chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blood test, Electroencephalogram, Headache, Herpes zoster
Clinical narrative: Information has been received from a 68 year old female patient with "incurable lung disease", blockage in carotid artery and penicillin allergy who "a couple of years ago" was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX (Merck) (LOT# not reported). "Eight days ago", on approximately 26-AUG-2010 the patient experienced a very bad headache, sores in hairline and ear, and was diagnosed with shingles on 01-SEP-2010 by her dermatologist. The patient was in the emergency room all day Saturday (on 28-AUG-2010) for the pain in her head and was prescribed morphine (manufacturer unspecified) intravenously to stop the pain. On Sunday (29-AUG-2010), the pain came back. The patient also found out "2 days ago", on approximately 31-AUG-2010 the patient had had several mini strokes. MRI with and without contrast, ultrasound of Carotid Artery, MRA, EEG, blood tests were performed and results were not reported. At this time of reporting, the patient was not recovered. Follow-up information has been received via a Herpes Zoster Questionnaire which reported that the patient experienced herpes zoster on 01-SEP-2010 with vesicles erupting on the chin, left ear, and scalp. No direct fluorescent antibody was done. No specimen was collected for PCR. No photos were taken. On an unspecified date, the patient recovered from herpes zoster. No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: Information has been received from a 68 year old female patient with "incurable lung disease", blockage in carotid artery and penicillin allergy who "a couple of years ago" was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX (Merck) (LOT# not reported). "Eight days ago", on approximately 26-AUG-2010 the patient experienced a very bad headache, sores in hairline and ear, and was diagnosed with shingles on 01-SEP-2010 by her dermatologist. The patient was in the emergency room all day Saturday (on 28-AUG-2010) for the pain in her head and was prescribed morphine (manufacturer unspecified) intravenously to stop the pain. On Sunday (29-AUG-2010), the pain came back. The patient also found out "2 days ago", on approximately 31-AUG-2010 the patient had had several mini strokes. MRI with and without contrast, ultrasound of Carotid Artery, MRA, EEG, blood tests were performed and results were not reported. At this time of reporting, the patient was not recovered. Follow-up information has been received via a Herpes Zoster Questionnaire which reported that the patient experienced herpes zoster on 01-SEP-2010 with vesicles erupting on the chin, left ear, and scalp. No direct fluorescent antibody was done. No specimen was collected for PCR. No photos were taken. On an unspecified date, the patient recovered from herpes zoster. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an unspecified health professional concerning a 60 year old female with no medical history who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) injection. Six month after being given ZOSTAVAX (Merck), the patient developed shingles. It was unspecified if the patient sought medical attention. On an unspecified date, the patient recovered from shingles. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a consumer concerning her/his 67 year old female cousin with a history of back problems who on approximately 05-JUL-2010 (also reported a during the second week in July 2010) was vaccinated SC with a 0.6 ml ZOSTAVAX (Merck). On 26-AUG-2010 the patient began experiencing a burning pain in her back beneath her shoulder blade. The pain had moved under her breast. No medical attention was sought. At the time of the report the patient had not recovered. No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old female with Parkinson's disease and drug reactions/allergies to AVELOX who on 31-AUG-2010 was vaccinated subcutaneously into right arm with a 0.65 ml dose of ZOSTAVAX (Merck). The lot # was 664630/0837Y, and the expiry date would be 17-DEC-2010. Concomitant therapy included XANAX, REQUIP, carbidopa/levodopa (manufacturer unknown), amantadine hydrochloride (manufacturer unknown) and EXELON. On 31-AUG-2010 the patient within 30 minutes of receiving ZOSTAVAX (Merck) experienced redness of her lower right arm. The patient was recovering from redness of her lower right arm. The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. Follow-up information was received from a physician who stated that she did not examine the patient for the problem relayed to her. The patient had a mild erythema down her arm. The patient's erythema was resolved without problem. Lab diagnostics studies were not performed. Additional information is not expected.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Computerised tomogram abnormal, Herpes zoster, Infection
