chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician and a health professional concerning an approximately 30 month old female with no pre-existing allergies, birth defects or medical conditions who on 10/18/02 was vaccinated in the right thigh with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. Subsequently, on 3/21/05, the pt experienced a mild case of breakthrough. She was noted to have scattered lesions on the right axilla, left scapula, right inguinal and right knee. The lesions were pea sized and erythematous, with small vesicles at the center. The outcome was reported as recovered. There was no relevant diagnostic tests or laboratory data. No further info was available. Unspecified medical attention was sought. There was no product quality complaint. No additional info is expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 7 year old female with no pertinent medical history and no drug reactions/allergies who in approximately 2000, was with a dose of varicella virus vaccine live. There was no concomitant medication. Subsequently, the pt experienced a breakthrough case of chickenpox. Unspecified medical attention was sought. Subsequently, the pt recovered. No lab diagnostic studies were performed. There was no product quality complaint. The reporter also indicated that one other pt was vaccinated with varicella virus vaccine live and developed chickenpox. Additional info has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Fatigue, Pain, Pyrexia
Clinical narrative: Info has been received from a CMA concerning a 28 year old black female pt with no allergies and an unremarkable medical history, who on 2/26/05, at 11:00, was vaccinated, SC, in the right arm with a 0.5ml 1st dose of varicella virus vaccine live. There was no concomitant medication or illness at the time of vaccination. On 3/15/05, the pt developed breakthrough, which the physician had noted to be "serious". It was noted that the number of lesions on the pt's body is unknown. The pt had a CBC performed (no results were provided). It was noted at the time of this report, that the pt still had lesions on her body and her current status is recovering. There was no product quality complaint reported. Unspecified medical attention was sought. Follow-up info indicated that on 3/14/05 (previously reported as 3/15/05), the pt developed varicella rash, achiness, fatigue and fever. On 3/16/05, she was seen in the office and the varicella rash was confirmed and was resolving at the follow-up visit on 3/25/05. The pt recovered and the date of recovery was reported as 3/26/05. No further info is available.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: Info has been received from a physician concerning a 7 year old female who was vaccinated with a dose of varicella virus vaccine live. The physician reported that the pt subsequently, developed 50 lesions and a 101 degree fever. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional info has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning an 8 year old female who was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt developed a very mild case of breakthrough varicella. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 5 year old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced a very minor breakthrough case of chickenpox. It was unknown if medical attention was sought. Additional info has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 9 year old male who was vaccinated with a SC, 0.5 ml dose of varicella virus vaccine live. It was reported that the pt presented to the office with a breakthrough case of chickenpox, with about 100 generalized lesions. The lesions were treated with Benadryl and calamine lotion. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info has been requested.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 5 year old male, with no medical history and no allergies, who on 11/20/00 was vaccinated with a SC, 1st dose in the left side of varicella virus vaccine live. There was no illness at the time of vaccination. It was reported that the pt had a two day history of a rash that began on 3/22/05. The rash was described as scattered chickenpox lesions with about 20 on the pt's forehead and face. The pt was afebrile. Oral Benadryl was given as treatment. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. Follow-up info from a health professional indicated that the pt's mother noted the rash on her body and she was afebrile. It was reported that the pt was seen in the office and 10 chickenpox lesions were noted on her face. Subsequently, the pt recovered. Additional info is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning her 9 years old daughter who in 1997, at 1 year of age, was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. The RN reported that sometime in 2005, her daughter developed chickenpox characterized by 25 lesions. Unspecified medical attention was sought. Four days after developing chickenpox, the pt recovered. Additional info has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Info has been received from a physician concerning a pt who was vaccinated with varicella virus vaccine live. Subsequently, the pt appeared to have chicken pox. No additional info regarding the adverse event or pt's outcome was not available at the time of this report. Additional info has been requested.
