chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old pt who  on 02/26/04 was vaccinated with a dose of varicella virus vaccine live. It was reported that on 01/19/2004  the pt experienced a case of breakthrough varicella. There were 60 lesions. Unspecified medical attention was sought, but there was no tx and no hospitalization. The pt recovered. No product quality complaint was involved. This is one pt out of 40 reported. 39 other cases (WAES 0407USA01446 and 0409USA01855 through 0409USA01877 and 0409USA01879 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old pt who on 07/17/1997 was vaccinated with a dose of varicella virus vaccine live . On 07/07/02 the pt experienced a case of breakthrough varicella. There  were less than 50 lesions. Unspecified medical attention was sought, but there was no tx or hospitalization. No product quality complaint was involved. This is one pt out of 39 others (WAES 0407USA01446 and 0409USA01855 through 0409USA01878 amd  0409USA01880 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine. Additional inoformation is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a pt who on 12/01/1996 was vaccinated with a dose of varicella virus vaccine live. On 05/16/1998 the pt experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought. but there was no tx and no hospitalization. The pt recovered. No product quality complaint was involved. This is one of 40 reported. Thirty nine other cases ( WAES 0407USA01446 and 0409USA01855 thriugh 0409USA01879 and 0409ISA01881 through 0409USA01893) experienced bredakthrough varicella after vaccination with varicella virus vaccine live. Additonal information has been requested.
Age: 1.94
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 5 year old pt who on 06/08/1996 was vaccinated with a dose of varicella virus vaccine live. On 03/29/2000 the pt experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no tx and no hospitalization. The pt recovered. No product quality complaint was involved. This is one pt out of 40 reported. Thirty nine other  cases (WAES 0407USA01446 and 0409USA01855 through 0409USA01880 and 0409USA01880 and 0409USA01882 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vacciene live. Additional information is not expected.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 27 month old pat who on 08/12/1999 was vaccinated with a dose of varicella virus vaccine live. On 12/01/2001 the pt experienced breakthrough varicella. There were less than 50 lesions. Unspecified medical attnetion was sought but there was  no tx or hospitalization. The pt recovered . No product quality complaint was involved. This is one pt out of 40 reported. Thirty nine other cases (WAES 0407USA01446 and 0409USA01855 through 0409USA01881 and 0409USA01883 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additonal information is not expected.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 5 year old pt who on 07/01/1995 was vaccinated with a dose of varicella virus vaccine live. On 03/18/97 the pt experienced a  case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought. but there was no tx or hospitalization. The pt recovered. There was no product quality complaint involved.
Age: 1.92
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 year old patient who on 4/7/99 was vaccinated with a dose of varicella virus vaccine live. On 11/3/03, the patient experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no treatment and no hospitalization. The patient recovered. No product quality complaint was involved. This is one patient out of 40 reported. Thirty nine other cases (WAES0407USA01446 and 0409USA01855 through 0409USA01883 and 0409USA01885 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
Age: 1.32
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 7 year old patient who on 10/04/1996 was vaccinated with a dose of varicella virus vaccine live.  On 03/26/2003 the patient experienced a case of breakthrough varicella.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  This is one patient out of 40 reported.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
Age: 0.91
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 3 year old patient who on 07/01/1995 was vaccinated with a dose of varicella virus vaccine live.  On 01/02/1998 the patient experienced a case of breakthrough varicella.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  This is one patient out of 40 reported.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who on 05/27/2003 was vaccinated with a dose of varicella virus vaccine live.  On 06/19/2003 the patient experienced a case of breakthrough varicella.  It was noted that it was questionable if it was from the vaccination.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  The is one patient out of 40 reported.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
Age: 32.0
Sex: U
Vaccine: VARCEL
