chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Varicella
Clinical narrative: Information has been received from a certified medical assistant concerning a 72 year old female with hypertension, high blood lipids, depression, gastrooesophageal reflux disease, a penicillin allergy, an allergy to streptomycin, and a hypersensitivity to Sprite, who on 19-JUN-2007 was vaccinated intramuscularly in the right arm with a dose of Zostavax (Oka/Merck).  Concomitant therapy included ezetimibe (MSD), ZESTRIL, hydrochlorothiazide (manufacturer unknown), LIPITOR, ZOLOFT, PROTONIX and ATIVAN.  On 04-JUL-2007 the patient developed a rash and itch at the axillary area of her right arm which spread to her trunk and face.  On 10-JUL-2007 the patient was diagnosed with chicken pox.  Unspecified medical attention was sought.  At the time of this report the patient was recovering.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 03-JUL-2007 was vaccinated with Zostavax (Oka/Merck) instead of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (MSD).  The incident was a mistake and was not due to product confusion.  The patients did not experienced any kind of symptoms.  This is one of several reports from the same patient.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Rash vesicular, Virus serology test
Clinical narrative: Information has been received from a health professional concerning a 60 year old female nurse who was vaccinating a patient with a dose of Zostavax (Oka/Merck).  It was reported that the vaccine was splashed on her arm and she washed the arm off.  Three hours later she developed a chickenpox looking rash on her arm.  The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biologic samples to be analyzed by PCR to identify if VZV is present and if it is present to identify whether it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain.  It was reported that the source of specimen for VZVIP program was collected from arm.  A VZV DNA and B-globin DNA amplification was not done.  The specimen collected was insufficient for analysis.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a physician concerning a female in remission from cancer who on 06-JUL-2007 was vaccinated with Zostavax (Oka/Merck) single series dose. On 09-JUL-2007 the patient went back to the physician's office with a bad case of zoster.  As of 10-JUL-2007, the patient had not recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2007. Follow-up information received indicated that this 67 year old female had shoulder pain, osteoporosis and a history of lymphoma at the time of vaccination. At 09:49 on 02-JUL-2007 the patient was vaccinated SC in the left arm with a first dose of ZOSTAVAX (Merck) (lot # 657764/0584U). On 05-JUL-2007 (previously reported as 09-JUL-2007) the patient developed shingles which was also described as a rash and pain. Medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 75 year old female who in July 2007, was vaccinated with a single dose of Zostavax (Oka/Merck).  It was reported that on 05-JUL-2007, after vaccination the patient developed a rash.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Medication error, No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from an other health professional concerning eight kids who were accidentally vaccinated with Zostavax (Oka/Merck) instead of Varivax (Oka/Merck).  The physician reported that the vaccine looked alike and were labeled almost identically.  No adverse events were reported.  Additional information is not expected.
Age: 96.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Information has been received from a pharmacist concerning a 92 year old female with sulfonamide allergy who on 29-JUN-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck) (lot # 656394/0162U).  On 11-JUL-2007 the patient developed blisters all over on her arms, behind her knees and on her back.  It was reported that the patient did  not have prior history of shingles.  The pharmacist referred the patient to her physician.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been received from the pharmacist who stated that the patient developed rash and she thought it as shingles.  The physician determined it was not related to vaccine.  At the time of report the patient had recovered.  No further information is expected.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 5 year old female who on 11-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck) instead of a dose of Varivax (Oka/Merck).  No problem was reported.  It was reported that it was not a product confusion but was a medication error.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Eye infection, Eye pain
