chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Lip swelling, Rash, Swelling face, Urticaria
Clinical narrative: Information has been received from a physician concerning a 6 year old female with no pertinent medical history or allergies who in approximately 2004 (2 to 3 years ago) was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. In approximately 2004 (2 to 3 years ago) the patient developed a rash on her trunk after receiving her first dose of varicella virus vaccine live (Oka/Merck). In approximately March 2007 (within the last six months) the patient received her 2nd dose of the vaccine. About one hour after receiving her second dose the patient's face and lips became red and swollen. Later that night her trunk also became red. The next day the patient had a hive on the opposite arm that the vaccine was administered. No diagnostic labs were performed. Unspecified medical attention was sought. The patient was treated with Benadryl and fully recovered from all adverse experiences. A product quality complaint was not involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 3 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The "patient was given varicella virus vaccine live (Oka/Merck) vaccinations but got chickenpox from their Daycare facility this week". Unspecified medical attention was sought. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a physician concerning a 12 month old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient experienced 10 lesions all over his body after receiving varicella virus vaccine live (Oka/Merck). The patient sought unspecified medical attention. A product quality complaint was not involved. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 15 year old male who in approximately 2002 was vaccinated with varicella virus vaccine live (Oka/Merck). In approximately 2002 when the patient was 10 years old, he developed chickenpox but the rash resolved two and a half weeks later. Medical attention was sought. The reporter did not know that exact date. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from an epidemiologist 1 concerning a 12 year old female who on 17-DEC-1997 was vaccinated with varicella virus vaccine live (Oka/Merck) (1st dose). On 25-JUN-2007 the patient received her second dose of varicella virus vaccine live (Oka/Merck) and broke out with mild chicken pox on 01-AUG-2007. The physician verified this by phone. On 08-AUG-2007 the epidemiologist spoke with the patients father and reported that the chickenpox was not spreading any more. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a nurse concerning her 15 year old daughter with outdoor allergies (hypersensitivity) who on 31-JUL-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). On 31-JUL-2007, the patient presented with a red and raised bump at the injection site. The patient sought unspecified medical attention. the patient's outcome was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash papular
Clinical narrative: Information has been received from a health professional concerning an 8 year old male with no pre existing allergies, or medical conditions who on 10-MAR-2000 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 631469/1346J). There was no illness at the time of vaccination. On 02-AUG-2007, at 10:30, the patient developed a rash, which lasted four days, with a papular lesions and an erythematous base. The patient was treated with Benadryl q 6hours PM. The patient status at the time of reporting was noted to be "unknown". Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Rash papular, Rash pustular, Varicella
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 11 year old adopted white male with an allergy to penicillin, and no prior medical history, who on 14-JUL-1997 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck) ("Lot # 0081E"). At the time of vaccination the patient was afebrile, but had otitis media, and a candida rash. On 01-AUG-2007, at 16:00, the patient developed a moderate red papular rash with pustules, on the back, chest, all extremities, and ears, which developed in crops. The patient had been in the mountains, and reportedly the park ranger thought it was poison oak. The first day of onset the patient was afebrile, and very itchy. The impression of the treating physician was atypical chickenpox. The patient was treated with hydroxyzine hydrochloride (ATARAX) 25 mg 1-2 tabs bid prn, diphenhydramine hydrochloride (BENADRYL) prn, and "Abx" soap. At the time of reporting the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated, at 1 year of age, with a dose of varicella virus vaccine live (Oka/Merck). It was reported the patient developed shingles between the ages of 1 and 4. Subsequently, the patient recovered from shingles. A product quality complaint was not involved. Additional information has been requested.
