chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.7
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Infection, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 20 month old white, female, with no medical history and no allergies, who on 09/27/2004 was vaccinated at 14:00 with a dose of varicella virus vaccine live.  Concomitant vaccines given on the same day at 14:00 included the following:  a subcutaneous first dose in the right leg of measles-mumps-rubella vaccine, a intramuscular fourth dose in the right leg of pneumococcal vaccine, a intramuscular fourth dose in the left leg of diphtheria toxoid, pertussis acellular Biken vaccine, tetanus toxoid, and a intramuscular fourth dose in the left leg of Hib vaccine.  It was noted that there was no illness at the time of vaccination and that there were no adverse events following prior vaccinations.  On 10/07/2004, at 08:00AM the patient experienced a varicella outbreak, with over 50 lesions over her trunk, neck and face.  The reporter felt that the varicella outbreak was from varicella virus vaccine live.  The patient was afebrile.  It was reported that the patient was given an antihistamine.  No laboratory or diagnostic tests were performed.  Subsequently, on 10/10/2004 the patient recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning an 11 year old African-American female, with no medical history and no allergies, who on 10/06/2004 was vaccinated with a subcutaneous dose in the left arm of varicella virus vaccine live.  It was noted that there was no illness at the time of vaccination and there were no adverse events following prior vaccination.  On 10/12/2004, in the morning, the patient experienced injection site swelling.  On 10/14/2004 the patient's arm was hot and swollen 3x2 cm.  Ice was applied for treatment.  By 10/15/2004 all swelling was gone.  There were no laboratory or diagnostic tests performed.  No product quality complaint was involved.  Follow up information indicated that on 10/12/2004 the patient developed a hot swollen area.  3x2 cm on arm where shot was given.  it was also reported that the patient did not go to the doctor.  On 10/15/2004 the patient was considered recovered.  Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Herpes zoster, Infection, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with a possible allergy to amoxicillin who on 02/26/2003 was vaccinated with a first dose of varicella virus vaccine live.  On 11/16/2004 the patient's parent called the doctors office because the child had a rash on her hand.  On 11/17/2004 the child presented to the office and the physician diagnosed her with shingles, vaccine related, described as 10-20 lesions at hand in c7 dermatome.  It was reported that there was no identified discomfort, but the patient apparently complained sore to mother.  A culture for bacteria was performed, results not yet available.  On 11/22/2004 a specimen was obtained from a scab and sent for PCR analysis.  All specimens were adequate and were negative for wild type varicella zoster virus and the vaccine strain virus.  The child was treated with acyclovir cream.  Subsequently the patient recovered.  There was no product quality complaint involved.  Follow up information from the physician indicated that the patient had no history of chickenpox or recent exposure to chickenpox or herpes zoster.  Additional information is not expected.
Age: 1.51
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dermatitis bullous, Pruritus
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 month old female with no pre-existing allergies or medical conditions who on 12/2/72004 at 11:30AM was vaccinated in the right vestus lateralis with the first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  According to the LPN, the patient developed varicella like rash on 12/29/2004.  She was seen by a physician on 01/04/2005, the rash consisted of generalized erythematous papules and some vesicles that were itchy and were seen on her scalp, trunk and extremities.  Upon assessment there was no fever, runny nose, or cough and her pulse was 90 and respiratory rate was 22.  The patient was prescribed diphenhydramine hcl and colloidal oatmeal baths PRN.  It was reported that the patient recovered.  Additional information is not expected.
Age: 1.51
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dermatitis bullous, Heart rate irregular
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 month old female with no pre-existing allergies or medical conditions who on 12/2/72004 at 11:30AM was vaccinated in the right vestus lateralis with the first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  According to the LPN, the patient developed varicella like rash on 12/29/2004.  She was seen by a physician on 01/04/2005, the rash consisted of generalized erythematous papules and some vesicles that were itchy and were seen on her scalp, trunk and extremities.  Upon assessment there was no fever, runny nose, or cough and her pulse was 90 and respiratory rate was 22.  The patient was prescribed diphenhydramine hcl and colloidal oatmeal baths PRN.  It was reported that the patient recovered.  Additional information is not expected.
