chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Malaise, Polymerase chain reaction, Pruritus
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning an 87 year old female with an allergy to BENADRYL and a history of chickenpox and all childhood diseases, who on 24-JUL-2007 was vaccinated subcutaneously in the left arm with a dose of 0.65 milliliters of Zostavax (Oka/Merck) (Lot #656858/0356U).  Concomitant therapy included hydrochlorothiazide (manufacturer unknown), simvastatin (manufacturer unknown), omeprazole (MSD) and PREMARIN.  On 06-AUG-2007 prodromal symptoms began and she developed 40+ vesicles (previously reported as 09-Aug-2007).  The patient experienced a varicella like rash on both legs buttocks and arms, upset stomach and didn't feel well.  The lesions were extremely itchy.  As of 13-AUG-2007, the patient was recovering.  Follow-up information received from nurse indicating that the patient was enrolled in a program to identify of VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The date that the herpes zoster was diagnosed and sample of the lesion was collected from a vesicle on 14-AUG-2007.  Follow-up results indicate the sample of the lesion was collected on 14-Aug-2007.  The sample was taken from a vesicle.  the PCR results for the specimen from the vesicle was negative for both the wild type varicella zoster virus and the vaccine strain virus. Follow-up information received indicates that the patient is a retired female. She was vaccinated on 24-JUL-2007 with a first dose of ZOSTAVAX. There was no illness at the time of vaccination. On an unspecified date, the patient recovered.  No more information is expected.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Stomach discomfort, Varicella virus test negative
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning an 87 year old female with an allergy to BENADRYL and a history of chickenpox and all childhood diseases, who on 24-JUL-2007 was vaccinated subcutaneously in the left arm with a dose of 0.65 milliliters of Zostavax (Oka/Merck) (Lot #656858/0356U).  Concomitant therapy included hydrochlorothiazide (manufacturer unknown), simvastatin (manufacturer unknown), omeprazole (MSD) and PREMARIN.  On 06-AUG-2007 prodromal symptoms began and she developed 40+ vesicles (previously reported as 09-Aug-2007).  The patient experienced a varicella like rash on both legs buttocks and arms, upset stomach and didn't feel well.  The lesions were extremely itchy.  As of 13-AUG-2007, the patient was recovering.  Follow-up information received from nurse indicating that the patient was enrolled in a program to identify of VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The date that the herpes zoster was diagnosed and sample of the lesion was collected from a vesicle on 14-AUG-2007.  Follow-up results indicate the sample of the lesion was collected on 14-Aug-2007.  The sample was taken from a vesicle.  the PCR results for the specimen from the vesicle was negative for both the wild type varicella zoster virus and the vaccine strain virus. Follow-up information received indicates that the patient is a retired female. She was vaccinated on 24-JUL-2007 with a first dose of ZOSTAVAX. There was no illness at the time of vaccination. On an unspecified date, the patient recovered.  No more information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown) who was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient experienced patient broke out in chicken pox after receiving Zostavax (Oka/Merck).  The outcome of the patient was unknown.  No product quality complaint.  Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a 62 year old male with leukaemia and a history of allergic reaction to LEVAQUIN who on 13-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included omeprazole (MSD).  Subsequently the patient experienced rash and itchiness on his back and leg.  The patient's rash and itchiness on his back and leg persisted.  Medical attention was not sought.  There was no product quality complaint involved.  No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old female with a history of "possible herpes simplex virus", and no known allergies, who on 25-MAY-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck) (Lot#652966/1211F).  It was noted that the patient had been taking VALTREX daily for 2 years to control the herpes simplex outbreaks, but discontinued it for 30 days prior to receiving the vaccine.  On 04-JUN-2007 (ten days after vaccination) the patient developed lesions in the same area as they had appeared prior to receiving the vaccination.  She started taking VALTREX again and her symptoms resolved.  The physician had her discontinue the VALTREX again for 30 days and her lesions reappeared.  Unspecified medical attention was sought.  No lab studies were performed.  At the time of this report the patient had not recovered.