chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old female who on 05-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot # 657558/0461U).  On 07-JUN-2007 within twenty four hours of vaccination, the patient experienced injection site reaction.  The reaction was described as a slightly raised red area with a three inch diameter around the injection site.  The patient sought unspecified medical attention.  The outcome was not reported.  There was no product quality complaint.  Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning an 80 year old female who on 13-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient experienced a 3-inch diameter red, raised rash at the injection site. The patient also developed itchiness at the injection site and tiredness. Medical attention was sought. The patient was treated with hydrocortisone cream which reduced the size of her rash and was relieving the itchiness. The patient's tiredness persisted. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pruritus
Clinical narrative: Information has been received from a 64-year-old female patient with no pertinent medical history who has a sulfonamide allergy, who on 29-JUN-2007 was vaccinated with an "injection in the left arm" of Zostavax (Oka/Merck) (product circular# 9815603).  Concomitant therapy included SYNTHROID, diclofenac and simvastatin (MSD).  On 01-JUL-2007 the patient developed red and itch fluid-filled blisters on her left foot.  They were not clustered, but the physician diagnosed them as shingles.  She has since developed one of the blisters on her left arm.  Unspecified medical attention was sought.  There were no laboratory diagnostic studies performed.  The outcome is reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Corneal scar, Eye pain, Herpes zoster ophthalmic, Keratitis herpetic
Clinical narrative: Information has been received from a physician concerning a female registered nurse (R.N.) from his office, who on 11-JUN-2007 was vaccinated subcutaneously with a "first vaccination of a single dose" of Zostavax (Oka/Merck). Two weeks following vaccination, (also reported as 16-Jul-2007) the patient experienced "pain in one of her eyes." The patient was seen by her optometrist who diagnosed her with herpes keratitis and was treated with antiviral eye drops. The virus was only directly in her eye. Specimens could not be obtained for analysis. A physician also reported that the patient had ophthalmic zoster. It is reported that the patient had corneal scarring. No product quality complaint was involved. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. The outcome is reported as not recovered.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Neuralgia, Rash
Clinical narrative: Information has been received from a relative of an 86-year-old female patient with high blood pressure, shingles for the last year, and has no allergies who "3 months ago" was vaccinated with a dose of Zostavax (Oka/Merck).  On an unspecified date, the patient experienced nerve pain and her mouth broke out with a rash.  It is reported that her physician gave her the vaccination to try and prevent the nerve pain from the shingles.  The lot number was not provided.  Unspecified medical attention was sought.  There were no laboratory diagnostic studies performed.  The outcome is reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis, Oedema peripheral, Pain in extremity, Rotator cuff syndrome, X-ray normal
Clinical narrative: Information has been received from a physician concerning a 64 year old female with hypertension and a history of depression and no allergies who on 04-JUN-2007 at 11:00 was vaccinated SC on right arm with a dose of Zostavax (Oka/Merck) (lot # 657675/0618U).  There was no illness at the time of vaccination.  On 04-JUN-2007 after vaccination at 11:00 AM the patient developed pain and swelling in upper arm that lasted for 2-3 weeks.  The patient was seen by the physician who stated that she had rotator cuff tendonitis and gave her DEPO MEDROL injection on right shoulder.  An X-ray of right shoulder was done which was normal.  On 29-JUN-2007 the patient recovered.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Additional information has been received from the physician who stated that after vaccination on right arm the patient experienced severe pain that kept her up at night and persisted. The patient was seen in the office and felt to have shoulder bursitis and was given DEPO-MEDROL on 22-JUN-2007. On 1-JUL-2007 (also reported as 29-JUN-2007) the patient recovered. No additional information is expected.
