chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Varicella
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old male with type 2 diabetes, other unspecified medical conditions and a mild reaction to flu vaccine, who on 01-MAY-2009 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 664029/0196Y), subcutaneously into the left arm. Concomitant secondary suspect therapy included simvastatin, (MSD), enalapril maleate (MSD) and hydrochlorothiazide (MSD). Other concomitant therapy included glipizide, metformin, ACTOS and antibiotics (manufacturer unspecified). On 01-MAY-2009, 3 to 4 hours after the patient received the ZOSTAVAX (Merck), he started experiencing swelling and pain on the injection site which lasted for 6 days. The patient also developed redness at the injection site. After that he noticed an egg size and shape swelling on the injection site and have rashes in it too. The patient also experienced pain in his shoulder joints and then later developed 2 chicken pox bumps on his chest. The pox lasted for 4 days. It was also reported that the patient had two lesions that were described as "pox" on his legs. The patient had x rays done and root canal one week before vaccination. At the time of this report the pain has lessened and the pox disappeared. The patient sought medical attention through a phone call. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old male with type 2 diabetes, other unspecified medical conditions and a mild reaction to flu vaccine, who on 01-MAY-2009 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 664029/0196Y), subcutaneously into the left arm. Concomitant secondary suspect therapy included simvastatin, (MSD), enalapril maleate (MSD) and hydrochlorothiazide (MSD). Other concomitant therapy included glipizide, metformin, ACTOS and antibiotics (manufacturer unspecified). On 01-MAY-2009, 3 to 4 hours after the patient received the ZOSTAVAX (Merck), he started experiencing swelling and pain on the injection site which lasted for 6 days. The patient also developed redness at the injection site. After that he noticed an egg size and shape swelling on the injection site and have rashes in it too. The patient also experienced pain in his shoulder joints and then later developed 2 chicken pox bumps on his chest. The pox lasted for 4 days. It was also reported that the patient had two lesions that were described as "pox" on his legs. The patient had x rays done and root canal one week before vaccination. At the time of this report the pain has lessened and the pox disappeared. The patient sought medical attention through a phone call. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a 65 year old female registered nurse concerning of herself with hypertension, hypercholesterolaemia, allergic reaction to AUGMENTIN and lincomycin who on 05-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot not reported). Concomitant therapy included LIPITOR, DAYPRO, estrogens, PREMARIN, hydrochlorothiazide, glucosamine, vitamin D (unspecified), potassium (unspecified) and aspirin. On 06-MAY-2009 the patient developed a flat, itchy rash at the injection site of the left upper arm. The injection site was swollen and tender. The patient added that she had a headache on 06-MAY-2009, which had resolved. At the time of reporting on 07-MAY-2009, the patient's flat, itchy rash at the injection site, the swollen and tender persisted. No further information is available.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Body temperature increased, Herpes zoster, Rash, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 89 year old male with chronic obstructive pulmonary disease, hypertension, anaemia, and chronic malnutrition and a history of hyponatraemia and methicillin-resistant staphylococcus aureus infection who on 23-APR-2009was vaccinated with a 0.65 ml dose of ZOSTAVAX vaccine (Merck) (lot number unavailable). Concomitant therapy included senna syrup, metoprolol, fluticasone inhaler, multi vitamins (unspecified) and ipratropium/albuterol inhaler. He did not have drug allergies. Subsequently the patient developed shingles on an unspecified date. At time of reporting, the patient did not recover. The patient was seen by the provider for medical attention. Follow-up information was received from the registered nurse who reported the patient also had history of subdural haematoma and hyponatraemia and and sacral decubitus, reflux oesophagitis, dysphagia, atypical psychosis, rhinitis, constipation, anxiety state-unspecified, aphasia, and unspecified psychosis. It was unknown if the patient had chickenpox previously. He had no recent exposure to chickenpox or shingles. The patient was vaccinated with a dose of ZOSTAVAX vaccine (MERCK) (lot #"01984") into the left upper extremity on 28-APR-2009 (previously reported as 23-APR-2009). Concomitant medication also included vitamins (unspecified), PREVACID, REGLAN, risperidone, and potassium chloride. On 03-MAY-2009, the patient had rash with vesicles which were not at the site of injection. Total 17 lesions extended from spine on lower left back to lower left quadrant. The maximum temperature was 99.1. The patient was still in healing process. 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 VZV strain or with the Merck vaccine VZV strain. The sample of vesicle lesion was taken from on left lower quadrant on 13-May-2009. The PCR results were reported as that of wild type strain. Additional information has been requested.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella zoster virus serology positive