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report proviously submitted on 9/24/2007. Initial informationhas been received from a registered nurse concerning a 68 year old female with a history of "possible herpes simplex virus", and no known allergies, who on 250May-2007 was vaccinated subcutaneously with a dose of ZOSTER vaccine live (OKA/Merck) (Lot # 652965/1211F). It was noted that the patient had been taking VALTREX daily for 2 years to control the herpes simplex outbreaks, but discontineud it for 30 days prior to receiving the vaccine. On 04-JUN-2007 (ten days after vaccination) the patient developed lesions in the same area as the had appeared prior to receiving the vaccination. She started taking VALTREX again and her symptoms resolved. The physiciam had her discontinue the VALTREX again for 30 days and her lesions reappeared. Unspecified medical attention was sought. No lab studies were performed. At the time of this report the patient had not recovered. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the patient had been under treatment for a circular lesion on her right buttock "about the size of a 50 cent piece". This was being treated with VALTREX which would clear up the lesion but ten days after she stopped taking it the lesion would reappear. She received a first dose of ZOSTER vaccine live (Oka/Merck) (Lot # 652966/1211F) SC in the left arm on 25-MAY-2007 after she was off of VALTREX for 30 days. Ten days after vaccination the lesion reappeared. The patient thought that the vaccine caused the lesion to reappear. The patient's outcome was not reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot
Clinical narrative: Information has been received from a pharmacist concerning a female (age not reported) who on 14-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot # not reported).  On 14-AUG-2007 the patient experienced light headed.  Subsequently, the patient recovered from light headed.  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 pharmacist concerning a 68 year old female with no known allergies or pertinent medical history who on 14-AUG-2007 at 14:40 was vaccinated SC with a first dose of ZOSTAVAX (Oka/Merck) (lot # 656858/0356U). There was no illness at the time of vaccination. On 14-AUG-2007 at 14:45 the patient felt lightheaded and also stated that she felt like "waves of heat were going through her". Unspecified medical attention was sought, she sat for 15 minutes, drank water and "was fine". No lab studies were performed. The patient was considered recovered. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 65 to 70 year old male who "about 1.5 years ago" on an unspecified date in 2006 was vaccinated with a dose of Zostavax (Oka/Merck).  Five to 7 days after the vaccination the patient developed chicken pox.  Unspecified medical attention was sought.  Subsequently, the patient recovered from the chicken pox.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 15-AUG-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  On 15-AUG-2007 the patient developed redness and swelling at the injection site.  Unspecified medical attention was sought.  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.
Age: 4.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a physician concerning a 4 year old male who on 16-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot#657559/0462U), instead of Varivax (Oka/Merck) (MSD), in the thigh or the arm.  Physician confirmed this was staff error and not quality complaint.  Unspecified medical attention was sought.  There was no adverse event.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (MSD).  No adverse reactions were reported.  Medical attention was not sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2007.  Follow up information was received from the nurse who stated it was a case of the nurse picking up the wrong vaccine and not double checking the label to make sure she had the right vaccine.  The nurse reported that the patient is a healthy young lady with no contraindications and fortunately did not experience any untoward effects.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning 3 patients who on unspecified dates were vaccinated with doses of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (MSD).  There were no known symptoms reported.  The incident was "due to human error". There was no further information provided.  There was no product quality complaint involved.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a physician and registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) (MSD). There were no known symptoms reported. The incident was "due to human error". There was no further information provided. There was no product quality complaint involved. This is one of several reports from the same source. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 75 year old female consumer with a history of shingles who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed shingles.  No further information was provided.  Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an approximately 83 year old female who on 01-AUG-2007 or 02-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 02-AUG-2007 or 03-AUG-2007 (the day after receiving vaccine) the patient developed shingles.  The diagnosis was made by an unspecified dermatologist.  No other 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 physician concerning an 83 year old female with hypertension, hyperlipidemia, anemia, and osteoporosis, who on 01-AUG-2007 at 14:45 was vaccinated SC in the right arm with a first dose of ZOSTAVAX (Oka/Merck) (Lot#658081/0743U). On 01-AUG-2007 in the evening the patient developed shingles. There was a non painful eruption of the left thigh, left lower leg and left medial ankle. The diagnosis was made by a dermatologist who saw the patient on 06-AUG-2007. It was noted that she had characteristic herpes zoster probably of the sacral dermatome on the left. The physician prescribed valacyclovir 1 gm orally three times a day for 1 week. No other information was provided. There was no product quality complaint involved. On an unknown date the patient recovered. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Headache, Tinnitus