Age: 1.25
Sex: F
Vaccine: MMR, MMR
Symptoms: Nonspecific reaction, Rash
Clinical narrative: 7 days after receiving the MMR vaccine, started running a 102+ fever and broke out with red bumps all over her body. She began breathing very rapidly and had to use Xopenex to slow the breathing. She was very pale and her face was swollen. These symptoms lasted a little over two days.
Age: 1.25
Sex: F
Vaccine: MMR, MMR
Symptoms: Face oedema, Pallor, Pyrexia, Rash, Respiratory rate increased
Clinical narrative: 7 days after receiving the MMR vaccine, started running a 102+ fever and broke out with red bumps all over her body. She began breathing very rapidly and had to use Xopenex to slow the breathing. She was very pale and her face was swollen. These symptoms lasted a little over two days.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Syncope
Clinical narrative: Patient had syncopal episode after receiving smallpox vaccine.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 10 year old male, with no known medical history or allergies, who on 6/27/96 was vaccinated with a dose of varicella virus vaccine live (lot # 616998/1658B). There was no concomitant medication. On 9/27/04, the patient developed a mild case of chicken pox, including 25 scattered lesions. It was reported that he was afebrile. The patient was seen in the office on 9/30/04 and no treatment was required. There was no product quality complaint involved. Follow up information from the physician indicated that he had forgotten the details concerning this. No further information is available.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male with seasonal allergies and asthma who in 2000 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included albuterol. On approximately 9/29/04, the child developed two vesicles on his face, four vesicles on the back of his neck and two vesicles on his belly, which the nurse believed to be chicken pox. It was reported that the patient was exposed to a female child (WAES0409USA02670) in the school setting who was vaccinated with varicella virus vaccine live and developed a rash and a high fever. Unspecified medical attention was sought and there were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Age: 1.62
Sex: F
Vaccine: VARCEL
Symptoms: Erythema multiforme, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 3 year old female, with no allergies or medical history, who on 1/30/03 at 14:000 was vaccinated in the left lateral thigh with the first dose of varicella virus vaccine live (lot # 643588/0804M). The physician reported that on 9/15/04 the patient developed 100-150 lesions all over the body. She was diagnosed with a moderate case of varicella but no laboratory/diagnostic tests were performed. The physician also reported that interestingly enough she also developed erythema multiforme with that. At the time of this report, 12/8/04, patient's outcome was unknown.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a female nursing student in her early 20s with a negative varicella titer, who in second week of September 2004, was vaccinated with her first dose of varicella virus vaccine live (lot # 649262/0588P). On approximately 10/02/04, the patient developed chicken pox. Unspecified medical attention was sought, but the patient had not yet seen a doctor. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 38 month old white female who on 7/29/02 was vaccinated SC in the right arm with a dose of varicella virus vaccine live (lot # 642676/0421M). At the time of vaccination the child had left otitis media. On 9/23/04 the patient experienced chicken pox and shingles. Subsequently, on 10/4/04 the patient recovered. Unspecified medical attention was sought. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning an 11 year old white female, with no allergies and no medical history, who on 10/14/99 was vaccinated with a SC first dose in the left arm of varicella virus vaccine live (lot 1130S). It was noted that she had an upper respiratory infection at the time of vaccination. It was reported that on 8/11/04, bumps were noticed on the patient's abdomen, and on 8/13/04 she was seen in the office and diagnosed with varicella. Supportive care was given and included acetaminophen, diphenhydramine hydrochloride, and calamine lotion. Subsequently, the patient recovered. It was also noted that her sibling, at 8 years of age, experienced varicella following vaccination with varicella virus vaccine live (WAES0408USA01569). Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Skin ulcer, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of varicella virus vaccine live (lot # not available). She indicated that the parent had contacted her concerning adverse events following immunization with varicella virus vaccine live. No specifics were available. She did not believe that the adverse events seemed severe. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that all of the reactions described by the physician were normal reactions. The reaction was described as local swelling. The child had a pox mark. Additional follow up received from the physician indicated that he did not have any patients with adverse reactions to varicella virus vaccine live. The reporter indicated that 2 other patients experienced adverse events (WAES0411USA03509). No additional information is expected.