Clinical narrative: Information has been received from a registered nurse concerning a 89 year old male with chronic obstructive pulmonary disease, hypertension, anaemia, and chronic malnutrition and a history of hyponatraemia and methicillin-resistant staphylococcus aureus infection who on 23-APR-2009was vaccinated with a 0.65 ml dose of ZOSTAVAX vaccine (Merck) (lot number unavailable). Concomitant therapy included senna syrup, metoprolol, fluticasone inhaler, multi vitamins (unspecified) and ipratropium/albuterol inhaler. He did not have drug allergies. Subsequently the patient developed shingles on an unspecified date. At time of reporting, the patient did not recover. The patient was seen by the provider for medical attention. Follow-up information was received from the registered nurse who reported the patient also had history of subdural haematoma and hyponatraemia and and sacral decubitus, reflux oesophagitis, dysphagia, atypical psychosis, rhinitis, constipation, anxiety state-unspecified, aphasia, and unspecified psychosis. It was unknown if the patient had chickenpox previously. He had no recent exposure to chickenpox or shingles. The patient was vaccinated with a dose of ZOSTAVAX vaccine (MERCK) (lot #"01984") into the left upper extremity on 28-APR-2009 (previously reported as 23-APR-2009). Concomitant medication also included vitamins (unspecified), PREVACID, REGLAN, risperidone, and potassium chloride. On 03-MAY-2009, the patient had rash with vesicles which were not at the site of injection. Total 17 lesions extended from spine on lower left back to lower left quadrant. The maximum temperature was 99.1. The patient was still in healing process. 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 VZV strain or with the Merck vaccine VZV strain. The sample of vesicle lesion was taken from on left lower quadrant on 13-May-2009. The PCR results were reported as that of wild type strain. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning an approximately 55 to 70 year old year old male with rheumatoid arthritis who on 2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not available). In this spring (approximately March 2009), the patient broke out in shingles and experienced some pain. Subsequently, the patient recovered on an unspecified date. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning two patients who on an unknown date were vaccinated with a dose of ZOSTAVAX (Merck) (lot # not provided) for prevention of shingles. Subsequently, after receiving the vaccine the patients experienced rashes around the injection site. The patients sought pharmacist attention. Follow up information received on 07-MAY-2007 from the pharmacist stated that the patient was vaccinated a couple of days prior to 21-APR-2009 with a dose of ZOSTAVAX (Merck) (lot # 664091/0140Y) by another pharmacist. This is one of two reports from the same source. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX (Merck).  The patient developed shingles after receiving the vaccine.  The patient sought unspecified medical attention.  Follow up information has been received from the physician concerning this 77 year old retired white male with prostate cancer and no history of chickenpox or recent exposure to chickenpox or herpes ZOSTER who on 28-APR-2007 (also reported as 27-APR-2007) was vaccinated SC with a first "0.5" dose of ZOSTAVAX (Merck) (lot # not reported) on the arm.  There was no illness at the time of vaccination, or rash at the site of injection or elsewhere within 42 days of vaccination.  On 29-APR-2009, the patient developed shingles on his right flank with a pain score of 7 9n a scale of 0 to 10.  Direct fluorescent antibody was not performed.  There were no photos taken and there were no specimens collected for PCR analysis.  Subsequently, the patient recovered on an unspecified date.  Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a 62 year old female with cholesterol high and breast cancer diagnosed in June 2006 who on 30-APR-2009 was vaccinated with a single dose of ZOSTAVAX (Merck) (route and site not reported). Concomitant therapy included ZOCOR (MSD), calcium (unspecified), vitamin D (unspecified), omega-3 marine triglycerides and tamoxifen citrate. On 07-MAY-2009 the patient started to itch on her feet, back, legs and arms. Lab diagnostics had not been performed. The patient had spoken to pharmacist to seek medical attention. At the time of reporting, the patient's symptoms were the same as it was on 07-MAY-2009. The patient stated that it could not be the medication she was taking since she had been on them for years and she had not changed any detergent or soap that she used. No further information is available.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning an approximately 74 year old female who on 06-MAY-2009 was vaccinated with ZOSTAVAX (Merck). The patient had a "red spot" at the injection site where ZOSTAVAX (Merck) was given. The patient sought medical attention by contacting the pharmacist and was not recovered. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the doctor's employee concerning an over 60 year old male who "recently" was vaccinated with ZOSTAVAX (Merck). A week later the patient came in and had shingles. The patient sought unspecified medical attention and the outcome of the patient was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning his 68 year old wife who unspecified date was vaccinated SQ with ZOSTAVAX (Merck) (dose and lot not reported). Subsequently the patient experienced injection site redness and swelling. The outcome of the patient was unknown. It was not specified if the patient sought medical attention. Follow up information has been received from a pharmacist. It was reported the patient experienced injection site redness, pain, swelling. The patient's injection site redness and swelling after administered the vaccine persisted. The pain had decreased so that the area was "tender to touch". Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin normal, Blood alkaline phosphatase increased
Clinical narrative: Information has been received from a Licensed Vocational nurse concerning a 52 year old female with allergies to codeine and DEMEROL and history of migraine and urinary tract infection, at time of vaccination who on 14-APR-2009 was vaccinated with first dose of ZOSTAVAX (Merck) (route unspecified, lot number: 663176/1554X) in her left deltoid at 14:22. On 15-APR-2009 at 15:00, the patient experienced fever, body aches, muscle pain over all body, decreased appetite and headache. On 20-APR-2009, the patient's laboratory test results showed elevated liver enzymes (see laboratory test section). The patient's test results on 20-APR-2009 also indicated that the patient had an increased glucose level (109 mg/dL; normal range 70-105 mg/dL). The patient's test results on 21-APR-2009 indicated that the patient had a low iron level (55 ug/dL; normal range 70-180 ug/dL). The outcome of the patient's increased glucose and low iron were unknown. The patient was also referred for an abdominal ultrasound for the elevated liver enzymes and abdominal pain (onset of abdominal pain was not reported). Results indicated that the liver had a "heterogeneous echotexture, although definable mass noted involving the liver" (also reported as "no definable mass noted involving liver"). The tail of pancreas was obscured by bowel and could not be evaluated. The head and body of the pancreas were visualized and were unremarkable. If patient continued to be symptomatic, further evaluation with CT would be recommended. The liver was otherwise remarkable. No abnormalities noted involving the spleen, left kidney, right kidney, abdominal aorta, or inferior vena cava. The patient was referred to gastroenterology for evaluation. The patient's outcome was unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood bilirubin increased, Blood chloride increased, Blood chloride normal, Blood creatinine normal, Blood glucose abnormal
Clinical narrative: Information has been received from a Licensed Vocational nurse concerning a 52 year old female with allergies to codeine and DEMEROL and history of migraine and urinary tract infection, at time of vaccination who on 14-APR-2009 was vaccinated with first dose of ZOSTAVAX (Merck) (route unspecified, lot number: 663176/1554X) in her left deltoid at 14:22. On 15-APR-2009 at 15:00, the patient experienced fever, body aches, muscle pain over all body, decreased appetite and headache. On 20-APR-2009, the patient's laboratory test results showed elevated liver enzymes (see laboratory test section). The patient's test results on 20-APR-2009 also indicated that the patient had an increased glucose level (109 mg/dL; normal range 70-105 mg/dL). The patient's test results on 21-APR-2009 indicated that the patient had a low iron level (55 ug/dL; normal range 70-180 ug/dL). The outcome of the patient's increased glucose and low iron were unknown. The patient was also referred for an abdominal ultrasound for the elevated liver enzymes and abdominal pain (onset of abdominal pain was not reported). Results indicated that the liver had a "heterogeneous echotexture, although definable mass noted involving the liver" (also reported as "no definable mass noted involving liver"). The tail of pancreas was obscured by bowel and could not be evaluated. The head and body of the pancreas were visualized and were unremarkable. If patient continued to be symptomatic, further evaluation with CT would be recommended. The liver was otherwise remarkable. No abnormalities noted involving the spleen, left kidney, right kidney, abdominal aorta, or inferior vena cava. The patient was referred to gastroenterology for evaluation. The patient's outcome was unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea increased, Decreased appetite, Glomerular filtration rate decreased