Clinical narrative: Information has been received from a female consumer concerning her 93 year old mother with pacemaker surgery in June 2010 and no known drug allergies who was vaccinated with a dose of ZOSTAVAX (Merck) two years ago. Concomitant therapies included: LIPITOR, metoprolol (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), lisinopril (manufacturer unknown), SYNTHROID and aspirin (manufacturer unknown). "Last week", the patient had shingles. She had about 20 to 25 blisters around her right eye. She was examined by her physician on 26-AUG-2010 and prescribed an antiviral medication. On 28-AUG-2010 she was taken to emergency room but not admitted. She was diagnosed with a secondary infection of the right eye and prescribed a high dose of amoxicillin. Laboratory diagnostic test performed: on 28-AUG-2010 CT scan of right eye area was performed. At the time of report the patient's status was not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a male patient with an active case of shingles who on an unspecified date ("a few weeks ago"), was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). Subsequently, the patient had a worsening of symptoms. Unspecified medical attention was sought. The patient's shingles persisted. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Tenderness
Clinical narrative: Information has been received from a physician concerning himself an 82 year old male with prostate cancer and that spread to bone and had had for 3 years and taking LUPRON which seemed to helping it and no drug reactions/allergies, who "3-4 years ago" (in approximately 2007) was vaccinated subcutaneously with the "full dose" of ZOSTAVAX (Merck) (LOT# not reported). Concomitant therapy included ZOCOR. There was no lab diagnostics studies performed. The patient received ZOSTAVAX (Merck) injection and in the last 6 months (In approximately 2007) had had 4 or 5 episodes of having tender, itchy rashes in certain spots. It was noted that in the past, the physician was able to self treat with ZOVIRAX cream or FAMVIR that would clear the rashes. Physician remembered one time about one year ago (in approximately August 2009), he had gotten a patch of rash and used ZOVIRAX ointment which took care of it. Currently, the physician had 3 spots (spots were patches of rash) on the one side of the body and couple of spots on the other side of his body. Physician just started FAMVIR. At this time of reporting, the patient was not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female patient with no known drug allergies or pertinent medical history who on 12-JUL-2010 was vaccinated IM in the left deltoid with a dose ZOSTAVAX (Merck) (lot number 665531/0698Z, expiration date 28-APR-2011). There was no concomitant medication. The medical assistant reported that the patient called on 16-JUL-2010 to report that she had developed a rash at the injection site. The patient was scheduled to be seen in the office on 19-JUL-2010. No therapy was prescribed. No laboratory tests were performed. At the time of the report the patient had not recovered. The patient contacted the physician's office by phone. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a Registered Pharmacist (R.Ph.) concerning an approximately 69 year old female with no drug reaction/allergy who in approximately 2005 (4-5 years ago) was vaccinated with a dose of ZOSTAVAX (Merck). There was no concomitant medication. In 2009 the patient developed shingles. It was unspecified if the patient sought medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 67 year old male patient who on 13-FEB-2007 was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot number 656412/1476F) (Expiration date: JUN-2008). The physician reported that on 27-MAY-2010, the patient was diagnosed with shingles. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Follow-up information was received from a medical assistant who reported that on 13-FEB-2007 at 11:30, the male patient (weight: 220 pounds) was vaccinated intramuscularly with the first dose of ZOSTAVAX (Merck) at a age of 64 years old. The patient received the ZOSTAVAX (Merck) and still developed shingles. The patient did not require an emergency room/doctor visit. Follow up information has been received from a complete questionnaire. It was reported that on 13-FEB-2007 the patient with no history of chickenpox and no recent exposure to chicken pox was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). There was no rash at the site of injection within 42 days of the vaccination. On 27-MAY-2010 the patient was diagnosed with herpes zoster. The pain the patient felt was of 7. It was also reported that the patient had a foot ulcer. On an unspecified date the patient recovered. No direct fluorescent antibody test was performed. No specimen was collected for polymerase chain reaction (PCR). No further information is expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Cellulitis, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 62 year old female who was vaccinated with ZOSTAVAX (Merck) (therapy dose, route and site unknown). The physician reported that the patient experienced anaphylaxis 24 hours after shingles vaccine and new with cellulitis. The patient sought medical attention. At the time of this report, the patient's outcome was unknown. Follow-up information has been received from the physician. The physician reported the patient's name and the patient was 68 year old (previously reported as 62 year old) female. She received the ZOSTAVAX (Merck) on 09-JUL-2010 and had