chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection, Pruritus
Clinical narrative: Information has been received from a RN concerning a 9 year old Caucasian male pt with no allergies and no past medical history who on 09/09/96 was vaccinated with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination.  Subsequently, the pt was exposed to chickenpox and had a "chickenpox break through".  On 09/26/03, the pt presented to the MD's office with a "3 day rash", which included an itchy and scaby lesion on the left arm, one vesicle on the left arm, one umbilicated lesion on the nose and several other scattered, crusty lesions, also described as small crusts, but no fever. Varicella was noted with an onset of 09/26/03. Lab tests were not performed. The pt was treated with Benadryl and calamine as needed. Subsequently, the pt recovered and returned to school. A product quality complaint was not involved. The reporter also mentioned a second pt who developed chickenpox post vaccination with varicella virus vaccine live (WAES # 0310USA00361).  Additional information is not expected.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 14 month old male who on 09/04/03 was vaccinated with a dose of varicella virus vaccine live (Lot # 644719/0016N).  On 10/03/03 the pt presented to the physician's with about 50 vesicular lesions. No other symptoms were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a LPN concerning a 7 year old female with an allergy to Vantin and no pertinent past medical history who on 10/31/97 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (Lot # 622749/0544E).  There was no concomitant medication. On 09/03/03 the pt developed an undocumented number of lesions on the chest, abdomen, and legs. The pt was treated with topical "Alveeno", oral Benadryl and oral Tylenol. The reporter indicated that the pt is "now" recovered. Unspecified medical attention was sought and treatment was required. A product quality complaint was not involved. Follow up was received from the LPN which indicated that no further information is available. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received form a consumer concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed chickenpox. Medical attention was not sought. A product quality complaint was not involved. Additional info has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. On approximately 29SEP2003, the patient developed a full case of chickenpox. No information about lot number, medications, age, gender, medical history, treatment, or outcome was given. Unspecified medical attention was sought. There was no product quality complaint. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a five or six year old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt had a breakthrough of chickenpox with approximately forty lesions. Unspecified medical attention was sought. There was no product quality complaint involved. No other information was provided. Additional info has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received on 07OCT2003 from an elementary school licensed practical nurse concerning an approximately 7 year old male who on 22APR1998 was vaccinated with varicella virus vaccine live. Subsequently, "within the last month,"the patient developed chicken pox. The pt sought unspecified medical attention.  It was also reported that five other children also developed chicken pox through WAES 0310USA01248). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a school nurse concerning a female child with no known medical history or allergies who in 1999 was vaccinated with varicella virus vaccine live. The lot number was not available because the child was not vaccinated at school. On approximately 16SEP2003, the patient developed chickenpox which was described as mild with 30-50 lesions on the her trunk and under her arms. Unspecified medical attention was sought and there was no product quality complaint involved. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Pruritus
Clinical narrative: This is a 44-year-old female who received a Yellow Fever vaccination on 04/29/2004. She relates that she had no difficulty with the vaccination initially.  She did not notice any difficulty until 05/03/04 when after showering she noticed that the injection site area was red, inflamed, warm to touch and itchy. She denies any reaction to prior vaccinations, including yellow fever. She denied any nausea, vomiting, diarrhea, fever, or chills. She denies any numbness, tingling or sensory changes in the left upper extremity. She prevents for evaluation of her adverse event.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a registered nurse RN concerning a 6 year old female who on 24SEP2002 was vaccinated SC with a dose of varicella virus vaccine live. The RN reported that on 07OCT2003, the patient developed a severe case of chickenpox characterized by a slight fever and a high number of lesions that started on her neck and soon spread to her whole body. At the time of this report, the patient had not sought medical attention and her chickenpox persisted. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Urticaria, Viral infection
