chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox.  Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 8 year old patient who on 04OCT1995 was vaccinated with a dose of varicella virus vaccine live. On 29MAR2003, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified.  Additional information is not expected.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox.  Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 8 year old patient who on 17APR1996 was vaccinated with a dose of varicella virus vaccine live. On 08APR2003, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified.  Additional information is not expected.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patient's developed mild cases of chicken pox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chicken pox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chicken pox have recovered. One of the previously vaccinated patients was a 7 year old patient who on 6/17/96 was vaccinated with a dose of varicella virus vaccine live. On 4/12/03, the patient developed chicken pox. The previously vaccinated patient's including two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chicken pox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chicken pox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that have experienced a chicken pox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chicken pox have recovered. One of the previously vaccinated patients was a 6 year old patient who on 5/15/97 was vaccinated with a dose of varicella virus vaccine live. In April 2003, the patient developed chicken pox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chicken pox. The other patients that developed chicken pox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chicken pox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chicken pox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chicken pox have recovered. One of the previously vaccinated patients was a 7 year old patient who on 10/2/97 was vaccinated with a dose of varicella virus vaccine live. On 4/28/03, the patient developed chicken pox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chicken pox. The other patients that developed chicken pox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chicken pox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chicken pox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chicken pox have recovered. One of the previously vaccinated patients was a 7 year old male patient in the first grade who on 8/1/97 was vaccinated with a dose of varicella virus vaccine live. The patient was vaccinated while his older brother (who is in middle school) was experiencing active chicken pox. In early March 2003, the patient developed a very mild case of chicken pox, which consisted of one on his chest and one on his neck... they were raised, pink in color and then faded. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chicken pox. The other patients that developed chicken pox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a health care professional concerning an approximately 17 year old female with no known medical history or allergies who was vaccinated in approximately 1995 (at the age of 13) with a first dose of varicella virus vaccine live. There was no concomitant medication. The patient did not receive a second dose at that time. In August 2003, at approximately 17 years of age, a titer was negative. On 8/27/03, the patient was vaccinated with a second dose of varicella virus vaccine live. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information indicated that the only problem we had was that she received her first dose at another facility a few days before she was nine years old, and her college required her to be nine. No further information is available.
Age: 1.6
Sex: F
Vaccine: VARCEL
Symptoms: Herpes simplex, Pyrexia, Rash, Skin ulcer
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 month old premature white female twin who on 3/26/03, was vaccinated SC in the left thigh with the first dose of varicella virus vaccine live (lot # 643593/0868M). Illness at the time of vaccination included allergic rhinitis and mild recurrent otitis media. The LPN reported that on 9/10/03, the patient developed a rash on her left arm that spread to her hands, feet, mouth, lips and diaper area. The patient was noted to have had more than 50 lesions total. At that time, it was also noted that the patient was exposed to chicken pox two weeks prior. On 9/11/03, the patient also developed a fever. On 9/12/03, the patient was seen by a physician, but no treatment was required. At that time, a diagnosis of herpetic simplex type I rash was made. On 9/17/03, the patient's mother contacted the physician indicating that her daughter had more lesions totaling a little less than 100. On 9/28/03, the patient recovered. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse who is the mother of a 5 year old female who at 12 months old, was vaccinated with a dose of varicella virus vaccine live. Subsequently, at 5 years old, the patient developed a breakthrough. On 9/16/03, it was reported that now at 8 years old, the patient just had shingles. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered medical assistant concerning a 46 month old female with no past medical history who on 11/15/00 was vaccinated with a varicella virus vaccine live (lot # 636357/0532K). There was no illness or concomitant medication at the time of vaccination. On 8/30/03 the patient had spots. On 9/3/03 the patient reportedly had breakthrough chicken pox. The patient's mother reported that there were a total of 16 chicken pox spots. The patient complained of itching but no fever. It was noted that the mother called the doctor's office with the total amount of spots on 9/12/03. It was noted that there were no relevant diagnostic tests or laboratory data. It was also noted that the patient had not experienced any adverse events following previous vaccinations. The patient's pustules were treated with bacitracin zinc (+) neomycin sulfate (+) polymyxin B sulfate. It was reported that the patient recovered. No further information is expected.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Erythema, Irritability, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female who on 9/8/03 at 11:30 (previously reported as 9/5/03) was vaccinated SQ in the left leg thigh with a first dose of varicella virus vaccine live (lot # 644562/1157M). Concomitant therapy on 9/8/03 at 11:30 included an IM fourth dose in the left leg thigh of HIB conjugate vaccine (lot # 644170/0861M) and a SQ first dose in the right thigh of MMR (lot # 645403/0131N). An illness at the time of vaccination was a URI without fever. On 9/18/03 (previously reported as 9/15/03) ten days after, the patient developed a fever of 99.4, was restless (also described as fussy), was not sleeping well, had a few enlarged lymph nodes and eight widely scattered red papules on her back, arms and chest described as a scattered red bums over body. Her heart rate was 114. As of 9/19/03, the patient was healing but was not 100% healed. There was no treatment required. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information indicated that the patient recovered. No further information is expected.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Restlessness, Sleep disorder
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female who on 9/8/03 at 11:30 (previously reported as 9/5/03) was vaccinated SQ in the left leg thigh with a first dose of varicella virus vaccine live (lot # 644562/1157M). Concomitant therapy on 9/8/03 at 11:30 included an IM fourth dose in the left leg thigh of HIB conjugate vaccine (lot # 644170/0861M) and a SQ first dose in the right thigh of MMR (lot # 645403/0131N). An illness at the time of vaccination was a URI without fever. On 9/18/03 (previously reported as 9/15/03) ten days after, the patient developed a fever of 99.4, was restless (also described as fussy), was not sleeping well, had a few enlarged lymph nodes and eight widely scattered red papules on her back, arms and chest described as a scattered red bums over body. Her heart rate was 114. As of 9/19/03, the patient was healing but was not 100% healed. There was no treatment required. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information indicated that the patient recovered. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a female patient with a history of a negative titer before becoming pregnant with her child who was vaccinated with 2 doses of varicella virus vaccine as scheduled. Subsequently, her titer after vaccination was negative. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Convulsion
Clinical narrative: Information has been received from a registered nurse concerning her 12 month old daughter with no pertinent medical history and no allergies who on 8/26/03 was vaccinated with a dose of varicella virus vaccine live. On 9/4/03 the patient experienced her first seizure. The mother stated that the child had a second seizure on 9/11/03, and a third seizure on 9/19/03. The child had no fever, and was not taken to the hospital or the emergency room. The child's physician was called for follow up. Unspecified medical attention was sought. There was no product quality complaint. No lab diagnostic studies were performed. Upon internal review, the patient's convulsions were considered to be other important medical events (OMIC). Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old Caucasian male with seasonal allergies only who on 3/24/03 in the PM was vaccinated with a first dose of varicella virus vaccine live (lot # 644089/1064M), SC in the right arm. There was no concomitant medication or illness at the time of vaccination. The patient's younger brother had developed chicken pox after the patient had been vaccinated. Subsequently, the patient developed a very mild case of chicken pox. The patient recovered. Additional information is not expected.