Age: 1.33
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a consumer concerning a 7 year old male with no known medical history or allergies who on 10/15/98 was vaccinated in his right arm with a first dose of varicella virus vaccine live (lot # 627747/1058H). There was no illness at the time of vaccination. Two weeks following his infant sister's immunization with varicella virus vaccine live, the patient developed a mild, atypical case of varicella with approximately 10 lesions. No fever was noted. Follow up information from the physician indicated that on 10/5/04 the patient developed varicella disease with a fever of 102 degrees F and a rash. No other adverse events were noted. Additional information is not expected.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a health professional concerning a 13 month old male with no known medical history or allergies who on 08/02/2004 was vaccinated with a dose of varicella virus vaccine live.  Concomitant therapy included sulfamethoxazole/trimethoprim and pimecrolimus.  On 09/23/2004 the patient developed a chickenpox like rash with papular and some vesicular lesions over his body.  The patient was afebrile.  It was reported that some spots appeared off and on for two weeks prior to this date.  Unspecified medical attention was sought.  Subsequently on 09/23/2004, a titer for IgG and IgM were negative.  The patient was treated with diphenhydramine hydrochloride.  There was no product quality complaint involved.  Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash erythematous, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 38 month old female with penicillin allergy and a history of tubes in her ears and otitis media who on 04Apr02 was vaccinated in the left arm with a dose of varicella virus vaccine live (lot 639488/0572L). On 07Jun04 the pt developed a rash with a dermatomal distribution C7-8 on left arm that had an erythematous base and clustered lesions. The following day she saw a dermatologist who agreed it was Herpes zoster. Interventions included Acyclovir orally and Acyclovir (Zovirax) topical cream. It has been reported that as of 14Jun04 the pt fully recovered from herpes zoster. There was no report of product quality complaint. The reporting physician considered herpes zoster to be an other important medical event (OMIC). Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site rash, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 7 yr old male who on 19Jul00 was vaccinated in the left arm with a dose of varicella virus vaccine live (lot 635981/0447K). On 03Oct04 the pt complained of soreness in his left arm. He had difficulty lifting his arm due to this soreness. On 05Oct04, he developed a rash on his left arm with a dermatomal distribution C 7-8. The rash had an erythematous base and clustered lesions. He was diagnosed with Herpes Zoster. Interventions included acyclovir (Zovirax) oral suspension. It was reported that the pt was recovering and will be seen again in two weeks. There was no product quality complaint involved. The pt's herpes zoster was considered to be an other important medical event (OMIC) by the reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Fatigue, Malaise, Pruritus, Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old white female with no pre-existing allergies, birth defects, or medical conditions who on 10/05/2004 at 10:45AM 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.  There was no concomitant medication.  On 10/06/2004 at 2:30PM the patient developed a generalized rash and malaise.  She was also tired and woozy.  The outcome was reported as not recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information received from a registered nurse indicated that on 10/06/2004, one day post vaccination, the patient developed a red, raised rash on her back, abdomen, and arms.  No fever was noted.  On 10/07/2004, the patient complained of feeling tired and woozy for 1 day duration.  The generalized rash lasted approximately 2 weeks, then the patient had developed 2-3 spots at a time over a course of 2-3 weeks.  The last episode of having the itchy spots appear was approximately 11/07/2004.  The outcome was reported as recovered on 11/07/2004.  There were no relevant diagnostic tests or laboratory data.  There were no adverse events following prior vaccinations of the patient or her siblings.  No additional information is expected.