Clinical narrative: Information has been received from an 82 year old female consumer with a history of shingles (February and April) who on 08-MAY-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  Concomitant therapy included calcium (unspecified) and vitamins (unspecified).  In "early June 2007" the patient developed an echoing in her ear and a headache in her forehead.  Unspecified medical attention was sought.  A hearing test was performed results not reported.  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.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 1 year old patient who on 08-JUN-2007 was vaccinated subcutaneously with a 0.65 ml dose of Zostavax (Oka/Merck).  There were no symptoms noted.  No further information was provided.  There was no product quality complaint involved.  Follow up information was received from the physician who said that the patient was supposed to receive a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (MSD) instead of Zostavax (Oka/Merck).  "A staff member at the office though they had a ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) vial out of the box in the freezer, but instead a vial of Zostavax (Oka/Merck) had been put in the ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (MSD) box by mistake.  The staff member realized the mistake after the vaccine had been administered, when they were recording the information in their vaccine records.  It was an oversight by the office and the office was instructed on proper vaccine storage and replacing the vials in their proper places."  The physician called the patient a week later and there had been no problems.  No further information is expected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 74 year old male consumer with no known allergies who on 12-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included ezetimibe + simvastatin (MSD), aspirin, LOPRESSOR and MAXZIDE.  On 19-JUN-2007 (a week after the vaccination) the patient developed shingles.  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. This is in follow-up to report (S) previously submitted 5/24/2007: 12/21/2007. Information has been received from a 74 year old male consumer with no known allergies who on 12-JUN-2007 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck).  On 19-JUN-2007 (a week after vaccination) the patient developed shingles. 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. In follow-up information received from the physician, it was reported that the patient was vaccinated on 12-JUN-2007 at 10:14 AM with a dose of ZOSTER vaccine live (Oka/Merck) (656008/0032U), SC in left arm. There was no illness at the time of vaccination. The physician reported that the patient is now under treatment for post herpetic neuralgia. In follow-up information received from the physcian. it was reported that the patient continued to experience post herpetic neuralgia chronic pain. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Dermatitis contact, Facial pain, Haematology test, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 65 year old male with penicillin allergy who on 12-JUL-2007 was vaccinated subcutaneously in the left deltoid with a 0.65 mL dose of Zostavax (Oka/Merck) (lot# 656609/0015U).  Concomitant therapy included LAMISIL.  On approximately 19-JUL-2007, one week post vaccination the patient developed shingles: 3 vesicular lesions and pain on left orbital, pain at back of left scalp and left ear.  The patient went to the emergency room and was treated with prednisone but was not hospitalized.  Patient was diagnosed with poison ivy.  Two weeks later he visited his doctor for a follow up.  Patient is recovering from shingles but still experiencing pain.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a 65 year old male with penicillin allergy who on 12-JUL-2007 was vaccinated subcutaneously in the left deltoid with a 0.65 mL dose of Zostavax (Oka/Merck) (lot# 656609/0015U).  Concomitant therapy included LAMISIL.  On approximately 19-JUL-2007, one week post vaccination the patient developed shingles: 3 vesicular lesions and pain on left orbital, pain at back of left scalp and left ear.  The patient went to the emergency room and was treated with prednisone but was not hospitalized.  Patient was diagnosed with poison ivy.  Two weeks later he visited his doctor for a follow up.  Patient is recovering from shingles but still experiencing pain.  Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning an 82 year old male who on 09-MAY-2007 was vaccinated with a single dose of Zostavax (Oka/Merck) (lot# 656861/0329U).  