chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: LYME
Symptoms: Rheumatoid factor, Skin burning sensation, Sopor
Clinical narrative: This case was reported by a lawyer and described the occurrence of mental fog in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix, for prophylaxis. A physician or other health care professional hs not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). On an unspecified date after vaccination with Lymerix, the subject experienced mental fog, arthralgias, myalgias, headaches, burning and tingling, eye problems, muscle spasms, ear pain , difficulty concentrating, shooting and stabbing pains, joint stiffness and weakness, and rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. He also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Age: 6.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Gait disturbance, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a physician and described the occurrence of limping in a 5 year old male subject who was vaccinated with Diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. The subject had no pre existing medical conditions. There were no concurrent medications. On 5/6/2006 at 5:00pm, the subject received 5th dose of Infanrix in the left thigh (lot AC14B035AA). On 5/6/2006, the subject also received the 2nd dose of measles, mumps and rubella virus vaccine MMR II lot 0151R, at an unspecified site of administration. On 5/7/2006, 1 day after vaccination with Infanrix, the subject experienced limping, and was noticed to have significant erythema and induration at the injection site of Infanrix. The subject was seen at a physicians office and was treated with Cetirizine hydrochloride Zyrtec, prednisolone Prelone and cephalexin. The physician considered the events were disabling because the child missed school and clinically significant or requiring intervention (OMIC). The events resolved on or after 5/7/2006 and on or before 5/12/2006. The physician considered the events to probably be related to vaccination with Infanrix.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: This case was reported by a physician and described the occurrence of injection site induration in a 4 year old female subject who was vaccinated with Diphtheria and tetanus toxoid and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. The subject had no pre existing medical conditions. There were no concurrent medications. On 5/2/2006 at 8:am, the subject received 5th dose of Infanrix in the left thigh (lot AC14B035AA). On 5/2/2006, the subject also received the 2nd dose of measles, mumps and rubella virus vaccine (MMR II, lot 0151R) at an unspecified site of administration. On 5/3/2006, 1 day after vaccination with Infanrix, the subject experienced erythema and induration at the injection site of Infanrix . The subject was seen at a physicians office and was treated with cetirizine hydrochloride Zyrtec, prednisolone Prelone and cephalexin. The physician considered the events were disabling because the child missed school, and clinically significant (or requiring intervention) (OMIC). The events resolved on or after 5/3/2006 and on or before 5/12/2006. The physician considered the events to probably be related to vaccination with Infanrix.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous
Clinical narrative: Rash mild prickly with redness, started on upper extremities and spread to trunk back and lower extremities. Rash onset 5/16/06. comment-MMR given related to mumps outbreak.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia, Skin discolouration
Clinical narrative: Given Dtap and arm swelling, redness, purple, fever, seen in ER, reported had allergic reaction. Mom states she saw her provider.
Sex: U
Vaccine: DTAP, IPV
Symptoms: Agitation, Crying, Dyskinesia, Injection site pain, Pyrexia
Clinical narrative: Got Dtap #4 3PM, pain all night, fever 103. This morning jerking motion until fine, cry.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Arrhythmia, Asthenia, Dizziness
Clinical narrative: Dizziness, feels weak, lost heart beat.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: DTAP administered 5/8/06, by 5/11, had significant swelling, redness and pain in L arm. 5/15/06, symptoms persist. Was seen to have erythematous flush, red to purple area of induration 3 1/2 X 4 1/2cm. Redness approx. 9 X 13cm surrounding. Dx: Cellulitis.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Hypokinesia, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Received TDAP on 5/10/06. On 5/13/06, a localized reaction. Was seen in ER c/o itching, pain, redness and swelling. On 5/15/06, seen at follow-up with persistent sympotoms, increased pain on movement of arm. Red and indurated area 7.5 cm in diameter also 15cm area of redness and heat.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pruritus
Clinical narrative: Received TDAP on 5/10/06. On 5/13/06, a localized reaction. Was seen in ER c/o itching, pain, redness and swelling. On 5/15/06, seen at follow-up with persistent sympotoms, increased pain on movement of arm. Red and indurated area 7.5 cm in diameter also 15cm area of redness and heat.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Redness, warm to touch and fever X 2 days. Arm sore 10/10. Evaluated 5/17/06 and given Advil 200mg q 6 hrs X 48 hrs, ice to RTC of 3 X 7. Unknown if recovered at this time, 5/17/06.
