chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a woman in a physician's office concerning an 8 year old male with a history of "SBE" who on 21-AUG-1998 was vaccinated SC in the right arm with a first dose of Varivax (lot # 625045/1573E). There was no illness at the time of vaccination. On 12-APR-2006, the patient developed chickenpox and was seen by the physician. No diagnostic laboratory tests were performed. Subsequently, the patient recovered from chickenpox on an unspecified date in April 2006. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a patient who on approximately 28-APR-2006 was vaccinated with a dose of Varivax. On approximately 29-APR-2006, 24 hours after vaccination, the patient developed chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Rash papular
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a patient (current weight 43 pounds, birth weight 8 pounds, 8 ounces) who on 20-APR-2004 was vaccinated subcutaneous (right side) with Varivax (lot # 646231/0542N). On 18-APR-2006 the patient developed 20-40 vesicles and papules all over the body, and the patient complained about being itchy. The patient was still having outbreaks. The patient's final outcome was not required. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 32 year old white female, with allergies to amoxicillin and sulfa, who "two weeks ago" on 21 Apr 2006, was vaccinated (route unknown) with a first dose of Varivax. There was no illness at the time of vaccination. The physician reported that the patient was vaccinated at another practice two weeks ago and on 08 May 2006 she developed a vesiculopapular rash with about 10-15 lesions on her trunk and arms. It was noted that the patient had no fever. The patient's status was reported as not recovered. Unspecified medical attention was sought, but no treatment was required at this time. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 36 month old patient (gender unknown) who on an unspecified date was previously vaccinated (route unknown) with a dose of Varivax (lot # unknown). Subsequently, on an unspecified date, the patient experienced mild case of breakthrough chicken pox after previously being vaccinated. The patient had developed approximately 5 lesions. The patient  had recovered. Unspecified medical attention was sought. No product quality complaint was involved. No additional information is expected.
Age: 1.75
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Urticaria, Varicella
Clinical narrative: Information has been received from a medical assistant concerning a 21 month old male, with unknown medical history and unknown drug reactions/allergies, who on an unspecified date was vaccinated (route unknown) with a dose of Varivax (Lot # unknown). Subsequently, "recently" on an unspecified date, the patient developed a "moderate" rash which may be chickenpox or hives. The patient's present status was reported as not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DPP, IPV, MMR, VARCEL
Symptoms: Rash pruritic, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old white male, with no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions and no drug reactions/allergies, who on 04 May 2000 was vaccinated subcutaneously with a 0.5 mL dose of Varivax (Lot # 632616/1688J). That same day he was also vaccinated with DTAP (Lot# DTPA921A2), MMR (Lot # 634043/1716J), and poliovirus (Lot# R0398-2). On 20 Apr 2006 the patient developed breakthrough varicella with a rash consisting of 50 to 100 lesions located over his entire body (also reported as a varicella rash on his head, ears and back, with less than 50 lesions). The rash was itchy and lasted for about 1 week, until approximately 27 Apr 2007. There was no fever present. The patient went to the physician who prescribed therapy with Augmentin for 10 days. Other treatment included oatmeal bathes. There were no other complications or symptoms noted. No product quality complaint was involved. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old white female, with unknown drug reaction/allergies, no adverse events following prior vaccinations and no illness at the time of vaccination. Vaccination history included the patient received 3 doses of DPT and Hep B on 24 May 1996, 19 Jul 1996 and 13 Sep 1996, 3 doses of Hep B on 24 May 1996, 19 Jul 1996 and 13 Sep 1996. 3 doses of Polio on 24 May 1996, 19 Jul 1996 and 13 Sep 1996, Hep B vaccine (generic) on 22 FEb 1996, 24 May 1996 and 13 Sep 1996. ON 06 Jun 1997 the patient was vaccinated subcutaneoulsy with a 0.5 mL dose of Varivax (Lot # 619271/1338D). On 06 Jun 1997 the patient was also vaccinated with DTP, HIB, MMR (lot # 618890/1247D). On 18 Apr 2006 the patient developed chicken pox. The rash consisted of 100 to 150 lesions (previously reported as greater than 50 lesions) over her eintire body. Most of the lesions were located on the client's arms, face and legs. The rash was itchy and lasted for about a week. The child also had low grade fever. Treatments included Tylenol, oatmeal, baths, vitamin C and anti itch lotion. The patient  did not undergo any diagnostic/lab tests. On 23 Apr 2006 the lesions were scabbed and the patient fully recovered. No product quality complaint was involved. On 03 May 2001 the patient was vaccinated with DPT, MMR II (lot 634427/F1390K). Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old white male who on 24 Nov 1999 was vaccinated subcutaneously with 0.5 ml first dose of Varivax (lot # 631168/0710J). On 13 Apr 2006 the patient developed a varicella rash on his back, buttocks and legs with a total of less than 50 lesions. He also had a fever. Unspecified medical attention was sought. Subsequently, it was reported that the patient recovered. No product quality complaint was involved. Follow up information indicated that on 13 Apr 2006, the patient presented with a rash on the back of both legs and buttocks. Less than 50 lesions were present. The outcome was recovered. Additional follow up information indicated that the reporter was not successful in finding any new information. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Rash papular, Varicella
Clinical narrative: Information has been received from a health professional concerning a 7 year old white female who on 11-SEP-2001 was vaccinated with Varivax. On 03-MAY-2006 the patient experienced chickenpox. She had "scattered small (2cm) on a red 4 mm base papular to front of pubic area and lower abdomen and chest." There were a few on the face and arms. It was noted that she was exposed to her grandfather who had shingles two weeks prior. There were no labs done and no treatment was needed. It was reported that the patient recovered. It was unknown if medical attention was sought. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a male who on 12 Jul 2002 was vaccinated with a dose Varivax. Subsequently the patient experienced mild, typical varicella. It was reported that the patient had recovered. Unspecified medial attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a pediatric patient who was vaccinated with a dose of Varivax. Subsequently the patient experienced breakthrough varicella. There was no product quality complaint involved. It was reported that the patient's parent (WAES#0605USA05215) experienced herpes zoster while the patient was experiencing breakthrough varicella. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Injection site inflammation
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old male with a history of foramen avale patent who on 21 Feb 2006 was vaccinated SC with a first dose of Varivax (lot# 652455/1018R). Concomitant vaccination included a fourth dose of ActHIB (lot # UE774AA) given IM. There was no illness at the time of vaccination. On 01 Mar 2006 the patient experienced vaccine site inflammation. He was seen for a doctor's visit and started on Omnicef 125/5 BID for 10 days. The patient's outcome was unknown. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a health professional concerning a 12 month old male with no known medical history who on 27 Apr 2006 was vaccinated SC with a 0.5 ml dose of Varivax. Concomitant vaccination the same day included doses of MMR, DPT, Daptacel, Poliovirus vaccine. On 09 May 2006 the patient experienced an itchy rash all over his body with red elevated bumps. No fever was noted. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. No laboratory tests were performed. There was no product quality complaint involved. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Pruritus generalised
Clinical narrative: Information has been received from a health professional concerning a 31 year old female with no pertinent medical history and no drug reactions/allergies who on 27 Apr 2006 was vaccinated SC with a 0.5 mL dose of Varivax (Lot# 652557/1024R). On 09 May 2006 the patient experienced swelling at the injection site and generalized itching of her body. No pox were noted. The outcome was reported as not recovered. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint.  No further information was available at that time. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Injection site inflammation
Clinical narrative: Information has been received from an licensed practical nurse concerning a 12 month old female who on 19 Apr 2006 was vaccinated SC in the right upper thigh with a first dose of Varivax (lot # 652452/1016R). Concomitant vaccination on the same day included an IM Fourth dose in the left upper thigh of ActHIB (lot # UE788AA). On 27 Apr 2006, the patient developed vaccine site inflammation. She was started on Keflex (400/5mL 6cc TID x 7 days), warm compresses, and Motrin as needed for pain. No further information is expected.
