chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Dermatitis contact, Rash papular, Skin hyperpigmentation
Clinical narrative: This is in follow-up to report(s) previously submitted on 12/23/2008. Information has been received form a 69 year old female with no known allergies a history of body aches while on pravastatin who on 16-SEP-2008 was vaccinated with ZOSTAVAX (Merck) 0.65ml. Concomitant therapy included vitamins (unspecified), calcium (unspecified), fish oil and niacin. The patient reported that "5 days ago" on 25-SEP-2008 she experienced poison ivy on wrist after receiving ZOSTAVAX (Merck). Patient also stated that she was given a steroid shot (manufacturer unknown) on the 29-AUG-2008. The physician reported that on 07-SEP-2008, on exam she had hyperpigmentation and resolving papules consistent with a contact dermatitis. No lab diagnostics were performed. The patient's poison ivy persisted. The patient sought unspecified medical attention. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received form a registered nurse concerning a 60 year old male who on 3-JUL-2008 was vaccinated with ZOSTER and "5 to 6 weeks later" on approximately 6-AUG-2008 the patient called the office because he had 3 very tiny bumps on his face. The patient was diagnosed of a mild case of shingles by a physician. On an unspecified date the patient recovered from mild case of shingles. The patient sought unspecified medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Oral herpes, Pain, Skin test negative
Clinical narrative: Initial and follow up information has been received from a 65 year old female with allergic reaction to tetracycline, ampicillin, KEFLEX, REGLAN, NIZORAL, NEURONTIN, oesophageal acid reflux and arthritis who on 29-JAN-2007 was vaccinated with ZOSTER SC on left arm (lot no. not reported). Concomitant therapy included PROTONIX and CELEBREX. On 13-DEC-2007 the patient experienced painful cold sore on upper lip. On 2 occasions she developed painful blisters on her buttocks. First time was 7-FEB-2008. Second time was on 12-JUL-2008. She was prescribed VALTREX for these event's for 5 days and recovered with 1 week after all events. All events occurred after she received the vaccine. Skin tests were negative. In office visit of 21-JUL-08, no lesions noted, but patient had a cold sore present for "a long time" till treated with VALTREX for 5 days. She recovered from cold sore on 28-JUL-2008. Family physician did not feel any of these events are related to therapy with ZOSTER. No further information is available.
Age: 78.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a pharmacist concerning a patient who on an unknown date was vaccinated with ZOSTER . The pharmacists reported that on an unknown date the patient developed a rash and shingles after vaccination with ZOSTER. The pharmacist reported that the patient was the friend of the friend of other patient. The person who developed shingles was "very ill for 3 months". No further information is available. Information has been received from a pharmacist concerning a 71 years old male patient who on 21-SEP-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) abdominal, intramuscularly. Concomitant medication includes a 13th dose of influenza virus vaccine (Glaxosmithkline), intramuscularly int o the left deltoid on 23-SEP-2008. The pharmacist reported that on 24-SEP-2008 the patient developed a rash and shingles after vaccination with ZOSTAVAX. The pharmacist reported that the patient was the friend of the friend of other patient. The person who developed shingles was "very ill for 3 months". Follow-up information received on 08-JAN-2009 stated that the patient developed localized breakout of rash and shingles with discoloration of skin. The patient recovered in 10 - to 14 days. The recovery date was reported to be 14-OCT-2008. No further information is available.
Age: 78.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Headache, Injection site erythema, Injection site haematoma, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a patient who on an unknown date was vaccinated with ZOSTER . The pharmacists reported that on an unknown date the patient developed a rash and shingles after vaccination with ZOSTER. The pharmacist reported that the patient was the friend of the friend of other patient. The person who developed shingles was "very ill for 3 months". No further information is available. Information has been received from a pharmacist concerning a 71 years old male patient who on 21-SEP-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) abdominal, intramuscularly. Concomitant medication includes a 13th dose of influenza virus vaccine (Glaxosmithkline), intramuscularly int o the left deltoid on 23-SEP-2008. The pharmacist reported that on 24-SEP-2008 the patient developed a rash and shingles after vaccination with ZOSTAVAX. The pharmacist reported that the patient was the friend of the friend of other patient. The person who developed shingles was "very ill for 3 months". Follow-up information received on 08-JAN-2009 stated that the patient developed localized breakout of rash and shingles with discoloration of skin. The patient recovered in 10 - to 14 days. The recovery date was reported to be 14-OCT-2008. No further information is available.