Age: 1.9
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Pyrexia, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning her 23 month old nephew who had on and off eczema and no known allergies who in approximately September 2002, at about 1 year old, was vaccinated with a dose of varicella virus vaccine life. The RN reported that on 9/14/03 the patient started to develop itching spots and had a fever. On 9/17/03 and 9/18/03, the patient again developed a fever. The patient's fevers were treated with acetaminophen. On the evening of 9/19/03, the child also developed hives which were treated with diphenhydramine and hydrocortisone cream. By 9/20/03, the patient was still breaking out with new itching spots. The nurse indicated that her nephew was covered with the itching spots and they were the worse case she had ever seen. As of 9/21/03, the child was still breaking out and had developed bruising under his skin. Unspecified medical attention was sought. Subsequently, the patient recovered from her events. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old male patient with no allergies and no pertinent medical history who on 8/3/99 was vaccinated with a dose of varicella virus vaccine live. According to the mother, on approximately 9/20/03, the patient developed a fever for a couple of days and then broke out in spots. On 9/27/03, the patient presented to the medical office with approximately 15 lesions. The reporter stated this was a mild case of chicken pox breakthrough. The patient was treated with diphenhydramine hydrochloride and calamine (+) camphor (+) pramoxine hydrochloride. A product quality complaint was not involved. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female with no relevant medical history and no allergies who in December 1999, at age 1.5 years was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 9/17/03, the patient developed shingles described as a few little bumps on her right arm which later spread. On 9/22/03, she was seen by her family physician with lesions on her right arm on the elbow, armpit, and fingers, following the dermatome, and was afebrile. On 9/22/03, a culture was sent and identified as shingles. The patient was treated with acetaminophen and hydroxyzine hydrochloride. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with an allergy to penicillin and no medical history who in 1992 was vaccinated with the first and second doses of varicella virus vaccine live. Concomitant therapy included iron tablets. In March 1992, the patient had a negative titer. No lot numbers were available. No additional information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old white female with no allergies or medical conditions who on 2/2/00 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 630678/0426J). There was no known illness at the time of vaccination. The nurse reported that one of her patients may have experienced a mild case of chicken pox even though the patient was immunized. It was noted that in retrospect, the patient's mother seemed to remember the patient having some lesions in her hair some time in August 2003. Therefore, it was assumed that the patient developed chicken pox. No medical attention was sought, a prescription drug was not required, and she appeared to be fully recovered in September 2003. There was no diagnostic tests performed. It was noted that neither the patient or her sibling had any adverse events following prior vaccination. A product quality complaint was not involved. Additional information was received from the registered nurse which indicated that there really was no follow up. Follow up information was received from the registered nurse which indicated that the patient probably did have varicella. It was noted 8/4/03 after the child's sibling had chicken pox, patient had few in scalp. No further information is expected. The nurse also reported a case of chicken pox in the patient's unvaccinated sibling.
Age: 2.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Hyperkeratosis, Infection
Clinical narrative: Information has been received from a physician concerning a 24 month old male with no pertinent medical history and no known drug allergies who on 9/5/03 was vaccinated in the upper left thigh with a dose of varicella virus vaccine live (lot # 642678/0761M). Concomitant therapy that day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine administered in the upper right thigh. On 9/15/00, 10 days later, the patient developed chicken pox. The reporter indicated that the patient recovered. No medical attention was sought. No laboratory diagnostic studies were performed. There was no product quality complaint. Follow up information received on 10/13/03 indicated that the child was seen in the office on 10/1/03 and was diagnosed with keratosis pilaris. It was noted that the child had not experienced chicken pox, as his mother had described. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed hardness and redness at the injection site. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Unintended pregnancy
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received through a manufactuer pregnancy registry from a 29 year old consumer who in February 2003 and March 2003 was vaccinated SC with a first and second dose of varicella virus vaccine live respectively. On 6/1/03, the patient became pregnant. The patient had blood work performed for the pregnancy and it was determined that she does not have a immunity to varicella. The patient was given immune globulin for varicella on 9/19/03 because she was exposed to varicella. At the time of the report the patient did not develop a break out of varicella. Medical attention was sought. A product quality complaint was not involved. Additional infomration was received from a receptionist in a physician's office who indicated that the patient delivered in March 2004. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection, Injection site erythema
Clinical narrative: Information has been received from the mother of a 13 month old female with no relevant medical history who on 09/08/03 was vaccinated with a dose of varicella virus vaccine live.  On approximately 08/30/03, concomitant medication included amoxicillin. At the time of vaccination the child had a "febrile respiratory infection" which had begun the weekend of 08/30/03 to 08/31/03.  On 09/09/03, the pt began to develop a rash on her legs, arms, face, abdomen and back. On approximately 09/25/03, it was noted that the rash had "changed to blisters now", with "50+ lesions". It was also noted that she developed a red mark at the injection site. There were no lab diagnostic studies performed. The physician had been contacted. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a RN concerning a pt who's 4 year old female sibling was vaccinated with a dose of varicella virus vaccine live (Lot # 630678/0426J) on 02/02/00.  The pt had never been immunized against chickenpox and developed a "classic case" of chickenpox on approximately 08/04/03.  The child's chickenpox was noted to be a "full case". Because the pt's sibling had some lesions in her hair some time in August 2003, it was assumed that the disease was transmitted to the pt. Additional information has been requested. The nurse also reported a case of chickenpox in the pt's sibling after being vaccinated with a dose of varicella virus live (WAES  #03090USA02503).