Clinical narrative: Information has been received from the grandmother of a female pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, she developed hives and 2 weeks later developed chickenpox. Unspecified medical attention was sought. It was noted that the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ascites, Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 36 month old white female who on 26NOV2001 was vaccinated in the right arm with a first dose of varicella virus vaccine live. Concomitant vaccination the same day included a first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live given in the left arm. There was no illness at the time of vaccination. On 08SEP2003 the patient developed a mild case of chickenpox. It was reported that the rash lasted 3-4 days. It was reported that the pt was previously vaccinated with hepatitis B virus vaccine rHBsAg + Hib conj vaccine, penumococcal  conj vacine (PREVNAR), polio virus vaccine inactivate VERO (IPOL) and diphtheria toxoid + pertussis acellular 3-component vaccine + tetanus toxoid (INFANRIX). No further information is available.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 9 year old white male who on 08AUG2003 was vaccinated in the left arm with a first dose of varicella virus vaccine live. The pt's mom called the drs office to report that the pt subsequently developed 30 lesions on his body . Subsequently, the pt recovered. Additional info. has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Lymphadenopathy, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 12 month old white female with no known allergies or medical history who on 16SEP2003, at 9:30, was vaccinated in the left thigh with the first dose of varicella virus vaccine live. Illness at the time of vaccination included symptoms of an upper respiratory infection. The physician reported on 29SEP2003, at 9:15, the pt developed multiple vesicular lesions on her head and trunk, a low grade fever of 100 degrees, a decreased appetite and occipital adenopathy. On 30SEP2003. the pt was seen by a physician and received symptomatic treatment for her events. On 07OCT2003, the pt's multiple vesicular lesions and occipital adenopathy resolved. At the time of this report, the outcome of the pt's decreased appetite and low grade fever was unknown. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a woman in a physician's office concerning a 12 year old white female who on 23MAY1995, was vaccinated with a dose of varicella virus vaccine live. It was reported that on 15AUG2003, the pt developed chickenpox. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a consumer concerning her 8 year old son who on 17JAN1996 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included montelukast sodium and cetirizine hydrochloride, Zyrtec. On 19SEP2003 the pt broke out in chickenpox. He was taken to a clinic on 20 SEP2003. On 22SEP2003, the pt was seen by another physician who diagnosed the pt as having chickenpox. The pt also developed an infection around the pox on his chest and was treated with an antibiotic. as of 08OCT2003, "the pt recovered and was now back in school". There was no product quality complaint involved. Follow up information from the health care professional indicated that the pt got active chickenpox in the fall of 2003. He had been vaccinated at 12-13 months of age. No unusual reaction to the vaccine and no serious chickenpox was reported. The reporter also indicated that the pt's brother had a similar experience following exposure to varicella virus vaccine live. No further info is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a child pt who in mid August 2003 was vaccinated with a dose of varicella virus vaccine live. On approximately 07OCT2003, the pt developed a vesicular rash of more than 50 lesions over the body. Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved.  Additional info has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Haematoma, Unintended pregnancy
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received through the manufacturer  pregnancy registry from a 21 year old female with no pertinent medical history who on 11AUG2003 was vaccinated SC with a dose of varicella virus vaccine live while unknowingly pregnant. There was no concomitant medication. The vaccine was vaccine administered on 11AUG2003 and the pt discovered that she was pregnant on 22AUG2003. The pt reported that she has suffered no personal side effects. She indicated that she intends to reschedule a revisit with her physician. No other information was provided. Unspecified medical attention was sought. There were no product quality complaint. Follow up information received from a consumer indicated that there was no local reaction at the vaccination site, no varicella symptoms post vaccination, and no herpes zoster symptoms post vaccination. On 24SEP2003 and 07NOV2003, routine ultrasounds were within normal limits. A follow up 20 week scan was ordered. On 28OCT2003, the routine MSAFP was negative. The pt has a history of 3 previous pregnancies. No birth defects occurred in any previous pregnancy. A still birth or miscarriage occurred in a previous pregnancy at 8 weeks (spontaneous abortion on 12JUL1996). It was unknown if the products of conception were examined. The fetus was normal. There were no complications during pregnancy, no infections or illnesses during pregnancy, and no concurrent medical conditions. Additional follow up information received on 23-May-2004 from a physician indicated that the patient presented in labor on 13-Apri-2004 at about 12:30 AM at 38 weeks with no rupture of membranes. She delivered a female infant, vaginally at 3:00 pm on 13-Apr-2004. The patient developed a hematoma on her left labia. The baby had a normal studies, no abnormalities, had routine newborn care and was completely normal. Mother and baby were discharged home in 2 days. The physician saw the patient on 05-May-2004 to check the hematoma. The hematoma had completely resolved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Pruritus, Pyrexia, Rash