Age: 1.72
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Info has been received from a physician concerning an 8 year old male who on 9/11/98 was vaccinated with a dose of varicella virus vaccine love. The pt was noted to have an itchy rash and fever believed to be a varicella rash with greater than 2 dozen pox. It was noted the some of the pox were infected. This was diagnosed on 2/28/05. The pt was treated with Keflex. No product quality complaint was involved. The pt's brother had varicella after vaccination with varicella virus vaccine live. Additional info has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning an 8 year old pt who was vaccinated with a dose of varicella virus vaccine live. "Sometime in 2005", the pt experienced a case of chickenpox that was the worse case the physician had seen in someone who had received varicella virus vaccine live. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info has been requested.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pruritus
Clinical narrative: Info has been received from an RN concerning a 4 year old male with autism who on 8/6/01 was vaccinated with a dose of varicella virus vaccine live. On approximately 3/22/05, the pt presented with "4 chickenpox/rash". It was reported that on 3/28/05, the rash was "still itchy" and the pt would not be attending school. The pt had a follow-up visit with the doctor, and the diagnosis was "undetermined if chickenpox". Unspecified medical attention was sought. At the time of the report, the pt was recovering. There was no product quality complaint involved. Additional info has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Info has been received from a pharmacist concerning a 7 year old female with no pertinent medical history and no known drug allergies who was vaccinated with a dose of varicella virus vaccine love. "Last was" on approximately 3/21/05, the pt developed chickenpox. She had multiple lesions on her face, back, legs and arms and also had a fever. Medical attention was not sought and there was no doctor visit. There were no laboratory diagnostic studies performed. It was reported that the pt was treated with Benadryl and Aveeno bath. At the time of the report, the pt was recovering. There was no product quality complaint involved. Additional info has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning a 12 month old female who on 3/21/05 was vaccinated with a dose of varicella virus vaccine live. The RN reported that on 3/23/05, the pt developed full-blown chickenpox. Unspecified medical attention was sought. In March 2005, the pt recovered from the full-blown chickenpox. Additional info has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact
Clinical narrative: Info has been received from an RN concerning a 5 year old white male who on 8/25/00 was vaccinated, SC, in the right thigh with a 1st dose of varicella virus vaccine live. On 3/22/05, the pt was seen in the physician's office for break through varicella after exposure to a child with chickenpox. The pt had about 10 lesions. No further info is expected.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 35 month old white male with chronic otitis media and no other pre-existing allergies, birth defects or medical conditions who on 3/31/03 (also reported as March 2004), was vaccinated, SC, in the left lower leg, with a 0.5 ml dose of varicella virus vaccine live. The pt was noted to have an upper respiratory infection and viral syndrome at the time of vaccination. Concomitant vaccination that day, included a 1st dose of MMRII, administered in the right lower extremity. Subsequently, on 3/25/05, two years post/vax, the pt was brought into the office with a full chickenpox rash. There were over 50 lesions. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the pt or his siblings. No additional info is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Convulsion
Clinical narrative: Information has been received from a lawyer concerning a patient who on 12/14/2000 was vaccinated with a dose of varicella virus vaccine live. Eleven days after, on 12/25/200, the patient experienced seizures. No product quality complaint was involved. Upon internal review it has been determined that seizure is an other important medical event (OMIC). No additional information was available.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed chickenpox breakthrough. Additional info has been requested.