Age: 1.2
Sex: F
Vaccine: HIBV, MMR, PNC, VARZOS
Symptoms: Irritability, Pyrexia, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 13-month-female who on 18-JUL-207 was vaccinated subcutaneously with a 0.65 milliliter dose of Zostavax (Oka/Merck) (lot# 654604/1406F) instead of Varivax (Oka/Merck). It is reported that this occurred because one vial of Zostavax (Oka/Merck) was put into the Varivax (Oka/Merck) vial box by someone in the office. When the administering nurse grabbed the vial to inject the patient she did not look to make sure that it was Varivax (Oka/Merck), since it came out of the Varivax box. She did not realize this until after the patient was injected. It is reported that the patient is not experiencing any known symptoms. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information received on 21-Aug-2007 indicated that the patient was a healthy black female with no illness at the time of vaccination. Secondary suspect vaccinations on 18-Jul-2007 included a first dose in the right thigh of MMR II (lot# 655410/1469F). Concomitant therapy included a fourth dose in the right thigh of PREVNAR (Wyeth) (lot# b08692F), a third dose in the right thigh of PROHIBIT (Aventis Pasteur) (lot# 1126F), and XOPENEX as needed. On 18-Jul-2007, the patient had a low grade fever which was treated with MOTRIN, and irritability which was treated with alternating TYLENOL and MOTRIN. No laboratory or diagnostic tests were ordered. No more information is expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a nurse concerning a 60 year old female with no known allergies or pertinent medical history who on 12-JUL-2007 was vaccinated subcutaneously in the arm with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 12-JUL-2007 the patient developed an injection site rash.  At the time of this report the patient was recovering.  No lab studies were performed.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 67 year old female who on 16-JUL-2007 was vaccinated with a single dose of Zostavax (Oka/Merck) (lot#658081/0743U).  Concomitant vaccination Pneumovax 23 (MSD) administered at a different site.  On 16-JUL-2007, about five hours after the vaccination, the patient developed a band of erythema at the injection site.  She also complained of redness, pain, and swelling "around her arm but on the back of her arm".  There was no adverse event at the site of the Pneumovax 23 (MSD) vaccine.  Unspecified medical attention was sought.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Incorrect route of drug administration
Clinical narrative: Information has been received from a 90 year old female with a history of dizzy spells and no known allergies who on 12-JUL-2007 was vaccinated (reported as oral) with a 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included fenofibrate, BONIVA and CLARITIN.  On 16-JUL-2007 the patient developed dizziness, and "not feeling like herself".  Medical attention was not 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.  It was also noted that the patient experienced an adverse event after therapy with alendronate sodium (MSD) (WAES#0708USA01689).
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 41 year old female who on 17-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck). On 17-JUL-2007 the patient inadvertently received Zostavax (Oka/Merck).  No adverse effect reported.  No product quality complaint.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse concerning a female who on an unspecified date was vaccinated subcutaneously with a first single dose of Zostavax (Oka/Merck).  Subsequently the patient vomited once on the same day as the vaccination.  The patient contacted the physician to inform her of this adverse event.  It was reported that the patient had recovered and felt better within the same day.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck).  Subsequently, 10 days after vaccination, the patient developed chicken pox.  Unspecified medical attention was sought.  At the time of this report patient's status was not reported.  No other information was provided.  There was no product quality complaint involved.
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact
Clinical narrative: Information has been received from a registered nurse concerning an adult female who in July 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  In July 2007, one week after vaccination the patient developed a severe case of poison ivy.  Medical attention was sought and patient was placed on prednisone 60mg by mouth daily.  No other information was provided.  There was no product quality complaint involved.  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 who on 06-JUN-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (Lot#656606/0033U).  On 10-JUN-2007 the patient developed a diverse "herpes/zoster/chicken pox lesion" on her body that was spreading to other parts of the body.  Unspecified medical attention was sought.  At the time of the report the patient had not recovered.  No other information was provided.  There was no product quality complaint involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who in approximately May 2007, was vaccinated with a 0.65ml dose of Zostavax (Oka/Merck).  In 2007 the patient developed shingles.  Unknown medical attention was sought.  The patient's status was recovering.  No product quality complaint reported.  No further information is available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Oedema peripheral, Pain, Pain in extremity, Rash
Clinical narrative: Information has been received from a physician concerning a 73 year old female with chronic foot pain who on 30-MAY-2007 at 15:30 PM was vaccinated SC in the right deltoid with a first dose of Zostavax (Oka/Merck).  One week after vaccination, on approximately 06-JUN-2007, the patient developed a painful rash on her right foot.  The patient also developed painless rashes on both of her arms and the physician noted that it was non-injection site reaction.  Five weeks after vaccination, on approximately 27-JUN-2007, the patient reported excruciating foot pain.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been received from the physician.  On 09-JUN-2007, 10 days after the vaccination, a rash developed on the left wrist and left foot.  Then the patient had increased swelling of the left foot.  She also experienced pain in the left foot.  The patient feels she developed shingles and post herpetic neuralgia from the injection.  No diagnostic laboratory tests were performed.  The patient's outcome was not specified.  No further information is expected.