Age: 1.1
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 13 month old asian-american male pt with left otitis media since 09/02/03, and no medical history who on 08/22/03 was vaccinated SC once in the right anterior thigh with a 0.5mL first dose of varicella virus vaccine live (Lot # 645290/0326N).  Concomitant vaccine administered in the left anterior thigh on 08/22/03 included a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197)(Prevnar, Lot # 492-402). On 09/19/03 the pt "broke out in a zoster/shingles like rash on his left buttock". The physician further described the Zoster as located on the L2 dermatome, the left superior buttock had approximately 30 confluent tiny papule vesicles, and the pt was asymptomatic. Therapy with varicella virus vaccine live was discontinued on 08/22/03.  The physician reported that he did not see the pt until 09/24/03 and by then most of the lesions had healed. It was noted the adverse event abated and the pt recovered on 09/24/03 at 12:00AM. No prescription drug was required. There was no product quality complaint reported. Unspecified medical attention was sought. Follow up information received from the physician reported that photographs had been taken of the pt, but the photographs were not readily available at the time of the report. The physician indicated that he would forward the pictures at a later date when they were made available. Follow up information received from a physician on 11/19/03 included the photographs of the pt's zoster/shingles like rash on his left superior buttock area. Follow up information contained the following adverse experience: Left otitis media onset 09/02/03.  Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a first and second dose of varicella virus vaccine live (Lot #'s not available) in 1998 and 1999, respectively. On 09/26/03 it was reported that titers were done "recently" and they do not show seroconversion. Unspecified medical attention was sought. There was no prescription drug required.  There was no product quality complaint involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a CMA concerning an 11 year old male with no known allergies who on 10/27/95 was vaccinated with varicella virus vaccine live (Lot # 609295/0440B). There was no concomitant medication. On 09/26/03 the pt presented in the office with chickenpox.  It was reported that the pt complained of pain but no itch. The rash appeared on his face and then spread over his body.  The number of lesions was not noted. The pt sought unspecified medical attention. There were no lab or diagnostic tests performed. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a NP concerning a 26 year old female who on 09/10/03 was vaccinated with a dose of varicella virus vaccine live (Lot # 644090/1065M). The NP reported that on approximately 09/23/03, the pt developed a mild case of chickenpox characterized by approximately 16 or 17 lesions diffusely scattered on her trunk, head and limbs. The pt was also noted to have mild lymphadenopathy, fever and malaise. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Headache, Lymphadenopathy, Malaise, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a NP concerning a 26 year old female who on 09/10/03 was vaccinated with a dose of varicella virus vaccine live (Lot # 644090/1065M). The NP reported that on approximately 09/23/03, the pt developed a mild case of chickenpox characterized by approximately 16 or 17 lesions diffusely scattered on her trunk, head and limbs. The pt was also noted to have mild lymphadenopathy, fever and malaise. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a NP concerning a 26 year old female who on 09/10/03 was vaccinated with a dose of varicella virus vaccine live (Lot # 644090/1065M). The NP reported that on approximately 09/23/03, the pt developed a mild case of chickenpox characterized by approximately 16 or 17 lesions diffusely scattered on her trunk, head and limbs. The pt was also noted to have mild lymphadenopathy, fever and malaise. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 10SEP2003 in the am was vaccinated in the left tricept with a first dose of varicella virus vaccine live. On 23SEP2003, the patient "started breaking out with lesions that appeared to be chickenpox", described as red, itchy lesions which began on her trunk with pins and needles sensation prior to the eruption. The pt returned to the physician on 26SEP2003 and the lesions had subsequently spread to the lower extremities, face, upper extremities and vaginal area (previously reported as "had about 20 lesions or so" on her upper body and face). She complained of headache, malaise and "had a temperature of 98.9 degrees F and developed palpable lymph nodes in the neck (previously reported as lymphadenopathy). The lesions crusted over and a few additional ones broke out but it appeared that the rash was "clearing up". No treatment was required for symptoms. Unspecified medical attention was sought. There was no product quality complaint involved. It was noted that there was no additional information at the time of this report. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Headache, Lymphadenopathy, Malaise, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 10SEP2003 in the am was vaccinated in the left tricept with a first dose of varicella virus vaccine live. On 23SEP2003, the patient "started breaking out with lesions that appeared to be chickenpox", described as red, itchy lesions which began on her trunk with pins and needles sensation prior to the eruption. The pt returned to the physician on 26SEP2003 and the lesions had subsequently spread to the lower extremities, face, upper extremities and vaginal area (previously reported as "had about 20 lesions or so" on her upper body and face). She complained of headache, malaise and "had a temperature of 98.9 degrees F and developed palpable lymph nodes in the neck (previously reported as lymphadenopathy). The lesions crusted over and a few additional ones broke out but it appeared that the rash was "clearing up". No treatment was required for symptoms. Unspecified medical attention was sought. There was no product quality complaint involved. It was noted that there was no additional information at the time of this report. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 10SEP2003 in the am was vaccinated in the left tricept with a first dose of varicella virus vaccine live. On 23SEP2003, the patient "started breaking out with lesions that appeared to be chickenpox", described as red, itchy lesions which began on her trunk with pins and needles sensation prior to the eruption. The pt returned to the physician on 26SEP2003 and the lesions had subsequently spread to the lower extremities, face, upper extremities and vaginal area (previously reported as "had about 20 lesions or so" on her upper body and face). She complained of headache, malaise and "had a temperature of 98.9 degrees F and developed palpable lymph nodes in the neck (previously reported as lymphadenopathy). The lesions crusted over and a few additional ones broke out but it appeared that the rash was "clearing up". No treatment was required for symptoms. Unspecified medical attention was sought. There was no product quality complaint involved. It was noted that there was no additional information at the time of this report. Additional information has been requested.
Age: 1.2
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a health professional concerning a 14 month old pt who at 12 months of age, in approximately July 2003, was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. On approximately 09/29/03 the pt has "now" developed less than 50 lesions all over the body with no fever. The lot # was not reported. The child was given some type of cream to treat the chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 5 year old white male with no past medical history and no known drug allergies who on 03/25/1999 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot # 928526/1673H). There was no illness at the time of vaccination. On 09/22/03 the pt developed approximately 20 pox. No fever was noted. Some itching was noted. Subsequently, the pt recovered on 09/27/03.  No relevant diagnostic tests or lab data were reported. There were no adverse events following prior vaccinations of the pt or his siblings. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a NP concerning a 6 year old white female who on 12/05/97 was vaccinated in the right arm with a dose of varicella virus vaccine live (Lot # 624249/1103E). There was no illness at the time of vaccination. On 09/29/03 the pt was seen with a break through case of varicella. The pt had approximately 20 lesions. Unspecified medical attention was sought. No lab tests or diagnostic studies were performed. A product quality complaint was not involved. Follow up information indicated that the pt developed a mild case of chickenpox on 09/26/03. Subsequently the pt recovered. No further information is expected.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a LPN concerning a 31 year old female adult pt who on 09/11/03 was vaccinated SC once with a 0.5mL dose of varicella virus vaccine live (Lot # not available). Today, on 10/01/03 the pt came to the office with "3 lesions of chickenpox". The LPN reported that the pt developed the chickenpox after being vaccinated on 09/11/03, and confirmed the rash started on 10/01/03.  