chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes simplex serology positive, Herpes zoster
Clinical narrative: Information has been received from a physician concerning an approximately 4 year old female patient who "several years ago" at her 1 year appointment was vaccinated with varicella virus vaccine live (Oka/Merck). Follow up information from the physician indicated that approximately 1 year (date unspecified) post vaccination, she developed herpes zoster. The patient on an unspecified date about 1.5 years (dated unspecified) after the first occurrence, she developed a second occurrence of herpes zoster. The physician indicated that the vesicular lesions were located on the anterior chest and had re-occurred in the same place. On 08-JAN-(year not specified), a culture was obtained by a dermatologist of the lesions that grew only herpes simplex virus. The patient currently is not enrolled in the VZV ID Program. The physician indicated that 1 or both of the parents are physician's and they believed that these events were related to vaccination with varicella virus vaccine live (Oka/Merck). The physician indicated to the parents that she felt the child should have an immunologic evaluation, including HIV testing, as 2 occurrences of zoster within 18 months may be indicative of an underlying undiagnosed immunodeficiency. The physician indicated that the patient's parents were not sure such an evaluation was necessary, and to her knowledge, they had not agreed to an immunologic work up of the patient. The physician also reported that the parents were insistent that the patient had not had any previous varicella exposure before or after vaccination as well as in utero. It was reported that the patient's brother has had recurrent lesions as well. Current patient status was not reported. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2008.  Follow-up information received indicated that the patient was not under the physician's care.  The name and information of the primary care physician had been provided.  Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a PharmD concerning a 46-year-old female with an allergy to penicillin and no pertinent medical history who was vaccinated twice in 2000 and twice in 2006 with a dose of varicella virus vaccine live (Oka/Merck) and continues to have  a negative varicella titer. The patient sought medical attention via a consultation with a pharmacist. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who on 10-JAN-2008 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (Lot # 658937/1560U) SQ in the left arm. On 11-Jan-2008, the patient experienced swollen, red 1 1/2 inch size area. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Information has been received from a health professional concerning a patient who on an unspecified date, was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) and developed a generalized rash after receiving the vaccine. It was indicated that on an unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a female who on 14-JAN-2008 was vaccinated SC with her first 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On approximately 15-JAN-2008 within a day or two after vaccination, the patient developed an area of redness and induration at the injection site. The patient contacted the physician by phone for medical attention. The patient was treated with Zyrtec. The outcome was unknown. There was no product quality complaint. Follow-up information has been received from the reporting registered nurse concerning a 22 year old white female who on 14-JAN-2008 was vaccinated SC with her first dose of varicella virus vaccine live (Oka/Merck) (lot# 658411/1023U). There was no illness at the time of vaccination. On 15-JAN-2008 the patient experienced redness, induration and heat at the injection site. The patient sought medical attention through a doctor visit. No labs or diagnostic studies were performed. On approximately 19-JAN-2008 about 5 days after injection, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 27 year old female with sulfonamide allergy and nickel sensitivity who on 20-DEC-2007 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) 0.5 ml SQ. Concomitant therapy included hormonal contraceptives (unspecified). On 21-DEC-2007 or 22-DEC-2007, the patient experienced injection site reaction. The area of the arm had erythema 6 inches in diameter and darker red are of induration that was three inches in diameter. The patient was seen in the doctor's office. The patient was treated with diphenhydramine hydrochloride (BENADRYL). No lab or diagnostic studies were performed. The reaction lasted for two days. This is one or two reports from the same source. Additional information has been requested. Folow up: There were no adverse events following prior vaccination. There was no illness at time of vaccination. The outcome was reported as recovered.