Age: 1.28
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Rash
Clinical narrative: Mother mentioned that girl was scratching a lot everywhere and only behind the neck had a small rash.  No treatment by pediatrician.  She was only put in the Emergency Room.  By Sunday 4/30 she did not have anything; patient does not have a rash nor red area.
Age: 68.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Evening of vaccine, pt began getting scattered, itchy hives on body. Pt using topical hydrocortisone. Instructed to use Benadryl 25mg PO q 4-6hrs for itching. Pt verbalized understanding. Resolved by 5/17/06 AM.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and erythema over injection site. Warmth over the site.
Age: 1.32
Sex: F
Vaccine: VARCEL
Symptoms: Immune system disorder, Pharyngitis, Rhinitis, Urticaria, Viral infection
Clinical narrative: Information has been received from a physician concerning a 15 month old female with no known medical history or allergies who on 02Sep04 was vaccinated SC with a 0.5mL first dose of varicella virus vaccine live (lot64717/0192P). There was no concomitant medication. There was no illness at the time of vaccination. On 08Sep04, six days after vaccination, the pt broke out with hives that started on the legs and then spread to the torso and face. Unspecified medical attention was sought. Antihistamines, specifically hydroxyzine, were given and the hives did fade but when the antihistamines were tapered off, the hives returned. It was reported that this went on for about three months. It was also reported that now whenever the pt gets exposed to a cold virus or immune system stress, she gets hives on her hands. The pt's parents think that varicella virus vaccine live (lot 647717/0192P) caused this, however the physician is not sure. It was reported that the pt's parents have pictures of the hives that the pt had post vaccination, and that the doctors did not actually see the pt when she had the hives. There were no relevant lab or diagnostic tests performed. The pt's adverse event improved after treatment with antihistamines over time and at the end of Dec 2004 the pt had recovered. It was reported that the pt had no adverse event following prior vaccination. There was no product quality complaint involved. Additional information is not expected.
Age: 0.98
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Skin ulcer, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 11Mar05 was vaccinated (route unk) with a dose of varicella virus vaccine (649274/0896P). Subsequently, in March 2005, the pt developed diarrhea and vomiting and was hospitalized. On 25Mar05, while hospitalized, the pt experienced a few, mild varicella lesions. Subsequently, the pt recovered from the few, mild varicella lesions on an unk date. Unspecified medical attention was sought. No product quality complaint was involved. Information received on 04Apr05 contained the following adverse experiences vomiting and diarrhea. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Infection transmission via personal contact, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 yr old male who on 02Oct1997 was vaccinated with a dose of varicella virus vaccine live. On 24Mar05 the pt presented with less than 30 lesions on the trunk and was diagnosed with breakthrough varicella. No treatment was required. It was reported that the pt recovered (date unspecified). No product quality complaint was involved. The physician also reported that the pt's older brother had breakthrough varicella after prior vaccination (associated WAES0504USA00522) and the unvaccinated sister also developed the same varicella rash (associated WAES0504USA00523). Additional information has been requested.
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Infection transmission via personal contact, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician and a certified medical assistant (CMA) concerning an 10 yr old male who on 25Mar96 was vaccinated with a dose of varicella virus vaccine live. On 24Mar05 the pt presented with about 30 lesions on the trunk and was diagnosed with breakthrough varicella. No treatment was required. It was reported that the pt recovered (date unspecified). No product quality complaint was involved. The physician also reported that the pt's younger brother developed varicella after receiving the vaccination (associated WAES0504USA00521) and his younger unvaccinated sister also developed the varicella rash (associated WAES0504USA00523). Additional information has been requested.