On 25-JUL-2007 the patient experienced two signs of rash on left side of neck and mid back and slight pain and itching.  Medical attention was sought.  The physician diagnosed the patient with having shingles.  The patient's outcome is unknown.  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 and licensed practical nurse respectively concerning an 82 year old male with an aetaminophen allergy, osteoporosis, prostatic specific antigen increased, rosacea, anaemia and dyslipidaemia and a history of chickenpox in 1929 who on 09-MAY-2007 was vaccinated SC in the left mid-arm with a 0.5 ml dose of ZOSTAVAX (Oka/Merck(Lot#656861/0329U). No rash occurred at the injection site or elsewhere within 42 days of vaccination. On 27-JUL-2007 the patient developed two sites of rash, the left side of his neck and mid-back. There was a rash which had papules and vesicles with itching at C-3 on the left with slight pain (2 on a scale of 0 least - 10 most). The phyician diagnosed shingles and treated the patient with unspecified antiviral medication. The patient had a maxiumum temperature of 98.2F. There was no recent exposure to chicken pox or herpes zoster, no DFA done. There was no specimen collected for PCR, and no photo was taken. On 06-AUG-2007 the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip exfoliation, Lip haemorrhage
Clinical narrative: Information has been received from a pharmacist concerning a female who on 26-JUL-2007 was vaccinated SQ with 0.65 mL of Zostavax (Oka/Merck).  Subsequently the patient experienced peeling of the skin around her lips and when the skin is pulled off, the area starts to bleed.  As of 07-AUG-2007, the patient had not recovered.  Medical attention was sought.  Additional information has been requested. 12/21/2007 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow-up information was received from the pharmacist indicating that the patient was vaccinated SQ in the right deltoid with 0.65 mL of ZOSTAVAX (Oka/Merck) (lot# 657676/0619U). No further information is expected.
Age: 8.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 5-year-old female who on 02-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) instead of "the varicella vaccine," Varivax (Oka/Merck).  It is reported that the office was out of the "the varicella one".  It is unspecified if medical attention was sought.  No adverse events were reported.  It is reported that this was a case of product confusion since the packing for both vaccines was similar.  This is one of several reports from the same reporter.  No more information is expected. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a nurse concerning an 8-year-old (previously reported as 5-years-old) female who on 07-AUG-2007 (previously reported as 02-AUG-2007) was vaccinated in the left deltoid at 9 AM with a first dose of ZOSTAVAX (Oka/Merck) (lot# 658082/0744U) instead of "the varicella vaccine", VARIVAX (Oka/Merck). It is reported that the office was out of the "the varicella one". No medical attention was sought. No adverse events were reported. It is reported that this was a case of product confusion since the packaging for both vaccines was similar. The R.N. also reported that the patient's sister was vaccinated with ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) (WAES# 0708USA01361). This is one of several reports from the same reporter. No more information is expected.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 8-year-old female who on 02-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) instead of "the varicella vaccine," Varivax (Oka/Merck).  It is reported that the office was out of "the varicella one".  It is unspecified if medical attention was sought.  No adverse events were reported.  It is reported that this was a case of product confusion since the packing for both vaccines was similar.  This is one of several reports from the same source.  Additional information has been requested. Follow-up: THe H.M. also reported that the patient's sister was vaccinated with ZOSTAVAX instead of VARIVAX (WAES# 0708USA01160). This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Information has been received from a physician concerning a female who on 02-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 03-AUG-2007 at 5 a.m. the patient developed back pain, and went to the local emergency room for unspecified medical attention.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cough
Clinical narrative: Information has been received from a physician concerning his wife who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient developed a cough after getting Zostavax (Oka/Merck).  This is one of two reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date in April 2007, was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  "A few months after vaccination" the patient developed a case of zoster.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Headache, Medical device complication
