chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.37
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Hypokinesia, Pain, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a healthy 9 year old male with no prior history of clinical chicken pox and no allergies who on 10/14/96 was vaccinated in the right arm with a dose of varicella virus vaccine live (lot # 617264/0565D). Concomitant medication included ibuprofen. It was noted that no rash occurred at the site of injection post vaccination. Subsequently, the patient developed herpes zoster (onset unspecified) which was reportedly described as a very painful zoster on his arm and shoulder. The pain was so severe that the patient's arm was in a sling. The patient was scheduled to be seen by his physician on 7/1/04. The physician noted that a lesion specimen would be submitted for polymerase chain reaction analysis. Additional information was received from a physician who indicated that the patient developed herpes zoster. It was described as a shingle-type rash with 50 to 100 lesions on the right arm, forearm, thumb, and second finger. A specimen from a vesicular lesion was obtained on 7/1/04 and was sent to a laboratory for varicella zoster virus identification on 7/7/04. It was noted that the patient had no recent exposure to chicken pox or shingles. Subsequently, the patient recovered and at the time of the report was doing well. Additional information was received which indicated that the specimen arrived at the laboratory on 7/8/04. The result from the varicella zoster viral identification polymerase chain reaction test indicated that it was an adequate specimen and was vaccine strain varicella zoster virus. B-globin DNA was not amplified. Upon internal review, herpes zoster was determined to be other important medical event (OMIC). Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Blister, Pruritus, Rash, Skin ulcer
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 4 year old male patient with no allergies or medical history who on 5/25/01 was vaccinated with a first dose of varicella virus vaccine live (lot # 637979/1899K). Concomitant vaccination on the same day included a first dose of MMR (lot # 638512/0165L), a fourth dose of HIB conjugate vaccine (lot # 637878/1414K), and a third dose of poliovirus vaccine inactivated (lot # T0624). Illness at the time of vaccination included a runny nose. The patient was noted to be on amoxicillin at the time of vaccination. On 6/30/04, the patient developed breakthrough chicken pox. On 7/1/04, the patient was examined in the physician's office and had only two of the classic vesicular lesions, the rest were diffuse mosquito bite-like lesions all over his body. The patient was generally itchy and afebrile. There was no treatment and the adverse event did not abate. The patient was not recovered at the time of the report. A product quality complaint was not involved. Follow up information was received from a licensed visiting nurse who indicated that on 6/30/04 in the PM, the patient had papular and vesicular lesions in various stages scattered over the trunk and extremities and itching. Subsequently, the patient recovered on 7/8/04. No diagnostic laboratory tests were performed. The patient had no adverse events following prior vaccination. No further information is expected.
Age: 1.56
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male patient who in January 2001 was vaccinated with a first (lot # 631778/1353J) and second (lot # 636568/0925K) dose of varicella virus vaccine live. On approximately 5/9/04, the patient experienced an outbreak of chicken pox. At the time of the report, the patient had not been seen by the physician and no treatment was ordered. There was no product quality complaint involved. The nurse also reported that the patient's older brother (WAES0405USA01259) also experienced chicken pox following exposure to varicella virus vaccine live. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Pruritus, Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 9 year old female with reactive airway disease who was vaccinated with a dose of varicella virus vaccine live (lot 1285J). Concomitant therapy included montelukast sodium. On 7/2/04, the patient presented to the office with a rash on her torso hands and face that was itchy. Diphenhydramine HCl was prescribed. On 7/6/04, the mother reported that the child had a headache and a low grade fever over the weekend. She also had 3 vesicular lesions on her face, 4 on her head, 20 on her torso and a few on her feet and legs. Medical attention was sought. No product quality complaint was involved. Follow up information indicated that on 7/2/04, there was a rash on the torso that was suspected varicella. There were 3 lesions on the face, 4 in her hair, 20 on her torso, and a few on her feet. She was seen by a physician and treated with diphenhydramine HCl. No labs were done. This event resolved spontaneously on 7/8/04. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Erythema, Pruritus, Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 10.5 year old male with asthma and a penicillin allergy and no other pertinent medical history who in March 1998, was vaccinated with a dose of varicella virus vaccine. Concomitant vaccination that day included a second dose of MMR. On 6/29/04 the patient broke out in an itchy rash and presented to the doctors office on 7/6/104. The child had red vesicles on his arm, left leg, back of neck and lower abdomen in all stages of development. It was reported that symptomatic treatment would be given as needed until all vesicles crusted over. It was unknown if labs were performed and it was reported that the child was recovering with sequelae. No product quality complaint was involved. Follow up information from a nurse indicated that the patient was seen on 7/6/04 with a one week history of an itchy rash that began on 6/27/04. On exam, he had discrete erythematous vesicles on the right lower extremity, back, neck and lower abdomen in various stages of healing. He was sent home for symptomatic treatment and told to isolate until all lesions were crusted over. The patient was seen for an asthma exacerbation on 7/27/04 and the chicken pox was cleared. No diagnostic laboratory tests were performed. No further information is expected.