Age: 6.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old white male with no pertinent medical history, drug reactions or allergies who on 02-AUG-2007 was vaccinated subcutaneously into the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657649/0815U). On 04-AUG-2007, the patient developed a swollen red lump at the injection site. There was no illness at the time of vaccination. The patient recovered on an unspecified date. There were no lab diagnostic studies performed. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 6 year old 51 lb. 46 3/4 in. male who on 02-AUG-2007 was vaccinated with subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot# 657941/0815U). There was no reported illness at the time of vaccination. On 04-AUG-2007, the patient developed a swollen, red, lump at the injection site. There were no relevant diagnostic tests or laboratory data. On an unspecified date, the patient recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 15 year old 130 lb. 62 in. female who on 07-AUG-2007, was vaccinated with a second subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot#657941/0851U). There was no reported illness at the time of vaccination. On 08-AUG-2007, the patient developed redness and pain at the injection site. Medical treatment sought was not reported. There was no relevant diagnostic and laboratory data reported. On an unspecified date, the patient recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who on 08-AUG-2007 was vaccinated SC on left hand with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657649/0815U). There was no illness at the time of vaccination. On 09-AUG-2007, the patient experienced red patch slightly raised itchy rash. On an unspecified date the patient recovered. No diagnostic laboratory tests were undertaken. Additional information has been requested. This is one of several reports received from the same source.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Skin warm, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old white female who on 13-AUG-2007 was vaccinated SC on left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657649/0815U). There was no illness at the time of vaccination. On approximately 13-AUG-2007, immediately after vaccination the patient experienced hard welt, red and hot to touch. It was reported that on 16-AUG-2007 the patient recovered. No diagnostic laboratory tests were undertaken. Additional information has been requested. This is one of several reports received from the same source.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood glucose abnormal, Diabetes mellitus
Clinical narrative: Information has been received from a consumer concerning his 8 year old son with no previous medical history or drug allergies who on 03-DEC-2007 was vaccinated SC with his second 0.5 mL dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 23-DEC-2007, the patient was diagnosed with diabetes 20 days after vaccination. Unspecified medical attention was sought. A blood test was performed. The patient was not recovered at the time of this report. There was no product quality complaint. No further information is available.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male who on 01-AUG-2007 was vaccinated SC on right arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657649/0815U). There was no illness at the time of vaccination. On 02-AUG-2007 at 14:50 PM, the patient experienced injection site "puffy" and swelling of 2-3". The patient's body temperature was slightly elevated at 100.1. The patient had itchiness at injection site. On 05-AUG-2007, the patient recovered. No diagnostic laboratory tests were undertaken. Additional information has been requested. This is one of several reports received from the same source.
Age: 0.4
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 7-month-old male infant who was vaccinated at 5 months of age with a dose of varicella virus vaccine live (Oka/Merck) and 2 months later developed a rash. The patient sought medical attention via an office visit. At the time of the report the patient's status was unknown. The physician stated the rash was not related to varicella virus vaccine live (Oka/Merck). A product quality complaint was not involved. No further information is available.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash papular, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old patient who on 31-AUG-2000 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). On 08-FEB-2007, the patient was vaccinated with the second dose of varicella virus vaccine live (MSD). On 29-NOV-2007, the patient developed two papules on his wrist and about six lesions on his neck. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 7 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and "came down with chickenpox". The physician did not know whether the patient had one shot or two of the vaccine. No additional information was provided. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female with no pertinent medical history and no drug reactions/allergies, who on 03-DEC-2001 and 17-JAN-2008 at 2:00 PM (previously reported ass 2:30 PM) was vaccinated SC in the right arm with a first 0.5 mL dose and a second dose of varicella virus vaccine live (Oka/Merck) (lot number: 659608/1761U). There was no concomitant medication. On 19-JAN-2008 in the AM the patient returned to the office because of an injection site reaction. Her upper right arm was erythematous and slightly raised 10 cm in diameter. The middle of this area was red and indurated approximately 5 cm. The periphery was more pink and there was no streaking. The area was very tender to the touch especially over the indurated area. The physician who examined her prescribed cephalexin (KEFLEX). No other details were provided. There were no lab diagnostic studies performed. Unspecified medical attention was sought in the office. The outcome was reported as recovering. There was no product quality complaint. Follow-up information indicated that there were no adverse events following prior vaccination. There was no illness at time of vaccination. The outcome was reported as recovered. No additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Ear infection, Pharyngitis, Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from an office manager concerning a 5 year old male with pre-existing allergies, birth defects, medical conditions that included: "NKDA", (previously reported as no pertinent medical history and no allergies), who on 22-AUG-2003 was vaccinated SC with a first and only 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot number: 645291//0201N). Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) in the right arm. On 16-JAN-2008, the patient was seen in the office with a varicella outbreak, pharyngitis, an ear infection in both ears and a low fever. Treatment was antibiotic, Aveeno soap and lotion. The patient had a follow-up visit with the doctor the next day. No other information. There were no lab diagnostic studies performed. Unspecified medical attention was sought in the office. The outcome was reported as not recovered. There was no product quality complaint. Follow-up information indicated that on 16-JAN-2008, the patient was diagnosed with varicella, fever. The outcome was reported as recovered. No additional information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 12-month-old female with no medical history or allergies who on 04-JAN-2008 was vaccinated subcutaneously with a 0.5 ml first dose of varicella virus vaccine live (Oka/Merck) (lot# 659356/1566U). There was no concomitant medication. On an unspecified date after 04-JAN-2008 the patient experienced cellulitis at the injection site area. The patient was seen by a physician on unspecified date and no laboratory or diagnostic tests were performed. Subsequently, the patient recovered from cellulitis at the injection site area as of 18-JAN-2008. No product quality complaint was involved. Additional information was received on 18-FEB-2008. The cellulitis began on 14-JAN-2008. No further information was reported at this time. Additional information is not expected.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 41 year old female with no medical history or allergies who on 21-JAN-2008 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 659698/1770U). There was no concomitant medication. On 22-JAN-2008 morning, the patient developed a red and slightly swollen area at injection site of the deltoid. The next day, 23-JAN-2008, there was increased swelling, afebrile. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Rash macular
Clinical narrative: Information has been received from a health professional concerning a 50 year old female with no medical history and allergy to PPD (causes redness) who on 21-JAN-2008 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 659698/1770U). There was no concomitant medication. On 23-JAN-2008, 48 hours post vaccination the patient developed a red blotch area at injection site of the deltoid. No diagnostic laboratory tests were undertaken. Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports recovered from the same source.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old patient who was vaccinated SC with a first 0.5 mL dose of varicella virus vaccine live (Oka/Merck). It was reported that after vaccination the patient had a breakthrough of chickenpox. The patient had less than 50 lesions of chickenpox. Unspecified medical attention was sought. a product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Serology negative
Clinical narrative: Information has been received from a physician concerning a 7 year old male with asthma and no allergies who on 28-JUN-2007 was vaccinated SC with a first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 653435/0561F0. Concomitant therapy included steroid medications. In August 2007, 3 to 4 months post vaccination the patient was found to be seronegative. No symptoms were reported. No medical attention was sought. A product quality complaint was not involved. Additional information has been requested. It was reported that patient's sister WAES # 0801USA04742 experienced a similar adverse event following vaccination with varicella virus vaccine live (Oka/Merck). This is one of several reports received from the same source.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella zoster serology negative
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/16/2008. Information has been received from a physician concerning a 10 year old female with no medical history or allergies who on 28-JUN-2007 was vaccinated SC with a first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 653435/0561F). There was no concomitant medication. In August 2007, 3 to 4 months post vaccination the patient was found to be seronegative. No symptoms were reported. No medical attention was sought. On 30-OCT-2007, the physician drew the varicella titre, and it came back negative (<0.91). The physician stated that the patient received a second varicella shot on 04-FEB-2008. A product quality complaint was not involved. No further information is available. It was reported that the patient's brother WAES # 0801USA047032 experienced a similar adverse event following vaccination with varicella virus vaccine live (Oka/Merck). This is one of several reports received from the same source.
