chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Dry skin, Erythema, Skin ulcer
Clinical narrative: Information has been received from a nurse practitioner concerning a 7 year old Caucasian female pt who on 22Sep1997 at 12 months of age was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot 623655/0807E). On 08Apr04, the pt developed a breakthrough rash of 50 to 100 pox with an infected vesicle. On 09Apr04, the pt was seen for a doctor visit with more than fifty papular and vesicular lesions on the face, neck, trunk and arms. Some of the lesions were crusted over. There was one yellow crusted lesion in the lower abdominal area with an approx 3cm diameter of erythema. The pt was afebrile. The diagnosis was varicella with an infected lesion. The pt was administered cephalexin (Keflex). Subsequently, the pt recovered.  A product quality complaint was not involved. Additional information is not expected.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 7 year old Caucasian female pt who on 22Sep1997 at 12 months of age was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot 623655/0807E). On 08Apr04, the pt developed a breakthrough rash of 50 to 100 pox with an infected vesicle. On 09Apr04, the pt was seen for a doctor visit with more than fifty papular and vesicular lesions on the face, neck, trunk and arms. Some of the lesions were crusted over. There was one yellow crusted lesion in the lower abdominal area with an approx 3cm diameter of erythema. The pt was afebrile. The diagnosis was varicella with an infected lesion. The pt was administered cephalexin (Keflex). Subsequently, the pt recovered.  A product quality complaint was not involved. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 12 yr old white female with no known drug allergies who on 25Oct98 was vaccinated in the left arm with a first dose of varicella virus vaccine live (624449/1422E). There was no illness at the time of vaccination. On 14Apr04 the pt developed chickenpox. The pt's father reporter that her brother (WAES0404USA01707) has chickenpox and now the pt has them. The pt's father reported that no tests were done and there was no need to be seen. The nurse reviewed the varicella protocol. Follow up information indicated that the pt subsequently recovered with no ill effects. No further information is expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 9 year old male who on 25Jun98 was vaccinated with a first dose of varicella virus vaccine live (lot 625475/0644H). There was no illness at the time of vaccination. On 12Apr04 the developed a rash on his chest. He was seen at the doctor's office with the rash, which was present for 24 hrs and was diagnosed with varicella. It was reported that no lab tests were performed. Follow up information indicated that the pt has recovered with no ill effects. The reporter also indicated that the pt's sister (WAES0404USa01705) had a similar experience following exposure to varicella virus vaccine live. No further information is available.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dry skin, Pruritus, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 7 year old male with no known medical history who on 30Oct97 was vaccinated with a first dose of varicella virus vaccine live. Concomitant vaccination included a first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On approx 04Apr04 the pt developed lesions which started on his legs and continued to spread all over the body and were itchy. On 12Apr04 the pt was seen by the physician and approx greater that 50 lesions were noted. Some lesions were beginning to scab over and the pt was afebrile. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician and someone at the physician's office concerning a 5 year old white male pt with a history of jaundice at birth who on 05Aug03 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination that day, 05Aug03, at 8:30AM included a SC second dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 645402/0130N). The physician reported that the pt received the varicella virus vaccine live and the measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  concomitantly. On 08Mar04 at 8:45AM the pt experienced break through chicken pox. The pt's case of chickenpox was mild. The pt recovered on 15Mar04. The physician stated that It was interesting since 3 or 4 other students who attend the same school also developed chickenpox. Additional information has been requested. The physician also reported that the pt's brother experienced breakthrough chickenpox following concomitant vaccination with varicella virus vaccine live and measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (WAES0404USA01731) (someone at physician's office confirmed that WAES0404USA01731 pertains to the pt's brother.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 year old white male pt with a history of jaundice at birth who on 14Jun02 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included vaccination at 9:00AM on 14Jun02 with a second dose of with measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 639914/0023M) given SC. The physician reported that the pt received the varicella virus vaccine live and the measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) concomitantly. On 22Mar04 at 8:30AM the pt experienced break through chicken pox times one week.  The physician reported that the pt's case of chickenpox was mild. The pt recovered on 29Mar04. The physician stated that It was interesting since 3 or 4 other students who attend the same school also developed chickenpox. No further information is available. The physician also reported that the pt's brother experienced breakthrough chickenpox following concomitant vaccination with varicella virus vaccine live and measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (WAES0404USA01730) (someone at physician's office confirmed that WAES0404USA01730 pertains to the pt's brother).