Clinical narrative: Information has been received from a physician concerning a female who was a caregiver to a patient who on 09-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot # 657767/0740U).  It was reported that while the patient was assisting an elderly patient who was receiving the vaccine.  At some point during the administration of the vaccine the caregiver believed that her eyes were exposed to a splash of the vaccine.  The caregiver was advised to rinse her eye with water.  On 10-JUL-2007 the caregiver experienced soreness in the affected eye.  The patient went to the emergency room and it was determined that she had a slight infection in the affected eye.  Unspecified medical attention was undertaken.  A product quality complaint was not involved.  Additional information has been requested. Follow-up information received 4/16/08 indicated that the reporter had "no recall of any known reaction" following vaccination with zoster vaccine live (Oka/Merck). No further information is expected.  This is in follow-up to report (s) previously submitted on 9/24/2007.  Information has been received from a physician concerning a female who was a caregiver to a patient who on 09-JUL-2007 was vaccinated with a dose of ZOSTAVAX (lot # 657767/0740U).  It was reported that while the patient was assisting an elderly patient who was receiving vaccine.  At some point during the administration of the vaccine the caregiver believed that her eyes were exposed to a splash of the vaccine.  The caregiver was advised to rinse her eye with water.  On 10-JUL-2007 the caregiver experienced soreness in the affected eye.  The patient went to the emergency room and it was determined that she had a slight infection in the affected eye.  Unspecified medical attention was undertaken.  A product quality complaint was not involved.  No further information is expected.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old patient who on 17-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (MSD).  She did not know if it was product confusion but felt it was human error only.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial and follow up information has been received from a registered nurse concerning a 12 month old patient who on 17-AUG-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) (MSD). The nurse learned of the event second hand from a co worker, and did not know the physician's name, the lot number or have any patient information. The nurse reported that the event was "just human error" that the patient received ZOSTAVAX (Oka/Merck), since the packaging was not similar. The patient did not experience any adverse event following the vaccination. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Local reaction, Oedema peripheral, Pain
Clinical narrative: Information has been received from a female (age not reported) with a history of Bell's palsy, herpes virus infection and allergy to sting and bites which have repeatedly resulted in major inflammations, welts, heavy itching and even infection, who on 09-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  "On approximately 10-AUG-2007 the patient reported that her arm was painful and inflamed.  On approximately, Saturday 11-AUG-2007, the inflammation covered an area about 6" x 4".  It was deep red surrounded by deep pink with a white edge, painful and swollen.  The patient reported she iced it over the weekend, and planned to call her doctor by the following Monday morning if the inflammation had not diminished.  On approximately, Monday 13-AUG-2007, it seemed a bit easier, but by afternoon the pain had increased - a mildly itchy, peculiarly stinging pain she evaluated at about 6 out of ten - so a nurse practitioner looked at it, deciding it was a localized reaction to the shot and prescribing Motrin and more icing, which helped.  The patient reported that by approximately 17-AUG-2007, the affected area was flat, with just a stain of darker skin where the deep red had been.  It was still somewhat painful, as is the muscle, which hurts when she has to reach high for something.  No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Skin discolouration
Clinical narrative: Information has been received from a female (age not reported) with a history of Bell's palsy, herpes virus infection and allergy to sting and bites which have repeatedly resulted in major inflammations, welts, heavy itching and even infection, who on 09-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  "On approximately 10-AUG-2007 the patient reported that her arm was painful and inflamed.  On approximately, Saturday 11-AUG-2007, the inflammation covered an area about 6" x 4".  It was deep red surrounded by deep pink with a white edge, painful and swollen.  The patient reported she iced it over the weekend, and planned to call her doctor by the following Monday morning if the inflammation had not diminished.  On approximately, Monday 13-AUG-2007, it seemed a bit easier, but by afternoon the pain had increased - a mildly itchy, peculiarly stinging pain she evaluated at about 6 out of ten - so a nurse practitioner looked at it, deciding it was a localized reaction to the shot and prescribing Motrin and more icing, which helped.  The patient reported that by approximately 17-AUG-2007, the affected area was flat, with just a stain of darker skin where the deep red had been.  It was still somewhat painful, as is the muscle, which hurts when she has to reach high for something.  No further information is available.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Gout