Age: 0.42
Sex: F
Vaccine: VARCEL
Symptoms: Infection transmission via personal contact, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning an 7 month old female who 8 and 10 yr old brothers were vaccinated with doses of varicella virus vaccine live on 02Oct97 and 25Mar96, respectively. Both of the brothers presented on 24Mar05 with varicella and on that same day the unvaccinated 7 month old pt presented with the same 30 lesion varicella rash on the trunk as the brothers (associated WAES0504USA00521 and 0504USA00522). It was reported that the pt recovered (date unspecified). No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Dermatitis bullous, Pruritus, Rash maculo-papular
Clinical narrative: Information has been received from a RN concerning a 4 yr old white male, with no pre-existing allergies, birth defects, medical conditions, and no illnesses at the time of the vaccination, who on 02Feb02 was vaccinated, by another healthcare provider, with a first dose of varicella virus vaccine live (route and lot number unk). There was no concomitant medication. On 04Apr05, at 19:00, the pt experienced blistery like rash on neck, anterior, chest, red raised rash and was itchy (it was previously reported that the pt experienced mild varicella like rash with 10 lesions on 04Apr05 and no other symptoms were noted). The report also indicated that no precipating factors or unusual exposures were noted. On 04Apr05 the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. No relevant diagnostic tests and lab studies were performed. There were no adverse events following prior vaccination of pt or siblings. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMR, OPV
Symptoms: Bacterial infection, Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning an 8 year old white female, with no pre-existing allergies, birth defects or medical conditions, who on 9/15/97 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccinations given on the same day included: the 3rd dose of poliovirus vaccine live oral (Orimune), given orally and the 1st dose of tuberculin purified protein derivative (Tubersol) given SC. There was no illness at the time of the vaccination. On 3/24/05, also reported as 3/25/05, the pt developed approximately 10 varicella lesions. It was also noted that the pt developed 12 diffuse chickenpox lesions on belly and ankles after immunization. The strep was treated with Amoxil. The pt was seen in the office on 4/2/05 for strep. It was reported that the pt recovered from varicella. No relevant diagnostic studies or laboratory tests were performed. Unspecified medical attention was sought. There was no product quality complaint involved. There were no adverse events following the vaccination of pts or siblings. Additional info is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Info has been received from a physician concerning an 8 year old male who in approximately 1998, at 1 year of age, was vaccinated with dose of varicella virus vaccine live. On 3/31/05, the pt presented at the physician's office with 25 lesions scattered around his body. No further info was given at the time of this report. No product quality complaint was involved. Additional info has been requested.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Info has been received from a physician concerning a 19 year old male, with no pertinent medical history reported and no drug reactions/allergies, who on 9/7/04 and 10/7/04 was vaccinated with 0.5 ml doses of varicella virus vaccine live. There was no concomitant medication. In 1/05, a titer was 0.48 ISR with less than 0.9 being negative. Outcome reported as not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Influenza like illness, Pyrexia
Clinical narrative: Info has been received from a health care provider concerning a 7 year old white female (previously reported as 5 years old), with no pre-existing allergies, birth defects, or medical conditions, who on 6/24/98, also reported as approximately April 2002, was vaccinated in the left leg with a 0.5 ml first dose of varicella virus vaccine live. On 3/28/05, the pt had "flu-like symptoms". On 3/29/05, it was noted that there was an outbreak. On 3/30/05, the pt had 35-40 lesions scattered everywhere which lasted 7 days. It was previously reported that the pt had 2 pox, had a fever of 101F and developed less than 30 pox. The physician stated that it was a mild case of breakthrough chicken pox. No relevant diagnostic tests or lab data were performed. Outcome reported as recovered. Unspecified medical attention was sought. No product quality complaint was involved. No additional info is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Info has been received from a physician concerning a male child who was vaccinated with a dose of varicella virus vaccine live. On an unspecified date. Subsequently, on an unspecified date, the pt developed red spots on his face. The physician indicated that she "did not know if it was a break through". Unspecified medical attention was sought. A product quality complaint was not involved. Additional info has been requested. The reporter also indicated that the pt's brother developed a few pox after therapy with varicella virus vaccine live.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 7 year old male who in 1999 was vaccinated with a 0.5ml dose of varicella virus vaccine live. "About one week ago", on approximately 3/29/05, the pt developed a mild case of chickenpox. Unspecified medical attention was sought. At the time of this report, the pt was reported as recovering. No product quality complaint was involved. Additional info has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Pyrexia
Clinical narrative: Info has been received from a health professional concerning an 8 year old white female with allergies to penicillin and sulfonamide who's mother called the office and said that her daughter was vaccinated with a dose of varicella virus vaccine live and had disease in the past. It was noted that the pt had strep pharyngitis and broke out with a rash at the time of vaccination. This day on 3/31/05 at 10:02 AM, the pt had 9 lesions and fever. Medical attention was not sought. Follow-up info from a health professional indicated that the pt's mother stated that, on 3/31/05, the child had a total of 45 lesions with no scars. There were new lesions for 5 days. It was reported that the pt had a scarlet fever rash and strep throat at the same time. The pt is now doing fine with no lasting problems from the disease. The pt was reported as recovered on 4/5/05. Additional info is not expected.
