chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin lesion, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a health care professional concerning a 34 month old female pt with a polymyxin B sulfate (+) trimethoprim allergy who on 06/01/1999 was vaccinated SC in the left thigh with a first dose of varicella vaccine. There was no illness reported at the time of vaccination. On 04/01/2001 the pt develped a varicella like rash with 30 lesions. On 04/02/2001 the pt was seein in the physician's office and the pt was noted to have 30 vesicular scattered lesions. It was reported that the pt's sister had chicken pox two weeks prior. No other symptoms were reported. The pt was started on acyclovir 300 mg QID x 5 days. It was reported that the pt subsequently recovered. No further information is expected.  Follow-up information received from a registered nurse indicated that the patient with no previous allergies or pertinent medical history presented on 13-FEB-2007 with a second episode of chicken pox breakthrough. The patient was observed to have 30 pustules scattered throughout the body. Unspecified medical attention was sought; symptomatic treatment was given. The outcome was reported as not recovered. No product quality complaint was involved. There was no additional information.2/11/10 Follow up information has been received from a registered nurse, who reports that the date of the patient's recovery was 15-FEB-2007.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a male pt who approximately 2 years ago, in approximately 1999, was vaccinated with varicella vaccine. It was reported that on 04/03/2001 that the pt recently developed "breakthrough chicken pox." No further info is available.
Age: 12.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Arthritis, Henoch-Schonlein purpura, Pain
Clinical narrative: Information has been received from a health care professional concerning a 12 year old male with pollen allergies who on 01/03/2001 was vaccinated SC in the left arm with a first dose of varicella vaccine. Concomitnat vaccination that day included a first dose of hep B vaccine given IM in the left arm. There was no illness at the time of vaccination. On 02/05/2001 the pt experienced severe abdominal pain for five days. There was no nausea, vomiting, or diarrhea reported or no complaints of headache. The pt presented to the ER on the 7th day with a purple rash on his feet and legs, swollen tops and sides on feet, and arthritic type leg pain. The pt was diagnosed with HS purpura. Follow-up info received from the health care professional indicated that the pt's mother reported that "the HSP can cause kidney damage and he will now have his kidney checked every 6-12 months for life." She also stated that "the damage could occur years from now." Additional info has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, OPV, VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from two registered nurses concerning a 4 year old female with no known drug allergies or past medical history, who on 03/02/1998 was vaccinated with the first dose of varicella vaccine SC in the left arm. On 03/02/1998, concomitant vaccinations included the first dose MMR which the pt received SC in the right arm and the third dose of oral polio vaccine. Originally the one nurse reported that on 03/31/2001, the pt experienced 50 or more lesions over his body. Unspecified medical attention was sought. No treatment has been ordered. In follow-up, another nurse reported that the pt experienced 50 plus lesions on her abdomen and back on 04/01/2001. This nurse reported that the pt recovered. The registered nurse also reported on the pt's sibling who had an experience following vaccination with varicella vaccine. No further info is expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 26 month old white female with no known allergies or past medical history who on 01/05/00 was vaccinated with Varicella virus vaccine live SQ in the left arm. There were no concomitant medications. On 04/03/01, the patient developed a mild case of the chicken pox, less than 20 pox and no other signs or symptoms and presented to the physician's office on 04/03/01. The child did not have a fever. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 21 year old female with no known drug allergies who on 03/03/1997 and 04/30/1997 was vaccinated with varicella vaccine. "Recently" in approximately 2001, the pt's titer was drawn and she was still susceptible. Additional information is not expected.
