chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a consumer concerning her 5 year old daughter with a history of an allergic reaction to antibiotics (not penicillin) who was vaccianted on an unspecified date with a dose of Varivax (Oka/Merck). There was no concomitant medication. Subsequently, on 27-JUN-2006 the patient began to break out in a rash. She presented to the Physician's office on 28-Jun-2006 with approximately 30-50 lesions and was diagnosed with chicken pox. The physician prescribed BENADRYL as needed for itching. No fever was noted. At the time of the report the patient had not recovered. There was no product quality complaint involved. The patient's sister (WAES#0607USA00907) developed a rash of approximately 6-10 lesions following vaccination with Varivax (Oka/Merck). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a consumer concerning her 4 year old daughter with a history of an abdominal hernia who on an unspecified date was vaccianted with a dose of Varivax (Oka/Merck). There was no concomitant medication. On 29-JUN-2006 the patient began to break out in a rash after her sister (WAES#0607USA00899) has been diagnosed with chicken pox on 28-Jun-2006. She had approximately 6-10 lesions and no fever was noted. At the time of the report the patient has recovered. No medical attention was sought though the physician's office was informed of her case. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: CSF test normal, Laboratory test, Nuclear magnetic resonance imaging normal, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old healthy male with no known allergies who on 12-NOV-2001 was vaccinated with a dose of Varivax. Subsequently the patient developed moderate breakthrough. Unspecified medical attention was sought and the patient recovered. A product quality complaint was not involved. Follow-up information was received from the physician who reported that in February 2005, the patient developed a severe case of varicella with encephalopathic behavior. He was admitted to a health care facility where an MRI and cerebrospinal fluid test was normal. The final diagnosis was no encephalopathy. The patient recovered. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Seroconversion test negative
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with no known drug allergies and no pertinent medical history who in November 2004, was vaccinated with first dose of Varivax (Oka/Merck) (lot number not provided). In January 2005, the patient was vaccianted with a second dose of Varivax (Oka/Merck) (lot number not provided). There was no concomitant medication. In June 2006, the patient had ELISA titer test which showed failure to seroconvert. There was no product complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a female physician who "a few years ago" was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently the patient underwent "lab work" which revealed no titer count. As of 07-JUL-2006, the patient had not recovered. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer concerning her 8-year-old daughter who was vaccinated with a dose of Varivax at the age of one year. Subsequently, the patient experienced varicella. No further information was available at the time of the report. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, Skin lesion
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccianted with the first and second dose of Varivax (Oak/Merck). Subsequently the patient experienced lesions. It was noted that the patient's titer was negative. No further information was provided. Follow up information indicated that there was no other information. No additional information is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a male who in 1996 was vaccinated with a dose of Varivax (Oak/Merck). Subsequently, "now" on approximately 17-APR-2006, the patient experienced severe case of chickenpox. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. The R.N. also reported that the patient's sister had a severe case of chickenpox (WAES#0604USA02691).
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from an unidentified source at a physician's office concerning a patient who was vaccinated with Varivax (Oak/Merck). Three years after vaccination with Varivax (Oak/Merck) the patient experienced breakthrough chicken pox. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse in a doctor's office concerning a 6 year old white male with no allergies or medical history who on 11-JUL-2001 was vaccinated in the left arm with a first 0.5 mL dose of Varivax (lot # 638243/0557L). There was no concomitant medication and there was no illness at the time of vaccination. On 07-JUL-2006 the patient experienced 20 to 30 lesions. The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. As of 10-JUL-2006 the patient's 20 to 30 lesions persisted. It was noted that the patient had no adverse events following prior vaccination. Follow-up information was received from the registered nurse who reported that on 07-JUL-2006 the patient had approximately 30 lesions on his face, neck, ears, chest, trunk and buttocks. Symptomatic care was provided. No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old female who on 04-JUN-1997 was vaccinated with Varivax. The patient had no pertinent medical history and no allergies/reactions. There was no concomitant therapy. On 09-JUL-2006, the patient sought medical attention for chickenpox. She had more than 50 lesions all over her body. The patient's chickenpox persisted. It was reported that the patient had been vaccinated at another office. Thus, the vaccine lot# was not available at the time of reporting. Follow-up information from the registered nurse indicated that the office did not administer the  vaccine and they could not provide any additional adverse event information. Chickenpox was considered to be immediately life-threatening. Additional information is not expected.