Symptoms: Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 32 month old patient who was vaccinated with a dose of varicella virus vaccine live.  On 01/30/1997 the patient experienced a case of breakthrough varicella.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a patient who on 08/12/1995 was vaccinated with a dose of varicella virus vaccine live.  on 01/20/1996 the patient experienced a case of breakthrough varicella.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  This is one patient out of 40 reported.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 4 year old patient who on 03/28/1997 was vaccinated with a dose of varicella virus vaccine live.  On 07/19/2000 the patient experienced a case of breakthrough varicella.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  This is one patient out of 40 reported.  Thirty nine other cases experienced a breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 7 year old patient who on 09/07/1995 was vaccinated with a dose of varicella virus vaccine live.  On 05/18/2000 the patient experienced a case of breakthrough varicella.  There were 20 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  This is one patient out of 40 reported.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 7 year old patient who on 06/18/1996 was vaccinated with a dose of varicella virus vaccine live.  On 11/10/2003 the patient experienced a case of breakthrough varicella.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  This is one patient out of 40 reported.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
Age: 1.58
Sex: U
Vaccine: VARCEL
Symptoms: Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 19 month old patient who on 03/06/2001 was vaccinated with a dose of varicella virus vaccine live.  On 03/16/2001 the patient experienced a case of breakthrough varicella.  It was noted that it was from the vaccine.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  This is one patient out of 40 reported.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a pharmacist concerning a 19 year old female, with no known medical history or allergies, who on 09/14/2004 was vaccinated with a second dose of varicella virus vaccine live.  Concomitant therapy included norelgestromin (Ortho Evra).  Five days later, on 09/19/2004, the patient started to break out on her arms and legs with few spots on her chest.  Unspecified medical attention was sought and hydroxyzine hydrochloride was ordered.  The first dose of varicella virus vaccine live was given at 14 years old and the patient experienced no adverse symptoms at that time.  There was no product quality complaint involved.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning an approximately 33 year old female patient no known allergies and no pertinent medical history who in October 1998 and November 1998, was vaccinated with a first and second dose, respectively of varicella virus vaccine live.  Subsequently the patient failed to seroconvert.  It was reported that she was revaccinated with a third dose on 09/22/2004.  No additional information was available.  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 2 year old female with an allergy to cefprozil who on 09/23/2003 was vaccinated with a first dose of varicella virus vaccine live.  On approximately 09/24/2003, a few days post vaccination, the patient had broken out in spotty rash and fever.  On 09/23/2004, it was reported that the child is still having problems with lesions on her body, arms, legs, torso.  It was noted that they look like individual little lesions, some fluid filled and some are not fluid filled.  The nurse indicated that the child has had multiple treatments which included: cetirizine hydrochloride 5mg, prednisone, triamcinolone, and different creams and salves.  The child was also tested for scabies, which was negative.  The child was referred to a dermatology specialist who has tired various therapies including pulmonary tests and some type of biopsy.  The nurse stated that the family has even bug sprayed and bombed their house for insects, and given up family pets, to rule out other factors.  The outcome was reported as not recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 34 year old male who on 09/16/2004 was vaccinated with a dose of varicella virus vaccine live.  On 09/17/2004 the patient developed chickenpox with 20 lesions with lasted 6 days.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male student with no medical history who on 10/21/1996 was vaccinated subcutaneously with the first dose of varicella virus vaccine live.  Concomitant vaccinations on that same day included the first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  The RN reported that in 2004, the patient developed breakthrough chickenpox.  In July 2004, the patient recovered from the breakthrough chickenpox.  Additional information has been requested.