Clinical narrative: Information has been received from a certified medical assistant, who is the grandmother, concerning her grandson, a 5 year old white male student who has an allergy to red dye, and who on 30DEC1998 was vaccinated SC with a first dose of varicella virus vaccine live. The certified medical assistant reported that the lot number and site of administration were not recorded. There was no concomitant medication. Also, it was noted that the pt had not received any other vaccinations on the same day. The certified medical assistant reported that on 21SEP2003 (also reported as 22SEP2003 by nurse practitioner) here grandson developed chicken pox even though he  was immunized with varicella virus vaccine live. She described that on 21SEP2003 her grandson developed an itchy rash, that spread and then blistered. At the onset, he also had a low grade fever. The certified medical assistant reported the rash distribution was especially on one leg, but she indicated that she did not know which leg, nor if it was the same leg used for varicella virus vaccine live administration. The certified medical assistant reported that "this case" was not as sever as others that the she has seen. The pt was prescribed cetririzine hydrochloride, Zyrtec, and calamine + camphor + pramoxine hydrochloride AVEENO baths for itching and a decongestant for nasal congestion. It was noted that as of today, 08OCT2003, the rash has cleared completely. It was noted that the adverse event abated and the pt recovered. There was no product complaint reported.  Follow up information was received form a nurse practitioner who reported that the pt's chickenpox were on his back, neck, lower legs, and arms for one week. Additionally, it was reported that the pt also had a low grade fever and slgiht cough, and he was out of school for one week. Subsequently, the patient recovered. The nurse practitioner reported that there were no relevant laboratory or diagnostic tests performed, and the patient did not have an illness at the time of vaccination. The nurse practitioner also reported that the patient did not develop a rash at the injection site or elsewhere within 42 days of varicella virus vaccine live administration. Unspecified medical attention was sought. Further information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a certified medical assistant, who is the grandmother, concerning her grandson, a 5 year old white male student who has an allergy to red dye, and who on 30DEC1998 was vaccinated SC with a first dose of varicella virus vaccine live. The certified medical assistant reported that the lot number and site of administration were not recorded. There was no concomitant medication. Also, it was noted that the pt had not received any other vaccinations on the same day. The certified medical assistant reported that on 21SEP2003 (also reported as 22SEP2003 by nurse practitioner) here grandson developed chicken pox even though he  was immunized with varicella virus vaccine live. She described that on 21SEP2003 her grandson developed an itchy rash, that spread and then blistered. At the onset, he also had a low grade fever. The certified medical assistant reported the rash distribution was especially on one leg, but she indicated that she did not know which leg, nor if it was the same leg used for varicella virus vaccine live administration. The certified medical assistant reported that "this case" was not as sever as others that the she has seen. The pt was prescribed cetririzine hydrochloride, Zyrtec, and calamine + camphor + pramoxine hydrochloride AVEENO baths for itching and a decongestant for nasal congestion. It was noted that as of today, 08OCT2003, the rash has cleared completely. It was noted that the adverse event abated and the pt recovered. There was no product complaint reported.  Follow up information was received form a nurse practitioner who reported that the pt's chickenpox were on his back, neck, lower legs, and arms for one week. Additionally, it was reported that the pt also had a low grade fever and slgiht cough, and he was out of school for one week. Subsequently, the patient recovered. The nurse practitioner reported that there were no relevant laboratory or diagnostic tests performed, and the patient did not have an illness at the time of vaccination. The nurse practitioner also reported that the patient did not develop a rash at the injection site or elsewhere within 42 days of varicella virus vaccine live administration. Unspecified medical attention was sought. Further information is not expected.