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 7 year old female birth twin with no pertinent medical history who on 25Apr02 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. In approx Apr 2004, the pt experienced break through chickenpox. She was exposed to her unvaccinated sibling and he had a bad case of natural varicella around that time. The pt was afebrile and had approx 10 lesions sporadically over her body. Unspecified medical attention was sought and no treatment was required. No diagnostic lab studies were performed. The pt was noted to be recovering with sequelae. A product quality complaint was not involved. Additional information has been requested. The licensed practical nurse also reported that the pt's twin had a similar experience after therapy with varicella virus vaccine live (lot 0404USA01851) as well as an increase in break through varicella after therapy with varicella virus vaccine live (lot 0404USA01852).
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning an 8 year old male pt who on 03Oct96 was vaccinated with a dose of varicella virus vaccine live. On 19Apr04 the pt presented to the office with less than 50 lesions on his trunk. Unspecified medical attention was sought. No product quality complaint was involved. It was reported that another pt (WAES0405USA01113) experienced chickenpox after vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 1.7
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old male pt who on 23Nov98 was vaccinated with a dose of varicella virus vaccine live (624656/1324E). On 18Apr04 the pt experienced a chickenpox rash with 13+ lesions. No other symptoms were reported. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 23 month old male with no past medical history who on 4/9/03 was vaccinated with varicella virus vaccine (lot # 641156/0794M). There was no illness at the time of vaccination. Subsequently, on 3/22/04, the patient developed a severe case of shingles on his face, was hospitalized and diagnosed with Ramsy Hunt syndrome. Medical attention was sought. He was given IV Acyclovir. There was no product quality complaint involved. The patient recovered. There were also three other cases reported (WAES0404USA01827, 0404USA01828, and 0404USA01829). Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Alanine aminotransferase increased, Pyrexia, Viral infection
Clinical narrative: Information has been received from a physician concerning a 34 year old healthy male with no food or medication allergies and was negative by history for chickenpox, with a confirmed negative IgG titer (previously reported as a history of previous varicella as a child) who is the father of a 15 month old female who was vaccinated on 11Mar04 with a 0.5ml dose of varicella virus vaccine live (lot 647521/1108N). There was no recent exposure to chickenpox or shingles. There was no concomitant medication. On 01Apr04, he presented with over 100 lesions but only mild symptoms. As of 15Apr04, the pt had over 500 lesions described as diffuse on the face, trunk, arms and legs but was still with mild varicella symptoms. Other systemic symptoms included fatigue (also described as malaise), fever and a mild increase in ALT. A DFA of the lesion was positive for VZV. On 13Apr04, the PCR analysis revealed the vesicle specimen contained wild type varicella zoster virus. It was noted that the pt had other labs drawn that were pending. It was also noted that the pt was being treated with acyclovir. Subsequently, the pt recovered. The reporter also mentioned that the daughter of the pt who was vaccinated with varicella virus vaccine live developed a low grade fever and 10 lesions on her trunk (WAES0405USA00164). Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Dehydration, Hypovolaemia, Nausea, Pyrexia, Rash
Clinical narrative: Information has been received from a RN concerning a 12 month old white female with congenital hypothyroidism who on 26Mar04 (also reported as 23Mar04) was vaccinated SC in the left thigh (also reported as left leg) with a first dose of varicella virus vaccine live (lot 647267/1099N). There was no illness at the time of vaccination. Concomitant therapies that day included a second dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (lot 0917N) administered IM in the right thigh and a first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 646125/0678N) admin IM in the right thigh. On 04Apr04, the pt was taken to the ER with nausea and vomiting. She was treated with IV fluids, and the nausea and vomiting resolved. On 06Apr04, the pt was again taken to the ER with vomiting, dehydration, a temp of 96.8 F, and a rash on her trunk, neck and diaper area. At that time the child was diagnosed with chickenpox. The child was treated and released. Unspecified medical attention was sought. There was no product quality complaint. The outcome was reported as recovered. Follow up information received from a registered nurse indicated that on 06Apr04 at 9:50AM, the pt was brought to the ER for dehydration and fever, had chickenpox rash on neck, trunk and diaper area (also reported as has bumps everywhere- neck, trunk, diaper area). It was noted that the child was seen 2 days ago (also reported as 04apr04) in the ER for hypervolemia and received IV fluids. No further information has been requested.