Age: 1.51
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash papular
Clinical narrative: Information has been received from a physician concerning a 9 year old male, with no known medical history or allergies, who on 09/30/1996 was vaccinated with a dose of varicella virus vaccine live.  There was no concomitant medication.  On 09/22/2004 the patient experienced a papular rash, later vesicular, with 50-100 papules.  Unspecified medical attention was sought and the patient was treated with ibuprofen and acyclovir was started.  There was no product quality complaint involved.  Follow up information from a registered nurse indicated that the patient developed a mild outbreak of chickenpox after being vaccinated in 1998.  She reported that the patient was fine.  No additional patient information was available.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 7 year old white male with no allergies or medical history who on 07/07/1998 was vaccinated subcutaneously in the right arm with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  On 08/24/2004, the patient was diagnosed with chickenpox.  The patient had about 10 to 15 lesions at that time.  Follow up information was received from the licensed visiting nurse who indicated that on 08/24/2004 the patient had macular lesions on the trunk and was diagnosed with varicella.  No diagnostic laboratory tests were performed.  The patient recovered on 08/30/2004.  Neither the patient nor his sibling had any adverse events following prior vaccination.  No further information is expected.  The nurse also reported that the patient's sister developed chickenpox after therapy with varicella virus vaccine live.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old black/white female with no known allergies who on 08/13/2004 at 15:00pm was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live.  On 08/24/2004, the patient presented with a red, swollen area at the injection site.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  A product quality complaint was not involved.  Follow up information was received from the licensed practical nurse who indicated that on 08/22/2004, the patient developed a red, slightly raised area at the vaccination site.  No further information is expected.  Th nurse also reported that the patient's adolescent brother developed a red, swollen area at the injections site after therapy with varicella virus vaccine live.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 13 month old male who on 07/20/2004 was vaccinated with varicella virus vaccine live.  On 07/20/2004 the patient experienced injection site reaction which went away the evening of the injection.  On approximately 07/27/2004 the patient experienced developed 5 lesions in difuse locations.  The patient was seen by the physician and he did not require any prescription treatments.  Subsequently the patient recovered.  It was reported that the patient was exposed to a 13 month old female who had a breakthrough case of varicella.  There was no product quality complaint involved.  The reporter also indicated that another patient had similar experience following exposure to varicella virus vaccine live.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Injection site swelling, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old female with alot of allergies who on 07/14/2004 was vaccinated with a dose of varicella virus vaccine live.  Concomitant therapy included montelukast sodium, albuterol, lansorprazole and fluticasone propionate.  On 07/17/2004 the patient experienced breakthrough case of varicella.  She developed 5 pox; one at the back of her neck, one back of her hand, two on her forehead, one on her ankle and one on her arm.  The patient also developed large swelling at the vaccination site which disappeared one to two hours later.  On 07/18/2004 the patient was seen by the physician.  Two weeks later at the site of injection, a lump appeared which does not seem to bother the patient.  The patient's pox have since scabbed over and are gone, but the injections site lump has lingered for two weeks.  It was also reported that the swelling lingers.  The patient had no known exposure to varicella.  There was no product quality complaint involved.  The reporter indicated that two other patients had similar experiences following exposure to varicella virus vaccine live.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male who on 09/09/2004 was vaccinated with a dose of varicella virus vaccine live.  On 09/09/2004, the patient developed a bright red quarter in size area at the injection site.  The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory.  The lot complies with the standards of the center for biologics evaluation and research and was released.  The nurse also reported a second child that had a similar reaction after therapy with the same lot number of varicella virus vaccine live.  The nurse noted that she had never had a patient react to vaccination in the past and then to have two patients so close together concerned her about the lot.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a health professional concerning a 12 month old male birth twin with no other medical history who on 09/23/2004 (previously reported as 09/24/2004) at 3:30PM was vaccinated subcutaneously in his left arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 646674/0709N).  There was no illness at the time of vaccination.  On 09/26/2004 (previously reported as 09/27/2004) at 6:00pm, the patient reported to the office with mild varicella all over his body (face, torso, legs).  The patient was being treated with hydroxyzine hydrochloride (ATARAX) and oatmeal baths.  The outcome was reported as not recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information from the health professional indicated that the lesions lasted 4-5 days and the patient was now recovered.  No further information is available.  The reporter also indicated that the patient's twin sister developed mild varicella after vaccination (WAES #0409USA02454).
