chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.32
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning an approximately 35 month old male patient who on 07/11/2002 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot#639778/0981L).  In February 2004, the patient had a breakout of chickenpox.  Unspecified medical attention was sought, but treatment was not required.  Subsequently, the patient fully recovered.  A product quality complaint was not involved.  Additional information is not expected.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female patient who on 08/18/1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  In February 2004, the patient developed a mild case of breakout chickenpox.  Unspecified medical attention was sought, but treatment was not required.  Subsequently, the patient fully recovered.  A product quality complaint was not involved.  The patient also mentioned another patient who developed chickenpox post vaccination with varicella virus vaccine live (Oka/Merck).  Additional information is not expected.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 13 month old patient who in approximately 1999 (reported as five years ago), was vaccinated with varicella virus vaccine live. The physician reported the patient developed cellulitis at the injection site a few days after the injection. The patient was seen in the emergency room and subsequently admitted to the hospital The patient's symptoms were redness, pain, and swelling of the leg. After a stay in the hospital (unknown duration) and unknown treatment, the patient's symptoms resolved and the patient recovered from cellulitis. The cellulitis symptoms, redness, pain and swelling of the leg were considered a significant disability/incapacity. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 9 year old female patient with no past medical history who on 07/01/1998 was vaccinated subcutaneously in the right arm with a 0.5ml first dose of varicella virus vaccine live (Oka/Merck) (lot#624778/1565E).  There was no concomitant medication.  On 04/11/2004 the patient experienced 25 chickenpox lesions and came into the office on 04/13/2004.  It was noted as breakthrough disease following exposure to a cousin with chickenpox.  No fever or complications were noted.  The patient was given diphenhydramine hydrochloride for itching and was sent home.  No lab tests were done.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a patient who in 1998, 6 years ago, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Now, on approximately 04/29/2004, the patient experienced chickenpox.  Unspecified medical attention was sought.  No product quality complaint was involved.  No additional information was provided.  Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site swelling, Skin ulcer
Clinical narrative: Information has been received on 04/29/2004 from a registered nurse concerning her 3 year old son who two weeks ago, was vaccinated with varicella virus vaccine live (Oka/Merck).  Subsequently, the patient developed a hot , swollen injection site lesion the size of a quarter.  Hospitalization was not required.  Unspecified medical attention was sought.  No product quality complaint involved.  It was also reported that about one year ago the patient was vaccinated with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, and had an injection site reaction.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male patient, who six years ago (approximately 1998), was vaccinated with varicella virus vaccine live (Oka/Merck).  The registered nurse reported that the child had breakthrough, which was described as approximately 20 lesions on the trunk of his body.  Nothing else was done.  No additional information is expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male with seasonal allergies who on 06/07/1999 was vaccinated in the left arm with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  Concomitant therapy included cetirizine hydrochloride for seasonal allergies.  On 04/22/2004 the patient developed vesicular lesions behind his ear and his trunk.  The lesions were not itchy.  Unspecified medical attention was sought.  The patient was treated with an increased dosage of his cetirizine hydrochloride, and calamine lotion.  Subsequently, the patient recovered.  There were no relevant diagnostic tests or laboratory data.  There were no adverse events following prior vaccinations.  Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 7 year old male patient who on 07/19/2000 was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on approximately 05/06/2004, the patient developed breakthrough chickenpox with less than 50 lesions.  Follow up information indicated that there was not a single report of adverse reaction following varicella vaccination.  The reporter indicated that 49 other patients developed breakthrough cases of chickenpox.  No additional information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning an 8 year old female who in July 1996, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  On 04/30/2004 the patient was diagnosed with an atypical mild case of chickenpox.  It was reported that the patient had one lesion in the mouth, 2 lesions on the scalp and 12 lesions on the trunk.  She had less than 50 lesions and was afebrile.  Unspecified medical attention was sought, but no treatment was required.  No product quality complaint was involved.  No additional information was available.  Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old male who on 09/05/2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot3634844/1869J).  In April 2004, the patient developed chickenpox with greater than 50 lesions.  He was being treated with acyclovir and hospitalization was not required.  A product quality complaint was not involved.  Follow up information indicated that the patient subsequently recovered.  No further information is expected.