Age: 1.01
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Information has been received from a RN concerning a 12 month old white female with congenital hypothyroidism who on 26Mar04 (also reported as 23Mar04) was vaccinated SC in the left thigh (also reported as left leg) with a first dose of varicella virus vaccine live (lot 647267/1099N). There was no illness at the time of vaccination. Concomitant therapies that day included a second dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (lot 0917N) administered IM in the right thigh and a first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 646125/0678N) admin IM in the right thigh. On 04Apr04, the pt was taken to the ER with nausea and vomiting. She was treated with IV fluids, and the nausea and vomiting resolved. On 06Apr04, the pt was again taken to the ER with vomiting, dehydration, a temp of 96.8 F, and a rash on her trunk, neck and diaper area. At that time the child was diagnosed with chickenpox. The child was treated and released. Unspecified medical attention was sought. There was no product quality complaint. The outcome was reported as recovered. Follow up information received from a registered nurse indicated that on 06Apr04 at 9:50AM, the pt was brought to the ER for dehydration and fever, had chickenpox rash on neck, trunk and diaper area (also reported as has bumps everywhere- neck, trunk, diaper area). It was noted that the child was seen 2 days ago (also reported as 04apr04) in the ER for hypervolemia and received IV fluids. No further information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a RN concerning her son who in July or August of 2000 was vaccinated with varicella virus vaccine live. On 15Apr04 the pt developed shingles, which spread down his inner thigh. Medical attention was sought. The physician prescribed an antihistamine, would let it run its course. No product quality complaint was involved. There were also three other cases reported (WAES0404USA01771, 0404USA01828, and 0404USA01829). Additional information has been requested.  Additional information received. The patient's age and date of birth have been added.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a RN concerning a 16 month old white female with no illness at the time of vaccination who on 14Nov03 was vaccinated with a first dose of varicella virus vaccine live (lot 644794/0334N), in the right thigh. On 06apr04 the pt developed herpes zoster on chest also reported as a mild case of shingles. Medical attention was sought. The pt was given acyclovir tablets. The pt recovered on 13Apr04. No product quality complaint involved. There were also three other cases reported (WAES0404USa01771, 0404USA01827, and 0404USA01829). No further information is expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a RN concerning a 11 year old male who was vaccinated with varicella virus vaccine live. On 29Mar04 the pt developed chickenpox with 300+ lesions. The mother stated that her son was vaccinated but the physician was unable to find any vaccination records on the pt. No product quality complaint involved. There were also three other cases reported (WAES0404USA01771, 0404USA01827, and 0404USA01828). Additional information has been requested.
Age: 1.75
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician and a woman from the physician's office concerning an approx 21 month old female who, at a different office, on 10Jul95 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included montelukast sodium and budesonide (Pulmicort). It was reported  that the pt recently developed a mild case of chicken pox. The pt's physician contacted an allergist who decided to treat the pt with acyclovir. There were no further adverse events. On 30Mar04 the pt recovered. No product quality complaint was involved. No further information is expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a 3 year old female who in 2002 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Subsequently, the pt developed a severe case of chicken pox. Unspecified medical attention was sought and no treatment was required. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a LPN concerning a 7 year old female birth twin with a penicillin allergy and no other pertinent medical history who on 25Apr02 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. In approx Apr 2004 the pt experienced break through chickenpox. She was exposed to her unvaccinated sibling and he had a bad case of natural varicella around that time. The pt was afebrile and had approx 10 lesions sporadically over her body. Unspecified medical attention was sought and no treatment was required. No diagnostic lab studies were performed. The pt was noted to be recovering with sequelae. A product quality complaint was not involved. Additional information has been requested. The LPN also reported that the pt's twin had a similar experience after therapy with varicella virus vaccine live (lot 0404USA01741) as well as an increase in breakthrough varicella after therapy with varicella virus vaccine live (lot 0404USA01852).