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 2 year old male who on 11/26/2002 was vaccinated subcutaneously with a dose of varicella virus vaccine live.  Subsequently the patient developed breakthrough varicella with less than 50 lesions and a low grade fever.  It was noted that there was no office visit.  Recommended therapy included acetaminophen and diphenhydramine hydrochloride for fever and itching.  At the time of the report the patient had recovered.  There was no product quality complaint involved.  Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Rash
Clinical narrative: Information has been received from a health professional concerning a 32 month old white male who on 01/17/2003 was vaccinated subcutaneously in the left arm with a 0.5ml dose of varicella virus vaccine live.  Concomitant vaccination included a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live in the right arm.  There was no illness at the time of vaccination.  On approximately 09/27/2004 the patient developed 15 papules on his trunk and arms, and 2 papules on his back.  Unspecified medical attention was sought.  The patient was treated with diphenhydramine hydrochloride and was recovering.  There was no product quality complaint involved.  Follow up information from the health professional indicated that on the 09/23/2004 the patient had a rash of 15 papules that spread to his arms and legs.  The papules on his arms were resolving.  The patient has subsequently recovered.  No further information is expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 4 yr old male who was vaccinated at approx 12 months of age with a dose of varicella virus vaccine live. At four years of age the child developed a case of chickenpox. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 14 month old male who  on approx 17Aug04 was vaccinated with a dose of varicella virus vaccine live. On 28Sep04 the pt presented with shingles. The physician reported that the child was not exposed to anyone with natural chickenpox and believes this case of shingles was from the vaccine.  Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a health professional concerning a 12 month old white female birth twin with no other medical history who on 23Sep04 (previously reported as 24Sep04) at 3:30PM was vaccinated SC in her left arm with a first dose of varicella virus vaccine live (lot 646674/0709N).There was no illness at the time of vaccination. On 26Sep04 (previously reported as 27Sep04) at 6:00PM, the pt reported to the office with mild varicella all over her body (face, torso, legs). The pt was being treated with hydroxyzine hydrochloride (Atarax) and oatmeal baths. The outcome was reported as not recovered. Unspecified medical attention was sought.  There was no product quality complaint involved. Follow up information form the health professional indicated that the pt's lesions lasted 4-5 days and the pt was now recovered. No further information is available. The reporter also indicated that the pt's twin brother developed mild varicella after vaccination (WAES0409USA02259).
Age: 25.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Chest pain, Headache, Injection site erythema, Myalgia, Oedema
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 yr old female health unit coordinator who on 14Sep04 was vaccinated SC in her right deltoid with a 0.5mL dose of varicella virus vaccine live (lot 647763/0191P). Concomitant vaccination that day included a second dose hep B virus vaccine rHBsAg (yeast) (Engerix B) (lot AHBVA058AA), given IM in her deltoid. There was no illness at the time of vaccination. On 26Sep04 the pt experienced headache, muscle ache, rash, swelling at the injection site and redness at the injection site. Unspecified medical attention was sought and the pt was taking acetaminophen (Tylenol) for the headache. It was reported that the pt's adverse events had not yet improved. There was no product quality complaint involved. Follow up information from the nurse practitioner indicated that on 26Sep04 the pt experienced a fever, sore throat, left chest wall pain, and spots over various location including her left arm and back. It was reported that the pt recovered on 04Oct04. There was no adverse event following prior vaccination. No further information is available.
