 year old female with arthritis, bronchitis, hypertension, acute back pain, hypothyroidism, sulfonamide allergy and shellfish/iodine allergy who on 07-JUL-2008 was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX (lot # 659672/0294X). Concomitant therapy included BENICAR, CRESTOR, LASIX, and SYNTHROID. On 13-JUL-2008, the patient experienced a cold sore, headache and an enlarged lymph node. The patient called the practice. The patient was recovering. No product quality complaint was involved. Additional information has been requested. Follow-up information was received from physician's office notes and a registered nurse (R.N.) who reported a 71 year old white female with sinus disorder and a history of positive chicken poz titer, measles adn rubella disease, hepatitis A and B (1995) and influenza vaccinations (2007) who on 07-JUL-2008 was vaccinated subcutaneously with a 0.65 ml dose of  ZOSTAVAX vaccine (Oka/Merck) (lot # 659672/0294X) in the left deltoid. Concomitant therapy included CELEBREX and methadone hydrochloride. There was no illness at time of vaccination. The patient had headache one to two days after vaccine that now had subsided and developed cold sore on right side of lip on 13-JUL-2008, with some swelling right lymph node/neck. No inflammation at site of injections (left side). The patient was counseled that she should refrain from taking VALTREX for 14 days after vaccination. The patient was advised to use topical creams, cold compresses. The patient started taking VALTREX on 15-JUL-2008, despite advice otherwise. The patient stated right side of face was swollen and very slight rash note on neck. The patient took VALTREX for ten days, then the rash disappeared and cold sore very small when VALTREX discontinued. On 24-JUL-2008, the physician's office called the patient regarding follow up after shingles and the cold sore and left a message. The physician discussed the lack of protection from shingles due to taking an antiviral medication before 14 days. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Rash, Swelling face
Clinical narrative: This is in follow-up to report (s) previously submitted on 9/24/2008 Information has been received from a registered nurse concerning a 71 year old female with arthritis, bronchitis, hypertension, acute back pain, hypothyroidism, sulfonamide allergy and shellfish/iodine allergy who on 07-JUL-2008 was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX (lot # 659672/0294X). Concomitant therapy included BENICAR, CRESTOR, LASIX, and SYNTHROID. On 13-JUL-2008, the patient experienced a cold sore, headache and an enlarged lymph node. The patient called the practice. The patient was recovering. No product quality complaint was involved. Additional information has been requested. Follow-up information was received from physician's office notes and a registered nurse (R.N.) who reported a 71 year old white female with sinus disorder and a history of positive chicken poz titer, measles adn rubella disease, hepatitis A and B (1995) and influenza vaccinations (2007) who on 07-JUL-2008 was vaccinated subcutaneously with a 0.65 ml dose of  ZOSTAVAX vaccine (Oka/Merck) (lot # 659672/0294X) in the left deltoid. Concomitant therapy included CELEBREX and methadone hydrochloride. There was no illness at time of vaccination. The patient had headache one to two days after vaccine that now had subsided and developed cold sore on right side of lip on 13-JUL-2008, with some swelling right lymph node/neck. No inflammation at site of injections (left side). The patient was counseled that she should refrain from taking VALTREX for 14 days after vaccination. The patient was advised to use topical creams, cold compresses. The patient started taking VALTREX on 15-JUL-2008, despite advice otherwise. The patient stated right side of face was swollen and very slight rash note on neck. The patient took VALTREX for ten days, then the rash disappeared and cold sore very small when VALTREX discontinued. On 24-JUL-2008, the physician's office called the patient regarding follow up after shingles and the cold sore and left a message. The physician discussed the lack of protection from shingles due to taking an antiviral medication before 14 days. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Pain, Pruritus
Clinical narrative: Information has been received from a 77 year old female with no relevant medical history or allergies who on 20-MAY-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot number, injection site and route not reported). Concomitant therapy included SYNTHROID, estrogens (unspecified), progesterone and alendronate sodium (manufacturer unknown). On the night of 09-JUL-2008 the patient experienced itching first on her forehead, face and back. Then through the next day and night she started to have stabbing pain/burning and itching feeling that would happen intermittently from her shoulder to her torso, she started on the forehead, back, under her breast bone etc. The consumer reported that the pain and itchiness got so bad that she started to take DYMATAP (manufacturer unspecified) during the day which help some, and took BENADRYL at night at which she could not tell if there was a problem because she thinks the BENADRYL mad her very tired. The consumer reported the pain is getting better. The consumer sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Antiphospholipid antibodies negative, Borrelia burgdorferi serology negative, Polyarthritis, Red blood cell count increased