Age: 1.0
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 8/3/1999 was vaccinated with a dose of varicella virus vaccine live. The patient reported to the office on 3/10/2005 with about one dozen pox. The mother noted that he was exposed to real chickenpox. No prescription was necessary. No product quality complaint was involved. The patients brother (WAES0503USA04739) also had Varicella after vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Erythema, Rash, Viral infection
Clinical narrative: Initial and follow up information has been received from a registered nurse in a physicians office as reported by a patients mother concerning a 2 year old male with milk allergy. Illnesses at the time of vaccination were unknown. On 3/8/2004 the patient was vaccinated subcutaneously with the first dose of varicella virus vaccine live (previously reported to have received measles virus vaccine live (enders Edmonston) + mumps virus vaccine live (Jeryl Lynn) + rubella virus vaccine live (Wistar RA 27/3). On 4/1/2005 at 9:00AM it was reported that the patient broke out with < 50 bumps just red dots. It was reported that there were no crusting or blisters. The patients mother reported to the physicians office that not many itch. The patients mother felt that the patient had developed chicken pox. The registered nurse further reported that the patient was diagnosed with break through chicken Pox after receiving the varicella virus vaccine live vaccine. It was reported that as the child was only 2 years old, he had not received MMR as he was not old enough and therefore did not have a reaction to the vaccine. The mother of the patient was to treat the patient with over the counter medications for itching if necessary. At the time of this report the patient had recovered (date unknown). No further information is available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Viral infection
Clinical narrative: Information has been received from a physician concerning a 13 year old male who on 10/25/2000 was vaccinated with a dose of varicella virus vaccine live. On 3/18/2005, the patient experienced few pox and was given acyclovir. Additional information has been requested. The reporter also indicated that the patients brother developed a red spots on his face after therapy with varicella virus vaccine live (WAES0504USA00679)
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Pyrexia, Viral infection
Clinical narrative: Information has been received from a medical assistant concerning her 5 year old daughter who on an unspecified date in 2000 was vaccinated with a dose of varicella virus vaccine live. On an unspecified date in Feb 2005, the patient developed pox on her arms, legs, back, and shoulder. She also had a fever and chills. As of 4/5/2005 the patient was recovered. Additional information has been requested.
