chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Laboratory test normal, Pain
Clinical narrative: Information has been received from the wife of a consumer concerning her 72 year old husband with "Mild Diabetes" in approximately "May or June 2007", was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included simvastatin (MSD) and diabetes medication (therapy unspecified).  In approximately June 2007, the patient experienced "some sort of sensitivity on his back".  There was no itching, but it felt like something was affecting his "nerve endings".  She said that this "sensitivity" progressed to "horrific pain" in his back and also in his mid-frontal or lower chest area.  They are shooting pains.  She added that he has no visible marks, rashes, or blisters on the skin of these areas.  He has had a variety of tests and all of the test results were negative.  The patient's some sort of sensitivity on his back and horrific pain persisted. Follow-up information received on 24-Sep-2007, from the wife of the patient indicating that her husband is still in pain.    No further information is available.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 76 year old male who on 09-MAR-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot#656608/0032U).  Subsequently the patient developed paresthesias.  Unspecified medical attention was sought.  There was no further information provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Pain
Clinical narrative: Information has been received from a 64 year old female with a history of shingles and an allergy to PLAQUENTIL who in January 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included trazodone HCl.  On approximately 30-MAY-2007 the patient developed on and off pain that usually signaled the onset of a shingles outbreak, and a cold sore that went away quickly without treatment.  No lab studies were performed.  No medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a female consumer who on 30-JUL-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  On 31-JUL-2007 the patient developed redness at the injection site.  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 is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 76 year old female who on 09-MAR-2007 was vaccinated with a dose of ZOSTAVAX. Subsequently the patient developed paresthesia. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 09/24/07. There was no product quality complaint involved. Additional information has been received from the physician who stated that the patient was not vaccinated at their office, No further information is expected.
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 (Oka/Merck).  Subsequently the patient developed herpes zoster less than 14 days 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: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 74 year old female consumer who on an unspecified date in December 2006, was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed shingles.  Unspecified medical attention was sought.  No further information was provided.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling
Clinical narrative: Information has been received from a male consumer who on approximately 26-JUL-2007 was vaccinated with a dose of ZOSTAVAX. On approximately 26-JUL-2007 4 days after vaccination the patient developed puffiness on both of his eyes which has "remained the same 3 days now" and it has not improved. Patient does not want to provide any further information. There was non product quality complaint involved. No further information is available.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an 8 year old(also reported as 10 year old) female who on an unspecified date was vaccinated with a dose of ZOSTAVAX instead of VARIVAX. The patient did not develop any symptoms. According to the reporter, the incident was due to human error and not product confusion. No further information was available. There was no product quality complaint involved. Follow up information has been received from the vaccine clinic nursing supervisor who said the patient received the wrong vaccine due to human error. She noted that " the clinic was very busy and one of the nurses took the ZOSTAVAX out for the administrating nurse on the private side and left it on the counter. The nurse who administered the ZOSTAVAX to the 10 year old picked it up thinking it was the VARIVAX. and administered it without double checking. The nursing supervisors stated that it was a trickle down effect of one person trying to help out and then in the rush of the moment, the administering nurse did not do the required double checks. The reason the event was even noticed was because there was only one vial left of VARIVAX and when the nurse who was to administer the ZOSTAVAX went to pick it up there was none left. The patient's mother was contacted and reported that the patient was doing just fine, and had no problems or reactions. No further information is expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Culture negative, Herpes simplex serology negative, Pain, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old female, with no known allergies, or pertinent medical history, who "about 4 to 6 weeks ago" on approximately 15-JUN-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck).  On 31-JUL-2007 the patient developed a zoster like rash on her right cheek.  She had about ten lesions or more, and the area was sore, tender, and itchy.  