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a healthcare worker concerning a 6 year old female patient with no pertinent medical history who on 05/27/1999 was vaccinated with varicella virus vaccine live (Oka/Merck).  There was no concomitant medication.  The healthcare worker reported that the patient was vaccinated at another location.  On 04/19/2004 the patient broke out in a rash and sought medical attention on 04/20/2004.  It was noted that the physician diagnosed the patient with varicella and prescribed the following treatments, calamine, camphor, pramoxine hydrochloride bath, acetaminophen and diphenhydramine.  The patient is still recovering at the time of this report.  No additional information was provided.  Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning his 8 year old daughter who in approximately 1998, when she was 2 years old was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Last week, approximately 04/15/2004, the child got a real bad case of full blown chickenpox.   It was reported that he prescribed his daughter acetaminophen and diphenhydramine hcl for treatment.  Medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning an 8 year old male with no past medical history and no known allergies who on 10/15/1996 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (Lot# 617911/0778D).  Subsequently the child was exposed at school, and developed chickenpox.  The number of lesions was unknown.  At the physician's office on 04/14/2004, the patient was given acyclovir.  Unspecified medical attention was sought.  There was no product quality complaint.  The reporter also mentioned another child who received varicella virus vaccine live (Oka/Merck) and developed an adverse experience.  Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Erythema, Infection, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male who was exposed 3 weeks ago to a child in his class who had chicken pox on 07/03/2000 was vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck)(lot#634512/0436k).  There was no concomitant medication.  On 04/20/2004 the patient broke out in a rash of scattered red spots with blisters on his back, chest and neck.  On 04/21/2004 the patient sought medical attention and was diagnosed with varicella.  There was no fever.  The physician did not prescribe any treatment and no diagnostic studies were performed.  The patient has not yet recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: BCG, HEP, VARCEL
Symptoms: Loss of consciousness, Sluggishness, Syncope
Clinical narrative: Information has been received from a health professional concerning a 15 year old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Concomitant therapy included a dose of BCG vaccine and a dose of Hepatitis B vaccine, recomb (manufacturer unknown).  Subsequently, the patient felt faint and passed out for under a minute.  The patient woke up and felt a little sluggish, but is now recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  No additional information was provided.  Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 4 year old female who on 6/12/00 was vaccinated with a dose of varicella virus vaccine live (lot # 634512/0436K). On approximately 4/5/04 the patient experienced mild fever and cough. On 4/12/04 the patient experienced moderate vesicular rash. The patient was treated with OTC topical products and acetaminophen. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 or 8 year old male who was vaccinated with a varicella virus vaccine live. Subsequently the patient experienced chicken pox. He had lesions on the trunk, chest and above the eye brow. The patient was seen by a physician. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning an 10 year old child who on 10/3/95 was vaccinated with a dose of varicella virus vaccine live. On 4/2/04, the patient developed chicken pox. Additional information has been requested. The nurse also reported a male patient who had a similar experienced after therapy with varicella virus vaccine live (WAES0404USA00393) and five or six other children with similar experiences after therapy with varicella virus vaccine live.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Viral infection
Clinical narrative: Information has been received from a nurse concerning her 17 year old daughter who in 1996 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed chicken pox. On 13Apr04 the pt began to develop lesions described as a rash mainly on the torso with 100 total lesions, perhaps 50 on the front and 50 on her back. She also had a very low grade fever of about 99 degrees. She missed school for one week, but now has recovered and is doing well. No treatment or doctor visit was necessary. No product quality complaint was involved. No additional information is expected.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a LPN concerning a 15 month old white male with a history of diaper rash who on 05Jan04 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot 646535/0575N). Concomitant therapy included loratadine (Claritin) and nystatin cream for the diaper rash. On 20Apr04 the pt developed classic pox like pustules all of his body. The onset of symptoms occurred after exposure to a sibling who was exposed. The pt was reported to have pox on his arms, legs, abdomen and hand. At the time of the report, the pt was being treated with diphenhydramine and Aveeno baths. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 20Apr04, three months after vaccination, the pt developed chicken pox. Only 25-50 lesions were noted. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a doctor of pharmacy concerning a pt who about 5 years ago was vaccinated with varicella virus vaccine live. It was reported that a recent titer did not show seroconversion. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
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 female with no allergies or medical history who on 03Oct1995 was vaccinated with a dose of varicella virus vaccine live. Subsequently the child was exposed at school and developed chickenpox. At the physician's office on 13Apr04, the pt was given acyclovir (Zovirax). The reporter also mentioned another child who received varicella virus vaccine live and developed an adverse experience (WAES0404USA01944). Additional information has been requested.