The LPN indicated the pt had received the vaccination at another location. It was noted the pt recovered from the chickenpox.  It was noted the therapy was discontinued. No treatment was required. There was no product quality complaint reported. Follow up information received from the LPN indicated that on 10/01/03, the pt had a VZV antibody (IgG) EIA,the result was 0.28 I.S.R. (reference range 0.0-0.90) with an interpretation of negative or non-immune, and was indicated as unsuitable for detection of post-vaccination immune status. Also on 10/01/03, she had a VZV antibody (IgM) EIA, the result was 0.61 I.S.R. (reference range 0.00-0.90), interpreted as negative, but indicated the result should not be used as a sole determinant of current or recent infection, and reliance on a single test could be misleading. It was reported the pt would have a repeat titer in 5 weeks (approximately 10/29/03).  Additional follow up information received on  11/20/03 from a LPN indicated that as of 11/14/03 the pt had not converted to an immune status with serum titers. On 11/05/03 the varicella zoster IgG was 0.61 I.S.R. (negative or non-immune), which reliably measures immunity due to previous infection, but is unsuitable for detection of post-vaccination immune status. On 11/05/03, the varicella zoster IgM was 0.42 I.S.R. (negative). Additional information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning an adult female pt who was vaccinated SC with a first and second 0.5mL dose of varicella virus vaccine live. It was reported that the pt had a negative antibody titer. Unspecified medical attention was sought and no prescription drug was required. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: DT, VARCEL
Symptoms: Dermatitis bullous, Infection, Injection site erythema, Pruritus, Pyrexia
Clinical narrative: Information has been received from a LPN concerning a 16 year old white female with asthma and no known drug allergies who on 08/21/03 at 8:40 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 643925/0936M).  On 08/21/03, at 8:40 concomitant therapy included an IM dose in the left arm of adult diphtheria toxoid (+) tetanus toxoid (Batch # U0842AA), it was noted that the series was finished on 04/28/92 respectively. On 08/21/03, "in the evening" (also reported as "about 3 days after" vaccination) the pt developed a low grade fever and "a few pox dispersed over her body". The pt's mother reported that there was a "hive-like itchy rash around injection site" and 3-4 days later developed "pox-like lesions" on her face which were red, raised vesicular lesions that scabbed over". There was no prescription drug required. Subsequently, the pt recovered. Medical attention was not sought. There was no product quality complaint involved. No further information is expected.
Age: 16.0
Sex: F
Vaccine: DT, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a LPN concerning a 16 year old white female with asthma and no known drug allergies who on 08/21/03 at 8:40 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 643925/0936M).  On 08/21/03, at 8:40 concomitant therapy included an IM dose in the left arm of adult diphtheria toxoid (+) tetanus toxoid (Batch # U0842AA), it was noted that the series was finished on 04/28/92 respectively. On 08/21/03, "in the evening" (also reported as "about 3 days after" vaccination) the pt developed a low grade fever and "a few pox dispersed over her body". The pt's mother reported that there was a "hive-like itchy rash around injection site" and 3-4 days later developed "pox-like lesions" on her face which were red, raised vesicular lesions that scabbed over". There was no prescription drug required. Subsequently, the pt recovered. Medical attention was not sought. There was no product quality complaint involved. No further information is expected.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a RN concerning an approximately 31 year old female pt who in 1999 was vaccinated with a first and second dose of varicella virus vaccine live. In 2002, the pt was in delivery. The pt's husband was present at the delivery and had shingles. The husband had natural chickenpox as a child. The physicians were concerned for the pt and infant. An antibody test was performed on the pt and the results were negative.  Unspecified medical attention was sought. It was noted that the child was born with no chickenpox, but did have reflux and was placed in the ICU with apnea. The infant recovered and was "perfectly healthy" at the time of the report. A product quality complaint was not involved. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a RN concerning a 6 year old male pt with no allergies and no past medical history who on 02/04/98 was vaccinated with a first dose of varicella virus vaccine live. Subsequently, the pt had a 'chickenpox break thru'. On 09/30/03, the pt presented to the doctor's office with an itchy rash, clear vesicles, approximately 20 lesions, but no fever. The pt was treated with Benadryl and calamine as needed. At the time of the report, the pt was improving and all lesions had crusted. A product quality complaint was not involved. The reporter also mentioned a second pt who developed chickenpox post vaccination with varicella virus vaccine live (WAES # 0310USA00574).  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Herpes zoster, Infection, Musculoskeletal stiffness, Pain