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning an 8-year-old patient with no known drug allergies who was vaccinated with a dose of Varivax (Oak/Merck). On 05-JUL-2006, the patient developed lesions on the chest, abdomen, and perineal area. there were <50 lesions. The outcome was recovered. There were no diagnostic test or laboratory data. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin lesion, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 14-month-old female (23 lb, 29.5 in) with no pertinent medical history or allergies, who on 27-APR-2006 was vaccinated subcutaneously in the left arm with a 0.5 ml first dose of Varivax (lot# 649998/0909R). Concomitant vaccination given on the same day included a first dose of MMR II (lot# 650105/0829R) given subcutaneously in the right arm and sodium fluoride. There was no illness at the time of vaccination. On 07-JUL-2006 the patient developed varicella. Unspecified medical attention was sought. It was reported that the patient had 50 lesions or more on various areas on her body, such as her scalp, underarms, arms, legs trunk and back. No laboratory or diagnostic tests were performed. TYLENOL and comfort measures were recommended to help with the symptoms. The patient recovered as of 20-JUL-2006. No product quality complaint was involved. The reporter considered the adverse experience to be other important medical event. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an approximately 7 or 8 year old who was vaccinated with a dose of Varivax (Oka/Merck). subsequently, the patient developed a full blown case of chickenpox. Lesions count was not available. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a child in third grade who was vaccinated with a dose of Varivax. On 03-APR-2006 the patient experienced shingles. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a child in kindergarten who was vaccinated with a dose of Varivax (Oak/Merck). On 06-FEB-2006 the patient experienced shingles. Unspecified medical attention was sought. No product quality complain was involved. No other information was provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: information has been received from registered nurse concerning a 11 year old male who in approximately 2000, at the age of 5-years-old vas vaccinated with Varivax (Oka/Merck). In May 2006, the patient experienced "breakthrough varicella rash". It was reported that the patient had "more than 50 rashes on upper parts of the body including scalp, face, shoulder and back". The patient sought unspecified medical attention. On approximately 12-JUN-2006, the patient recovered from the event. It was reported that the patient had a 12 year old brother, who at the age of 5-years-old was vaccinated with Varivax (Oka/Merck) at a different place and different time and subsequently experienced "breakthrough varicella rash" (MSD, WAES#0607USA04106). Additional information has been requested.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a male patient who on 19-JUN-2006 was vaccinated with a dose of Varivax (Oka/Merck). Concomitant vaccination included a dose of MMR II (MSD). Subsequently, on 07-JUL-2006, eighteen days after vaccination, the patient developed a rash. Unspecified medical attention was sought. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 39 month old male with no known medical history of allergies who on 24-MAY-2006 was vaccinated with a dose of Varivax (Oka/Merck). concomitant therapy included BENADRYL. On 10-JUL-2006 at 9:10 am the patient presented with breakthrough rash that began on 08-JUL-2006. There were 60-75 spots with diffused fluid filled vesicles. it appeared on the torso, groin and extremities. The patient did not have a fever but experienced itching. There were no additional problems. BENADRYL was used for itching relief. medical attention was sought. No laboratory diagnostic test were performed. The patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 22-month-old male who on 16-SEP-2005was vaccinated in the left arm with a dose of Varivax (Oka/Merck) (lot# 649738/0120R). On 30-JUN-2006 at 08:00 am the patient broke out with chickenpox. It was not reported if medical attention was sought. Subsequently, the patient recovered. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 7 year old male who on 08-MAY-2000 was vaccinated in the left arm with a first dose of Varivax (Oka/Merck) (lot # 632042/1360J). On 11-JUL-2006 at 15:00, the patient broke out with chicken pox. Subsequently, the patient recovered. No additional information is expected.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Headache, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning an 8 year old female with no known allergies who on 13-May-1999 was vaccinated SC in the right arm with a first dose of Varivax (Oka/Merck) (lot# 629613/0285J). Concomitant vaccination included a first dose of MMR II (lot# 629567/1793H) given SC in the left arm. On 07-JUL-2006 the patient experienced rash, fever of 103 and headache. The fever lasted for one day. On 11-JUN-2006 the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female who on 06-NOV-1998 was vaccinated SC in the right arm with a first dose of Varivax (Oka/Merck) (lot# 628147/1262H). Concomitant vaccinations included Dtap and poliovirus vaccine live oral. On 28-JUN-2006 the patient developed varicella disease with moderate to many papules. The patient had an office visit for confirmation on 30-JUN-2006. Subsequently, the patient recovered. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a physician concerning a 13 year old male who "seven years ago", in approximately 1999 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. There was no concomitant medication. Subsequently, "last week" in July 2006, the patient developed breakthrough varicella with more than 50 lesions. Unspecified medical attention was sought. There was no product quality complaint involved.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer concerning her 11-year-old nephew who was previously vaccinated with a dose of Varivax (Oka/Merck) on 22-APR-1996. subsequently, it was reported that the patient experienced varicella. It was unspecified if medical attention was sought. No further information was available at the time of the report. Follow-up information received from a healthcare facility stated that no reaction was documented following vaccination. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old male who in approximately 1999, at the age of 5-years-old was vaccinated with Varivax. On an unspecified date, the patient experienced "breakthrough varicella rash". It was reported that the patient had "more than 50 rashes on upper parts of the body including scalp, face, shoulder and back". At the time of this report, the outcome of the event was unknown. It was reported that the patient had a 11 year old brother, who at the age of 5-years-old was vaccinated with varicella virus vaccine at a different place and different time and subsequently experienced "breakthrough varicella rash" (MSD, WAES# 0607USA02437). Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 9 year old patient who "at a younger age" was vaccinated with a dose of Varivax. Subsequently the patient developed full blown varicella, it was reported that the patient no fever. Subsequently, the patient recovered. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 month old male who on 16-MAR-2006, at 12 months of age, was vaccinated in the left thigh with a first 0.5 ml dose of Varivax (lot# 646816/0631R). Concomitant vaccination included a first doe of MMR II (lot# 650349/0969R) SC in the left thigh and a third dose of IPOL (lot# Y0824) SC in the right thigh. On 15-JUL-2006 the patient developed shingles which were reported to be at C-5, C-6, some on the upper right shoulder/scapula, antecubital fossa and wrist. There was no fever and a pain rating of 0 on a scale of 0 (least) to 10 (most). No other systemic symptoms were noted. There was no history of chickenpox or recent exposure to chickenpox or herpes zoster. Unspecified medical attention was sought. Subsequently the patient recovered on 23-JUL-2006. No further information was available. There was no product quality complaint involved. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male with no known medical history or allergies who on 15-JUN-2001 was vaccinated with a dose of Varivax (Oka/Merck). It was unknown if there was an illness at the time of vaccination. On 22-JUN-2006 the patient developed a chickenpox-like rash that started on the trunk and spread to his neck, face, shoulder and legs. There were greater that 50 lesions. There was no fever. It was not reported if medical attention was sought. On 28-JUN-2006 the patient recovered. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: FLU3, PNC, VARCEL
Symptoms: Blister, Otitis media, Rash papular, Upper respiratory tract infection, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 22 month old female with a peanut allergy who on 16-SEP-2005, was vaccinated SC with a first dose of Varivax (Oka/Merck) (lot# 649270/0987P). Concomitant vaccination included a first dose of FLUZONE (lot# U1743JA) IM and a fourth dose of PREVNAR (lot# A56H7F) IM. There was no illness at the time of vaccination. On approximately 14-JUL-2006 the patient developed bilateral otitis media and an upper respiratory tract infection which were treated with AUGMENTIN ES-600 bid for 10 days, with improvement. On 18-JUL-2006 the patient developed a breakthrough rash described as vesicles filled with clear fluid on her left arm, left leg, and face. On 20-JUL-2006 the patient was seen in the office and the physician noted 10 pink papules, 2 vesicles, and no fever. The patient was seen in the office and the physician noted 10 pink papules, 2 vesicles, and no fever. The patient was diagnosed with a possible mild varicella. Supportive care was provided. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an adult male with liver failure who in approximately July 2006 was vaccinated with a dose of Varivax. The physician reported that in approximately July 2006, 1-2 post-vaccination, the patient developed breakthrough varicella. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. It was noted that the patient was not immunosuppressed, but was awaiting a liver transplant. At the time of this report, the patient's breakthrough varicella persisted. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 10 year old patient who "at a younger age" was vaccinated with a dose of Varivax. Subsequently the patient developed full blown varicella, it was reported that the patient had no fever but did have some scarring. Subsequently, the patient recovered. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Information has been received from a physician concerning an 11 year old patient who "at a younger age" was vaccinated with a dose of Varivax. Subsequently the patient developed full blown varicella and was completely covered with lesions. It was reported that the patient also had a slight fever. Subsequently, the patient recovered. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 13 year old male who "about 6 years ago" in approximately 2000 was vaccinated with a dose of Varivax. Subsequently "about 6 years ago" in approximately 2000 the patient experienced breakthrough chickenpox. It was not known if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. It was reported that the patient's brother (WAES# 0607USA04566) and sister (WAES# 0605USA04472) developed similar adverse experienced after vaccination with Varivax. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 7 year old male who "about 6 years ago) in approximately 2000 was vaccinated with a dose of Varivax. Subsequently "about 6 years ago" in approximately 2000 the patient experienced breakthrough chickenpox. It was not reported if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. It was reported that the patient's brother (WAES# 0607USA04565) and sister (WAES# 0605USA04471) developed similar adverse experienced after vaccination with Varivax. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 9 year old male with no known medical history or allergies who on 09-DEC-1997 was vaccinated SC in the left thigh with a first dose of Varivax (lot # 623135/0689E). Concomitant vaccination included a SC first dose in the right thigh of MMR II (lot # 622737/0739E). There was no illness at the time of vaccination. On 15-JUL-2006 (also reported as 17-JUL-2006) the patient developed many pox (rash) on back and chest. Medical attention was not sought. The patient recovered on 24-JUL-2006. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male with an amoxicillin allergy and no known medical history who on 27-JUL-2000 was vaccinated in the left thigh with a first dose of Varivax (lot# 631779/1354J). These was no illness at the time of vaccination or concomitant medication. On 22-JUL-2006 the patient's mother called the physician's office to report that the patient had a two day history of chicken pox. It was reported that the patient had approximately 20 "pimple like" lesions which were scattered papules none of which were crusted, on his trunk and leg. Several lesions were vesicular and fluid-filled. Unspecified medical attention was sought. The patient's mother called the physician's office on 24-JUL-2006 and reported that two of the lesions were crusted and the rest of the rash had disappeared. On 24-JUL-2006 the patient recovered. There was no product quality complaint involved. Additional information received indicated that the patient was seen in the office on 22-JUL-2006 with a one day history of several "not itchy, pimple like" bumps on his arms, shoulder and neck area. Several of these were noted to be vesicular. The patients mother called the office on 23-JUL-2006 to report that the rash was gone with two areas crusted over. On 23-JUL-2006 the patient recovered. It was reported that the patient had no adverse event following prior vaccination. No additional information is expected.
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician's office concerning a 6 year old female with no known allergies or past medical history who on 15-JUN-2001 was vaccinated SC in the right arm with a dose of Varivax (lot# 636368/1341K). Concomitant vaccination included a dose of MMR (lot #638359/0163L) SC in the left arm. There was no illness at the time of vaccination. On 12-JUL-2006 the patient developed 10-15 scattered vesicular lesions all over. The patient was treated with diphenhydramine hydrochloride (Benadryl). Subsequently, the patient recovered. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 32 month old male with no known allergies or past medical history, who on 22-NOV-2004 was vaccinated in the left thigh with a first dose of Varivax (lot#647528/1242N). There was no illness at the time of vaccination. The patient's Grandmother, who lives with the patient's family "recently" had shingles and on 18-JUL-2006 the patient developed a rash of pimples, tiny red dots that increased in size during the day. On 25-JUL-2006 the patient presented to the Physician's office with hot, 0.5 centimeter red non vesicular papules on his arms and legs. The patient was afebrile. There was no treatment. On 28-JUL-2006 the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a patient's mother concerning her 12 year old daughter who in approximately 1995, at the age of 1, was vaccinated with a 0.5 ml dose of Varivax. "Three years ago", in approximately 2003 at the age of nine, the patient developed chicken pox. Subsequently, the patient recovered. No further information was available. There was no product quality complaint involved. No further information is available. No further information is available.
Age: 62.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old patient who was inadvertently vaccinated with a dose of Varivax. The patient was supposed to have received Zostavax. The person administering the vaccine thought it would protect the patient against shingles. Unspecified medical attention was sought. A product quality complaint was not involved. No further information is available.