Age: 1.29
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a woman in a medical office concerning a 27 month old female patient with no allergies and no past medical history who on 2/5/03 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 640556/0258M). Concomitant vaccination on 2/5/03 included a third IM dose in the left arm of HIB conjugate vaccine. Concomitant vaccination on 2/24/03 included a first SC dose in the right arm of MMR (lot # 641722/0127M) and a fourth IM dose in the left arm of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (lot # 491193). There was no illness at the time of vaccination. On 2/11/04, the patient developed chicken pox. Medical attention was not sought. Subsequently, the patient recovered. The reporter also mentioned five other patients who developed chicken pox post vaccination with varicella virus vaccine live (WAES0407USA00539, 0407USA00540, 0407USA00542, 0407USA00544, and 0407USA00548). Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a woman in a medical office concerning a 8 year old white female patient who on 6/4/98 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 625047/1574E). On 5/3/04, the patient developed chicken pox. Medical attention was not sought. Subsequently, the patient recovered. The reporter also mentioned five other patients who developed chicken pox post vaccination with varicella virus vaccine live (WAES0407usa00537, 0407USA00540, 0407USA00542, 0407USA00544, and 0407USA00548). Additional information is not expected.
Age: 1.49
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a woman in a medical office concerning a 5 year old male patient who on 9/7/00 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live. On 4/24/04, the patient developed chicken pox. Medical attention was not sought. Subsequently, the patient recovered. The reporter also mentioned five other patients who developed chicken pox post vaccination with varicella virus vaccine live (WAES0407USA00537, 0407USA00539, 0407USA00542, 0407USA00544, and 0407USA00548). Additional information is not expected.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a woman in a medical office concerning a 36 month old female patient who on 4/11/02 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot # 641267/1294L). On 4/22/04, the patient developed chicken pox. Medical attention was not sought. Subsequently, the patient recovered. The reporter also mentioned five other patients who developed chicken pox post vaccination with varicella virus vaccine live (WAES0407USA00537, 0407USA00539, 0407USA00540, 0407USA00544, and 0407USA00548). Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a woman in a medical office concerning a 10 year old male patient who on 6/29/95 was vaccinated with a dose of varicella virus vaccine live. On 4/12/04, the patient developed chicken pox. Medical attention was not sought. Subsequently, the patient recovered. The reporter also mentioned five other patients who developed chicken pox post vaccination with varicella virus vaccine live (WAES0407USA00537, 0407USA00539, 0407USA00540, 0407USA00542, and 0407USA00548). Additional information is not expected.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a woman in a medical office concerning a 43 month old male with Williams' syndrome who on 9/27/01 was vaccinated SC in the right leg with a first dose of varicella virus vaccine live. In April 2004, the patient developed chicken pox. Medical attention was not sought. Subsequently, the patient recovered. The reporter also mentioned five other patients who developed chicken pox post vaccination with varicella virus vaccine live (WAES0407USA00537, 0407USA00539, 0407USA00540, 0407USA00542, and 0407USA00544). Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse with a public health department concerning a female student who on 6/18/04 was vaccinated with a dose of varicella virus vaccine live. The registered nurse reported that she was told by another schools' school nurse, that a female student developed a vesicular rash around her nipple. It was unknown as to whether the patient sought medical attention. There was no product quality complaint reported. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old white female patient who on 6/29/04 at 10:15 AM was vaccinated SC once with a 0.5ml first dose of varicella virus vaccine live (lot # 648042/1344N). Concomitant vaccine administered at 10:15 AM on the same day 6/29/04, included a SC first dose of MMR (lot # 646886/0949N). On 7/1/04, in the AM, the patient developed vesicles on her hands and she was taken to the physician's office for examination. It was noted that the patient had four lesions on each hand and more lesions continued to appear on her abdomen and trunk while she was in the office. The physician diagnosed her with a mild case of varicella. There was no fever. No treatment was required. It was noted that therapy was not discontinued. There was no product quality complaint reported. Follow up information received from a registered nurse reported that the patient recovered. No additional information is expected.