Age: 1.46
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 42 month old male who on 30Mar02 was vaccinated with a dose of varicella virus vaccine live. Reported to physician on 14Apr04 and the physician noted that this was mild case of generalized varicella (also described as chicken pox breakthrough). Subsequently, the pt was recovering. The reporter also mentioned a female pt who was vaccinated with varicella virus vaccine live (WAES0404USa02517) and experienced a similar reaction. Additional information has been requested.
Age: 0.99
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 year old male who on 05Apr1998 was vaccinated with varicella virus vaccine live.  On 22Apr04 it was reported that the pt came in early this week with just a few pox and came back yesterday with a moderate case. The pt was reportedly covered in pox. Medical attention was sought. The pt was treated with acetaminophen (Tylenol) and colloidal oatmeal (Aveeno bath). No product quality complaint involved.  Additional information has been requested.  It was also reported that another pt had a similar experience (WAES0404USA02171).
Age: 1.05
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Bacterial infection, Herpes zoster
Clinical narrative: Varicella (wild type) diagnosed on 5/23/05.  Treated with acyclovir.
Age: 1.36
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema, Rash
Clinical narrative: a rash is noted left anterior thigh: 6-7cm by 4 cm;  the color is mainly red;  it is best characterized as moderate swelling;
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: swelling and redness and warmth at site of dtap immunization
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, Pruritus
Clinical narrative: REDNESS AT INJECTION SITE OF HIS LEFT UPPER ARM. ITCHING, SWELLING, PAINFUL, NO FEVER,NO SHAKES, NO CHILLS. NO SHORTNESS OF BREATH."VERY SHARP LINE OF DEMARCATION. IT IS TENDER TO TOUCH. HE HAS NO AXILLARY NODES, NO CERVICAL NODES NOTED." GIVEN DECADRON 6 MG INJECTION, ATARAX SYRUP, KEFLEX PROPHYLAXIS.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Tenderness
Clinical narrative: REDNESS AT INJECTION SITE OF HIS LEFT UPPER ARM. ITCHING, SWELLING, PAINFUL, NO FEVER,NO SHAKES, NO CHILLS. NO SHORTNESS OF BREATH."VERY SHARP LINE OF DEMARCATION. IT IS TENDER TO TOUCH. HE HAS NO AXILLARY NODES, NO CERVICAL NODES NOTED." GIVEN DECADRON 6 MG INJECTION, ATARAX SYRUP, KEFLEX PROPHYLAXIS.
Age: 39.0
Sex: F
Vaccine: RAB
Symptoms: Rash
Clinical narrative: Donor developed rash next day
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a 40 year old female RN who on 01-MAR-1996 and 19-APR-1996 was vaccinated with a first and second dose of varicella virus vaccine live. In August 1996, the pt had a titer drawn which was negative. Subsequently, she had two children and was titered again when each child was born and those titers were also negative. On 21-APR-2004, her 13 month old child, who was not yet vaccinated with varicella virus vaccine live, developed chicken pox. The nurse called the CDC and asked them if there was a newer titer on the market that could show if she had antibodies because the nurse works in the recovery room with transplant patients and did not want to be contagious. The CDC told her to have and "ultratiter" done. That titer was also negative. The nurse is taking a few weeks off from work and stated she would notify us if she contracted chicken pox from her child. Unspecified medical attention was sought and no treatment was required. No product quality complaint was involved. Additional information has been requested. Follow up - No information provided.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Hyporeflexia, Paraesthesia, Sensation of heaviness
Clinical narrative: Approx 3 weeks after receiving flu vaccine. Pt began to experienced numbness and tingling in hands and feet with lack of reflex response in arms and legs. Has seen MD 3 times in last month and due to revisit this week. Still experiencing tingling/numbness and also heaviness in arms and legs. MD suspects Guillain Barre Syndrome.
