chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Dermatitis bullous, Headache, Pruritus, Rash pustular
Clinical narrative: Information has been received from a health professional concerning a 28 year old black female with polycystic ovarian syndrome who on 07-JUL-2005 was vaccinated SC with a 0.5 ml first dose of varicella virus vaccine live (Oka/Merck) (lot # 648297/02178R). Concomitant therapy included a first (lot ABBVB074AA) and second (lot AHBVB074BA) dos IM of hepatitis B virus vaccine rHBsAg (yeast) (ENGERIX-B) on 09-JUN-2005 and 07-JUL-2005 respectively. There was no illness at the time of vaccination. "Two weeks later", on approximately 21-JUL-2005, the patient developed a varicella like rash. All symptoms have since resolved and the patient is recovered. Unspecified medical attention was sought. Follow-up information indicated that on 23-JUL-2005 the patient had a headache. On 24-JUL-2005 the patient had watery pustules on the back, abdomen and chest that were itching constantly. The patient had a doctor visit and recovered on 01-AUG-2005. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Info has been received from an RN concerning a child who was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live. The RN reported that in 2005, the pt broke out with less than 100 lesions 7-10 days post vaccination. Unspecified medical attention was sought, but no treatment was administered. At the time of this report, the outcome was unknown. Additional info has been requested.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, OPV, VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Info has been received from an RN concerning a 7 year old white female with no allergies or medical history who on 4/6/99 at 10:40 AM was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live. Concomitant vaccinations given on the same day and time included: the 5th dose of Hib conj vaccine (Hib-Titer) (lot 402253A) given IM, in the right leg, the 4th dose of (Acel-Immune) ( lot 457792) given IM, in the left leg, the 1st dose of MMRII (lot 645399/0103N), given SC, in the right leg and the 4th dose of poliovirus vaccine live oral (Orimune) (lot 794L1) given PO. On 8/19/05, the pt experienced 5 lesions on the right shoulder and abdomen which was described as chickenpox characterized by a generalized red rash with slightly pruritic skin lesions. The pt also had 4 open sore areas on the antecubital area of the right arm which was described as impetigo. There was no fever. The pt was treated with Augmentin, 500mg/5ml, 2 tsp BID for 10 days; Tylenol and Benadryl or Claritin for itching. No diagnostic lab test were performed. At the time of the report, the pt's outcome was reported as unknown. No product quality complaint was involved. Follow-up info received from an RN on 9/26/05, indicated that there was no info on the recovery of the pt because the pt's parents had not called back. Additional info is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a consumer, who had chickenpox as a child, according to her mother, who had cared for two children who had chickenpox, and who had a titer which showed no immunity to the disease, who, "about seven years ago", in approximately 1998, was vaccinated with a series of varicella virus vaccine live (Oka/Merck). It was reported that "recently", in 2005, the patient had another titer and it again showed no immunity. It was noted that the patient's doctor suggested to get the series again. Additional information has been requested.
Age: 1.13
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician and a school nurse concerning a 13 month old male between the 2nd and 5th grad who on 11/13/95 was vaccinated with a dose of varicella virus vaccine live. It was noted that the pt also received a dose of MMRII on 11/3/95 (within 30 days of varicella virus vaccine live. A school nurse reported to the physician that the child developed a mild cases of breakthrough varicella with less than 50 lesions. Unspecified medical attention was sought. A product quality complaint was not involved. Follow-up info indicated that on 3/24/05, the pt developed a mild case of breakthrough varicella. The outcome was reported as recovered. No additional info is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a school nurse concerning a senior in high school who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). the school nurse reported a case of break through chickenpox that began on approximately 07-MAR-2005. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a child who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "Several year ago" the patient developed break through chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. No further information is available.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a health professional concerning a 21 year old female who in her youth, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that on 04-AUG-2005 the patient failed to show seroconversion in a recent test. The patient had two titers drawn and both were equivocal. Unspecified medical attention was sought. No product quality complaint was involved No other information was provided.
