chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus, Urticaria
Clinical narrative: Patient experienced immediate reaction following MMR with a large 23mmx30mm hive with redness about 60mm in length. She also complained of itching. Right afterwards she developed hives on her arms, chest, neck, and back. No breathing problems. Physician came back in room and Benadryl was administered. Observed for 20 minutes then allowed patient to leave.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Patient started with rash on face 12 days after administration of varicella vaccine. Rash now on arms and chest. Patient to use Benadryl as needed.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Red, swollen, 2in-3in, hot. Hot packs on day 3; cleared by day 5.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Immediately after receiving the MMR SC in the left arm, patient developed a large hive with redness at injection site. No other hives were noted. No itching and no breathing problems. Benadryl was given to patient per physicians request and patient was allowed to leave.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 4 year old white male with no medical history who on 08/09/2000 was vaccinated in the right thigh with the first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  On 05/13/2004, the patient initially developed tow spots on his neck.  Overnight, the patient developed a varicella rash in his scalp.  The patient was noted to be afebrile, but was very sleepy.  A diagnosis of breakthrough chickenpox was made.  Unspecified medical attention was sought and the patient was treated with liquid diphenhydramine pramoxine zine acetate, and ibuprophen.  On 05/20/2004, the patient recovered from the chickenpox.  Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning an 8 year old white male with asthma who on 10-FEB-1998 was vaccinated SC in the left arm with the first dose of varicella virus vaccine live. Concomitant therapy included albuterol and loratadine (Claritin). There was no illness at the time of vaccination. The RN reported that in April 2004, the pt developed chickenpox breakthrough on his trunk area, neck and right thigh. Medical attention was not sought and no laboratory/diagnostic tests were performed. Subsequently, the pt recovered. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Decreased appetite, Depression, Fatigue, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a female who on 10-JUL-1998 was vaccinated SQ with a 0.5 ml dose of varicella virus vaccine live (lot 625048/1575E). Subsequently the pt experienced a vesicular rash with fever, fatigue and a decreased appetite. It was reported that prescription drug treatment was required for the experience and that the pt had not recovered. It was also reported that in 2003 the pt was placed on Prozac (10 mg PO) for depression and on 24-MAY-2004 the pt was placed on Clarinex (5 mg PO) for allergic rhinitis, Cefzil (500 mg PO) for sinusitis and Singulair for a cough. Information received on 07-JUN-2004 contained the following adverse experiences: depression, allergic rhinitis, sinusitis and cough. Follow up information received by a nurse indicated that prescription drug treatment was required to treat the pt's experience. At the time of this report the experience was still being treated and the outcome was pending. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Rhinitis allergic, Sinusitis
Clinical narrative: Information has been received from a health professional concerning a female who on 10-JUL-1998 was vaccinated SQ with a 0.5 ml dose of varicella virus vaccine live (lot 625048/1575E). Subsequently the pt experienced a vesicular rash with fever, fatigue and a decreased appetite. It was reported that prescription drug treatment was required for the experience and that the pt had not recovered. It was also reported that in 2003 the pt was placed on Prozac (10 mg PO) for depression and on 24-MAY-2004 the pt was placed on Clarinex (5 mg PO) for allergic rhinitis, Cefzil (500 mg PO) for sinusitis and Singulair for a cough. Information received on 07-JUN-2004 contained the following adverse experiences: depression, allergic rhinitis, sinusitis and cough. Follow up information received by a nurse indicated that prescription drug treatment was required to treat the pt's experience. At the time of this report the experience was still being treated and the outcome was pending. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Drug ineffective, Otitis media, Pruritus, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 14 month old female with no allergies or medical history who on 17-MAR-2004 at 9:10 AM was vaccinated  SC in the left thigh with a first dose of varicella virus vaccine live (lot # 647521/1108N). Illness at the time of vaccination included a right ear infection. The nurse reported that the pt developed break through chickenpox. The pt developed a cough, clear nasal discharge, and red bumps on her face one week before her doctor visit on 03-JUN-2004. A fever started two days before the doctor visit. On 03-JUN-2004, the pt presented with 15 papular lesions on the arms, hands, and face with one crusted lesion. The pt was treated with oral Benadryl and Aveeno as needed. On 05-JUN-2004, the pt presented again and the lesions spread and the pt had a cough and a fever. The pt was diagnosed with an ear infection. The pt was treated with antibiotic therapy for 10 days. On 08-JUN-2004, the RN called the mother who reported that the child's condition was somewhat improved. It was noted that the adverse events did not abate and the pt was recovering with sequelae. A product quality complaint was not involved. Follow up information was received from the RN who indicated that the pt was seen in the office on 03-JUN-2004 with one week history of a cough, clear nasal discharge, and red bumps on her face (onset date 27-MAY-2004 in the AM). She has a temperature of 102 two days prior to the visit. When she was seen in the office, she had 3 to 5 mm itchy papules on her arm. hand, and face (one was crusted) for about 15 lesions total. "Sx Rx" was advised with five days of isolation. The pt was seen again in the office on 05-JUN-2004 and the lesions had spread and she had a fever and a cough. She was diagnosed with an ear infection and put on amoxicillin for 10 days. On 08-JUN-2004, the mother indicated that the pt still had some lesions. Subsequently, on 16-JUN-2004, the pt recovered. No diagnostic laboratory tests were performed. The pt had no adverse events following prior vaccination. No further information is expected.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash papular, Rhinorrhoea, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a RN concerning a 14 month old female with no allergies or medical history who on 17-MAR-2004 at 9:10 AM was vaccinated  SC in the left thigh with a first dose of varicella virus vaccine live (lot # 647521/1108N). Illness at the time of vaccination included a right ear infection. The nurse reported that the pt developed break through chickenpox. The pt developed a cough, clear nasal discharge, and red bumps on her face one week before her doctor visit on 03-JUN-2004. A fever started two days before the doctor visit. On 03-JUN-2004, the pt presented with 15 papular lesions on the arms, hands, and face with one crusted lesion. The pt was treated with oral Benadryl and Aveeno as needed. On 05-JUN-2004, the pt presented again and the lesions spread and the pt had a cough and a fever. The pt was diagnosed with an ear infection. The pt was treated with antibiotic therapy for 10 days. On 08-JUN-2004, the RN called the mother who reported that the child's condition was somewhat improved. It was noted that the adverse events did not abate and the pt was recovering with sequelae. A product quality complaint was not involved. Follow up information was received from the RN who indicated that the pt was seen in the office on 03-JUN-2004 with one week history of a cough, clear nasal discharge, and red bumps on her face (onset date 27-MAY-2004 in the AM). She has a temperature of 102 two days prior to the visit. When she was seen in the office, she had 3 to 5 mm itchy papules on her arm. hand, and face (one was crusted) for about 15 lesions total. "Sx Rx" was advised with five days of isolation. The pt was seen again in the office on 05-JUN-2004 and the lesions had spread and she had a fever and a cough. She was diagnosed with an ear infection and put on amoxicillin for 10 days. On 08-JUN-2004, the mother indicated that the pt still had some lesions. Subsequently, on 16-JUN-2004, the pt recovered. No diagnostic laboratory tests were performed. The pt had no adverse events following prior vaccination. No further information is expected.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Laboratory test abnormal, Pruritus, Rash vesicular
Clinical narrative: Information has been received from a RN concerning a 28 year old white female pt, who is a nurse with no pre-existing medical conditions, who on 05/24/2004 at 3:00 PM was vaccinated SQ in the LA with a 3rd dose of varicella virus vaccine, live. Concomitant medication included oral contraceptive pill. The pt was no ill at the time of vaccination. The RN reported that on 06/05/2004, the pt developed a red bump on her left hand and on 06/06/04. she developed a vesicular rash on her left arm and shoulder. The rash was itchy. There were no other sx. It was noted that the pt did not have any adverse events following prior vaccinations. A direct flourescent  antibody (DFA) test was incomplete and no results were available. There was no product quality complaint reported. Unspecified medical attention was sought. Follow up information received from a RN reported that hte pt recovered from her rash and returned to work. No additonal information is expected.