Age: 25.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Pharyngolaryngeal pain, Pyrexia, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 yr old female health unit coordinator who on 14Sep04 was vaccinated SC in her right deltoid with a 0.5mL dose of varicella virus vaccine live (lot 647763/0191P). Concomitant vaccination that day included a second dose hep B virus vaccine rHBsAg (yeast) (Engerix B) (lot AHBVA058AA), given IM in her deltoid. There was no illness at the time of vaccination. On 26Sep04 the pt experienced headache, muscle ache, rash, swelling at the injection site and redness at the injection site. Unspecified medical attention was sought and the pt was taking acetaminophen (Tylenol) for the headache. It was reported that the pt's adverse events had not yet improved. There was no product quality complaint involved. Follow up information from the nurse practitioner indicated that on 26Sep04 the pt experienced a fever, sore throat, left chest wall pain, and spots over various location including her left arm and back. It was reported that the pt recovered on 04Oct04. There was no adverse event following prior vaccination. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a female who on 28Sep04, in the morning, was vaccinated with a dose of varicella virus vaccine live. Subsequently on 28Sep04 the pt developed chickenpox. Unspecified medical treatment was sought and the pt was given diphenhydramine hydrochloride (Benadryl) and oatmeal bath for treatment. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 5 yr old male who on 20Sep99 was vaccinated with a dose of varicella virus vaccine live. On 24Aug04 the pt presented with breakthrough chickenpox, less than fifty lesions were noted. There was no product quality complaint involved. The reporter indicated that the pt's sister (WAES0409USA00192) had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 5 yr old white male who on 02Jan02 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. On 14Apr04 the pt developed chickenpox. Unspecified medical attention was sought. Subsequently he recovered. There was no product quality complaint involved. No further information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a RN concerning a 4 yr old female with no known drug allergies who on 07Sep04 was vaccinated with a dose of varicella virus vaccine live. On 24Sep04 the pt developed a high fever and a rash. Her primary care physician treated her with antibiotics. No improvement was noted. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. The outcome was reported as not recovered/not resolved. The reporter also noted that a male child received varicella virus vaccine live and developed chickenpox (WAES0410USA00050). Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a person working in a physician's office concerning an approx 6 yr old male who in June 1999 was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt had a recent mild case of chicken pox that resolved without incident.  Unspecified medical attention was sought.  No product quality complaint was involved. No other information was provided.  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 9 year old white male with no medical history and no allergies, who on 09Aug96 was vaccinated with an IM first dose in the right lateral thigh of varicella virus vaccine live (lot 612222/0241D). There was no illness at the time of vaccination. It was reported that the pt was seen in the office on 10Sep04 with vesicular lesions on his trunk, face, and upper thigh. On 16Sep04 the pt recovered. Unspecified medical attention was sought. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Lymphoma, Neoplasm, Neoplasm malignant
Clinical narrative: NHL - Diffuse Large Cell B diagnosed Jan 2005. As per follow up report I am traditional air national guard that was diagnosed with non hodgekins large cell B diffuse lymphoma while on active duty in Iraq. I received a live of Duty for my cancer meaning it developed in Iraq. My last anthrax and smallpox was given several months before being called up to active duty. Because I was given an LOD I cannot say it was related to the shots.
Age: 23.0
Sex: F
Vaccine: FLU3, SMALL, TYP
Symptoms: Injection site vesicles
Clinical narrative: Patient has another small oozing blister approx. 2inch from primary site.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pyrexia, Rash erythematous, Viral infection
Clinical narrative: Received Varicella vaccine on 5/13/05. On 5/27/05 reported feeling achy/feverish and developed red, raised rash on numerous parts of body. Went to ED on 5/28/05 and diagnosed with chickenpox.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Patient developed low grade fever and extreme fussiness within one hour of receiving vaccines. He cried non-stop until 8 P.M., when he fell asleep until 3 A.M. He continued crying with low grade fever into the next day - Mother gave infant Tylenol as directed. He was seen by M.D. on 5/27/05. He ordered DT instead of DTaP.