Age: 3.2
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 38 month old male (also reported from registered nurse as female) with bilateral otitis media at the time of vaccination, asthma, and no known allergies and a history of hand surgery and tympanostomy tube placement. On 12/08/1998 the pt was vaccinated with the first dose of varicella vaccine IM in the left thigh. Concomitant therapy included albuteral. On 03/15/2001 the pt was diagnosed with chicken pox. The pt had one lesion on the tonsil area, a few on the legs and trunk, and a number on the face. On 03/21/2001 the pt recovered. It was noted that the pt did not have an adverse reaction following a prior vaccination. No further info is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning his son who on 02/13/1997 was vaccinated with Varicella virus vaccine live. On 03/25/2001, the pt developed chicken pox. The patient sought unspecified medical attention. The physician also provided information regarding other patients who were vaccinated with vVaricella virus vaccine live. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Bacterial infection, Drug ineffective, Pharyngitis, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 year old male with no known allergies, who on 09/07/1995 was vaccinated with the first dose of varicella vaccine. ON 04/02/2001, the pt experienced "strep throat and 8-10 lesions." On 04/03/2001, the pt was seen by his physician and diagnosed with varicella. In follow-up, the physician reported that the pt "had strep throat prior to getting varicella." No treatment was needed. There was no relevant diagnostic tests and lab data. In follow-up, the physician reported that pt had "8-10 lesions concern, younger sibling and grandmother status post renal transplant and on immunosuppressive therapy. Otherwise, he felt pretty well." In follow-up, the physician reported that the pt recovered and "had very few symptoms of varicella." No further info is available.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female with allergies who on 01/20/1996 was vaccinated with varicella vaccine IM in the left arm. This does not comply with the recommended route of administration. On 04/02/2001, the pt called the physician's office. On 04/03/2001, the pt was seen in the physician's office with greater than 50 lesions. In follow-up, the nurse reported the pt had "scattered papules, red-few vesicles at different stages, approximately 50 spots, and was diagnosed with atypical chicken pox." The pt recovered from the chicken pox. No further info is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a patient's aunt and mother concerning a 6 year old male who on 10/27/1995 was vaccinated with Varicella virus vaccine live. On approximately 03/22/01, the patient developed a mild case of chickenpox with less than 20 lesions. Unspecified medical attention was sought. In follow-up, the patient's physician reported that the patient transferred out of the practice on 03/03/1998. The patient's aunt and his mother also reported on the patient's siblings who also had an experience following vaccination with varicella virus vaccine live. No further information is available.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female who on 03/20/2001 was vaccinated with varicella vaccine SC in the right arm. Concomitant therapy included MMR, IPOL and alum, Tripedia. On 03/20/2001 in the late evening the pt experienced rash. On 04/05/2001 the pt was seen at the physician's office and had developed 10-15 maculopapular papulovesicular lesions and low grade fever of 99.1 degrees. No other symptoms were noted. No further info is expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male child who on 09/28/1995 was vaccinated with a first dose of varicella vaccine. On 04/01/2001 the pt experienced varicella that included head to foot lesions. The lesions began on the head and were "all over the body." The number of lesions were not reported. The pt was treated with Tylenol, Benadryl and calamine lotion. The pt recovered. No further info is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male who in January 1997, was vaccinated with varicella vaccine. In January/February the pt was exposed to a severe breakout at school. In approximately February 2001, the pt developed greater than 100 lesions all over the body, face, torso, and mucal membranes on throat. The pt received acyclovir treament. It was also reported that the pt's sibling had similar experiences. Additional info has been requested.
Age: 3.2
Sex: M
Vaccine: MMR, OPV, VARCEL
Symptoms: Drug ineffective, Herpes zoster
Clinical narrative: Information has been received from a pharmacist regarding her son and from the child's physician concerning a 34 month old male with no past medical history who on 05/14/1999 at one year old was vaccinated in the right arm with a first dose of varicella vaccine, a first dose of MMR in the left arm and a dose of oral polio. there was no illness at the time of vaccination. On 03/23/2001 the child broke out with "rash/crusted lesion" on his right arm which the mother described as "shingles." The mother was told it was the "C 6 nerve." Subsequently, the pt recovered within one week. The physician provided follow-up info stating the pt's experience was a "vesicular rash, right arm in the C6 dermatome, likely shingles." The pt sought unspecified medical attention and was seen at the doctor's office on 03/26/2001. It was noted that the pt recovered.