Age: 60.0
Sex: F
Vaccine: HEP, UNK
Symptoms: Hypoaesthesia, Pain, Swelling face, Tongue oedema
Clinical narrative: Swelling and redness in face and limbs. Tingling of face. Itching and rashes all over body, metallic taste in mouth. Some symptoms last for days, some for hours. They come and go. Take antihistamine for itching. I need help. Whole body swells. Follow up: I'm still suffering from the effects of Hep B shots.
Age: 60.0
Sex: F
Vaccine: HEP, UNK
Symptoms: Dysgeusia, Erythema, Face oedema, Injection site hypersensitivity, Oedema peripheral
Clinical narrative: Swelling and redness in face and limbs. Tingling of face. Itching and rashes all over body, metallic taste in mouth. Some symptoms last for days, some for hours. They come and go. Take antihistamine for itching. I need help. Whole body swells. Follow up: I'm still suffering from the effects of Hep B shots.
Age: 60.0
Sex: F
Vaccine: HEP, UNK
Symptoms: Rash pruritic
Clinical narrative: Swelling and redness in face and limbs. Tingling of face. Itching and rashes all over body, metallic taste in mouth. Some symptoms last for days, some for hours. They come and go. Take antihistamine for itching. I need help. Whole body swells. Follow up: I'm still suffering from the effects of Hep B shots.
Age: 1.52
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Information has been received from an MD concerning a 9 year old black male who on  08/19/1996 was vaccinated with a 2nd dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 05/08/2004, the pt broke out with severe chickenpox in his mouth, eyes, and rectum. The child was taken to the ER. No other information is available. The outcome was reported recovering with sequelae. There was no product quality complaint. There were no relevant diagnostic tests or lab data. Follow up information indicated that the pt recovered on 05/13/04. No further information is expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a RN concerning a 7 year old male pt who on 08/29/1997 was vaccinated with a dose of varicella virus vaccine, live. On 05/24/04, the pt presented with "50 +" vesicular lesions over his entire body. No other sx were noted. Unspecified medical attention was sought but tx was not required. A product quality complaint was not involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash
Clinical narrative: Information has been received from an MD concerning a 25 year old " healthy" female who on 05/10/2004 was vaccinated with a dose of varicella virus vaccine, live. There was no concomitant  medication. On 05/24/04, the pt developed a rash. She had 3 papules at the injection site and one broken vesicle on her chest. Unspecified medical attention was sought and no Tx was required. No product quality complaint was involved. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 year old male pt who in approximately 1997, at one year of age, was vaccinated with a dose of varicella virus vaccine live. On 05/24/2004, the reporter stated that the pt now has shingles on his right arm. Medical attention was sought, but hospitalization was not required. The pt was treated with Acyclovir and naproxen. At the time of the report, the pt was getting better. A quality complaint was not involved.  Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a nurse concerning a 6 year old male who was vaccinated with a dose of varicella virus vaccine, live. Subsequently, the pt developed chickenpox described as 6 fluid filled vesicles post vaccination. Unspecified medical attention was sought. There was no product quality complaint involved. Additonal information has been requested.
Age: 1.02
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Drug ineffective, Pyrexia, Viral infection
Clinical narrative: Information has been received from a RN and mother concerning a 15 month old well appearing white male with a sulfa allergy who on 01/13/04, at 11:00 was vaccinated SQ in the thigh with the 1st dose of varicella virus vaccine, live. Concomitant medications on that same day  and time included the 1st  dose SQ in the thigh of the MMR, and the 4th dose IM in the thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (crm197) (Prevnar). There was no illness or other concomitant therapy at the time of vaccination. The RN reported that on 04/16/04 (also reported by the pt mother as 02/2004), the pt developed a rash characterized by papules on the back of both hands and face. On 04/17/04, the pt presented to an MD with a papular rash suggestive of chickenpox. The pt was treated with diphenhydramine hydrochloride (Benadryl), PRN and was instructed to follow up with the pediatrician as needed. Subsequently, the pt recovered. The pt's mother also reported her other son also  developed chicken pox after being vaccianted with varicella virus vaccine, live. (WAES#0405USA01245). Additional information is not expected.
Age: 1.26
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 7 year old white male student with no known drug allergies who on 07/20/1998 was vaccinated in the RL (thigh) with a dose of varicella virus vaccine, live. There was no illness at the time of vaccination. On 05/19/04, the pt's mother called and stated that the pt had been exposed to varicella. It was noted that a visit to the physicians office confirmed the pt has chicken pox. No testing was done. There was no relevant lab or diagnostic tests performed. The pt recovered with no px. No further information is expected.