Age: 1.7
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 21 month old female who in OCT-2006 was vaccinated with varicella virus vaccine live (Oka/Merck). It was reported that in approximately August 2007, "the patient got chickenpox from her daycare facility this week". At the time of reporting the patient was considered to be recovering. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a male who on 03-AUG-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 656282/1505F). On 03-AUG-2007, the patient was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) rather than zoster vaccine live (Oka/Merck) (MSD). The nurse states this was not a case of product confusion. No adverse experience was reported. A product quality complaint was not involved. Follow-up information was received on 10-SEP-2007. Follow-up information was received via a telephone call with a registered nurse who stated she administered varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD) purely due to her own inexperience. She further explained that she has not worked in a clinic in over 20 years and  confused the two vaccines. She reported the patient was fine and had received the zoster vaccine live (Oka/Merck) (MSD). She thought it would be beneficial to have the vaccines marked adults only. Further information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who in July 2007, was vaccinated subcutaneously with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). The nurse stated this was an error by a staff member and not product confusion. No adverse experience is related to this event. No further information was provided. There was no product quality complaint involved. Follow up information from the registered nurse indicated this was truly a human error by a new employee (nurse) who had been trained on vaccinations for 1 month. The nurse was not paying attention and the office believes that the nurse may have dyslexia as other issues have arisen in their office which indicate this (none were provided). The patient did not experience any adverse events from the vaccination. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a physician assistant concerning a 5 year old male who on 15-AUG-2003 was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Additional suspect therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) given in the other arm. "Ten days after vaccination" on 25-AUG-2003 the patient developed about 20 lesions all over the body. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. The patient's twin brother had the same experience after vaccination with varicella virus vaccine live (Oka/Merck) and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) WAES# 0708USA01604.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction, Oedema peripheral
Clinical narrative: Information has been received from a physician's office concerning a patient who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed an injection site reaction and a swollen arm. No further information was provided. There was no product quality complaint involved. No further information is available.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Chest discomfort, Headache
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no known allergies who on 06-AUG-2007 was vaccinated with a 0.5 mL first dose of varicella virus vaccine live (Oka/Merck) (Lot#658024/0833U). There was no concomitant medication. On 06-AUG-2007 or 07-AUG-2007 the patient developed a headache, chest discomfort and abdominal pain. Unspecified medical attention was sought. No lab studies were performed. At the time of this report the patient was recovering. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Rhinorrhoea, Varicella
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 12-month-old male, who on 11-Jun-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Approximately 2 weeks post vaccination, on about 25-Jun-2007, the patient had a "mild outbreak of varicella" that was considered to be not life threatening. The patient also had a cough and runny nose for which he was treated with some cough medicine and some oral diphenhydramine hydrochloride (BENADRYL). The only medical treatment he had was to visit the doctor. On an unspecified date, his symptoms subsided and he was considered recovered. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a healthy 13-month-old male, who approximately 11-Jun-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. Approximately two weeks post vaccination, on about 25-Jun-2007, the patient came down with a "mild case, a mild outbreak of varicella" that was considered to be not life threatening. No medications were given to the patient during the time of the outbreak. It is unspecified if medical attention was sought. On an unspecified date, the patient recovered. This is one of several reports from the same reporter. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 8 year old female who on 05-JUN-2007 was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). It was reported that within 36-48 hours after receiving  the vaccination the patient experienced soreness and a larger than normal red area around the injection site. Unspecified medical attention was sought. No product quality complaint was involved. This is one of two reports from the same source. Additional information is expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Scab, Varicella
Clinical narrative: Initial and follow up information has been received from a pharmacist concerning her 11 year old male child, with no known allergies or pertinent medical history, who on 24-MAR-1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. Subsequently, in April 2005 the patient developed a mild case of chickenpox with approximately 7 pox behind his left ear, 4 on his upper left arm and 1 on his lower left forearm, previously reported as about 30 spots. The patient had a fever. In 2-3 days they scabbed over and he recovered. On 26-JUL-2007, the child developed another mild case of chickenpox with about 5 spots on his right pinky finger. The spots crusted over by 29-JUL-2007. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Adverse drug reaction, Erythema