Age: 0.09
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 6 year old Hispanic female with no allergies or medical history who on 10/15/99 (at 12 months of age) was vaccinated SC, in the right thigh with a 0.5 ml first dose of varicella virus vaccine live. The physician reported that the pt came into the office on 3/29/05, with a case of chicken pox. The pt had greater than 50 lesions. Unspecified medical attention was sought. Outcome unknown. No product quality complaint was involved. Follow-up info indicated that the pt recovered after one week. Additional info is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash papular
Clinical narrative: Info has been received from an RN concerning a 10 year old white male with an innocent heart murmur who on 3/22/99 was vaccinated , in the left arm with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 3/16/05, the pt developed a rash with approximately 30 papules and vesicles. The rash was also noted to be itchy. Benadryl and Tylenol were recommended for treatment. The outcome was reported as recovered. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations. No additional info is expected.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 12 year old male who in 1998 was vaccinated with a dose of varicella virus vaccine live. In February 2005, the pt developed a full blown case of chicken pox. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Info has been received from an RN concerning a 2 year old female who on 3/26/04, was vaccinated with a dose of varicella virus vaccine live. The nurse reported that on 3/29/05, the pt experienced a case of breakthrough varicella, with about 50 lesions and a low-grade fever. The pt was not treated at the time of the report. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Age: 1.05
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Drug ineffective, Gastroenteritis, Infection
Clinical narrative: Info has been received from an RN concerning a 22 month old white female with a history of conjunctivitis and no drug allergies who on 6/11/04 was vaccinated, SC in the left thigh, with 0.5 ml 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. Concomitant vaccinations included a 1st dose of MMRII live administered, SC in the right thigh and a 3rd dose of poliovirus vaccine inactivated, administered IM, in the left thigh. There was no other concomitant medication. The child presented to the physician's office on 3/29/05, with a diagnosis of gastroenteritis, and a rash on her stomach, which was breakthrough chickenpox. No fever or itchiness was noted. No treatment was required. Unspecified medication attention was sought. There was no product quality complaint. The outcome was report as recovering. There were no laboratory diagnostic studies performed. There were no adverse events following prior vaccination of the pt or sibling. Follow-up info received from a nurse indicated that she was unable to locate the report of breakthrough. Additional follow-up info indicated that the pt had breakthrough chickenpox of approximated 10 lesions on  her upper chest and back and 3/29/05. It was diagnosed by clinical exam in the office. No additional info is expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Info has been received from a health professional concerning a 2 year old male who on 8/14/03 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed herpes zoster with no complications or hospitalizations. Unspecified medical attention was sought. There was no product quality complaint. Additional info has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a PA concerning a 12 month old female who on 3/16/05 was vaccinated with a dose of varicella virus vaccine live. On 3/28/05, the pt experienced breakthrough varicella of not more than 50 lesions. The pt is recovering. No treatment is necessary. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a nurse concerning a 7 year old white female with no known drug allergies who on 12/5/1997 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot 624249/1103E). On approximately 3/30/2005, now she has experienced full blown chicken pox with lesions on her neck, scalp, head, legs and trunk. She is being treated with acyclovir (Zovirax). No product quality complaint was involved. Follow up information indicated that the patient had varicella illness on 3/27/2005. No labs or diagnostic test were done. The patient recovered. The patients experienced was considered an other important medical event (OMIC). Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Info has been received from a physician concerning a 17 month old white male, with no medical history and no allergies, who on 10/04/04, was vaccinated with a 1st SC dose, in the left arm of varicella virus vaccine live. It was noted that there was no illness at the time of vaccination. On 3/29/05, in the morning, the pt experienced 10 erythropapular vesicular lesions. The pt had 2 oral lesions and some on his trunk. It was reported that the pt had no fever and was not ill appearing. Additional info is not expected.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 3 to 4 year old pt who was vaccinated with a dose of varicella virus vaccine live. On 2/15/05, the pt experienced breakthrough varicella of about 10 or 12 lesions. Subsequently, the pt recovered. The report indicates no treatment. Unspecified medical treatment was sought. No product quality complaint was involved. Additional info has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection parasitic, Laboratory test abnormal