Age: 1.0
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Injection site inflammation
Clinical narrative: Information has been received from a health professional concerning a 12 month old white male with gastroesophageal reflux disease, a history of premature birth at 34 weeks, and who was a twin, who on 27 Feb 2006 was vaccinated with a first subcutaneous dose of Varivax (Lot# 652455/1018R). Concomitant vaccine administered on the same day included a fourth intramusculuar dose of ActHIB (Lot #UE709AA). The patient was experiencing an upper respiratory infection at the time of vaccination and was being treated with over the counter medications. On 10 Mar 2006 the patient was seen in the office with a vaccine site inflammation. The patient was started on Ceftin, 125/5, 4 ml, twice per day for 10 days. It was reported that the patient recovered on 17 Mar 2006. The patient's twin sister experienced a vaccine site inflammation following vaccination with Varivax (WAES# 0605USA01887). Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: HBHEPB, VARCEL
Symptoms: Injection site inflammation
Clinical narrative: Information has been received from a health professional concerning a 12 month old white female with club feet and a history of premature birth at 34 weeks and who was a twin, who on 27-FEB-2006 was vaccinated with a first subcutaneous dose of Varivax (Lot# 652455/1018R). Concomitant vaccine administered that day included a fourth intramuscular dose of COMVAX (Lot# 647098/0964N). Concomitant therapy included ZITHROMAX, beginning on 27-FEB-2006, for the treatment of an upper respiratory infection with right otitis media, which the patient was experiencing at the time of vaccination. On 10-MAR-2006 the patient was experiencing at the time of vaccination. On 10-MAR-2006 the patient was seen in the office with a vaccine site inflammation. The patient was started on CEFTIN, 125 mg, twice per day for 10 days. It was reported that the patient recovered on 17-MAR-2006. The patient's twin brother experienced vaccine site inflammation following vaccination with Varivax (WAES# 0605USA01854). Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: No therapeutic response, Rash vesicular
Clinical narrative: Information has been received from a pediatrician who traveled to different sites daily. On 11-MAY-2006, she reported that she had seen a varicella outbreak over the previous 2 weeks. She personally had seen 6 cases and had heard other physicians talking about it as well. All the children were less than 18 years old. The 5 cases were mild break through cases (WAES0608USA05466). The 6th patient was an 8-10 year old male with no pertinent medical history who was vaccinated with Varivax and must have been a nonresponder since he had a severe case of lesions all over his body that were full of pus. The physician prescribed antibiotics because she was afraid the patient's skin would become infected. On 11-MAY-2006, the patient recovered his experience. The physician also noted that she had been practicing for over 18 years and had not seen this type of outbreak. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash pustular
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a dose of Varivax. On 10-MAY-2006 the patient experienced rash with may pustules scabbed over. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Erythema, Pruritus, Rash, Varicella
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 10-year-old male student with attention deficit/hyperactivity disorder (ADHD) and no known allergies who on 12-NOV-1999 was vaccinated SC in the left arm with a 0.5 mL first dose of Varivax (Lot #631071/1002J). Concomitant therapy included ADDERALL. There was no illness at the time of vaccination. The NP reported that on 11-MAY-2006, the patient developed spots all over. He was seen in the office with several pustules with one scabbed over, red itchy, raised rash, early stage varicella and low grade temperature. There were approximately 16-24 lesions and papules over his arms and torso with three on his face in various stages. He was treated with Aveeno Bath, BENADRYL and TYLENOL or MOTRIN. No laboratory/diagnostic tests were performed. On 15-MAY-2006, the patient recovered. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Herpes simplex serology positive, Herpes zoster, Skin ulcer