Age: 1.49
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella zoster serology negative
Clinical narrative: Information has been received from an physician concerning a female with no pertinent medical history or allergies who on 07-JUN-2007 was vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck) (653435/0561F). Concomitant therapy included measles-mumps-rubella vaccine (manufacturer unknown). When the patient had her titers tested for varicella virus vaccine live (Oka/Merck) she was found to be seronegative. No symptoms were reported. No medical attention was sought. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. 3/25/2010 Follow up information was received from the physician concernign a 23-month-old female who on 05-Jun2001 (oreviously reported as 07-Jun-2008) was vaccinated at 5:00 with a first dose of VARIVAX in the "RT". At 1:00 on 08-Nov-007, the paitient had a varicell titier drawn which came back negative.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health care worker concerning an patient in their "60's" who on 24-JAN-2008, was inadvertently vaccinated with 0.5 ml dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The patient sought unspecified medical attention at a clinic. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, Seroconversion test negative
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with 2 doses varicella virus vaccine live (Oka/Merck) and failed to seroconvert. The patient was tested for seropositivity after exposure to the varicella-zoster virus and had a negative titer. No additional information is expected.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old patient who in 2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). It was reported that after vaccination on approximately 16-JAN-2008, the patient had a breakthrough of chickenpox. The patient had less than 50 lesions of chickenpox. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Sex: F
Vaccine: DTAP, MEN, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician's office manager, that a female patient on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant vaccination included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), and meningococcal vaccine (manufacturer unspecified). It was indicated that after receiving the vaccine, the patient had fainted. Medical treatment and current patient status was not reported. A product quality complaint was not reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2009. Follow-up indicated that the health care provider believed it was dut to other factors that had caused the patient to have fainted, and not feel that the varicella virus vaccine live (Merck) was a factor. Current patient status was not reported. Additional information is not expected.
Age: 1.8
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 10 year old male who on 23-JUN-1999 was vaccinated with a first 0.5 mL. subcutaneous dose in the arm of varicella virus vaccine live. (Oka/Merck) (lot#629614/0286J). On 27-DEC-2007, the patient developed a rash with less than 50 lesions. There was no reported fever. Medical attention was sought via the phone. No laboratory or diagnostic studies were performed. The reporter indicated that on 22-JAN-2008, the patient had recovered. Follow up information from a nurse provided no additional information. This is one of four reports from the same source. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Skin lesion
Clinical narrative: Information has been received from a health professional concerning a 9 year old female who on 17-SEP-1999, was vaccinated with a first 0.5 ml subcutaneous dose in the arm of varicella virus vaccine live (Oka/Merck) (lot # 629614/0286J). On 04-JAN-2008, the patient developed a rash with 50 to 100 lesions and fever to 102.8 degrees Fahrenheit. The patient sought medical attention via the phone. No laboratory or diagnostic studies were performed. The reporter indicated that on 24-JAN-2008, the patient had recovered. A product quality complaint was not reported. Follow up information from the health profession provided no additional information. This is one of 4 reports from the same source. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 9-year-old male who on 15-OCT-1999 was vaccinated subcutaneous with a 0.5 mg dose of varicella virus vaccine live (Oka/Merck) (lot # 631168/0710J). On 13-JAN-2008, the patient developed a rash with less than 50 lesions and fever. The patient sought medical attention via a phone call. No diagnostic labs were performed. On 18-JAN-2008, the patient recovered. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 6-year-old female who on 30-AUG-2002 was vaccinated subcutaneous with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot # 643117/0502M). On 10-DEC-2007 the patient developed a rash with less than 50 lesions, no fever. The patient sought medical attention via a phone call. No diagnostic labs were performed. On 22-JAN-2008, the patient recovered. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2008.  Information has been received from a registered nurse concerning a 6-year-old female who on 30-AUG-2002 was vaccinated subcutaneous in the right arm with a first 0.5 ml dose of VARIVAX (Merck) (lot # 643117/0502M).  On 10-DEC-2007 the patient developed a rash with less than 50 lesions, no fever.  The patient sought medical attention via a phone call.   No diagnostic labs were performed.  On 22-JAN-2008, the patient recovered.  A product quality complaint was not involved.  