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Diarrhoea, Irritability, Listless, Pyrexia
Clinical narrative: Mother states 1 hr after receiving immunizations child ran temp of 104, site gave Tylenol, fever down to 102 (at 104 child was listless, not raising head, 102 child was grouchy). Child had diarrhea x 2 days, fever 101 x 1 wk. Mother called pediatricians next day. No treatment, not seen in office.
Age: 1.08
Sex: M
Vaccine: IPV, MMR, PNC
Symptoms: Cough, Otitis media, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Child received vaccines on Tuesday morning, 3/2/04. Fever developed the following wk, Wednesday morning, 3/10/04 and lasted for 3 days, highest recording 104 degrees F. All over body rash developed following Monday AM, 3/15/04. Mom called MD and was told it was a reaction to MMR vaccine, child not seen by MD. Rash lasted 3 days. Child then developed runny nose, cough and mother took child to MD who diagnosed an ear infection. Placed on antibiotic for infection.
Age: 1.01
Sex: F
Vaccine: HBHEPB, VARCEL
Symptoms: Abdominal pain upper, Blister, Pruritus, Viral infection
Clinical narrative: Information has been received from a RN concerning a 29 month old female pt with no past medical who on 19-NOV-2002 at approximately 13:00 was vaccinated in the right thigh with a dose of varicella virus vaccine live. Concomitant vaccination on 19-NOV-2002 at approximately 13:00 included a second dose of Comvax (lot# 643659/0921M). There was no illness at the time of vaccination. Subsequently, the parents noted eight "blisters". On 29-APR-2004, the pt presented for an office visit with chickenpox and an onset date of 28-APR-2004 was noted. The pt had been exposed to family members with shingles. On examination, there were approximately 25 vesicular lesions (also described as "blisters"), mostly on the back. The pt also complained of a mild stomach ache and itching. No other symptoms were noted. Treatment was not required and laboratory tests were not performed. The pt was sent home with supportive care instructions. At the time of the report, it was unknown if the pt recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: I received varicella vaccine 4/14/04 on 4/24/04 area noted to be very erythematous, sore and swollen x 5-6 days. Presented 5/4/05 with 1.5 x 2cm firm mass in region of vaccine.
Age: 1.46
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Arnold-Chiari malformation, Blister, Rash vesicular, Spina bifida, Talipes
Clinical narrative: Information has been received from a physician concerning a 6 year old female patient with spina bifida, congenital clubfoot, Arnold-Chiari malformation and a ventriculo-pertinoeal shunt who on 1/28/99 was vaccinated in the right thigh with a first dose of varicella virus vaccine live (lot # 626768/0669H). Concomitant therapy that day (1/28/99) included a first dose of MMR vaccine live administered in the right thigh, and a fourth dose of both diphtheria toxoid (+) pertussis acellular 4-component vaccine (+) tetanus toxoid (batch # 451498) and HIB conjugate vaccine (batch # 402203A), each administered in the left thigh. On 3/1/04 the patient presented to the physician's office with chicken pox. It was noted that the patient had vesicles scattered on various areas of her body. There were 5 pox on her trunk, 1 on her chin, 1 on her buttocks, 1 on her abdomen and 1 on her wrist. No fever was noted. No treatment was required and no laboratory studies performed. The patient had not been ill at the time of vaccination. The physician reported that the vaccine was administered at another facility. The child recovered. There was no product quality complaint. Unspecified medical attention was sought. Additional information has been requested. This in follow-up to report(s) previously submitted on 5/16/2005. Information has been received from a physician concerning a 6-year-old white female patient with spina bifida, congenital clubfoot, Arnold-Chiari malformation, and a ventriculo-peritoneal abunt who on 28-JAN-1999 was vaccinated in the right thigh with a first dose of VARIVAX (lot# 626768/0669H). Concomitant therapy that day (28-JAN-1999) included a first dose of MMR II administered in the right thigh, and a fourth dose of of both ACEL-IMUNE (lot # 451-498) and HIBTITER (lot # 402203A), each administered in the left thigh. On 01-MAR-2004, the patient presented to the physician's office with chickenpox. It was noted that the patient had vesicles scattered on various areas of her body. There were five pox on her trunk, one on her chin, one on her buttocks, one on her abdomen, and one on her wrist. No fever was noted. No treatment was required and no laboratory studies performed. The patient had not been ill at the time of vaccination. The physician reported that the vaccine was administered at another facility. The child recovered. There was no product quality complaint. Unspecified medical attention was sought. Additional information has been requested.This is an amended report. The lot numbers for ACEL-IMUNE and HIBTITER have been added. This report is corrected, as needed.