Age: 78.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old female with no known allergies, and an unknown eye disorder who on 23-SEP-2008, was vaccinated with ZOSTER vaccine subcutaneously in her abdomen. Concomitant therapy included influenza virus vaccine (unspecified). The pharmacist reported that on 24-SEP-2008, the patient developed an injection site reaction after receiving ZOSTER vaccine. The injection site looked red, bruised and painful to the touch, The site was the size of a quarter. The patient had also had a headache. The pharmacists reported that the patient's physician recommended TYLENOL as treatment. The patient called doctor's office. At the time of the report the patient had not recovered. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Headache, Injection site erythema, Injection site haematoma, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old female with no known allergies, and an unknown eye disorder who on 23-SEP-2008, was vaccinated with ZOSTER vaccine subcutaneously in her abdomen. Concomitant therapy included influenza virus vaccine (unspecified). The pharmacist reported that on 24-SEP-2008, the patient developed an injection site reaction after receiving ZOSTER vaccine. The injection site looked red, bruised and painful to the touch, The site was the size of a quarter. The patient had also had a headache. The pharmacists reported that the patient's physician recommended TYLENOL as treatment. The patient called doctor's office. At the time of the report the patient had not recovered. Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a 47 year old female nurse got splashed on her hand with ZOSTAVAX (Merck) solution while she was withdrawing a syringe from the vial. On 21-SEP-2008 the nurse developed shingles rash on her right side of her back. The nurse's shingles persisted. No further information is available. The medical attention was sought by the patient. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a female patient in her 70's who were vaccinated subcutaneously with ZOSTAVAX (Merck) and developed shingles after receiving the vaccine. This is one of two reports from the same source. No further information is available.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Initial and follow up information has been received from a physician concerning a 80 years old female patient with diabetes type II, who on an unknown date at private doctor's office/hospital was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included PREDNISONE (manufactured unknown). The physician reported that the patient experienced herpes zoster (shingles) on 17-SEP-2008. On 01-OCT-2007, the patient recovered it, reported that the physician's office does not carry the vaccine but they give the vaccine if brought to them. There were no lab diagnostic studies performed. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pruritus
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 63 year old white female who in January 2008 was vaccinated with a dose of ZOSTAVAX (Merck) SQ.  Subsequently the patient had a mild case of shingles in August 2008, 7 months after the vaccine was given.  It was also reported that on 15-AUG-2008, the patient had pain on left back (trunk).  The pain was mild to moderate.  The patient was most concerned when couldn't determine what problem was.  The patient recovered from shingles.  The patient recovered from the pain on left back (trunk) on 15-SEP-2008.  In further follow-up, the patient reported that her pain on left back (trunk) had an onset date on 05-AUG-2008.  It was also reported that the patient was treated with famciclovir 500 mg and MOBIC "7.5" for pain.  The patient reported that on 05-AUG-2008 she also experienced a major itching on stomach.  The patient also reported that her rash didn't occur at the site of injection.  She assessed her pain as 4 (10 as the most painful).  The patient had a history of chickenpox in 1953 and had not been exposed recently to herpes zoster.  No additional information is expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Micturition urgency, Oropharyngeal blistering, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old female pacemaker user with mild pulmonary hypertension and tachycardia after taking antihistamines and a history of lateral mastectomy with chemo completed on October 2006 who on 10-SEP-2008 was vaccinated with ZOSTAVAX (Merck) (lot # reported as 659326/1824U) subcutaneously in right arm.  Concomitant therapy included RYTHMOL, CARDIOL, LASIX, K-LOR, ATACAND, MSD, CELEXA, FEMARA, and ZITHROMAX.  On 14-SEP-2008.  The patient experienced urinary urgency with itching and then found a patch of blisters in the buttock and vaginal regions (also reported by the patient as shingles or chickenpox).  The patient was taking ZITHROMAX for a sinus infection and thought the itching was related to antibiotic use.  The patient contacted the physician on 17-SEP-2008 and a culture of the lesions was performed.  Then she returned to the physician on 19-Sep-2008 and was placed on FAMCICLOVIR 500 mg three times a day.  The patient is reporting continued zoster at the original location and blisters in the mouth at the time of the report.  Follow-up information was received from the nurse who reported that she was not interested in VZV analysis by polymerase chain reaction (PCR), but the physician may be interested.  The nurse was going to provide information to the physician about the VZV program.  This is a consolidation of two reports concerning the same patient.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Virus culture