experienced difficulty breathing and swelling at the injection site. She used her albuterol inhaler twice to control her breathing. By the time the physician saw the patient on 13-JUL-2010, the patient's breathing had resolved and only slight redness remained at the injection site. At the time of reporting, the patient's outcome of swelling at the injection site and slight redness remained at the injection site were unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist doctor concerning a 68 year old female with allergy to sulfa drugs and with no medical history who on 30-APR-2010 was vaccinated with ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included losartan potassium (MSD) and lisinopril (manufacturer unknown). In July 2010 the patient went to the pharmacist office and informed her that she had experienced rash predominantly on the right side of her face along her "facial nerve" that had reoccurred every month since getting the ZOSTAVAX (Merck). The pharmacist stated that the patient had seen her medical doctor regarding this rash. At the time of the report the patient's status was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP, HPV4, MNQ, TDAP, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female patient who on 19-JUL-2010, was vaccinated SQ with a dose of ZOSTAVAX (Merck) (Lot#: 665525/0695Z). The licensed practical nurse mentioned that the patient inadvertently was administered a dose of ZOSTAVAX (Merck) as her second dose in the VARIVAX (Merck) schedule on 19-JUL-2010. The first dose of VARIVAX (Merck) (Lot#: not reported) was given on 03-JUN-1998. No adverse effects were reported. This was a human error, there was no a PQC involved. Follow-up has been received from a licensed practical nurse concerning a 16 year old female student who on 19-JUL-2010, was vaccinated SQ in the right arm with the first dose of ZOSTAVAX (Merck) (Lot# 665525/0695Z), IM in the left arm with the first dose of GARDASIL (Lot# 665547/1318Y), IM in the left arm with the first dose of MENACTRA (Lot# U3432AA), IM in the right arm with the first dose of ADACEL (Lot# UF544CA) and IM in the right arm with the first dose of ENGERIX-B (Lot# AHAVB437AA). There was no illness at time of vaccination, no pre-existing allergies, no birth defects, no medical conditions, no relevant diagnostic test and there was no adverse events reported. No further information is available.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a 75 year old female patient who on 30-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). On 02-JUL-2010 the patient experienced a rash at the injection site. The patient's rash at the injection site persisted. The patient sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a registered pharmacist concerning a male patient who "the week of 09-JUN-2010" was vaccinated with ZOSTAVAX (Merck). The registered pharmacist reported that the patient developed an unspecified rash. The rash developed within 5 days of vaccination. The outcome of the patient was not reported. The patient sought medical attention and spoke to the pharmacist. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her 72 year old male cousin who in July 2008 (2 years ago), was vaccinated with ZOSTAVAX (Merck). 6 months later, in January 2009 the patient experienced shingles. The patient had fully recovered from shingles. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a female licensed visiting nurse who on 22-JUL-2010 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck). The nurse reported that after receiving ZOSTAVAX (Merck) on 22-JUL-2010 she experienced redness, swelling and throbbing at the injection site and also experienced headaches. The nurse reported that she had not seen her physician about this yet but did not specify if she had spoken to the office as of yet. The patient had not recovered. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Information has been received from an unspecified reporter concerning a 60 year old male with "numerous allergies/reaction" and a history of "inflammatory spinal condition", who on 16-JUL-2010 was an "injection" of vaccinated with ZOSTAVAX (Merck). On 20-JUL-2010 the patient experienced slight joint pain and muscle pain. He stated that he read this may occur with ZOSTAVAX (Merck) and wanted to find out how long it would last. The patient did not have medical attention. The patient's slight joint pain and muscle pain persisted. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old female with no drug reactions/allergies who on 19-JUL-2010 was vaccinated subcutaneously in back of left upper arm with a dose of ZOSTAVAX (Merck) (LOT# 664669/0152Z, expiration 28-MAR-2011). On 21-JUL-2010 the patient presented back to pharmacy with a 1.5 in "rash" at the injection site. The lesion was raised in the center. The pharmacist recommended BENADRYL for the reaction. On 23-JUL-2010 the patient again presented to the pharmacy and the "rash" was resolving, but harder under the surface of the skin than it was previously. There was no lab diagnostics studies performed. No other lesions on the patient's body, no other symptoms were stated. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 71 year old female patient with no known allergies who on 27-JUL-2010 was vaccinated subcutaneously in the back of her right arm with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# 665513/0146Z). The pharmacist reported that "last night" on 27-JUL-2010, the patient noticed a red, round, itchy spot 1/4 inch size, on her right shoulder about 4 inches away from the injection site. The patient told pharmacist that "the spot looks better today" (on 28-JUL-2010). However, the patient told the pharmacist  that she also had a spot on her left arm that was about the size of a half dollar. The patient told pharmacist that she was using triple antibiotic cream. Pharmacist stated that the patient lived in another town, so she did not come in to be seen. But pharmacist stated she did not think this was a chicken pox rash, but possibly bug bites. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. Follow up information has been received from the doctor of pharmacy concerning the female patient who on 27-JUL-2010 at 10:00 was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot# 665513/0146Z). Diluent (MSD) for ZOSTAVAX (Merck) (Lot# 60764). The onset date of the adverse events was reported as 30-JUL-2010 (previously reported as 27-JUL-2010). The pharmacist reported that the patient was advised to see her primary care provider if symptoms persisted or worsened. The patient's primary care provider was notified of possible reaction to vaccine. At the time of the report, the patient's outcome was reported as unknown (previously reported as recovering). No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered pharmacists as reported by a physician concerning a patient who on an unspecified date, within the last four years was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, dose and route no reported). The pharmacist reported that the patients developed shingles after receiving the vaccine (on an unspecified date). It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was no reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 77 year old female patient with no pertinent medical history and no drug allergies, who on 09-JUL-2007 was vaccinated with one dose of ZOSTAVAX (Merck) (lot # 657767/0740U). Concomitant therapy included "Cyphoid", ACCUPRIL, hydrochlorothiazide, COREG, glucosamine and vitamins (unspecified). Caller reported that 3 years after receiving ZOSTAVAX (Merck) on 23-JUL-2010 she developed a case of shingles. The doctor informed her that she had a severe case classified as "T3." She reported that her whole shoulder and arm are covered with the rash and she hasn't been able to sleep for 2-3 nights. There were no labs or diagnostic tests performed. The patient had not recovered. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning an approximately 77 year old female patient with no pertinent medical history, no drug reactions/allergies who on 09-JUL-2007, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#: not reported). There were not concomitant medication. The registered pharmacist reported that the patient was currently suffering from a case of shingles. At the time of the report, the patient had no recovered from a case of shingles. The patient sought unspecified medical attention. Follow-up has been received from a pharmacist concerning a 77 year old female patient who on 09-JUL-2010, was vaccinated SC with a second dose of ZOSTAVAX (Merck) (Lot# 657767/0740U). On July 2010, the patient came down with shingles. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient who on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#: not reported). The registered pharmacist stated that the patient developed shingles after getting ZOSTAVAX (Merck). The patient had the "horrible" and painful shingles on her face. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a 75 year old female patient with diabetes mellitus, high blood pressure, "thyroid", penicillin and sulfonamide allergies who "3 years ago" in July 2007 was vaccinated SC with a dose of ZOSTAVAX (Merck) (Lot# unknown). Concomitant therapy included metformin hydrochloride (+) sitagliptin phosphate (MSD) and SYNTHROID. The patient stated that "about a month ago" in approximately June 2010, she experienced a "bad case of shingles", in which she was sick for two weeks prior to break out. The patient also stated, that she experienced a bad back ache, blisters, scabs, skin discoloration and a stabbing pain that feels like your skin was on fire and your did not want to touch it. There were no laboratory tests or diagnostic studies performed. At the time of the reported, the patient was recovering. The patient sought unspecified medical attention. Follow up information has been received from a completed questionnaire. A physician indicated that on 27-DEC-2007 the patient with no illness at the time of vaccination and a history of chickenpox at childhood was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 658863/1414U) in his left arm. Rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. The physician stated that there was no adverse effect of vaccine. There was no recent exposure to chickenpox or Herpes zoster. The vaccine was not effective and on 23-JUL-2010 the patient developed herpes zoster, a fairly severe case with postherpetic neuralgia which lasted four months; the patient recovered from Herpes zoster. Distribution of dermatomes involved was T8 and T9 at 25 lesions. Pain was described as 8 in a scale from 0 to 10. The patient's maximum temperature was 98.4. There were no other systemic symptoms. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Skin discolouration