Clinical narrative: Information has been received from a physician concerning a female who on approximately 03-JUN-2008 was vaccinated with ZOSTAVAX. On approximately 17-JUN-2008 the patient experienced acute polyarthritis which has affected her arms, shoulders and knees. The patient's acute polyarthritis persisted. The patient sought medical attention and saw physician. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site nodule, Neuritis, Neuropathy peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a physician with no pertinent medical history and no know drug allergies who on approximately 25-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) 0.65ml SC. In June 2008, the patient developed neuropathy within a day or 2 after vaccination. The patient's neuropathy persisted. The patient sought medical attention and the patient was the prescriber. Follow up information was received from the physician (concerning himself) with arthritis, high blood pressure, lipid abnormal and Benign prostatic hyperplasia and a history of mild herpes zoster at age 35 who developed left arm neuritis after self administering the vaccine 0.65ml in left deltoid about 5 weeks ago on approximately 16-JUN-2008. There was no illness at the time of vaccination. The patient developed pain in the left elbow and a granulomatous lesion at the injection site in the left deltoid about 3 weeks ago on approximately 2 weeks after self injection the patient experienced mild sensory discomfort. The pain was described as extending from the elbow to the wrist on the volar side and was most bothersome at the antecubital fossa not related to use. There was no motor change and the pain was not constant, there was more time without discomfort than with. The pain severity was described as a one 1 of 10 and the pain was improving without treatment. There were not relevant diagnostic tests and laboratory data. The patient felt that the symptoms were "pre zoster" type changes recognized before appearance of zoster. No other symptoms or treatment reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2008. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female patient who was vaccinated with ZOSTAVAX (Oka/Merck). The patient developed Shingles two weeks after vaccination. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with ZOSTAVAX. Subsequently, the patient developed a mild case of shingles. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Erythema, Herpes simplex, Injection site erythema, Lip ulceration
Clinical narrative: Information has been received from a physician concerning a 60 year old female with allergies to codeine, DEMEROL, anti-inflammatory agents, OMNICEF and doxycycline who on 12-JUL-2008 was vaccinated with the first dose of ZOSTAVAX. On 12-JUL-2008, the patient experienced redness at the injection. On 16-JUL-2008, the patient experienced a sore on lip. The sore on her lip was either herpes simplex or poison ivy. The physician examined the patient on 16-JUL-2008. The patient's redness at the injection and sore on lip persisted. It was also reported the patient experienced right upper arm erythema and edema with no vesicles. The size was 10 cm-28cm. There was no vesicle on upper lip. Additional information has been requested. On 03-Oct-2008, the patient recovered from the events, no redness and no scar reported. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema
Clinical narrative: Information has been received from a physician concerning a 60 year old female with allergies to codeine, DEMEROL, anti-inflammatory agents, OMNICEF and doxycycline who on 12-JUL-2008 was vaccinated with the first dose of ZOSTAVAX. On 12-JUL-2008, the patient experienced redness at the injection. On 16-JUL-2008, the patient experienced a sore on lip. The sore on her lip was either herpes simplex or poison ivy. The physician examined the patient on 16-JUL-2008. The patient's redness at the injection and sore on lip persisted. It was also reported the patient experienced right upper arm erythema and edema with no vesicles. The size was 10 cm-28cm. There was no vesicle on upper lip. Additional information has been requested. On 03-Oct-2008, the patient recovered from the events, no redness and no scar reported. Additional information is not expected.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 86 year old male who on 15-MAR-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 656607/0163U). On 08-JUL-2008 the patient experienced Shingles along the left side of his stomach. The patient's Shingles persisted. The patient sought medical attention. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Myositis, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 71 year old white male, a full length TED stockings wearer, weight 161.51lb, with deep vein thrombosis, allergies to Sulfa (cause hives), HYTRIN (cause rapid pulse rate), ACE inhibitor, CARDURA (increase heart rate) and anything containing HCL (raise blood pressure and cause jumpy) and a history of pulmonary embolism and shingles 12 years ago and no illness at the time of vaccination, who at 13:27 on 14-JUL-2008 was vaccinated with one dose ZOSTAVAX (lot#: 659672/0294X) 0.65mL SQ in the left arm. Concomitant therapy included CRESTOR, LOVENOX, meclizine, warfarin, VIAGRA, LOPID, DEBROX, PHENERGAN, CITRUCEL and lorazepam. One week prior to receiving ZOSTAVAX, the patient was taking COUMADIN for deep vein thrombosis. Subsequently, on 14-JUL-2008 the patient experienced pain at the right hip area, which was the same area where the patient experienced shingles prior to receiving the vaccine. The pain gradually moved down to the leg and by the next day the pain was present in the right foot. Within an hour of vaccination the patient also felt a strange taste in his mouth. On 17-JUL-2008, the patient saw the physician. His blood pressure was 138/74 mmhg, pulse: 80 bpm, T: 98.1F. The exam demonstrated the patient appeared healthy and well developed. His weight was stable. He can communicate normally. He had myalgia and the exam was normal. His right hip range of motion was normal. The patient was diagnosed with myalgia and myositis. The reporting physician considered the adverse events were most likely due to overexertion, however, doubt related to the vaccine. As of 17-JUL-2008, the patient adverse events persisted. The physician prescribed CELEBREX for the pain. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 70 year old male with asthma and a history of back surgery and with no known drug reactions/allergies, who on 02-FEB-2008 had an outbreak of shingles. The patient mentioned that it was a bad case on his right leg and he had severe nerve pain. On 25-MAR-2008, the patient was vaccinated with a single dose of ZOSTAVAX (route and administrating site not reported) at a hospital. Concomitant therapy included montelukast sodium (MSD) (dose, duration and indication not reported), AZMACORT, INTAL, AZOR, ADVICOR and allergenic extract. Thereafter, the patient had three separate episodes of shingles. On 19-MAY-2008, the patient developed shingles on his right arm and right side. On 02-JUL-2008, the patient had shingles in his right leg and on the right side of his nose and face. Subsequently, the patient fully recovered from all of these outbreaks of shingles. The patient sought unspecified medical attention. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old female with a history of Shingles who in October 2007, was vaccinated with ZOSTAVAX (Oka/Merck). In April 2008, the patient experienced Shingles outbreak 6 months after she was given ZOSTAVAX (Oka/Merck). The patient recovered from Shingles. The patient sought medical attention. Additional information has been request.
Age: 1.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who was vaccinated with ZOSTAVAX (lot no. not reported) instead of VARIVAX (Oka/Merck). No adverse event was reported. It is unknown if the patient sought medical attention. No additional information reported. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister, Lip ulceration, Mouth ulceration, Oral herpes
Clinical narrative: Information has been received from a consumer concerning her 85 year old mother with osteoporosis who on 21-SEP-2007 was vaccinated with ZOSTAVAX. Concomitant therapy included alendronate sodium, tablet (MSD). The consumer stated that in December 2007, her mother experienced a blister on her lip and ulceration on lip and roof of mouth after receiving ZOSTAVAX. The physician felt blister was a cold sore. In January 2008, the patient recovered. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Nausea, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Information has been received from a healthcare professional concerning a 62 year old female patient with no known allergies who on 10-JUL-2008 was vaccinated with ZOSTAVAX (Oka/Merck). The patient was being treated for "staph infection" at the time of vaccination. Concomitant therapy included tetracycline. Subsequently, on 13-JUL-2008 the patient developed nausea, dizziness and fatigue after vaccine administration. The patient's throat was sore and swollen. Medical attention was sought in the office. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information is available.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 64 year old male who on 02-NOV-2007 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck) SQ (lot# 658398/1087U). On 15-JUL-2008 the patient experienced Shingles. The patient was treated with VALTREX. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid oedema, Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a female with a history of cancer and Shingles and with no known drug reactions/allergies, who on 15-JUL-2008 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck) SQ. There was no concomitant medication. On 18-JUL-2008 the patient experienced redness at the injection site of the left upper arm and swelling of the left eyelids. The patient's redness at the injection site of the left upper arm and swelling of the left eyelids persisted. The patient sought medical attention by calling the pharmacy. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 28 year old female with environmental allergy and asthma who on 27-MAY-2008 was vaccinated with the first dose of VARIVAX (Oka/Merck), Lot # 657938/0848U, subcutaneous in her left arm, sometime between 1-6 pm. It was reported that the patient came to adult immunization clinic to get her second VARIVAX (Oka/Merck), but on 24-JUN-2008, she was given ZOSTAVAX (Oka/Merck), sometime between 1-4:30 pm, in error. When error was found 3 days later, on 27-JUN-2008, the patient was called and informed of same. The patient stated she had soreness at the site injection (relieved by MOTRIN), but otherwise had no other side effects. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site warmth