Age: 38.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Contusion, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a emergency medical technician concerning a 38 year old female with a penicillin allergy and no other known medical history who on 7/2/04 at12:45 PM was vaccinated SC in the right upper arm with 0.5ml first dose of varicella virus vaccine live (lot # 645288/0689N). Concomitant vaccination at the same time included a SC dose in the left upper arm of MMR (lot # 647276/0963N), and an IM dose in the left deltoid of diphtheria toxoid (+) tetanus toxoid (lot # TD104). She also had a tuberculin purified protein derivative applied on the same day. There was no illness at the time of vaccination. On 7/5/04, the patient experienced a warm spot at the injection site. The spot was 8cm in size and was red and bruised, not raised or painful. The reporter also noted that the patient experienced a reaction to the tuberculosis skin test which appeared as a 50mm raised mark with clearly defined borders with a 22mm centrally located and raised mark. The next vaccine administration of varicella virus vaccine live had been cancelled on the recommendation of the physician. The area was treated with ice and pain relievers were recommended on an as needed basis. The patient did not actively seek medical attention but was returning for a routine check of a tuberculosis skin test site. No diagnostic laboratory tests were performed. At the time of the report the patient had not recovered. A product quality complaint was not involved. Follow up information was received from the emergency medical technician who indicated that the patient is a healthy woman from another country who came to the physician's office for a required physical exam (which was normal) and an immunization update in order to get a permanent resident card. When the patient returned to the physician's office to have her tuberculin test read, she had a large area (80mm in diameter) of warm erythema at the site of the varicella virus vaccine live injection. It was not painful or pruritic and she had no other symptoms. She had no known prior history of chicken pox, shingles, or vaccination for either. It was noted that the tuberculin test was strongly positive at 22mm induration. There was 50mm of erythema surrounding the indurated area. A chest x-ray was negative. The reaction subsided over the following week and the patient recovered. The patient had no adverse events following prior vaccination. No further information is expected.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient who on 5/12/03 was vaccinated on the left side with a dose of varicella virus vaccine live (lot # 641599/0204M). Concomitant vaccines that day included a dose of MMR and a dose of HIB conjugate vaccine. Subsequently, the patient developed shingles on the right side of the groin, lower hip and buttocks. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old white female patient who on 12/15/98 was vaccinated SC in the left arm with a 0.5ml first dose of varicella virus vaccine live (lot # 627875/1245H). On 6/30/04, the patient developed chicken pox and the mother called the medical office to report the outbreak of chicken pox. Unspecified medical attention was sought, but the medical office did not see the patient in person to confirm anything. It was noted that therapy with varicella virus vaccine live was discontinued. The patient's sibling had chicken pox the week before this report. A product quality complaint was not involved. Follow up information from the nurse indicated that on 6/30/04, chicken pox disease was suspected post exposure to her sister (WAES0409USA00474) who had chicken pox. No complications were noted for the patient. The patient was not seen in the office for a diagnosis. Subsequently, the patient recovered. No further information is expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female who on 3/16/01 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. On 7/8/04, it was reported to the physician's office that the patient developed breakthrough varicella. Unspecified medical attention was sought. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. No further information was available. The nurse also reported that the patient's female sibling had a similar experience after therapy with varicella virus vaccine live (WAES0408USA00470).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Agitation, Insomnia, Medication error