Clinical narrative: Information has been received from a 75 year old female patient with diabetes mellitus, high blood pressure, "thyroid", penicillin and sulfonamide allergies who "3 years ago" in July 2007 was vaccinated SC with a dose of ZOSTAVAX (Merck) (Lot# unknown). Concomitant therapy included metformin hydrochloride (+) sitagliptin phosphate (MSD) and SYNTHROID. The patient stated that "about a month ago" in approximately June 2010, she experienced a "bad case of shingles", in which she was sick for two weeks prior to break out. The patient also stated, that she experienced a bad back ache, blisters, scabs, skin discoloration and a stabbing pain that feels like your skin was on fire and your did not want to touch it. There were no laboratory tests or diagnostic studies performed. At the time of the reported, the patient was recovering. The patient sought unspecified medical attention. Follow up information has been received from a completed questionnaire. A physician indicated that on 27-DEC-2007 the patient with no illness at the time of vaccination and a history of chickenpox at childhood was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 658863/1414U) in his left arm. Rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. The physician stated that there was no adverse effect of vaccine. There was no recent exposure to chickenpox or Herpes zoster. The vaccine was not effective and on 23-JUL-2010 the patient developed herpes zoster, a fairly severe case with postherpetic neuralgia which lasted four months; the patient recovered from Herpes zoster. Distribution of dermatomes involved was T8 and T9 at 25 lesions. Pain was described as 8 in a scale from 0 to 10. The patient's maximum temperature was 98.4. There were no other systemic symptoms. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a healthcare worker concerning an approximately 80 year old female patient with allergies to shell fish, alendronate sodium (MSD) (WAES # 1007USA03489), enalapril maleate (MSD) (WAES # 1007USA03493), ZIAC, codeine and "NICOVACT" and no pertinent medical history, who on 04-JUN-2007 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck). There was no concomitant medication. The healthcare worker reported that on 07-JUL-2010 the patient developed pruritic rash on her right upper chest and back covering a large area after administration of ZOSTAVAX (Merck). No laboratory diagnostic tests were performed. At the time of the report, the patient was recovering. The patient sought via an office visit. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 66 year old female patient who in September 2009, was vaccinated with a SC dose of ZOSTAVAX (Merck). On 03-JUN-2010, the patient experienced shingles. No lab diagnostics studies were performed. At the time of reporting, the outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test abnormal, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a female patient who her husband on an unspecified date was vaccinated with a 0.65 ml single dose of ZOSTAVAX (Merck) (Lot#: not reported). The physician stated that after her husband received the vaccine, on an unspecified date the patient experienced shingles. At the time of the report, the patient outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from the physician who reported that a 73 year old male patient of his with hypertension, cardiac artery disease and sleep apnea went to the local clinic and received a dose of ZOSTAVAX (Merck). The physician did not know the lot number or type of vaccination. After the vaccination that night while going to sleep he sneezed in his 68 year old wife's face. One week after the incident, his wife was diagnosed with herpes zoster at a local urgent care. The physician did not know if the wife's herpes zoster was related to her husband's vaccination or sneezing. The physician also reported that the wife's medical condition included osteoarthritis, gastrooesophageal reflux disease and hypertension. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacy student concerning a 58 year old female with drug hypersensitivity to corticotrophin who on 13-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# not reported). On an unspecified date (In July 2010), the patient experienced shingles on her lower flank. The patient had not seen her physician but called the pharmacy and had diagnosed the shingles herself. At this time of reporting, the patient was not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female with hypertension and hypothyroidism and a history of "fever blister" in the past and no known drug allergies/reactions who on 15-JUL-2010 was vaccinated SC with a dose of ZOSTAVAX (Merck) (dose and lot number not reported). Concomitant therapy included SYNTHROID and COREG. It was reported that in the morning of 16-JUL-2010, the patient developed fever blister. No laboratory tests were performed. The patient sought unspecified medical attention by making a phone call. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated
Clinical narrative: Information has been received from a 61 year old male patient with no drug reactions or allergies and a calcium deposit in his shoulder who on 03-SEP-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). Concomitant therapy included AZOR and CRESTOR. The patient reported that on 07-SEP-2010 after receiving ZOSTAVAX (Merck), he experienced a flare up in his shoulder where he had the calcium deposit. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. The patient did not seek medical attention. No further information is available.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a medical assistant concerning an 80 year old female patient with sulfa and LIPITOR allergy and a history of chemotherapy and radiotherapy in February 2010, who on 26-AUG-2009, was vaccinated SQ with a dose of ZOSTAVAX (Merck) (Lot# not reported). The medical assistant reported that on 21-AUG-2010, the patient developed severe shingles on her stomach and back after receiving ZOSTAVAX (Merck). The blisters were painful to the touch and she had the pain from neck to back. No lab tests were performed. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Follow-up information was received which reported that the physician was very upset, because she saw the patient and the patient had still not recovered, the patient was seeing a pain management specialist. The physician has asked for follow-up from the safety department and from the medical information department. The physician also stated that the patient on unspecified date experienced post herpetic neuralgia (PHN), with severe pain (pins and needle-type pain) and the rash had healed. At the time of the report the patient's outcome from post herpetic neuralgia (PHN) was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient who in July 2010 (exact date unknown), was vaccinated with a dose of ZOSTAVAX (Merck). The patient reported that since receiving the vaccine, she had already been diagnosed with shingles two times (dates unspecified). The outcome of the patient was not reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a Nurse Practitioner concerning a male patient who on 03-SEP-2010 was inadvertently vaccinated SQ with a single dose of ZOSTAVAX (Merck) (Lot# unknown). The nurse reported that the patient was intended to receive VARIVAX (Merck). No adverse symptoms were reported. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female with sleep disorder, hypertension and no drug allergies who on 09-SEP-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (dose and lot number unspecified). Pharmacist indicated that the injection was given intramuscularly. Concomitant therapy included NORVASC, EVISTA, CRESTOR and AMBIEN. On an unspecified date, the patient experienced redness and warmth at the injection site. On 13-SEP-2010 the patient visited the pharmacist to have the area on her arm evaluated. No laboratory diagnostics studies were performed. At the time of reporting, the patient's redness and warmth at the injection site had not recovered. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Auricular swelling, Ear pain, Erythema, Eye pain, Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a female patient with a history of splenectomy who on 15-APR-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not provided, expiration date on 16-JAN-2011). It was reported that on 02-JUL-2010 the patient experienced shingles. The nurse reported that on 08-OCT-2010 the patient still had a rash (location unspecified), redness, and swelling of her ear. The patient was being treated with NEURONTIN. At the time of this report, the patient's outcome was unknown. The patient sought medical attention at the physician's office. Follow-up information has been received from a completed questionnaire from a registered nurse concerning a 79 year old female patient with a history of chickenpox and no allergies (medications, food, other), who on 15-APR-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 664628/1018Y) into right upper arm. Concomitant medications included prednisone, methotrexate, and leucovorin calcium. On 02-JUL-2010 the patient developed shingles. The patient had a rash in right breast to back right ear. The rash did not occur at the site of injection. The lesions were diffuse and distribution was linear putting. The patient had not recent exposure to chickenpox. Physician conclusion: the right ear was swollen, red, and painful in the eye and ear. The patient saw the physician of mom and stated that the patient should not have gotten shingles vaccine since she had a splenectomy 7 years ago. The patient was recently diagnosed in July 2010 with relapsing polychondritis. 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 Merck vaccine strain. On an unspecified date the sample was obtained from vesicle/lesion. The patient recovered from chickenpox on an unspecified date. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Polychondritis, Rash