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. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a registered nurse concerning a 63 year old female, with no known allergies, sun damage, and a history of non-melanoma skin cancer (previously reported as no pertinent medical history), who "about 4 to 6 weeks ago" in June or July 2007 was vaccinated subcutaneously with a dose of ZOSTAVAX (Oka/Merck). On 31-JUL-2007 the patient developed a zoster like rash on her right cheek. She had about ten lesions or more, and the area was sore, tender, and itchy. 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 no rash occurred at the site of injection or elsewhere within 42 hours of the vaccination. A herpes simplex virus culture of the right cheek was performed with results of none detected. A viral culture of the right cheek was done, no virus was isolated. The patient's pain was a 2 on a scale of 0 (least) to 10 (most). The patient has tried POLYSPORIN and cortisone acetate. The rash are grouped vesicles in an erythematous base. The patient was treated with VALTREX 1 gm by mouth three times a day for 7 days. It was unknown if there was recent exposure to chicken pox or herpes zoster. A DFA was not done. There was no photo taken. On an unspecified date the patient recovered. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash vesicular, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old female, with no known allergies, or pertinent medical history, who "about 4 to 6 weeks ago" on approximately 15-JUN-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck).  On 31-JUL-2007 the patient developed a zoster like rash on her right cheek.  She had about ten lesions or more, and the area was sore, tender, and itchy.  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. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a registered nurse concerning a 63 year old female, with no known allergies, sun damage, and a history of non-melanoma skin cancer (previously reported as no pertinent medical history), who "about 4 to 6 weeks ago" in June or July 2007 was vaccinated subcutaneously with a dose of ZOSTAVAX (Oka/Merck). On 31-JUL-2007 the patient developed a zoster like rash on her right cheek. She had about ten lesions or more, and the area was sore, tender, and itchy. 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 no rash occurred at the site of injection or elsewhere within 42 hours of the vaccination. A herpes simplex virus culture of the right cheek was performed with results of none detected. A viral culture of the right cheek was done, no virus was isolated. The patient's pain was a 2 on a scale of 0 (least) to 10 (most). The patient has tried POLYSPORIN and cortisone acetate. The rash are grouped vesicles in an erythematous base. The patient was treated with VALTREX 1 gm by mouth three times a day for 7 days. It was unknown if there was recent exposure to chicken pox or herpes zoster. A DFA was not done. There was no photo taken. On an unspecified date the patient recovered. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, Pain, Rash vesicular
Clinical narrative: Information has been received from a physician's assistant concerning a 59 year old female with a history of coronary artery disease, hypercholesterolaemia, hypothyroidism, vitamin B12 deficiency, vitiligo, and allergic reaction to erythromycin and LIPITOR who on 13-JUL-2007 was vaccinated subcutaneously with a 0.5 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included PREMARIN, levothyroxine Na, niacin and simvastatin (manufacturer unknown).  On 29-JUL-2007 the patient developed a rash on her cheeks that looked like zoster.  The rash was bilateral and did not cause pain.  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. Follow up information indicated that the patient did experience pain of a level 3 on a 0-10 scale (0 least 10 most). The patient had no other syatemic symptoms. There was no recent exposures to chicken pox or herpes zoster. A specimen was not collected for PCR. On 29-AUG-2007 the patient recovered. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 71 year old female consumer who on 04-APR-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included BONIVA, SYNTHROID and PREVACID.  In April 2007, "week and a half after vaccination" the patient experienced 3 outbreaks of shingles.  Medical attention was sought.  The patient's 3 outbreaks of shingles persisted.  The physician was notified of the VZV identification program.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoacusis
Clinical narrative: Information has been received from a retired nurse who on 11-JUL-2007 was vaccinated with ZOSTAVAX. Concomitant therapy included PRAVACHOL, atenolol, nitroglycerin, LORTAB, DALMANE, ATIVAN and CELEXA. In August 2007, the patient experienced difficulty  hearing. Medical attention was sought. The patient's difficulty hearing persisted. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Headache, Induration, Insomnia