This is one of several reports received from the same source.  Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 14 (age unit not specified) patient who on 10-JAN-2008 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot # 659209/1504U). On 10-JAN-2008,, the patient developed a red welt at injection site. On 12-JAN-2008, the patient recovered from the red welt at injection site. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning an approximately 12 year old female who in 1996 was vaccinated with varicella virus vaccine live (Oka/Merck). In 2004, the patient developed herpes zoster. On an unspecified date, the patient recovered. A product quality complaint was not reported. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 9 year old male who when he was 5 years old (approximately 2003), he was vaccinated with a second 0.5 mL. dose of varicella virus vaccine live (Oka/Merck). On 23-JAN-2008, he developed "breakouts". Five days later (28-JAN-2008), he was seen at the clinic, and it was indicated had developed shingles on his right T7 anterior and posterior dermatome. Medical treatment and current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning her 29 year old daughter with no known allergies or pertinent medical history who one month ago (December 2007), was vaccinated with varicella virus vaccine live (Oka/Merck). There was no concomitant medication. After receiving the vaccine (December 2007), the patient developed what the physician was questioning as an injection site reaction. She indicated that there was redness and swelling around the area of administration, the patient was seen by a physician. No laboratory or diagnostic studies were performed. On an unspecified date, the patient had recovered.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 6 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #658004/0729U). Subsequently the patient experienced an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This is one of several from the same source. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 35 month old male with eczema and allergies to peanuts and eggs, who on 27-FEB-2006 was vaccinated with a first dose in the left thigh of varicella virus vaccine live (Oka/Merck) (lot# "B08663B"). Concomitant vaccine administered on the same day included a fourth dose in the right thigh of Prevnar (Lot# B08633B). There was no illness at the time of vaccination and no adverse events following prior vaccination. It was indicated that one week ago (approx 23-JAN-2008), the patient developed chicken pox. The patient sought medical attention at the physician's office. At the time of this report, the patient was reported to be recovering. There were no laboratory or diagnostic tests performed. A product quality complaint was not reported. Follow-up information from a health professional indicated that the patient's chickenpox was an average case. Subsequently the patient recovered. This is one of two reports from the same source. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 71 year old male who on 30-JAN-2008, was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 646313/0065R) instead of zoster vaccine live (Oka/Merck). The patient sought medical attention at the physician's office. Current patient status was not reported. The reporter indicated that the event was staff error only. A product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck). It was indicated that on an unspecified date, the patient developed chicken pox. Medical attention sought and current patient status was not reported. A product quality complaint was not reported. This is one of two reports from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 14 year old male who on 18-SEP-1998 was vaccinated with a 0.5 mL. dose of varicella virus vaccine live (Oka/Merck) (lot# 627337/1057H) once. On 07-JAN-2008, the reporter indicated that he developed breakthrough varicella. Unspecified medical attention was sought. No laboratory or diagnostic studies were performed. The reporter indicated that the physician had assumed that the patient recovered since they had not heard from the patient since the initial contact. A product quality complaint was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 13 month old male with no known drug allergies and no pertinent medical history who on 10-DEC-2007, was vaccinated with a 0.5 cc subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot# 1350U). Concomitant vaccination included measles-mumps-rubella vaccine (MSD). There was no concomitant medication. On 27-JAN-2008, the patient developed breakthrough chickenpox. No laboratory studies were done. It was indicated that at the time of this report, the patient was recovering. A product quality complaint was not reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health care worker concerning a patient who on 01-FEB-2008, was inadvertently given a 0.5mL. subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot# 658587/1520U) instead of zoster vaccine live (Oka/Merck). The reporter indicated that the event was not product confusion. No adverse event was reported. The patient was seen in the physicians office. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Age: 1.13
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Varicella post vaccine, Viral DNA test positive