Age: 0.93
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Herpes zoster, Viral infection
Clinical narrative: Information has been received from a physician concerning her 4 year old daughter with no pertinent medical history and no allergies who in Feb 2002, at age 1, was vaccinated in the left arm with a dose of VARIVAX. Concomitant vaccination, also given at age 1, include a dose of MMR II. It was reported that the child had never been exposed to varicella. On 3/29/2005 (also reported as 3/31/2005) she developed quite a few zoster in the same dermatome that she was vaccinated in, left arm left deltoid. Unspecified medical attention was sought, no treatment was required. It was reported to be varicella zoster. The physician reported that the duration of the incident was 6-7 days and recovered on approximately 4/5/2005. It was also noted that the varicella zoster was resolved before the paperwork was received to obtain samples for cultures. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 5 year old patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed a rash which was reported as questionable chickenpox, the physician also described it as breakthrough chickenpox. Unspecified medical attention was sought and it was reported as a mild case, if it was chickenpox. At the time of this report the child was recovered. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Bacterial infection, Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a school nurse concerning a 15 year old male who on 5/16/2000 was vaccinated with a dose of varicella virus vaccine live. On 4/4/2005 the patient experienced chickenpox and developed impetigo in his lesions. Unspecified medical attention was sought. It was noted that the chickenpox stemmed from the one wild type case. There was no outcome reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Herpes zoster, Rash, Viral infection
Clinical narrative: information has been received from a health professional concerning a 4 and 10/12 year old female, with no medical history and no known drug allergies, who on 6/13/2001 was vaccinated in the right arm with a subcutaneous first dose of varicella virus vaccine live (lot 638495/1904K). There was no concomitant medication. There was no illness at the time of vaccination. It was reported that the patient developed shingles on her right arm, which was the same arm used for injection of varicella virus vaccine live. The patient was seen at the ER on Tuesday, 4/5/2005, and she is being treated with acyclovir and acetaminophen Tylenol with codeine. There were no laboratory or diagnostic tests. No product quality complaint was involved. Follow up information from a health professional indicated that on 4/7/2005 the patient developed shingles, varicella and a red rash on her right arm with multiple vesicles from fingers to her elbows. The patients status was reported as recovered. Shingles was considered to be other important medical event by the reporter (OMIC). Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Info has been received from a health professional concerning a 14 year old white male with a shell fish allergy who on 10/9/95, was vaccinated with a SC, 1st dose, in the right arm of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. I was reported that the pt presented with break through chickenpox at an office visit on 4/4/05. The pt had approximately 50 lesions with the rash all over his body including his trunk, scalp, face and extremities. It was noted that the pt also had a fever of 100. Treatment and comfort care was performed as needed. It was reported that the lesions are crusted and the pt is recovering. No lab or diagnostic tests were performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info from a health professional indicated that on 4/3/05, the pt developed a rash over his trunk, scalp, face, and extremities of approximately 50=75 lesions. The pt's status was reported as recovered. Additional info is no expected.
Age: 1.04
Sex: F
Vaccine: DTAP, HBHEPB, MMR, OPV, VARCEL
Symptoms: Infection
Clinical narrative: Info has been received from a health professional concerning a 6 year old white, female, with a history varicella exposure, who on 12/9/99, at 09:30 AM, was vaccinated with a SC dose in left upper leg of varicella virus vaccine live. Concomitant vaccines administered on the same day included a 3rd, IM dose in the upper right leg of DTAP, a 3rd oral dose of poliovirus vaccine inactivated (IPOL), a 2nd SC dose in the upper right leg of MMRII. It was noted that at the time of vaccination, the pt was seen for well child care. On 4/2/05, the experienced 7 pox on the abdomen with no other symptoms. Medical attention was sought. No product quality complaint was involved. Follow-up info from a health professional indicated that on 4/5/05, at 08:20 AM, the pt broke out with 7-10 pox. On 4/8/05, the pt recovered and was doing well. Additional info is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 4.5 year old male who in September of 2004 was vaccinated with a dose of varicella virus vaccine live. Recently, the pt developed a mild case of chickenpox. The physician reported that the pt was recovering. No additional info was provided at the time of this report. No additional product quality complaint was involved. Additional info has been requested.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning an 18 month old male who in 11/04, "6 months ago", was vaccinated with a dose of varicella virus vaccine love. At a later date, the pt developed a mild case of chickenpox and is now completely recovered. No product quality complaint was involved. Additional info has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a nurse practitioner concerning a 7 year old male who on 8/1/2002 was vaccinated with a dose of varicella virus vaccine live. On 3/29/2005 a titer indicated that the patient did no show seroconversion. No symptoms were noted. No other information was available. There was no product quality complaint. Additional information has been requested.