Clinical narrative: Information has been received from a LPN and a physician concerning a 5 year old white female student with no known drug allergies and no past medical  history who on 08/16/99 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot # 631065/0445J).  Concomitant vaccination on the same day included a first dose SC in the right arm of MMRII (Lot # 630119/1983H). There was no other concomitant medication. On 07/14/03, the pt was vaccinated with a second dose of MMRII. On 10/01/03 (also reported as 09/30/03), the pt developed a rash included approximately 10 lesions on the left side of her face, neck and ear. The pt had a maximum temperature of 99.3. Pain was quantified as 7 out of 10. Other systemic symptoms included a stiff neck. Medical attention was sought. The physician diagnosed herpes zoster. The diagnosis was not confirmed by lab tests. There was no history of chickenpox and no recent exposure to chickenpox or herpes zoster. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. A direct fluorescent antibody was not done, a specimen was not collected for PCR and a photo was not taken. No treatment was given to the pt. Subsequently, the pt recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a LPN and a physician concerning a 5 year old white female student with no known drug allergies and no past medical  history who on 08/16/99 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot # 631065/0445J).  Concomitant vaccination on the same day included a first dose SC in the right arm of MMRII (Lot # 630119/1983H). There was no other concomitant medication. On 07/14/03, the pt was vaccinated with a second dose of MMRII. On 10/01/03 (also reported as 09/30/03), the pt developed a rash included approximately 10 lesions on the left side of her face, neck and ear. The pt had a maximum temperature of 99.3. Pain was quantified as 7 out of 10. Other systemic symptoms included a stiff neck. Medical attention was sought. The physician diagnosed herpes zoster. The diagnosis was not confirmed by lab tests. There was no history of chickenpox and no recent exposure to chickenpox or herpes zoster. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. A direct fluorescent antibody was not done, a specimen was not collected for PCR and a photo was not taken. No treatment was given to the pt. Subsequently, the pt recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a 28 year old white female nurse midwife with no allergies or medical conditions who on 02/20/98 was vaccinated with a second dose of varicella virus vaccine live. The pt was vaccinated with a first dose of varicella vaccine live on 12/11/97. Concomitant therapy included ethinyl estradiol (+) etonogrestrel for birth control. There was no illness at the time of vaccination.  The reporter indicated that a recent varicella titer did not sow seroconversion and was negative. The pt did not seek medical attention and no treatment was required. A product quality complaint was not involved. Additional information was received from the nurse midwife which indicated that on 09/25/03 a varicella zoster virus antibody immunoglobulin G was negative. The reporter was revaccinated. No further information is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Information has been received from a NP concerning a 6 year old male who on 09/23/03, was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (Lot # 644795/0335N) after his 12 year old sister broke out with a severe case of shingles. The NP reported that on 10/02/03, the pt developed a papular rash characterized by approximately 20 lesions.  The NP indicated that the lesions were not vesicular or blistered and she was unsure if the rash was varicella.  Unspecified medical attention was sought, but no lab/diagnostic tests were done and no prescription drugs were required to treat the papular rash. The pt was being isolated as a precaution.  The NP indicated that the pt's rash never became vesicular and concluded that the rash was viral in nature versus a rash related to shingles exposure or to varicella virus vaccine live. Subsequently, the pt's viral rash resolved. Additional information is not expected.