Clinical narrative: Information has been received from a Licensed Vocational nurse concerning a 52 year old female with allergies to codeine and DEMEROL and history of migraine and urinary tract infection, at time of vaccination who on 14-APR-2009 was vaccinated with first dose of ZOSTAVAX (Merck) (route unspecified, lot number: 663176/1554X) in her left deltoid at 14:22. On 15-APR-2009 at 15:00, the patient experienced fever, body aches, muscle pain over all body, decreased appetite and headache. On 20-APR-2009, the patient's laboratory test results showed elevated liver enzymes (see laboratory test section). The patient's test results on 20-APR-2009 also indicated that the patient had an increased glucose level (109 mg/dL; normal range 70-105 mg/dL). The patient's test results on 21-APR-2009 indicated that the patient had a low iron level (55 ug/dL; normal range 70-180 ug/dL). The outcome of the patient's increased glucose and low iron were unknown. The patient was also referred for an abdominal ultrasound for the elevated liver enzymes and abdominal pain (onset of abdominal pain was not reported). Results indicated that the liver had a "heterogeneous echotexture, although definable mass noted involving the liver" (also reported as "no definable mass noted involving liver"). The tail of pancreas was obscured by bowel and could not be evaluated. The head and body of the pancreas were visualized and were unremarkable. If patient continued to be symptomatic, further evaluation with CT would be recommended. The liver was otherwise remarkable. No abnormalities noted involving the spleen, left kidney, right kidney, abdominal aorta, or inferior vena cava. The patient was referred to gastroenterology for evaluation. The patient's outcome was unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hepatitis A antibody, Iron binding capacity total abnormal, Iron binding capacity unsaturated, Myalgia
Clinical narrative: Information has been received from a Licensed Vocational nurse concerning a 52 year old female with allergies to codeine and DEMEROL and history of migraine and urinary tract infection, at time of vaccination who on 14-APR-2009 was vaccinated with first dose of ZOSTAVAX (Merck) (route unspecified, lot number: 663176/1554X) in her left deltoid at 14:22. On 15-APR-2009 at 15:00, the patient experienced fever, body aches, muscle pain over all body, decreased appetite and headache. On 20-APR-2009, the patient's laboratory test results showed elevated liver enzymes (see laboratory test section). The patient's test results on 20-APR-2009 also indicated that the patient had an increased glucose level (109 mg/dL; normal range 70-105 mg/dL). The patient's test results on 21-APR-2009 indicated that the patient had a low iron level (55 ug/dL; normal range 70-180 ug/dL). The outcome of the patient's increased glucose and low iron were unknown. The patient was also referred for an abdominal ultrasound for the elevated liver enzymes and abdominal pain (onset of abdominal pain was not reported). Results indicated that the liver had a "heterogeneous echotexture, although definable mass noted involving the liver" (also reported as "no definable mass noted involving liver"). The tail of pancreas was obscured by bowel and could not be evaluated. The head and body of the pancreas were visualized and were unremarkable. If patient continued to be symptomatic, further evaluation with CT would be recommended. The liver was otherwise remarkable. No abnormalities noted involving the spleen, left kidney, right kidney, abdominal aorta, or inferior vena cava. The patient was referred to gastroenterology for evaluation. The patient's outcome was unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Protein total normal, Pyrexia, Red blood cell sedimentation rate increased, Transferrin decreased
Clinical narrative: Information has been received from a Licensed Vocational nurse concerning a 52 year old female with allergies to codeine and DEMEROL and history of migraine and urinary tract infection, at time of vaccination who on 14-APR-2009 was vaccinated with first dose of ZOSTAVAX (Merck) (route unspecified, lot number: 663176/1554X) in her left deltoid at 14:22. On 15-APR-2009 at 15:00, the patient experienced fever, body aches, muscle pain over all body, decreased appetite and headache. On 20-APR-2009, the patient's laboratory test results showed elevated liver enzymes (see laboratory test section). The patient's test results on 20-APR-2009 also indicated that the patient had an increased glucose level (109 mg/dL; normal range 70-105 mg/dL). The patient's test results on 21-APR-2009 indicated that the patient had a low iron level (55 ug/dL; normal range 70-180 ug/dL). The outcome of the patient's increased glucose and low iron were unknown. The patient was also referred for an abdominal ultrasound for the elevated liver enzymes and abdominal pain (onset of abdominal pain was not reported). Results indicated that the liver had a "heterogeneous echotexture, although definable mass noted involving the liver" (also reported as "no definable mass noted involving liver"). The tail of pancreas was obscured by bowel and could not be evaluated. The head and body of the pancreas were visualized and were unremarkable. If patient continued to be symptomatic, further evaluation with CT would be recommended. The liver was otherwise remarkable. No abnormalities noted involving the spleen, left kidney, right kidney, abdominal aorta, or inferior vena cava. The patient was referred to gastroenterology for evaluation. The patient's outcome was unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a Licensed Vocational nurse concerning a 52 year old female with allergies to codeine and DEMEROL and history of migraine and urinary tract infection, at time of vaccination who on 14-APR-2009 was vaccinated with first dose of ZOSTAVAX (Merck) (route