Age: 25.0
Sex: M
Vaccine: HEPAB, VARCEL
Symptoms: Pharyngitis, Pruritus, Pyrexia, Rash erythematous, Rhinitis
Clinical narrative: Information has been received from a RN concerning a 25 yr old male student who on 16Sep04 at 09:00 was vaccinated SC in the left arm with his first dose of varicella virus vaccine live (lot 641990/1313N). Concomitant vaccinations included the first dose of hep A virus vaccine inactivated (+) hep B virus vaccine rHBsAg (yeast) (Twinrix) (lot AHABA015BA) given IM in the left arm. The nurse reported the pt developed a mild fever and cold symptoms on 30Sep04 which lasted 2-3 days. On 03Oct04, the pt developed approx 8-10 red, raised itchy bumps on his face, left hand and head; no pustules were present. Unspecified medical attention was sought. The lesions resolved after about one week and the pt was noted to have fully recovered. The pt received a second dose of varicella virus vaccine live (lot 641990/1313N) SC in the left arm on 20Oct04 at 08:30. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live.  Subsequently the patient experienced a mild breakthrough of varicella.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live.  Subsequently the patient was still experiencing mild breakthrough at the time of the report.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information indicated that the physician's office was unable to give more information because they needed more specific patient information.  No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced mild break through varicella. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Headache, Infection
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old caucasian male with an amoxicillin, clavulanate potassium allergy and no illness at the time he was vaccinated with a dose of varicella virus vaccine live.  Concomitant vaccinations included:  Hib and measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  The nurse reported that the patient broke out with chickenpox and developed a headache.  He was seen in the office on 10/08/2004.  No treatment was recommended and no laboratory/diagnostic tests were performed.  At the time of this report the patient's status was unknown.  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 RN concerning a 23 yr old female who was vaccinated with a full adult dose of varicella virus vaccine live (lot 645051/0200N) several years ago. A titer was done recently, it did not show seroconversion. Medical attention was sought and according to the RN a third dose of Varivax was given this week (approx 11Oct04). No symptoms were noted. Additional information has been requested.
Age: 39.0
Sex: U
Vaccine: VARCEL
Symptoms: Infection transmission via personal contact, Viral infection
Clinical narrative: Information received from published information indicated that a 39 yr old health care worker developed varicella with 10 lesions 8-14 days. Secondary transmission was noted. Analysis of material from this secondary case indicated that it was also vaccine strain, which occurred despite a previous history of wild type varicella. There was no evidence of immunosuppression by clinical history or immunologic testing, and the pt was not taking immunosuppressive medications. The published information also discussed 3 other cases (WAES0403USA01096, WAES0403USA01097, and WAES0410USA01876).
Sex: U
Vaccine: VARCEL
Symptoms: Infection transmission via personal contact, Viral infection
Clinical narrative: Published information indicated that a case of zoster presented in a pt, shown by sequence analysis to be wild type VZV. Secondary transmission was noted. The information also discussed three other cases (WAES0403USA01096, WAES0403USA01097, WAES0410USA01875).