Clinical narrative: Info has been received through the mfr pregnancy registry from an RN concerning a 17 year old black female with no prior pregnancy history who on 12/3/04 was vaccinated with a dose of varicella virus vaccine live. The pt was not tested for varicella antibodies before vaccination with varicella virus vaccine live. It was noted that the pt became pregnant within a month of receiving the vaccine. The date of her LMP-12/04 and the EDD-9/11/05. Unspecified medical attention was sought. On 3/6/05 an ultrasound was performed for dating purposes, results indicated 17 weeks, 0 days, and on 4/6/05, a maternal serum alpha fetoprotein test was performed and negative. There was no product quality complaint. Follow-up info has been received indicating that the pt gave birth on 9/3/05 at 38 weeks to a normal 6 lb 1 oz female infant. The reporter noted that the mother had increased blood pressure during the labor/delivery. Follow-up info received on 11/18/05 contained the following adverse experiences chlamydia (approx. 4/5/05). Additional info is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning a 9 year old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced breakthrough. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the pt's brother developed breakthrough after vaccination with varicella virus vaccine live. No additional info is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal, Unintended pregnancy
Clinical narrative: Info has been received through the mfr pregnancy registry from a physician concerning a pregnant teenage female who in 1996 was vaccinated SC, in the "shoulder" with a 3rd dose of varicella virus vaccine live. It was noted that the her titer was negative based on a commercial ELISA test. It was also noted that the pt was exposed to varicella VZV in a school outbreak. Unspecified medical attention was sought. There was no product quality complaint. Follow-up info received from a physician indicated that the pt never developed VZV. At the time of the report, there were no problems with the pregnancy "so far". There was no adverse event. It was noted that the pt was vaccinated following the negative titer. No additional info is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Info has been received from a health professional concerning a male employee in his 20's with no known medical history who on 3/14/05 was vaccinated with a 1st dose of varicella virus vaccine live. There was no concomitant medication. On 3/28/05, two weeks post/vax, the pt experienced a headache and developed a fever of 99.9F. On 3/29/05, the pt developed 4 bumps. It was reported that "the bumps did not look like normal chickenpox and never drained or became a vesicle". The pt still experiences headaches upon awaking. The pt's bumps never completely resolved. It was reported that the injection site was fine with no marks, redness or pain in the arm. At the time of the report the pt had not yet recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional info has been requested.
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Info has been received from a physician and a CMA concerning an 8 year old Caucasian male who on 12/9/97 was vaccinated with a dose of varicella virus vaccine love. On 3/5/05 (previously reported as 3/8/05), the pt presented with about 40 lesions on the trunk that were spreading and was diagnosed with breakthrough varicella. In follow-up, the pt was said to have a fever (previously reported that no fever was present) and no treatment was required. It was reported that the pt recovered (date unspecified). No product quality complaint was involved. Additional info has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an MA concerning an 8 year old female with an "unremarkable" history and no known allergies who on 12/18/97 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 3/30/05, the pt experienced serious breakthrough of varicella. Lesions were noted on her face, neck, scalp, trunk and back. On 3/31/05, the pt was seen in the office and according to her family "there were more lesions than yesterday". At the time of the report, the pt had not recovered. There was no product quality complaint involved. Additional info has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 24 month old Hispanic female who was vaccinated IM, with a dose of varicella virus vaccine live. The reporter indicated that the pt was vaccinated in a clinic and then "last week", on approximately 3/24/05, the pt traveled to another country and was exposed to a wild type of chickenpox. The pt experienced break through chickenpox with greater than 50 lesions. The reporter indicated that it did not last as long as wild type varicella. Unspecified medical attention was sought. At the time of the report, the pt was noted to be recovering. A product quality complaint was not involved. The reporter noted that the case was reported to the state health department. Additional info has been requested.