Sex: F
Vaccine: DTP, HEP, HIBV, IPV
Symptoms: Bronchiolitis, Congenital central nervous system anomaly, Difficulty in walking, Drooling, Hypokinesia
Clinical narrative: From initial information received on 5/19/05 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a female patient, now age 9, received a DTP vaccination, a Hepatitis B vaccination, a Polio vaccination, and a HIB vaccination when she was two months old, exact date of vaccination unknown. No information regarding the manufacturers, the lot numbers, the route and sites were provided. Reportedly, three days post vaccination the patient developed cold symptoms, her eyes started to cross and she began wheezing. The patient was hospitalized and diagnosed with bronchiolitis. After the patient was discharged from the hospital, she developed drooling and her eye began turning inward. At eight months old the patient still could not roll over. The patient was seen by a neurologist and began therapy. The drooling continued until the patient was two years old. She needs braces to walk which started when she was 22 months old. The patient's recovery status is listed as not recovered. From additional information received on 5/24/05 from a nurse, this child was diagnosed with Cerebral Palsy as per mother. Also, the mother thinks the polio vaccine given was an injection.
Sex: F
Vaccine: DTP, HEP, HIBV, IPV
Symptoms: Pharyngitis, Rhinitis, Strabismus, Wheezing
Clinical narrative: From initial information received on 5/19/05 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a female patient, now age 9, received a DTP vaccination, a Hepatitis B vaccination, a Polio vaccination, and a HIB vaccination when she was two months old, exact date of vaccination unknown. No information regarding the manufacturers, the lot numbers, the route and sites were provided. Reportedly, three days post vaccination the patient developed cold symptoms, her eyes started to cross and she began wheezing. The patient was hospitalized and diagnosed with bronchiolitis. After the patient was discharged from the hospital, she developed drooling and her eye began turning inward. At eight months old the patient still could not roll over. The patient was seen by a neurologist and began therapy. The drooling continued until the patient was two years old. She needs braces to walk which started when she was 22 months old. The patient's recovery status is listed as not recovered. From additional information received on 5/24/05 from a nurse, this child was diagnosed with Cerebral Palsy as per mother. Also, the mother thinks the polio vaccine given was an injection.
Age: 67.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Abdominal pain, Biliary colic, Cardiac failure congestive, Chest discomfort, Cholestasis
Clinical narrative: A 67 year old female received RSV vaccine or placebo and Influenza vaccine on 10/18/02, and 115 days later was admitted to the hospital with exacerbation of COPD, exacerbation of CHF, and cholestasis/biliary colic on 2/10/03. Signs and symptoms included shortness of breath and chest discomfort. The patient was treated with Rocephin, Zithromax, Solumedrol, Lasix, and Aldactone. The patient recovered and was discharged on 2/14/03. The patient has a history of COPD and CHF. The investigator assessed the event as possibly related to the study products. Follow up information received on 3/25/03: Hospital discharge summary for 2/10/03 to 2/14/03. The patient was admitted with the above presumptive diagnosis with the possibility of pneumonia, but review of chest x-ray revealed no acute infiltrates, but pulmonary vascular congestion was present. Her therapy consisted of balance of intravascular volume and improvement of respiratory status while reducing preload and afterload, and she produced sputum well, diuresed well, and saturations improved to a level of 92 to 94 on room air by 2/14/03. Procedures done to evaluate her ongoing abdominal pain in the light of her acute presentation with dyspnea, revealed a normal ultrasound but a severely reduced gall bladder ejection fraction. She was however tolerating normal diet and ambulation, breathing without supplemental O2, normal bladder and bowel function were present, and she was requesting discharge on 2/14/03. This was granted with instructions to restart her usual medication with the following exceptions. She was to increase her Aldactone to 50mg PO BID, she was prescribed Humibid LA BID, she was to increase Lasix to 40mg BID, and she was to decrease Covera HS to 180mg q hs. She was prescribed doxycycline 100mg BID for 10 days and advised to maintain a low fat, low sodium, no sugar, low starch diet. She was to recheck in my office in one week and call if having any problems. Manufacturer Report number 200300028 was previously reported as 2003031078. 11/03: New version created in order to perform recoding of AE following data conversion project. Unblinding information received on 5/16/05. The subject received Placebo.