Age: 1.34
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Information has been received from a mother concerning her 21 month old white male son with a history of ear infections and no allergies, who on 04-MAR-2005, was vaccinated once with a subcutaneous 0.5ml dose in the right thigh of varicella virus vaccine live (Oka/Merck) (Lot# 648944/0894P). There was no concomitant medication. It was noted that the patient was healthy child at the time of vaccination and that there were no adverse events following prior vaccination. On 22-AUG-2005 the patient experienced shingles covering the right side of his chest and back and his stomach. At the time of the report the patient had not recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from the patient's mother indicated that he was given acyclovir (ZOVIRAX) and that he had no complications and no secondary infections or problems. It was reported that the patient recovered. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 3-year-old female who on 19-AUG-2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 27-AUG-2005the patient developed less that 50 lesions and on 28-AUG-2005 the patient developed a fever. Unspecified medical attention was sought. No further information was available at the time of the report. No product quality complaint was involved. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site vesicles, Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 38 year old white female with an allergy to cephalexin and no medical history who on 8/10/05, at 9:00 am, was vaccinated SC in the right upper arm with a 0.5ml first dose of varicella virus vaccine live (lot # 648315/0072R). There was no illness at the time of vaccination. Concomitant therapy included topiramate, Sumatriptan succinate, and cyclobenzaprine HCl. On 8/25/05, the patient developed less than 10 skin lesions and vesicles generalized at the site, back, calf, genitalia, and abdomen with a cough. On 8/29/05, the patient was seen at the office with a few more lesions. The patient was treated with calamine lotion and diphenhydramine hydrochloride. It was noted that she also had pain in the arm at the injection site with soreness that felt like it had roots. No redness was noted. The patient was afebrile. No diagnostic laboratory tests were performed. at the time of the report, the patient had not recovered. A product quality complaint was not involved. Follow up information indicated that on 8/25/05, at 12 AM, (10 days after vaccine administration) the patient complained of itching vesicles. There were 3 on the right upper arm, 1 on the abdomen, 1 on the right breast. 14 days after the vaccine, the patient had additional lesions 1 on the left calf, 2 on the right arm, and 1 on the genitalia. There was soreness at the right upper arm injection site, but there was no visible redness. The patient recovered on 9/1/05. Additional information is not expected.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 9 year old male who with not known medical history or allergies who on 01-OCT-1996 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 26-August-2005 the patient developed 75 chickenpox lesions on chest, back, and abdomen. The lesions were described by the physician as "some healed, some papular, some scaly and some vesicular". The physician said in the chart "questionable healing varicella". The patient was itchy with no fever. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. At the time of this report the patient was recovering. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site hypersensitivity, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 9-year-old white female who on 13-JUL-2005, at approximately 14:00 was vaccinated SC in the right arm with the first dose of varicella virus vaccine live (Lot #647264/0437P). The physician reported that on 13-JUL-2005, right after vaccination, the patient developed a welt at the site. The physician also reported that on 22-JUL-2005, the patient's injection site area became red, swollen and with a rash. The patient was treated with amoxicillin (250mg/5mL, 3 12 tsp. BID x 10 days). As of 28-JUL-2005, the patient's injection site area was noted to be healed. No further information is available.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a health professional concerning a 44 year old female with multiple sclerosis and no allergies who "about 10 years ago" in approximately 1995, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "In the past year", in approximately 2005, the patient had titer which was negative. It was reported that the patient has not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a female patient who was vaccinated once with a 0.5ml SC dose of varicella virus vaccine live. It was reported that the patient came to the office with about seven chicken pox lesions. 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: Rash, Viral infection
Clinical narrative: Information has been received from a physician's employee concerning her 8 year old son who about seven years ago (in approximately 1998) was vaccinated with a dose of varicella virus vaccine live. Within the last month, in August 2005, the patient experienced serious breakthrough chickenpox. Unspecified medical attention was sought. It was reported that the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 22 month old male (previously reported as about 2 and 1/2 years old) with no known medical history or allergies who on 9/14/04 was vaccinated in the PM in the left arm with a SC first dose of varicella virus vaccine live (lot 3 648048/1347N). Concomitant vaccination that day included an IM second dose of HIB conj-hepatitis B Vaccine (lot # 647595/0027P) in the left arm. There was no illness at the time of vaccination. On 6/30/05 at 14:00 the patient developed a mild case of breakthrough varicella. It was later reported that the patient had a fever of 104 and two days later erupted in an erythematous vesicular rash in clusters. Unspecified medical attention was sought. The patient was treated with supportive care. No laboratory diagnostic tests were performed. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Medication error, Musculoskeletal stiffness, Pain, Pyrexia, Rash macular