Age: 1.09
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 year old female who on 10/23/1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  The nurse reported that on 04/29/2004 the patient developed chickenpox characterized by about 50 lesions on her body and about three lesions in her mouth.  Unspecified medical attention was sought with unspecified treatment required.  At the time of this report, the outcome was unknown.  The nurse also reported that another patient developed breakthrough chickenpox after being vaccinated with varicella virus vaccine live (Oka/Merck) (WAES 0405USA00765).  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old healthy female with no known allergies and no past medical history who on 08/15/1997 was vaccinated subcutaneously in the right arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot#622750/0545E).  There was no illness at the time of vaccination.  On 04/30/2004 the patient presented with 20-25 "insect like bites" on her neck, back, chest, and upper extremities.  The patient was afebrile.  The patient was treated with calamine lotion and diphenhydramine hydrochloride.  No other information was available.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information received from a nurse practitioner indicated that on 04/30/2004, the patient developed 20-25 lesions and a maculopapular rash on her neck, back, chest, and upper extremities.  The outcome was reported as recovered. No further information is expected.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female patient who on 06/14/1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  In February 2004, the patient developed a mild case of breakout chickenpox.  Unspecified medical attention was sought, but treatment was not required.  Subsequently, the patient recovered.  A product quality complaint was not involved.  The patient also mentioned another patient who developed chickenpox post vaccination with varicella virus vaccine live.  Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old disabled male with a significant past medical history and his own nurse who on 05/13/1998 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot#625372/0057H).  On 05/03/2004 the patient's nurse, who is his caregiver, contacted the doctor's office and reported that the child had more than 50 lesions/blisters.  It was noted that the nurse will call them back to confirm if it was chickenpox.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information received from a registered nurse indicated that none of the patient's medical history is relevant to this mild breakthrough.  It was noted that on 04/30/2004, the patient broke out with 3 lesions, 2 on his face and one his arm.  The outcome was reported as recovered.   The reporter also indicated that one other patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed chickenpox (WAES#0404USA02328).  Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a RN concerning a 30 year old white male systems analyst with no medical Hx or know of any allergies who, on 04/07/04 was vaccinated IM in the deltoid with the first dose of varicella virus vaccine, live. There was no concomitant therapy or other vaccinations given on that same day. There was no illness at the time of vaccination. The NP reported that on the morning of 04/28/04- The pt developed a 20 pox rash on his torso, legs, and arms. There was a little focal itching , but no fever. Unspecified medical atterntion was sought and a serum varicella zoster virus antibody test was Negative.  At that time the pt's pox were mostly crusted. On 05/03/05, the pt recovered.
Age: 22.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Unintended pregnancy
Clinical narrative: Information has been received through a manufacturer pregnancy registry from a LVN concerning a 22 year old black female , with a Hx of no pregnancies, no live births who on 04/26/04 was vaccinated with varicella virus vaccinee live, + measles virus vaccine live, + mumps virus vaccine live + rubella virus vaccine live. On 05/03/04 it was reported that the pt was "now pregnant". . Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a LVN indicated that the pt did not have a local rxn at the vaccination site, no varicella Sx post vaccination, and no herpes zoster SX after vaccine. It was noted that the pt did have the flu during her pregnancy, but had no other complications. There were no medications used during pregnancy . On 01/07/2005, she delivered a normal, healthy female baby weighing 6lbs 4 oz. It was reported that the infant has no adverse events per MD chart in clinic. Additional informtion is not expected.