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old female pacemaker user with mild pulmonary hypertension and tachycardia after taking antihistamines and a history of lateral mastectomy with chemo completed on October 2006 who on 10-SEP-2008 was vaccinated with ZOSTAVAX (Merck) (lot # reported as 659326/1824U) subcutaneously in right arm.  Concomitant therapy included RYTHMOL, CARDIOL, LASIX, K-LOR, ATACAND, MSD, CELEXA, FEMARA, and ZITHROMAX.  On 14-SEP-2008.  The patient experienced urinary urgency with itching and then found a patch of blisters in the buttock and vaginal regions (also reported by the patient as shingles or chickenpox).  The patient was taking ZITHROMAX for a sinus infection and thought the itching was related to antibiotic use.  The patient contacted the physician on 17-SEP-2008 and a culture of the lesions was performed.  Then she returned to the physician on 19-Sep-2008 and was placed on FAMCICLOVIR 500 mg three times a day.  The patient is reporting continued zoster at the original location and blisters in the mouth at the time of the report.  Follow-up information was received from the nurse who reported that she was not interested in VZV analysis by polymerase chain reaction (PCR), but the physician may be interested.  The nurse was going to provide information to the physician about the VZV program.  This is a consolidation of two reports concerning the same patient.  Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Inappropriate schedule of drug administration, Laboratory test, Pain, Thyroid function test
Clinical narrative: Information has been received from a physician concerning a 54 year old female with hypersensitivity to sulfa, steroids, KLONOPIN, NSAIDS and a history of arthritis who on 03-May-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included CELEBREX, Allopurinol, ABILIFY, Lithium Acetate and Liotrix. On approximately 12-May-2008 the patient reported she experienced left foot numbness that spread to the rest of her body, Burning pain when wearing clothing and jewelry The patient had "Thyroid test ", "Blood work" and the result was not reported. The numbness and the burning pain when wearing jewelry persisted. The patient sought medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old female with no known drug reactions or allergies who on 17-SEP-2008 was vaccinated with a dose of ZOSTAVAX (Merck).  On 18-SEP-2008 the patient's arm was red, sore, itchy, and hot at the injection site.  The patient sought medical attention at the office and was treated with ice.  At time of reporting, the patient had not recovered.  This is one of two reports from the same source.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a 62 year old female physician who 2 years ago, approximately in September 2006, was vaccinated with ZOSTAVAX 0.65mL and about a year later, approximately in September 2007, she had a rash on hands and feet with vesicles that do not follow a pattern or dermatome. The episodes are sporadic lasting for undisclosed period of time. The rash the reoccurs from time to time. At time of reporting, the patient had no rash or lesions. There were no lab diagnostics studies performed. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Stomatitis
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 61 year old female patient with a history of sores which lasted for about 6 months, then resolved and later reappeared, who on 17-SEP-2008 was vaccinated with a first dose of ZOSTAVAX (Merck).  On 18-SEP-2008, on the next day, the dentist noticed a white sore in her mouth.  Neither the dentist nor the pharmacist felt this related to the vaccine.  The dentist ordered VALTREX.  This pharmacist stated that the sore in his mouth was prior to receiving ZOSTAVAX (Merck).  The patient had not taken the VALTREX yet.  Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female with no pertinent medical history or drug reaction/allergies, who on 17-JUL-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 659673/0557X) S.Q. into the right arm.  There was no concomitant medication.  On 24-JUL-2008, the patient developed a non-raised, red, linear rash on her right leg from her ankle to thigh after vaccination.  The pharmacist might be interested in VARICELLA ZOSTER virus analysis by PCR.  The patient sought medical attention via pharmacist.  No laboratory diagnostic studies were performed.  Subsequently, the patient recovered from the non-raised, red, linear rash.  This is in follow-up to report(s) previously submitted on 12/23/2008.  Follow up information was received from a pharmacist who reported that "after the patient received ZOSTAVAX (Merck).  The patient developed a rash down her leg" on 24-JUL-2008.  No further information was reported.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic, Pain
Clinical narrative: Information has been received from a physician concerning an 80 year old female who in January 2008, was vaccinated with ZOSTAVAX (Merck), and a few weeks ago she presented with ophthalmic zoster.  At the time of this report, the patient was recovering. The patient sought medical attention in the physician's office.  Follow up information has been received concerning the female patient with Penicillin allergy who on 30-JAN-2008 at 12:00 PM, was vaccinated in the physician's office with the first dose of ZOSTAVAX (Merck) (Lot # 658210/1079U), subcutaneously, under the left arm.  On 09-SEP-2008, the patient developed pain and typical lesions of ZOSTER but not lesions that could be swabbed for viral culture.  The patient experience required an ER/doctor visit.  Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Nerve injury