Clinical narrative: Rash maculopapular; Pain; Headache; Pyrexia; Incorrect route of drug administration; Musculoskeletal stiffness. Information has been received from a physician concerning a 17 year old white male with no allergies or medical conditions who on 10-AUG-2005 was vaccinated IM in the left arm with a dose of varicella virus vaccine live (Oka/Merck) (lot #645288/0689N). On approximately 31-AUG-2005, the patient experienced about eight maculopapular lesions and achiness. On 31-AUG-2005, the patient was seen in the emergency and had not recovered. A product quality complaint was not involved. Follow up information indicated that on 30-AUG-2005, the patient developed 7 or 8 sporadic varicella like lesions that were maculopapular on the trunk and extremities. They were noted on exam on 30-AOG-2005. The patient also complained of a headache, achiness and a stiff neck with a low grade fever. The patient went to the ER on 31-AUG-2005 but no treatment was required. It was felt the symptoms were secondary to a side effect of the vaccine and that his age group can get a rash after vaccination. The patient's symptoms resolved and he is doing well. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Rash maculopapular; Pain; Headache; Pyrexia; Incorrect route of drug administration; Musculoskeletal stiffness. Information has been received from a physician concerning a 17 year old white male with no allergies or medical conditions who on 10-AUG-2005 was vaccinated IM in the left arm with a dose of varicella virus vaccine live (Oka/Merck) (lot #645288/0689N). On approximately 31-AUG-2005, the patient experienced about eight maculopapular lesions and achiness. On 31-AUG-2005, the patient was seen in the emergency and had not recovered. A product quality complaint was not involved. Follow up information indicated that on 30-AUG-2005, the patient developed 7 or 8 sporadic varicella like lesions that were maculopapular on the trunk and extremities. They were noted on exam on 30-AOG-2005. The patient also complained of a headache, achiness and a stiff neck with a low grade fever. The patient went to the ER on 31-AUG-2005 but no treatment was required. It was felt the symptoms were secondary to a side effect of the vaccine and that his age group can get a rash after vaccination. The patient's symptoms resolved and he is doing well. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella Information has been received from a physician concerning a 6 year old female described as healthy who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Within the last few weeks, in August 2005, the patient developed breakthrough varicella with about 10 lesions. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity
Clinical narrative: Hypersensitivity Information has been received from a pharmacist concerning a 21 year old female who in 2004 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, in 2004, the patient developed a reaction from the gelatin. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complain involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site pain, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 05-AUG-2005 was vaccinated with a dose of VARIVAX(Merck). On 10-AUG-2005 the patient experienced pain in her left arm injection site. This was followed on 13-AUG-2005 by appearance of greater than 100 injection site lesions which the physician believes to be characteristic of shingles lesions. The patient was seen by a health professional at a facility on an unspecified date and on 17-AUG-2005 the patient began a 10 day course of treatment with valacyclovir. A second 10 day course of valacyclovir was necessary. The patient was also given Vicodin for pain. There was no information regarding the patient's present status. No product quality complain was involved. The physician considered the adverse experiences to be other important medical events. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 13-month-old male who on 23-AUG-2005 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot # 651042/0214R). On 01-SEP-2005 the patient presented to the physician's office with a generalized itchy rash. The physician noted that the patient did not have a fever or malaise. At the time of this report the patient had not recovered. No further information available. No product quality complaint was involved. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Information has been received from an office manager concerning her 4-year-old daughter who, in approximately 1995, at 4 years of age, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Between the age of 4 and 14, from approximately 1995 to 2005, the patient developed 3 outbreaks of what were believed to be shingles. These outbreaks developed on a regular interval about every 3-4 years. The outbreaks were described as bands that went around the child's abdomen (first outbreak), her legs (second outbreak) and her back (third outbreak). Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Rash vesicular