unspecified, lot number: 663176/1554X) in her left deltoid at 14:22. On 15-APR-2009 at 15:00, the patient experienced fever, body aches, muscle pain over all body, decreased appetite and headache. On 20-APR-2009, the patient's laboratory test results showed elevated liver enzymes (see laboratory test section). The patient's test results on 20-APR-2009 also indicated that the patient had an increased glucose level (109 mg/dL; normal range 70-105 mg/dL). The patient's test results on 21-APR-2009 indicated that the patient had a low iron level (55 ug/dL; normal range 70-180 ug/dL). The outcome of the patient's increased glucose and low iron were unknown. The patient was also referred for an abdominal ultrasound for the elevated liver enzymes and abdominal pain (onset of abdominal pain was not reported). Results indicated that the liver had a "heterogeneous echotexture, although definable mass noted involving the liver" (also reported as "no definable mass noted involving liver"). The tail of pancreas was obscured by bowel and could not be evaluated. The head and body of the pancreas were visualized and were unremarkable. If patient continued to be symptomatic, further evaluation with CT would be recommended. The liver was otherwise remarkable. No abnormalities noted involving the spleen, left kidney, right kidney, abdominal aorta, or inferior vena cava. The patient was referred to gastroenterology for evaluation. The patient's outcome was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 62 year old male patient with diabetes and no known drug allergies /drug reaction who on 24-Apr-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#664092/0198Y) subcutaneously. Concomitant therapy included Lasix, Lisinopril (manufacturer unknown), glyburide (unspecified), ferrous sulfate (unspecified), Tricor, Cialis and minoxidil (unspecified). It was reported that the day after vaccination the patient experienced dry cough. The patient spoke with the pharmacist. There were no laboratory diagnostic test performed. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning a 71 year old female patient with no known drug allergies, hypertension, hyperlipidemia, hypothyroidism, sleep apnea, osteoarthritis, diverticulitis, and anemia and a history of breast cancer, left total knee replacement and childhood chickenpox who on 20-FEB-2008, was vaccinated SQ in the left arm with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number 658838/1412U).  Concomitant therapy included lisinorpril (manufacturer unknown), hydrochlorothiazide, lovastatin, LEVOXYL, INDERAL and aspirin.  There was no rash at the site of injection or elsewhere within 42 days of the vaccination.  Subsequently, on 04-MAY-2009, the patient developed shingles.  The patient had a vesicular rash with multiple lesions on her left breast to her mid back.  Her maximum temperature was 98.6 F.  The patient's pain was rated 8-9 on a scale from 0 to 10.  There was no recent exposure to chicken pox or shingles.  Medical attention was sought at an Urgent Care Clinic, as the patient was out of town when this occurred.  A specimen was not collected for PCR analysis because the lesions had dried up at the time of follow-up.  At the time of the report, the patient was recovering.  Additional information is not expected.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous
Clinical narrative: Information has been received from a medical assistant concerning an 86 year old male with unspecified drug reactions / allergies and medical history who in September 2007 was vaccinated with ZOSTAVAX (Merck) (dose, route, lot number unspecified). The medical assistant reported the patient was diagnosed on 11-May-2009 with shingles. The patient developed red lesions, with a distribution from under the left axilla and extending into the left axilla, on 7-May-2009. The medical assistant stated the physician prescribed an unspecified therapy. The outcome of the patient was not recovered. The patient sought medical attention by office. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Herpes zoster, Impaired work ability, Neuropathy peripheral, Pain
Clinical narrative: Information has been received from a physician concerning a 79 year old male with a history of chickenpox (when was child) who on 05-May-2009 was vaccinated with one dose of ZOSTAVAX (Merck) (route unspecified, lot number 664028/0137Y) on right arm, also on the same day the patient received a dose of PNEUMOVAX (dose, route and lot number unspecified) in the other arm. Concomitant therapy included Aspirin, Atenolol, Lisinopril, Viagra and generic Synthroid. A diagnosed laboratory (specimen collected for PCR) was performed on 11-May-2009 (results were not reported). The patient reported he had no exposure to chicken pox or herpes zoster recently. The physician stated that on 07-May-2009 the patient went to the physician office because he had a rash, which the physician said was a classical shingle rash type dermatome vesicular with 8 lesions distributed on his right shoulder, up the neck behind his right ear (C-4-5). Other systemic symptoms were reported in the same day: (Maximum temperature: 97.8), fatigue, neuropathy and pruritus. The patient's pain was rated at 8 on a scale from 0 to 10. The physician reported that she diagnosed the patient with the shingles and she did not go back to work until 15-May-2009. At the time of reporting, the outcome of the patient was unknown. 