Age: 1.46
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Vaccination failure, Ventriculo-peritoneal shunt, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 year old female patient with spina bifida, congenital clubfoot, Arnold-Chiari malformation and a ventriculo-pertinoeal shunt who on 1/28/99 was vaccinated in the right thigh with a first dose of varicella virus vaccine live (lot # 626768/0669H). Concomitant therapy that day (1/28/99) included a first dose of MMR vaccine live administered in the right thigh, and a fourth dose of both diphtheria toxoid (+) pertussis acellular 4-component vaccine (+) tetanus toxoid (batch # 451498) and HIB conjugate vaccine (batch # 402203A), each administered in the left thigh. On 3/1/04 the patient presented to the physician's office with chicken pox. It was noted that the patient had vesicles scattered on various areas of her body. There were 5 pox on her trunk, 1 on her chin, 1 on her buttocks, 1 on her abdomen and 1 on her wrist. No fever was noted. No treatment was required and no laboratory studies performed. The patient had not been ill at the time of vaccination. The physician reported that the vaccine was administered at another facility. The child recovered. There was no product quality complaint. Unspecified medical attention was sought. Additional information has been requested. This in follow-up to report(s) previously submitted on 5/16/2005. Information has been received from a physician concerning a 6-year-old white female patient with spina bifida, congenital clubfoot, Arnold-Chiari malformation, and a ventriculo-peritoneal abunt who on 28-JAN-1999 was vaccinated in the right thigh with a first dose of VARIVAX (lot# 626768/0669H). Concomitant therapy that day (28-JAN-1999) included a first dose of MMR II administered in the right thigh, and a fourth dose of of both ACEL-IMUNE (lot # 451-498) and HIBTITER (lot # 402203A), each administered in the left thigh. On 01-MAR-2004, the patient presented to the physician's office with chickenpox. It was noted that the patient had vesicles scattered on various areas of her body. There were five pox on her trunk, one on her chin, one on her buttocks, one on her abdomen, and one on her wrist. No fever was noted. No treatment was required and no laboratory studies performed. The patient had not been ill at the time of vaccination. The physician reported that the vaccine was administered at another facility. The child recovered. There was no product quality complaint. Unspecified medical attention was sought. Additional information has been requested.This is an amended report. The lot numbers for ACEL-IMUNE and HIBTITER have been added. This report is corrected, as needed.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Anorexia, Diarrhoea, Face oedema, Pyrexia
Clinical narrative: Child received flu vaccine on 11/09/2004 in AM and was sent home from preschool in afternoon because child had swollen face and low grade temp. Child had swollen face through 11/18/2004 accompanied by loss of appetite and diarrhea. No medical treatment sought.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 10 year old male patient who in 1995 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. On 4/26/04, the patient came into the medical office covered with lesions (more than 50). Treatment was not required. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 12 month old healthy female who on 4/15/04 was vaccinated with a dose of varicella virus vaccine live (lot # 647709/1247N). Concomitant vaccinations on that same day included a dose of MMR. The physician reported that on 4/25/04 the patient developed a varicella rash characterized by 30-40 lesions on her skin and mouth and a fever of 104.9. On 4/26/04, the patient was seen in the emergency room and was prescribed Acyclovir, diphenhydramine HCl, acetaminophen, ibuprofen, and topical oatmeal for itching. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male who on 8/28/00 was vaccinated with a dose of varicella virus vaccine live (lot # 0442K). On 4/21/04, the patient presented with a chicken pox rash of about 60 vesicular lesions. No other symptoms were reported. The patient was treated with hydroxyzine hydrochloride and OTC acetaminophen. At the time of this report, no follow up information has been received from the patient's mother. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that one other patient was vaccinated with a dose of varicella virus vaccine live and developed chicken pox (WAES0404USA00092). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, 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. The RN reported that the patient subsequently developed a severe case of chicken pox. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. The RN also reported that another patient developed a mild case of chicken pox after being vaccinated with varicella virus vaccine live (WAES0404USA02413). No further information is expected.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old female with no relevant medical history who on 3/12/04 was vaccinated IM in the thigh with a first dose of varicella virus vaccine live (lot # 643768/1063M). There was no concomitant medication. There was no illness at the time of vaccination. It was noted that the patient developed some chicken pox like lesions on 4/21/04 on her arm (also reported as rash under arm, 1 lesion) and she was seen in the office on 4/22/04. The patient returned to the office on 4/26/04, the rash had spread to her left arm, abdomen and back and she was diagnosed with chicken pox. The nurse was unable to identify if the patient was given a specific treatment for the condition (it was also noted that no treatment was required). Unspecified medical attention was sought. There was no product quality complaint involved. Subsequently, the patient had not recovered. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 8 year old female student with a history of chronic otitis media who on 7/30/02 in the PM was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 640821/1438L). Illness at the time of vaccination included left otitis externa treated with hydrocortisone (+) neomycin sulfate (+) polymyxin B sulfate. On 4/26/04, the patient presented with her mother to the office with over 150 vesicular lesions, which were diagnosed as chicken pox by the physician. An onset time of 15:50 on 4/26/04 was noted. The lesions were confined mostly to the upper torso. The patient had a fever of 99 to 100 degrees F. The physician recommended Aveno, diphenhydramine hydrochloride and calamine lotion, but no aspirin. The physician also stated that patient should be isolated. Laboratory tests were not performed. On 5/6/04, the patient recovered and returned to school. A product quality complaint was not involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, 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. Subsequently, the patient developed a mild case of chicken pox. No further information was provided. No product quality complaint was involved. It was also reported that another child was vaccinated with a dose of varicella virus vaccine live and developed a severe case of chicken pox (WAES0404USA02368). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a consumer concerning a child patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed breakthrough chicken pox, in spite of being vaccinated with varicella virus vaccine live. This was also described as a case of slight breakthrough varicella. The patient was exposed to varicella when the patient's father developed shingles. It was unknown if medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a health professional concerning an adult male patient who on 04/12/2004 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  In April,2004, soon after vaccination, the patient developed chikcenpox rash.  It was noted that the patient had recently moved to the United States.  The treatment was diphenhydramine hcl (Benadryl).  Unspecified medical attention was sought.  There was no product quality complaint.  The reporter also mentioned two other patients:  the patient's spouse who was vaccinated with varicella virus vaccine live (Oka/Merck) and developed a chickenpox rash, the patient's child who developed a rash through secondary transmission.  Follow up information indicated that the patient was a contractor and the reporter was unable to obtain information requested.  No further information is expected.
Age: 1.66
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female with no allergies or medical history who on 02/05/1999 was vaccinated with a dose of varicella virus vaccine live (oka/merck).  There was no concomitant medication.  On 04/09/2004, the patient experienced a case of varicella with a vesicular pruritic rash on her face, scalp, arms, legs, and trunk.  She was noted to be afebrile.  The patient had been exposed to a case of varicella at school prior to the start of symptoms.  She was treated with acyclovir, diphenhydramine hydrochloride, calamine, camphor, pramoxine hydrochloride, oatmeal baths, and ibuprofen or acetaminophen.  A product quality complaint was not involved. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning an 8 year old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Reported to physician on 03/13/2004 and the physician noted that this was a moderate case of generalized varicella (also described as chickenpox breakthrough).  It was noted that the patient had over 50 lesions as part of the condition.  Subsequently, the patient recovered.