Age: 8.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old female who on 15-JUN-2007 was vaccinated SC on right deltoid with a first dose of zoster vaccine live (Oka/Merck) (Lot #656607/0163U).  It was reported that the patient was supposed to receive second dose of varicella virus vaccine live (Oka/Merck) (MSD).  It was reported that it was human error not a product confusion.  Additional information stated that the patient had no reaction.  No further information is expected.  the patient's siblings had similar experience after therapy with zoster vaccine live (MSD) WAES# 0707USA01867 and WAES #0706USA02773.
Age: 9.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 9 year old male who on 15-JUN-2007 was vaccinated SC on left deltoid with a first dose of Zostavax (Oka/Merck) (Lot # 656607/0163U).  It was reported that the patient was supposed to received second dose of Varivax (Oka/Merck) (MSD).  It was reported that it was human error not a product confusion.  Additional information stated that the patient had no reaction.  No further information is expected.  The patient's siblings had similar experiences after therapy with Zostavax (MSD) WAES # 0707USA01865 and WAES # 0706USA02773.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a physician and a woman from a physician's office concerning a 63 year old female patient who on 02 JUL 2007 was vaccinated subcutaneously in the left arm with a first dose of zoster vaccine live (Oka/Merck) (lot# 657765/0585U).  two weeks after vaccination, on approximately 16 JUL 2007, the patient experienced multiple cold sores on both sides of her mouth, 4 on the outside and multiple on the inside.  No medical attention was sought.  There were no laboratory or diagnostic tests performed.  The outcome is reported as recovered on approximately 26 JUL 2007.  No product quality complaint was involved.  No more information is expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 71 year old female consumer with no known allergies and a history of shingles "20 years ago" who "four to five months ago" in approximately February 2007 was vaccinated SC with a dose of Zostavax (Oka/Merck).  Concomitant therapy included acyclovir.  Subsequently the patient has had three to four shingles outbreaks since vaccination.  Medical attention was not sought, no lab studies were performed.  At the time of the report the patient was recovering.  There was no product quality complaint involved.  No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Excoriation, Pruritus, Rash
Clinical narrative: Information has been received from a physician assistant concerning a 66 year old female who on 08 JUN 2007 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck).  On 09 JUL 2007, the patient came into the doctor's office because she experienced a three by three centimeter rash on her mid-back.  The rash was excoriated from scratching.  There was no signs of vesicles.  The patient experienced itching but no pain.  The rash started off as spots.  The patient was treated with antihistamine and the reporter has not heard back from the patient.  A product quality complaint was not involved.  Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 64 year old male with a history of chickenpox and no known allergies who on 02 JUL 2007 (also reported on 03 JUL 2007) was vaccinated on right deltoid muscle with a 0.65 ml dose of zoster vaccine live (Oka/Merck) (lot # 657765/0585U).  On 06-JUL-2007 the patient experienced bad rash.  There was no recent exposure to chickenpox.  It was reported that the rash developed 3 days after vaccination.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a consumer concerning his 82 year old wife who has had shingles all her life and was scheduled for back surgery on 25-JUL-2007 who on 11-APR-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  The reason for vaccination was to lessen the pain she has each time she gets shingles, not to prevent shingles.  On approximately 12-JUN-2007 the patient developed mild shingles. On 12-JUL-2007 the patient developed shingles with severe pain in the small of the back.  Medical attention was not sought.  She began to use a LIDODERM patch and LYRICA.  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: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an 82 year old female who on 08 MAY 2007 was vaccinated with an injection of a 0.65 milliliter dose of zoster vaccine live (Oka/Merck) (lot # 657764/0584U).  On an unspecified date, the patient experienced 10 chicken pox-like lesions at injection site.  Unspecified medical treatment was sought.  The outcome is reported as recovered.  No product quality complaint was involved. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow-up information received indicates that the patient is an 83-year-old (previously reported as 82-year-old) female who has allergies to penicillin and codeine. Concomitant therapy included amitriptyline hydrochloride (MSD), ezetimibe (MSD), LOPID, hydrochlorothiazide (manufacturer unspecified), SANCTURA, DIOVAN, AVANDIA and unspecified thyroid medication. There were no illnesses at the time of vaccination. The patient developed a case of chicken pox "2 to 3 weeks" after receiving the vaccination, approximately on 22-May-2007. No laboratory or diagnostic studies were performed. It was reported that the patient and her siblings have not had any adverse reactions following previous vaccinations. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 65 year old female who on 19 SEP 2006 (previously reported as 11 APR 2007) was vaccinated, with zoster vaccine live (Oka/Merck) lot # 652965/0623F).  