Age: 2.4
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a patient's aunt, physician, and mother concerning a 29 month old female with no past medical history who on 10/15/1999 was vaccinated with the first dose of varicella virus vaccine SC in the right lower thigh. On 10/15/1999, the pt was also vaccinated with the first dose of MMR SC in the left lower thigh. There was no illness at the time of vaccination. Initially it was reported by the pt's aunt that on 04/05/2001, the pt develped 6 or 7 lesions. In follow-up, the pt's physician reported that on 04/09/2001, the pt's mother phoned the office stating that the pt had chicken pox. The physician reported that the pt did recover from "the illness wihtout incidient." Unspecified medical attention was sought. The pt's aunt and his mother also reported on the pt's sibling who also had an experience following vaccination with varicella virus vaccine. Additional info has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Eye swelling, Fatigue, Rash
Clinical narrative: Information has been received from the mother of a male child with no past medical history and no known allergies who on 08/01/2000 was vaccinated with varicella virus vaccine. There was no concomitant therapy. The child was exposed to another child with chicken pox during the week of 04/01/2001. On approximately 04/07/2001, the child was tired and had swollen eyes. On 04/09/2001 the child developed a rash behind his ear, and on his face and neck. No medical attention was sought. Additional info has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Eczema, Injection site oedema, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old female pt with no past medical history, no known allergies, and no concomitant medications who on 03/28/2001 was vaccinated with one dose of varicella virus vaccine. On 04/06/2001, the mother reported a swollen, tender leg where the injection was given. There was an induration of approximately 1 to 1 1/4 inches seen along with a small macular papular rash around site. The pt had no fever or other complaints. The pt sought unspecified medical attention. Upon follow-up, it was reported that the pt's initial experience involved the injection site reaction, however, she also had extension of the rash to her leg, was seen by a dermatologist, and diagnosed with eczema "not related to varicella vaccine." Subsequently, all conditions resolved. In addition, it was reported that the pt's 6 year old brother, who was vaccinated with one dose of varicella virus vaccine live that same day, also developed a similar reaction. Additional info has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning her 10 year old son who in January 1997 was vaccinated with varicella vaccine. In approximately January 2001, the pt develped moderate to severe chicken pox described as hundreds of pox all over including the throat. The reporter was concerned about the effectiveness of the vaccine. The reporter's youngest son, who was also vaccinated with varicella vaccine but at another physician's office did not develop chicken pox. The mother also reported that her oldest son also developed the chicken pox after vaccination with varicella vaccine. The reporter noted that one of her son's required acyclovir during the outbreak to minimize it as much as possible. Additional info has been requested.
Age: 2.6
Sex: F
Vaccine: VARCEL
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician and a consumer concerning the consumer's 31 month old daughter with no known drug allergies who on 03/22/2001 was vaccinated with varicella vaccine in the right thigh. At the time of vaccination, the pt had an upper respiratory infection and "adenitis." The pt's mother reported that about one week after, she took off the pt's bandaid and there were "2 small red hard bumps where they gave the shot." She reported that about two weeks later "it's not red now and the bumps are nearly gone." In follow-up, the physician's office reported that the onset was 04/10/2001. The physician's office reported that the pt's mother called and was told,to apply ice at site of injection, if continues to break out to call for appointment. In follow-up, it was reported by the physician's office that the pt recovered.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 36 year old female hospital employee with a history of back injury who in 2000 was vaccinated with two doses of varicella vaccine. Concomitant therapy included unspecified anti-inflammatory drugs and unspecified pain medication. The registered nurse reported that the pt's titer pre-vaccination was 0.6 and her titer post-vaccination was 0.7. Unspecified medical attention was sought. Additional info has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis, Rash papular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a female pt who in October 1999 was vaccinated with varicella virus vaccine. The registered nurse reported that the pt subsequently "got chicken pox twice." Subsequently the pt presented with "non-specific dermatitis, possible bug bites. Multiple erythematous papular areas on the forehead." The pt presented on 04/06/2001 with a "papular, non-vesicular, non-pruritic rash on the torso and extremities." The pt's outcome was not reported. The registered nurse also reported on the pt's sibling who had an experience following the vaccination with varicella virus vaccine and on an unspecified number of children who developed chicken pox following vaccination with varicella vaccine. Additional info has been requested.
Age: 59.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 59 year old female with Ceclor allergy, pcn allergy, cephalexin allergy and Ceftin allergy who on 02/20/2001 was vaccinated with varicella vaccine. Concomitant therapy included Lipitor, Zestril, Lopressor and aspirin. On approximately 03/26/2001, the pt developed two lesions, both 0.5 inches in diameter that were slightly red and cracked. The first lesion was on the front of bicep and the second lesion was below the pt's clavicle. The second lesion has totally resolved. Unspecified medical attention was sought. Additional info has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 23 year old female who was vaccinated with two doses of varicella vaccine in January 1999 and February 1999. In September 1999, a serum varicella virus antibody test was "weakly positive." In approximately April 2001, the serum varicella virus antibody test revealed "no seroconversion." No further info is expected.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Ear disorder, Headache, Infection, Pyrexia, Rash
Clinical narrative: Information has been received from a health professional concerning a 12 year old male with no known allergies who on 03/06/1997 was vaccinated with varicella vaccine SC in right arm. On 04/09/2001 the pt presented to doctor's office with ear pain. The child was diagnosed with a right ear infection. On 04/10/2001, the child presented again and had 50-75 lesions/rash on face, neck, upper trunk and extremities. He also had a fever of 102 deg. F and headaches. The pt denied pain from the rash. The pt was unsure if recent exposure to chicken pox. The pt recovered.