Clinical narrative: Information has been received from a female consumer with a history of shingles who on 23-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 24-JUL-2007 (within 24 hours) the patient developed a severe headache, swelling of the arm, and a large red itchy area that was hard and hot to the touch.  The patient was uncomfortable and unable to sleep.  The patient treated the condition with BENADRYL for five days, and eight hour TYLENOL.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Information has been received from a female consumer with a history of shingles who on 23-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 24-JUL-2007 (within 24 hours) the patient developed a severe headache, swelling of the arm, and a large red itchy area that was hard and hot to the touch.  The patient was uncomfortable and unable to sleep.  The patient treated the condition with BENADRYL for five days, and eight hour TYLENOL.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated subcutaneously with a 0.65 ml dose of Zostavax (Oka/Merck).  Subsequently the patient developed a rash all over the body.  Unspecified medical attention was sought.  The patient was told to take BENADRYL.  Subsequently, the patient recovered.  No additional 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning an immunosuppressed patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX. It was reported that the patient developed shingles after vaccination. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 72 year old female with no known allergies and high blood pressure and cholesterol who on 29-JUN-2007 was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX. Concomitant therapy included lovastatin (manufacturer not reported), HCTZ and atenolol. On 30-JUN-2007 the patient experienced rash on right buttock and thigh. The patient had sought unspecified medical attention. As of 02-JUL-2007 the patient's rash on right buttock and thigh persisted. Follow up information indicated that the patient was given a topical steroid. The out come was recovered on 04-JUL-2007. The reporter indicated that she does not believe that the rash was secondary to ZOSTAVAX. There were not relevant diagnostic tests or laboratory data. No additional information is expected.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a 46 year old female registered nurse with no known allergies, depression and tendonitis and a history of herpes zoster who administered Zostavax (Oka/Merck) to multiple patients on 19-JUN-2007, 21-JUN-2007, 26-JUN-2007, and 28-JUN-2007.  Concomitant therapy included trazodone HCl, CELEXA and nonsteroidal anti-inflammatory drug (unspecified).  The nurse reported that on 29-JUN-2007, she developed a widespread red, raised, itchy rash.  The physician prescribed oral prednisone and BENADRYL.  On 02-JUL-2007, the nurse was examined at a local emergency room complaining of intense itching and was prescribed ATARAX.  The patient's widespread red raised rash and itchy rash persisted.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Local reaction
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient experienced allergic local reaction.  Unspecified medical attention was sought.  No further information is available.  There was no product quality complaint.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 62 year old female physician who on 25-JUN-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # 656609/0015U). Concomitant therapy included several unspecified medications (the patient was not taking any immunosuppressive therapy). On 01-JUL-2007 the patient called the reporting physician and stated that she had a shingles rash on the left side of her chest. Medical attention was sought, the patient expressed interest in VZV analysis though at the time of reporting no lab studies had been performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.  This is in folow-up to report (s) previously submitted on 9/24/2007. Initial and follow-up information has been received from a pphysician concerning a 62 year old female physician who on 25-JUN-2007 at 15:00 was vaccinated SC in the left posterior arm wiht a 0.65 ml dose of ZOSTAVAX vaccine (Merck) (lot # 656609/0015U).
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: HIV test, Laboratory test, Mouth ulceration, Oral discomfort, Oral pain
Clinical narrative: Information has been received from a male with hypertension and oesophageal acid reflux who on 01-MAR-2007 was vaccinated SQ with Zostavax (Oka/Merck).  Concomitant therapy included LIPITOR, NEXIUM and AVALIDE.  On approximately 09-APR-2007 the patient's ride side of his mouth and tongue were full of ulcers.  His mouth started out by feeling strange and progressed from soreness to the ulcers.  As of 02-JUL-2007 the patient's ulcers were improving but his mouth was still extremely hot and burned all the time.  Medical attention was sought and unspecified blood work, infectious test and an AIDS test were performed (results not reported).  Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: Information has been received from a male with hypertension and oesophageal acid reflux who on 01-MAR-2007 was vaccinated SQ with Zostavax (Oka/Merck).  Concomitant therapy included LIPITOR, NEXIUM and AVALIDE.  On approximately 09-APR-2007 the patient's ride side of his mouth and tongue were full of ulcers.  His mouth started out by feeling strange and progressed from soreness to the ulcers.  As of 02-JUL-2007 the patient's ulcers were improving but his mouth was still extremely hot and burned all the time.  Medical attention was sought and unspecified blood work, infectious test and an AIDS test were performed (results not reported).  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning an "about 66 year old" female who "a few weeks ago" on approximately 11-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On the same day as the vaccination the patient developed a rash about 2 inches around the injection site.  Unspecified medical attention was sought.  There were no lab studies performed.  Subsequently the patient recovered.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 65 year old female who previously in October 2006 was diagnosed with a case of shingles who on 17-MAY-2007 was vaccinated with a dose of ZOSTAVAX. On 25-MAY-2007 the patient experienced rash associated with shingles on the left part of her back. Medical attention was sought. The patient recovered from rash associated with shingles on the left part of her back. No product quality complaint was involved. Information to process a specimen for PCR analysis was sent to the physician. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Secondary transmission