Clinical narrative: Information has been received from a licensed practical nurse concerning an 12-month-old female who on 01-DEC-2000 was vaccinated SC with a 0.5 mL dose of Varivax. Concomitant vaccination on the same day included a dose of MMR, a dose of PEDVAX HIB, and a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. On an unspecified date in 2001, the patient experienced atopic dermatitis. On 30-JAN-2006, the patient presented to the office with a "significant outbreak." There were ulcers on the legs and arms, but no ulcers on the trunk or face. Soaks were ordered and a vesicle culture was done with the result positive for "herpes simplex". The child recovered, but several chickenpox scars were still visible at the time of the report. A product quality complaint was not involved. Follow-up information from the licensed practical nurse indicated that on 07-DEC-2000 the patient developed a rash on her body that the provider determined to be a reaction to amoxicillin. On 30-JAN-206 the patient developed herpes zoster with ulcers noted on leg and arms. There were none on the patients trunk or face as of 30-JAN-2006. They were vesicular per provider. The patient's temperature and other systemic symptoms were not documented. The patient recovered. There was no history of chickenpox or recent exposure to chickenpox or herpes zoster. There was no documentation of a direct fluorescent antibody being performed. A specimen was not collected for PCR and a photo was not taken. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 7-year-old male on 29-JUL-1999 was vaccinated with a 0.5mL dose of Varivax (Lot # 630687/0443J). It was unknown if there was any illness at the time of vaccination. Concomitant therapy that day included a first 0.5cc dose (Lot # 631054/0374F) of MMR (second dose administered on 05-AUG-2007). Other therapy included: a first, second and fifth dose of diphtheria (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid on 09-SEP-1998, and 05-AUG-2002; a third and fourth 0.5cc dose of ACEL-IMUNE on 21-JAN-1999 (Lot # 457-790) and 26-OCT-1999 (Lot # 464305); a first and second dose of hepatitis B vaccine recomb on 24-JUL-1998 and 09-SEP-1998; a first and second dose of HIBTITER on 09-SEP-1998 and 19-NOV-1998; a fourth dose of HIBTITER (Batch # 423203A) on 26-OCT-1999; a third 0.5cc dose of COMVAX (Lot # 629303/1615H) on 21-JAN-2999; a 0.5mL dose of FLUZONE (Batch # U1172AA) on 15-DEC-2003; a first, second, and fourth dose of IPV on 09-SEP-1998, 19-NOV-1998, and 05-AUG-2002, a third 0.5cc dose of IPV (Batch # P0126) on 26-OCT-1999; and a dose of diphtheria toxoid/tetanus toxoid on 05-AUG-2002. On 02-MAY-2006 the patient experienced chickenpox. Unspecified medical attention was sought. Subsequently, the patient recovered from chicken pox. No additional information is expected.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 15-year-old male who was vaccinated SC with a 0.5 mL dose of Varivax. The physician reported that the patient subsequently developed breakthrough chickenpox. Unspecified medical attention was sought. At the time of this report, the patient's chicken pox were noted to be improved while on therapy (unspecified). No additional information is expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 10-year-old male with no pertinent medical history or allergies who on 06-FEB-1997 was vaccinated SC with a 0.5 mL dose of Varivax. There was no concomitant therapy. The physician reported that on 10-MAY-2006, the patient developed six chickenpox on his trunk. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. At the time of this report, the patient was recovering from the chickenpox. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Headache, Injection site rash, Pyrexia, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 16-year-old female with no pertinent medical history and with an allergy to EXTENDRYL and RAD who on 21-APR-2006 was vaccinated with a 0.5mL dose of Varivax (Lot # 652722/1127R). There was no concomitant medication. ON 04-MAY-2006 the patient experienced a rash at the injection site and two lesions on her abdomen and one on back. No treatment was required. There were no lab diagnostic studies performed. The outcome was reported as recovering. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information from the nurse indicated that the patient had a rash at the injection site, 2 lesions on the abdomen and one on the back, a fever of 101.5, a headache and dizziness. It was reported that the patient recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning a 12-year-old female with Crohn's disease, auto immune suppressed, with no known drug allergies, who at 3 years of age was vaccinated with a dose of Varivax. Subsequently, on an unspecified date, the patient underwent a serum varicella zoster virus antibody test that was negative. Unspecified medical attention was sought. No product quality complaint was involved. At the time of this report, the patient was on methotrexate. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 12-year-old male with no medical history or allergies who on 01-FEB-1996 was vaccinated SC with a 0.5 mL dose of Varivax. There was no concomitant therapy. The physician reported that on 10-MAY-2006, the patient developed breakthrough characterized by over 200 lesions above his chest. Unspecified medical attention was sought and the patient was treated with acyclovir. No laboratory/diagnostic tests were performed. At the time of this report, the patient's breakthrough persisted. The reporting physician considered breakthrough to be an other important medical event. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Scab, Varicella
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a female who on 19-SEP-2000 was vaccinated with a dose of Varivax (Lot #635188/0761K). The NP reported that the patient subsequently developed mild breakthrough chickenpox. Unspecified medical attention was sought. At the time of this report, the patient was noted to be recovering from the chickenpox as scabs had formed. Follow-up information from the NP indicated that she was unable to locate the patient's information. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a woman in a physician's office concerning a 7 year old male who was vaccinated with a dose of Varivax. The reporter noted that the patient was not vaccinated at her facility. On 21-APR-2006, the patient developed chickenpox and subsequently recovered. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Skin warm, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning a 6 year old male with no history of chickenpox who on 14-DEC-2001 was vaccinated on the left side with a 0.5 mL dose of Varivax (lot # 640072/0791L). No rash occurred at the site of injection or elsewhere within 42 days of vaccination. On 31-MAY-2006, the patient developed herpes zoster. His temperature was not taken but he felt warm. He had no other systemic symptoms. At the time of the report, he still had spots. The physician noted that she would like to submit a specimen for varicella zoster virus identification. Additional information was received from a health professional which indicated that a vesicular lesion specimen was obtained on 15-MAY-2006 and sent to the laboratory for varicella zoster virus identification on 16-MAY-2006. Varicella zoster virus DNA was amplified and the interpretation was adequate specimen, vaccine strain. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a pediatric patient who was vaccinated with a dose of Varivax. Subsequently the patient developed a mild case of chickenpox. No further information is available. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Body temperature increased, Varicella
Clinical narrative: Information has been received from a health professional concerning a 10 year old female, with no medical history or no allergies, who on 20-FEB-2001 was vaccinated with a dose of Varivax. Subsequently, the patient experienced mild, breakthrough chickenpox. At the time of the report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a health professional indicated that on 15-MAY-2006 the patient came into the office with a chief complaint of a rash on her belly and back that began "approximately 2 days ago", on approximately 13-MAY-2006, on the back. It was reported that the rash was blister-like and was crusting. The patient was instructed to continue calamine lotion and could return to school since all lesions were crusted. It was reported that the patient had recovered. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site rash, Lymphocyte count increased, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 7 year old white male with no known medical history or allergies who was vaccinated IM in the right thigh with a first 0.5 mL dose of Varivax. On 20-FEB-2006 the patient developed singles at the injection site. A doctor's visit was required. A CBC was performed which showed a high white blood cell count (11.7 K/uL) and an high lymphocyte count (4.3). The patient was treated with acyclovir (ZOVIRAX). The patient's outcome was not reported. There was no product quality complaint involved. Additional information is not expected.