Clinical narrative: Information has been received from a 30 year old female Licensed Practical Nurse who on 07-AUG-2007 was in the process of administering Zostavax (Oka/Merck) (Lot #658081/0743U) when the needle fell off and the vaccine squirted into her eyes.  There was no concomitant medication.  She rinsed out her eyes and she reported having a headache since the accident.  As of 07-AUG-2007, the patient had not recovered from her headache.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 68 year old sister with hypertension and "many drug allergies" who on approximately 01-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On approximately 02-AUG-2007 the patient developed a rash.  Concomitant therapies are blood pressure and cholesterol control medications (names unknown by caller).  Unspecified medical attention was sought. She was administered an antihistamine for the rash.  No further information was provided.  There was no product quality complaint involved.  No further information is expected.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been from a family member of a patient with a history of allergies who approximately 05-JUL-2007 was vaccinated with a single first dose of ZOSTAVAX. On approximately 03-AUG-2007 the patient developed shingles. Unspecified medical attention was sought. There was no further information provided. There was no product quality complaint involved. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Information has been received from an 82-year-old female consumer with a history of vertigo who "2 weeks ago" on approximately 25-JUL-2007 was vaccinated with a "single dose" of Zostavax (Oka/Merck).  On approximately 25-JUL-2007 the patient experienced itching all over her body.  Unspecified medical attention was sought.  No laboratory or diagnostic tests were performed.  The outcome is reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 82-year-old female consumer with allergies to PERCOCET and NOVACAIN and a history of shingles 16 years ago, who on "about the 9th or 10th of July, 2007" was vaccinated with a 0.65 milliliter dose of Zostavax (Oka/Merck).  Concomitant therapy included ezetimibe (+) simvastatin (MSD), OS-CAL, CENTRUM, vitamin D (unspecified), ECOTRIN and ACIPHEX.  It is reported that the patient felt shingles symptoms coming on a couple of days before she received her vaccination.  The day after vaccination, 10-Jul-2007 or 11-Jul-2007, the patient developed lesions.  Unspecified medical attention was sought.  There were no laboratory or diagnostic tests performed.  The outcome is reported as recovering.  No product quality complaint was involved.  Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 12-year-old female who on 08-AUG-2007 was vaccinated subcutaneously with a 0.65 milliliter dose of Zostavax (Oka/Merck) (lot# 658086/0761U) instead of Varivax.  It is reported that this was human error, not product confusion.  No symptoms have been reported.  It is unspecified if medical attention was sought.  No product quality complaint was involved.  Follow up information from the certified medical assistant who indicated that the person administering the vaccine grabbed the wrong vial.  She said she was not happy about the situation, and it should not have happened, "but it was definitely human error".  She did not specify why the error was made or what led to it.  The patient was doing fine and did not have any adverse events.  Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 10-year-old male who on 03-AUG-2007 was vaccinated with a single Subcutaneous dose of ZOSTAVAX instead of varicella virus live. Subsequently, it is reported that the patient experienced no problems. It is unspecified if medical attention was sought. No product complaint was involved. Additional information is not expected. This is in follow-up to report (s) previously submitted on 9/24/2007.  Follow-up information received from a medical assistant indicated that both vaccines were in the same container in the freezer.  The wrong vaccine was pulled for use.  Since the event, the vaccines have been separated into two containers in the freezer and labeled with the vaccine names.  Regarding the patient, there has been no report of any adverse effect.  Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Rash vesicular, Varicella
Clinical narrative: Information has been received from a physician concerning an 80-year-old male who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck) (lot# "05840").  Subsequently the patient experienced a chickenpox, varicella like rash.  The patient did require one doctor's visit for follow-up.  The outcome is reported as recovering.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2007. Follow-up information received indicates that y=the patient is a 74 year old (previously reported as 80-year-old), with bladder cancer, chronic renal failure, hypothyroidism and allergies to sulfa, penicillin, FLAGYL and MACROBID who on 10-JUL-2007 at 1100 was vaccinated subcutaneously in the abdomen with a first dose of ZOSTAVAX ( lot # 657764/0584U) . There were no illnesses at the time of the vaccination. On 28-JUL-2007, the patient developed an acute diffuse vesicular rash diagnosed as acute chickenpox. On an unspecified date the patient recovered. It was reported that the patient and his siblings have had no adverse events following prior vaccinations. Additional information is not expected.