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 strain or with the Merck vaccine strain. Follow up information has been received from the VZV identification program. It was reported that the PCR results for the specimen from a vesicular lesion identified the presence of Wild Type VZV. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pruritus, Rash vesicular, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning a 79 year old male with a history of chickenpox (when was child) who on 05-May-2009 was vaccinated with one dose of ZOSTAVAX (Merck) (route unspecified, lot number 664028/0137Y) on right arm, also on the same day the patient received a dose of PNEUMOVAX (dose, route and lot number unspecified) in the other arm. Concomitant therapy included Aspirin, Atenolol, Lisinopril, Viagra and generic Synthroid. A diagnosed laboratory (specimen collected for PCR) was performed on 11-May-2009 (results were not reported). The patient reported he had no exposure to chicken pox or herpes zoster recently. The physician stated that on 07-May-2009 the patient went to the physician office because he had a rash, which the physician said was a classical shingle rash type dermatome vesicular with 8 lesions distributed on his right shoulder, up the neck behind his right ear (C-4-5). Other systemic symptoms were reported in the same day: (Maximum temperature: 97.8), fatigue, neuropathy and pruritus. The patient's pain was rated at 8 on a scale from 0 to 10. The physician reported that she diagnosed the patient with the shingles and she did not go back to work until 15-May-2009. At the time of reporting, the outcome of the patient was unknown. 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 strain or with the Merck vaccine strain. Follow up information has been received from the VZV identification program. It was reported that the PCR results for the specimen from a vesicular lesion identified the presence of Wild Type VZV. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a 60 year old female with unspecified allergy who in May 2009 (last week, date unspecified), was vaccinated with a 0.65 ml dose ZOSTAVAX (Merck) (lot number not available). Concomitant therapy included ZYRTEC. In May 2009 (date unspecified), 3 days after receiving ZOSTAVAX (Merck), the patient experienced itching and redness all over the injection site. The physician noted that the patient had rashes on both sides of her trunk. The patient was treated with 20mg prednisone (manufacturer unknown) and low dose steroids (manufacturer unknown) and after taking them, the patient felt better the next day. Subsequently, the patient recovered on unspecified dates. The patient sought unspecified medical attention. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Information has been received from a licensed practical nurse concerning an 82 year old male patient with chronic obstructive pulmonary disease, hypertension, congestive cardiac failure, and coronary artery disease and a history of renal cancer and nephrectomy (in 2006) who on 15-NOV-2007 was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot #658395/0966U).  The patient took other unspecified medications.  On 11-May-2009 the patient was seen in the office for shingles to the right side of the chest.  The nurse reported the lesions were "high blisters and pretty severe".  At time of reporting, the patient did not recover.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a 72 year old male patient with no pertinent medical history and with seasonal allergies who on 05-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 1448X, validated for ROTATEQ subcutaneously. Concomitant therapy included FLONASE and VIAGRA. It was reported that two days later (on 07-MAY-2009) the patient developed a shingles rash on the left leg. The patient sought medical attention with an office visit. Diagnosis of shingles was confirmed by dermatologist. There were no laboratory diagnostic tests performed. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Pain, Rash papular, Skin irritation
Clinical narrative: Information has been received from a pharmacist concerning a female who on 04-MAY-2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck).  On 13-MAY-2009 the patient developed a rash on the left side by her hips that was painful and looked just like her husband's rash when he had the shingles.  At the time of reporting the patient did not recovered.  Follow up information was received concerning the 62 year old female patient who on 04-MAY-2009 (at 5:22 pm) was vaccinated subcutaneously in the right deltoid with a single 0.65 ml dose of ZOSTAVAX (Merck) (lot # 664090/0139Y).  On 10-MAY-2009 the patient developed a rash which was a composed of papular lesions.  The patient also experienced flu like illness a few days before eruption (10-MAY-2009).  It was reported that the patient was not recently exposed to chicken pox 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 13-MAY-2009."  Follow up information received via telephone from the pharmacist on 13-MAY-2009 reported that the patient had an appointment that afternoon with a physician and provided the phone number and fax number of the physician.  