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 28-year-old female who on 23-AUG-2005 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 649439/0115R) adult schedule. About one day after being vaccinated, on 24-AUG-2005,5 the patient experienced vesicular rash. Unspecified medical attention was sought. The rash has resolved but the patient still complains of soreness and redness at the injection site. At the time of reporting it was reported that the patient is recovering from the soreness and redness at the injection site. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 32-year-old male who in 1997 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck)., adult schedule. On 14-JUL-2005 the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot# 648297/0217R). About one day post vaccination (on 15-JUL-2005, the patient experienced a slight rash on her arm. Subsequently, the patient recovered. No further information was given. No product quality complaint was involved. Additional information has been requested.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Medication error, Rash vesicular
Clinical narrative: Varicella; medication error Information has been received from a physician concerning a 7 year old female with a healthy medical history and no allergies who on 15-SEP-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) that the reported noted had been ordered through the local hospital and did not think was transported properly to the office. There was no concomitant medication. It was reported that on 07SEP-2005 the patient experienced breakthrough varicella of about 20 crusted lesions and no fever. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. Body temp 09/07/05 no fever
Age: 0.98
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Varicella Information has been received from a registered nurse concerning a 7 year old male with no pertinent medical history and no drug reactions/allergies who on 02-DEC-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. There was no concomitant medication. On 08-SEP-2005 the patient was seen by a physician for a rash scattered over his trunk, axilla, and groin. No rash was noted on his face. No fever or other complaints were noted. The physician prescribed isolation for 5 days and treated symptomatically. The outcome was reported as no recovered. No lab diagnostic studies were performed. There was no product quality complaint. Follow up information received from a registered nurse indicated that the office note indicated "florid varicella rash in crops: trunk red axilla red groin". Total number of lesions was noted to be greater than 150. The patient was afebrile. Symptomatic treatment was noted. The outcome was recovered on 11-SEP-2005. There were no adverse events following prior vaccinations.  No additional information is expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 9 year old white female, with no medical history and no allergies who on 30-OCT-1996 was vaccinated with a first subcutaneous dose n the left arm of varicella virus vaccine live (Oka/Merck) (Lot# 617263/0564D). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. On 03-SEP-2005, the patient experienced a case of breakthrough of about 50 lesions with no complications. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that on 01-SEP-2005 the patient experienced a varicella illness with approximately 50 lesions. It was reported that the patient recovered on 08-SEP-2005. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 13-year-old male patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The physician reported that the patient subsequently developed chickenpox (also reported as possible breakthrough varicella) characterized by approximately 80 lesions. Unspecified medical attention was sought. at the time of this report, the outcome was unknown. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 42-month-old male who on 18-MAR-2003 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). The RN reported that on 02-SEP-2005, the patient developed 10 lesions after he was exposed to his mother who had wild-type chickenpox. Unspecified medical attention was sought and the patient was noted to be afebrile. At the time of this report, the patient was recovering and he was noted to be doing well. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Hypersensitivity, Rash
Clinical narrative: Rash Information has been received from a health professional concerning a 14 month old white male with topical sensitivities who on 17-AUG-2005 was vaccinated SC in the left anterior leg with a first dose of varicella virus vaccine live (Oka/Merck) (lot #646547/0392R). Concomitant vaccine therapy that day included a first subcutaneous dose in the left upper arm of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Winstar RA 27/31) (MSD) (lot#649509/0773P), a first dose IM in the left anterior leg with HIB conj-hepatitis B vaccine (MSD) (lot #650989/357R), a third dose IM in the right anterior leg of diphtheria toxoid (+) pertussis acellular 3 component vaccine (+) tetanus toxoid (Infanrix) (lot #AC14A006BA) and a third dose SC in the right anterior leg of poliovirus vaccine inactivated (Vero) (IPOL) (lot Y0325). There was no illness at the time of vaccination. It was reported that the patient had previously received 2 doses of Hib vaccine (unspecified) (manufacturer unknown) and 2 doses of hepatitis B virus vaccine (unspecified) (manufacturer unknown). On 29-AUG-2005 the patient experienced a rash on his body. It seemed to start on his back and spread to the front and the arms. On 01-SEP-2005 the patient had a faint rash on the face. It was noted that the patient had a doctor appointment on 06-SEP-2005 and will report back to the office if anything comes up. He was given diphenhydramine hcl (Benadryl) last night and today with good results. No labs were done. No additional information was reported. Follow-up information from a health professional indicated that the patient's mother reported that the child's doctor thought that the patient was hyper allergenic and encouraged the use of diphenhydramine hcl (Benadryl). It was reported that since the original episode the patient had had four outbreaks from topical agents. I was noted that the patient never had a fever and had no food sensitivities, just topical sensitivities. Additional information is not expected.