Age: 64.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 64 year old male patient who was inadvertently vaccinated with a dose of Varivax instead of Zostavax. There was no product quality complaint involved. Additional information indicated that Zostavax was ordered however Varivax was given on 26-JUL-2006. The pharmacist indicated that it was a "med sound alike error." No further information was available.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old white male with a sulfa allergy and no other medical history who on 29-OCT-2001 at around 10:00 am was vaccinated with SC in the right arm with a 0.5 mL first dose of Varivax (lot # 639684/0976L). There was no concomitant medication. On 23-JUL-2006 the patient developed varicella. Medical attention was sought. On 26-JUL-2006 the patient was diagnosed with a case of breakthrough varicella. He had multiple vesicles with some crusted over. No laboratory diagnostic tests were performed. He was treated and on 28-JUL-2006 the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning her 12 year old daughter who on an unspecified date was vaccinated with a 0.5 ml dose of Varivax. On 26-JUL-2006 the patient developed possible breakthrough varicella. Unspecified medical attention was sought. At the time of the report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 9-year-old Asian female with no pre-existing allergies, birth defects or medical conditions who on 25-AUG-2999 was vaccinated subcutaneously in the left arm with a first dose of Varivax (lot # 631073/0450J). There was no concomitant medication. There was no illness at the time of vaccination. On 08-JUL-2006 the patient was seen in the physicians office by a pediatric nurse practitioner with a 10 day rash, a few spots on her abdomen and arms, vesicles and papules at various stages. She was treated with BENADRYL and AVEENO BATH. There were no diagnostic or laboratory tests performed. The patient recovered. Additional information is not available.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning his son who on an unspecified date was vaccinated with a dose of Varivax. Subsequently the patient now "suffers from breakouts of Zoster". Thee was no other information provided. There was no product complaint involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Nasopharyngitis, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male with no known allergies or past medical history who on 25-JAN-1999 was vaccinated SC in the left arm with a first dose of Varivax (lot# 627333/1244H). There was no illness at the time of vaccination. On 17-JUL-2006 the patient developed modified chicken pox, with vesicles and papules on his chest and abdomen, and cold symptoms. Unspecified medical attention was sought. The symptoms were treated with BENADRYL and AVEENO. The patient recovered. There was no product quality complaint involved. The patient had no adverse events following prior vaccination. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated on an unspecified date with a 0.5 ml dose of Varivax. Subsequently the patient developed a breakthrough case of chickenpox. Unspecified medical attention was sought. The patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning her 12-month-old daughter with no pertinent medical history and no drug reaction/allergies who on 24-JUL-2006 was vaccinated with a dose of Varivax. There was no concomitant medication. On 27-JUL-2006 the patient developed 10 raised lesions, red with a white center. Unspecified medical attention was sought. The outcome was reported as not recovered. No other information was available. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an 8-year-old male who in approximately 1999, at "12 months of age", was vaccinated with a dose of Varivax. "About two weeks ago", on approximately 14-JUL-2006, the patient experienced varicella breakthrough of more than 50 lesions. Unspecified medical attention was sought. No outcome information was reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a healthcare worker concerning a 13-month-old female who about one month ago, on approximately 28-JUN-2006, was vaccinated with a dose of Varivax. Secondary suspect vaccination given on the same day included a dose of MMR. About one month ago, on approximately 28-JUN-2006, the patient experienced erythema and rash at the injection site. Unspecified medical attention was sought. It was reported that the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a female pharmacist in her 20's with no pertinent medical history or allergies who in 2000 was vaccinated with a first and second dose of Varivax. "About one month ago" in approximately June 2006, an antibody titer was drawn and the patient filed to seroconvert. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a health professional concerning a patient who on 27-JUL-2006 was vaccinated with a second dose of Varivax. Subsequently the patient developed blisters at the injection site measuring 2-3 cm in diameter with a surrounding 8cm of erythema. The outcome was unknown. It was also reported that the patient's sibling experienced a reaction (WAES # 0608USA00025). No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a health professional concerning a patient who on 27-JUL-2006 was vaccinated with a second dose of Varivax. Subsequently the patient developed blisters at the injection site measuring 1-2cm in diameter with surrounding 4 cm of erythema. The outcome was unknown. The reporter also indicated that the patient's sibling experienced an adverse event (WAES # 0608USA00024). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Irritability, Pyrexia, Urinary tract infection, Vesicoureteric reflux