On 12 JUL 2007 the patient developed shingles.  Unspecified medical attention was sought.  The patient's shingles persisted.  At the time of this report the patient had not recovered.  No further information was available.  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: Information has been received from a physician concerning a 4 year old male who on 19 JUN 2007 was vaccinated with zoster vaccine live (Oka/Merck) (lot # 657558/04610) instead of booster for varicella virus vaccine live (Oka/Merck) (MSD).  No symptoms were reported.  The physician noted that these were cases of human error, not product confusion.  This is one of two reports received from the same source.  Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, MEN, VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old patient who on 12 JUL 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck).  There was no adverse event.  There was no further information provided.  There was no product quality complaint involved.  Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Injection site irritation; blood pressure increased; injection site erythema; injection site pain.  Information has been received from a pharmacist concerning a 69 year old female who on 07 JUL 2007 was vaccinated with zoster vaccine live (Oka/Merck).  On 08 JUL 2007, the day following vaccination, the patient developed injection site redness, pain, and intermittent burning.  The patient was seen by her physician and was treated with cetirizine HCL (ZYRTEC).  The patients blood pressure was also found to be elevated while at the physician's office.  At the time of the report the patient was recovering.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site erythema; injection site swelling.  Information has been received from a physician concerning a female who on 05 JUL 2007 or  JUL 2007 was vaccinated sc with a first single dose of zoster vaccine live (Oka/Merck).  This patient was receiving unspecified concomitant therapy.  Over the weekend of 07 JUL 2007 to 08 JUL 2007 the patient developed redness and swelling at the injection site.  The patient visited the physician's office for follow up and was treated with fexofenadine HCL (ALLEGRA) and a methylprednisolone dose pack (MEDROL).  On an unspecified date the patient recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Injection site swelling.  Information has been received from a pharmacist concerning an 84 year old female who on 11 JUL 2007 was vaccinated with a .65 ml dose of zoster vaccine live (Oka/Merck) subcutaneously.  On 14 JUL 2007, the patient experienced injection site swelling:  2.5 inches, which persisted.  Outcome was not reported.  No further information is available.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac fibrillation, Fatigue, Myalgia, Myalgia
Clinical narrative: Cardiac Fibrillation; Myalgia; Fatigue.  Information has been received from a 64 year old male with no medical history or allergies who on 02 JUL 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck).  Concomitant therapy included atorvastatin calcium (LIPITOR), irbesartan (AVAPRO), and esomeprazole magnesium (NEXIUM).  On approximately 13 JUL 2007, the patient began feeling very fatigued and he was experiencing muscle aches all over his body.  For one night only, on approximately 13 JUL 2007, he experienced heart fibrillation.  Unspecified medical attention was sought.  No diagnostic laboratory tests were performed.  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested. This is in follow-up to report (s) previously sumitted on 9/24/2007. Follow-up information received from the physician indicating that the patient was extremely lethargic 48 hours after the vaccine lasting 4 - 5 days, also extreme muscle aches. It is unknown if the exteme muscle aches resolved. No illness at the time of vaccination. No further information is available.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Inappropriate schedule of drug administration, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a 50 year old female consumer with sulfonamide, Percocet, and morphine allergies.  The patient also reports fentanyl caused vomiting and dizziness.  She has a history of chronic shingles, for about 23 years, tumor of right femur, post-traumatic stress disorder, three cesarean sections, hysterectomy, oophorectomy and right hip surgery who in Mary 2007, was vaccinated with a single dose of Zostavax (Oka/Merck).  Concomitant therapy included oxycodone HCl, cyclobenzaprine HCl (MSD), NEURONTIN, SEROQUEL, ESTRACE, lorazepam, clonidine HCl and hydrochlorothiazide (MSD).  Prior to vaccination some years she had outbreaks of shingles once a month or more often, other years outbreaks were approximately once every two months.  Almost always her shingles occurred on the outer portion of her left thigh.  She also had post herpetic neuralgia down her left leg.  Her outbreaks had been very painful and the rash was red with tiny bumps.  Since vaccination in May 2007 she has had four or five more outbreaks of shingles (starting three weeks after vaccination).  These outbreaks have all occurred on the outer portion of her left thigh (as in the past), however the size of the rash has been smaller than in the past.   The post herpetic neuralgia has been very painful, but the level of pain was less than in the past.  Her most recent outbreak was on 13-JUL-2007.  At the time of the report the patient had not recovered.  Unspecified medical attention was sought.  No labs were performed.