Clinical narrative: Information has been received from a consumer his 5 year old son with no allergies or medical history who on 7/6/04 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot # 641987/1018N). Concomitant vaccination on the same day included a second SC dose in the right arm of MMR (lot # 646738/0819N), a fifth IM dose in the left arm of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid (lot # C1354BA), and a fourth SC dose in the left arm of poliovirus vaccine inactivated (lot # W1619). The reporter indicated that the patient received varicella virus vaccine live that was exposed to temperatures above recommended. He also reported that on 7/7/04 the patient was experiencing sleeplessness and appeared edgier than usual. No medical attention was sought and no treatment was required. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information was received from a registered nurse who indicated that the varicella virus vaccine live had been previously exposed to higher than recommended temperatures. The vaccine received on revised use by date and was past the revised use by date, but not past the expiration date. Follow up information was received from the registered nurse who indicated that she was not aware of any adverse event. She notified the patient's father that the vaccine was administered past the use by date and needed to be repeated after 8/6/04. The father was concerned about this affect on his child. The vaccine had an earlier use by date than assigned expiration date. No further information is expected.
Age: 1.11
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Rash, Rash pruritic, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning an 18 month old male with eczema and no known allergies who on 1/27/04 at 9 AM was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live. Concomitant vaccination included a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (lot # 495033) given IM in the right thigh. There was no illness at the time of vaccination. On 7/1/04, the patient developed an itchy rash which started as small bump over a few days and became larger with a head. No chicken pox exposure was known. He was seen in the office and diagnosed with chicken pox. He had approximately 15-20 lesions on his legs, arms, and face and none on his palms or soles. He was advised symptomatic treatment, isolate till lesions were crusted over and to call PRN with signs and symptoms of illness. on 7/8/04 the nurse reported that the patient was recovering. No adverse events following prior vaccination were known. There was no product quality complaint. Follow up information from the nurse indicated that the physician has seen the patient since his chicken pox and the child was doing fine. No further information is expected.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician's assistant concerning a female who on 11/2/98 and in May 2001, was vaccinated with the first and second doses of varicella virus vaccine live. A titer was drawn on 6/5/01 indicated that the patient failed to seroconvert. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that another patient failed to seroconvert (WAES0407USA01108). Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 9 year old female who was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Four to five days after vaccination, the patient experienced a pretty healthy case of chicken pox. It was described as a rash with greater than 50 lesions. Unspecified medical attention was sought, but no treatment was required. No product quality complaint was involved. Additional information has been requested.