Age: 0.9
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a consumer concerning her 11 month old daughter who was vaccinated with a dose of VARIVAX. There was no concomitant medication. It was reported that the patient was vaccinated five days prior to her first birthday. The patient had a red spot at the injection site which went away. It was noted that there were no other adverse reactions. No medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Dermatitis bullous, Viral infection
Clinical narrative: Information has been received from a LPN concerning a 6 year old male student with a PCN allergy who on 01/19/1999 was vaccinated SC in the left arm with the first dose of varicella virus vaccine, live. Concomitant vaccinations on that same day included the first dose of measles virus vaccine, live + mumps virus vaccine, live + rubella virus vaccine live,(MMR), and the fourth dose of Hib conjugate vaccine. There was no illness at the time of vaccination. It was noted that the pt was not on any chronic medications. The LPN reported that on 05/01/04, the pt developed  "little bumps here and there" and " more bumps on Sunday".  On 05/03/04- the pt was seen by the school nurse who noted that he had approximately 50 tiny red , fluid filled lesions that were very itchy. The pt was a febrile. A DX of chicken pox was made. It was noted that there was a known exposure to chicken pox at school. TX or lab/diag. tests were not required and the pt recovered on 05/08/04. On 05/10/04, the pt returned to school. Additional information is not expected.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Dermatitis bullous, Pyrexia, Viral infection
Clinical narrative: Information has been received from a RN concerning a 12 month 0old Caucasian male patient with no allergies and no past medical history who on 04/14/04 (post one year of age) was vaccinated SQ in the LUL with a first 0.5cc dose of varicella virus vaccine live. There was no illness at the time of the vaccination. There were no concomitant therapies. On 04/23/04, the pt developed a fever and broke out with pox, which were also described as blisters or a  red base over his face, legs, and torso. The MD verified the pt had varicella. The pt was treated symptomatically. ON 5/01/04, the pt recovered. Additional information is not expected.
Age: 1.19
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 6 year old Caucasian female student with a PCN allergy who on 10/07/1998 was vaccinated with a dose of varicella virus vaccine, live. ON 04/16/2004, the pt developed approximately 30 lesions. The pt was taken  to the medical center for a MD visit. It was noted that the pt was DX by an MD, subsequently, the pt recovered. Additional information is not expected..
Age: 1.28
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Information has been received form a RN concerning a 6 year old Caucasian male student  who on 05/14/99 was vaccinated with a dose of varicella virus vaccine live. On 04/12/04, the pt developed approximately 20 lesions, per the pt mother. The pt had a MD visit and the MD DX chickenpox. On 04/19/04, the pt returned to school. It was noted that the pt recovered. Additional information is not expected.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 15 month old female who was vaccinated on 03/11/04 with a 0.5ml dose of varicella virus vaccine live. One week later, on 03/18/04, the pt has a low grade fever and 10 lesions to her trunk. The reporter also mentioned that the father of the pt who was a
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Cyst, Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Information has been received from a MA concerning a 10 year old male with no known allergies who on 04/27/04 was vaccinated with a dose of varicella virus vaccine, live. On 04/27/04 was vaccinated with a dose of varicella virus vaccine, live. There was concomitant therapy or other vaccinations given that same day. The MA  reported that on 04/29/04,  developed a rash with tried papules of varying size. Some with some with ruptured cyst heads. There was no itching or fever noticed on that same day the pt was seen in the PMD's office and acyclovir was rx;S but no laboratory or relevant diagnostic tersxts were performed. At the time of this report, the outcome was iunknown. NOr further information is agailable
Age: 1.24
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a 6 year old female student who on 3/29/99, at 15 months of age, was vaccinated in the right deltoid with the first dose of varicella virus vaccine live (lot # 628246/1655H). The physician reported that on 4/3/04, the patient broke out in a rash on her right arm. A diagnosis of herpes zoster was made. Unspecified medical attention was sought and the patient was treated with Acyclovir for five days. Subsequently, the patient recovered from the herpes zoster. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male patient who on 11/26/02 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination administered on 11/29/102 included a dose of hepatitis B virus vaccine. The registered nurse reported that the patient was vaccinated from a different physician in another state. On 2/24/04, the patient developed chicken pox. The nurse described the patient's case of varicella as greater than 100 lesions. The registered nurse also mentioned that several other school classmates had it as well. The registered nurse did not have the lot or other information to offer. It was noted that no treatment was required and no product quality complaint was reported. The patient recovered. Unspecified medical attention was sought. No additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Jaundice cholestatic, Laboratory test abnormal, Medication error, Unintended pregnancy