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: Information has been received from a consumer concerning his 62 year old wife with hypertension and hypercholesterolaemia who on 12-FEB-2007 was vaccinated with Zostavax (Oka/Merck).  "About 7 days later" on 19-FEB-2007 the patient developed mouth sores.  Unspecified medical attention was sought.  The patient was being treated with ZOVIRAX.  At the time of the 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: Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a female who on 11-JUL-2007 was vaccinated with a 0.65ml dose of Zostavax (Oka/Merck).  On 12-JUL-2007 the patient developed a red mark the size of a quarter at the injection site which grew to the size of a half dollar, and developed a "blister looking rash".  Unspecified medical attention was sought.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus
Clinical narrative: Information has been received from a physician concerning a male who on an unspecified date was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  Subsequently the patient developed a rash at the injection site.  The patient also had complaints of itching.  The nurse believed the injection may have been given intramuscularly.  Unspecified medical attention was sought.  At the time of the report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Body temperature, Herpes zoster, Pain
Clinical narrative: Information has been received from a consumer concerning his 84 year old wife, with no known allergies who on 05-JUN-2007 was vaccinated in the left arm (also reported as left deltoid) with a 0.5 ml dose of Zostavax (Oka/Merck) (lot # 657559/0462U).  Concomitant therapy included aspirin 81 mg, HCTZ/triamterene, NORVASC, NEXIUM and vitamins (unspecified).  A week and a half after the vaccination, on approximately 15-JUN-2007, the patient developed blisters and pain on the right arm.  The patient visited her physician on 06-JUL-2007 and was diagnosed with shingles.  At the time of report the blisters were gone, but the pain still persisted.  No further information was provided.  There was no product quality complaint involved.  Additional information has been received from a medical assistant.  She confirmed that the patient was seen at the office on 06-JUL-2007 and diagnosed with shingles.  Patient was being treated with tapering doses of prednisone and LYRICA 75mg by mouth twice a day.  Medical assistant requested information about the VZVID program.  Additional information was received from a physician.  The patient has concurrent conditions of hypertension, increased cholesterol, coronary artery stenosis, glucose intolerance, and renal insufficiency.  The patient has a codeine allergy (previously reported as no known allergies).  The patient was vaccinated in the left deltoid on 05-JUN-2007 with a 0.5 ml dose of Zostavax (Oka/Merck) (lot#657559/0462U).  No rash occurred at the injection site post vaccination.  On 01-JUL-2007 (reported by the consumer as one and a half weeks after vaccination) the patient developed herpes zoster which was diagnosed on 06-JUL-2007.  The patient's rash was described as multiple vesicular herpetic lesions down the right arm.  The patient's maximum temperature was 99 degrees Fahrenheit (also reported as 98 degrees).  The patient's pain was rated as a six on a scale of zero to ten (zero equals least ten equals most).  The patient has no history of chicken pox and there was no recent exposure to chicken pox or herpes zoster.  A direct fluorescent antibody was not done, nor was a specimen collected for PCR.  On an unspecified date the patient recovered.  Additional information was received indicating that the patient was" trying to get recourse."  Additional information has been requested at this time.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a female who on an unspecified date was vaccinated with a subcutaneous first single dose of Zostavax (Oka/Merck).  Subsequently the patient developed a rash on her arm at the injection site about a week after vaccination.  It was noted that the patient was gardening at the time she noticed the rash.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 74 year old male who on 20-JUN-2007 was vaccinated with a 0.65 ml first dose of Zostavax (Oka/Merck) (lot#657767/0740U).  On 12-JUL-2007 the patient developed a shingles outbreak.  It was noted that the patient had eight painless rashes on his leg and hip area.  Unspecified medical attention was sought.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a immunization coordinator concerning a 69 year old female with no medical history or allergies who on 11-MAY-2007 at 9:30 Am, was vaccinated SC on arm with a dose of Zostavax (Oka/Merck) (lot # 657558/0461U). There was no illnes at the time of vaccination within 24 hours, after vaccination the patient developed a quarter inch welt at injection site.  The welt lasted for 10 days and then resolved.  Unspecified medical attention was sought.  At the time of report the patient had recovered.  A product quality complaint was not involved.  Additional information has been received from a immunization coordinator who stated that the patient developed a rash on arm within 24 hours of vaccination. No diagnostic laboratory tests were undertaken. On 14-MAY-2007 the patient had recovered. No information is expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Photosensitivity reaction, Rash, Rash generalised