Age: 1.49
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a woman at a physician's office concerning a 6 year old white female child with no pre-existing medical conditions, who on 8/19/99 was vaccinated with a first dose of varicella virus vaccine live. The patient was not ill at the time of vaccination. The reporter noted that the patient's mother called the physician's office and reported that yesterday, on 7/7/04, the patient developed a rash on her trunk and is covered with vesicles. It was noted the patient did not visit the physician's office. The patient's mother also reported that the child's best friend has chicken pox. Follow up information was received from a woman in the physician's office who reported that the patient recovered on 10/26/04. No additional information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician's assistant concerning a female who on 11/2/98 and in 12/2/98, was vaccinated with the first and second doses of varicella virus vaccine live. A titer drawn on 6/2/04 indicated that the patient failed to seroconvert. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that another patient failed to seroconvert (WAES0407USA00982). Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash papular, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 23 month old male patient who on 11/20/03 was vaccinated IM in the right thigh with a dose of varicella virus vaccine live (lot # 646230/0541N). On 7/13/04, the patient presented with a mild zoster like rash under his left arm. No other symptoms were noted. Unspecified medical attention was sought, but treatment was not required. PCR testing was offered, but declined. At the time of the report, the rash was crusted over and healing. A product quality complaint was not involved. Follow up information from the physician indicated that the patient was seen in the clinic on 7/13/04 with multiple papular and vesicular lesions in his axilla along T1 dermatome, which started on 7/9/04. The patient was diagnosed with  herpes zoster. Subsequently, the patient developed similar lesions on his left axilla, same dermatome and a couple other lesions in other areas which was diagnosed as chicken pox. The patient was treated with Acyclovir for 5 days. The lesions cleared but the patient developed a few lesions on his abdomen. The diagnosis was then changed to impetigo and lesions were treated with mupirocin. No further information is expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning the 8 year old daughter of a physician who on 3/20/97 was vaccinated SC with a dose of varicella virus vaccine live (lot #621201/0082E). The RN reported that on 7/12/04, the physician diagnosed her daughter with varicella characterized by more than 100 lesions with itching, but no fever. The patient was treated with Acyclovir (400mg, 1.5 tablet QID) and diphenhydramine HCl. Subsequently, the patient recovered from the varicella. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Pharyngolaryngeal pain, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 3 year old female patient who was previously vaccinated with varicella virus vaccine live. The physician reported that recently, within the past week or two (July 2004) the patient developed a sore throat and had a breakthrough of a mild case of chicken pox with only two or three lesions. No other information was provided. It is unknown as to whether the chicken pox breakthrough and sore throat abated. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.97
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old white male with no allergies or medical history who on 3/18/97 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 621065/1543D). There was no concomitant medication. On 7/9/04, the patient experienced lesions on most of body, especially the shoulders, chest, and back. He was noted to be afebrile. Unspecified medical attention was sought and he was treated with calamine (+) camphor (+) praxomine hydrochloride baths and diphenhydramine hydrochloride. A product quality complaint was not involved. Follow up information was received from the registered nurse who indicated that the father called the physician's office stating that the patient had chicken pox on 7/12/04. The mother brought the patient to the physician's office on 7/13/04 to confirm chicken pox. It was noted that the adverse event began on 7/9/04. The chicken pox was resolving as of 7/16/04. It was also noted that the patient recovered. No diagnostic laboratory tests were performed. The patient had no adverse events following prior vaccination. No further information is expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia, Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a nurse at a physician's office and follow up was received from the physician concerning a 5 year old white male patient with a history of recurrent ear infections, who was vaccinated with varicella virus vaccine live. On 4/20/04 the patient was brought to the office for the first time by the father and was seen by the physician. The patient had a few lesions to the right lower extremity, which were described as vesicles on an erythematous base. As per the patient's father the patient had lesions to the face and chest and also had a temperature of 102 on the day prior to the examination at the physician's office. In the physician's office the patient's temperature was 100. The physician diagnosed the infection as suspected breakthrough varicella. Otherwise, the patient appeared alert, in no apparent distress and well hydrated. He was treated with Aveeno oatmeal baths and diphenhydramine. The patient was instructed not to return to school until the lesions crust over. It was reported that the patient did well. There was no other information regarding the date of vaccination, however, according to the father, the patient was vaccinated with varicella virus vaccine live. No laboratory tests were done. There was no product quality complaint reported. Additional information has been requested. The nurse also mentioned another patient, a 23 month old female who had a similar experience following vaccination with varicella virus vaccine live (WAES0407USA01555).