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a four year old male patient with no allergies or pertinent medical history who on 17-AUG-2001 was vaccinated with varicella virus vaccine live (Oka/Merck) by his previous pediatrician. The patient was not ill at the time of vaccination. On 17-JUL-2005 a rash appeared., it was reported to be a chicken-pox breakthrough (also reported as "not clear cut varicella, but suspicious"). It is unknown as to whether the patient has a fever because no temperature was taken, but as per the patient's mother the patient felt warm. The patient presented to the office on 19-JUL-2005 with less than 50 non-vesicle lesions on his face, back, and behind ears. The patient's treatment was reported as symptomatic treatment which included instruction to watch for fever. There were no laboratory or diagnostic tests performed. The patient recovered on 20-JUL-2005. The patient did not have adverse events following prior vaccinations. There was no product quality complaint reported. No additional information is expected. The reporter also mentioned that the patient's male sibling had chicken pox breakthrough following vaccination with varicella virus vaccine live (Oka/Merck) (WAES# 0507USA02835).
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Neuralgia, Pain, Skin burning sensation
Clinical narrative: Herpes Zoster; Varicella Information has been received from a physician concerning her healthy 17 year old daughter with an allergy to cefaclor (Ceclor) who "15 years ago" at the "age of two" in "approximately 1990" was vaccinated with a 0.5ml subcutaneous dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. "At age 5" in approximately 1993, the patient was exposed to chicken pox and developed a few lesions. Then, on 08-SEP-2005, the patient complained of shoulder pain. On 10-SEP-2005 she developed zoster on her arm with pain and burning. At the time of the report the patient was receiving acyclovir therapy and had broken out in two new areas wit the last 24 hours. At the time of the report it was noted that the patient had not recovered. No product quality complain was involved. No other information was provided. Follow-up information from a physician indicated that the patient developed full blown shingles, one dermatome, described as a classic rash with pain and neuralgia. It was also noted the patient had fluid filled vesicles and was pretty uncomfortable. Follow-up information from a physician indicated that the patient had a recent exposure to shingles from a classmate in school. It was also noted that a vesicle was obtained for VZV identification. Follow-up information from a physician indicated on 14-AUG-2005 a lesion was obtained for VZV identification and VZV DNA was amplified. The interpretation was that it was an adequate specimen wild type strain. On 16-SEP-2005 a lesion was obtained for VZV identification and no VZV DNA or B-globin DNA was amplified and it was interpreted to be an inadequate specimen, negative for B-globin, no strain identification. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: Varicella Information has been received from a physician and a licensed practical nurse (LPN) concerning a 26 month old white male with a penicillin allergy and no other medical history who on 02-SEP-2005 at 10:00 was vaccinated SC in the right arm with the first does of varicella virus vaccine live (Oka/Merck) (Lot #648936/0114R). There was no concomitant therapy or illness at the time of vaccination. It was reported that on 10-SEP-2005, the patient developed a fever. On12-SEP-2005 the patient developed a rash on his torso. The patient was seen by a physician who determined that the patient had atypical varicella resolved. There was no product quality complaint. Additional information is not expected. Body temp 09/10/05 fever.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: Varicella;Varicella Information has been received from a woman working in a physician's office concerning a 9 year old white female with no medical history and no allergies who on 19-SEP-1995 was vaccinated with a first subcutaneous dose in the right arm of varicella virus vaccine live (Oka/Merck) (Lot# "0397159196"). There was no illness at the time of vaccination. In May 2000, the patient had an outbreak of chickenpox vesicles described as itchy, diffuse and spreading with a low grade fever. The experience resolved after approximately 1 week. In July 2003, the patient had a second outbreak of chickenpox vesicles described as itchy diffuse and spreading with a low grade fever. This experience also resolved after approximately 1 week. Additional information has been requested. Body temp 5/00 low grade fever body temp 7/03 low grade fever.