Age: 67.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Condition aggravated, Dyspnoea, Gallbladder disorder, Hypoxia, Lung disorder
Clinical narrative: A 67 year old female received RSV vaccine or placebo and Influenza vaccine on 10/18/02, and 115 days later was admitted to the hospital with exacerbation of COPD, exacerbation of CHF, and cholestasis/biliary colic on 2/10/03. Signs and symptoms included shortness of breath and chest discomfort. The patient was treated with Rocephin, Zithromax, Solumedrol, Lasix, and Aldactone. The patient recovered and was discharged on 2/14/03. The patient has a history of COPD and CHF. The investigator assessed the event as possibly related to the study products. Follow up information received on 3/25/03: Hospital discharge summary for 2/10/03 to 2/14/03. The patient was admitted with the above presumptive diagnosis with the possibility of pneumonia, but review of chest x-ray revealed no acute infiltrates, but pulmonary vascular congestion was present. Her therapy consisted of balance of intravascular volume and improvement of respiratory status while reducing preload and afterload, and she produced sputum well, diuresed well, and saturations improved to a level of 92 to 94 on room air by 2/14/03. Procedures done to evaluate her ongoing abdominal pain in the light of her acute presentation with dyspnea, revealed a normal ultrasound but a severely reduced gall bladder ejection fraction. She was however tolerating normal diet and ambulation, breathing without supplemental O2, normal bladder and bowel function were present, and she was requesting discharge on 2/14/03. This was granted with instructions to restart her usual medication with the following exceptions. She was to increase her Aldactone to 50mg PO BID, she was prescribed Humibid LA BID, she was to increase Lasix to 40mg BID, and she was to decrease Covera HS to 180mg q hs. She was prescribed doxycycline 100mg BID for 10 days and advised to maintain a low fat, low sodium, no sugar, low starch diet. She was to recheck in my office in one week and call if having any problems. Manufacturer Report number 200300028 was previously reported as 2003031078. 11/03: New version created in order to perform recoding of AE following data conversion project. Unblinding information received on 5/16/05. The subject received Placebo.
Age: 67.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Pneumonia, Pulmonary congestion
Clinical narrative: A 67 year old female received RSV vaccine or placebo and Influenza vaccine on 10/18/02, and 115 days later was admitted to the hospital with exacerbation of COPD, exacerbation of CHF, and cholestasis/biliary colic on 2/10/03. Signs and symptoms included shortness of breath and chest discomfort. The patient was treated with Rocephin, Zithromax, Solumedrol, Lasix, and Aldactone. The patient recovered and was discharged on 2/14/03. The patient has a history of COPD and CHF. The investigator assessed the event as possibly related to the study products. Follow up information received on 3/25/03: Hospital discharge summary for 2/10/03 to 2/14/03. The patient was admitted with the above presumptive diagnosis with the possibility of pneumonia, but review of chest x-ray revealed no acute infiltrates, but pulmonary vascular congestion was present. Her therapy consisted of balance of intravascular volume and improvement of respiratory status while reducing preload and afterload, and she produced sputum well, diuresed well, and saturations improved to a level of 92 to 94 on room air by 2/14/03. Procedures done to evaluate her ongoing abdominal pain in the light of her acute presentation with dyspnea, revealed a normal ultrasound but a severely reduced gall bladder ejection fraction. She was however tolerating normal diet and ambulation, breathing without supplemental O2, normal bladder and bowel function were present, and she was requesting discharge on 2/14/03. This was granted with instructions to restart her usual medication with the following exceptions. She was to increase her Aldactone to 50mg PO BID, she was prescribed Humibid LA BID, she was to increase Lasix to 40mg BID, and she was to decrease Covera HS to 180mg q hs. She was prescribed doxycycline 100mg BID for 10 days and advised to maintain a low fat, low sodium, no sugar, low starch diet. She was to recheck in my office in one week and call if having any problems. Manufacturer Report number 200300028 was previously reported as 2003031078. 11/03: New version created in order to perform recoding of AE following data conversion project. Unblinding information received on 5/16/05. The subject received Placebo.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3, UNK