Clinical narrative: Information has been received from a 82 year old female patient with diabetes, penicillin and TOPROL allergies, who on 17-MAR-2008, was vaccinated with a dose of ZOSTAVAX (Merck) S.Q. into the left arm.  Concomitant therapy included insulin.  The patient received the vaccine while she already had shingles and shortly after on 17-MAR-2008, her shingles worsened.  She had experienced severe nerve damage.  The patient's shingles and severe nerve damage persisted.  The patient sought unspecified medical attention.  No further information is expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin necrosis
Clinical narrative: Information has been received from a physician concerning a 68 year old female who was vaccinated with ZOSTAVAX (Merck) (lot # not reported).  Concomitant therapy included doxycycline hyclate.  On 04-AUG-2008 the patient developed necrosis of the skin.  Subsequently, the patient recovered from necrosis of the skin.  The patient sought medical attention.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician and a 76 year old female retired registered nurse with chronic obstructive pulmonary disease and drug hypersensitivity to codeine and aspirin who on 27-Feb-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 659324/1835U) SQ in her left deltoid.  Concomitant therapy included MAXZIDE, SPIRIVA, ADVAIR, vitamins (unspecified) and LIPITOR.  On an unspecified date the LIPITOR was discontinued for liver function abnormal.  On 11-SEP-2008 the patient developed shingles (nonspecified rash on left leg, possible shingles).  The rash developed around the knee.  The patient was examined by the physician on 12-SEP-2008 and was prescribed FAMVIR and MEDROL dose pack.  The patient was seen by the physician on 16-SEP-2008, it was documented that the patient's rash had decreased.  The patient had a follow-up visit schedule for 19-DEC-2008.  Follow-up information was received from an office manager.  The patient was not exposed to chickenpox.  The patient did not have a direct fluorescent antibody drawn and the patient did not have a specimen collected for PCR.  It was reported that the patient did not have a biopsy.  It was reported that the patient's rash decreased after four days.  Subsequently, the patient recovered from the shingles.  The outcome of liver function abnormal was not reported.  Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration, Pain, Ultrasound scan
Clinical narrative: Information has been received from a physician concerning a 75 year old female who on 28-MAY-2008 was vaccinated with ZOSTAVAX (Merck) (lot #659325/1823U) via IM into her right deltoid.  On 09-SEP-2008 the patient experienced prodromal pain followed by a shingles rash on her lower abdomen.  An ultrasound was performed (results not provided).  As of the reporting date, the patient was recovering.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Heat rash, Rash erythematous
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning her 69 year old husband with no pertinent medical history or allergies who in late June 2008, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (lot #659409/0409X) which has been stored in the freezer in their home for about one month before it was reconstituted and given.  The freezer temperature was minus 12 degree Fahrenheit.  About a week later, the patient developed a mild, red rash and "heat" rash across his shoulders.  Unspecified medical attention was sought and no laboratory or diagnostics tests were performed.  The rash resolved in less than a week.  Follow up information was received from the R.N. who reported that her husband who at 9 AM of 12-JUL-2008 was vaccinated subcutaneously with a first dose of ZOSTAVAX (Merck) in his right arm.  There was no illness at the time of the vaccination.  Additional information has been requested.  This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacy student concerning a female patient who in March 2008 ("6 months ago") received a dose of ZOSTAVAX (Merck) (lot number, route and injection site not reported).  On approximately 09-SEP-2008 ("within the past week"), 6 months after the vaccination, the patient developed "a zoster rash on her right side mid-section".  The patient sought medical attention via telephone.  At the time of reporting, she was not recovered from the event.  Follow-up information has been received from a questionnaire concerning the patient, a 79-year-old female who has a history of allergy to penicillin.  She received a dose of ZOSTAVAX (Merck) via subcutaneous route in her right arm on 14-JAN-2008 (previously reported as in March).  No rash occurred  the site of injection or elsewhere within 42 days of the vaccination.  Around 09-SEP-2008, she developed "a zoster rash on her right side mid-section".   Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a nurse, via a company representative, concerning herself, a 61-year-old female, who on an unspecified date received a dose of ZOSTAVAX (Merck) (lot number, route and injection site not reported) for shingles prevention from her primary care physician (information not provided).  Subsequently, she developed itching at the injection site for 3 weeks.  The patient sought unspecified medical attention and recovered on an unknown date.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Information has received from a physician concerning a patient who on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Merck) for the prevention of shingles.  The physician reported that on an unknown date, the patient experienced "flu-like symptoms" after receiving the zoster vaccine.  The patient sought unspecified medical attention.  Outcome was not reported.   Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Inappropriate schedule of drug administration, Pruritus