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a certified medical assistant concerning a pt who was vaccinated with a dose of varicella virus vaccine live (lot 632037/1355J). The CMA reported that shortly after receiving Varivax the pt was seen in the doctor's office with shingles. At the time of this report the pt's outcome was unk and there was no product quality complaint. Additional information has been requested.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Acne, Drug ineffective, Dry skin, Pyrexia, Viral infection
Clinical narrative: Information has been received from a consumer concerning her 6 yr old daughter who, on 25Mar99 was vaccinated with a dose of varicella virus vaccine live. On 13Oct04 the pt developed about 3 to 4 dozen pimple like spots, some crusty, around neck, over torso, arms, legs and face. The consumer also reported a fever of 100-102F. The pt was seen by a healthcare professional (HCP) that same day and the child was diagnosed with chicken pox. At the time of this report there was no further information and the pt's status was unk. There was no product quality complaint. Additional information has been received from the reported administering/responsible physician's office stating that they did not give this pt the vaccine, nor did they see her for a reaction. No additional information is available.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Malaise, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a RN concerning a 4 yr old male with asthma who on 09Jan02 was vaccinated with a dose of varicella virus vaccine live (lot 640311/0794L). The RN reported that the pt developed chickenpox on 14Oct04. The mother of the pt called the doctor's office and said he had 15 lesions on his back and that he was not feeling well. At the time of this report the pt had not recovered and no further information was available. There was no product quality complaint. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Lip ulceration
Clinical narrative: Information has been received from a RN concerning her 5 yr old daughter with an allergy to Neomycin who on 06Oct04 was vaccinated with a dose of varicella virus vaccine live. The pt's mother reports that on 13Oct04 the pt developed one sore on lip that appeared as a cold sore. At the time of this report no medical attention was sought and the pt was recovering. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Medication error, Pain
Clinical narrative: Information has been received from a 50 yr old female registered nurse with hypertension, diabetes and allergies to codeine and acetaminophen (hydrocodone bitartrate (Vicodin) who on 18Oct04 was splashed in the eye with varicella virus vaccine live during administration. Concomitant therapy included diltiazem hydrochloride (Cardizem), lisinopril 9 (manf unk), estrogens, conjugated (Premarin), levothyroxine sodium (Synthroid) and omeprazole (Prilosec). The nurse experienced a slight stinging sensation in her eye and rinsed her eye with water as an intervention. She did not seek medical attention. There was no product quality complaint involved. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Information has been received from a RN concerning a healthy 12 month old male with no illness at the time of vaccination, who on 27Sep04 at 13:30 was vaccinated SC with the first dose of varicella virus vaccine live. Concomitant vaccinations included measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no illness at the time of vaccination. On 15Oct04 at 09:00, the pt developed scattered lesions on trunk, neck, thighs and two on his forehead. The pt was seen in the doctor's office on 18Oct2004 with varicella lesions; seven lesions were scattered throughout trunk and 2 on forehead and thighs. Mupirocin (Bactroban) was recommended for lesions which were infected. No laboratory or diagnostic tests were done. Subsequently, the pt recovered. There was no product quality complaint. The nurse initially considered scattered varicella lesions to be an other important medical event; however follow up information from the same nurse indicated that they were not. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a medical assistant concerning a female who was vaccinated with a dose of varicella virus vaccine live and subsequently, developed chickenpox. It was reported that the family was tested for chickenpox when the child developed chickenpox. Unspecified medical attention was sought. No further information was given at the time of this report and the pt's outcome was unk. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a physician concerning her 12 month old son who on 12Jul04 was vaccinated with a dose of varicella virus vaccine live in his right thigh. On approx 22Jul04 the pt developed a red, warm site reaction, about 5cm in diameter. Unspecified medical attention was sought and the reaction site was treated with ice; it resolved within a day or so. At the time of this report no further information was available and there was no product quality complaint. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, VARCEL