Sex: U
Vaccine: DTAP, HEPA, IPV, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (MSD).  Concomitant therapy included DTaP, IPV, Vaqta (manufacturer unknown) and MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (MSD).  No adverse experiences were reported.  Additional information has been requested.  The patient's sibling had the same experience (WAES # 0708USA04598).
Age: 1.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from Registered Nurse concerning a 12 month old male (24 lbs. 11 oz.) who on 09-AUG-2007 was vaccinated with ZOSTAVAX (657764/0584U) instead of varicella virus vaccine live. No problems were reported. This was not a case of product confusion. No further information available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a consumer, a 73 year old female with no drug allergies, hypertension, high cholesterol and depression who on 06-AUG-2007 was vaccinated with a 0.65ml SC dose of Zostavax (Oka/Merck).  Concomitant therapy included trazodone HCl, PROCARDIA XL, CYMBALTA and ezetimibe (+) simvastatin (MSD).  On 08-AUG-2007 the patient developed a rash where she received the vaccine.  No medical attention was sought.  No diagnostic studies or labs were performed.  It was noted that the patient was not recovered.  There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient ( age and gender unknown) who on 30-JUL-2007 was inadvertently vaccinated with vaccinated with a dose of ZOSTAVAX (lot# reported 02904), instead of varicella virus vaccine live. No adverse effects were reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast disorder female, Ecchymosis, Erythema
Clinical narrative: Information has been received from a physician concerning a 68 year old female with a history of radiotherapy to breast 3 years ago who on 19-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (657765/0585U).  On 06-AUG-2007 the patient experienced left breast became red and vascular after she was given Zostavax (Oka/Merck).  Outcome of the patient is unknown.  No product quality complaint.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow-up information received from the physician on 05-Sep-2007 indicating that the patient received the vaccination in the left arm and also developed the AE of ecchymosis of the breast on the side of the vaccination, 1 to 2 weeks after the vaccination. All adverse events resolved on an unknown date in Aug-2007. The physician also reported an invalid lot# of 30370 (also reported previously as (657765/0585U). No further information is expected.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Neurological examination, Rash, Skin test
Clinical narrative: Information has been received from a consumer concerning a 79 year old female who in May 2006, was vaccinated SC with a 0.65 mL dose of Zostavax (Oka/Merck).  Six months later, in November 2006, the patient developed a rash on her arms and legs on the right side of her body.  She also had a severe nerve pain from the back of her neck that "ran all the way up."  The reporter could not supply the lot number.  Unspecified medical attention was sought.  "Nerve tests" and "dermatology tests" were performed (results not provided).  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  No further information is available.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Eyelid oedema, Swelling face
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old male who on 27-JUN-2007 was vaccinated with a single dose of ZOSTAVAX. Concomitant therapy included NIZORAL. On 04-JUL-2007 the patient developed swelling of the eyelids and face. Unspecified medical attention was sought. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an approximately 60 year old patient who was vaccinated with a dose of ZOSTAVAX. Subsequently the patient developed herpes zoster of the T4 dermatome distribution of the back one week after administration of the vaccine. The patient was prescribed unspecified antiviral medication and at the time of this report was recovering. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus generalised
Clinical narrative: Information has been received from a physician concerning an approximately 70 year old male who on approximately 14-JUL-2007 (within the last two weeks from 31-JUL-2007) was vaccinated with a dose of Zostavax (Oka/Merck).  On approximately 16-JUL-2007 (two days after vaccination) the patient developed general itching.  The physician believes this to be a "mild allergic reaction".  Unspecified medical attention was sought.  At the time of this report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Ear pain, Insomnia