Clinical narrative: Information has been received from a health professional concerning an 82 year old female with sulfonamide allergy who in early part of June 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  On 29-JUN-2007 the patient developed a rash on her forearm which was treated with a steroid cream.  The rash was seen by the dermatologist and was believed to be a photosensitivity rash.  Shortly after the initial experience the rash spread all over the patient's head, neck and body.  The patient was treated with prednisone 20 mg and ATARAX.  On 16-JUL-2007 the patient was still experiencing rash.  It was reported that the patient was vaccinated at other dermatology office.  A product quality complaint was not involved.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 60 year old female who was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that after vaccination the patient developed a big, red swelling at injection site.  The physician characterized the appearance of the reaction as being similar to the appearance of Lyme disease.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an office manager concerning a male who was vaccinated subcutaneously in the deltoid with a 0.65 ml dose of Zostavax (Oka/Merck).  Subsequently, within 4 days post vaccination, the patient developed a" mild case of shingles".  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 70 year old male who on 29-JUN-2007 or 02-JUL-2007, was vaccinated SC with a single dose of Zostavax (Oka/Merck).  It was reported that immediately after vaccination the patient developed swelling and rash at injection site.  The patient was observed in the office and no treatment was required.  At the time of report the patient had recovered.  A product quality complaint was not involved.  Additional information has been requested.  This is one of several reports received from the same source.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site irritation, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a physician concerning an 82 year old female who on 01-JUL-2007 at 13:30 was vaccinated SC in the left arm with a first dose of Zostavax (Oka/Merck).  There was no illness at the time of vaccination.  Immediately after vaccination, on 01-JUL-2007 at 13:30, the patient developed a rash, redness, swelling, itching, and burning at the injection site.  The patient was observed in the office and treatment was not required.  No diagnostic laboratory tests were performed.  The patient fully recovered on 02-JUL-2007.  A product quality complaint was not involved.  No further information is expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 82 year old female who on 01-JUL-2007 at 13:30 was vaccinated SC in the left arm with a first dose of Zostavax (Oka/Merck).  There was no illness at the time of vaccination.  Immediately after vaccination, on 01-JUL-2007 at 13:30, the patient developed a rash, redness, swelling, itching, and burning at the injection site.  The patient was observed in the office and treatment was not required.  No diagnostic laboratory tests were performed.  The patient fully recovered on 02-JUL-2007.  A product quality complaint was not involved.  No further information is expected.
Age: 7.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker concerning a 7-year-old female who on 06-JUL-2007 was vaccinated subcutaneously with "one vial" of Zostavax (Oka/Merck) (lot# 654604/1406F) instead of Varivax.  Medical attention was not sought.  The outcome was not provided.  No product quality complaint was involved.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female (187 pounds) with no illness at the time of vaccination and allergies to penicillin, tetracycline, cephalosporins and ZITHROMAX who on 28-JUN-2007 was vaccinated subcutaneously with Zostavax (Oka/Merck) (lot # 657764/0584U).  On 29-JUN-2007 the patient developed a cellulitis hypersensitivity reaction to Zostavax (Oka/Merck).  The patient was prescribed CIPRO, 500 mg twice a day for 7 days and loratadine, 10 mg daily as needed.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who on 09-JUL-2007 was inadvertently vaccinated with a dose of Zostavax (Oka/Merck) instead of VARIVAX.  It was reported that the error was not due to product confusion.  There was no adverse experience related to this event.  There was no product quality complaint involved.  No further information was provided.  Additional information from the registered nurse indicated that there were 2 boxes in the refrigerator and she grabbed the vial out of the wrong box.  She called the patient the next day and she was fine.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Additional information from the physician indicated that the patient had no known allergies or pertinent medical history. There was no illness at the time of vaccination. There were no labs performed. The physician also confirmed that the patient had no adverse experience. Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Vaccination complication
Clinical narrative: Information has been received from a physician concerning an 81 year old female with hypertension, hyperthyroidism, osteoarthritis, sulfonamide allergy and an allergy to calcium channel blockers who on approximately 25-JUN-2007 was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient experienced pains 3 or 4 days post vaccination and the left side of the face was red.  The patient experienced a shingles outbreak.  The patient will be seen and is concerned about eye involvement.  The physician did not think this was vaccine failure but instead a vaccine related side effect.  The physician is interested in the VZV ID program.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Blister, Tenderness