Symptoms: Diarrhoea, Irritability, Rash papular, Urticaria, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 month old white female with asthma, a history of sinusitis and no known drug allergies who on 21Sep04 was vaccinated SC in the left thigh with the first dose of varicella virus vaccine live (lot 648088/0100P). Concomitant vaccinations given on that same day included: the second dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (lot 647099/1290N) given IM in the right thigh; the third dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (Infanrix) (DTPA63902) given IM in the right thigh; the second dose of poliovirus vaccine inactivated (Ipol) (X1040) given IM in the right thigh; and the second dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (PREVNAR) (A74398K) given IM in the right leg. At the time of vaccination the pt had a cough and diarrhea. The pt was exposed to child at daycare who had also received a dose of varicella virus vaccine live  and developed a rash (WAES0410USA04291). Subsequently, on 20Oct04, the 13 month old pt experienced vomiting, diarrhea, and a scattered papular urticarial rash following exposure. The pt was seen in the physician's office. The pt was noted to be fussy and without a fever. A rapid strep test was performed; the results were negative. It was reported that the pt recovered. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a RN concerning a 5 yr old white male with seasonal allergies and no other medical history who on 11Dec02 was vaccinated SC with a first dose of varicella virus vaccine live (lot 641148/0791M). Concomitant vaccines that day included a fifth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) (lot C0948AA) given IM and a fourth dose of poliovirus vaccine inactivated (Ipol) (lot W0010) given SC. Concomitant therapy included cetirizine hydrochloride (Zyrtec). On 18Oct04 the pt developed 15 lesions on his back and face with more appearing. The pt was seen for a doctor's visit and the lesions were classified as modified varicella. The pt was treated with calamine (+) camphor (+) pramoxine hydrochloride (Aveeno) and diphenhydramine hydrochloride (Benadryl). Subsequently, the pt recovered from the modified varicella. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a licensed visiting nurse (LVN) concerning a 3 yr old Caucasian male who on 27Feb02 was vaccinated SC in the left thigh with the first dose of varicella virus vaccine live (lot 639490/0574L). The LVN reported that on 20Oct04, the pt developed breakthrough varicella with 8 to 10 fluid filled lesions on scalp that were not itchy. The pt did not have a fever. Unspecified medical attention was sought but no treatment was prescribed. It was reported that the pt recovered from the varicella. A product quality complaint was not involved. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 yr old male with no known medical history or allergies who on 08Mar99 was vaccinated with a dose of varicella virus vaccine live (628697/1838H). On approx 21Oct04 the pt developed a chickenpox rash with over 100 lesions from scalp to torso. It was reported that the child was exposed to chickenpox at an elementary school. Unspecified medical attention was sought and no treatment was required. At the time of the report the child was recovering, but still having some lesions breakout. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning his son who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed a fever. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with varicella virus vaccine live. Subsequently the pt experienced a breakthrough after vaccination. it was unspecified if medical attention was sought. The pt's present status was unk. No further information was given at the time of this report and there was no produt quality complaint.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered pharmacist concerning an adult female who in 2002 was vaccinated with two dosed of varicella virus vaccine live. The pharmacist reports that the pt now has a negative titer. Unspecified medical attention was sought. No further information was reported. At the time of this report there was no product quality complaint. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a LPN concerning a 4 yr old white female with no pre-existing allergies, birth defects, or medical conditions who on 08Noc00 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot 634502/0538K). The pt had otitis media at the time of vaccination. Concomitant therapy that day included a first dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (PREVNAR) (batch 473-810) admin IM in the right thigh. On 22Oct04 the pt experienced chickenpox with fewer than 50 vesicular lesions. No other symptoms were noted. Unspecified medical attention was sought. The outcome was reported as recovering. There was no product quality complaint. Follow up information indicated that the AE onset date was 21Oct04. The pt was seen in the office on 22Oct04. It was noted that she had just returned from vacation. She arrived home 2 days prior and on 21Oct04 the mother noted some rash on her abdominal area that spread to her legs and pelvic area. She was diagnosed with chickenpox. She had less than 50 lesions, and the mother stated that she recovered on 26Oct04. There were no diagnostic tests or lab data. It was also noted that the pt's brother developed an adverse event (WAES0411USA03493). No additional information is expected.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Eye irritation, Medication error, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 25 year old female nurse with a sulfa drug allergy and a history of sinus surgery on 10/1/04 who on 10/22/04 was squirted in one eye with one drop of varicella virus vaccine live. Concomitant therapy included fexofenadine hydrochloride (+) pseudoephedrine hydrochloride, mometasone furoate, and duloxetine hydrochloride. She has felt slight itching and irritation, but no other effects from the varicella virus vaccine live. It was reported that she already had chicken pox. Medical attention was sought, but no labs were performed. A product quality complaint was not involved. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Erythema, Rash papular, Viral infection