Clinical narrative: Information has been received from a registered nurse concerning a female patient with a history of splenectomy who on 15-APR-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not provided, expiration date on 16-JAN-2011). It was reported that on 02-JUL-2010 the patient experienced shingles. The nurse reported that on 08-OCT-2010 the patient still had a rash (location unspecified), redness, and swelling of her ear. The patient was being treated with NEURONTIN. At the time of this report, the patient's outcome was unknown. The patient sought medical attention at the physician's office. Follow-up information has been received from a completed questionnaire from a registered nurse concerning a 79 year old female patient with a history of chickenpox and no allergies (medications, food, other), who on 15-APR-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 664628/1018Y) into right upper arm. Concomitant medications included prednisone, methotrexate, and leucovorin calcium. On 02-JUL-2010 the patient developed shingles. The patient had a rash in right breast to back right ear. The rash did not occur at the site of injection. The lesions were diffuse and distribution was linear putting. The patient had not recent exposure to chickenpox. Physician conclusion: the right ear was swollen, red, and painful in the eye and ear. The patient saw the physician of mom and stated that the patient should not have gotten shingles vaccine since she had a splenectomy 7 years ago. The patient was recently diagnosed in July 2010 with relapsing polychondritis. 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 Merck vaccine strain. On an unspecified date the sample was obtained from vesicle/lesion. The patient recovered from chickenpox on an unspecified date. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning three patients who on unspecified dates was vaccinated with the dose of ZOSTAVAX (Merck) (LOT# not reported). On unspecified dates, the patients experienced shingles. The physician did not report the patients' outcomes at this time. It was unspecified if the patient sought medical attention. Follow-up information has been received from the physician who stated that he did not consider these adverse experiences but considered them part of the 48% of patients who could potentially got shingles after receiving ZOSTAVAX (Merck). He said that no vaccine was 100% and that at least the cases of shingles that patients got after ZOSTAVAX (Merck) were milder. Follow-up information has been received on 14-SEP-2010 from the physician who on 07-SEP-2010 reported that these occurrences were three episodes of shingles occurring 1.5 to 3 years after ZOSTAVAX (Merck) vaccination so the physician did not consider these to be reportable adverse events. Follow-up inconsistently information has been received from the physician who stated that the patient was no adverse reaction. This is one of several reports received from same source. No further information is available.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Information has been received from a consumer concerning his 77 year old wife with sulfonamide, penicillin, DARVOCET, TALWIN, DEMEROL, CIPRO, "BINRA TAB", "ERYTAHCION", MORPHINE, codeine, CLARITIN, "MUSCLE RELAXERS" allergy and dye allergy who on 09-SEP-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included lisinopril and furosemide. On 09-SEP-2010 the patient developed red patch, itching and rash. No medical attention was sought. The patient's red patch and itching and rash persisted. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female with penicillin allergy who on 06-SEP-2010 was vaccinated SC with 0.65 ml ZOSTAVAX (Merck) (single dose). On 08-SEP-2010 the patient called the pharmacy complaining of a two inch by three inch area, centered on the injection site, that she described as warm, swollen, hard and cyst-like. Medical attention was sought by calling pharmacist. At the time of the report, the patient status was not reported. Follow-up information was received from the pharmacist concerning the 61 year old female who on 06-SEP-2010 at 11:00 AM was vaccinated SC in the left arm with the first dose of ZOSTAVAX (Merck) (lot # 664670/0151Z) at a pharmacy. On 08-SEP-2010 AM the patient experienced 2 inch x 3 inch warm, swollen, tender, hard (cyst-like) (duration unknown). At the time of the report, the outcome of the events was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a register pharmacist concerning a 70 year old female patient with no pertinent medical history and no drug reactions or allergies who on 26-JUL-2010, was vaccinated SQ with 0.65 ml once dose of ZOSTAVAX (Merck) (Lot# 665531/0698Z). The pharmacist stated that, the patient had a rash at the injection site on her arm after receiving ZOSTAVAX (Merck) on approximately 26-JUL-2010. The patient was seen at an emergent care facility and was given a prescription for VALTREX. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Information has been received concerning a 61 year old female physician assistant with allergy to DESYREL and no pertinent medical history who on 26-AUG-2010 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot # unknown). Concomitant therapy included metoprolol, levothyroxine Na, PROZAC, PROTONIX, MIRAPEX, simvastatin (Manufacturer unknown), montelukast sodium (MSD) and FLEXERIL. The patient stated that on 27-AUG-2010 she developed a local injection site reaction after receiving ZOSTAVAX (Merck). She developed approximately a 5cm x 3cm rash and 15cm x 15cm hives at the site. No laboratory diagnostics studies were performed. At the time of report, the patient recovered from hives and some rash persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a nurse concerning a 61 year old male with high cholesterol, hypertension and allergy to LIPITOR (muscle aching), pravastatin (muscle aching), colestipol (muscle aching) who on 02-JUL-2010 was vaccinated with ZOSTAVAX (Merck) S.C. 0.65ml (therapy site unknown). Concomitant therapy included atenolol, aspirin, omega-3 marine triglycerides, chondroitin sulfate sodium (+) glucosamine sulfate and vitamins (unspecified). On 06-JUL-2010 the patient experienced shingles and a vesicular rash on his right forearm. The patient sought medical attention. At the time of this report, the patient's shingles and vesicular rash on his right forearm persisted. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Initial and follow-up information have been received from a physician concerning an 83 year old female with drug allergy to bisphosphonates and a history of intolerance to alendronate sodium (MSD, WAES 1007USA02286), and no other medical history who on the evening of 12-JUL-2010 was vaccinated subcutaneously into the left arm with a standard dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included simvastatin (manufacture unknown), vitamins (unspecified), aspirin, senna and glucosamine. The patient was not recently exposed to shingles. On 13-JUL-2010 (also reported as 15-JUL-2010, 24 hours since vaccine exposure) the patient experienced shingles like rash on her right temple, forehead and right side of face. It was described as a "burning rash". The rash did not occur at the injection site. The physician also reported that the rash type was varicella and was distributed on the right cheek and forehead with less than 20 of lesions. Maximum temperature was 97.8 F. The patient refused to provide any specimen. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash papular, Urticaria
Clinical narrative: Information has been received from a 60 year old female patient with nickel, neomycin and "THERMISEROL" and no pertinent medical history who on 10-AUG-2010 was vaccinated with 0.65 ml dose of ZOSTAVAX (Merck) (route and Lot# Not reported). Concomitant therapy included FLONASE, thyroid medicine, "e-strain" and vitamins (manufacturer unspecified). The caller stated that she had received the ZOSTAVAX (Merck) and "about 4 to 5 weeks later". "About mid-September" on approximately 15-SEP-2010, broke out in a pimply, acne-like rash accompanied with bad itching and hive-like rash on her trunk, upper leg and thigh and backside. Three biopsies were performed as a laboratories diagnostics studies to determine cause of rash (results not reported). At the time of the report the patient's outcome was recovering. The patient sought unspecified medical attention. Follow-up information has been received from the physician who reported that retired female patient with no allergies at the time of vaccination and nickel, AUGMENTIN, erythromycin, formaldehyde, neomycin and thimerosal pre-existing allergies. Concomitant therapy included PRILOSEC, aspirin, levothyroxine sodium.  The physician stated that in October 2010 the patient experienced a very pruritic rash on trunk and proximal to thighs. Two skin biopsies were performed that were unremarkable. The physician also stated that the rash lasted 2 to 3 months. The physician claimed that the patient was seen by two separate dermatologists and he did not have those records. In February 2011, the patient recovered. No further information is available.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning an approximately 65 year old female with no medical history who in approximately September 2009 (fall of 2009), was vaccinated with ZOSTAVAX (Merck) (lot# not reported). There was no concomitant medication. In July 2010, the patient experienced developed shingles in the groin area. The nurse would check with the physician to see if testing was desired. Unspecified medical attention was sought. The outcome of the event was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a 66 year old female with hypothyroidism and osteoarthritis and no allergies who on 22-SEP-2010 was vaccinated with a dose of 0.5 ml of PNEUMOVAX 23 (lot # 667136/0499Z, expire date 25-NOV-2011) intramuscularly. Concomitant therapy included NEURONTIN, CARDIZEM, LEVOXYL, IMITREX, calcium (unspecified) (+) vitamin D (unspecified) and PROZAC. On 23-SEP-2010 it was reported that patient awoke with pain, redness and induration of right deltoid and was treated with TYLENOL and ice packs. The patient was insured if she had received the vaccine in the past but the office had no record of previous vaccination. At the time of the report the patient was recovering. The patient sought unspecified medical attention. There were no laboratories diagnostics studies performed. Additional information has been requested.