Clinical narrative: Information has been received from a 27 year old female medical assistant who in approximately April 2007, got Zostavax (Oka/Merck) (Lot #656606/0033U) on her fingers while reconstituting it.  Concomitant therapy included ibuprofen.  In approximately April 2007, the patient experienced white, clear fluid filled blisters on her index and middle finger of her right hand, in the area where she was exposed to the vaccine.  The blisters come and go, and are tender to the touch.  As of 09-JUL-2007, the patient had not recovered.  Medical attention was sought.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her 75 year old mother with a history of shingles who on 10-MAY-2007 was vaccinated SC with a dose of Zostavax (Oka/Merck).  Concomitant therapy included SYNTHROID, ZOVIRAX, VALTREX and "2 blood pressure pills."  Subsequently the patient has had two outbreaks of shingles on 18-JUN-2007 and 04-JUL-2007.  Unspecified medical attention was sought.  There were no lab studies 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.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from an 85 year old female with hay fever and allergies to rofecoxib (MSD) (WAES # 0707USA02086), ibuprofen and penicillin who on 06-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 08-JUL-2007, the patient experienced redness and itching at the injection site.  Unspecified medical attention was sought.  No diagnostic laboratory tests were performed.  At the time of the report, the patient was recovering.  A product quality complaint was not involved.  Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 14 year old patient who was inadvertently vaccinated with a dose of Zostavax (Oka/Merck).  There were no adverse symptoms.  A product quality complaint was not involved.  Additional information has been received from the health professional who reported that the patient received a dose of Zostavax (Oka/Merck) instead of a dose of Varivax (Oka/Merck) (MSD).  It was confirmed to be product confusion (not further specified).  No further information is expected.
Age: 14.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 14 year old patient was vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck).  The physician stated that this was not a case of product confusion.  The patient sought unspecified medical attention.  No product quality complaint.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 65 year old female who was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently, seven days after receiving the vaccination, the patient developed a rash all over her body that looked more like chicken pox than shingles.  The physician wasn't the one that gave the vaccine, it was given at the patient's "army base".  The patient did have a titer drawn prior to getting the vaccine and there was an indication that the patient already had chicken pox.  The physician prescribed "antivirals".  Unspecified medical attention was sought.  No product quality complaint.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension
Clinical narrative: Information has been received from a pharmacist concerning a female (age unknown) who was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed high blood pressure 7 to 10 days after receiving vaccination.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a medical assistant concerning a 69-year-old female with (no known allergies), has type II diabetes mellitus, hyperlipidaemia, hypertension and hypothyroidism who on 28-FEB-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 656606/0033U).  Concomitant therapy included CRESTOR, hydrochlorothiazide, minocycline, lisinopril, SYNTHROID, vitamin E, CAL-CITRATE, alprazolam and ACTOS.  On 06-Jul-2007 a dermatologist diagnosed the patient with a mild case of shingles.  She was prescribed FAMVIR for the shingles and ALEVE as needed for the pain.  No laboratory or diagnostic tests were performed.  The patient states that she is not in pain.  No outcome was reported.  No product quality complaint was involved.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 68 year old female who in February 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included FAMVIR.  Subsequently the patient developed a case of shingles.  Unspecified medical attention was sought.  No additional 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.  Initial and follow up information has been received from a physician concerning a 68 year old retired female who on 28-FEB-2007 was vaccinated in the right deltoid with a dose of ZOSTAVAX (Oka/Merck) (Lot # 656606/0033U).  Subsequently in July 2007 the patient developed a case of shingles in her right buttock area.  The patient was seen by a dermatologist and was prescribed FAMVIR 500mg three times a day for ten days.  The patient did not have a rash at the injection site or elsewhere within 42 days of the vaccination.  The patient had a history of chickenpox as a child, but there was no recent exposure to chickenpox or herpes zoster.  There was no direct fluorescent antibody done, nor was a specimen collected for PCR.  No additional information was provided.  At the time of this report the patient had recovered.  There was no product quality complaint involved.  Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a pharmacist concerning an adult female who in May 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  In May 2007, after vaccination the patient developed chicken pox.  It was reported that the patient was covered from head to toe.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.