Clinical narrative: Information has been received from a 61 year old female consumer with cholesterol, blood pressure and penicillin allergy concerning herself who on 18-JUL-2008 was vaccinated with the first dose of ZOSTAVAX (Oka/Merck) into the arm. Concomitant therapy included an unspecified natural medicine for cholesterol and blood pressure. On 20-JUL-2008 the patient developed redness about the size of two quarters and also a bruise at the injection site. The site of injection was a little warm to the touch. At the time of this report, the patient's symptoms persisted. The patient did not seek medical attention. No further information is available.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician assistant concerning a 59 year old female with high blood pressure, high cholesterol, unidentified allergies, RAYNAUD'S disease and many unspecified drug allergies who on 07-JUL-2008 was vaccinated with a dose of ZOSTAVAX (LOT# 657675/0618U). Concomitant therapy included hydrochlorothiazide (manufacturer unknown), verapamil,
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a 70 year old female with hypothyroid and acid reflux and a history of drug reaction to unspecified flu shot who on 15-JUL-2008 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included SYNTHROID, NEXIUM and ACTONEL. On 16-JUL-2008, the patient developed soreness and lump on the injection site. On 21-JUL-2008, the patient
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) 0.65 ml SQ. The patient developed Shingles within 2 weeks of receiving the vaccination. The patient sought unspecified medical attention. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Polymerase chain reaction
Clinical narrative: Information has been received from a registered physician assistant concerning a 71 year old female with diabetes mellitus and a history of chickenpox when she was 10 years old, who on 23-OCT-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 652947/1212F) 0.5 ml subcutaneously in her left deltoid (start date also reported as 11-SEP-2006). Concomitant therapy included citalopram, LIPITOR, DIOVAN, and LEVOXYL. The physician assistant reported that on 16-JUL-2008, the patient developed a mild case of Shingles on the right side of her chest, 4-6 small lesions, R T7 distribution. There were no other systemic symptom and no rash at the injection site post vaccination. The patient was treated with VALTREX. On 23-JUL-2008, the patient had a vesicle specimen collection send to the laboratory (test results not provided). At the time of the report, the patient was recovering. The patient sought medical attention at the physician's office. Follow up information was received which reported the results of the CPR. The specimen was obtain from a vesicle lesion. VZV DNA and B-globin DNA was amplified. Interpretation: adequate specimen, wild type strain. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician's receptionist concerning her husband who was vaccinated with ZOSTAVAX. The receptionist at the physician's office reported her husband experienced injection site reaction after receiving the ZOSTAVAX. This report is one of two reports received from the same source. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Hyperaesthesia, Insomnia, Musculoskeletal pain
Clinical narrative: Information has been received from a physician concerning his 64 year old female employee with no known drug allergies and no pertinent medical history, who on 07-JUL-2008 was vaccinated subcutaneously with ZOSTAVAX (Lot # 659406/0298X) 0.65 mL, into her left upper arm. There was no concomitant therapy. On 15-JUL-2008, the patient developed pain in her left shoulder and then a painful red, papular rash that ran under her left axillary area and down her arm. There were no vesicles present, but there were 15+ patches that ran along the left C4, C5 dermatome. There was no fever. The patient also had nerve pain, loss of sleep, sensitivity to touch & cold air, burning and itching. The patient sought medical attention at the office. The patient was diagnosed as definitely having shingles and was treated with VALTREX. At the time of the report the patient was recovering. 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 was associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The sample was collected on 23-JUL-2008. The result was inadequate specimen, negative for B-globin and no strain I.D. This is one of several reports received from the same source. Standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Pruritus, Rash, Rash papular
Clinical narrative: Information has been received from a physician concerning his 64 year old female employee with no known drug allergies and no pertinent medical history, who on 07-JUL-2008 was vaccinated subcutaneously with ZOSTAVAX (Lot # 659406/0298X) 0.65 mL, into her left upper arm. There was no concomitant therapy. On 15-JUL-2008, the patient developed pain in her left shoulder and then a painful red, papular rash that ran under her left axillary area and down her arm. There were no vesicles present, but there were 15+ patches that ran along the left C4, C5 dermatome. There was no fever. The patient also had nerve pain, loss of sleep, sensitivity to touch & cold air, burning and itching. The patient sought medical attention at the office. The patient was diagnosed as definitely having shingles and was treated with VALTREX. At the time of the report the patient was recovering. 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 was associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The sample was collected on 23-JUL-2008. The result was inadequate specimen, negative for B-globin and no strain I.D. This is one of several reports received from the same source. Standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Viral test
