chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a county health registered nurse concerning a 9 year old male who on 04-APR-2007 was vaccinated with VARIVAX (Oka/Merck).  On 10-APR-2007 the patient developed varicella < 50 lesions.  The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation.  An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Oka/Merck).  This is one of 28 reports received from the same source.  No further information is available.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a county health registered nurse concerning a 7 year old male who on 10-MAY-2001 was vaccinated with VARIVAX (Oka/Merck).  On 30-MAR-2007 the patient developed varicella < 50 lesions.  The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation.  An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Oka/Merck).  This is one of 28 reports received from the same source.  No further information is available.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning a 36 month old male who on 08-OCT-2001 was vaccinated with VARIVAX (Merck). On 27-APR-2001, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Merck). This is one of 28 reports received from the same source. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced an injection site reaction. The patient's sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced an injection site reaction. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is on of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced and injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning a 6 year old female who on 21-JUN-2002 was vaccinated with varicella virus vaccine live (Oka/Merck). On 07-MAR-2007, the patient developed varicella, <50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007 and this student was identified during the county health investigation. An immunization clinic was conducted in the school were students received a second dose of varicella virus vaccine live (Oka/Merck). This is on of 28 reports received from the same source. No further information is available.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning a 6 year old patient who on 27-APR-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). On 23-MAR-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning a 7 year old male who on 22-JAN-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). On 08-APR-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning a 9 year old male who on 08-MAR-2000 was vaccinated with varicella virus vaccine live (Oka/Merck). On 23-MAR-2007 the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning an 8 year old male who on 21-SEP-1999 was vaccinated with varicella virus vaccine live (Oka/Merck). On 23-MAR-2007 the patient developed varicella, , 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Age: 1.7
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning a 6 year old female who on 20-APR-2002 was vaccinated with varicella virus vaccine live (Oka/Merck). On 23-MAR-2007 the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse (school nurse) concerning a child between the ages of 6 and 11 years old who on 02-JAN-1999, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 03-DEC-2007, the patient was experiencing chickenpox. It was not specified how many doses of varicella virus vaccine live (Oka/Merck) the patient received. Medical attention was sought via an office visit with the physician. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse (school nurse) concerning a child between the ages of 6 and 11 years old who on 05-OCT-1999, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 03-DEC-2007, the patient was experiencing chickenpox. It was not specified how many doses of varicella virus vaccine live (Oka/Merck) the patient received. Medical attention was sought via an office visit with the physician. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse (school nurse) concerning a child between the ages of 6 and 11 years old who on 13-MAY-1998, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 03-DEC-2007 the patient was experiencing chickenpox. It was not specified how many doses of varicella virus vaccine live (Oka/Merck) the patient received. Medical attention was sought via an office visit with the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse (school nurse) concerning a child between the ages of 6 and 11 years old who on 20-JUN-2002, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 03-DEC-2007 the patient was experiencing chickenpox. It was not specified how may doses of varicella virus vaccine live (Oka/Merck) the patient received. Medical attention was sought via an office visit with the physician. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who on 08-JAN-2008 was inadvertently vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The incident was not due to product confusion. The patient did not experience any known symptoms. No further information was available. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 13 year old female who at the age of 2 years (approximately 1997) was vaccinated with a varicella virus vaccine live (Oka/Merck). The reporter indicated that the patient's mother reported that the patient developed a mild case of chicken pox at the age of 3 years (approximately 1998) after receiving the varicella virus vaccine live (Oka/Merck). It was noted that on 20-FEB-2008, at the age of 13 years, she received a booster dose of varicella virus vaccine live (Oka/Merck) with no reported adverse symptoms. A product complaint was not reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an approximate 7-year-old patient who on 18-JUN-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008 the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an approximate 8-year-old patient who on 01-FEB-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an 8 year old patient who received a second dose of varicella virus vaccine live (Oka/Merck) and developed break through chicken pox. A product quality complaint was not reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Hypersensitivity, Pruritus generalised, Urticaria
Clinical narrative: Information has been received through the Merck pregnancy registry from a 41 year old female with no pertinent medical history and no known drug reactions/allergies, who on 19-FEB-2008 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 659232/1514U). Concomitant therapy included Lexapro and levothyroxine sodium. On 10-MAR-2008, she discovered that she was 7 weeks pregnant. On 25-FEB-2008, the patient reported that she had an allergic reaction to something, and went to the emergency room department because she had "hives and itching all over her body". It was indicated by the patient that the hives went away. Laboratory and diagnostic studies were not performed. A quality complaint was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/16/08. Information has been received through the Merck pregnancy registry  and from a physician concerning a 41 year old female with a history of 1 pregnancies (1 live birth and also a stillbirth or miscarriage) and no pertinent medical history and no known drug reactions/allergies, who on 19-FEB-2008 was vaccinated with a 0.5 ml of VARIVAX (Oka/Merck) (lot# 659232/1514U). Concomitant therapy included LEXAPRO and levothyroxine and prenatal vitamin. On 25-FEB-2008, the patient reported that she had an allergic reaction to something, and went to the emergency department because she had "hives and itching all over her body". It was indicated by the patient that the hives went away. On 10-MAR-2008, the patient discovered that she was 7 weeks pregnant. Laboratory and diagnostic studies were not performed. A quality complaint was not reported. Additional information has been requested. 6/18/10 Follow up information was received from a nurse. It was reported that the patient had a live birth and there was no indication of any birth defects. She stated that she had no further information on the baby. No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 5 year old female with no pertinent medical history and known drug allergies who on 06-AUG-2007, received a first dose of varicella virus live vaccine (Oka/Merck). She developed chicken pox, and on 06-MAR-2008, she presented to the office for exam with greater than 50 lesions. The lesions were located behind each ear, on the back of the neck and on the front and back of her torso. No treatment was prescribed, and no laboratory or diagnostic studies were performed. It was noted that the child was kept out of school until all the lesions were scabbed over. The Nurse indicated that the patient would not be receiving a second dose of varicella virus vaccine live (Oka/Merck) due to the chicken pox outbreak. A product quality complaint was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/16/2008. Information has been received from a health professional concerning a 5 year old 33 lb. 41 1/4 in, female with no pertinent medical history and known drug allergies who on 06-AUG-2007, received a first dose of VARIVAX. There was no reported illness at the time of vaccination. It was noted that on 11-SEP-2007), she received a second dose in the right upper thigh of MMR (lot# "1410F"). She developed chicken pox, and on 06-MAR-2008 at 13:00 hours, she presented to the office for a sick visit exam with greater than 50 lesions. The lesions were located behind each ear, on the back of the neck, and on the front and back of her torso. No treatment was prescribed, and no laboratory or diagnostic studies were performed. It was noted that the child was kept out of school until all the lesions were scabbed over. The Nurse indicated that the patient would not be receiving a second dose of VARIVAX due to the chicken pox outbreak. On 12-MAR-2008, she had recovered. A product quality complaint was not reported. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a male physician who "about one week ago" (approximately 03-MAR-2008), was vaccinated with a 0.5 mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) for the prevention of shingles. The physician indicated that he was not sure if it was product confusion, although he state that he had originally ordered the wrong product (varicella virus vaccine live, Oka/Merck), then ordered zoster vaccine live (Oka/Merck). The physician indicated that both vaccines were in the freezer, and "they were not familiar with pediatric vaccines". No adverse experience was related to the event. Current patient status was not reported. A product quality complaint was not reported.