Clinical narrative: Information has been received from an health care worker at the physician's office concerning a 7 year old male who on 25-JUL-2001, was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations included: a fourth dose of Hib conj vaccine (OMPC) (manufacturer unspecified), a third dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), and a first dose of Prevnar. There was no reported illness at the time of the vaccinations. On 07-January 2008, the patient was diagnosed with chicken pox. It was indicated that unspecified blood work was performed (results not reported). On 07-JAN-2008, a specimen was obtained from a "superficial site" for VZV by PCR. The specimen was collected and processed at a local hospital. The PCR results for the specimen from the "superficial site" identified VZV DNA was detected. On an unspecified date, the patient had recovered. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician assistant concerning a 69 year old male who on 02-FEB-2008 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The physician assistant felt that the similarity in names (varicella virus) confused him and he checked the wrong box on an order form. There were no problems reported. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Body temperature increased, Pyrexia, Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male who on 17-JAN-2008 was vaccinated SC with his first dose of VARIVAX vaccine (Merck) (lot# 652868/0267F) in the right thigh. On approximately 19-JAN-2008 11 days after vaccination, the patient developed chickenpox. On 28-JAN-2008, the patient was seen in the physician's office with 2 different forms of chickenpox: erythematous-based vesicles and small pinpoint spots located on the patient's chest, abdomen, under arms, posterior thigh and 1 in the suprapubic region. The child also had a fever of 101. The nurse stated that they have not heard from the parent, so the patient was believed to be recovering. There was no product quality complaint. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/16/2008. Follow-up information from the reporting registered nurse indicated that the 12 month old male with penicillin allergy (amoxicillin) who on 17-JAN-2008 was vaccinated SC with his first dose of VARIVAX vaccine (Merck) (lot# 652868/0267F) in the right tigh. There was no illness at the time of vaccination. Concomitant vaccinations administered on that same day included the firs SC dose of MMR II (MSD) (lot# 654892/1028F) in the right tigh. On 28-JAN-2008 11 days after vaccination, the patient developed chickenpox characterized by a rash with vesicles and an erythematous base and pin-point lesions. Subsequently, the patient recovered. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 15-month-old male with no pertinent medical history or allergies, who on 17-JAN-2008 was vaccinated subcutaneously with a first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 658182/1559U). Concomitant therapy included a dose of ActHIB. On 02-Feb-2008, the patient developed a rash on his lower extremities. The patient was seen in the office on 04-FEB-2008, and was diagnosed with chicken pox. The R.N. reported that there were greater than 50 lesions. There were no laboratory or diagnostic studies performed. The outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow-up information was received concerning a male with no pre-existing allergies, birth defects or medical conditions. On 17-Jan-2008 the patient was vaccinated in the left leg with a first dose of VARIVAX (Merck) (lot# 658182/1559U). There was no illness at the time of vaccination. On 04-Feb-2008, previously reported as 02-Feb-2008, the patient developed greater than 50 "eryth" papules in clusters/crops on the lower extremities. BENADRYL was administered. On an unspecified date, the patient recovered. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: OPV, VARCEL
Symptoms: Streptococcal identification test negative, Varicella post vaccine
Clinical narrative: Information has been received from a certified medical assistant concerning a 10 year old female with no pertinent medial history or drug allergies who on 12-DEC-1998 was vaccinated with a single dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination administered on that same day included a oral dose of poliovirus vaccine live. On 01-FEB-2008, the patient developed a widespread rash. On 02-FEB-2008, the patient was examined in the physician's office and diagnosed with chickenpox characterized by 20 scattered vesicles and 6 crusted lesions. A strep culture was performed which was negative. The patient was treated with Benadryl. The patient was noted to be recovering. There was no product quality complaint. Follow-up information form the reporting certified medical assistant concerning a 10 year old male (also reported as female) who on 12-DEC-1998 was vaccinated with a single dose of varicella virus vaccine live (Oka/Merck) at another's doctor's office. At the time of vaccination the patient had a low grade temperature and a sore throat. On 01-FEB-2008 the patient developed 6 scabbed vesicles on the heck and back (amount not noted). Strep cultures at 24 hours and 48 hours were performed which showed a negative result. The physician reviewed the protocol for chickenpox. The patient was recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on 04-JAN-2008 was vaccinated subcutaneously with varicella virus vaccine live (Oka/Merck) (Lot # 656826/030BU) instead of zoster vaccine live (Oka/Merck). The physician noted it was human error and not product confusion. The physician stated " the patient has not experienced any difficulties". No further information is available.