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning an adult female who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced spots. It was reported that the patient recovered. Unspecified medical attention was sought. No other information was provided. No other information was provided. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Antibody test negative; Information has been received from a health professional concerning a female employee who in February 1998 and April 1998 was vaccinated with doses of varicella virus vaccine live (Oka/Merck). A titer done in June 1998 was negative. She received a dose of varicella virus live (Oka/Mercek) again on 21-JUN-1999. A titer done on 13-JUL-1999 was positive. On -3-DEC-2001 the patient had another titer done that was negative. It was reported that the patient did not recover. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Choking, Dysphagia, Dyspnoea, Joint stiffness, Joint swelling
Clinical narrative: Local Swelling; Dyspnea; Malaise; Choking Sensation; Dysphagia; Sputum Retention; Joint Swelling; Musculoskeletal Stiffness Information has been received from a health professional concerning a 34 year old white female with allergies to dust, mites, grass and mold, and a history of heart palpitations who was vaccinated with a first and second dose of varicella virus vaccine live (Oka/Merck) on 16-JUN-2005 and 12-SEP-2005 (lot #649442/0220R, administered SC at 16:00) Concomitant vaccination given at 16:00 on 12-SEP-2005 included an intradermal dose of tuberculin purified protein derivative (TUBERSOL). There was no illness at the time of vaccination. On 13-SEP-2005, the patient developed swelling in her neck and shoulders which was not visible. She did not feel well and could not swallow or breath normally. The patient was afebrile. Unspecified medical attention was sought. The nurse reported that she was going to give the patient diphenhydramine hydrochloride (Benadryl). No laboratory diagnostic tests were performed. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that on 15-SEP-2005 at 14:00 the patient complained of feeling swollen on both sides of the neck, her throat felt sticky and she couldn't breath properly, she had to take deep breathes to get air. The patient had a body temperature of 97.8. She had a stiff neck. The patient was treated with diphenhydramine hydrochloride (Benadryl). The patient felt like her throat was closing up. She was given methylprednisolone (MEDROL) dose pack. It was reported that the patient "had no problems" after her first dose of varicella virus vaccine live (Oka/Merck) At the time of the report the patient's status was unknown. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Malaise, Musculoskeletal stiffness, Productive cough, Swelling
Clinical narrative: Local Swelling; Dyspnea; Malaise; Choking Sensation; Dysphagia; Sputum Retention; Joint Swelling; Musculoskeletal Stiffness Information has been received from a health professional concerning a 34 year old white female with allergies to dust, mites, grass and mold, and a history of heart palpitations who was vaccinated with a first and second dose of varicella virus vaccine live (Oka/Merck) on 16-JUN-2005 and 12-SEP-2005 (lot #649442/0220R, administered SC at 16:00) Concomitant vaccination given at 16:00 on 12-SEP-2005 included an intradermal dose of tuberculin purified protein derivative (TUBERSOL). There was no illness at the time of vaccination. On 13-SEP-2005, the patient developed swelling in her neck and shoulders which was not visible. She did not feel well and could not swallow or breath normally. The patient was afebrile. Unspecified medical attention was sought. The nurse reported that she was going to give the patient diphenhydramine hydrochloride (Benadryl). No laboratory diagnostic tests were performed. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that on 15-SEP-2005 at 14:00 the patient complained of feeling swollen on both sides of the neck, her throat felt sticky and she couldn't breath properly, she had to take deep breathes to get air. The patient had a body temperature of 97.8. She had a stiff neck. The patient was treated with diphenhydramine hydrochloride (Benadryl). The patient felt like her throat was closing up. She was given methylprednisolone (MEDROL) dose pack. It was reported that the patient "had no problems" after her first dose of varicella virus vaccine live (Oka/Merck) At the time of the report the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: Varicella Information has been received from a physician concerning her middle child (child has 4 siblings) who at the age of 1, was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (Oka/Merck). In February or March 2005, the patient broke out with chickenpox during a school outbreak, developing 10 lesions and a slight fever. unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the patient's 2 sibling also developed chickenpox. (WAES #0507USA00260 and WAES #0509USA02319).