Clinical narrative: Information has been received from a physician concerning a 63 year old female with osteoporosis, rosacea, gastrooesophageal reflux disease (GERD), rhinitis allergic, and drug allergies to penicillin and ampicillin (caused blotches on face and fatigue), TRILAFON and COMPAZINE (caused dystonia), CILOXAN and TOBREK (caused eye swelling), CARBOCAINE (caused ear burning and fatigue), alendronate sodium (MSD) (caused some GI distress) (WAES# 0708USA05256) and ACTONEL (caused weakness and presyncope) who on 13-APR-2007 was vaccinated SQ with 0.65 mL Zostavax (Oka/Merck) (lot # 656606/0033U). Concomitant therapy included PREVACID, multivitamin (unspecified) and a calcium carbonate supplement.  On 13-APR-2007 the patient developed a bad earache the night of her injection which lasted for several days.  The earache kept the patient up at nights.  She also experienced an altered taste sensations for a few weeks.  She sought medical attention.  No lab diagnostic studies were performed.  The earache resolved within several days, and the altered taste resolved after 2 to 3 weeks.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Information has been received from a nurse within the physician's office concerning a female who was vaccinated with a first dose of ZOSTAVAX. Subsequently two weeks post vaccination the patient experienced painful rash on the same arm in which she received the vaccination. It was unknown whether medical attention was sought. The patient recovered from painful rash. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2007. Follow-up information was received from a healthcare professional indicating that their office did not give shot and was just expressing a patients concern.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Hot flush, Joint stiffness, Musculoskeletal stiffness, Pain
Clinical narrative: Information has been received from a physician concerning a 73 year old female who on 05-SEP-2006 was vaccinated SC in the right arm  with a dose of ZOSTAVAX (Lot# 652965/0622F). Subsequently the patient developed paresthesia. Unspecified medical attention was sought. Subsequently, the patient recovered. 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. Follow-up information was received from the physician. This 73 year old female with sulfonamide allergy, latex allergy, irritable bowel, migraine, shoulder pain, osteoporosis, diverticulosis, back pain, cholesterol high, hypertension, hiatus hernia, oesophageal reflux and caffeine and a history of hysterectomy, colonoscopy and cholecystectomy was vaccinated SC in the right arm on 05-SEP-2006 with a dose of ZOSTAVAX (Oka/Merck) (Lot# 652965/0622F). Concomitant therapy included RESTASIS, NORVASC, FLONASE, calcium (unspecified) (+) vitamin D (unspecified), aspirin, ESTRACE and glucosamine. It was noted that the patient was seen for a scheduled follow-up visit on 26-JUL-2007. At that time she indicated that she had lower back and hip pain, she also had stiffness in those areas. It was noted that her back pain was severe and "began when she was on the floor". The pain increased with sitting in a chair but would go away with laying. The patient's hip pain began in the left hip and then the right hip was bothering her. It was also noted that she had burning pain of her back that began after vaccination. The pain shot across both scapulae then gravitated to the upper back area. This was not associated with a prolonged rash but an initial rash. At the time of the office visit there were no rashes. The patient also had hot flashes that would come and go. The patient was prescribed PRAVACHOL and alendronate sodium (MSD). The patient was also scheduled to have an MRI of the thoracic and lumbar spines. On an unspecified date the patient recovered. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 73 year old female who on 05-SEP-2006 was vaccinated SC in the right arm  with a dose of ZOSTAVAX (Lot# 652965/0622F). Subsequently the patient developed paresthesia. Unspecified medical attention was sought. Subsequently, the patient recovered. 