Age: 1.92
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact
Clinical narrative: Info has been received from a health professional concerning 2 adolescent pts who in 1997 were vaccinated with doses of varicella virus vaccine live. "Recently", in approximately January 2005, the pts experienced mild cases of chicken pox. The children were recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available. Follow-up info has been received regarding one of the pts, an 8 year old white male with no medical history or allergies, who on 8/26/98 was vaccinated SC in the left upper leg, with a dose of varicella virus vaccine live. It was reported that on 1/2/05, the child had pruritic lesions scattered about the scalp, chest, thighs and scrotum. All were in different stages of development. It was noted that the child was exposed to a classmate that had chicken pox. It was also noted that the pt recovered. No additional info is expected.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed a rash which was reported as questionable chickenpox and also described as breakthrough chickenpox. Unspecified medical attention was sought and it was reported as a mild case, if it was chickenpox. AT the time of this report the child was recovered. No product quality complaint was involved. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Info has been received from a health professional concerning a 21 month old Hispanic and white female, with no medical history and no allergies, who on 9/23/04, was vaccinated with a 1st SC dose in the right arm of varicella virus vaccine live. Concomitant vaccine, administered on the same day, included a 1st SC dose in the left arm of MMRII. It was noted that there was no illness at the time of vaccination and no adverse events following prior vaccination. On 3/30/05, the pt experienced a rash on her trunk, consisting of 7 lesions that were described as pleomorphic and itchy. It was noted to be a mild case. The pt was prescribed, by the doctor, symptomatic care consisting of Benadryl and Motrin. There were no lab or diagnostic tests performed. Subsequently, the pt recovered. Additional info is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Info has been received from a physician concerning an adolescent pt who was vaccinated SC, with a 1st 0.5 ml dose of varicella virus vaccine live. It was reported that the pt experienced breakthrough varicella. It was noted that the pt did not appear to be sick. The pt may have had a slight fever. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info has been requested.
Age: 1.08
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact, Pyrexia, Rhinorrhoea
Clinical narrative: Info has been received from a health professional concerning a 14 month old white female described as healthy with no known medical history or allergies who on 1/28/2005 at 10:30 AM, was vaccinated SC in the left arm with a 1st dose of MMRII. In the right arm, an IM 4th dose of Daptacel, in the left thigh and an IM 4th dose of ActHib, in the right thigh. There was no illness at the time of vaccination. On 3/20/05, the pt developed breakthrough varicella that started with a few, about 25-30, lesions in the diaper area after exposure to a child with chickenpox in a church nursery. The pt also had a runny nose and a slight fever. It was reported that the pt's illness lasted about 1 1/2 weeks. Unspecified medical attention was sought. There was no treatment given. There were no relevant lab or diagnostic tests performed. The pt's vaccination history included a 1st , 2nd and third dose of DTAP on 3/4/04. 5/14/04 (lot FU1258DA), 7/23/03 (lot FU1314DA), a 1st, 2nd and 3rd dose of Hib on 3/4/04, on 5/14/04 (lot PUE089AE) and on 7/23/04 (lot P1216M), a 1st, 2nd and 3rd dose of poliovirus vaccine inactivated on 3/4/04, 5/14/04 (lot FX05542) and 7/23/04 (lot FX05542), a 1st and 2nd dose Hep-B on 1/05/04 and 3/4/04, a 1st dose of Hep-B virus vaccine rHBaAg: yeast) (+) Hib conj vaccine on 7/23/04 (lot F1216M), and a 1st dose of pneumococcal conj vaccine on 3/4/04. There were no adverse events following prior vaccination. Subsequently, the pt recovered. There was no product quality complaint involved. Additional info is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 2 year old male pt who on 9/30/04 was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 4/8/05, the pt developed breakthrough characterized by 15-20 lesions. Unspecified medical attention was sought. At the time of this report, the pt's breakthrough persisted. Additional info has been requested.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Info has been received from an RN concerning an 18 month old female who on 10/15/04 was vaccinated, SC with a 0.5 ml dose of varicella virus vaccine live. The RN reported, that on the morning of 4/8/05, the pt developed chickenpox characterized by a rash consisting of red, raised pustules. The RN indicated that the pt was not feeling well when the lesions appeared. The pt was noted to have 2 lesions on her hand between the index finger and thumb, a few on her chest and about 6 on her face. The lesions were noted not to be itchy and no fever was reported. Unspecified medical attention was sought and the pt was advised of the "usual varicella precautions and treatment". At the time of this report, the pt's chickenpox persisted. Th RN also reported that she had seen a few other cases of breakthrough. Additional info has been requested.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 10 year old white male who on 6/19/95, was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 2/1/05, the developed breakthrough chickenpox during a local outbreak in his school. Subsequently, the pt recovered from the breakthrough chickenpox. No further info is available.