Symptoms: Asthenia, Cardiac failure congestive, Chest discomfort, Dyspnoea, Influenza like illness
Clinical narrative: An 80 year old female received RSV vaccine or Placebo and Influenza vaccine on 10/22/02 and 174 days later experienced Congestive Heart Failure, shortness of breath, chest discomfort, and was admitted to hospital on 4/14/03. Patient was discharged on 4/18/03. Outcome: Recovered. Follow up information received 4/28/03. The investigator assessed the event as possibly related to the study product. Follow up information received 5/6/03. Cross reference with manufacturer report 200300607. See relevant history. Follow up information received on 5/19/03. HISTORY AND PHYSICAL EXAMINATION 4/15/03. ADMISSION DATE: 4/15/03. INDICATION FOR ADMISSION: Severe weakness, shortness of breath. HISTORY OF PRESENT ILLNESS: An 80 year old white female admitted primarily because of swelling in the lower extremity, flu-like symptoms and generalized weakness Patient is extremely short of breath in the office. Chest x-ray showed questionable early congestive heart failure symptoms. Clinically the patient just feels poorly and it was felt that the patient should be admitted for further evaluation. PAST MEDICAL HISTORY: Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Unblinding information received on 5/16/05. The subject received Non-Adjuvanted RSV vaccine.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3, UNK
Symptoms: Malaise, Oedema
Clinical narrative: An 80 year old female received RSV vaccine or Placebo and Influenza vaccine on 10/22/02 and 174 days later experienced Congestive Heart Failure, shortness of breath, chest discomfort, and was admitted to hospital on 4/14/03. Patient was discharged on 4/18/03. Outcome: Recovered. Follow up information received 4/28/03. The investigator assessed the event as possibly related to the study product. Follow up information received 5/6/03. Cross reference with manufacturer report 200300607. See relevant history. Follow up information received on 5/19/03. HISTORY AND PHYSICAL EXAMINATION 4/15/03. ADMISSION DATE: 4/15/03. INDICATION FOR ADMISSION: Severe weakness, shortness of breath. HISTORY OF PRESENT ILLNESS: An 80 year old white female admitted primarily because of swelling in the lower extremity, flu-like symptoms and generalized weakness Patient is extremely short of breath in the office. Chest x-ray showed questionable early congestive heart failure symptoms. Clinically the patient just feels poorly and it was felt that the patient should be admitted for further evaluation. PAST MEDICAL HISTORY: Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Unblinding information received on 5/16/05. The subject received Non-Adjuvanted RSV vaccine.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3, UNK
Symptoms: Arrhythmia, Asthenia, Asthma, Cardiac failure congestive, Cerebrovascular accident
Clinical narrative: An 80 year old female received RSV vaccine or Placebo and Influenza vaccine on 10/22/02 and 174 days later experienced Congestive Heart Failure, shortness of breath, chest discomfort, and was admitted to hospital on 4/14/03. Patient was discharged on 4/18/03. Outcome: Recovered. Follow up information received 4/28/03. The investigator assessed the event as possibly related to the study product. Follow up information received 5/6/03. Cross reference with manufacturer report 200300607. See relevant history. Follow up information received on 5/19/03. HISTORY AND PHYSICAL EXAMINATION 4/15/03. ADMISSION DATE: 4/15/03. INDICATION FOR ADMISSION: Severe weakness, shortness of breath. HISTORY OF PRESENT ILLNESS: An 80 year old white female admitted primarily because of swelling in the lower extremity, flu-like symptoms and generalized weakness Patient is extremely short of breath in the office. Chest x-ray showed questionable early congestive heart failure symptoms. Clinically the patient just feels poorly and it was felt that the patient should be admitted for further evaluation. PAST MEDICAL HISTORY: Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Unblinding information received on 5/16/05. The subject received Non-Adjuvanted RSV vaccine.