Clinical narrative: Information has been received from a nurse concerning a 45 year old male who on 09-SEP-2008 was vaccinated with ZOSTAVAX (Merck).  There was no concomitant medication.  On 11-SEP-2008, two days after receiving vaccine, the patient developed shingles.  The patient sought medical attention as an office visit.  He reported that the outbreak was minimal with no pain and only itching.  The duration of the blister like rash was "a couple of days" and only a red spot described as centimeter in length remains at the rash site (right lower back).  No other symptoms or treatment reported.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Carpal tunnel syndrome, Myalgia, Nerve conduction studies abnormal, Neurological examination abnormal
Clinical narrative: Information has been received from a nurse concerning a 76 year old female with cholesterol high, hypertension, ventricular tachycardia, sinus tachycardia and urticaria chronic and a history of unspecified allergies to ACE inhibitors, sulfa, PROCARDIA and Rofecoxib (MSD, WAES # 0809USA03423) who on 25-FEB-2008 was vaccinated with ZOSTAVAX (Merck) (Lot # 659323/1613U) via SC route.  Concomitant therapy included INNOPRAN, simvastatin (MSD), and MICARDIS.  On 09-APR-2008, the patient visited the physician's office and stated that she had pain in her left arm since receiving the vaccine and her shoulder burns if she lays on her left side.  Point of tenderness at deltoid, treated with steroid injection for tendonitis and nerve palsy radial.  She stated injection did not help.  On 30-JUL-2008 she was seen stating she had deltoid muscle pain with some pain with reduction resistance.  Radial nerve conduction test and appointment with neurologist on 25-AUG-2008 showed mild bilateral carpal tunnel syndrome, more on right than left, with slightly prolonged latencies on right.  Patient called office on 04-SEP-2008 stating the pain is continuing.  Started on CELEBREX for 7 days and MEDROL dose pack.  Referred to orthopedist and had appointment on 06-AUG-2008, no report received, and another appointment for 17-SEP-2008.   Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Radial nerve palsy, Tenderness, Tendonitis
Clinical narrative: Information has been received from a nurse concerning a 76 year old female with cholesterol high, hypertension, ventricular tachycardia, sinus tachycardia and urticaria chronic and a history of unspecified allergies to ACE inhibitors, sulfa, PROCARDIA and Rofecoxib (MSD, WAES # 0809USA03423) who on 25-FEB-2008 was vaccinated with ZOSTAVAX (Merck) (Lot # 659323/1613U) via SC route.  Concomitant therapy included INNOPRAN, simvastatin (MSD), and MICARDIS.  On 09-APR-2008, the patient visited the physician's office and stated that she had pain in her left arm since receiving the vaccine and her shoulder burns if she lays on her left side.  Point of tenderness at deltoid, treated with steroid injection for tendonitis and nerve palsy radial.  She stated injection did not help.  On 30-JUL-2008 she was seen stating she had deltoid muscle pain with some pain with reduction resistance.  Radial nerve conduction test and appointment with neurologist on 25-AUG-2008 showed mild bilateral carpal tunnel syndrome, more on right than left, with slightly prolonged latencies on right.  Patient called office on 04-SEP-2008 stating the pain is continuing.  Started on CELEBREX for 7 days and MEDROL dose pack.  Referred to orthopedist and had appointment on 06-AUG-2008, no report received, and another appointment for 17-SEP-2008.   Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Endotracheal intubation, Life support, Syncope
Clinical narrative: Information has been received from a consumer concerning a 66 year old female friend who in end of May or early June 2008, was vaccinated with single dose of ZOSTAVAX (Merck).  Concomitant therapy included blood pressure medication, antidepressant and high cholesterol medications which the names were unspecified by reporter.  During the first couple days of September 2008, the patient collapsed and emergency medical technician (EMT) was called.  The patient was taken to hospital.  At the hospital they had to intabate her and she was put on life support.  The patient was on hospital for about a week and she was home and doing better (recovering).  The patient was not diagnosed with anything at the time she was at the hospital.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a consumer concerning her husband who on approximately 23-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Merck).  The consumer reported that her husband experienced some slight swelling and itching on his arm.  At the time of reporting, the outcome of the patient was unknown.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 66 years old male, with no illness at time of vaccination, with gout, hypertension and hypercholesterolaemia and a history of chickenpox who on 22-FEB 2008, was vaccinated with a first dose of 0.65 ml of ZOSTAVAX (Merck) (lot no 659267/1836U) IM, into the left arm.  Concomitant therapy included LIPITOR, allopurinol, DYAZIDE (also reported as MAXZIDE), aspirin and sotolol.  On 29-AUG-2008, the patient developed shingles on left mid thorax.  The number of lesions was unknown.  There was no rash at the site of elsewhere within 42 days of the vaccination.  The patient had no recent exposure to chickenpox or herpes zoster.  Two weeks after the onset date of the event adverse, on approximately, 12-SEP-2008, the patient recovered from shingles.  The patient was seen by physician and sought unspecified medical attention.  A specimen was not collected for PCR.  No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Stomach discomfort