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male patient who on 4/2/01 was vaccinated SC in the left arm with a second 0.5cc dose of varicella virus vaccine (lot # 637668/1607K) (first dose given post 1 year of age). There was no concomitant therapy. On 6/21/04, the mother noticed the patient was very tired and was not playing much. On 7/22/04, the patient awoke with approximately ten small raised red spots. Some of the spots looked blister-like. Within about two hours, approximately five to ten more spots appeared, which were blister-like on a red base. Chicken pox was verified in the office. Symptomatic care was discussed and when to call the office back. On 7/4/04, the patient recovered. Additional information is not expected.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Irritability, Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning his 4 year old white son who on 1/19/01 was vaccinated at 1 year of age with a first dose of varicella virus vaccine live (lot # 632387/1238K). There was no illness at the time of vaccination. Concomitant therapy included cetirizine hydrochloride syrup. Subsequently, on 6/1/04 at 9:00 AM, the patient developed chicken pox. It was noted that the child was exposed to his cousin (non-vaccinated) who had a full blown case of the chicken pox. The child had a total of 12 pox and a low grade fever. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a physician indicated that the patient developed 14 vesicles that progressed through typical stages. He was also noted to have a fever to 102 degrees and was irritable. The outcome was reported as recovered. There were no relevant diagnostic tests or laboratory data. No further information is expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Viral infection
Clinical narrative: Information has been received from a consumer, the patient's mother, concerning her 4 year old son who on 7/9/01 was vaccinated with a dose of varicella virus vaccine live. The consumer reported that on 7/14/04 the patient developed a case of chicken pox. It was noted that the patient has red sots over his trunk both front and back and some of the spots have yellowish heads. The patient is using diphenhydramine hydrochloride to treat the itching. It was noted that the patient is doing fine. The lot number was not provided. There was no product quality complaint reported. Unspecified medical treatment was sought. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a female patient, who about a month ago (approximately June 2004) was vaccinated with a dose of varicella virus vaccine live. The physician reported that the patient plans to conceive a child in the near future. The physician had blood work drawn to see whether she had developed chicken pox immunity. The lab results showed that the antibody detection was low and therefore the patient would not be protected if exposed to chicken pox. However, it was noted that there was a disclaimer on the laboratory result sheet which stated that the test may not detect vaccine acquired antibody levels, just natural exposure immunity. The physician noted that the patient did not receive the vaccine at their office so he did not have a lot number. There was no further information provided regarding the adverse event. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female who on 4/16/97 was vaccinated SC in the right arm with a first dose varicella virus vaccine live (lot # 621073/0083E). In approximately July 2004, the patient had a negative titer of 0.31 (0.90 or greater is considered a positive titer for this lab). Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved. Follow up information was received from a physician who indicated that the patient was negative for immunity when titers were drawn on 7/9/04. No further information is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a nurse practitioner concerning a male who in March 2004, was vaccinated with a dose of varicella virus vaccine live.  The nurse practitioner reported that on 07/15/2004, the patient developed full blown chickenpox.  Unspecified medical attention was sought, but no treatment was required.  Subsequently, the patient recovered.  Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a licensed practical nurse concerning a 41 year old female patient with an allergy to acetaminophen, diphenhydramine hydrochloride, reported as developing itchy palms and no other pertinent past medical history who on 08/12/2003 at 12:00PM was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live.  On 10/17/2003 a laboratory test, VZV AB (IGM), EIA was performed and resulted 0.17 and a VZV AB (IGG), EIA resulted 0.35; both of which were negative.  On 10/22/2003 at 12:00PM she was vaccinated subcutaneously in the right arm with a second dose of varicella virus vaccine live.  On 07/15/2004 a VZV AG (IGG), EIA resulted negative at 0.41, no VZV IgG antibody was detected.  It was noted that the patient was not ill at the time of vaccination.  The reporter indicated that the patient failed to seroconvert.  A pre-vaccination titer VZV AB (IGG) on 10/17/2003 and HB S AB on 07/15/2004.  A product quality complaint was not involved.  Unspecified medical attention was sought.  No additional information is expected.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 6 year old white female with no medical history who on 12/02/1998 was vaccinated in the right thigh with a dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  The physician reported that on 04/14/2004, the patient developed vesiculopapular lesions.  It was unknown if medical attention was sought.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a physician concerning an adult male patient in his thirties, who, a couple weeks ago (approximately July 2004) was vaccinated with a dose of varicella virus vaccine live.  The physician noted that on 07/16/2004 the patient developed about 20 varicella like lesions on his trunk.  There was no other information available regarding the lot number.  There was no treatment required for the varicella like lesions and no product quality complaint was reported.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 0.93
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash
Clinical narrative: Information has been received from a physician concerning patients who were vaccinated with doses of VARIVAX (Merck) since 1996.  She has logged about 45 cases of breakthrough varicella in the patients.  It was reported that medical attention was sought, all cases had less than 50 lesions, none had to be treated or hospitalized and all recovered.  No product quality complaint was involved.  Additional information has been received from the physician concerning one of the patients.  It was reported that a 12 month old patient was vaccinated on 07/01/1997 with a dose of VARIVAX.  On 08/14/1997 the patient experienced varicella.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a patient who on 12/09/1996 was vaccinated with a dose of varicella virus vaccine live.  The physician reported that on 10/30/1997, the patient presented to the office with chickenpox characterized by less than 50 lesions.  Treatment was not required.  At the time of this report, the outcome was unknown.  The physician also reported that three other patients developed chickenpox after being vaccinated with varicella virus vaccine live.  Additional information is not expected.