Clinical narrative: Information has been received through a pregnancy registry from a registered nurse concerning a 18 year old healthy female with no concurrent medical conditions who on 11/26/03 was vaccinated with a dose of varicella virus vaccine live. Subsequently, she became pregnant. It was noted that it has been an unremarkable pregnancy as of 5/5/04. Laboratory diagnostic tests performed on 2/23/04 included an MSAFP that was negative and on 3/12/04 an ultrasound that was negative and revealed 19.3 weeks. The LMP was 10/27/03 and the EDD was 8/2/04. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information indicated that the patient gave birth to a normal male live born infant weighing 280 grams on 7/21/04 at 39 weeks from her LMP. There were no congenital anomalies and no other complications. There were no complications during pregnancy. It was noted that the patient was induced for cholestatic jaundice of the pregnancy. Laboratory tests during pregnancy included A CBC on 7/19/04. An alkaline phosphatase was 262, alanine aminotransferase was 70, aspartate aminotransferase was 46, bilirubin was 0.51, and creatinine was 0.6. Medications used during pregnancy included prenatal vitamins once daily (not further specified). The infant had no feature of congenital varicella zoster syndrome. No further information is expected.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a medical assistant concerning an 8 year old male patient who on 10/1/96 was vaccinated in the right arm with a second dose of varicella virus vaccine live (lot # 619677/0834D). Concomitant vaccination on 10/1/96 included a first dose in the left arm of MMR (lot # 630633/0102K). On 5/3/04, the patient was seen for a doctor visit with 15 to 30 lesions and a low grade fever. The patient was diagnosed with a mild case of varicella and an onset date of 4/30/04 was noted. Treatment was not required. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning his 8 year old son who in 1997, 7 years ago, was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. In March 2004, the patient experienced chicken pox. It was reported that there were about 50 lesions on the throat and chest area. There was no fever. The rash lasted about 5 days. Unspecified medical attention was sought, but no treatment was given. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Erythema, Pruritus, Rash, Rash papular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 15 month old female (also reported as male) with a cough and runny nose who on 1/30/04, at 13:45, was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot # 646535/0575N). Concomitant medications included a fourth dose IM in the right thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (lot 495033) and guaifenesin. On 5/6/04 the patient presented to the office with a chicken pox rash. There were about 15 lesions confined mostly to the abdomen, legs, and feet. Medical attention was sought, but no treatment was required. No product quality complaint was involved. No other information is available. Follow up information indicated that the patient was seen in the office on 5/6/04 with a cough, runny nose, and rash which started with small bumps on 5/5/04. At the office, the patient had one red papule on the abdomen, about 10 red papules on the feet and legs, and 1 on the labial margin. It appeared to be itchy. Symptomatic treatment and isolation was advised and the parent was told to follow up as needed. No labs or diagnostic tests were done and recovery status is unknown. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 15 month old male with no known medical history who on 1/9/04 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot # 646535/0575N). There was no concomitant medication. On 5/4/04 the patient developed full blown chicken pox. On 5/6/04, the patient was seen at the physicians office with 100 pox-like lesions and no fever or malaise was noted. At the time of the report, the patient had not recovered. There was no laboratory studies performed and no treatment was required. A product quality complaint was not involved. Follow up information from the registered nurse indicated that the patient was seen in the office on 5/6/04 with a classic varicella rash from head to toe which started on 5/5/04. The patient was afebrile. Symptomatic relief was noted. On 5/10/04, the patient recovered. No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a male patient who's child was vaccinated with a dose of varicella virus vaccine live on 4/28/04. The RN reported that on 5/4/04, the patient developed chicken pox. Unspecified medical attention was sought. The RN noted that the patient and his child had not had a follow up titer. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain, Headache, Pharyngolaryngeal pain, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning her 8 year old son with no allergies, attention deficit disorder, a history of premature birth (33 week preemie) (also reported as no medical history) who on 7/18/96 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot # 616997/1656B). There was no illness at the time of vaccination. Concomitant therapy included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate. On 5/3/04, the patient experienced headache, a sore throat, abdominal pain, and fever 101 degrees F. The following day, on 5/4/04, the patient started with a rash of about 50 lesions. He was treated with diphenhydramine hydrochloride and acetaminophen. A product quality complaint was not involved. Follow up information was received from a registered nurse who indicated that on 5/4/04 the patient developed break through varicella with 30 to 40 spots. He had a fever for two days with a maximum temperature of 101. Subsequently, the patient recovered. No diagnostic laboratory tests were performed. The physician also reported a varicella outbreak in 30 children in the patient's school after therapy with varicella virus vaccine live.