Clinical narrative: Information has been received from a physician concerning a 10 year old male who on 03-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # 657194/0364U). On 04-AUG-2007 the patient experienced a "severe shot reaction and erythema". The patient was taken to the emergency room but was not hospitalized. Subsequently, the patient recovered from all adverse experiences. A product quality complaint was not involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a physician assistant concerning a 5 year old male who on 15-AUG-2003 was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Additional suspect therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) given in the other arm. "Ten days after vaccination" on 25-AUG-2003 the patient developed about 20 lesions all over the body. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. The patient's twin brother had the same experience after vaccination with varicella virus vaccine live (Oka/Merck) and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) WAES#0708USA01289.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Full blood count, Injection site pain
Clinical narrative: Information has been received through the Merck Pregnancy Registry concerning a 31 year old female with an allergy to penicillin and a history of pulmonary embolism who on 20-JUL-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). On 20 JUL 2007 the patient reported experiencing pain at the injection site after receiving her vaccination with varicella virus vaccine live (Oka/Merck). The pain resolved, and the patient was recovered on 24 JUL 2007. Concomitant therapy included warfarin sodium (COUMADIN). The lot number was not available. On 02 AUG 2007 the patient was tested and discovered she was pregnant. Unspecified medical attention was sought. There was no product quality complaint.  This in follow-up to report(s) previously reported on 5/16/2008. On 08-JUN-2009, attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from the physician that the 31 year old female patient and delivered a normal infant without congenital anomaly. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who on 09-AUG-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No problems were reported. The nurse confirms this was not a case of product confusion. There was no product quality complaint. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Blood test, Dermatitis contact, Varicella
Clinical narrative: Information has been received from a health professional concerning a patients who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 24-MAY-2007, the patient was diagnosed with chickenpox and currently waiting for blood work. The patient was seen in physician's office on 09-AUG-2007. The physician was in the process of determining if the reaction patient had was poison ivy or chickenpox. The physician was waiting for the blood work to confirm whether this was a chickenpox reaction. The physician did not want to provide any more information yet. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Additional information is expected.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old white female who on 27-MAY-2003 was vaccinated with varicella virus vaccine live (Oka/Merck) first dose (Lot #644571/1160M) right arm. Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (LOT # 644151/1002M) given in left arm first dose. On 02-AUG-2007 the patient developed 14 lesions on her face and neck. The patient was treated with AVEENO and diphenhydramine hcl (BENADRYL). It was reported that the patient recovered on an unspecified date. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer concerning her friend's son (age not reported) who on approximately 26-JUL-2007 was vaccinated with his second dose of varicella virus vaccine live (Oka/Merck). In August 2007, the patient broke out with a significant amount of chicken pox lesions. No further information was given. No further information is available.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 9 year old female who on 14-JUN-1999 was vaccinated SC with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 630037/0290J). Concomitant therapy included a SC first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot # 644644/1080M). There was no illness at the time of vaccination. It was reported that on 29-JUL-2007 the patient experienced a breakthrough of varicella with 200 lesions 2 weeks after patient's sibling had experienced a breakthrough. At the time of report the patient had recovered and it was also stated as "on going". Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning an 11 year old male with no pertinent medical history, drug reactions or allergies who on 07-AUG-2007, at 14:00, was vaccinated subcutaneously with a second dose of varicella virus vaccine live (Oka/Merck) in the right arm (Lot# 652724/0459U). On 08 AUG 2007, the patient developed the following injection site reactions in the right arm: rash (12 cm x 10 cm), swelling, induration (3 cm x 3 cm), and erythema (dark red in the center and pink in the periphery). The area, which was not painful, was reported to resemble a "wasp sting". There was no illness at the time of vaccination. Unspecified medical attention was sought. The patient recovered on an unspecified date. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a medical assistant concerning a 11 year old female who in 1995 was vaccinated with varicella virus vaccine live (Oka/Merck). In 1995 the patient experienced developed 10-20 lesions after administration of her first dose. The medical assistant was unaware of the details of the rash or if any treatment was required at the time. The patient recovered from the rash and was not administered the second dose. No further information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site papule, Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old white female with cefdinir (OMICEF) allergy, sulfa allergy and urinary reflux who on 16-AUG-2002 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). On 03-AUG-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot #652868/0267F) SQ in the left deltoid. There was no concomitant medication. There was no illness at the time of vaccination. On approximately 04-AUG-2007 (24-48 hours after vaccination) the patient experienced red raised bumps (papules, not fluid filled) at the injection site. The registered nurse reported that a rash broke out at the deltoid area. There was itching to the area. The area lasted less than five days in length. The patient did not have a temperature. No treatment was administered. No diagnostic laboratory test were performed. The nurse called because they wanted to if the site was contagious to others and if it was truly a pox. Medical attention was sought. Subsequently, the patient recovered. No further information has been requested.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Erythema, Pruritus, Rash pustular