Clinical narrative: Information has been received from a consumer concerning her 75 year old husband with no known allergies or pertinent medical history who on 12-JUN-2007 was vaccinated SC with a 0.65 ml one time dose of Zostavax (Oka/Merck).  Concomitant therapy included ezetimibe (MSD) and FLOMAX.  About a week after the vaccination on approximately 19-JUN-2007 the patient developed gout in his feet and it " keeps getting worse".  Unspecified medical attention was sought.  No lab studies were performed.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a consumer concerning a male who " a couple of months ago" was vaccinated with a dose of Zostavax (Oka/Merck).  On 13-AUG-2007 the patient's spouse was diagnosed with shingles.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician concerning an "approximately 70 year old" male who in "July" 2007, was vaccinated with a 0.65 mL dose of Zostavax (Oka/Merck) (lot # not reported).  In "July" 2007, the patient developed ophthalmic zoster within two weeks of receiving a dose of Zostavax (Oka/Merck).  The patient sought unspecified medical attention.  The patient's ophthalmic zoster persisted.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2007.  On an unspecified date "patient has had a complete recovery from herpes zoster".  There was no product quality complaint.  Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a 79-year-old female with no reported medical history or allergies, who on 27-JUN-2007, was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included HCTZ/triamterene, ACTONEL and LEVOXYL.  On 02-JUL-2007, the patient developed blisters on the left side of her upper torso which stretched from her chest area to under her left arm and on the left side of her back.  The patient went to her physician and she was diagnosed with shingles.  The blisters have occasionally caused her some stabbing pains.  The patient reported that on one occasion, the blisters began to bleed when she made a sudden arm movement. As of 17-AUG-2007, the blisters had dried up and she had some scarring.  The patient stated that the dried up blisters felt like a bad sunburn and the stabbing pains have diminished somewhat.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/24/2007. Follow-up information has been received from a physician's assistant concerning a 79-year-old retired female with hypertension, osteoarthritis, hypothyroidism and osteopenia who was vaccinated intramuscularly in the left arm on the morning of 27-Jun-2007 with a first fose of ZOSTAVAX (Merck). There was no illness at the time of vaccination. Concomitant medications included: hydrochlorotiazide (+) triamterene and LEVOXYL, ACTONEL and prediem-otc". On 02-Jul-2007 (also reported as 06-JUL-2007) she developed a vesicular eruption in a dermatomal pattern under the left axillia, across left chest and left upper back that was diagnosed as shingles. It was reported that the patient was seen for office visits on 11-JUL-2007 and 15-AUG-2007. The patient experienced burning, pain, and tenderness. She was treated with VALTREX. 1 gram, TID x 7 days. On 03-Aug-2007 her condition was not improving and she was diagnosed with postherpetic neuralgia and was prescribed NEURONTIN 300 miligrams, PO before bed. On 15-Aug-2007, the NEURONTIN was increased to 300 miligrams, PO, TID for postherpetic neuralgia. No laboratory or diagnostic tests were performed. At the time of the report the patient had not recovered. additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Scar, Tenderness
Clinical narrative: Information has been received from a 79-year-old female with no reported medical history or allergies, who on 27-JUN-2007, was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included HCTZ/triamterene, ACTONEL and LEVOXYL.  On 02-JUL-2007, the patient developed blisters on the left side of her upper torso which stretched from her chest area to under her left arm and on the left side of her back.  The patient went to her physician and she was diagnosed with shingles.  The blisters have occasionally caused her some stabbing pains.  The patient reported that on one occasion, the blisters began to bleed when she made a sudden arm movement. As of 17-AUG-2007, the blisters had dried up and she had some scarring.  The patient stated that the dried up blisters felt like a bad sunburn and the stabbing pains have diminished somewhat.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/24/2007. Follow-up information has been received from a physician's assistant concerning a 79-year-old retired female with hypertension, osteoarthritis, hypothyroidism and osteopenia who was vaccinated intramuscularly in the left arm on the morning of 27-Jun-2007 with a first fose of ZOSTAVAX (Merck). There was no illness at the time of vaccination. Concomitant medications included: hydrochlorotiazide (+) triamterene and LEVOXYL, ACTONEL and prediem-otc". On 02-Jul-2007 (also reported as 06-JUL-2007) she developed a vesicular eruption in a dermatomal pattern under the left axillia, across left chest and left upper back that was diagnosed as shingles. It was reported that the patient was seen for office visits on 11-JUL-2007 and 15-AUG-2007. The patient experienced burning, pain, and tenderness. She was treated with VALTREX. 1 gram, TID x 7 days. On 03-Aug-2007 her condition was not improving and she was diagnosed with postherpetic neuralgia and was prescribed NEURONTIN 300 miligrams, PO before bed. On 15-Aug-2007, the NEURONTIN was increased to 300 miligrams, PO, TID for postherpetic neuralgia. No laboratory or diagnostic tests were performed. At the time of the report the patient had not recovered. additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning 4 patients (ages and gender no reported) who on 13-JUL-2007 were vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck).  No adverse events were reported.  The physician reported that the wrong container of medications were picked up from the pharmacy and it was not a product confusion.  Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old female who on 07-AUG-2007 was vaccinated with Zostavax (Oka/Merck) (Lot #658086/0761U).  On 09-AUG-2007 the patient experienced a break out of zoster in her facial area.  The break out was on the right side of her face and mouth area.  The pharmacist administered the vaccination and the patient did go to her physician and she also saw a dentist.  As of 17-AUG-2007, the patient was recovering.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who, on 15-AUG-2007, was vaccinated with Zostavax (Oka/Merck, Lot #657676/0619U) in the left deltoid.  No information was provided with regard to the patient's medical history and concomitant therapy.  Subsequently, on 19-AUG-2007, the patient developed shingles on the left lower medial arm.  In follow-up it was reported the patient had no recent exposure to chickenpox or herpes zoster.  No direct fluorescent antibody was performed.  no specimen was collected for PCR, and not photographs were taken.  The patient also experienced a headache.  The patient outcomes were not reported.  Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature, CSF glucose increased, CSF protein normal, CSF white blood cell count positive, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 75 year old male with an allergy to dye who on 05-APR-2007 was vaccinated in the left deltoid with a 0.5 mL of Zostavax (Oka/Merck) (lot# 656609/0015U).  Concomitant therapy included vitamins (unspecified), glucosamine, ADVIL, simvastatin (MSD), PLAVIX, ALAVERT and TYLENOL PM EXTRA STRENGTH.  On 05-JUL-2007 the patient experienced a bad outbreak of shingles after receiving the vaccination on 05-APR-2007.  The patient went to the emergency room where he was diagnosed with shingles at dermatome T10.  Lab tests included cerebral spinal fluid results of protein was negative, glucose 98, RBC 4.29 and WBC 540.  Temperature 98.1.  Pain 6/10.  The patient contacted his physician the following week because he was experiencing tremendous pain.  He was treated with pain medication.  The physician also noted that this was the worst case of shingles that she had ever seen.  As of 20-AUG-2007 the patient was recovered.  Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Red blood cells CSF positive
Clinical narrative: Information has been received from a physician concerning a 75 year old male with an allergy to dye who on 05-APR-2007 was vaccinated in the left deltoid with a 0.5 mL of Zostavax (Oka/Merck) (lot# 656609/0015U).  Concomitant therapy included vitamins (unspecified), glucosamine, ADVIL, simvastatin (MSD), PLAVIX, ALAVERT and TYLENOL PM EXTRA STRENGTH.  On 05-JUL-2007 the patient experienced a bad outbreak of shingles after receiving the vaccination on 05-APR-2007.  The patient went to the emergency room where he was diagnosed with shingles at dermatome T10.  Lab tests included cerebral spinal fluid results of protein was negative, glucose 98, RBC 4.29 and WBC 540.  Temperature 98.1.  Pain 6/10.  The patient contacted his physician the following week because he was experiencing tremendous pain.  He was treated with pain medication.  The physician also noted that this was the worst case of shingles that she had ever seen.  As of 20-AUG-2007 the patient was recovered.  Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient experienced redness at the injection site.  No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a 65 year old female with a penicillin allergy who on 17-AUG-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included lisinopril (manufacturer not provided) and lovastatin (manufacturer not provided).  On 17-AUG-2007 the patient developed local redness and itching at the injection site. In 2007, the  patient recovered from the local redness and itching at the injection site. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with Zostavax (Oka/Merck) (lot658082/0744U).  On the second day after vaccination, the patient developed a dark red, hot to touch and itchy, 3 inch injection site reaction.  On day 3 the redness decreased but the site became lumpy.  The patient was treated with TYLENOL and cool compresses.  This is one report of several reports received from the same source.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a male who was vaccinated with Zostavax (Oka/Merck) (lot658082/0744U).  On the second day after vaccination, the patient developed a dark red, hot to touch and itchy, 3 inch injection site reaction.  On day 3 the redness decreased but the site became lumpy.  The patient was treated with TYLENOL and cool compresses.  This is one report of several reports received from the same source.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Information has been received from a physician concerning a male who, "two weeks ago," on approximately 07-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  "Two weeks ago," on approximately 07-AUG-2007 the patient experienced a localized redness reaction where the injection site was.  Unspecified medical attention was sought.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 80 year old female who was vaccinated with a dose of Zostavax (Oka/Merck).  Approximately 6 months after receiving the vaccine the patient experienced shingles.  Unspecified medical attention was sought.  No product quality complaint.  Outcome of patient was unknown.  No further information is available.