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Injection site rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/16/2008. Information has been received from a health professional concerning an approximately 12 year old male patient who on 25-APR-2000 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (lot number, dose, route unknown). On 05-MAR-2008, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot number 659113/1360U, dose, route unknown). Concomitant therapy included hepatitis A virus vaccine (unspecified) (manufacturer unknown). On an unspecified date, the patient developed a localized rash at the injection site. The physician's office was contacted regarding this experience. This is the third of three reports of rash with the same varicella virus vaccine live (Oka/Merck) (lot number 659113/1360U). The patient recovered from injection site rash on an unspecified date. The caller requested a lot check for this lot number. There was no product quality complaint reported. A lot check has been requested. Additional information has been requested. 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.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient (unknown gender and age) who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (dose and lot number not provided) instead of a dose of zoster live (Oka/Merck) (lot number not provided). It was not reported if medical attention was sought or what the patient's outcome was. There was no product quality complaint. No further information is available. In follow-up information received from a physician, it was confirmed that this event was not a case of product confusion, but a result of human error. No further information is available. This is one of several reports from the same source.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a health professional concerning an approximately 7 year old female patient who on 16-APR-2001 was vaccinated with the first does of VARIVAX (Oka/Merck) (lot number not provided). On 18-DEC-2007, the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot number 659113/1360U, route, dose unknown). Concomitant therapy included hepatitis A virus vaccine (unspecified) (manufacturer unknown). On an unspecified date, the patient developed a localized rash at the injection site. The physician's office was contacted regarding this experience. This is the first of three reports of rash with the same varicella virus vaccine live (Oka/Merck) (lot number 659113/1360U). The patient recovered from injection site rash on an unspecified date. The caller requested a lot check for this lot number. There was no product quality complaint reported. A lot check has been requested. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008. 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 government and was released.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Injection site rash
Clinical narrative: Information has been received from a health professional concerning an approximately 10 year old female patient who on 10-AUG-1998 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck)(lot number not provided). On 18-DEC-2007, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot number 659113/1360U, route, dose unknown). Concomitant therapy included hepatitis A virus vaccine (unspecified)(manufacturer unknown). On an unspecified date, the patient developed a localized rash at the injection site. The physician's office was contacted regarding this experience. This is the second of three reports of rash with the same varicella virus vaccine live (Oka/Merck) (lot number 659113/1360U). The patient recovered from injection site rash on an unspecified date. The caller requested a lot check for this lot number. There was no product quality complaint reported. A lot check has been requested. Additional information has been requested. 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 and was released.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse via a mother concerning her son who was vaccinated on an unknown date with one dose of varicella virus vaccine live (Oka/Merck). On an unspecified date, post vaccination, the patient's mother "thinks" the patient had chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Cyst, Rash, Respiratory tract congestion
Clinical narrative: Information has been received from a pharmacist concerning her 12 month old daughter with no pertinent medical history, drug reactions or allergies who on 22-FEB-2008 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy included "other vaccinations appropriate for one year of age". The pharmacist reported that sometime after vaccination with varicella virus vaccine live (Oka/Merck), "within the last week" (approximately 06-Mar-2008) her daughter developed "a little rash on the side of her thigh". Three to four days later the pharmacist noticed the rash became little cysts on the outer left thigh. "Last evening", 12 MAR 2008, the pharmacist reported noticing the start of a rash on her daughter's chest. It was noted that the child was also a little congested and may have been teething. The pharmacist reported the treatment had been Tylenol. The patient recovered on 13 MAR 2008. It was report that the physician had been contacted, but is unknown if medical attention was sought. There was no product quality complaint.