Age: 1.9
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Rash, Rash vesicular, Sinusitis, Vulval disorder
Clinical narrative: Information has been received from a registered nurse concerning a 23 month old Caucasian female patient with no allergies an no past medical history who on 08OCT2002 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live. Concomitant vaccination on 08OCT2003 included a first subcutaneous dose in the right arm of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. There was no illness at the time of vaccination. On 07OCT2003, the pt developed varicella lesions. On 08OCT2003, the pt was seen int he office with 40 scabbed lesions on her chest and back, as well as some vesicles. No treatment was required for the varicella lesions and no laboratory tests were performed. Subsequently, the pt recovered from varicella. It was also noted that the pt had sinusitis since 11SEP2003 with coughing and diaper rash, which "does not appear to be associated with varicella". On 11SEP2003, amoxicillin + cavulanate potassium (AUGMENTIN) was started and renewed on 01OCT2003 for the sinusitis. The pt was also treated with levalbuterol hydrochloride nebulizer (Xopenex) for the cough associated with the sinusitis. The pt was treated with nystatin cream three times a day for vulvitis, which was probably from the diaper rash. Subsequently, the symptoms of sinusisits, cough and diaper rash all improved. The reporter noted that there were no further problems and the pt recovered. On 21OCT2003, the pt was vaccinated in the left arm with a first intramuscular dose of influenza virus split virion 3v vaccine inactivated (Fluzone). A product quality complaint was not involved. Additional info is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received on 07OCT2003 from an elementary school licensed practical nurse concerning a 7 year old male who was vaccinated on 11Sep1997 with varicella virus vaccine live. Subsequently, "within the last month," the pt developed chicken pox. The pt sought unspecified medical attention. It was also reported that five other children also developed chicken pox. Additonal info has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received on 07OCT2003 from an elementary school licensed practical nurse concerning a 7 year old male who was vaccinated on 30APR1997 with varicella virus vaccine live. Subsequently, "within the last month," the pt developed chicken pox. The pt sought unspecified medical attention. It was also reported that five other children also developed chicken pox. Additonal info has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received on 07-Oct-2003 from an elementary school licensed practical nurse concerning a 7 year old male who on 12-Jun-1996 was vaccinated with varicella virus vaccine live (site unknown). Subsequently, "within the last month," the patient developed chicken pox. The patient sough unspecified medical attention. It was also reported that five other children also developed chicken pox (WAES #0310USA01069, WAES #0310USA01244, WAES #0310USA01245, WAES #0310USA01247, and WAES #0310USA01248. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received on 07-Oct-2003 from an elementary school licensed practical nurse concerning a 7 year old who on 07-Oct-1996 was vaccinated with varicella virus vaccine live (site unknown). Subsequently, "within the last month," the patient developed chicken pox. The patient sought unspecified medical attention. It was also reported that five other children also developed chicken pox (WAES #0310USA01244 through WAES #0310USA01246, WAES #0310USA01248 and WAES #0310USA01249). Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received on 07-Oct-2003 from an elementary school licensed practical nurse concerning a 7 year old who on 07-Oct-1996 was vaccinated with varicella virus vaccine live (site unknown). Subsequently, "within the last month," the patient developed chicken pox. The patient sought unspecified medical attention. It was also reported that five other children also developed chicken pox (WAES #0310USA01069 through WAES #0310USA01069, WAES #0310USA01244 through WAES #0310USA01247). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Pyrexia, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 month old white male with no past medical history and no recent exposure to chicken pox or shingles who on 30-Sep-2003 was vaccinated with a first dose of varicella virus vaccine live (lot #645048/0197N) (0.5 ml), subcutaenously in the right thigh. There was no concomitant medication or illness at the time of vaccination. On 08-Oct-2003 at 12:00 PM the patient developed shingles with a vesicular rash "on his right side only, from his spine to his nipple, that has continued to the present." The number of lesions were reported to be too numerous to count. It was also reported that the patient "had shingles on left side of body from mid back around the nipple/low grade fever." The patient had a body temperature of 101 F. There was no product quality complaint involved. The patient sought unspecified medical attention. On 15-Oct 2003 the patient was improving and a dried lesion previously collected on 10-Oct-2003 was going to be sent for analysis. The specimen was sent to the laboratory on 13-Oct-2003. Subsequently the specimen was reported to be positive. The VZV DNA was amplified and the results of the PCR analysis revealed that the specimen contained the wild-type varicella zoster virus. On 14-Nov-2003 follow-up information from the reporter stated that the patient had "recovered completely and to date, has no further problems." Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Pruritus, Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 39 year old white female patient with hypothyroidism and rheumatoid arthritis and no known drug allergies who on 25-Sep-2003, at 9:45 am, was vaccinated SC in the right arm with a 5.0 ml first dose of varicella virus vaccine live (lot #643083/0572M). Concomitant vaccine therapy included a fourth dose IM in the left arm of hepatitis B virus vaccine rHBsAg (yeast) (lot 643166/0249M). (P1-P3 in 1993) Other concomitant therapy included levothyroxine Na (Synthroid), naproxen prn and hydroxychloroquineSo4 (Plaquenil). There was no illness at the time of vaccination. On 09-Oct-2003, in the am, the patient presented with an injection site varicelliform rash. It was reported that the patient had rash at the injection site, itching at the injection site and 2 erythematous papules at the injection site. It was reported that nothing has been done to treat it, but the patient had not recovered. No labs or diagnostic studies were done. No product quality complaint was involved. Follow up information indicated that the patient recovered on 15-Oct-2003. Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Skin nodule
Clinical narrative: Information has been received from a health professional concerning a 39 year old white female patient with hypothyroidism and rheumatoid arthritis and no known drug allergies who on 25-Sep-2003, at 9:45 am, was vaccinated SC in the right arm with a 5.0 ml first dose of varicella virus vaccine live (lot #643083/0572M). Concomitant vaccine therapy included a fourth dose IM in the left arm of hepatitis B virus vaccine rHBsAg (yeast) (lot 643166/0249M). (P1-P3 in 1993) Other concomitant therapy included levothyroxine Na (Synthroid), naproxen prn and hydroxychloroquineSo4 (Plaquenil). There was no illness at the time of vaccination. On 09-Oct-2003, in the am, the patient presented with an injection site varicelliform rash. It was reported that the patient had rash at the injection site, itching at the injection site and 2 erythematous papules at the injection site. It was reported that nothing has been done to treat it, but the patient had not recovered. No labs or diagnostic studies were done. No product quality complaint was involved. Follow up information indicated that the patient recovered on 15-Oct-2003. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site rash, Nasal congestion, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 36-year-old white female with allergies to penicillin, "sulfa" clarithromycin (BIAXIN), erythromycin (E-Mycin), levofloxacin (Levaquin), and ciprofloxacin hydrochloride (CIPRO) who on 23-Sep-2003 was vaccinated with a dose of varicella virus vaccine live (lot information not available). It was unknown if there was an illness at the time of vaccination. Subsequently the patient developed a localized rash and a fever. The reporter indicated that she "believes patient has recovered". Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 03-Oct-2003, 10 days after vaccination, the patient was seen for achiness, nasal congestion, and redness and slight tenderness at the vaccine area. The outcome was reported as recovered on 10-Oct-2003. No relevant diagnostic tests or laboratory data were reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Tenderness
Clinical narrative: Information has been received from a physician concerning a 36-year-old white female with allergies to penicillin, "sulfa" clarithromycin (BIAXIN), erythromycin (E-Mycin), levofloxacin (Levaquin), and ciprofloxacin hydrochloride (CIPRO) who on 23-Sep-2003 was vaccinated with a dose of varicella virus vaccine live (lot information not available). It was unknown if there was an illness at the time of vaccination. Subsequently the patient developed a localized rash and a fever. The reporter indicated that she "believes patient has recovered". Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 03-Oct-2003, 10 days after vaccination, the patient was seen for achiness, nasal congestion, and redness and slight tenderness at the vaccine area. The outcome was reported as recovered on 10-Oct-2003. No relevant diagnostic tests or laboratory data were reported. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Asthma, Cardiac flutter, Cough, Oesophagitis, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 43-month old obese white male with allergies to penicillin and the pertussis vaccine (unspecified) which caused hives, asthma, esophagitis and a heart murmur who on 01-Jun-2001 was vaccinated SC in the right arm with the first dose of varicella virus vaccine live (lot #635461/1246K). Other concomitant vaccinations administered on that same day included a SC dose (1st) in the left arm of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #636400/1276K) and an IM dose (3rd) in the left thigh of Hib conj vaccine (Lot #628914/1618H), and an IM dose (2nd) in the left thight of pneumococcal 4 6B 9V 18C 19F 23 F conj vaccine (CRM197) (Lot #474-947). Illness at the time of vaccination included baby bottle caries and clear rhinorrhea. The LPN reported that on 29-Sep-2003, the patient was seen in the emergency room (ER) for cough. On 08-Oct-2003, the patient developed a fever and vomiting. On 09-Oct-2003, the patient developed a rash characterized by more than 100 lesions. It was noted that, three weeks prior, the patient was exposed to a cousin who had chickenpox despite being vaccinated with varicella virus vaccine live (WAES #0310USA01683). On 10-Oct-2003, the patient was seen by a physician and a diagnosis of lesions consistent with atypical varicella infection was made. It was noted that the patient's mother stated by the patient and his sister "broke out" in hives after getting pertussis vaccination, however the LPN reported that she found no documentation in the patient's chart that this was diagnosed by the physician. No laboratory/diagnostic tests were performed. On 20-Oct-2003, the patient recovered. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Rash, Skin ulcer, Urticaria, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 43-month old obese white male with allergies to penicillin and the pertussis vaccine (unspecified) which caused hives, asthma, esophagitis and a heart murmur who on 01-Jun-2001 was vaccinated SC in the right arm with the first dose of varicella virus vaccine live (lot #635461/1246K). Other concomitant vaccinations administered on that same day included a SC dose (1st) in the left arm of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #636400/1276K) and an IM dose (3rd) in the left thigh of Hib conj vaccine (Lot #628914/1618H), and an IM dose (2nd) in the left thight of pneumococcal 4 6B 9V 18C 19F 23 F conj vaccine (CRM197) (Lot #474-947). Illness at the time of vaccination included baby bottle caries and clear rhinorrhea. The LPN reported that on 29-Sep-2003, the patient was seen in the emergency room (ER) for cough. On 08-Oct-2003, the patient developed a fever and vomiting. On 09-Oct-2003, the patient developed a rash characterized by more than 100 lesions. It was noted that, three weeks prior, the patient was exposed to a cousin who had chickenpox despite being vaccinated with varicella virus vaccine live (WAES #0310USA01683). On 10-Oct-2003, the patient was seen by a physician and a diagnosis of lesions consistent with atypical varicella infection was made. It was noted that the patient's mother stated by the patient and his sister "broke out" in hives after getting pertussis vaccination, however the LPN reported that she found no documentation in the patient's chart that this was diagnosed by the physician. No laboratory/diagnostic tests were performed. On 20-Oct-2003, the patient recovered. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old white male patient, who was adopted from Romania at two years of age, with no drug allergies and no known past medical history who on 22-Sep-1997 was vaccinated subcutaneously in the left arm with a first 0.5 ml dose of varicella virus vaccine live (Lot #622852/0540E). There was no concomitant medication. On 09-Oct-2003, the patient developed shingle. The reporter noted that since the patient was adopted from Russia, it was unknown if he had a previous infection with chickenpox. The patient was seen by a physician and was treated with acyclovir (Zovirax) and acetaminophen (+) hydrocodone bitartrate (LORTAB). A VZV analysis was not requested. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated in 2000 with a dose of varicella virus vaccine live. On 13-Oct-2003 the patient experienced breakthrough disease on both arms and the nape of his neck. No fever was noted. Unspecified medical attention was sought. There as no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a patient who was vaccinated with a dose of varicella virus vaccine live. The LPN reported that, in approximately September 2003, the patient in developed chickenpox. The LPN also reported that the patient exposed a cousin to chickenpox (WAES #0310USA01481). Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a mother concerning her 9 year old son with no pertinent medical history who in 1995 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The patient's mother reported that on 09-Oct-2003, the patient developed over 100 chickenpox lesions. Unspecified medical attention was sought, but no treatment or laboratory/diagnostic tests were required. At the time of this report, the patient ws recovering with sequalae (unspecified). A nurse in the patient's physician's office indicated that the office had seen two similar cases that same week and that four other children in the patient's class also developed chickenpox that same week as well. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Drug ineffective, Infection, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old white female with allergies to penicillin and pertussis, intermittant reflux and asthma and a history of a heart murmur, bleeding ulcers, esophagitis and hives from pertussis who on 27-Jun-2001 was vaccinated in the left arm with a first dose of varicella virus vaccine lvie (lot #535461/1246K). It was reported that the patient had vomiting and diarrhea at the time of vaccination. On 14-Oct-2003 the patient presented with about 25 vesicular lesions, generally disseminated and a low grade fever. No treatment was required for the AE. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available. Follow-up information indicated that the mother brought the patient to the office for a rash. She indicated that the patient was exposed to chicken pox three weeks ago and the patient's brother (WAES 0310USA01481) broke out with them on 09-Oct-2003. The onset was reported as 12-Oct-2003 and the patient had 25 lesions. It was also reported that the mother stated that the patient only had 10-12 lesions. The diagnosis was "atypical chickenpox presentation. The patient recovered on 17-Oct-2003. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old white female with allergies to penicillin and pertussis, intermittant reflux and asthma and a history of a heart murmur, bleeding ulcers, esophagitis and hives from pertussis who on 27-Jun-2001 was vaccinated in the left arm with a first dose of varicella virus vaccine lvie (lot #535461/1246K). It was reported that the patient had vomiting and diarrhea at the time of vaccination. On 14-Oct-2003 the patient presented with about 25 vesicular lesions, generally disseminated and a low grade fever. No treatment was required for the AE. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available. Follow-up information indicated that the mother brought the patient to the office for a rash. She indicated that the patient was exposed to chicken pox three weeks ago and the patient's brother (WAES 0310USA01481) broke out with them on 09-Oct-2003. The onset was reported as 12-Oct-2003 and the patient had 25 lesions. It was also reported that the mother stated that the patient only had 10-12 lesions. The diagnosis was "atypical chickenpox presentation. The patient recovered on 17-Oct-2003. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received form a consumer who is a office working concerning her approximately 18 month old daughter with no medical history or allergies who on 12-Mar-1999 was vaccinated SC in the "H" thigh with a first dose of varicella virus vaccine live (lot #629256/1850H). It was reported that the child was 12-15 months old at the time of vaccination. There was no concomitant medication. In September 1999 and in December 2001 the patient experienced breakthrough cases of varicella. No laboratory tests or diagnostic studies were performed. Both cases were described as mild by the mother. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No additional information was available. Follow up information from the consumer indicated that the child had a normal heart murmur and a sulfa allergy. The two episodes of chicken pox were reported to be in August 1999 and 12-Dec-2001. Medical attention was sought and the patient recovered. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a physician concerning a female medical assistant in her mid 20's who in January 2003, and in March or April 2003 was vaccinated with a first and second dose kof varicella virus vaccine live. On 30-Sep-2003 the patient developed chicken pox. She said that she felt awful and itchy and had one blister on her arm the first day. She counted about 6-10 blisters overall. She still has a couple red marks which she stated are scars. Unspecified medical was sought and no treatment was required. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Drug ineffective, Headache, Infection, Lethargy
Clinical narrative: Information has been received from a physician concerning a female who in April, 2003 was vaccinated with a dose of varicella virus vaccine live. In October 2003, the patient developed headaches, lethargy and cellulitis and "possibly shingles on the area of her body where the vaccine was given". It was unknown if treatment was provided. Unspecified medical attention was sought. There was no product quality complaint involved. No other information was provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Infection, Pyrexia, Rash papular
Clinical narrative: Information has been received from a physician concerning an 11 year old female hispanic student with no allergies, no past medical history and no adverse events following prior vaccinations who in 1998 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 13-Oct-2003, the patient developed chickenpox. The patient had a fever for two days and a rash characterized by papules, vesicles and crusting. Unspecified medical attention was sought, but the patient was not seen by the reporting physician. Laboratory tests were not performed. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a health professional concerning a female patient who in 2001 was vaccinated with a dose of varicella virus vaccine live. Recent titers did not show seroconversion. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information indicated that no additional information was available or expected from this location.