Age: 8.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from an office manager concerning an 8 year old female who on 20-AUG-2007 was vaccinated with Zostavax (Oka/Merck) instead of Varivax (Oka/Merck).  No adverse experience was reported.  Unspecified medical attention was sought.  It was also reported that the patient's sister also received a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (WAES # 0708USA04612).  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a male (approximately 4 years of age to 15 years of age) who on 01-AUG-2007 was vaccinated with Zostavax (Oka/Merck, lot # 657558/0461U) instead of Varivax (MSD).  Subsequently no adverse experiences have been reported.  Unspecified medical attention was sought.  This is one of several reports received from the same source.  Additional information has been requested.  The nurse reported in follow-up that the packaging for the ZOSTAVAX (Merck) and VARIVAX was similar and the 2 vaccines werew stored in the same freezer. The VARIVAX had run out and the ZOSTAVAX (Merck) was picked mistakenly. The nurse hoped to avoid this event in the future. There have been positive results noted from the parents of the vaccinated child.  This is one of several reports received from the same source.  Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Granulocytes abnormal, Herpes zoster, Monocyte count increased, Pain, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a female who "last week" was vaccinated with a single dose of Zostavax (Oka/Merck).  In August 2007, the patient came back in to the office and she had shingles on the patient's thoracic area.  The patient was not immunocompromised.  Medical attention was sought and the physician put the patient on an antiviral medication.  The patient was recovering.  No product quality complaint was involved.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial and follow up information has been received from a physician concerning a 77 year old female with a history of allergic reaction to E-MYCIN, KEFLEX, DORYX, MACRODANTIN, sulfonamide allergy and an ULTRAM allergy who on 02-AUG-2007 at 10:55 was vaccinated SC in the left arm with a first dose of ZOSTAVAX (Oka/Merck) (Lot#658086/0761U). The patient was not immunocompromised at the time of vaccination. There was no illness at the time of vaccination. On 08-AUG-2007 the patient developed red lesions on the left side of her abdomen and a little bit on the lateral side of her rib cage. This had been "very painful" for her. The patient was diagnosed with shingles on her thoracic area. Medical attention was sought on 10-AUG-2007 and the physician prescribed FAMVIR 500 mg twice a day for 7 days. Additional therapy as of 10-AUG-2007 included calcium (unspecified), chondroitin sulfate sodium (+) glucosamine sulfate, CENTRUM, aspirin, VAGIFEM, cefaclor, MONUROL, rizatriptan benzoate (MSD), hydrocodone bitartrate, alendronate sodium (MSD) and LOPRESSOR. It was noted that as far as the physician knew, the patient does not have any history of being immunocomprised so he is going to check some basic lab work such as cell counts and things like these just to make sure nothing funny is going on. Lab studies were performed with abnormal results of WBC 11.3, Granulocyte % 78, Absolute Granulocyte of 8.8 and Absolute Monocyte of 1.1. The patient was recovering. There was no further information provided. No product quality complaint was involved. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: White blood cell disorder
Clinical narrative: Information has been received from a physician concerning a female who "last week" was vaccinated with a single dose of Zostavax (Oka/Merck).  In August 2007, the patient came back in to the office and she had shingles on the patient's thoracic area.  The patient was not immunocompromised.  Medical attention was sought and the physician put the patient on an antiviral medication.  The patient was recovering.  No product quality complaint was involved.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial and follow up information has been received from a physician concerning a 77 year old female with a history of allergic reaction to E-MYCIN, KEFLEX, DORYX, MACRODANTIN, sulfonamide allergy and an ULTRAM allergy who on 02-AUG-2007 at 10:55 was vaccinated SC in the left arm with a first dose of ZOSTAVAX (Oka/Merck) (Lot#658086/0761U). The patient was not immunocompromised at the time of vaccination. There was no illness at the time of vaccination. On 08-AUG-2007 the patient developed red lesions on the left side of her abdomen and a little bit on the lateral side of her rib cage. This had been "very painful" for her. The patient was diagnosed with shingles on her thoracic area. Medical attention was sought on 10-AUG-2007 and the physician prescribed FAMVIR 500 mg twice a day for 7 days. Additional therapy as of 10-AUG-2007 included calcium (unspecified), chondroitin sulfate sodium (+) glucosamine sulfate, CENTRUM, aspirin, VAGIFEM, cefaclor, MONUROL, rizatriptan benzoate (MSD), hydrocodone bitartrate, alendronate sodium (MSD) and LOPRESSOR. It was noted that as far as the physician knew, the patient does not have any history of being immunocomprised so he is going to check some basic lab work such as cell counts and things like these just to make sure nothing funny is going on. Lab studies were performed with abnormal results of WBC 11.3, Granulocyte % 78, Absolute Granulocyte of 8.8 and Absolute Monocyte of 1.1. The patient was recovering. There was no further information provided. No product quality complaint was involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site warmth, Nausea