Clinical narrative: Information has been received from a registered medical assistant concerning a 5 year old male who on 21-MAY-2003 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 643591/0867M). The patient, who has a history of eczema, was experiencing an eczema exacerbation at the time of vaccination. Concomitant therapy, that same day, included a third dose, intramuscularly of Prevnar (lot # 49392). On 07-Aug-2007, the patient developed itchy, red, pustuled lesions that erupted in crops. The onset of new ones occurred hours later with minimal crusting. The patient had about 12-15 spots total at the time of examination. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from an emergency room physician concerning a 7-year-old female with no pertinent medical history and no allergies, who on 07-JUL-2007 was vaccinated with a booster dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 07-AUG-2007, the patient went to the emergency room because of a generalized varicella rash mostly on the trunk area. No laboratory tests or diagnostic tests were performed. The outcome was reported as not recovered. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a patient with a history of chickenpox as a child who on 10-JUL-2007 was vaccinated in the left arm with a dose of varicella virus vaccine live (Oka/Merck). It was reported the patient was administered varicella virus vaccine live (Oka/Merck) to prevent shingles. No adverse experience was reported. A product quality complaint was not involved. Follow-up information was received on 10-SEP-2007. Follow-up information was received via a telephone call with a physician who stated: "I thought it was the same as the zoster vaccine live (Oka/Merck) (MSD)". When the physician was asked if this confusion was based on the storage, location, or packaging he re-stated that he took full responsibility for administering the varicella virus vaccine live (Oka/Merck). Further information is not expected.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning an 11-year-old male with no pertinent medical history or allergies, who on 27-JUL-2007 was vaccinated subcutaneously in the right arm with a second dose of 0.5 milliliter's of varicella virus vaccine live (Oka/Merck) (lot# 657455/0599U). There was no concomitant medication. On 10-AUG-2007, the patient developed as rash all over his body. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. The outcome was reported as recovering. No product quality complaint was involved. Follow-up information was received concerning a male student with no pre-existing allergies, birth defects or medical conditions, who was vaccinated at 9 AM with a second dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included an intramuscular first dose in the left deltoid of Adacel (lot # PMCC2609AA) (Sanofi Pasteur) at  9 AM. There was no illness at the time of vaccination. On 09-Aug-2007, (previously reported as 10-AUG-2007) at 8 AM, the patient developed a light rash on his abdomen and trunk area. There was no fever. The rash was slightly raised and non-puritic. The patient was advised to stay out of school until the rash was cleared. The outcome was reported as recovered and the patient returned to school on 18-Aug-2007. Additional vaccinations received includes a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) on 12-Jan-1996, 22-Mar-1996, 13-May-1996, 04-Mar-1997 and 03-Apr-2000; a dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) on 12-Jan-1996, 22-Mar-1996 and 16-Jul-1996; a dose of Hib conj vaccine (unspecified carrier) (manufacturer unknown) on 12-Jan-1996, 22-Mar-1996, 13-May-1996 and 01-Nov-1996; a dose of poliovirus vaccine inactivated (unspecified) (manufacturer unknown) on 03-Apr-2000; a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (HPV-77) (manufacturer unknown) on 01-Nov-1996, and 03-Apr-2000; and a dose of poliovirus vaccine live oral (manufacturer unknown) on 12-Jan-1996, 22-Mar-1996, 13-May-1996. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Full blood count normal, Red blood cell count increased, Varicella zoster serology negative
Clinical narrative: Information has been received from a registered nurse concerning an 18-year-old male with mild asthma and no allergies, who on 23-AUG-1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included albuterol. On 01-AUG-2007, the patient tested negative, with a titer value of 0.48 for chickenpox. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Follow-up information indicates that the patient is a student who did not seroconvert from the primary varicella virus vaccine live (Oka/Merck). The vaccination was not administered by the reporting facility. On 30-Jul-2007 (previously reported as 01-Aug-2007) the patient tested negative, with a titer value of 0.48 for chickenpox. On 01-Aug-2007, he had a CBC drawn that was normal except for his red blood cell count which was 5375 million/uL. Vaccination history includes: a dose of Hib conj vaccine (OMPC) (manufacturer unknown) on 03-Oct-1990, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) on 05-Jun-1989, 07-Aug-1989, 09-Oct-1989, 03-Oct-1990 and 20-Sep-1993; a dose of measles virus vaccine live (Enders-Edmonston) (manufacturer unknown) on 08-Aug-1994; a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar 27/3) (manufacturer unknown) on 16-Jul-1990; a dose of poliovirus vaccine live oral (manufacturer unknown) on 05-Jun-1989, 07-Aug-1989, 09-Oct-1989, 03-Oct-1990, and 20-Sep-1993 and tuberculin purified protein derivative (manufacturer unknown) on 29-Mar-1992 and 08-Aug-1994. This is one of several reports from the same source. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella zoster serology negative