Additional information received via telephone from the physician explained that 9 days ago (on 04-MAY-2009) the patient had been vaccinated with a dose of ZOSTAVAX (Merck).  Four days post vaccination the patient developed irritation on her skin which was painful.  The rash was 5 days old and there was a small area at L5 on the left side.  Additional information received from a pharmacy on 14-MAY-2009 reported that the patient was vaccinated subcutaneously in the left deltoid with a dose of ZOSTAVAX (Merck) (lot # 664090/0139Y) (exp. 24-JUL-2010) on 04-MAY-2009 at 5:22 pm.  Additional information has been received from the pharmacist and an associate research scientist.  The pharmacist reported that the patient experienced a rash (description Herpes ZOSTER) and flu like illness before eruption.  The diluent's lot number was 4115X.  The pharmacist reported that the patient had no recent exposure to chickenpox or shingles.  The associate research scientist reported that a sample of the lesion was collected on 13-MAY-2009 from a vesicle/papule and was sent to laboratory on 14-MAY-2009.  The sample was adequate.  The VZV DNA was amplified and the results showed a wild type strain of VZV.  No further information is expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Viral DNA test positive
Clinical narrative: Information has been received from a pharmacist concerning a female who on 04-MAY-2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck).  On 13-MAY-2009 the patient developed a rash on the left side by her hips that was painful and looked just like her husband's rash when he had the shingles.  At the time of reporting the patient did not recovered.  Follow up information was received concerning the 62 year old female patient who on 04-MAY-2009 (at 5:22 pm) was vaccinated subcutaneously in the right deltoid with a single 0.65 ml dose of ZOSTAVAX (Merck) (lot # 664090/0139Y).  On 10-MAY-2009 the patient developed a rash which was a composed of papular lesions.  The patient also experienced flu like illness a few days before eruption (10-MAY-2009).  It was reported that the patient was not recently exposed to chicken pox 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 13-MAY-2009."  Follow up information received via telephone from the pharmacist on 13-MAY-2009 reported that the patient had an appointment that afternoon with a physician and provided the phone number and fax number of the physician.  Additional information received via telephone from the physician explained that 9 days ago (on 04-MAY-2009) the patient had been vaccinated with a dose of ZOSTAVAX (Merck).  Four days post vaccination the patient developed irritation on her skin which was painful.  The rash was 5 days old and there was a small area at L5 on the left side.  Additional information received from a pharmacy on 14-MAY-2009 reported that the patient was vaccinated subcutaneously in the left deltoid with a dose of ZOSTAVAX (Merck) (lot # 664090/0139Y) (exp. 24-JUL-2010) on 04-MAY-2009 at 5:22 pm.  Additional information has been received from the pharmacist and an associate research scientist.  The pharmacist reported that the patient experienced a rash (description Herpes ZOSTER) and flu like illness before eruption.  The diluent's lot number was 4115X.  The pharmacist reported that the patient had no recent exposure to chickenpox or shingles.  The associate research scientist reported that a sample of the lesion was collected on 13-MAY-2009 from a vesicle/papule and was sent to laboratory on 14-MAY-2009.  The sample was adequate.  The VZV DNA was amplified and the results showed a wild type strain of VZV.  No further information is expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female who on 11-FEB-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (no lot number was provided).  Concomitant therapy included CIPRO.  It was reported that on 15-FEB-2009 the patient experienced pain down her left arm and a rash.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Viral DNA test positive
Clinical narrative: Information has been received from a nurse concerning a 60 year old male with hypothyroidism and hyperlipidemia as well as no drug allergies who on 29-APR-2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (663894/0129Y).  Concomitant therapy included VYTORIN, LEVOXYL, MSD, hydrochlorothiazide and an unspecified fenofibrate.  On 30-APR-2009 the patient developed shingle-like rashes on the right thoracic in one dermatone.  The patient sought medical attention and was seen by a physician.  At the time of reporting the patient was recovering.  Follow up information was received from the physician concerning the 60 year old male with niacin allergy who on 29-APR-2009 was vaccinated in the right deltoid with a 0.65 year old male with niacin allergy who on 29-APR-2009 was vaccinated in the right deltoid with a 0.65 ml dose of ZOSTAVAX (Merck) (663894/0129Y).  On 30-APR-2009 the patient developed shingle-like rashes on the right thoracic.  The patient was enrolled in a 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 Merck vaccine VZV strain.  At the time of reporting the patient was recovering.   It was reported that the patient was not recently exposed to chicken pox or shingles.  The sample of the lesion was collected.  The PCR results for the specimen from rash identified the presence of WT VZV.  