Age: 1.27
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 7 year old white male student with no known drug allergies who on 10/23/1997 was vaccinated with a dose of varicella virus vaccine, live. There was no illness at the time of vaccination. The RN reported that the pt was given the varicella virus vaccine, live at a different practice. The pt mother called and reported that on 05/18/04, the pt had a rash on his trunk, chest, back, and face. The mother reported that the diagnosis of varicella was confirmed on 05/19/2004. There were no laboratory or diagnostic tests performed. The pt recovered with no problems. No furhter information is expected.
Age: 1.03
Sex: M
Vaccine: MMR, OPV, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 year old white male pt with no pre existing medical conditions, who on 03/30/1999 was vaccinated in the right lateral thigh with a 1st dose of varicella virus vaccine, live. Concomitant vaccinations administered on 03/30/99 included a 1st dose of MMR, in the left lateral thigh and a PO  3rd dose of poliovirus vaccine live,oral (Orimune). The physician reported that on 05/14/2004, the pt developed  varicella, which the physician diagnosed on 05/15/04, as a mild case of varicella. The physician reported that the pt "will recover". It  was noted that  the pt was not ill at the time of vaccination and did not have adverse events following prior vaccination. There was no lab or diagnostic tests performed. Follow up information received from the physician reported that the pt recovered on 05/24/04. No additional information is expected.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 37 year old male  pt who on 05/06/04 was vaccinated with a 1st dose of varicella virus vaccine, live. Approximately 2 weeks later, the pt developed a vesicular rash of approximately 15 lesions spread over his body. Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Information has been received from a LPN concerning a 19 month old white female with no pre-existing allergies, birth defects, or medical conditions who on 09/18/03 was vaccinated with a 1st dose of varicella virus vaccine, live. Concomitant therapy that day included a first dose of MMR. There was no illness at the time of vaccination. On 05/12/04, the pt came down with chickenpox after being exposed to the virus at day care. Follow up information indicated that the pt recovered. There were no relevant diagnostic tests or lab data. No further information is expected.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male who on 4/28/98 was vaccinated SC in the left arm with a 0.5cc first dose of varicella virus vaccine live (lot # 625127/1581E). The patient was not ill at the time of vaccination. On 4/28/04 the patient started breaking out with blister-like spots on red base over torso, face, and neck. The patient was seen in the physician office on 5/3/04 and varicella was confirmed. The patient recovered from varicella on an unknown date. No additional information is expected.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 4 year old patient who was vaccinated with a dose of varicella virus vaccine live (lot # not available). Subsequently, the patient developed an atypical rash. No further information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 26 year old licensed practical nurse with asthma and hypertension and allergies to phenytoin, carbamazepine, IV contrast dye, and meiricaine who on 2/8/01 and 3/23/01 was vaccinated with the first and second doses of varicella virus vaccine live (lot # unknown), each given six weeks apart. There was no illness at the time of vaccination. It was noted that a titer was drawn on 4/14/03 and the patient was non-immune and failed to seroconvert. The varicella zoster IgG was <0.91 (negative). A repeat vaccination and a recheck of the titer was recommended. Unspecified medical attention was sought. There was no product quality complaint. There were no adverse events following prior vaccinations of the patient or her siblings. No further information is expected.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Herpes zoster, Rash
Clinical narrative: Information has been received from an employee health registered nurse concerning a 48 year old female anesthesiologist with a history of anemia, arthritis, asthma, hay fever, and kidney disease, who on 4/27/04 was vaccinated SC on the left side with a 0.5cc dose of VARIVAX (lot # 645044/0207N). Prior to vaccination, on 4/19/04, an antibody titer for varicella was negative. By 5/23/04, the patient had developed a rash on the hairline of her scalp, then on the scalp, and then on the rest of her body. The patient reported that it looked like chicken pox and she went to a dermatologist. The patient had no history of chicken pox and no recent exposure to chicken pox or herpes zoster. The patient was treated with steroids for the inflammation. On 5/26/04, a biopsy of a lesion confirmed herpes zoster. The patient was treated with a prescription anti-viral medication. The rash had a duration of one to two weeks and subsequently, the patient recovered. A product quality complaint was not involved. The reporter considered herpes zoster to be an other important medical event (OMIC). Additional information is not expected.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Infection transmission via personal contact, Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female with recurrent ear infection who on 5/20/97 was vaccinated with a first dose of varicella virus vaccine live (lot # 622971/0420E), in the right anterior thigh. There was no illness at the time of vaccination. On 4/17/04 at 9:00 AM, the patient developed chicken pox. It was reported that the patient's mother had chicken pox, then child came down with them. The patient's mother reported to the doctor's office that the child had 15 pox and ran temperature of 100-101 for 2 days. The patient recovered. It was also reported that the patient's brother had a similar reaction (WAES0405USA02057). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a patient with no allergies or medical history who on 03/02/1998 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (lot#625052/1579E).  There was no illness at the time of vaccination.  The physician indicated that on 05/18/2004, the patient developed about 50 vesicular lesions with an erythematous base.  The patient was seen in the physicians office on 05/19/2004.  It progressed to over 100 lesions in 2 days.  No diagnostic laboratory tests were performed.  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 registered nurse concerning a 6 years old white male with recurrent ear infection, PET tubes and febrile seizures who on 01/05/1999 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck)(lot#628246/1655H), in the right thigh.  On 05/01/2004 at 9:00AM the patient developed chickenpox.  It was reported that the patient's 39 year old mother had chickenpox on 04/03/2004 then child came down with them.  The mother reported to the doctor's office that the patient had 30 pox.  On the same day of the outbreak the patient was started on Acyclovir.  It was noted that the patient had no temperature.  Subsequently, the patient recovered from chickenpox.  It was also reported that the patient's sister had a similar reaction. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning an 8 year olf male who in 1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  On 05/17/2004 the patient developed chickenpox with about 300 lesions on his body.  Unspecified medical attention was sought and the patient was treated with acyclovir and diphenhydramine.  Subsequently, the patient recovered.  No product quality complaint was involved.  Follow up correspondence received from the physician reported that there is no additional information.  It was also reported that a female patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed chickenpox.  No additional information is expected.
Age: 1.07
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 month old white male with no allergies or medical conditions who on 05/27/2004, at 11:00AM, was vaccinated in the right forearm with a first dose of varicella virus vaccine live.  Concomitant therapy included a dose of measles vaccine live, mumps virus vaccine live, rubella virus vaccine live.  There was no illness at the time of vaccination.  It was reported that it was given intradermally by accident.  The syringe was withdrawn and the patient only received about 0.1ml of vaccine.  It was reported that the child developed a wheal, induration and erythema at the injection site.  Medical attention was sought but no treatment was required.  No product quality complaint was involved.  Follow up information from the physician indicated that the patient had mild induration and erythema 5mm in diameter that appeared 15 minutes and resolved completely after 2 hours.  No medication was given and no labs were done.  Conflicting information indicated that the vaccine was given subcutaneously.  Additional information is not expected.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a healthcare facility concerning a 7 year old white female who on 01/17/1998 was vaccinated subcutaneously with a dose of varicella virus vaccine live.  On 05/16/2004 the patient developed more than 30 lesions.  Follow up information indicated that on 05/18/2004 the patient presented with a rash on the abdomen and groin and scabs on her head which started on 05/15/2004.  Greater than 30 lesions were noted and the patient was diagnosed with atypical varicella.  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old white female student with no allergies and no medical history who on 01/11/1999 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  On 05/19/2004 the patient was diagnosed with varicella by her school nurse.  No medical attention was sought and no diagnostic tests were done.  The varicella all scabbed over and on 05/24/2004 the patient recovered.  On 05/24/2004 the patient was to return to school.  No further information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning his 4 year old daughter who in the summer of 1998 was vaccinated with a dose of varicella virus vaccine live.  In July 1999 the patient developed chickenpox.  The patient was treated with diphenhydramine.  Subsequently, the patient recovered.  No product quality complaint was involved.  It was also reported that a male patient was vaccinated with a dose of varicella virus vaccine live and developed chickenpox.  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 9 year old male who on 01/16/1998 was vaccinated subcutaneously with a dose of varicella virus vaccine live.  The patient presented on 05/21/2004 with a breakthrough case of chickenpox.  The case was mild, with no fever and about 30-40 maculopapular lesions on the upper and lower extremities.  The child was given diphenhydramine for the itching.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no relevant medical history who on 02/06/2001 was vaccinated subcutaneously with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  On 05/12/2004, the patient developed 13 lesions on the body, that were positive varicella.  Subsequently, the patient recovered on 05/19/2004.  No further information has been requested.