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning her 8 year old son with no allergies, attention deficit disorder, a history of premature birth (33 week preemie) (also reported as no medical history) who on 7/18/96 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot # 616997/1656B). There was no illness at the time of vaccination. Concomitant therapy included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate. On 5/3/04, the patient experienced headache, a sore throat, abdominal pain, and fever 101 degrees F. The following day, on 5/4/04, the patient started with a rash of about 50 lesions. He was treated with diphenhydramine hydrochloride and acetaminophen. A product quality complaint was not involved. Follow up information was received from a registered nurse who indicated that on 5/4/04 the patient developed break through varicella with 30 to 40 spots. He had a fever for two days with a maximum temperature of 101. Subsequently, the patient recovered. No diagnostic laboratory tests were performed. The physician also reported a varicella outbreak in 30 children in the patient's school after therapy with varicella virus vaccine live.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 38 year old female with asthma and a gastrointestinal intolerance to erythromycin who on 4/8/04 was vaccinated with varicella virus vaccine live (lot # 643823/0869M). Concomitant therapy included montelukast sodium and fluticasone propionate (+) salmeterol xinafoate. There was no illness at the time of vaccination. The RN reported that, two weeks later, on approximatley 4/22/04, the patient developed hardness at the injection site as well as silver dollar redness, soreness and swelling at the injection site with body aches. Unspecified medical attention was sought. In April 2004, 24 to 48 hours following the initiation of azithromycin, the patient's events were considered to be resolved. No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 4 year old female with no allergies or medical history who at 12 months of age 4 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. On 5/3/04, the patient came to the physician with a breakout of 20 lesions. No treatment was required. It was noted that therapy was discontinued. A product quality complaint was not involved. Follow up information received from the physician who indicated that the patient had a break through varicella with about 70 lesions. Subsequently, the patient recovered. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a RN concerning an adult female pt who on 12Apr04 was vaccinated with a dose of varicella virus vaccine live. In Apr 2004, soon after vaccination, the pt developed a chickenpox rash. It was noted that the pt had recently moved. The treatment was diphenhydramine HC1 (Benadryl). Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned two other pt's: (WAES0405USA02435) the pt's spouse who was vaccinated with varicella virus vaccine live and developed a chickenpox rash; (WAES0405USA00428) the pt's child who developed a rash through secondary transmission. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a RN concerning an adult male pt (WAES0404USA02435) and his spouse (WAES0405USA00427) who on 12Apr04 were vaccinated with a dose of varicella virus vaccine live. In Apr 2004, soon after vaccination, both the husband and wife developed a chickenpox rash. Their child who was 6 years old was not vaccinated, but was reported to have developed a rash within the last day or so, on approx 27Apr04. The treatment was diphenhydramine HC1 (Benadryl). Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old white female with no allergies and no medical history who on 12Apr04 was vaccinated in the right anterior thigh with a first dose of varicella virus vaccine live (lot 647708/1246N). Concomitant therapy included fourth dose given in the left anterior thigh of poliovirus vaccine inactivated (Ipol) (batch X0707) and a first dose given in the right thigh of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 645519/0295N). There was no illness at the time of vaccination. On 07May04 the pt developed a wide spread rash of about 15 tiny vesicular lesions to her forehead, hairline, right ear, trunk, and extremities. No other symptoms were reported. The pt was seen by a physician and no treatment was required. The pt was diagnosed with modified chickenpox. Subsequently, the pt recovered. No product quality complaint involved. No further information is expected.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 33 year old female employee who on 4/5/04 was vaccinated SC in the left arm with a dose of varicella virus vaccine live (lot # 639782/0535N). Within 24 hours post vaccination, the patient developed a local reaction that included swelling, redness, and itching. The reaction maxed out at 48 hours post vaccination. The patient did not seek medical attention and did not require any kind of treatment. After four days, the patient completely recovered. A product quality complaint was not involved. Additional information has been request.