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella Information has been received from a physician concerning her youngest child (child ahs 4 siblings) who was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (Oka/Merck). In February or March 2005, the patient broke out with chickenpox during a school outbreak. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the patient's 2 siblings also developed chickenpox. (WAES #0507USA00260 and WAES#0509USA2318). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Skin Lesion Information has been received from a physician concerning a 4 year old male with no allergies who on 17-SEP-2002 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot#637976/0264M0. There was no concomitant medication. On 14-SEP-2005 the patient experienced lesions in the C6 dermatome. Unspecified medical attention was sought. There was no treatment given at the time of this report and no laboratory or diagnostic tests were performed. It was noted that the physician "may collect isolates for VZVID". The patient was recovering. The physician also reported that the patient was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD), diphtheria toxoid (+) pertussis vaccine (unspecified) + tetanus toxoid and poliovirus vaccine inactivated (unspecified) on the day prior to the onset of lesion (13-SEP-2005). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster Information has been received from a nurse practitioner concerning a 17 month old female who on 14-MAR-2005 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot#649483/0766P). The nurse reported that the patient broke out in shingles and was seen at the physician's office on 25-AUG-2005. The patient was treated with acyclovir. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Dermatitis contact, Erythema, Pyrexia, Rash
Clinical narrative: Rash, erythematous, cough, pyrexia, skin lesion, sneezing, rash pruritic, rash papular Information has been received from a registered nurse concerning a 9-year-old male with a history of faint contact dermatitis who on 19-Feb-1997 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live.  Concomitant vaccination 18-Feb-1997 included a first dose in the deltoid of measles virus live (+) mumps virus vaccine live (+) rubella virus vaccine live.  There was no illness at the time of vaccination.   On 19-Sept-2005 the patient presented with a fever, cough, sneezing, and a red itchy rash of about 70 lesions.  He was treated with over the counter lotion and oral diphenhydramine hydrochloride (Benadryl).  At the time of the report, the patient was recovering.  A product quality complaint was not involved.  Additional information was received from the registered nurse who reported that on 19-Sept-2005 the patient had lesions, a slight cough, and sneezing.  Physical exam revealed about 73 papular lesions on the face, neck, chest and back.  No diagnostic laboratory tests were performed. There were no adverse events following prior vaccination.  No further information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Skin ulcer, Sneezing
Clinical narrative: Rash, erythematous, cough, pyrexia, skin lesion, sneezing, rash pruritic, rash papular Information has been received from a registered nurse concerning a 9-year-old male with a history of faint contact dermatitis who on 19-Feb-1997 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live.  Concomitant vaccination 18-Feb-1997 included a first dose in the deltoid of measles virus live (+) mumps virus vaccine live (+) rubella virus vaccine live.  There was no illness at the time of vaccination.   On 19-Sept-2005 the patient presented with a fever, cough, sneezing, and a red itchy rash of about 70 lesions.  He was treated with over the counter lotion and oral diphenhydramine hydrochloride (Benadryl).  At the time of the report, the patient was recovering.  A product quality complaint was not involved.  Additional information was received from the registered nurse who reported that on 19-Sept-2005 the patient had lesions, a slight cough, and sneezing.  Physical exam revealed about 73 papular lesions on the face, neck, chest and back.  No diagnostic laboratory tests were performed. There were no adverse events following prior vaccination.  No further information is expected.