Age: 21.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Antibody test negative, Skin lesion
Clinical narrative: Information has been received from a health professional concerning a 21 year old male with no pertinent medical history and no known drug allergies/reactions, who on 04-JAN-2008 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 659116/1363U). Concomitant vaccination included hepatitis B vaccine, recombinant (RECOMBIVAX). About one month, on "02-FEB-2008 or 03-FEB-2008" after vaccination with varicella virus vaccine live (Oka/Merck), the patient developed four 1 mm skin lesions under his eye. The reporter indicated that the lesions looked like abraded skin or dried vesicles. It was noted that on an unspecified date, the patient had a negative varicella titer. A dermatology consult was planned. At the time of this report, the patient had not recovered. A product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker concerning a patient who on 05-FEB-2008 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 659207/1472U) instead of zoster vaccine live (Oka/Merck). This was not a case of product confusion. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse (RN) concerning her 3-year-old daughter who was "not immunocompromised", who in approximately 2004, 2006 and 2007, at 1, 3 and 4 years of age, was vaccinated with a first, second and third dose of varicella virus vaccine live (Oka/Merck) in Germany. Concomitant therapy for the second and third doses of varicella virus vaccine live (Oka/Merck) included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). After the second and third doses, in approximately 2006 and 2007 the patient developed a generalized varicella rash which lasted over 1 month. Subsequently, the patient recovered from both occurrances of generalized varicella rash. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Pain
Clinical narrative: Information has been received from a health professional concerning a female patient "around 9 years old" who on approximately 13-FEB-2008 was vaccinated with a second 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot# 659071/1475U). There was no concomitant medication. On approximately 13-FEB-2008, the patient developed a large red welt around the injection site and severe pain (location not specified). It was reported that at the time of this report, the patient had not recovered. A product quality complaint was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning his 11 year old son with no pertinent medical history and no known allergies, who about 10 years ago ("1997), received his first and only dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included methylphenidate hydrochloride (CONCERTA). On 14-FEB-2008, the patient developed a chicken pox break through. No laboratory or diagnostic studies were performed. A product quality complaint was not reported. Additional information has been requested.
Age: 1.9
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning an approximately 24 month old female who in October 2007, was vaccinated with varicella virus vaccine live (Oka/Merck). In November 2007, the patient developed a zoster like rash. At the time of this report, the patient has not recovered. A product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Information has been received from a physician concerning a patient who were vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced "localized reaction that required follow-up visits-not a varicella-like rash". The physician stated that he believed that the patient had to come back twice. There was no pharmacological intervention. The physician reported that he has started vaccinating his adolescent patients with a second dose of varicella virus vaccine live (Oka/Merck). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Laboratory test, Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated on an unspecified date with a dose of varicella virus vaccine live (Oka/Merck) (lot# 658302/1032U). Subsequently, on an unknown date, the patient developed a persistent fever. The patient sought medical attention with an exam in the office. A "work-up" of unspecified tests has not revealed a cause of the fever. The outcome is reported as not recovered. The physician requests a lot check. No product quality complaint was involved. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same reporter. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Chills, Dizziness, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician and a health care professional concerning a 9 year old 73 lb 53 1/8 in white male who on 24-JAN-2008, was vaccinated with a second subcutaneous dose in the left arm of varicella virus vaccine  live (Oka/Merck) (lot# 659166/1499U). Concomitant vaccination included hepatitis A vaccine (inactive) (manufacturer unspecified). Illness at the time of vaccination was reported as dizziness. On 25-JAN-2008, the patient developed at the left arm at the injection site redness and was "swollen" at the injection site. The physician indicated that the redness began as one inch in diameter and on 26-JAN-2008, it had spread to six inches in diameter. It was also noted on 26-JAN-2008, that he had also developed fever, chills, and dizziness. It was indicated that the patient sought treatment at an urgent care facility. Treatment was initiated with cephalexin (KEFLEX). No laboratory or diagnostic studies were performed. On an unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.