Clinical narrative: Information has been received from a consumer concerning a "friend of the family", a male in his 50's with a history of shingles who on 30-JUN-2007 sat next to the reporter's parents who were vaccinated with Zostavax (Oka/Merck) on 25-JUN-2007.  On 01-JUL-2007 the patient broke out in a rash.  It was noted that he "may have developed shingles".  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 60-year-old female who on 27-JUN-2007 was vaccinated with a 0.65 milliliter injection of ZOSTAVAX (Lot# was not provided). Concomitant therapy included methotrexate and prednisone (indication and total daily dose not provided). On 28-JUN-2007, a day after getting the vaccination, the patient experienced a rash on the face which was determined to be shingles. Unspecified medical attention was sought. The patient recovered on an unspecified date. No product quality complaint was involved. Follow-up information received on 02-Aug-2007 indicates that the patient did have a rash after getting the ZOSTAVAX, but it was determined later by the family physician that the patient did not have shingles. The patient was not given any antiviral medicine as treatment. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 13 year old patient who on 03-JUL-2007 was vaccinated with a dose of ZOSTAVAX instead of VARIVAX. It was reported that it was not a product confusion but a medical error. No problems reported. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the physician who stated that the patient was fine and had no fever and no rash at the injection site. They had the patient on close watch but there were no ill effects. No further information is expected. 03/25/2010 Additional information has been received from the physician who stated that there wer eno adverse effects noted. No further information is expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Injection site pustule, Injection site reaction, Laboratory test abnormal
Clinical narrative: Information has been received from a nurse concerning an "around 80-year-old female" who on approximately 11-JUN-2007 was vaccinated with an injection of Zostavax (Oka/Merck).  "Immediately after getting the vaccination, the patient presented with a little shingles case around the injection area (pustules)".  Also the patients "FED blood rate was elevated".  It is unspecified if medical attention was sought.  It is reported that the patients condition is improving.  No product quality complaint was involved.  Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: Information has been received from a nurse concerning an "around 80-year-old female" who on approximately 11-JUN-2007 was vaccinated with an injection of Zostavax (Oka/Merck).  "Immediately after getting the vaccination, the patient presented with a little shingles case around the injection area (pustules)".  Also the patients "FED blood rate was elevated".  It is unspecified if medical attention was sought.  It is reported that the patients condition is improving.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise, Rash
Clinical narrative: Information has been received from a physician concerning a female with rheumatoid arthritis who on 21-JUN-2007 was vaccinated with a single 0.65 ml dose of Zostavax (Oka/Merck) (Lot # 657559/0462U).  On approximately 21-JUN-2007 the patient experienced ill feeling with arthralgia and skin rash.  Unspecified medical attention was undertaken.  At the time of report the patient had recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 74 year old female asthma, aspergillosis and an allergy to PROZAC who on 21-JUN-2007 was vaccinated SC in the left arm with a dose of ZOSTAVAX (lot # 656395/0290U). Concomitant therapy included ALLEGRA-D, albuterol, montelukast sodium (MSD), FLONASE, EVISTA, ADVAIR, prednisone, TOPROL XL TABLETS, omeprazole (MSD), calcium unspecified (+) vitamin D (unspecified), NASONEX, ESTRACE and PAXIL CR. On an unspecified date in June or July 2007, the patient experienced swelling the size of a quarter at the injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested. Follow-up information states that for this Caucasian patient, there was no illness at the time of vaccination. The patient experienced and area of redness and swelling at the injection site with pain on 22-JUN-2007. The patient recovered.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed visiting nurse (L.V.N.) concerning a 67-year-old retired female who is positive for hepatitis C and has penicillin and morphine allergies, who on 21-JUN-2007 was vaccinated subcutaneously in the left arm with a first dose of Zostavax (Oka/Merck) (lot # 656395/0290U).  There was no illness at the time of vaccination.  Concomitant therapy included aspirin and omega-3 marine triglycerides.  On 22-Jun-2007, the patient developed an area of redness and swelling at the injection site the size of a golf ball with pain.  Unspecified medical attention was sought.  No laboratory or diagnostic tests were ordered.  On an unspecified date the patient recovered.  This is one of several reports from the same source.  Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Nodule, Rash papular