Clinical narrative: Information has been received from a 69 year old female with a history of shingles at age 32 who on 08-AUG-2007 at 15:00 PM was vaccinated with a dose of Zostavax (Oka/Merck). Exactly 24 hours later, on 09-AUG-2007 at 15:00, the injection site was red, hot, and hard and about 3.5 inches in diameter.  Soon after that, chills, fever, and nausea set in.  On 10-AUG-2007, the size, redness, hotness, and hardness had reduced in size to a bit bigger than a silver dollar.  The chills and fever had abated and the nausea was gone.  The reporter noticed that these were certainly not bad side effects compared to actually having a bad case of shingles.  She was going to have her physician take a look at the injection site in a few hours and take whatever actions she deemed was necessary.  No further information is available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Information has been received from a 69 year old female with a history of shingles at age 32 who on 08-AUG-2007 at 15:00 PM was vaccinated with a dose of Zostavax (Oka/Merck). Exactly 24 hours later, on 09-AUG-2007 at 15:00, the injection site was red, hot, and hard and about 3.5 inches in diameter.  Soon after that, chills, fever, and nausea set in.  On 10-AUG-2007, the size, redness, hotness, and hardness had reduced in size to a bit bigger than a silver dollar.  The chills and fever had abated and the nausea was gone.  The reporter noticed that these were certainly not bad side effects compared to actually having a bad case of shingles.  She was going to have her physician take a look at the injection site in a few hours and take whatever actions she deemed was necessary.  No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pain, Injection site rash, Musculoskeletal pain, Neck pain
Clinical narrative: Information has been received from a 68 year old female with migraines, high blood pressure, an allergy to penicillin and DILANTIN, a history of chickenpox, and whose mother was noted to have suffered from shingles who on 31-JUL-2007 was vaccinated IM in the left arm with a dose of Zostavax (Oka/Merck).  Concomitant therapy included LOPRESSOR, hydrochlorothiazide, CALTRATE in the morning, CALTRATE + D in the evening, ascorbic acid, CENTRUM SILVER, codeine as needed for migraines, and FIOICET TABLETS as needed for migraines.  On 01-AUG-2007, the patient developed a rash at the injection site.  Then she developed pain in her left arm which included her left shoulder and left side of her neck.  She also experienced a stinging sensation at the injection site.  She also mentioned that she was experiencing pain in her right arm; however, she was carrying a heavy basket which may have contributed to the pain.  She consulted her physician who indicated that these were normal reactions to the vaccine.  She also reported that the reactions were worse as time went by.  The patient reported that on the evening of 15-AUG-2007, she experienced "four sting-like" sensations in her left arm, near the injection site.  She also developed a rash on her back near her neck.  She was still experiencing burning sensations in her left arm.  Unspecified medical attention was sought.  No diagnostic laboratory tests were performed.  At the time of the report, the patient had not recovered.  Follow-up information received on 22-Aug-2007 from the consumer states that the burning sensation has worsened and is now in her arm, back, neck and face.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Information has been received from a 68 year old female with migraines, high blood pressure, an allergy to penicillin and DILANTIN, a history of chickenpox, and whose mother was noted to have suffered from shingles who on 31-JUL-2007 was vaccinated IM in the left arm with a dose of Zostavax (Oka/Merck).  Concomitant therapy included LOPRESSOR, hydrochlorothiazide, CALTRATE in the morning, CALTRATE + D in the evening, ascorbic acid, CENTRUM SILVER, codeine as needed for migraines, and FIOICET TABLETS as needed for migraines.  On 01-AUG-2007, the patient developed a rash at the injection site.  Then she developed pain in her left arm which included her left shoulder and left side of her neck.  She also experienced a stinging sensation at the injection site.  She also mentioned that she was experiencing pain in her right arm; however, she was carrying a heavy basket which may have contributed to the pain.  She consulted her physician who indicated that these were normal reactions to the vaccine.  She also reported that the reactions were worse as time went by.  The patient reported that on the evening of 15-AUG-2007, she experienced "four sting-like" sensations in her left arm, near the injection site.  She also developed a rash on her back near her neck.  She was still experiencing burning sensations in her left arm.  Unspecified medical attention was sought.  No diagnostic laboratory tests were performed.  At the time of the report, the patient had not recovered.  Follow-up information received on 22-Aug-2007 from the consumer states that the burning sensation has worsened and is now in her arm, back, neck and face.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Skin lesion