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a school registered nurse concerning a 12 year old female student in the sixth grade who on 8/24/96 was vaccinated with a dose of varicella virus vaccine live. The school registered nurse reported that on 5/3/04 at 08:30 AM the student presented with multiple vesicles on her torso, palms of hands and legs. The school nurse reported that the student had breakthrough chicken pox and described the rash as 20 or less pox that were unusual in appearance and unusual in location. The nurse noted the student did not have fever or malaise. The school nurse mentioned that the student had been seen by her family practice for the diagnosis of breakthrough chicken pox. It was noted that the student lost five days of school, however, no treatment was required for the adverse event of breakthrough chicken pox. The breakthrough chicken pox abated and the student recovered on 5/10/04. There was no product quality complaint reported. Unspecified medical attention was sought. No additional information is expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old male with on previous medical history who on 6/2/98 was vaccinated in the right arm with the first dose of varicella virus vaccine live (lot # 624778/1565E). Illness at the time of vaccination included an ear infection which was treated with azithromycin. The physician reported that on 4/11/04, after being exposed to a cousin who had chicken pox (WAES0404USA02562), the patient developed breakthrough chicken pox characterized by 25 lesions. There was no fever or other complications. Medical attention was not sought and no laboratory/diagnostic tests were performed. Subsequently, in 2004, the patient recovered from the breakthrough chicken pox. No further information is available.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male on 12/10/96 was vaccinated with a dose of varicella virus vaccine live (lot # 617313/0769D). The RN reported that on 5/7/04, the patient developed a chicken pox rash of abut 40 lesions mostly on his torso. No other symptoms were noted. Unspecified medical attention was sought, but treatment was not required. At the time of this report, the outcome was unknown. No further information is available.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 5 year old female with no medical history who on 7/19/99 was vaccinated with a dose of varicella virus vaccine live. The physician reported that on approximately 4/5/04, while visiting relatives, the patient developed a mildly pruritic rash characterized by 13 pink spots on her body. The patient was seen by a pediatrician, but no laboratory/diagnostic tests were performed. On 4/9/04, the patient's rash resolved. No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old male who was vaccinated with a dose of varicella virus vaccine live. The child was seen on 5/8/04 with definite varicella. Per the mother, the child had all childhood immunizations. It was noted that the child was fine and no therapy was needed. The physician did not want to be contacted for follow up. Unspecified medical attention was sought. There was no product quality complaint involved. No further information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 3 year old female who was vaccinated a couple years before with varicella virus vaccine live. Subsequently, the patient came to the office with a mild chicken pox rash, fever, and less than fifty lesions. There was no product quality complaint involved. The reporter also indicated that the patient's sister (WAES0405USA00653) and another male patient (WAES0403USA02431) had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 year old female who was vaccinated a couple of years before with varicella virus vaccine live. Subsequently, the patient came to the office with a mild chicken pox rash, fever, and less than fifty lesions. There was no product quality complaint involved. The reporter also indicated that patient's sister (WAES0405USA00652) and another male patient (WAES0403USA02431) had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Subsequently, about 5 days after receiving the vaccination, the patient developed a rash covering his/her entire body.  The patient was sent to the lab for blood draw, but nobody would draw blood until 4 days later when the rash subsided.  No further information was available.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 1.09
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 7 year old white male who on 03/04/1998 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (Lot#624643/1328E).  There was no illness at the time of vaccination.  On 05/03/2004, the patient presented to the office with chickenpox.  There was no prescription drug treatment required.  There was no relevant diagnostic laboratory tests performed.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No further information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 5 year old male who on 04/05/2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Subsequently in February 2004, the patient experienced breakthrough chickenpox.  It was reported that there was a total of 45 cases of breakthrough in the patient's school, including the patient, and 17 were vaccine recipients.  Unspecified medical attention was sought.  There was no product quality complaint involved.  The reporter indicated that 16 other patients (WAES0403USA00131 and 0405USA00741 through 0405USA00745) had similar experiences following exposure to varicella virus vaccine live (Oka/Merck).  Additional information has bee requested.