Clinical narrative: Information has been received from a male who in December 2007, was vaccinated with ZOSTAVAX (Merck) (lot no., route, injection site not reported).  Shortly after the vaccination, on the same day, the patient experienced upset stomach.  The patient did not seek medical attention.  No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Clumsiness, Herpes zoster, Incorrect route of drug administration, Pain
Clinical narrative: Information has been received from physician concerning a 65 year old female who on 20-Aug-2008 was vaccinated with ZOSTAVAX (lot#659407/0295X) via IM into her left deltoid. On 01-Sep-2008 the patient also experienced prodromal pain followed by a shingles rash. The patient also experienced  "clumsiness" on her left side especially in the use of her hand. The patient sought unspecified medical attention. As of the reporting date, the patient
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Headache, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a pharmacist and follow up information from a physician concerning a patient who received ZOSTAVAX and "broke out with full blown VZV". The physician stated that a 72 year old male patient with Lisinopril (manufacturer not reported) hypersensitivity and hypertension was vaccinated with ZOSTAVAX (lot #658859/0411X) in his left arm on 05-SEP-2008. Concomitant therapy included clonidine, simvastain (MSD), hydrochlorothiazide (+) Metoprolol Succinate, Omeprazole and Oxbutynin. 2 days after the vaccination, the patient experienced "small blisters" on his forearm and lower abdomen. The physician also stated that the patient experienced a headache and fatigue, but the patient was afebrile. The physician also stated that the patient's rash "looks like shingles". The symptoms were ongoing at the time of the report In follow up the physician also described the event as a rash with vesicular lesions occurring 3 days after vaccination. The patient had not had recent exposure to chickenpox or shingles. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 12-SEP-2008. The sample was taken from a vesicular lesion. The PCR result for the specimen was inadequate specimen no strain identified. No further information is available.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Viral test
Clinical narrative: Information has been received from a pharmacist and follow up information from a physician concerning a patient who received ZOSTAVAX and "broke out with full blown VZV". The physician stated that a 72 year old male patient with Lisinopril (manufacturer not reported) hypersensitivity and hypertension was vaccinated with ZOSTAVAX (lot #658859/0411X) in his left arm on 05-SEP-2008. Concomitant therapy included clonidine, simvastain (MSD), hydrochlorothiazide (+) Metoprolol Succinate, Omeprazole and Oxbutynin. 2 days after the vaccination, the patient experienced "small blisters" on his forearm and lower abdomen. The physician also stated that the patient experienced a headache and fatigue, but the patient was afebrile. The physician also stated that the patient's rash "looks like shingles". The symptoms were ongoing at the time of the report In follow up the physician also described the event as a rash with vesicular lesions occurring 3 days after vaccination. The patient had not had recent exposure to chickenpox or shingles. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 12-SEP-2008. The sample was taken from a vesicular lesion. The PCR result for the specimen was inadequate specimen no strain identified. No further information is available.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Pain
Clinical narrative: Information has been received from a 75 year old female patient with blood cholesterol abnormal who in April or May 2007 was vaccinated with ZOSTAVAX. On 26-AUG-2008, the patient developed shingles on her upper right corner of her face. Routine lab tests were done, but results not reported. The pain and rash was healed about 10 days after her diagnoses. No further information was provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Ear pain
Clinical narrative: Information has been received from a physician concerning a 68 year old female with breast cancer (2006) and rhinitis allergic and a history of deep vein thrombosis (resolved), pulmonary embolism, benign brain stem tumor, gastroesophageal, reflux disease, pancreatitis, peptic ulcer disease, benign pulmonary nodule and kidney surgery for a benign tumor who in June 2008, was vaccinated with ZOSTAVAX (lot #659267/1836U). Concomitant therapy included Astelin, Coumadin, Flonase, Lovastatin and Tamoxifan Citrate. Three weeks later she developed dizziness and left ear pain. The patient has been following up with a neurologist and an otolaryngologist (the reporting physician had not received dictation reports from these physicians). The patient had been placed on Amoxicillin (+) Augmentin and was beginning to show improvement. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Information has been received from the wife concerning her husband (age not reported) who on 20-AUG-2007 (also reported as 16-AUG-2007) was vaccinated with a dose of ZOSTAVAX. On approximately 22-AUG-2007, the patient experienced headaches, dizziness and fatigue. The patient began to feel better after a few days. The patient's wife also experienced adverse events after receiving ZOSTAVAX. (WAES# 0808USA04947). No further information is available.