Age: 3.58
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: Information has bee received from a physician concerning a 43-month old white male with no allergies or medical conditions who on 31-Aug-1999 was vaccinated in the left arm with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  VARICELLA, PYREXIA  Two days after vaccination on 02-Sep - 1999 at "one year of age" the patient experienced a fever of 103 degrees.  Subsequently, the patient recovered.  On 20-Jun-2005 the patient developed a varicella illness with diffuse lesions on the face, neck, scalp, trunk, and thighs.  No diagnostic tests were performed. Subsequently, the patient recovered.  Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 10 year old male who on 16-May1996 was vaccinated SC in the right thigh with a dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  On 1-Sep-2005, the patient presented with varicella zoster.  It was extensive over the right hip and thigh area to the knee on the same side as the vaccine.  The patient had significant pain one to two days prior to the onset of the rash.  It was a significant vesicular rash with pain which continues to persist on day number three.  The nurse sent for a viral culture for herpes varicella zoster of a lesion on the right inner thigh.  It was unknown if the patient recovered.    Follow up information indicated that the mother of the child "wishes patient would have chicken pox instead of shingles"  She also indicated that she regrets having the varicella vaccine given.  The outcome was reported as recovered the week of 10-Oct-2005.  No additional information is expected.
Age: 11.0
Sex: M
Vaccine: DTP, MMR, OPV, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Information has been received from a certified medical assistant concerning an 11 year old white male with no allergies or medical conditions who on 08-May-1999 was vaccinated in the right arm with a first dose of varicella virus vaccine live/  Concomitant vaccination on the same day included a second dose in the left arm of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, a fourth dose of poliovirus vaccine live oral and a fifth dose in the right thigh of diphtheria toxoid (+) pertussis acellular 4 component vaccine (+) tetanus toxoid.  There was no illness at the time of vaccination.  On approximately 20-Sep-2005, the patent developed chickenpox characterized by 50-60 generalized papular lesions.  He also experienced a fever.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  A product quality complain was not involved.  Additional information has been received from the medical assistant who reported that on 17-Sep-2005, the patient had a rash for two days with 50-60 scattered papules.  He was treated with diphenhydramine hydrochloride (Benadryl) and calamine (+) camphor (+) pramoxine hydrochloride (AVEENO) and subsequently recovered.  No further information is expected.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Convulsion, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 16 year old male with a history of seizures who on 07-Sep-2005 was vaccinated with a 0.5 mL dose of varicella virus vaccine live.  There was no concomitant medication.  On 10-Sep-2005, the patient returned to the physician's office and was diagnosed with chickenpox.  Unspecified medical attention was sought.  No laboratory or diagnostic tests were performed.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.    Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning an approximately 13-year-old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Shortly after receiving the vaccine, the patient developed a rash of 20 pox on her body. It was noted that the patient had titers drawn before vaccination that showed immunity to varicella. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a registered nurse concerning an 13-year-old male with no allergies or medical history who was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (lot # 649440/0116R). There was no concomitant medication. On 29-AUG-2005, the patient was seen in the office with a rash on his whole body which started on his ears on 25-AUG-2005 or 27-AUG-2005. He had 20 lesions, some had vesicles, some were crusted. He was treated with fexofenadine hydrochloride (ALLEGRA) 30 mg tab, two tabs BID. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 15-month-old male who on 16-JUL-2001 was vaccinated with a dose of varicella virus vaccine live. On 19-SEP-2001 the patient experienced breakthrough varicella. The patient had less than 50 lesions and no treatment was necessary, though unspecified medical attention had been sought. The patient's present status was unknown at the time of reporting. No product quality complaint was involved. Additional information has been requested.