Age: 1.24
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Vaccine positive rechallenge
Clinical narrative: Info has been received from a physician concerning a 7 year old white female who on 9/10/98 was vaccinated with the 1st dose of varicella virus vaccine live. Concomitant vaccinations on the same day, included the 1st dose of MMRII and the 4th dose of Hib-Titer. On 2/19/05, the pt developed 6 lesions after exposure to a child with active chickenpox, 2 weeks earlier. It was reported that the pt recovered. No product quality complaint was involved. Additional info has been requested.
Age: 0.99
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 9 year old white male, with no medical history and no allergies, who on 11/27/96, was vaccinated with a 1st dose of varicella virus vaccine live. There was no concomitant medications. It was reported that the pt presented to the office on 4/9/05, with approximately, 30-50 chickenpox lesions. It was noted that there was no treatment. The pt's status was reported as recovering. There were no lab or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info from a health professional indicated that on 4/9/05, the pt experienced a breakthrough varicella rash with 30-40 lesions. It was reported that the pt recovered. Additional info is not expected.
Age: 0.75
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Info has been received from an RN concerning an 8 month old female twin, with a healthy pertinent medical history born prematurely at 28 weeks and no known drug reactions/allergies, who in 6/04, was vaccinated in another country with a dose of varicella virus vaccine live. A varicella lab diagnostic studies was performed on 4/1/05, which came back negative. Outcome unknown. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info was received from an RN indicating that the pt was vaccinated again on 4/19/05. The reporter also noted that the pt's twin sister was vaccinated with a dose of varicella virus vaccine live and has a negative titer. Additional info has been requested.
Age: 1.14
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 9 year old male with no allergies or medical history who on 9/3/96 was vaccinated in the left thigh with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. In approximately, 4/05, "now", the pt has experienced a mild case of chickenpox. At the time of the report, the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info from a physician indicated that on 4/5/05, the pt developed a mild breakthrough varicella infection. No lab tests were done and the pt recovered on an unknown date. Additional info is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 6 year old female who in approx. 2000, at 12 months of age, was vaccinated with a dose of varicella virus vaccine live. On 4/4/05, the pt presented to the office with a mild case of chickenpox. The outcome was reported as recovering. No other info was available. Unspecified medical attention was sought. There was no product quality complaint. Additional info has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Encephalitis
Clinical narrative: Info has been received from a physician concerning a pt who was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. Subsequently, the pt developed encephalitis. Unspecified medical attention was sought. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. Additional info has been requested.