Clinical narrative: Information has been received from a physician concerning his 64 year old female employee with no known drug allergies and no pertinent medical history, who on 07-JUL-2008 was vaccinated subcutaneously with ZOSTAVAX (Lot # 659406/0298X) 0.65 mL, into her left upper arm. There was no concomitant therapy. On 15-JUL-2008, the patient developed pain in her left shoulder and then a painful red, papular rash that ran under her left axillary area and down her arm. There were no vesicles present, but there were 15+ patches that ran along the left C4, C5 dermatome. There was no fever. The patient also had nerve pain, loss of sleep, sensitivity to touch & cold air, burning and itching. The patient sought medical attention at the office. The patient was diagnosed as definitely having shingles and was treated with VALTREX. At the time of the report the patient was recovering. 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 was associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The sample was collected on 23-JUL-2008. The result was inadequate specimen, negative for B-globin and no strain I.D. This is one of several reports received from the same source. Standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning an 88 year old female with hypertension who on 12-JAN-2007 was vaccinated with ZOSTAVAX. Concomitant therapy included VALTREX and cardiovascular medications. The pharmacist reported that approximately on 07-JUL-2008, the patient experienced shingles. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a consumer concerning his wife a 76 year old female with penicillin allergy and no other medical history who on 20-MAR-2008 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included other unspecified medication. On approximately 24-JUN-2008, the patient experienced tremendous pain on the right side of her head. It was reported that the pain was so bad that even when the patient put her hand near her head she had a lot of pain. The patient had seen her physician and had had a MRI done. It was also reported that the pain now was every day it came and went. The patient's tremendous pain on the right side of her head persisted. The reporter felt that tremendous pain on the right side of her head was definitely related to therapy with ZOSTAVAX. No product quality complaint was involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 71 year old female with a history of breast cancer who was recently vaccinated with a dose of ZOSTAVAX (Oka/Merck). There was no concomitant medication. About one week post vaccination the patient developed pain and went to the emergency room. The physician at the ER felt the pain might be caused by Shingles still in the prodromal stage. The patient was placed on an anti-viral medication and released. The patient was recovering from pain. No product quality complaint was involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Erythema, Feeling hot, Flushing
Clinical narrative: Information has been received from a 76 year old white female with osteoarthritis, osteopenia and hypothyroidism and allergic to meclofenamate who on 17-JUL-2008 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included LEVOXYL, alendronate sodium (MSD) and ADVIL. On 21-JUL-2008, the patient experienced hot flashes, flushed feeling without a fever. The patient's hot flashes persisted. The patient did not seek medical attention. No product quality complaint was involved. Follow up information was received which reported that on 23-JUL-2008, the patient had a office visit. The patient stated she received ZOSTAVAX last week on 17-JUL-2008, she stated she tolerated the injection well. Had no pain at the injection site and had no side effects until 21-JUL-2008, four days after the injection. She stated that in the morning her face felt like it was on fire. It was warm, slightly red, lasted no more than fifteen minutes, almost a stinging sensation. She had no other bodily symptoms. No difficulty breathing. She did not feel ill. No body aches. No urinary symptoms. She stated that night about six p.m. it happened again, seemed less severe. On 22-JUL-2008, same symptoms were less severe, and on 23-JUL-2008 about noontime, which was approximately three hours ago, she had it, lasted only a few minutes and was less severe. The patient was told that this was likely a transient reaction and should go away. The patient was having no other adverse side effects. Office visit indicated that the patient was a pleasant, well-developed, well-nourished seventy-six old female, no acute distress. Vital signs: Blood pressure 138178. Heart rate 72. Weight is 152. HEENT: Normocephalic, atraumatic. Sclerae and conjunctivae are clear. Bilateral ears are clear. Oropharyngeal area without erythema or exudates. NECK: No lymphadenopathy or thyromegaly. LUNGS: Clear to auscultation and percussion throughout. Respiratory effort is unlabored. CARDIAC: S1, S without murmur, rub or gallop. ABDOMEN: Benign. Extremities: Without edema. Follow-up information also contained the following adverse event: low back pain. Additional information has been requested. Follow-up information was received from a physician which reported that the patient had not had any firther episodes for two weeks.  The physician would report any further problems.  Additonal information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Hot flush, Pain