Age: 5.0
Sex: F
Vaccine: DTP, HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Medication error
Clinical narrative: Info has been received from a consumer concerning her 5 year old daughter with an insect bite allergy and no other medical history who on 3/29/05 was inadvertently vaccinated, SC with a 0.5 ml 2nd dose of varicella virus vaccine live. Concomitant vaccination at the same injection site included a dose of DTP. Other concomitant vaccination in different injection sites included a dose of MMRII and a dose of Hep-A vaccine (inactive). The pt had received a 1st dose of varicella virus vaccine live at 12 months of age. On 3/30/05, the pt experienced an injection site reaction. No medical attention was sought and no diagnostic laboratory tests were performed. At the time of the report, the pt's injection site reaction persisted. A product quality complaint was not involved. No further info was available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning an 8 year old male who, at 12 months of age", in approximately 1998 was vaccinated with a dose of varicella virus vaccine live. "Three weeks ago", in March 2005, the pt was diagnosed with chickenpox and had greater than 100 vesicles. It was reported that the pt was ordered to take an antiviral, "VEREX", for 5 days. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Age: 1.07
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pneumonia, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 4 year old male with no allergies or medical history who on 5/1/2001 was vaccinated IM in the right arm with a 0.5ml first dose of varicella virus vaccine live (lot 636574/1466K). Concomitant therapy included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. On 3/8/2005, the patient developed severe pneumonia immediately following the crusting of a lesion. It was progressive and the patient was hospitalized for two weeks. The patient had two chest tubes and Iv vancomycin and ceftriaxone sodium (Rocephin) for one month. On organism was recovered but MRSA was suspected. At the time of the report, the patient had not recovered. Follow up information was received from the physician who reported that on 3/8/2005, the patient had varicella consisting of mild skin lesions but subsequently had within 48 hours severe pneumonia requiring a chest tube and intravenous antibiotics for four weeks. It was noted that no organisms grew. The patient was hospitalized for two weeks. Additional information was received from the physician who reported that the patient is now better. The patient still has residual finding on X ray but is asymptomatic. No further information is expected.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Otitis media, Rhinorrhoea
Clinical narrative: Info has been received from a physician concerning a 31 month old male with Down's Syndrome, who on 2/20/04 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. On 3/28/05, the pt developed a breakthrough case of varicella. The pt came to the office with approximately 50 lesions and most of the lesions were on his face. There were some vesicular lesions on his abdomen. The physician prescribed an antibiotic because the pt also had a runny nose and ear infection. No antiviral medication was given. There was no product quality complaint involved. Additional info has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Info has been received from a physician concerning a 4 year old male who in 2002, at age 1, was vaccinated with a dose of varicella virus vaccine live. In approximately April 2005 (reported as "very recently"), the pt developed 20 lesions on his trunk and in his mouth. Unspecified medical attention was sought. The pt had no fever and there were no other problems. Subsequently, the pt recovered one week after the lesions began. No product quality complaint was involved. Additional info has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Info has been received from a health professional concerning a 31 year old, white female, CNA, with an allergy to erythromycin, who on 3/14/05 was vaccinated in the morning with a first SC dose, in the upper arm of varicella virus vaccine live. It was noted that there was no illness at the time of vaccination. On 3/30/05 (also report as 3/29/05), the pt developed a varicella-like rash of about 30 lesions and a low-grade fever. It was reported that the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Follow-up info from a health professional indicated that the pt developed a low-grade fever on 3/29/05, at 15:00 PM, followed by an outbreak of vesicles, on the face, scalp and torso, on 3/30/05. It was reported that on 4/11/05, the pt recovered. Additional info is not expected.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Info has been received from a physician and a 50 year old female immunization consultant with high cholesterol, arthritis and no allergies who in 1999 and 2000 was vaccinated with 2 doses, respectively, of VARIVAX, 5 to 6 months apart. Concomitant therapy included Celebrex, Synthroid and simvastatin. In 2001, the pt had her thyroid removed due to "cancerous spots". On 3/23/05, the pt developed a rash on her upper left cheek and neck area and behind her ear. She saw a physician on 3/28/05 and was diagnosed with shingles on left T1 dermatome. Valtrex and prednisone were prescribed as treatment. No laboratory or diagnostic studies were performed. It was also reported that the pt never experienced chickenpox as a child and she only experienced "very slight pain". At the time of this report, the physician reported that the pt had recovered. No product quality complaint was involved. The reporter considered her shingles to be an other important medical event: however, the physician did not assess the shingles as to be an other important medical event. Additional info has been requested.