Clinical narrative: Information has been received from a woman in a physician's office concerning a 4 year old female who on 11/7/00 was vaccinated with a SC first dose of varicella virus vaccine live (lot #636569/0926K). It was reported that there was no illness at the time of vaccination. On 10/20/04, the patient reportedly had vaccine failure and was seen in the office with chicken pox. The outcome was unknown. It was reported that a patient was vaccinated with a dose of MMR and developed an AE (WAES0410USA02742). Follow up information has been received from a health professional. On 10/18/04, the patient experienced breakthrough chicken pox described as a papulovesicular rash, erythematous, diffuse on trunk, face, neck and legs. Subsequently, the patient recovered. Unspecified medical attention was sought. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced breakthrough disease. Follow up information indicated that the registered nurse could not provide additional information at this time. Additional information is not expected.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 43 month old white male with Down's Syndrome, hydronephrosis, and an unspecified congenital anomaly who on 3/20/02 was vaccinated with his first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 10/19/04, the patient experienced rash on trunk for one day with approximately 40 lesions; the patient did not have a fever. The patient was seen at the pediatrician's office, no laboratory/diagnostic tests were done. It was reported that the patient recovered with no problems. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning an adult female with no known medical history or allergies who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient had the gpELISA antibody test performed and the results was 0.91 equivocal. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information from the physician indicated that he was inquiring to request information regarding ELISA titers that would be expected after vaccination, not because of an adverse experience. No further information is expected.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old female who on 9/10/01 was vaccinated with a dose of varicella virus vaccine live. On 10/24/04, the patient developed a mild case of shingles on her right upper chest. She saw a doctor, no medical treatment was ordered and there is no information on the patient's present status. There was no product quality complaint involved. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a woman in a physician's office concerning a 12 month old male who on 1/18/01 was vaccinated IM with a first dose of varicella virus vaccine live. On 10/19/04 at 09:00 AM, the patient was diagnosed with varicella disease in the physician's office. At the time of the report, it was unknown if the patient recovered. The patient had no adverse events following prior vaccination. Follow up information was received from the physician's office which indicated that the event was never reported as given IM instead of SC. The patient had varicella after receiving varicella virus vaccine live on 1/18/01 and varicella was diagnosed on 10/19/04. No further information is expected.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old white female with no known allergies who on 2/12/01 was vaccinated in the left upper extremity with a first dose of varicella virus vaccine live (lot # 635461/1246K). Illness at the time of vaccination included a rash. On 10/18/04 (also reported as 10/19/04), the patient developed an outbreak of varicella (also reported as varicella rash). The patient recovered on 10/26/04. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a registered nurse and a certified pediatric nurse practitioner concerning a 4 year old male who on 3/6/01 was vaccinated with a dose of varicella virus vaccine live. It was also reported that the patient received a dose of MMR, a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine, and a third dose of poliovirus vaccine inactivated. It was noted that the patient received the first and second dose of poliovirus vaccine inactivated on 2/24/00 and 5/3/00. On 10/23/04, the patient developed less than 50 varicella lesions and he was seen by the nurse practitioner on 10/25/04. She noted the patient to have a runny nose-clear with a normal medical exam except for the less than 50 papular red spots along his neck (some beginning to scab) and she diagnosed him with varicella. No treatment was ordered. At the time of the report, the patient had recovered. There was no product quality complaint. Additional information is not expected.