Clinical narrative: Information has been received from a 64 year old female with an allergy to tetracycline and a history of food allergy when she was younger who on 07-AUG-2007 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck).  Concomitant therapy included EVISTA, ezetimibe (MSD), over-the-counter calcium (unspecified) and a daily multi-vitamin (unspecified).  On approximately 07-AUG-2007, the patient developed a quarter sized redness and itching at the injection site.  She also had two spots underneath her right arm on the right, one spot was two inches below the other one.  She had no pain but was wondering if it could be an outbreak of shingles.  She noted that should would contact her physician.  No medical attention was sought and no diagnostic laboratory tests were performed.  At the time of the report, she had not recovered.  A product quality complaint was not involved.  No further information is available.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Gait disturbance, Myalgia, Walking aid user
Clinical narrative: Information has been received from an 88-year-old female consumer with no pertinent medical history who has an allergy to codeine, who on 02-AUG-2007 was vaccinated with a 0.65 milliliter dose of Zostavax (Oka/Merck).  Concomitant therapy included SYNTHROID and vitamins (unspecified).  "A couple days after the shot", on approximately 04-Aug-2007, the patient experienced fatigue, muscle pain in arms and legs, weakness and difficulty walking. It was reported that no medical attention was sought.  No laboratory or diagnostic tests were performed.  The outcome is reported as recovering.  No product quality complaint was involved.  Additional information received on 24-Aug-2007 from the consumer indicates that she is still experiencing fatigue and muscle weakness.  She has difficulty walking a uses a cane or walker.  Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female consumer who in January of 2007 was vaccinated with a 0.65 milliliter dose of Zostavax (Oka/Merck).  On 11-JUN-2007 the patient developed shingles.  Unspecified medical attention was sought.  The outcome has not been reported.  No product quality complaint was issued.  No further information is available. Follow-up information received indicates that the patient is 76-year-old and sought medical attention on 19-Jul-2007. She was instructed to continue with her usual medications, given wound care instructions, to return if area becomes red, swollen or warm, and given follow-up information. On 24-Jul-2007, the patient sought medical attention again. She was administered AVELOX 400 mg once a day for 7 days, LOTRISONE Cream twice a day for 5 dayd, and NASACORT. She was instructed to call if symptoms increased, or if she developed a fever or became short of breath. No further information is available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Information has been received from a male who on 17-MAY-2007 was vaccinated with Zostavax (Oka/Merck).  On 17-MAY-2007 the patient experienced an aching arm and not being able to move his arm in certain ways.  As of 13-AUG-2007, the patient had not recovered.  No further information is available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site anaesthesia, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a male who on 17-MAY-2007 was vaccinated with Zostavax (Oka/Merck).  On 17-MAY-2007 the patient experienced an aching arm and not being able to move his arm in certain ways.  As of 13-AUG-2007, the patient had not recovered.  No further information is available.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Information has been received from a 67 year old male consumer with hyperlipidaemia and an allergy to sulfonamide who on 17-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck) on the right arm.  Concomitant therapy included simvastatin (manufacturer unspecified), esomeprazole (manufacturer unspecified) and aspirin.  On 17-MAY-2007 the patient experienced numbness, warmth and muscle pain at the injection site.  Medical attention was sought.  The patient's numbness, warmth and muscle pain at the injection site persisted.  No product quality complaint was involved.  Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site anaesthesia, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a 67 year old male consumer with hyperlipidaemia and an allergy to sulfonamide who on 17-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck) on the right arm.  