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 25 yr old male with no illness at the time of the vaccination and no pre-existing allergies, birth defect, or medical conditions, who on 11Mar05 was vaccinated SC with a first dose of varicella virus vaccine live. Concomitant therapy included acyclovir (Zovirax). Approx 2 wks after vaccination, on approx 26Mar05 the pt experienced <50 vesicular rash on back and chest, (also reported as mild rash on abdomen and back). The pt had no pain and no fever. The pt was treated with acyclovir orally 5 times daily 5 to 7 days. The pt recovered within 2 weeks, on 06Apr05 from the vesicular rash. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 10 yr old female who was vaccinated subcutaneously on an unk date (when she was younger) with 0.5mL of a dose of varicella virus vaccine live (lot unk). In early Mar 2005 the pt experienced breakthrough case of varicella with about 20 lesions on her chest and behind her ears. She also had a low grade fever. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a RN concerning a 6 yr old male who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced breakthrough. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the pt's brother developed breakthrough after vaccination with varicella virus vaccine live (WAES0504USA00025).  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 5 yr old Hispanic female who was vaccinated IM with a dose of varicella virus vaccine live. The reporter indicated that the pt was vaccinated in a clinic and then last week on approx 24Mar05, experienced breakthrough chickenpox with greater than 50 lesions. The reporter indicated that it did not last as long as wild type varicella. Unspecified medical attention was sought. At the time of the report, the pt was noted to be recovering. A product quality complaint was not involved. The reporter noted that the case was reported to the state health dept.
Age: 1.07
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 yr old white (previously reported as Hispanic) male who on 02Sep99 was vaccinated IM with a first dose of varicella virus vaccine live. The reporter indicated that the pt was 24Mar05, experienced break through chickenpox with greater than 50 lesions. The reporter indicated that it did not last long as wild type varicella. Unspecified medical attention was sought. At the time of the report, the pt was noted to be recovering. A product quality complaint was not involved. The reporter noted that the case was reported to the state health dept. Follow up information was received from the physician who reported that the pt had a total of 17 vesiculopapular lesions. No further information is expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 10 yr old Hispanic female who was vaccinated IM with a dose of varicella virus vaccine live. The reporter indicated that the pt was vaccinated in a clinic and then last week, on approx 24Mar05, the pt experienced break through chickenpox with greater than 50 lesions. The reporter indicated that it did not last as long as wild type varicella. Unspecified medical attention was sought. At the time of the report, the pt was noted to be recovering. A product quality complaint was not involved. The reporter noted that the case was reported to the state health dept. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypoaesthesia, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 5 to 7 year old male who, within the last year, in 2004, was vaccinated with a dose of varicella virus vaccine live. It was noted that a lidocaine (+) prilocaine patch was used to numb the area prior to the injection of varicella virus vaccine live. It was reported that vesicular lesions developed a few days after the injection where the lidocaine (+) prilocaine patch was located. The lesions lasted a week. It was unk if medical attention was sought. No additional information was provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: 05-03-06 Pneumococcal vaccine adm. 05-05-06 Pt. presents to clinic with s/s and diagnosis cellulitis at INJ site and surrounding area extending down to wrist. Pt had Levaquin treatment x10days with three office follow up visits before s/s resolved 05/15/06.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Cyst, Ear discomfort, Ear disorder, Nasopharyngitis, Otitis media
Clinical narrative: In 1998 after receiving the first Anthrax shot, I immediately developed a severe ear infection in both ears.  I was unable to fly for over 1 month due to Eustachian Tube Dysfunction.  I was put on several decongestants and antibiotics after seeing 2 ENT specialists.  Over the next 2 years, I still had problems completely clearing my ears at all times.  I eventually had sinus surgery in Jan 2001 in an attempt to relieve the symptoms.  This gave me little to no relief and I still have chronic problems with both ears.  The main symptoms that still exist after 8 years are constant crackling and popping in both ears, completely clogged Eustachian tubes on occasion, especially when flying inverted, and occasional ringing of the ears.  I have since seen 3 more ENT specialists and an Allergist who have been unable to help.  I was forced to take 3 more Anthrax boosters through Nov of 1999, despite my symptoms; I was also never told or advised that I could fill out a VAERS form until now for the reactions that I had after the shot.  