Age: 1.31
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 37 month old female who on 1/10/03 was vaccinated with a dose of varicella virus vaccine live (lot # 637975/1897K). Subsequently, on 10/25/04, the patient developed a vesicular rash with about 20 lesions. No other symptoms were noted. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Rash, Rhinorrhoea, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 19 month old female with no known medical history or allergies who on 3/1/04 was vaccinated with a dose of varicella virus vaccine live (lot # 644796/0336N). Concomitant therapy included MMR. Subsequently on 10/15/04 the patient developed chicken pox which included 72 lesions. It was reported that she was afebrile, irritable and had a runny nose. Unspecified medical attention was sought. Calamine lotion and ibuprofen were prescribed. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old white male student with asthma and no known allergies who on 9/30/96 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 616866/1508B). There was no illness at the time of vaccination. On 10/2/04, when in the office for vaccination, the patient presented with a rash with papules on his trunk in various stages. Unspecified over the counter treatment was used for comfort. Subsequently, the patient recovered from the rash. There was no product quality complaint involved. It was reported that the patient had no adverse events following prior vaccination. Additional information has been requested.
Age: 1.14
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 10 year old male who in approximately June 1995 was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 10/17/04, the patient developed a full case of chicken pox. Unspecified medical attention was sought, but no prescription drug treatment was required. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 6 year old male with reactive airway disease and recurrent otitis media who on 11/30/98 was vaccinated SC in his left arm with a first dose of varicella virus vaccine live (lot # 628149/1325H). Concomitant vaccinations included MMR. Subsequently, the patient experienced breakthrough varicella with less than 50 lesions at 09:45 AM on 10/27/04. Medical attention was sought, the patient was diagnosed with chicken pox, and no treatment was given. At the time of this report the patient was recovered. no product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a child (name, gender, and demographics were not provided) who received a dose of varicella virus vaccine live and developed a rash. It was unknown if medical attention was sought. No further information was given at the time of this report and the patient's status was unknown. There was no product quality complaint. The physician also reported at a 13 month old patient experienced vomiting, diarrhea, and a papular urticarial rash following exposure to the vaccinated patient (WAES0410USA03135). Follow up information was obtained from a registered nurse in the physician's office regarding this report. The nurse confirmed that this was a child from daycare but she indicated that she had no way to find out who the patient was. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old female with no pre-existing allergies or medical history who on 10/20/04 was vaccinated SC (previously reported as IM) in the right deltoid with the first dose of varicella virus vaccine live (lot # 646676/0711N). There was no illness or concomitant medication at the time of vaccination. On 10/26/04 (previously reported as 10/27/04) the patient developed chicken pox and on 10/28/04 she was seen in the doctor's office. The patient had more than 50 lesions all over her body and no fever. No laboratory or diagnostic testing was performed. It was reported that the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site vesicles, Musculoskeletal stiffness, Pain, Rash, Tenderness
Clinical narrative: Information has been received from a physician concerning her son a 17 year old male who is overweight, has gastroesophageal reflux disease, acne, and is allergic to sulfamethoxazole (+) trimethoprim, and amoxicillin who 9/19/04 was vaccinated SC in his right deltoid with a first dose of varicella virus vaccine live (lot # 648313/0281P). Concomitant therapy included omeprazole and fexofenadine hydrochloride. Subsequently, the patient experienced a stiff neck and a rash on his forearm. It was reported that the rash did not appear to be varicella. The patient's stiff neck cleared up in six days. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. Follow up information from a healthcare professional indicated that on 9/20/04, the patient experienced a stiff neck that was tender to touch, a rash on his forearm, blisters at site of vaccination and his right arm hurt. Subsequently, the patient recovered. The physician stated that she did not see the patient, his mother is a physician and reported this to her on 10/28/04. The patient was advised to get titer and possibly eliminate the need for a second immunization. No further information is available.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 36 year old female who was vaccinated with a first and second dose of varicella virus vaccine live on 6/23/04 and 8/4/04, respectively. It was reported that the patient's varicella zoster IgG titer came back negative. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.