Age: 1.13
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who on 12/09/1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot #625047/1574E).  Subsequently in February 2004, the patient experienced breakthrough chickenpox.  It was reported that there was a total of 45 cases of breakthrough in the patient's school, including the patient, and 17 were vaccine recipients.  Unspecified medical attention was sought.  There was no product quality complaint involved.  The reporter indicated that 16 other patients had similar experiences following exposure to varicella virus vaccine live.  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 7 year old female who on 11/24/1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Subsequently in February 2004, the patient experienced breakthrough chickenpox.  It was reported that there was a total of 45 cases of breakthrough in the patient's school, including the patient, and 17 were vaccine recipients.  Unspecified medical attention was sought.  There was no product quality complaint involved.  The reporter indicated that 16 other patients had similar experiences following exposure to varicella virus vaccine live (Oka/Merck).  Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 7 year old male who on 12/10/1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck)(lot#622680/0086E).  Subsequently in February 2004, the patient experienced breakthrough chickenpox.  It was reported that there was a total of 45 cases of breakthrough in the patient's school, including the patient, and 17 were vaccine recipients.  Unspecified medical attention was sought.  There was no product quality complaint involved.  The reporter indicated that 16 other patients had similar experiences following exposure to varicella virus vaccine live (Oka/Merck).  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who on 04/27/2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Subsequently in February 2004, the patient experienced breakthrough chickenpox.  It was reported that there was a total of 45 cases of breakthrough in the patient's school, including the patient, and 17 were vaccine recipients.  Unspecified medical attention was sought.  There was no product quality complaint involved.  The reporter indicated that her sister (WAES # 0405USA00743) had similar experiences following exposure to varicella virus vaccine live (oka/Merck).  Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 7 year old female who on 04/27/2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Subsequently in February 2004, the patient experienced breakthrough chickenpox.  It was reported that there was a total of 45 cases of breakthrough in the patient's school, including the patient, and 17 were vaccine recipients.  Unspecified medical attention was sought.  There was no product quality complaint involved.  The reporter indicated that the patient's sister and 15 other patients had similar experiences following exposure to varicella virus vaccine live (Oka/Merck).
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 10 year old healthy female who on 12/15/1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot#608317/0402B).  The physician reported that on 03/29/2004, the patient experienced breakthrough.  Unspecified medical attention was sought, but no treatment was required. The physician also reported that another patient also developed breakthrough after being vaccinated with varicella virus vaccine live (Oka/Merck)(WAES #0404USA00138).  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of varicella virus vaccine live. The NP reported in April 2004, the patient developed breakthrough chicken pox. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. The NP also reported that another patient developed chicken pox after being vaccinated with varicella virus vaccine live (WAES0405USA00037). Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Immunoglobulins decreased, Rash, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 7 year old white male with IgA deficiency who at one year old was vaccinated with varicella virus vaccine live (0.5ml, SC). There was no illnesses at the time of vaccination. It was reported that now the patient broke out with chicken pox about 100 lesions of which only 12 were vesicular. Unspecified medical attention was sought. No product quality complaint involved. Follow up information received from a licensed practical nurse indicated that on 5/8/04, the patient developed chicken pox of over 150 pox. The patient recovered on 5/13/04. No additional information is expected.
Age: 1.11
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning his 9 year old son with no medical history who on 2/9/96 was vaccinated in the right thigh with the first dose of varicella virus vaccine live (lot # 608582/0410B). There was no concomitant therapy or illness at the time of vaccination. The physician reported that on 4/30/04, his son was diagnosed with chicken pox. The physician noted that it was not a case of breakthrough chicken pox, but was much more severe with his son developing a mild fever and lesions on his trunk and genital area. The patient was treated with Acyclovir and subsequently recovered from the chicken pox. The physician also reported that eight other children in his son's school also developed chicken pox after being vaccinated with varicella virus vaccine live. Additional information is not expected.
Age: 1.15
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old white male patient with an allergy to penicillin who was vaccinated in the left thigh on 3/22/99 with a first dose of varicella virus vaccine live (lot # 628522/1843H). On approximately 5/12/04, earlier this week, the patient developed a chicken pox like rash. There were no other symptoms. There was no treatment required. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information received from a registered nurse indicated that on 5/11/04 the patient developed red dots and white pustules. The mother had called the office and indicated that her other children had chicken pox prior, and it looks same. The patient was not seen by the physician, but was advised to keep home until lesions crusted over. No fever was noted. The outcome was reported as recovered. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning an adult patient who was vaccinated with two doses of varicella virus vaccine live and has not seroconverted. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.