Clinical narrative: Information has been received from a physician concerning a male, who on 03-JUL-2007 was vaccinated with a "single dose" of Zostavax (Oka/Merck).  The day after the vaccination, on 04-JUL-2007, the patient experienced a "papular nodular rash with a small vesicle" on his chest.  Unspecified medical treatment was sought.  No outcome was reported.  No product quality complaint was involved.  Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a, 43-year-old female housewife with no pre-existing allergies, birth defects or medical conditions who on 05-JUL-2007 was inadvertently vaccinated with a subcutaneous dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck).  There were no illnesses at the time of vaccination.  It is reported that this error was not due to product confusion but due to human error.  It is unspecified if medical attention was sought.  No adverse experience was related to this event.  No further information is available.  No product quality complaint was involved.  Follow-up information received on 30-Jul-2007 via a telephone call from the registered nurse indicated that there has been no further contact from the female patient and there is no information about adverse experiences.  The patient's name was unknown, the physician involved was unavailable and the box of Zostavax (Oka/Merck) has since been emptied so the lot number could not be obtained.  The nurse reported that the event happened because the nurse administering the vaccination thought she was grabbing a vile of generic varicella.  The boxes were stored one in front of the other.  No more information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a female employee (age unknown) with a history of chickenpox who was accidentally exposed to a droplet of ZOSTAVAX. Subsequently the employee believes that she may have had a drop of vaccine come in contact with her hand at one time or another and developed shingles. Subsequently the patient recovered. No medical attention was sought. No product quality complaint. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a 64 year old male consumer concerning himself who on 21-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 02-JUL-2007 the patient experienced broke out with chicken pox.  Unspecified medical attention was sought.  No product quality complaint.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning an approximately 60 year old female who was vaccinated in the back of the arm with a dose of ZOSTAVAX. The patient had no initial reaction to the vaccine. Subsequently, 5 days later, the patient developed a 5 inch area at the injection site which was red, itchy, burning hot and hard. Medical attention was sought and the patient was given ice and BENADRYL and sent home. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Information has been received from a nurse practitioner concerning a 63 year old female with mitral valve prolapse and a thyroid nodule who on 26-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included LEXAPRO, PROTONIX and ADDERALL TABLETS.  On 05-JUL-2007 the patient developed one red spot on her stomach.  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.
Sex: F
Vaccine: VARZOS
Symptoms: Nodule
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a single dose of ZOSTAVAX. After the patient received the dose of ZOSTAVAX, she developed a small knot on her arm. No other information was reported. This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Fluid retention
Clinical narrative: Information has been received from a nurse concerning a female patient in her nineties who was vaccinated in the arm with a dose of Zostavax (Oka/Merck).  Two days after vaccination, the patient came back into the office and "her entire arm looked like cellulitis with fluid in it."  The injection was given in the back of the affected arm.  The patient was given BENADRYL and told to put ice on the arm area and was sent home.  A product quality complaint was not involved.  No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: ACTH stimulation test, Hypoaesthesia, Laboratory test
Clinical narrative: Information has been received from a 64 year old female with neurology problems, carpal tunnel syndrome and a history of right wrist surgery who on 28-JUN-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included NASACORT, SYNTHROID, allergenic extract, methyltestosterone, montelukast sodium (MSD), NIASPAN, ATROVENT and CLARINEX.  On 30-JUN-2007 the patient experienced numbness in both feet.  That same day the physician did an adrenal insufficiency test in which something was injected, possibly cortisone (results not reported).  On 02-JUL-2007 a strength test was performed on her feet where she was stuck with pins (results not reported).  Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an "over 60" male with "a lot of problems" who "about a month ago" on approximately 05-Jun-2007, was vaccinated subsequently with 0.65 milliliter dose of ZOSTAVAX. It is reported that "recently", "about a month" after receiving the vaccination the patient developed shingles.  