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a female who was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). It was noted that this was a staff error only, and not a product quality complaint. No further information was provided. Follow up information was received from the pharmacist who reported that the patient did not experience any symptoms. No further information is available.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in August 1996, was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (no lot# provided). On 14-MAR-2008 twelve years after vaccination, the patient experienced chickenpox. The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on 14-MAR-2008 was inadvertently vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The patient is not experiencing any known symptoms. It was noted there was no product confusion involved. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Exposure to communicable disease
Clinical narrative: Information has been received from a consumer concerning her husband who on 04-MAR-2008 noticed two blisters on his arm after his daughter was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and was diagnosed with shingles. He was not sure if it was related to his daughter' case of shingles. No further information was given. There was no product quality complaint. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 7-year-old male with no pertinent medical history or drug allergies who "had received the two doses of varicella virus vaccine live (Oka/Merck)". The last subcutaneous dose of 0.5 ml was "over a year ago". There was no concomitant medication. On an unspecified date, he developed episodes of clusters of blisters. Medical attention was sought via an office visit. The patient' pediatrician states that "these are chicken pox", however it was reported that an infectious disease doctor was not sure if the blisters were chicken pox. On 20-Feb-2008 the patient had IgG and IgM testing performed and had negative results. The patient has been out of school for 6 weeks due to his recent outbreak. The outcome was reported as recovering. No product quality complaint was involved. The physician also reported that the patient's sister developed adverse events following vaccine administration (WAES numbers: 0803USA02974). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Musculoskeletal stiffness
Clinical narrative: Information has been received from an office nurse concerning a patient who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 658586/1272U). In January 2008, the patient experienced cellulitis at the injection site on the thigh. It was indicated that the patient also experienced stiffness of the leg. The patient was treated with antibiotic (therapy unspecified). On an unspecified date the patient recovered. A product quality complaint was not reported. This is one of three reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from an office nurse concerning a patient who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 658586/1272U). In January 2008, the patient experienced cellulitis at the injection site on the thigh. The patient was treated with an antibiotic (therapy unspecified). On an unspecified date the patient recovered. A product quality complaint was not reported. This is of three reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse via a mother concerning her son who was vaccinated on an unknown date with one dose of varicella virus vaccine live (Oka/Merck). On an unspecified date, post vaccination, the patient's mother "thinks" the patient had chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of two reports received from same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria thermal
Clinical narrative: Information has been received from a physician concerning a 16 year old female consumer with no pertinent medical history who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck). There was no concomitant medication. Subsequently, the patient developed cold-induced urticaria 1-2 weeks after administration of first dose of varicella virus vaccine live (Oka/Merck). Medical attention was sought, the patient was examined in the office. There was no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a patient, with congenital muscle disease, who was vaccinated intramuscular on an unspecified date with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient experienced a break through of varicella (less than 50 lesions). At the time of the report the patient's status was unknown.  A product quality complaint was not involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M normal, Varicella
Clinical narrative: Information has been received from a physician concerning a 10-year-old female with no pertinent medical history or drug allergies who "had received the two doses of varicella virus vaccine live (Oka/Merck)". The last subcutaneous dose of 0.5 mL was "over a year a year ago". There was no concomitant medication. On an unspecified date, she developed episodes of clusters of blisters. Medical attention was sought via an office visit. The patient's pediatrician states that "these are chicken pox", however it was reported that an infectious disease doctor was not sure if the blisters were chicken pox. On 20-FEB-2008, the patient had IgG and IgM testing performed and had negative results. The outcome was reported as recovering. No product quality complaint was involved. The physician also reported that the patient's brother developed an adverse event following vaccine administration (WAES numbers: 0803USA02523). Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning two patients, both "older children" who received on an unspecified date a second dose of varicella virus vaccine live (Oka/Merck). On an unspecified date, it was indicated that the two patients developed breakthrough varicella. No intervention was reported. On an unspecified date, both patients had recovered. A product quality complaint was not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Follow up information form the nurse, identified a 22 month old male child, who on 03-DEC-1997 was vaccinated with the first dose of varicella virus vaccine (lot # not reported). In June 1998 he had a mild case of chickenpox. On 11-Jan-2008, at 11 years of age, he had a "full blown case" of chickenpox. It was previously reported that the child had recovered. No further details were provided.