Concomitant therapy included simvastatin (manufacturer unspecified), esomeprazole (manufacturer unspecified) and aspirin.  On 17-MAY-2007 the patient experienced numbness, warmth and muscle pain at the injection site.  Medical attention was sought.  The patient's numbness, warmth and muscle pain at the injection site persisted.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a registered nurse concerning a patient (age and gender not reported) who in approximately July 2007 (approximately a month ago), was vaccinated with a dose of Zostavax (Oka/Merck) (lot# not reported).  Subsequently the patient experienced "some type of allergic reaction."  The outcome was not reported.  There were no product quality complaint.  Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a physician concerning an 80 year old female with a history of thrombin who on 24-APR-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included gabapentin.  On 08-JUN-2007 the patient experienced tingling on the right side of stomach.  Medical attention was sought.  The patient's tingling on the right side of stomach persisted.  No product quality complaint was involved.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a physician concerning an 80 year old female with no known allergies and a history of "throbin" who on 24-APR-2007 was vaccinated in the right hip with a first dose of ZOSTAVAX (Oka/Merck) (Lot#652925/0621F). On 08-JUN-2007 the patient developed tingling on the right side of her stomach. Medical attention was sought. The patient's tingling on the right side of stomach persisted. No product quality complaint was involved. Follow up information from the patient indicated that on an unspecified date both of her hands started tingling and throbbing. Her physician prescribed gabapentin which was making her dizzy. Additional follow up information from the physician indicated that the patient's adverse events started on 14-MAY-2007, but the patient first complained to the doctor on 08-JUN-2007. It was noted that the patient's problems continued through 10-SEP-2007. An exam was performed and was "normal". There was no recent exposure to chicken pox or shingles, and no rash occurred at the site of injection or elsewhere within 42 days of vaccination. No further information was provided. Follow-up information was received from the physician which indicated that the patient's tingling, numb hands have persisted. On 08-OCT-2007, the patient underwent a nerve conduction study which revealed carpal tunnel. The physician did not feel the patient's symptoms were related to ZOSTAVAX. No additional information is expected.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Facial pain, Herpes zoster, Lip swelling
Clinical narrative: Information has been received from a 77 year old male consumer who in winter 2006 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included simvastatin (manufacturer unspecified), lisinopril and SYNTHROID.  On approximately 03-AUG-2007 "about 10 days ago" the patient experienced a breakthrough shingles.  The patient had blisters on lips which were swollen.  It hurts and was red under his lips at the jaw and around left ear.  He went to a dermatologist who said it was from the trigeminal nerves and diagnosed the shingles on 13-Aug-2007.  Dermatologist prescribed VALTREX and a cream (unspecified).  The patient's shingles persisted.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who on 25-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot # not provided).  The patient started to notice bumps that were chicken pox like bumps on 26-JUL-2007.  The patient called the physician on 07-AUG-2007 reporting that they had more bumps.  The outcome was not reported.  No further information is available.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Paraesthesia oral, Rash, Stomatitis
Clinical narrative: Information has been received from a pharmacist concerning an 83 year old female with osteoarthritis, hypertension, hyperlipidaemia and allergies to xylocaine and epinephrine who in July 2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included TENORMIN, ACCUPRIL, hydrochlorothiazide and AROMASIN.  On 07-AUG-2007 the patient started to experience shingles-like symptoms that included sores on both sides of her mouth, swelling of the lips, tingling sensation in her lips and rash on each cheek, forehead and one of her hands.  As of 13-AUG-2007, the patient had not recovered from her experiences.  Medical attention was sought.  Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 75 year old male who in approximately February 2007, was vaccinated with Zostavax (Oka/Merck) and shortly after developed shingles.  The patient recovered from shingles.  Medical attention was sought.  No further information is available.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning a 50 year old female with diabetes who on 23-JUL-2007 was vaccinated with Zostavax (Oka/Merck).  On 11-AUG-2007 the patient experienced Bell's palsy.  As of 13-AUG-2007, the patient had not recovered.  Additional information has been requested.