Follow up information was received reported that the sample of the lesion was collected on 14-MAY-2009.  The sample was taken from scabs when swabbing.  It was confirmed the patient experienced rash.  VZV DNA was amplified and the PCR results for the specimen from rash identified the presence of Wild Type VZV.  B-globin DNA was not amplified.  Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from an Adult Nurse Practitioner (A.N.P) concerning an 86 year old female patient with hypertension and sulfonamide allergy who on 12-MAY-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 664090/0139Y) subcutaneously. Concomitant therapy included lisinopril (manufacturer unknown) and meclizine (unspecified). It was reported that the patient experienced tingling all over her body since the night of 13-MAY-2009. The patient spoke with the Nurse Practitioner. There were no laboratory diagnostic test performed. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Information has been received from a 60 year old female consumer with 'allergies to some chemicals in perfumes' and a history of shingles in March 2008, who on  13-May-2009 was vaccinated with a 0.6ml dose of ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy included estrogens, Premarin (dose, duration and indication not reported). Subsequently, early on the 14-May-2009, the patient experienced knot, redness and warmth to the touch at the injection site. The patient did not seek medical attention and there were no laboratory studies performed. At the time of report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a female patient who on 15-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck). On 16-MAY-2009 the patient experienced redness, swelling, warmth and itching at the injection site. She had not spoken with her physician. The patient did not seek medical attention. No further information is available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Information has been received from a pharmacist concerning a female patient in "late sixties" with no allergies or medical history who "last week" on approximately 11-MAY-2009 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 663882/0133Y) SQ.  There was no concomitant medication.  Subsequently the patient developed a painful rash after administration of the vaccine.  The pharmacist suspected that it was zoster but had not seen the rash yet.  The pharmacist was not interested in VZV Analysis by polymerase chain reaction (PCR).  No diagnostic laboratory tests were performed.  The patient had sought medical attention via pharmacist.  The patient's painful rash persisted.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Breast inflammation, Breast tenderness, Gynaecomastia
Clinical narrative: Information has been received from a  registered pharmacist concerning a approximately 65 years old male who on 13-FEB-2009 was vaccinated with ZOSTAVAX (Merck) (lot number, route and site not reported).  Concomitant therapy included CRESTOR, MSD, PROZAC and promethazine.  On approximately 15-FEB-2009,within 48 to 72 hours after receiving the vaccine, the patient developed gynecomastia.  He complained of left breast enlargement, tenderness and inflammation.  The patient had sought unspecified medical attention.  Mammogram was performed, but the result was not reported.  At the time of reporting, the patient didn't recovered.  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 on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# not reported). Approximately two weeks after vaccination, the patient developed shingles on her face. The patient sought medical attention and was seen by a physician. After treating with an unknown therapy, the shingles improved.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Lung disorder, X-ray abnormal
Clinical narrative: Information has been received from a consumer concerning her husband a 91 year old male who on unspecified dates was vaccinated subcutaneously with ZOSTAVAX (Merck) (lot# not reported). On an unspecified date, after vaccination the patient started coughing. An X-Ray showed that "there is something on his lung". It was also reported that the patient sought unspecified medical attention. No outcome was provided. Additional information has been requested.
Age: 1.2
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 14 month old patient who on 19-MAY-2009 was vaccinated with ZOSTAVAX (Merck) instead of VARIVAX (Merck). There was no product confusion involved. The patient has not experienced any know symptoms by the report time. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 69 year old female patient with allergic reaction to CECLOR and AUGMENTIN who on 04-MAY-2009 was vaccinated with a dose of ZOSTAVAX (lot # 663883/0132Y; 6018Y diluent), 0.65ml subcutaneously in her left arm. Concomitant therapy included multiple unspecified medications. The medical assistant reported that on 05-MAY-2009 after receiving the ZOSTAVAX, the patient developed itching, redness and swelling of her left arm at the injection site, and was diagnosed with cellulitis. The patient was treated with KEFLEX and BENADRYL and on 12-MAY-2009, was noted to be 90% improved. There were no laboratory diagnostics studies performed. The patient sought medical attention at the physician's office. Additional information has been requested.