Age: 1.9
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received concerning an 8 year old male student with seasonal allergies who on 1/27/97 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. The patient was exposed to chicken pox from a classmate on 10/31/03. On 11/14/03, the patient broke out with chicken pox, which was reported to be a light case. The outcome was reported as recovered on 11/20/03. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the patient or his siblings. No further information is expected.
Age: 1.42
Sex: F
Vaccine: VARCEL
Symptoms: Mouth ulceration, Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received concerning an 8 year old female with reactive airway disease and seasonal allergies who on 8/7/96 was vaccinated SC with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 10/31/03 in the PM (also reported as in the afternoon), the patient broke out with a rash. It was noted that the patient was exposed 2 weeks prior to breaking out. The patient had a fever of 102 degrees F for 3 to 4 days, and she continued to break out until the rash covered her body, inside her mouth, and the palms of her hands. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the patient or her siblings. The outcome was reported as recovered on 11/10/03. No additional information is expected.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female registered nurse employee with asthma and a history of chicken pox exposure, hypertension, kidney stones, and rash post dibrompropamidine isethionate (+) promethazine and thimerosal. On 8/01/01, a varicella zoster titer was 0.19 (less than or equal to 0.90 is negative; greater than or equal to 1.10 is positive). On 8/10/01 and 9/11/01, the patient was vaccinated with a first and second dose of varicella virus vaccine live (lot # 639782/0844L), respectively. On 5/20/04 at06:45, a varicella zoster titer was collected and the result was 0.44 (less than or equal to 0.90 is negative; greater than or equal to 1.10 is positive). The reporter stated the patient failed to seroconvert and the adverse event was non-responsive by titer. Unspecified medical attention was sought. On 6/13/04 in the PM, the patient was vaccinated SC in the right arm with a third dose of varicella virus vaccine live. A product quality complaint was not involved. Additional information is not expected.
Age: 1.07
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash pruritic, Skin ulcer
Clinical narrative: Information has been received from a registered nurse practitioner concerning a 9 year old female with no medical history and no allergies who on 4/19/96 was vaccinated SC in the arm with a first dose of varicella virus vaccine live (lot # 616862/1504B). Concomitant vaccine therapy given SC in the arm included a first dose of MMR live (lot # 613405/1415B). There was no illness at the time of vaccination. On 5/29/04 the patient presented to the physician's office with about 500 plus lesions and a pruritic rash that spread to his back, arms, face, and legs. The patient was treated with diphenhydramine. No lab studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Anorexia, Blister, Diarrhoea, Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 35 month old male with no past medical history who on 6/30/03 was vaccinated with varicella virus vaccine live. There was no illness at the time of vaccination. It was reported on 6/2/04 that the patient presented with chicken pox breakthrough yesterday. The patient had a new rash eruptions on face and arms, and crops of pimple-like itchy vesicles. The patient reportedly had diarrhea, loss of appetite and fever three days prior. The patient was treated with colloidal oatmeal and diphenhydramine HCl. No product quality complaint involved. It was reported that the patient recovered. There were no relevant diagnostic tests or laboratory data. No further information is expected.