Unspecified medical treatment was sought.  The patient's outcome is unspecified. No product complaint was involved. No more information is expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning a 70-year-old female with a medical history of high cholesterol, stomach disorder, seizures, osteoporosis, depression, and has allergies to sulfa and trimethoprim.  On 15-MAY-2007 she was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant medication included "many prescription drugs".  On 02-JUL-2007 the patient developed a red, vesicular rash on the right side of her face going from her temple down to her cheek bone.  Her physician thinks it might be shingles.  The patient was treated with LIDEX.  There were no laboratory or diagnostic tests performed.  Outcome is reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a 57 year old white female medical assistant who on on 15-JUN-2007 at 14:00 was vaccinated SC in the right arm with a first dose of ZOSTAVAX (lot # 656607/0163U). Concomitant therapy included levothyroxine Na. It was reported that on 15-JUN-2007 at 14:00 the patient developed a fever and redness and swelling at the injection site for 6 days. No further information was provided. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Inappropriate schedule of drug administration, Therapeutic response unexpected
Clinical narrative: Information has been received from a 50 year old female patient who received two doses of "pediatric chicken pox" VARIVAX, WAES #0708USA02982 and one dose of ZOSTAVAX for the treatment of sacral and left hip "herpetic pain". The patient reported that she experienced improvement of her pain after the immunizations. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site papule
Clinical narrative: Information has been received from an 83 year old female with no known allergies and no reported medical history who approximately 31-JUL-2007 was vaccinated with ZOSTAVAX. Concomitant therapy included LIPITOR and blood pressure medication (unspecified). The patient reported that about 12 hours after getting the shot (on approximately 31-JUL-2007), she experienced blisters over the age spots on her arms (2 blisters on her left arm and one her right) and a red raised spot at the injection site. As of 21-AUG-2007, the patient was recovering from her experienced from her experienced. The patient did not seek medical attention. No additional information is expected.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Skin lesion
Clinical narrative: Information has been received from a physician Assistant concerning a 55 year old male who was vaccinated with ZOSTAVAX for the prevention of shingles. Concomitant therapy included acyclovir. The physician Assistant reported that the patient had received the ZOSTAVAX and developed lesions on his abdomen. If this occurs again the office plans to conducted a viral lesion culture on the patient. Subsequently, the patient recovered from lesions on his abdomen. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a female with codeine allergy who on 06-AUG-2007 was vaccinated with ZOSTAVAX (Lot # 657764/0584U). Concomitant therapy included insulin, metformin, ZYRTEC, simvastatin (MSD) and aspirin. On approximately 09-AUG-2007 the patient developed shingles lesions on the left side of her back. Subsequently, the patient recovered from the lesions. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male over 65 years old who on approximately 22-APR-2007 was vaccinated with ZOSTAVAX. On approximately 22-JUL-2007 the patient experienced mild outbreak of shingles. The patient visited the physician's office for an examination. The physician performed a biopsy to ensure that the patient had shingles and not something else. Patient received the vaccination at a local pharmacy. On approximately 29-JUL-2007 the patient recovered. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 86 year old female consumer with no known allergies or pertinent medical history who on 14-JUN-2007 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck).   Concomitant therapy included metformin, "tapatril", hydrochlorothiazide (manufacturer unknown), ALEVE and "soricane".  On 18-AUG-2007 the patient developed shingles on the right side waist and side of breast.  Medical attention was sought.  There were no labs performed.  It was noted that the physician believed the patient had a mild case because she received the shot and she had no pain.  At the time of the report the patient had not recovered.  There was no product quality complaint involved. 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 nurse practitioner concerning an 83 year old female who was on an unspecified date vaccinated with a single dose of Zostavax (Oka/Merck).  Subsequently, a week after vaccination the patient developed shingles.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site oedema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female in her 60's with a history of local injection site sensitivity who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient developed a swollen hard know at the injection site.  