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Candida serology negative, Hepatitis C test negative, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 4 year old male patient, who in approximately 2004 when he as a year old, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Now the patient who is 4 years old had shingles. He did not require going to the hospital, but was on methotrexate for an amorphous skin condition. Acyclovir was added. Unknown medical attention was sought. The child recovered. Further information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a health professional concerning 3 patients who on an unspecified date, were vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 659727/1771U). It was indicated that they all presented with a similar presentation of after 5 to 10 seconds of receiving the vaccine, they developed a local reaction of a hive at the injection site. Specific treatment for those patients was not reported. Current patient status was not reported. A product quality complaint was not reported. The healthcare worker requested a lot check. This is one of 3 reports from the same source. Attempts are being made to obtain additional identifying information is distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is in follow-up to report (s) previously submitted 5/16/2008. 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.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a health professional concerning two patients who were vaccinated with varicella virus vaccine live (Oka/Merck). Each experienced a local reaction at injection site. The patients' outcomes were unknown. There was no product quality complaint. This information is on of several reports from the same source. No further information was available.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema
Clinical narrative: Information has been received from a physician concerning a 10 year old female with no medical history or allergies, who on 07-MAR-2008 was vaccinated with a booster dose of varicella virus vaccine live (Oka/Merck) (lot# 659430/1587U). There was no concomitant medication. On 09-MAR-2008, the patient developed a large erythematous area approximately 4X4 inches that had a vesicle in the middle. It was reported that there were no other symptoms. It was also reported that the patient went to the office. No diagnostic laboratory studies were performed. The patient's large erythematous area persisted. No product quality was involved. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood test normal, No adverse event
Clinical narrative: Information has been received from a physician assistant concerning a 44 year old male who in approximately 1999 was vaccinated with a 2 dose series of varicella virus vaccine live (Oka/Merck) at another location. There was no concomitant medication. A recent titer was negative. No additional information at the time. Unspecified medical attention was sought in the office. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a female patient who on 18-FEB-2008 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) for the prevention of shingles. The physician indicated that he was not sure if it was product confusion, although he stated that he had originally ordered the wrong product (varicella virus vaccine live, (Oka/Merck), then ordered zoster vaccine live (Oka/Merck). The physician indicated that both vaccines were in the freezer, and "they were not familiar with pediatric vaccines". No adverse experience was related to the the event. Current patient status was no reported. A product quality complaint was not reported. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature, Varicella
Clinical narrative: Information has been received from a nurse with an unspecified health department concerning a 6 year old female who on 02-MAR-2008 was vaccinated with a 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot# 654127/0918F). On 03-MAR-2008, it was indicated that she developed chicken pox. No fever was noted. At the time of this report, it was indicated that the lesions were crusted over. The nurse did not know if the patient had any recent exposure to chicken pox. No laboratory or diagnostic studies were performed. At the time of this repot, it was indicated that the patient was recovering. A product quality complaint was not reported. Additional information is not expected.
Age: 1.1
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Herpes simplex serology negative, Rash papular, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning a 4 year old patient with morphoea skin diagnosis 24-SEP-2007 who on 11-MAR-2005 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 647264/0437P) in the right deltoid. Concomitant therapy included measles-mumps-rubella vaccine (MSD) (lot# 649614/0777P) in the left deltoid. On 12-FEB-2008, the patient developed raised lesions on the right arm and shoulder. The patient was found to have papulovesicular lesions of the right arm. The sample of th lesion was collected from an independent lab on 13-FEB-2008 two times. The sample was take from a skin lesion and right antecubital skin lesion. The PCR (VZV Varicella-Zoster Virus of the specimen from the skin lesion and right antecubital skin lesion was positive. The sample of the lesion was collected from an independent lab on 13-FEB-2008. The sample was taken from the right antecubital skin lesion. The PCR (HSV) Herpes Simplex Virus results for the specimen from the right antecubital skin lesion was negative. The patient was treated orally with acyclovir. At the time of reporting the outcome was unknown. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Skin lesion, Varicella
Clinical narrative: Information has been received from a county health registered nurse concerning a 7 year old male who on 02-OCT-2002 was vaccinated with varicella virus vaccine live (Oka/Merck). On 24-MAR-2007 the patient developed varicella < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the the same source. No further information is available.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an approximate 9-year-old patient who on 17-JUL-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a county health registered nurse concerning a 6 year old patient who on 03-OCT-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). On 22-Mar-2007  the patient developed varicella < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an approximate 7-year-old patient who on 13-DEC-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.6
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an approximate 9-year-old patient who on 08-AUG-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. At the time if the report the patient's status was unknown. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 8-year-old patient who on 05-JUN-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. this is one of several reports received from the same source. Additional information has been requested.
Age: 1.9
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 9-year-old patient who on 30-JUN-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 10-year-old patient who on 21-JUN-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an approximate 9-year-old patient who on 20-SEP-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 8-year-old patient who on 18-AUG-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved.  This is one of several reports received from the same source. Additional information has been requested.