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. Follow-up information was received from the physician. This 73 year old female with sulfonamide allergy, latex allergy, irritable bowel, migraine, shoulder pain, osteoporosis, diverticulosis, back pain, cholesterol high, hypertension, hiatus hernia, oesophageal reflux and caffeine and a history of hysterectomy, colonoscopy and cholecystectomy was vaccinated SC in the right arm on 05-SEP-2006 with a dose of ZOSTAVAX (Oka/Merck) (Lot# 652965/0622F). Concomitant therapy included RESTASIS, NORVASC, FLONASE, calcium (unspecified) (+) vitamin D (unspecified), aspirin, ESTRACE and glucosamine. It was noted that the patient was seen for a scheduled follow-up visit on 26-JUL-2007. At that time she indicated that she had lower back and hip pain, she also had stiffness in those areas. It was noted that her back pain was severe and "began when she was on the floor". The pain increased with sitting in a chair but would go away with laying. The patient's hip pain began in the left hip and then the right hip was bothering her. It was also noted that she had burning pain of her back that began after vaccination. The pain shot across both scapulae then gravitated to the upper back area. This was not associated with a prolonged rash but an initial rash. At the time of the office visit there were no rashes. The patient also had hot flashes that would come and go. The patient was prescribed PRAVACHOL and alendronate sodium (MSD). The patient was also scheduled to have an MRI of the thoracic and lumbar spines. On an unspecified date the patient recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a female pharmacist who on approximately 27-JUL-2007 was vaccinated with the first dose of ZOSTAVAX (No lot number given) in the left arm. On approximately 01-AUG-2007 the patient developed injection site discoloration, itching and swelling. No medical attention was sought. Subsequently the patient was recovering. There was no product quality complaint. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Oral herpes, Polymerase chain reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old female female with allergy to macrodantin, and no pertinent medical history, who on 25-JUL-2007 was vaccinated SC in the left arm with a 0.65 ml dose of ZOSTAVAX (Lot# 656858/0356U). Concomitant therapy included progesterone and TOFRANIL. On 26-JUL-2007 the patient developed shingles on her right great toe area. On 27-JUL-2007 the patient developed shingles on her face near her mouth. Medical attention was sought. The physician wrote in chart a painless cluster noted on foot. Office had not seen the patient's face yet. They are trying to get the patient to come back into the office. VZVID program offered to nurse and she will speak to the physician about it. Will send directions on specimen collection. No product quality was involved. Follow up information received from the physician indicated that the patient developed a cluster of blisters on the right great toe within 42 days of the vaccination. A rash did not occur at the site of injection post vaccination. There was no pain associated with the blisters (zero, on a scale of zero to ten, zero being the least). It was noted that the patient had no recent exposure to chicken pox or shingles. A direct fluorescent antibody was not done. A photo was taken. A specimen was obtain from a vesicle on 02-AUG-2007 for lab testing. Results reported the specimen to be inadequate ("all I got was a dried spot of blood-ran it twice"). No further information was provided. The patient was enrolled in the VZVIF program: the Varicella Zoster Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the OKA/MERCK VACCINE VZV strain. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow up information was received concerning a female with no pre-existing birth defects or medical conditions who on 02-AUG-2007 (previously reported as 26-Jul-2007) developed a fever blister on her left upper lip. There was no illness at the time of vaccination. She was treated for one week with VALTREX 500 milligrams, TID and CLEOCIN 300 milligrams, QID x 10 days. On an unspecified date, the patient recovered. The sample of the lesion was collected on 02-Aug-2007. The sample was taken from a vesicle (spot of blood). The results for the specimen from the vesicle were inadequate, ("all I got was a dried spot of blood-ran it twice"), no strain identified. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female with a history of shingles who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed shingles.  No further information was provided.  There was no product quality complaint involved.  No further information is available.