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 a 61 year old female with a history of local injection site sensitivity after receiving tetanus toxoid who on 20-AUG-2007 was vaccinated with ZOSTAVAX in her R arm (Oka/Merck). On 21-AUG-2007 the patient developed a swollen hard knot at the injection site. The local reaction was erythemic, edematous and swollen (10cm x 10cm). Subsequently the patient recovered. Additional information is not available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female who on 14-JUN-2007 was vaccinated with ZOSTAVAX. In 2007 the patient developed shingles. No further information is available.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a 79 year old female who on 08-AUG-2007 was vaccinated with Zostavax (Oka/Merck).  On approximately 13-AUG-2007 the patient developed a rash on both legs in her lower extremity area.  As of 22-AUG-2007 the patient was recovering.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who on 07-MAR-2007 was vaccinated with ZOSTAVAX. On 03-JUL-2007 the patient visited the physician and was diagnosed with shingles. Subsequently, the patient recovered from shingles. This is one of several 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 in her mid 90's who in approximately April 2007 was vaccinated with Zostavax (Oka/Merck).  The physician reported that the patient, in approximately June 2007, developed a case of shingles.  The physician reported that the patient had had shingles numerous times and this case was the first time that she did not have post herpetic neuralgia.  Subsequently, the patient recovered from the shingles.  Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a doctory of pharmacy concerning an 80 year old female who on 04-MAY-2007 was vaccinated with ZOSTAVAX (656859/0357U). There was no concomitant medication. On 15-JUN-2007 the patient developed lesions on her back and trunk. She was diagnosed with a mild case of herpes zoster. The lesions were no longer present as of 22-AUG-2007, but she did have postherpetic neuralgia. She was treated with NEURONTIN. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with ZOSTAVAX. Subsequently the patient developed a rash around the injection site. The patient sought unspecified medical attention. Subsequently, the patient recovered from the rash around the injection site. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female who on 31-MAY-2007 was vaccinated with Zostavax (Oka/Merck).  On 21-JUN-2007 the patient developed a full blown case of shingles just above the hip area.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and an office manager concerning an 8 year old female patient who on 15-AUG-2007 or 16-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot#656394/0162U) instead of Varivax (Oka/Merck) (MSD).  No adverse symptoms were noted.  No further information was provided.  There was no product quality complaint involved.  The patient's twin sister had a similar experience.  (WAES#0708USA04533)  This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: DTAP, HEPA, IPV, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX instead of VARIVAX. Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, polio vaccine, VAQTA and MMR II. No adverse experience were reported. Additional information has been requested. The patient's sibling had the same (WAES # 0708USA01715).
Age: 6.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received concerning a 6 year old female with no reported medical history or allergies who on 20-AUG-2007 was vaccinated with ZOSTAVAX (lot # 656859/0357U) instead of VARIVAX. Concomitant therapy included VAQTA (lot # 658172/0800U) and measles-mumps-rubella vaccine (MSD) (lot # 656038/0204U). No adverse event was reported. Unspecified medical attention was sought. It was also reported that the patient's sister also received a dose of ZOSTAVAX instead of VARIVAX (WAES # 0708USA03966). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician and a nurse concerning a male with diabetes and sulfa allergy who on 06-AUG-2007 was vaccinated with ZOSTAVAX (Lot # 657764/0584U). Concomitant therapy included FLOMAX and ezetimibe (+) simvastatin (MSD). The nurse reported on 09-AUG-2007 the patient developed shingles lesions on the left side of his back. The physician reported that on 13-AUG-2007 the patient presented to her office with 2 - 3 vesicles at the T6 dermatome site. He was also complaining of pain. He was treated with DARVOCET and gabapentin. The physician stated that she saw the patient again in her office on 21-AUG-2007 and he was recovering. The lesions were dried and he had no further pain. She stated there was no specimen to be sent as the patient was recovering. The physician did not feel the patient's symptoms were caused by the vaccine. This is one of several reports from the same source. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, No reaction on previous exposure to drug
Clinical narrative: 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 white male with a history of chronic lymphocytic leukaemia (on no treatment with stable blood counts) and no known allergies who on 18-JUL-2007 was vaccinated SC in the left upper arm with a first dose of ZOSTAVAX (Merck). The vaccination was recommended by the V.A. On 29-JUL-2007 the patient developed a facial pain. On 31-JUL-2007 the patient sought medical attention and was diagnosed with herpes zoster of the facial nerve. No further information was provided. Follow-up information received from the physician indicated that the patient was seen on 10-SEP-2007 with continued improvement in the zoster. It was noted that the patient had no adverse events following prior vaccination. Additional information has been requested.