Age: 0.73
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: on has been received from a licensed practical nurse concerning a 9 year old male with no known medical history who in 1996 was vaccinated with a dose of varicella virus vaccine live.  There was no concomitant medication.  On 07/16/2004 the patient was brought into the physician's office with a mild skin rash which started on 07/16/2004 and was reported to be chickenpox.  The patient was being treated with calamine lotion.  At the time of the report the patient had not recovered.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLU3, HEP, VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 27 year old caucasian female patient in human resources with no allergies and oral herpes who on 11/03/2003 abd 12/03/2003 was vaccinated subcutaneously in the arm with a first and second dose of varicella virus vaccine live, respectively.  Concomitant vaccination on 12/03/2003 included an intramuscular dose of influenza virus split virion 3v vaccine inactivated (Fluzone) and an intramuscular dose of hepatitis B virus vaccine rHBsAG.  Previous vaccination on 11/03/2003 included an intramuscular dose of hepatitis B virus vaccine rHBsAG.  There was no illness at the time of vaccination.  On 07/13/2004, an IgG EIA titer was 0.25.  The reporter stated that patient failed to serconvert and indicated non for adverse events.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a nurse at a physician's office and a physician concerning a 23 month old white female patient with no pre-existing allergies or medical conditions, who on 07/01/2003 was vaccinated subcutaneously in the right leg with a first dose of varicella virus vaccine live.  Other vaccines administered concomitantly on 07/01/2003 included a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live administered subcutaneously in the left leg and a third dose of poliovirus vaccine inactivated, administered subcutaneously in the right leg.  The patient was not ill at the time of vaccination and did not have adverse events following prior vaccination.  On 05/24/2004, the patient developed fever, followed by vesicular/pustular lesions on her buttocks, abdomen, arms, legs, oropharynx.  On 05/25/2004 the patient was seen in the physician office and was suspected to have a breakthrough varicella infection.  The lesions were reported to be in multiple stages of healing.  The physician noted possible attentuated varicella as it was 10 months post vaccination.  It was unknown as to whether or not treatment was required.  The patient recovered.  There was no product quality complaint reported.   No additional information is expected.  The nurse also mentioned another patient, a 5 year old male who had a similar experience following vaccination with varicella virus vaccine live.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live.  On approximately 06/15/2004, the patient presented to the physician with breakthrough chickenpox.  A product quality complaint was not involved.  The reporter also mentioned a second patient who developed chickenpox post vaccination with varicella virus vaccine live.  Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Blister, Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 21 month old white female patient with a pre-existing medical condition of Asthma and no other medical history, who on 10/10/2003 at 13:40PM was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live.  Concomitant vaccine therapy administered at 13:40PM was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live.  Concomitant vaccine therapy administered at 13:40PM on 10/10/2003, included a fourth dose of pneumococcal vaccine, administered intramuscularly in the right thigh.  On 07/06/2004 in the AM the patient developed a rash.  She was seen in the physician's office on 07/16/2004 with a one week history of rash.  On examination she had 2 discrete vesicles on her abdomen and crusting numerous macules/small vesicles at various stages on her chest, abdomen, and back.  The patient was positive for itch.  The physician diagnosed chicken pox.  She was discharged from the physician office to home and instructed to isolate until lesions crusted and symptoms resolved.  The patient was also instructed to follow up as needed.  There were no laboratory or diagnostic tests performed.  The patient did not have adverse events following prior vaccinations and she was without lesions at the time of vaccination.  The patient recovered on 07/23/2004.  No additional information is expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Irritability, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female patient with no known drug allergies and no pertinent past medical history who on 07/20/2004 was vaccinated in the left thigh with a dose of varicella virus vaccine live.  Immediately post vaccination on 07/20/2004, a bilateral rash appeared.  The rash was blotchy and spread upwards towards the buttocks.  On 07/20/2004, the patient became cranky.  Unspecified medical attention was sought.  The patient was treated with oral diphenhydramine hydrochloride.  Laboratory tests were not performed.  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective
Clinical narrative: Information has been received from a medical assistant concerning a 25 month old white male with an amoxicillin clavulanate potassium allergy who on 05/13/2003 was vaccinated subcutaneously in the right thigh with the first dose of varicella virus vaccine live.  Concomitant vaccinations on that same day included the first dose subcutaneously in the left thigh of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  The MA reported that on 07/11/2004, the patient was seen developed chickenpox like rash characterized by a few spots on his abdomen.  On 07/12/2004, the patient was seen in the medical office with spots on his abdomen, legs and face with papules many with a rose petal patch.  The patient was noted to be afebrile and had no itching.  Treatment was not required.  It was also noted that the patient's brother had shingles three months prior.  In 07/2004,  7-10 days after onset, the patient's chickenpox like rash resolved.  Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective
Clinical narrative: Information has been received from a nurse concerning a 3 year old male patient who on 03/12/2002 was vaccinated with a dose of varicella virus vaccine live.  On 07/18/2004, the patient developed more than fifty varicella lesions on his chest and legs.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a nurse concerning an 18 month old male who in January 2004, was vaccinated subcutaneously with 0.5 ml dose of varicella virus vaccine live.  The nurse reported that in 2004 the patient developed 2 big lesions on his trunk and several small ones.  The patient was noted to be afebrile.  Unspecified medical attention was sought, but no treatment was required.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTP, HEP, VARCEL
Symptoms: Anorexia, Cough, Rash, Rhinorrhoea, Viral infection
Clinical narrative: Information has been received from a  consumer concerning her healthy 27 year old grandson who on 7/9/04 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination included hepatitis B virus vaccine and diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. On 7/19/04, the patient developed spots. The child also had loss of appetite, a nasal discharge and a non-productive cough. The grandmother reported that he was still developing spots and was falling down more than usual. Unspecified medical attention was sought and no treatment was required. Information from the physician's office indicated that the mother of the child called and only reported that the patient had a chicken pox rash after varicella virus vaccine live vaccination. There was no product quality complaint involved. Additional information has been requested.
Age: 1.24
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a health department nurse concerning a 5 year old female who on 3/1/00 was vaccinated with a dose of varicella virus vaccine live (lot # 631775/1032J). The nurse reported a case of break through varicella between May and July 2004. The case appeared mild. It was unknown if medical attention was sought or if treatment was required. A product quality complaint was not involved. Follow up information was received from the nurse who reported that in late spring of 2004, in approximately June 2004, the patient developed varicella after being exposed at her day care to an infectious, unvaccinated 5 year old male child who had a fever and greater than 100 lesions and vesicles on his face, chest, back, arms, and legs. The patient's mother stated that the varicella was mild with about 15 lesions and no fever. The varicella lasted a few days and the patient recovered. The nurse reported that there were no adverse experiences related to vaccine, but rather evidence that the vaccine prevented the child from developing a severe case of varicella. No further 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 a dose of varicella virus vaccine live. The reporter stated the patient received two doses of varicella virus vaccine live and had a negative titer. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.