Age: 1.11
Sex: F
Vaccine: VARCEL
Symptoms: Anorexia, Herpes zoster, Pruritus, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 22 month old female who on 7/24/03 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (644788/0328N). In April 2004, the patient developed shingles. Medical attention was sought and the patient was treated with Acyclovir for two weeks. Hospitalization was not required. It was reported that the patient has fully recovered. No product quality complaint was involved. Follow up information from the physician indicated that the onset was 4/04, at 10:00 AM (before 4/14/04) however, it was also reported that she had a fever and anorexia on and off around 3/31/04. There was multiple vesicular rash and scab over the left anterior chest and medial side of the left upper arm. She was seen on 4/14/04 and was treated with Zovirax 1 tsp PO QID for 2 weeks. She did not have a fever in the office, but had a fever on and off at home with questionable itching. She had an appointment on 4/28/04, but she didn't keep it. She was seen on 5/20/04 and there was no more rash. The physician reported that it was one month duration. No other labs or diagnostic tests were done and there was no rash at site of injection or elsewhere within 42 days of the vaccination. There was also no history of chicken pox and there no recent exposure to chicken pox or zoster. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female student with no allergies and no past medical history who on 8/17/00 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 632039/1357J). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. There was no concomitant medication. On 1/5/04, the patient developed a light case and the mother counted 27 spots. Medical attention was sought and laboratory tests were not performed. Approximately one week later, the patient recovered. Additional information is not expected.
Age: 1.46
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Pruritus, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a registered nurse and the parent of an 8 year old healthy male with no allergies and no medical history who on 3/7/97 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 619271/1338D). On 3/7/97, the patient was also vaccinated IM in the right thigh with a fourth dose of HIB conjugate vaccine (batch # 6K81443), a fourth dose given IM in the left thigh of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (batch # 6K71127), and a first dose given SC in the right arm of MMR. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. On 5/12/04 the patient developed 10-15 itchy lesions, 5 of which were vesicular, a very few of which contained fluid. They were on his trunk, behind his ears and on his neck. It was also noted that the patient's parent just wanted to let you know that the patient did get a mild case of chicken pox. On 5/19/04, the patient recovered. The patient was not seen by a doctor and no treatment or diagnostic tests were required. No product quality complaint was involved. It was also reported that on 9/21/95, 1/12/95, and 5/24/96, the patient was vaccinated with a first, second, and third dose of hepatitis B virus vaccine. On 1/12/96, 3/8/96, and 5/24/96, the patient was vaccinated with a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (+) HIB conjugate vaccine, and a dose of hepatitis A virus vaccine inactivated (lot # FVHA523A4). On 6/16/00, the patient was vaccinated with a dose of MMR (lot # 631639/0109K), a dose of poliovirus vaccine inactivated (lot # FR02352) and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (lot # FDTPA939A2). No further information is expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 5/29/04, was vaccinated with a 0.5ml dose of varicella virus vaccine live. On 6/2/04, the patient was seen in the clinic with a fever and slight rash post vaccination syndrome. Follow up information was received from the physician who indicated that the patient was vaccinated by his primary care physician. The reporter saw the patient due to a generalized rash in urgent care. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a pharmacist concerning an adult male who in 2003 was vaccinated with a dose of varicella virus vaccine live. The pharmacist reported that the patient did not have the second vaccination. A titer in approximately May 2004 was negative. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested/
Age: 1.09
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female with no allergies or medical history who on 5/2/97 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 5/29/04, the patient experienced one spot or pox on her stomach. She had more spots the next day and some were red and others were red with white pinpoint scabs. More pox were noted on 6/1/04 with a total of approximately 200 eruptions or pox. Unspecified medical attention was sought and she was treated with acetaminophen and diphenhydramine hydrochloride cream. The nurse also suggested diphenhydramine hydrochloride for treatment. A product quality complaint was not involved. Follow up information was received from the registered nurse who indicated that on the evening of 5/29/04, the patient's mother called the reporter's office and asked when she could send the patient back to school. It was noted that her usual physician was out of the office. The patient had hundred of red bumps but only about 150 blistered and then not too severely. It was noted that chicken pox was going around her school at that time. The patient was sent back to school with scabs on 6/4/04. Subsequently, the patient recovered in mid June 2004. No diagnostic laboratory tests were performed as the patient was not seen by her medical provided. Neither the patient nor her sibling had any adverse events following prior vaccinatino. No further information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old female with no allergies or medical history who on 6/1/04 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot # 647710/1248N). There was no concomitant medication. On 6/2/04, the patient developed a rash on her body. There were a total of 40 spots on her elbow, legs, armpits, back and face. The mother of the child believed that she developed chicken pox as a result of receiving the vaccine and not prior exposure. No medical attention was sought and no treatment was required. A product quality complaint was not involved. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Headache, Pruritus, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male with no allergies or medical history who on 12/3/96 was vaccinated SC with a dose of varicella virus vaccine live (lot # 612222/0241D). Concomitant vaccination on 12/3/96 included a dose of MMR. On 5/31/04, the child developed a headache. On 6/1/04, the child was seen with a vesicular non-herpetic rash (a few spots) on the back and shoulders which was noted as breakthrough chicken pox. There were no laboratory tests performed. On 6/2/04, the mother called the office to report that the spots were everywhere. The child had no fever and was not scratching, but the mother had given oral diphenhydramine HCl just in case. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information was received from a physician who indicated that on 6/1/04, the patient had a vesicular rash that continued to appear over several days. It was noted to be itchy and had bumps to blisters to crusting. Diphenhydramine HCl and acetaminophen were used as needed. No further information is expected.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 5 year old male who on 11/11/99 was vaccinated with a dose of varicella virus vaccine live. The patient presented to the office on 6/2/04 and was diagnosed with varicella breakthrough, described as 75-100 lesions on the child's body. The patient was afebrile. There were no diagnostic laboratory tests performed. It was noted that the physician did not provide any treatment at the time of visit. Unspecified medical attention was sought. The outcome was not recovered. there was no product quality complaint involved. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a 35 year old female patient with an allergy to sulfa and no pertinent medical history who on 4/5/02 and 5/16/02 was vaccinated with a first and second dose of varicella virus vaccine live (641159/1301L). There was no concomitant medication. On 5/7/04, the patient had a titer drawn for antibodies. The laboratory test, Varicella Zoster V AB, IgG, Varicella zoster IgG results reported that she tested negative. The nurse reported that the patient has a negative varicella titer. The patient sought unspecified medical attention. No additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 9 year old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed varicella wild type breakthrough. Her case was considered to be serious (OMIC). It was reported that the patient transmitted the varicella infections to an uncle (WAES0406USA01126) who had never been immunized or had never developed wild type varicella in the past. The uncle was subsequently vaccinated with Varivax and still developed the wild type infection. Unspecified medical attention was sought. There was no product quality complaint involved. Upon internal review, the patient's varicella breakthrough was considered to be an other important medical event (OMIC). The patient's brother (WAES0406USA01125) also developed an adverse event after vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 1.23
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Medication error
Clinical narrative: Information has been received from a registered nurse concerning a 14 month old female with asthma and no allergies who on 6/3/04 was vaccinated SC in the left leg with a first dose of varicella virus vaccine live (lot # 636582/0447M). Concomitant vaccination the same day included a first dose of MMR (lot # 644618/1036M) given SC in the left leg. Other concomitant medication includes albuterol nebulizer and fluoride supplement. There was no illness at the time of vaccination. It was reported that the varicella virus vaccine live expired on 5/23/04. No adverse symptoms were noted. Unspecified medical attention was sought and no treatment was required. There was no product quality complaint involved. Follow up information indicated that the patient had no adverse events except for mild pain at the site of injection. On 6/4/04 the patient recovered. No further information is available.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old female patient with no pre-existing medical conditions who on 8/13/99 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 630409/0297J). Concomitant vaccine therapy administered on the same day included a SC first dose of MMR (lot # 631645/0921J). The patient was not ill at the time of vaccination. On 5/22/04, the patient developed varicella. The licensed practical nurse reported that the patient recovered. No laboratory or diagnostic test was performed. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a male physician who in the 1980's was vaccinated with a dose of varicella virus vaccine live. In the 1980's, the physician was involved in varicella research and was vaccinated with varicella virus vaccine live as an adult. A titer was drawn during the research was positive for varicella, however, all other commercial titers drawn there after were negative. The physician had treated women with natural varicella and never developed chickenpox. On 6/1/04, the physician had a commercial titer drawn and the results was negative. Unspecified medical attention was sought. Subsequently, on 6/1/04, the physician was re-vaccinated. A product quality complaint was not involved. The physician mentioned his son (WAES0406USA01257) and a friend of his son (WAES0406USA01258) who were both vaccinated with varicella virus vaccine live and subsequently developed chicken pox. Additional information has been requested.