Clinical narrative: Information has been received from a registered nurse concerning a 13-year-old male with asthma that is under control with medications, and an allergy to Cefzil, who on 23-AUG-1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included Advair, Flonase and albuterol. On 09-AUG-2007, the patient had a negative titer level of 0.58 for chickenpox. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (no lot numbers available). The patient developed a varicella outbreak shortly after vaccination characterized by a generalized vesicular rash. It was unknown if medical attention was sought. Subsequently, the patient recovered and the rashes have since resolved. There was no product quality complaint. This is one of several reports from the same source.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: Information has received from a licensed practical nurse concerning her 8 year old daughter with no pertinent medical history or drug allergies who on 05-SEP-2000 and 25-JUL-2007 at 14:30 was vaccinated with her first (Lot # 632716/1690J) and second (Lot# 656823/0305U) 0.5mL SC does of varicella virus vaccine live (Oka/Merck) in the left thigh. There was no illness at the time of vaccination. There was no concomitant medication. On 31-JUL-2007, the student developed a 2 cm circular lesion on her left thigh area at the injection site which was also red and swollen. Unspecified medical attention was sought. No lab diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Pain
Clinical narrative: Information has been received from a pharmacist concerning her 10 year old daughter who on 14-AUG-2007 was vaccinated IM with the second dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 14-AUG-2007, the patient experienced pain immediately after vaccination. As of 14-AUG-2007, the patient had not recovered. No further information is available.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Culture urine, Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner and a registered nurse concerning a 7 year old female with no pertinent medical history or drug allergies who on 12-AUG-2000 was vaccinated with a SC dose of varicella virus vaccine live (Oka/Merck). It was unknown if there was any illness at the time of vaccination. Concomitant vaccinations administered on that day included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD), a dose of poliovirus vaccine inactivated (unspecified), a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of hepatitis B virus vaccine rHBsAg  (yeast) (manufacturer unknown), and a dose of Hib conj vaccine (OMPC) (manufacturer unknown). On 30-MAY-2007 the patient developed a rash and experienced the onset of varicella disease with less than 50 lesions. On 31-MAY-2007, the patient was seen by the office and diagnosed with chickenpox. The lab diagnostic study performed was a urine culture (results not reported). Subsequently, the patient recovered. There was a breakout during this time at the patient's school. There was no product quality complaint. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 26-NOV-2007 and 29-MAR-2007 was vaccinated with her first and second (lot# 656173/1499F) SC dose of varicella virus vaccine live (Oka/Merck). On 14-AUG-2007, the patient developed a breakthrough of varicella that presented as an itchy rash of approximately 30 lesions, with the majority was papular and 2 to 3 vesicular under close examination. Unspecified medical attention was sought. The patient was treated with calamine lotion and Benadryl. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacy student concerning a 10 year old female who on an unspecified date was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck) intramuscularly. Subsequently the patient developed soreness and redness at the injection site. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information is not available.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Injection site urticaria, Wrong drug administered
Clinical narrative: Information has been received from a parent on behalf of a female patient that was vaccinated with a varicella virus vaccine live (Oka/Merck). Concomitant vaccine administered included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck) upgrade process). Three weeks ago, on approximately 25-JUL-2007, the patient developed a circular welt on her leg at the injection site and it is still there. At the time of this report, the patient is still not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No further information was provided. No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a nurse concerning a 5 year old female who 4 years ago, in 2003, was vaccinated with a 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck). About 4 years ago, in approximately 2003, the patient developed vesicular lesions at the injection site. No other symptoms were noted. Subsequently, the patient fully recovered. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female who on 22-MAY-2007 was vaccinated with a 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot # 657191/0365U) in the right upper arm. The patient developed erythema at the right upper arm injection site 5 minutes after administration of varicella virus vaccine live (Oka/Merck). No therapy was recommended. The outcome is unknown. No laboratory or diagnostic testing was done. Unspecified medical attention was sought. No further information was available at the time of this report. No product quality complaint was involved This is patient 1 of 2. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 22-MAY-2007 was vaccinate with a 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot # 657191/0365U). The patient developed erythema and swelling at the injection site 5 minutes after administration of the vaccine. No therapy was recommended. There were no laboratory or diagnostic tests performed. The outcome is unknown. No further information was available at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. This is patient 2 of 2. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 12-year-old female who on 17-Jun-1996 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (HPV-77) (MMR). At the time of vaccinations, it was reported that the patient presented with no known illnesses. In June 1999, the patient experienced a mild case of chickenpox. It was unspecified if medical attention was sought. On 30-APR-2007, the patient experienced a moderate case of chickenpox and was treated with Atarax and Zovirax. Subsequently, the patient recovered on 08-May-2007. It was unspecified if a product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning his 12 year old son who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 09-MAY-2007, the patient developed a breakthrough of chickenpox. The patient's status was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning his 16 year old son who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 09-May-2007, the patient developed a breakthrough of chickenpox. The patient's status was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning an adult patient, who on an unspecified date, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck) (MSD). Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 5 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient developed breakthrough chickenpox in December 2006. No further information was provided. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a registered nurse (RN) concerning a female who was vaccinated with varicella virus vaccine live (Oka/Merck). In May 2007, after the booster dose of varicella virus vaccine live (Oka/Merck), the patient experienced a local injection site reaction described as a large hive at the site of injection. The patient was treated with benadryl and cortisone cream. 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 for the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a registered nurse (RN) concerning a male who was vaccinated with varicella virus vaccine live (Oka/Merck). On 24-May-2007, after the booster dose of varicella virus vaccine live (Oka/Merck), the patient experienced a local injection site reaction described as a large hive at the site of injection (date of first vaccination not reported). The patient was not seen in the physician's office and has been treated symtomatically by his mother at home (treatment therapy not reported). As of 25-May-2007, the patient was reported to have been recovering. The primary reporter requested a lot check be completed on lot # 654754/1333F. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a male patient who on 15-Feb-2000 and 15-Mar-2007 was vaccinated with a first and second dose of varicella virus vaccine live (Oka/Merck). It was reported that approximately one year after the first vaccine, in 2004, the patient developed a mild case of chicken pox. The patient received the second vaccine and on 07-May-2007 the patient again experienced a mild case of chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. The patient's brother had a similar experience after therapy with a varicella virus vaccine live (Oka/Merck) (WAES number 0705USA02062). Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 7 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a breakthrough case of varicella. Unspecified medical attention was sought. No product quality complaint was involved. This is the one of several reports from the same source. Additional information is expected.
Age: 14.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 14-year-old female with asthma who was vaccinated with her second dose of varicella virus vaccine live (VARIVAX) on 25-MAY-2007. Concomitant therapy included a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). On 27-MAY-2007 the patient developed a rash on her arms and legs that resembled "dried mosquito bites". The rash was itchy. Unspecified medical attention was sought. The outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a nurse practitioner concerning her 7-year-old daughter who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed chicken pox after vaccination. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was issued. Follow-up information received indicates that the patient is a healthy, white 7-year-old female with no pre-existing allergies, birth defects, or medical conditions, who on 15-Feb-2001 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included a first dose of measles virus vaccine live (Wistar RA 27/3). There was no illness at the time of vaccination. In the morning of 23-May-2007, the patient developed chicken pox. It was unknown if laboratory of diagnostic tests were performed. On 30-May-2007 the patient recovered. Additional information is not expected.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Headache, Pyrexia, Sneezing, Varicella
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 9-year-old male with a concurrent condition of asthma, who was vaccinated at the pediatricians office with a dose of varicella virus vaccine live (Oka/Merck) on 13-SEP-1999. There was no illness at the time of vaccination. Concomitant therapy included albuterol. On 28-MAY-2007 (also reported as 29-May-2007), the patient presented with chickenpox. The symptoms included, headache, fever, sneezing and vesicles on his right lower chest, left upper quadrant of abdomen, sternal area, right lower quadrant of abdomen, anterior aspect of right distal thigh and left and right mid back. Unspecified medical attention was sought. The outcome was reported as recovered. No product quality complaint was involved. Additional information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic, Rash vesicular, Scab, Varicella
Clinical narrative: Information has been received from a registered  nurse concerning a 9 year old male with no reported medical history who on 15-DEC-1999 was vaccinated once with a 0.5ml dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 26-MAY-2007 the patient developed chickenpox rash. When the nurse saw him on 29-MAY-2007, the mildly itchy rash was vesicular and crusting on his upper thigh and trunk. No laboratory or diagnostic tests were performed. Unspecified medical attention was sought. No product quality complaint was involved. The patient's sibling experienced lesions following his second dose of vaccination with varicella virus vaccine live (Oka/Merck) (WAES# 0708USA00107). Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician and registered nurse concerning a 9 year old male who on 02-DEC-1998 at another health care facility was vaccinated with varicella virus vaccine live (Oka/Merck). On 23-MAY-2007 the patient presented to the office with "full blown chicken pox" (actual onset date not provided). It was reported that the patient had chicken pox on the trunk of his body, and it looked like his back had more than fifty lesions which were not pustules. At the time of this report the patient's status was not reported. No other information was reported. There was no product quality complaint involved. Additional information has been requested.