Clinical narrative: Information has been received from a physician and a consumer concerning her 12-month-old Caucasian daughter who on 19-JUL-2006 was vaccinated with a dose of Varivax. There was no concomitant medication. On 19-JUL2006 the patient developed a fever of 103.9 and began "behaving really cranky". Unspecified medical attention was sought. It was noted that the fever was intermittent for approximately one month without other signs or symptoms and was eventually diagnosed with a UTI and ureteral reflux. No laboratory or diagnostic tests were reported. The reporter noted that the fever was probably unrelated to the vaccine but coincidentally began at the same time. No outcome was reported. No product quality complaint was involved. Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Body temperature increased, Constipation, Cyanosis, Feeling hot, Rhinorrhoea
Clinical narrative: Information has been received from a medical assistant and a physician concerning a 12-month-old patient with a history of otitis media who on 19-JUL-2006 was vaccinated with a dose of Varivax. Subsequently, the following evening, the patient experienced increased temperatures. Fevers went as high as 104.3 degrees Fahrenheit and intermittent for approximately 2 and a half weeks (it was also noted that the patient's fever was 103.6 degrees Fahrenheit and "had not gone away"). The patient was also intermittently irritability. The patient's irritability was noted to have decreased. The patient appeared well between episodes. The patient had a runny nose during the course of the fever, and has been constipated. There was no evidence of rash or other symptoms. As of 01-AUG-2006 in the evening, the patient "felt hot", was shaking, and the lips were "blue". No respiratory distress or cough was noted. The patient was subsequently sleeping and appeared "totally fine". Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Tremor
Clinical narrative: Information has been received from a medical assistant and a physician concerning a 12-month-old patient with a history of otitis media who on 19-JUL-2006 was vaccinated with a dose of Varivax. Subsequently, the following evening, the patient experienced increased temperatures. Fevers went as high as 104.3 degrees Fahrenheit and intermittent for approximately 2 and a half weeks (it was also noted that the patient's fever was 103.6 degrees Fahrenheit and "had not gone away"). The patient was also intermittently irritability. The patient's irritability was noted to have decreased. The patient appeared well between episodes. The patient had a runny nose during the course of the fever, and has been constipated. There was no evidence of rash or other symptoms. As of 01-AUG-2006 in the evening, the patient "felt hot", was shaking, and the lips were "blue". No respiratory distress or cough was noted. The patient was subsequently sleeping and appeared "totally fine". Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 6-year-old female who, on an unspecified date, was vaccinated with a dose of Varivax. In April 2006, the patient developed a mild breakthrough case of varicella. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 11-year-old male who, on an unspecified date, was vaccinated with a dose of Varivax. In April 2006, the patient developed a mild breakthrough case of varicella. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an approximately 10-year-old female who, on an unspecified date, was vaccinated with a dose of Varivax. In April 2006, the patient developed a mild breakthrough case of varicella. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health care facility concerning a 12 month old white male with no known allergies or past medical history who on 14-JUL-2006 was vaccinated SC in the right upper leg with a first dose of Varivax (lot#651045/034R). There was no concomitant medication or illness at the time of vaccination. On 23-JUL-2006 the patient developed chickenpox. Medical attention was sought at an urgent care center. Subsequently, in July 2006, the patient recovered. Additional information is not expected.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an unspecified person at a medical facility concerning a 9-year-old white female with a penicillin allergy who on 16-MAR-1998 was vaccinated in the left thigh with a first dose of Varivax (lot# 623510/0694E). There was no illness at the time of vaccination. On 17-JUL-2006 the patient developed shingles. She was seen at a physician's office. On 22-JUL-2006, she was rechecked in the office and was fully recovered. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Back pain, Chest pain, Herpes zoster, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning a 5 year old female with no known allergies or past medical history who on 21-DEC-2001 was vaccinated in the left thigh with a first 0.5 ml dose of Varivax (lot#638931/1144L). Concomitant vaccination included a first dose of MMR. There was no illness at the time of vaccination. On 30-JUL-2006 the patient developed right chest and back pain. On 31-JUL-2006 the patient developed a painful polyvesicular rash with dermatomal distribution on her anterior and posterior trunk, which was noted to be herpes zoster. The patient rated her pain at 8 on a scale of 0 (LEAST)-10(most). Maximum temperature was 98.3 F. It was reported that the patient has not had a recent exposure to chickenpox or shingles. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the vaccine VZV strain. On 01-AUG-2006 the patient was seen by the physician, specimens were obtained from vesicles on her anterior and posterior torso, and sent for PCR analysis and it was found to be vaccine strain, previously reported as wild type strain. It was reported that VZV DNA was amplified but that B-globin DNA was not amplified. Subsequently, the patient recovered. It was reported that there was no adverse events following prior vaccination with the patient or her siblings. There was no product quality complaint involved. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 6 year old male who on 30-MAY-2001 was vaccinated with a dose of Varivax (lot# 635789/1892K). On 12-JUL-2006 the patient developed herpes zoster in the cranial nerve C-8. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Genital rash, Varicella, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a registered nurse concerning a 37 year old female with no known allergies or past medical history who was vaccinated SC with a first and second dose of Varivax (lot# 652557/1024R) on 16-JUN-2006 and 20-JUL-2006 respectively. There was no concomitant medication. On 21-JUL-2006 the patient developed a breakthrough rash on her genitalia, confirmed to be chickenpox by "lab work". The patient was being treated with VALTREX. At the time of the report, the rash with open vesicles was continuing. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse who in 1996 was vaccinated with a dose of Varivax. Recently, a titer was negative. She was not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Rash erythematous, Rash papular, Scab
Clinical narrative: Information has been received from a physician concerning a 20-month-old white female with a history of respiratory distress syndrome (RDS) at birth and no allergies who on 20-OCT-2005, at approximately 1000, was vaccinated SC in the left leg with the first 0.5 mL dose of Varivax (Lot #651045/0324R). There was no concomitant therapy or illness at the time of vaccination. The physician reported that in June 2006 (also reported as approximately 01-JUL-2006), the patient developed a possible zoster-type rash on the back of her right leg and a blister on her right calf. The blister started to resolve and then became a "patch" of about 1.5-2 cm in diameter with vesicular lesions and some scabs. There was no recent exposure to chickenpox or shingles. On 01-AUG-2006, the patient was seen by the physician. At that time, the patient presented with a cluster of tiny red papulo-vesicular lesions with small central vesicles/scabs (not large enough to extract fluid). She had a maximum temperature of 99.5by ear, but no other systemic symptoms. A PCR swab of a lesion on her left leg/calf was sent for analysis. On 16-AUG-2006, the patient was noted to be recovered. Interpretation of the PCR swab indicated an inadequate specimen, negative for B-globin, no strain I.D. VZV DNA was not amplified. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a male physician who on 19-JUL-2006 vaccinated himself with a dose of Varivax thinking it was the vaccine for herpes zoster. The pharmacist indicated that this was not an issue of product confusion. It was unknown if medical attention was sought. No adverse experiences have been related to this event. Additional information from the pharmacist indicated that she could not recall specific demographic information for the patient. She indicated that the physician called back and she believes that he did administer the "correct vaccine after all". She had no additional information. No additional information is expected.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a person working in a physician's office concerning a 9 year old white female who on 22-JUN-1998 was vaccinated with a first subcutaneous dose of Varivax (Lot# "0062"). On 11-JUL-2006 the patient was diagnosed with chickenpox. Subsequently, the patient recovered. Medical attention was not sought. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 14-year old female who on 15-JAN-1997, at 5 years of age, was vaccinated subcutaneously with a first dose of Varivax (lot# 617907/1070D). On 10-JUL-2006 the patient developed chickenpox. Subsequently, the patient recovered from chickenpox. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 11-APR-2002 was vaccinated SC with a first dose of Varivax (lot#639899/0977L). On 05-JUL-2006 the patient developed chickenpox. Subsequently, the patient recovered. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 21-JAN-1997 was vaccinated SC with a first dose of Varivax (lot# 617907/1076D). On 10-JUL-2006 the patient developed chickenpox. Subsequently the patient recovered. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Myalgia, Pruritus, Rash, Varicella
Clinical narrative: Information has been received from a physician concerning an 8 year old white female (66 lb, 53") with an allergic rhinitis due to pollen who on 06-MAY-1999 was vaccinated with a dose of Varivax (lot# not provided). On 26-JUL-2006 the patient developed rash, headaches, muscle ache and itchiness. The patient was diagnosed with chicken pox. On 31-JUL-2006, the patient recovered. Additional information is not expected.