Age: 78.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Abdominal pain, Blood bilirubin increased, Cholelithiasis, Hepatitis A antibody negative, Hepatitis B test negative
Clinical narrative: Initial and follow-up information has been received from a retired nurse and a physician, concerning the retired nurse, a 78 year old female with hypertension, who on approximately 13-Mar-2008 or 14-Mar-2008 was vaccinated subcutaneously with 0.65ml dose of ZOSTAVAX. Concomitant therapy included diphtheria toxoid and pertussis whole cell vaccine and tetanus toxoid. The physician reported that on 13-March-2008 for annual exam, the patient received the prescription for the ZOSTAVAX but it was administered elsewhere. Laboratory tests showed that she had increased Bilirubin. However, hepatitis A, B, C has been ruled out. On 04-Jul-2008, the patient was diagnosed with gall stones. On 29-July-2008, the patient was seen by doctor. She had abdominal pain and jaundice. Tests revealed increased liver function tests. gallstones and dilated bile duct. A surgery for her was pending. At the time of reporting, her gall stones persisted. The patient herself did not report to PCP any adverse reaction to ZOSTAVAX. No further information is available.
Age: 78.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Hepatitis C test negative, Jaundice, Liver function test abnormal
Clinical narrative: Initial and follow-up information has been received from a retired nurse and a physician, concerning the retired nurse, a 78 year old female with hypertension, who on approximately 13-Mar-2008 or 14-Mar-2008 was vaccinated subcutaneously with 0.65ml dose of ZOSTAVAX. Concomitant therapy included diphtheria toxoid and pertussis whole cell vaccine and tetanus toxoid. The physician reported that on 13-March-2008 for annual exam, the patient received the prescription for the ZOSTAVAX but it was administered elsewhere. Laboratory tests showed that she had increased Bilirubin. However, hepatitis A, B, C has been ruled out. On 04-Jul-2008, the patient was diagnosed with gall stones. On 29-July-2008, the patient was seen by doctor. She had abdominal pain and jaundice. Tests revealed increased liver function tests. gallstones and dilated bile duct. A surgery for her was pending. At the time of reporting, her gall stones persisted. The patient herself did not report to PCP any adverse reaction to ZOSTAVAX. No further information is available.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic, Vaccination failure
Clinical narrative: Information has been received from a physician concerning a 88 year old male patient with many chronic health issues, who in January 2007 was vaccinated with ZOSTER vaccine, In September 2008 the patient had a case of shingles around his eye. The patient was started on treatment and seen by opthomologist. The physician was not interested in obtaining specimen and was not interested in being contacted. The reporting physician reported that shingles had nothing to do with ZOSTER vaccine the vaccine just did not work. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Colonoscopy normal, Computerised tomogram normal, Dysphagia, Eating disorder
Clinical narrative: Information has been received from a 70 year old female with sciatica and no drug reactions/allergies, "approximately 1.5 months ago" was vaccinated with one dose of ZOSTAVAX. Concomitant medication included Montelukast sodium (MSD), ALprazolam, Nexium, and Gabapentin. Approximately one week after receiving ZOSTAVAX, she initially developed ulcer sores in her mouth. Subsequently, these sores spread to her throat as well. Also, she has had difficulty eating and swallowing food and every time she eats she experiences nausea. Since all this began, she has lost 17 lbs. She said that she has had a colonoscopy, a CAT scan, and blood tests but all of the test results have come back normal. As of the reporting date, the events have not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Mouth ulceration, Nausea, Throat lesion, Weight decreased
Clinical narrative: Information has been received from a 70 year old female with sciatica and no drug reactions/allergies, "approximately 1.5 months ago" was vaccinated with one dose of ZOSTAVAX. Concomitant medication included Montelukast sodium (MSD), ALprazolam, Nexium, and Gabapentin. Approximately one week after receiving ZOSTAVAX, she initially developed ulcer sores in her mouth. Subsequently, these sores spread to her throat as well. Also, she has had difficulty eating and swallowing food and every time she eats she experiences nausea. Since all this began, she has lost 17 lbs. She said that she has had a colonoscopy, a CAT scan, and blood tests but all of the test results have come back normal. As of the reporting date, the events have not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from a physician concerning a less than 60 year old patient who was vaccinated with a dose of ZOSTERVAX. The patient had remission of genital herpes outbreaks. No medical attention was sought and no laboratory or diagnostics tests where preformed. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site inflammation, Wrong technique in drug usage process