I was told that there was no possible way that the Anthrax shots were linked with my Eustachian Tube Dysfunction. 54 page medical history received from patient-these records encompass dates of service 11/30/1998-4/21/2006 from both military and civilian medical providers of care. Office notes for visit of 11/30/1998, 6 days after anthrax vaccine (11/24/1998) patient arrived with c/o 3-4 day of left ear pressure and crackling, ear ache and inability to Valsalva. Current medication include Afrin. Physical exam revealed normal right tympanic membrane with normal Valsalva and left slightly bulging with slow Valsalva. DX eustachian tube dysfunction (ETD). RX included Entex LA and follow-up in 3 days at which time records document on 12/2/1998 normal right TM and Valsalva with left bulging and no valsalvae. RX with Sudafed, DC Entex. Continued with same complaints and changes to RX to include Prednisone through 12/7/1998 at which time a referral to civilian physician was made due to patient's role as pilot of an F15 that requires toleration of barometric pressure between 8000' and 11,000' and he experiences difficulty with Valsalva maneuvers on left.. Note of 12/11/1998 documents that patient drove in the mountains shortly after Anthrax vaccine and has continued with ETD. Physical exam revealed nasopharyngitis with blocked eustachian tube. RX with Augmentin. Follow-up visit on 12/14/1998 revealed clear ears without difficulty, notices a nonpainful squeak in left ear with clearing. DX Sinusitis, ETD resolved. Symptoms returned 1/28/1999, Subsequently RX's with Zithromax and Floxin ear drops. 01/18/2001 bilateral anterior intranasal endoscopic ethmoidectomy and bilateral endoscopic maxillary antrostomy performed. No medical visits for c/o ETD between 02/08/2001 and 06/24/2004.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Sinusitis, Tinnitus
Clinical narrative: In 1998 after receiving the first Anthrax shot, I immediately developed a severe ear infection in both ears.  I was unable to fly for over 1 month due to Eustachian Tube Dysfunction.  I was put on several decongestants and antibiotics after seeing 2 ENT specialists.  Over the next 2 years, I still had problems completely clearing my ears at all times.  I eventually had sinus surgery in Jan 2001 in an attempt to relieve the symptoms.  This gave me little to no relief and I still have chronic problems with both ears.  The main symptoms that still exist after 8 years are constant crackling and popping in both ears, completely clogged Eustachian tubes on occasion, especially when flying inverted, and occasional ringing of the ears.  I have since seen 3 more ENT specialists and an Allergist who have been unable to help.  I was forced to take 3 more Anthrax boosters through Nov of 1999, despite my symptoms; I was also never told or advised that I could fill out a VAERS form until now for the reactions that I had after the shot.  I was told that there was no possible way that the Anthrax shots were linked with my Eustachian Tube Dysfunction. 54 page medical history received from patient-these records encompass dates of service 11/30/1998-4/21/2006 from both military and civilian medical providers of care. Office notes for visit of 11/30/1998, 6 days after anthrax vaccine (11/24/1998) patient arrived with c/o 3-4 day of left ear pressure and crackling, ear ache and inability to Valsalva. Current medication include Afrin. Physical exam revealed normal right tympanic membrane with normal Valsalva and left slightly bulging with slow Valsalva. DX eustachian tube dysfunction (ETD). RX included Entex LA and follow-up in 3 days at which time records document on 12/2/1998 normal right TM and Valsalva with left bulging and no valsalvae. RX with Sudafed, DC Entex. Continued with same complaints and changes to RX to include Prednisone through 12/7/1998 at which time a referral to civilian physician was made due to patient's role as pilot of an F15 that requires toleration of barometric pressure between 8000' and 11,000' and he experiences difficulty with Valsalva maneuvers on left.. Note of 12/11/1998 documents that patient drove in the mountains shortly after Anthrax vaccine and has continued with ETD. Physical exam revealed nasopharyngitis with blocked eustachian tube. RX with Augmentin. Follow-up visit on 12/14/1998 revealed clear ears without difficulty, notices a nonpainful squeak in left ear with clearing. DX Sinusitis, ETD resolved. Symptoms returned 1/28/1999, Subsequently RX's with Zithromax and Floxin ear drops. 01/18/2001 bilateral anterior intranasal endoscopic ethmoidectomy and bilateral endoscopic maxillary antrostomy performed. No medical visits for c/o ETD between 02/08/2001 and 06/24/2004.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Right arm swelling, erythema, pain upper arm. Came in next day-dx allergic reaction. Given script for Prednisone 20mg bidx3days. When called to check on patient the next week-patient never filled script-thought it would upset her stomach. States arm is fine now.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 05-16-06 Pneumococcal vaccine adm. 05-17-06 Pt. presents to clinic with approx 9x14cm erythema and feverish area surrrounding INJ site and distal left arm. Pt was treated with Keflex and Prednisone and instructed to return to physician if s/s didn't subside.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: MEASLE-LIKE RASH 9 DAYS AFTER ADMINISTRATION OF MMR.