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 14-year-old male with no known drug allergies and no past medical history who on 04-Sep-2001 was vaccinated SC with a dose of varicella virus vaccine live (Lot #635607/1153K). There was no illness at the time of vaccination. In September 2003, the patient developed chicken pox lesions. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a physician indicated that in September 2003 the patient recovered. There were no adverse events following prior vaccinations of the patient or his siblings. No relevant diagnostic test or laboratory data were reported. No further information is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a school nurse concerning a male patient who in 1999 was vaccinated with on 0.5 ml dose SC of varicella virus vaccine live. On 14-Oct-2003 the patient broke out in chicken pox. No labs or diagnostic studies were performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female with unspecified food allergies who on 6/29/98 was vaccinated with the second dose of varicella virus vaccine live. There was no illness at the time of vaccination. The RN reported that on 9/23/03, at 9:00, the patient developed varicella. It was unknown if medical attention was sought. On 9/30/03, the patient's varicella resolved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a physician concerning a 4 year old pt who was vaccinated between 15 and 18 months of age, with a dose of varicella virus vaccine live. The physician reported that the pt subsequently developed breakthrough varicella characterized by a handful of vesicles. Unspecified medical attention was sought and it was unknown if treatment was required for the breakthrough varicella. Subsequently, the pt recovered from the breakthrough varicella. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HBHEPB, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from nurse practitioner concerning a healthy 28 month old black male pt with no known allergies and a history of one episode of reactive airway disease at 34 weeks of age who on 21May2002 was vaccinated with a dose of varicella virus vaccine live. Concomitant medication on 21May2003 included a third IM dose in the left thigh of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC), a first SC dose in the right arm of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  and a third SC dose in the left arm of poliovirus vaccine inactivated. The pt had no adverse events following prior vaccinations. On 16Oct2003, the pt developed varicella. The pt presented to the medical office with approximately five to seven vesicular lesions. The pt was afebrile, eating well and in no apparent distress. The pt was treated with diphenhydramine hydrochloride (Benadryl Elixir), calamine lotion and acetaminophen (Tylenol). The pt had a varicella titer during the week and the results were pending. There were no other laboratory tests. Subsequently, the pt recovered. The reporter noted that the pt's two sisters had not experienced symptoms. A product quality complaint was not involved. The reporter also mentioned that the pt's two older brother's developed more symptomatic varicella illness post vaccination with varicella virus vaccine live. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Information has been received from a consumer concerning a 5 year old granddaughter who was vaccinated "a few years ago" with varicella virus vaccine live. On 14Oct2003 the pt developed a rash on her legs which was four inches wide. The rash extended from her leg up to her groin area. The doctor diagnosed this rash as shingles and gave her acyclovir to treat the shingles. On 17Oct2003 it reported that the pain has gotten better for her since 14Oct2003. It was reported that the pt was recovering with sequelae. There was no product quality complaint involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 36 month old male who on 26Jan2001 was vaccinated with a first dose of varicella virus vaccine live. On 15Oct2003 the pt developed a breakthrough case of varicella. It was reported as a mild case of chickenpox. No treatment was necessary. No further information was given. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that the pt developed chickenpox 3 years after vaccination. No other details of vaccination are known. The pt was reported as recovered. No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Injection site reaction, Urticaria
Clinical narrative: Information has been received from a RN concerning a 12 month old female with no allergies or medical history who on 07Oct03 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 19Oct2003 the pt's family called the physician's office to report a light body rash on 18Oct2003 that was gone on 19Oct2003, but a nickel size welt was present at the injection site with two white areas that were draining and crusted. The pt was noted to be afebrile and was treated with warm compresses. Unspecified medical attention was sought and a prescription drug was required. A product quality complaint was not involved. Additional information has been requested.