Clinical narrative: Information has been received from a pharmacist concerning a male who on 10-Sept-2008, was vaccinated with one dose of ZOSTAVAX that was inadvertently reconstituted with PNEUMOVAX. On 12-Sep-2008, follow-up information was received from the pharmacist who reported that the patient experienced mild inflammation at the injection site. The patient's inflammation had improved. It was unknown if the patient sought medical attention. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Antibody test abnormal
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX . Subsequently the patient had "low titers." No adverse reactions" were reported by the physician. Follow up information was received from the physician who indicated that he did not have any further information and he could not remember who called for a consult as he got 3-7 consults per day by the phone. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning his wife who participated in an unspecified study for ZOSTAVAX on an unspecified date.  At first the patient received a placebo and later she was administered the actual ZOSTAVAX.  A year after that she developed a mild case of shingles.  The shingles went away after about 3 days.  It was not reported if the patient sought medical attention.  No further information is available
Sex: U
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from a physician concerning a less than 60 year old patient who was vaccinated with a dose of ZOSTAVAX. The patient had remission of genital herpes outbreaks. No medical attention was sought and no laboratory or diagnostic tests were performed. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Herpes zoster, Influenza like illness, Pain
Clinical narrative: Information has been received from a consumer concerning an "around 60 year old" female who was vaccinated with ZOSTAVAX (Merck) "single dose of series".  After receiving ZOSTAVAX (Merck) the patient came down with flu like symptoms, was very achy, very fatigue and had developed blisters on her back side.  The patient was diagnosed with shingles.  The patient's shingles persisted.  No further information is available. This is in follow-up report(s) previously submitted on 12/23/2008. Follow-up information was received from the consumer. The consumer reported the patient was also a nurse who in approximately December 2006 "about two year ago" received ZOSTAVAX (Merck) and then in approximately September 2008, "about two or three months" ago she came down with flu like symptoms and then developed a bad case of the shingles. The patient believed that because she fell a few times while hiking that trauma of falling may have caused the outbreak of singles she had. Follow-up information was received from the consumer. The patient said that she had gotten her vaccine 2 years prior to becoming ill and breaking out with shingles. She believes that at the time she received the vaccine that perhaps knowledge of refrigeration methods was not available that her vaccine may not have been effective for that reason. She was fine at the report time. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Neck pain
Clinical narrative: Information has been received from a office receptionist concerning a female who in March 2008, was vaccinated with ZOSTER (Oka-Merck) 0.65 mL, subcutaneously.  A short time later, the patient developed a bilateral wrist pain and neck pain.  The patient's bilateral wrist pain and neck pain persisted.  The patient was referred to a neurologist for evaluation.  The patient sought medical attention in office.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacy student concerning a female who on 02-SEP-2008 was vaccinated with her single dose of ZOSTAVAX (Merck) subcutaneously (Lot # 659672/0294X).  Concomitant therapy included unspecified cortisone intra-articular injections 4 times per year.  In September 2008, the patient experienced an area of redness at the injection site of the left upper arm.  The patient's injection site redness persisted.  The patient sought medical attention contacting the pharmacy by phone.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 72 year old female with hypertension, osteoporosis, cholesterol high, penicillin allergy and folate low who on 09-JUL-2008 was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included PLAVIX, LEXAPRO, MAXZIDE, CRESTOR, K-DUR, PREDNISONE, MSD, FOLTX, AVAPRO, TRICOR and TOPAMAX.  Subsequently "within 10 days", the patient experienced a headache characterized as "brain freeze in the front of the forehead above her eyes"  after receiving ZOSTAVAX (Merck).  Laboratory diagnosis test studies included a magnetic resonance imaging, and blood tests were performed and her physician could not find anything wrong.  The patient's headache persisted.  It has lasted 8 weeks so far it only goes away when she take pain medicine.  Additional information is available.