Age: 30.0
Sex: F
Vaccine: TTOX
Symptoms: Influenza like illness, Myalgia, Pyrexia, Skin irritation
Clinical narrative: Patient called today with complaints of fever since the day of the injection, muscle soreness and local skin irritation.  Patient also states she has flulike symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Pain, Pyrexia, Skin striae
Clinical narrative: Shots given 5-9-06. That evening, began having pain, redness and swelling of upper Left arm and fever of 100. Mom gave tylenol and cool compresses. Swelling and redness were worse on 5-10-06 involving area from shoulder down to elbow-area was also hard, so they went to Nurse Practitioner. Temp in office was 98.9. Told to continue tylenol around the clock while child was awake and to add ibuprofen if fever went up and that if fever became high or swelling became worse, to go to emergency room, and to return to office Monday if not getting better.  When I called the Mom on 5-15-06, she said that Thursday night(5-11-06), they had noticed a red streak down the arm to the elbow and had taken child to emergency room. Child was placed on Amoxicillin and sent home. Mom stated that arm was beginning to get better, now with less swelling, redness, hardness and pain noted.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling
Clinical narrative: Shots given 5-9-06. That evening, began having pain, redness and swelling of upper Left arm and fever of 100. Mom gave tylenol and cool compresses. Swelling and redness were worse on 5-10-06 involving area from shoulder down to elbow-area was also hard, so they went to Nurse Practitioner. Temp in office was 98.9. Told to continue tylenol around the clock while child was awake and to add ibuprofen if fever went up and that if fever became high or swelling became worse, to go to emergency room, and to return to office Monday if not getting better.  When I called the Mom on 5-15-06, she said that Thursday night(5-11-06), they had noticed a red streak down the arm to the elbow and had taken child to emergency room. Child was placed on Amoxicillin and sent home. Mom stated that arm was beginning to get better, now with less swelling, redness, hardness and pain noted.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Asthenia, Cognitive disorder, Disturbance in attention, Ear pain
Clinical narrative: This case was reported by a lawyer and described the occurrence of mental fog in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix, for prophylaxis. A physician or other health care professional hs not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). On an unspecified date after vaccination with Lymerix, the subject experienced mental fog, arthralgias, myalgias, headaches, burning and tingling, eye problems, muscle spasms, ear pain , difficulty concentrating, shooting and stabbing pains, joint stiffness and weakness, and rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. He also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: M
Vaccine: LYME
Symptoms: Eye disorder, Fatigue, Headache, Immune system disorder, Joint stiffness
Clinical narrative: This case was reported by a lawyer and described the occurrence of mental fog in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix, for prophylaxis. A physician or other health care professional hs not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). On an unspecified date after vaccination with Lymerix, the subject experienced mental fog, arthralgias, myalgias, headaches, burning and tingling, eye problems, muscle spasms, ear pain , difficulty concentrating, shooting and stabbing pains, joint stiffness and weakness, and rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. He also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: M
Vaccine: LYME
Symptoms: Muscle spasms, Myalgia, Nervous system disorder, Pain, Paraesthesia
Clinical narrative: This case was reported by a lawyer and described the occurrence of mental fog in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix, for prophylaxis. A physician or other health care professional hs not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). On an unspecified date after vaccination with Lymerix, the subject experienced mental fog, arthralgias, myalgias, headaches, burning and tingling, eye problems, muscle spasms, ear pain , difficulty concentrating, shooting and stabbing pains, joint stiffness and weakness, and rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. He also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.