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 5 year old white female who on 1/24/01 was vaccinated with a 0.5 ml, SC dose of varicella virus vaccine live. It was reported that the pt was brought into the office on 4/8/05, with a few lesions on the back of her neck and some on her chest that were diagnosed as chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Info has been received from a physician concerning a female pt who on 12/24/96 was vaccinated with a SC dose of varicella virus vaccine live. It was reported that the pt developed shingles. It was reported that at the time of the report, the pt has not recovered. It was noted that 2 children that she was exposed to, one 12 months old and the 7 months old, developed chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info from a physician indicated that the pt developed zoster on her right upper leg on 3/21/05. The pt was treated with acyclovir and the rash cleared within 2 days. It was reported that the pt has fully recovered. No other info was provided. Additional info has been requested.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 4 year old patient with no known medical history or allergies who on 4/17/2002 was vaccinated with a dose of varicella virus vaccine live. On 3/15/2005 the patient developed breakthrough varicella. At the time of this report the patient had recovered. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a school nurse concerning a 12 year old female who in March 1999, was vaccinated with a dose of varicella virus vaccine live. The child's mother claims she had chickenpox on 5/6/2003 and again on 3/7/2005. Unspecified medical attention was sought. It was noted that the chickenpox stemmed from one wild type case. It was reported that she has recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Information has been received from a school nurse concerning a female who was vaccinated with a dose of varicella virus vaccine live on an unspecified date. Subsequently, the patient developed a breakthrough case of chickenpox and herpes zoster as well. The patient was seen by a physician, the zoster was diagnosed by the physician. There was no outcome information given. At the time of this report there were no further details available. It was noted that the chickenpox stemmed from one wild type case. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who was exposed to a woman that developed shingles following subcutaneous vaccination with varicella virus vaccine live (WAES0504USA01512). It was reported that the patient then developed chickenpox. No other information was provided. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: VARCEL
Symptoms: Medication error, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 month old patient who was exposed to a woman that developed shingles following subcutaneous vaccination with varicella virus vaccine live WAES0504USA01512. It was reported that the patient then developed chickenpox. No other information was provided. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 10 year old male who in 1998 was vaccinated with a dose of varicella virus vaccine live. On 4/2/2005 the patient experienced chickenpox from head to toe.  It was noted that they were even in the conjunctiva. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 13 year old female with no allergies or history who in June 1998, was vaccinated with a dose of varicella virus vaccine live. On 2/2/2005 the patient experienced 75 to 100 diffuse pox. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that on 4/1/2005 the patient had about 75-100 pox that were very small with few vesicles. The patient recovered on 4/6/2005. No additional records are available. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 10 year old female who in 1996 was vaccinated with a dose of varicella virus vaccine live. Now, on approximately 4/12/2005 the patient experienced mild chicken pox with less than 50 lesions. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning her son who was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. Subsequently two months after vaccination he developed herpes zoster. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old male who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed breakthrough chickenpox. There was no product quality complaint involved. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pustular, Rhinorrhoea
Clinical narrative: Information has been received from a health professional concerning an 8 year old male with no known medical history or allergies who in June 1997, was vaccinated SC with a first dose of varicella virus vaccine live (lot 622757/0348E). There was no illness at the time of vaccination. On 3/24/2005 the patient experienced a runny nose and pustules. It was reported that the patient had ten pustules, 3-7 mm in size, on his chest and back. It was reported that he had the runny nose for four days and pustules for two days. On 3/29/2005 the patient recovered. No further information is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning her son who was vaccinated with a dose of varicella virus vaccine live. Around December 2004 or January 2005, he developed chicken pox. Subsequently, the doctor's son recovered. It was also reported that two additional patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and experienced adverse events (WAES0504USA00669 and WAES0504USA01870). No further information is expected.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Discomfort, Laboratory test abnormal
Clinical narrative: Information has been received from a health professional concerning a 41 year old female, with an allergy to bupropion hydrochloride Zyban and a history of no immunity per lab work, who on 5/28/1997 and 7/16/1997 was vaccinated with a first and second, 0.5ml, subcutaneous dose in the right arm of varicella virus vaccine live (lot 52162/1358D). Concomitant therapy included amitriptyline hydrochloride and birth control pills (unspecified). There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that a titer in April 2005 was 0.40. The patients status was reported as not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that on 5/28/1997 the patient was told no pregnancy for 3 months, the side effects were reviewed, and that she would receive the second dose in 4-8 months. On 8/20/1997 the patient experienced ankle  discomfort and had a second opinion. In April 2005 a documented immunity level was required for admission to nursery school. Additional information in not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Info has been received from a registered pharmacist concerning an adult female who on 3/27/05 was vaccinated with d dose of varicella virus vaccine live. On 4/12/05, the pt developed a vesicular rash and a mild fever. Unspecified medical attention was sought. At the time of this report, the pt was said to be recovering. No further info was available. No product quality complaint was involved. Additional info has been requested.