Clinical narrative: Information has been received from a 76 year old white female with osteoarthritis, osteopenia and hypothyroidism and allergic to meclofenamate who on 17-JUL-2008 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included LEVOXYL, alendronate sodium (MSD) and ADVIL. On 21-JUL-2008, the patient experienced hot flashes, flushed feeling without a fever. The patient's hot flashes persisted. The patient did not seek medical attention. No product quality complaint was involved. Follow up information was received which reported that on 23-JUL-2008, the patient had a office visit. The patient stated she received ZOSTAVAX last week on 17-JUL-2008, she stated she tolerated the injection well. Had no pain at the injection site and had no side effects until 21-JUL-2008, four days after the injection. She stated that in the morning her face felt like it was on fire. It was warm, slightly red, lasted no more than fifteen minutes, almost a stinging sensation. She had no other bodily symptoms. No difficulty breathing. She did not feel ill. No body aches. No urinary symptoms. She stated that night about six p.m. it happened again, seemed less severe. On 22-JUL-2008, same symptoms were less severe, and on 23-JUL-2008 about noontime, which was approximately three hours ago, she had it, lasted only a few minutes and was less severe. The patient was told that this was likely a transient reaction and should go away. The patient was having no other adverse side effects. Office visit indicated that the patient was a pleasant, well-developed, well-nourished seventy-six old female, no acute distress. Vital signs: Blood pressure 138178. Heart rate 72. Weight is 152. HEENT: Normocephalic, atraumatic. Sclerae and conjunctivae are clear. Bilateral ears are clear. Oropharyngeal area without erythema or exudates. NECK: No lymphadenopathy or thyromegaly. LUNGS: Clear to auscultation and percussion throughout. Respiratory effort is unlabored. CARDIAC: S1, S without murmur, rub or gallop. ABDOMEN: Benign. Extremities: Without edema. Follow-up information also contained the following adverse event: low back pain. Additional information has been requested. Follow-up information was received from a physician which reported that the patient had not had any firther episodes for two weeks.  The physician would report any further problems.  Additonal information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old female with allergy to hydrochlorothiazide who on 18-JUL-2008 was vaccinated with a 0.65 mL dose of ZOSTAVAX by subcutaneous injection (lot number and injection site not reported). Concomitant therapy included lisinopril (manufacturer unknown), calcium (unspecified) and baby aspirin. On 19-JUL-2008, the patient developed shingles like blisters on the injection site area. She had one 4 cm blister in the center with tiny blisters surrounding the center blister. The total reaction area is about 6 cm in diameter. The patient's event persisted. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Headache, Herpes zoster, Rash pustular, Visual acuity reduced
Clinical narrative: Information has been received from a 77 year old female with high blood pressure and no known allergies, who on 29-JAN-2008 was vaccinated with a first dose of ZOSTAVAX. On 11-JUL-2008, was vaccinated with a second dose of ZOSTAVAX. Concomitant therapy included NORVASC, TOPROL XL TABLETS and ZOLOFT. The patient reported that on 11-JUL-2008 she started to experience pain on her eye. Patient reported that the next day she was in agony and had a terrible pain coming down to her head. When the patient went to see her physician, the physician told her that she has shingles. Patient reported that right now, (23-JUL-2008) she can't see because of the pain in her eye and her eyelid has pustules. Patient noted that she doesn't have history of shingles prior to receiving ZOSTAVAX. The patient's adverse experiences persisted. No lab diagnostics were performed. The patient sought medical attention, she was seen in the physician office. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with ZOSTAVAX. The day after vaccination, the patient came back to the office and said the vaccination gave him/her shingles. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a female patient who was vaccinated with ZOSTAVAX. She reported that she experienced injection site reaction after receiving the ZOSTAVAX. This report is one of the two reports received from the same source. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 61 year old female with allergy to DEMEROL and influenza vaccine who on 10-JUL-2008 (also reported 11-JUL-2008) was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included MAXALT. On 22-JUL-2008, the patient developed a swollen, red and warm area about the size of a baseball on her left arm at the site of injection. The area burned and itched. The patient visited a pharmacist. No laboratory diagnostics studies were performed. At the time of report, the events persisted. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 24-JUL-2008 was vaccinated with a dose of ZOSTAVAX instead of VARIVAX. The nurse did not state this was a product confusion. Follow up information was received from R.N. indicated that this was a human error. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site papule, Injection site rash, Nausea