Age: 1.2
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 6 year old patient who on 19-JAN-2001 was vaccinated with Varivax, 0.5 mL once. On 08-MAR-2006 the patient had a breakthrough case of chickenpox lesions. The patient's outcome was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 7-year-old white female who on 09-JUN-1999 was vaccinated subcutaneously with Varivax (Lot # 630474/0422J), 0.5 mL once. On 08-MAR-2006 (previously reported as 02-MAR-2006), the patient had a breakthrough case of chickenpox lesions. Unspecified medical attention was sought. The patient's outcome was reported as recovered. There was no product quality complaint involved. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an unspecified number of patients (at least 5) who on unspecified dates were vaccinated with doses of Varivax. Subsequently the patients developed breakthrough cases of chickenpox. The patients' outcomes were not reported. No further information is available.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 2 year old male who was vaccinated with a dose of Varivax. "Last week", on approximately 09-MAY-2006 the patient developed chickenpox., Unspecified medical attention was sought. The patient's outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Rash generalised, Varicella
Clinical narrative: Information has been received from a physician concerning a 45-month-old male who in December 2003, was vaccinated PO with a dose of Varivax (Lot # 645289/0325N). On 17-APR-2006 the patient presented to the office with a rash all over his body. The physician called it full blown varicella. On 02-MAY-2006, the child still had a rash. On 16-MAY-2006, the child only had three open lesions on his face and the rash had improved on the rest of his body. The outcome was reported as recovered. No other information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Adverse event
Clinical narrative: Information has been received concerning an 8 year old female who was vaccinated with a dose of Varivax. On 10-MAY-2006 the patient developed "less than 50". The patient's outcome was unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a nurse practitioner concerning a female child who on 17-APR-2003 was vaccinated SQ with a 0.5 mL dose of Varivax. Recently, the patient developed "full blown case" of chickenpox. The child had several hundred lesions and went to the ER. The patient's outcome was reported as recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male with no known allergies or medical history, who on 14-JAN-1999 was vaccinated in the left arm with a first dose of Varivax (lot # 628147/1262H). There was no illness at the time of vaccination. ON 12-MAY-2006 the patient developed a breakthrough case of varicella of about 20 lesions on his trunk, arms, neck and face. The patient was seen in the physician's office but he received no treatment and he was not hospitalized. No diagnostic or lab tests were performed. Subsequently the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old male who on 12-JUN-1996 was vaccinated with a dose of Varivax. On 15-MAY-2006 the patient developed a breakthrough case of varicella. It was reported that the patient had 50+ lesions on his trunk and extremities. The patient was seen in the physician's office but he received no treatment and he was not hospitalized. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a health professional concerning a 44 year old female employee, with no medical history and no allergies, who was vaccinated with a 0.5 ml subcutaneous dose of Varivax (Lot# 649644/1050P) on 18-JAN-2006 and another 0.5 ml subcutaneous dose of Varivax (649644/1050P) on 01-MAR-2006. There was no concomitant medication. It was reported that on 26-APR-2006 the patient had a titer that was 0.68 and prior to vaccination her titer was 0.64. It was reported that the patient had not recovered at the time of the report. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Culture, Herpes zoster, Incorrect route of drug administration, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 13-month-old healthy male with no pertinent medical history of allergies and known history of varicella exposure, who on 24-JAN-2006 was vaccinated intramuscularly in the left leg with a 0.5 ml dose of Varivax (lot# 652081/0942R). There was no concomitant medication. On 13-MAY-2006 the patient developed a rash with many lesions. On 17-MAY-2006, the patient was seen by a pediatric dermatologist and was diagnosed with zoster. The site of the zoster was the right groin and buttock and involved 2 dermatomes. It was reported that the physician cultured the lesions for PCR analysis but results are pending at the time of the report. The patient had not recovered. No product quality complaint was involved. Follow-up information received on 01-JUN-2006 and 06-JUN-2006 indicated that the 2 large swab specimens were inadequate; therefore, no results were reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a registered nurse (RN) concerning a phone call from the mother of a 6-year-old white male with no known drug allergy who on 09-MAY-2001 was vaccinated subcutaneously in the left thigh with a first dose of Varivax (lot# 637957/1882K). Concomitant therapy included a first dose of MMR II (lot# 638373/0164L) given subcutaneously in the right thigh. There was no illness at the time of vaccination. On 12-MAY-2006 the patient developed a rash described as small, pinpoint and red with blisters in some areas. The rash was in small clusters on his chest, back and neck and was itchy. No fever was reported. No medical attention was sought; no laboratory or diagnostic tests were performed. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular
Clinical narrative: information has been received from a registered nurse concerning an 8-year-old white male with no known drug allergies, birth defects, or medical conditions who on 20-NOV-1998 was vaccinated in the left thigh with a dose of Varivax (Lot # 627748/1059H). There was no illness at the time of vaccination. On 10-MAY-2006 in the AM, the patient developed 40 spots on his back, chest, and legs. They were noted to be itchy, vesicles, and crusted. Follow up information indicated that no additional information was available. No additional information is expected.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 13-month-old female who about 10 days prior to the adverse experienced, on approximately 06-MAY-2006, was vaccinated with a dose of Varivax at the health department. On 16-MAY-2006 the patient developed an erythematous rash, with a vesicular papule by her right nipple with a few barely raised tiny papules on her abdomen and fading papules on her right arm. No lesions were scabbed. She was seen in the physician's office on 16-MAY-2006. It was noted that it may have been a possible reaction to the vaccine. The patient's mother was told to call if the rash increased or worsened. No outcome was reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Information has been received from a health professional concerning a 7 year old white male with no known allergies who on 03-JUN-1999 was vaccinated SC in the right thigh with a first dose of Varivax (lot # 630037/0290J). Concomitant therapy included a first dose in the right thigh SC of MMR (lot # 630101/0117J). There was no illness at the time of vaccination. On 10-MAY-2006 the patient's mother reported that he had little red dots on his shoulders and a few on his back. He complained of itchiness. Some spots were crusted over. It was a "very light case" per mom. No labs were done and no medical attention was sought. Subsequently the patient recovered. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood culture, Blood immunoglobulin G increased, Blood immunoglobulin M, Dermatitis atopic, Exposure to communicable disease
Clinical narrative: Information has been received from a physician concerning a 9-year-old male who was vaccinated with Varivax on an unspecified date. On 18-MAY-2006 it was reported that "in the last few days" the patient showed signs of varicella virus. Unspecified medical attention was sought and the patient was hospitalized. No lesion count was reported. No length of admission was reported and at the time of the report the patient had not yet recovered. No product quality complaint was involved. Follow-up information was received on 05-OCT-2006 from a physician indicating that the patient's rash was a varicella-like rash which was experienced 8 years after vaccination. The rash appeared as a super-infected varicella rash; however, it is not certain whether the rash is varicella related. The physician noted that there were no serological reports to support it. It was also reported that the patient was hospitalized twice. No recovery information was reported. Follow-up information was received on 12-OCT-2006 indicating that the patient was 7-years-old (not 9 as previously reported) and he received the Varivax as a toddler. As of 16-MAY-2006, he was treated for what was thought to be superinfected varicella after an exposure to shingles. However, the IgM was not at all elevated indicating no current infection and the IgG was elevated, likely indicating immunity. Hence, the reporter noted that this was unlikely varicella, more likely a variant of atopic dermatitis, superinfected. The patient was hospitalized for seven days. The following laboratory or diagnostic tests were performed: Herpes simplex and varicella zoster boil specimens negative; and negative for clostridium diff toxins in feces. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes simplex serology negative, Rash vesicular, Stool analysis normal, Varicella, Viral test negative
Clinical narrative: Information has been received from a physician concerning a 9-year-old male who was vaccinated with Varivax on an unspecified date. On 18-MAY-2006 it was reported that "in the last few days" the patient showed signs of varicella virus. Unspecified medical attention was sought and the patient was hospitalized. No lesion count was reported. No length of admission was reported and at the time of the report the patient had not yet recovered. No product quality complaint was involved. Follow-up information was received on 05-OCT-2006 from a physician indicating that the patient's rash was a varicella-like rash which was experienced 8 years after vaccination. The rash appeared as a super-infected varicella rash; however, it is not certain whether the rash is varicella related. The physician noted that there were no serological reports to support it. It was also reported that the patient was hospitalized twice. No recovery information was reported. Follow-up information was received on 12-OCT-2006 indicating that the patient was 7-years-old (not 9 as previously reported) and he received the Varivax as a toddler. As of 16-MAY-2006, he was treated for what was thought to be superinfected varicella after an exposure to shingles. However, the IgM was not at all elevated indicating no current infection and the IgG was elevated, likely indicating immunity. Hence, the reporter noted that this was unlikely varicella, more likely a variant of atopic dermatitis, superinfected. The patient was hospitalized for seven days. The following laboratory or diagnostic tests were performed: Herpes simplex and varicella zoster boil specimens negative; and negative for clostridium diff toxins in feces. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 10 year old white female who on 16-AUG-1996 was vaccinated SC in the left thigh with a dose of Varivax (lot # 617265/0566D0. On 16-MAY-2006, at 1:00 p.m., the patient started with spots on the neck area and then had them on the back, face, and chest. She also had a few on the arms and legs. The experience required a doctor visit. On an unspecified date, the patient recovered. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Herpes zoster, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 6 year old (previously reported as a 4 year old) white female who on 12-JUN-2001 (previously reported as one day the week of 09-MAY-2006) was vaccinated SC on the left side with a first dose of Varivax (lot # 637974/1896K). There was no illness at the time of vaccination. On 04-MAY-2006 the patient developed shingles around the eye and face with second degree cellulitis. Unspecified medical attention was sought. On 04-MAY-2006 a culture was done that was positive for the varicella-zoster virus. She was treated with acyclovir, mupirocin (BACTROBAN), ceftriaxone sodium (ROCEPHIN), and amoxicillin (+) clavulanate potassium (AUGMENTIN). Subsequently, the patient recovered. The patient's shingles was considered to be an other important medical event. No further information is available.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 5 year old male who was vaccinated with a 0.5ml SC dose of Varivax. On 08-MAR-2006 the patient experienced breakthrough varicella. Unspecified medical attention was sought. 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 physician concerning a 4 year old male who on 06-JUN-2002 was vaccinated with a 0.5ml SC dose of Varivax. On 16-MAR-2006 the patient experienced breakthrough varicella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 4 year old male who on 28-APR-2003 was vaccinated with a 0.5 ml SC dose of Varivax. On 09-FEB-2006 the patient experienced breakthrough varicella. Unspecified medical attention was sought. 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 physician concerning a 6 year old male who on 29-AUG-2000 was vaccinated with a 0.5ml SC dose of Varivax. On 23-MAR-2006 the patient experienced breakthrough varicella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 17 month old female who on 09-MAR-2006 was vaccinated SC with a 0.5ml dose of Varivax. On 20-MAR-2006 the patient experienced breakthrough varicella. Unspecified medical attention was sought. No product quality complaint was 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 7 year old male who on 29-NOV-1999 was vaccinated with a 0.5 ml SC dose of Varivax. On 06-MAR-2006 the patient experienced breakthrough varicella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 24 month old male who on 07-JUN-2005 was vaccinated SC with a 0.5ml dose of Varivax. On 03-MAR-2006 the patient experienced breakthrough varicella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 6 year old male who was vaccinated SC with a 0.5ml dose of Varivax. On 27-MAR-2006 the patient experienced breakthrough varicella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old hispanic male with attention deficit/hyperactivity disorder and no allergies who on 15-JUN-1998 was vaccinated SC with first dose of Varivax (lot # 625372/0057H). Concomitant vaccination on the same day included an IM fourth dose of HIBTITER (lot # M240R). Concomitant therapy included POCALIN, ZOLOFT, vitamins (unspecified), and "XR-20". There was no illness at the time of vaccination. On 08-MAY-2006, the patient developed varicella breakthrough on his trunk, arms, legs, and face. The nurse states the lesions were too numerous to count. Unspecified medical attention was sought and he was treated with calamine lotion. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date. A product quality complaint was not involved. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning an employee's child who was vaccinated with a dose of Varivax and "recently", in approximately April 2006, the patient had a mild case of chicken pox breakthrough. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from an office manager concerning a 20 month old female who on 19-AUG-2005 was vaccinated with Varivax (lot # 646817/1063N). In January 2006 the patient experienced chicken pox. It was unknown if medical attention was sought. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a health professional concerning a 32 year old female, with no medical history and no allergies, who was vaccinated with a first and second dose on 10-JUN-2002 and 08-JUL-2002, respectively, of Varivax. It was reported that a varicella titer on 16-MAR-2006 was negative. It was reported that at the time of the report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer concerning her son a 7 year old male with asthma and no known allergies who in October 1999, was vaccinated SC with a 0.5 mL dose of Varivax. Concomitant therapy included montelukast sodium. On 17-MAY-2006 the patient developed mild case of chickenpox. Unspecified medical attention was sought. No laboratory tests were performed. At the time of the report the patient was improving. There was no product quality complaint involved. Additional information has been requested.