Clinical narrative: Information has been received from a pharmacist concerning a 80 year old female who on 21-JUL-2008 was vaccinated with ZOSTAVAX (lot # 659672/0294X) SC in the left arm at 1300. There was no illness at time of vaccination. The patient experienced a size of quarter red rash and little bump at the injection site on left arm for a week. The patient said that she usually got a rash with any vaccines but was concerned about the bump. The patient was also feeling nauseated for one week. On approximately 01-AUG-2008, the patient recovered from the rash at the injection site and bump at the injection site. The patient sought medical attention in pharmacy. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 54 years old white female patient with history of drug reaction/allergies to Sulfa and codeine, who on 21-JUL-2008 was vaccinated SC with a dose of ZOSTAVAX (Lot # 659673/0557X). Concomitant therapy included hydrocortisone. The pharmacist reported that the patient developed an injection site reaction after vaccination with ZOSTAVAX. The patient developed a large swelling and itching in a 2" X 3" area around the injection site. The patient sought medical attention, phone call. Follow-up information was received. The patient was concerned because swelling did not go down after 2 days. On application of cortisone ointment swelling went down. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an office manager concerning a 65 year old female who on 06-APR-2007 was vaccinated with ZOSTAVAX. The office manager reported that on 10-JUL-2008, the patient had a mild shingles outbreak. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Muscle spasms, Myalgia, Neuralgia, Pain in extremity
Clinical narrative: Information has been received from an 81 year old female with type 2 diabetes mellitus, chronic obstructive pulmonary disease and carpal tunnel syndrome in both hands and no drug reactions or allergies who on 18-DEC-2007 was vaccinated with a single dose of ZOSTAVAX. Concomitant therapy included glyburide and metformin. "Approximately two months after receiving ZOSTAVAX," in February 2008, the patient began to experience both muscle pain and nerve pain in various parts of her body. The pain began in her right arm and then she had a Charlie horse type of pain in her right calf. She also had pain and soreness on her hip and in both arms. At the time of the report, the patient's muscle pain and nerve pain persisted. Unspecified medical attention was sought. No further information is available.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site irritation
Clinical narrative: Information has been received from a pharmacist concerning a 49 year old male with a history of five episodes of Shingles who on 25-JUL-2008, was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 659672/0294X) SQ into his left arm. Concomitant therapy included other unspecified medications. On 25-JUL-2008, the patient told the pharmacist he had burning in the left arm. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Rash erythematous, Skin lesion
Clinical narrative: Information has been received from a consumer concerning to his 74 years old wife with osteopenia and cholesterol who on 10-JUL-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included generic alendronate sodium (manufacturer unknown) and lovastatin (manufacturer unknown). On 21-JUL-2008, the patient experienced excruciating, terrible head pain and sores from the nape of her heck to the crown of her head, on 1 side. The sores were "small, pink and rounded." The consumer and patient suspected it was shingles. Physician prescribed VALTREX. The patient went to the ER on Wednesday 30-JUL-2008. The patient sought medical attention at the emergency room. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male who on 23-JUL-2008 was vaccinated with ZOSTAVAX (Oka/Merck) instead of the second dose of VARIVAX. No adverse reaction noted. Follow information received from the nurse indicated that she did not administer the vaccine. She indicated that this was human error as the nurse administering the vaccine did not read the label. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Secondary transmission
Clinical narrative: Information has been received from a nurse practitioner concerning a nurse developed Shingles (unspecified time frame) after administering ZOSTAVAX (Oka/Merck) to an unspecified number of patient's over past several months (dates unspecified). The staff nurse developed a facial rash that was evaluated by an unspecified physician and an ophthalmologist. The staff nurse thought the shingles was transmitted from handling and administering the ZOSTAVAX vaccine (Merck) to patients. No other symptoms or treatment reported. The staff nurse's lesions had completed resolved and she had recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2008. Additional information is not expected.