Sex: U
Vaccine: VARCEL
Symptoms: Discomfort, Injection site pain
Clinical narrative: Information has been received from a pt who on 02/08/2001 was vaccinated with varicella vaccine. The pt reports that the nurse gave her the injection IM instead of SC. Subsequently the injection site has been somewhat sore and wakes the pt with discomfort at night. The pt reports that there is no swelling or discoloration at the injection site. It was noted that the pt received a second injection of varicella vaccine on approximately 03/22/2001. This injection was given SC without any problems. Additional info has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 43-month-old female who on 12/15/1998 was vaccinated with Varicella virus vaccine live. On 04/03/1998, the patient developed a fever and 04/05/2001 broke out with a rash. It was reported that the child had a case of chicken pox with 50-100 lesions including a lesion in the mouth. The child was happy and not scratching the lesions. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 33 year old male with a history of positive 13mm PPD tuberculosis test but who had normal chest films. On 11/11/2000, the pt's serum varicella zoster virus antibody test was negative. On 01/18/2001, the pt was vaccinated with the first dose of varicella vaccine SC in left deltoid. On 02/16/2001, the pt was vaccinated with the second dose of varicella vaccine SC in the right deltoid. The nurse reported that the pt did not "seroconvert." On 04/05/2001, the pt's serum varicella zoster virus antibody test was negative after two varicella vaccines.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning an unknown number of patients who were vaccinated with varicella virus vaccine. The physician and his colleagues subsequently noticed a "25% failure or break through" among their patients that had been immunized. Additional info has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Skin ulcer
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6 year old male who on 03/28/2001 was vaccinated with one dose of varicella vaccine. On 04/11/2001 the pt developed a rash and "other lesion." The LPN reported that the pt's sibling also was vaccinated with one dose of varicella vaccine, that same day, and developed side effects. The pt sought unspecified medical attention. Upon follow-up, the physician reported that the initial adverse event pertained to the injection site and that the condition resolved. Additional info has been requested.
Age: 30.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 30 year old male who was vaccinated with varicella vaccine. Subsequently, within one week, the pt experienced "uro-genital pox-like rash." The physician stated that the pt had a "small number of lesions and it does not look like simplex." Unspecified medical attention was sought. Additional info has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old caucasian female patient who on 09/10/1998 was vaccinated with Varicella virus vaccine live SC. The registered nurse reported that the patient "got chicken pox twice". On 06/23/00, the pt presented with a "erythmatous papular rash. The registered nurse reported that on 04/06/01, the pt presented again with the same type of symptoms. The patient's outcome was not reported. Unspecified medical attention was sought.  In follow-up, the registered nurse reported that the pt experienced "no adverse effects. The registered nurse reported, "pt received vaccine 09/10/1998 then had chickenpox looking rash 06/23/00 and again 04/09/01. the registered nurse also reported on the pt's sibling, WAES #01041029, who had an experience following vaccination with Varicella virus vaccine live and on an unspecified number of children who developed chicken pox following vaccination with Varicella virus vaccine live (WAES01041411). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from an RN concerning many pts who were vaccinated with varicella virus vaccine live. The RN reported "an awful lot of kids are getting chickenpox after being vaccinated". Unspecified medical attention was sought. The RN also reported 2 siblings developed chickenpox while on therapy with varicella virus vaccine live (WAES01041410 and 01041029). Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Acne
Clinical narrative: Information has been received from a mother-in-law concerning a 32 year old female who in approx. 1977 was vaccinated with varicella virus vaccine live at approx. 8 years of age. Subsequently, in approx. 1977, the pt developed acne that has lasted 24 years. The mother-in-law wondered if "this is why her daughter-in-law has kept a bad case of acne in the face. The pt did not seek medical attention. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: PATIENT PRESENTED WITH RASH 7 DAYS AFTER VACCINATION; VACCINE ACQUIRED MEASLES
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: IMMUNIZATION & SCHOOL PHYSICAL 5/14/02 TEMPERATURE UP TO 103 PER MOTHER 5/15/02 SEEN IN CLINIC FOR FEVER & C/O ABDOMINAL  PAIN 5/16/02 TEMP RESPONDING WELL TO TYLENOL (98.8) EXAM WNL. ADVISED TO INCREASE NONCAFFIENATED LIQUIDS, TYLENO q 4 PRN.  RV IF NOT IMPROVING.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been removed from a health professional concerning a 6-year-old white female who on 03/07/1996 was vaccinated with Varicella virus vaccine live. There was no illness at the time of vaccination. On 03/21/2001, the patient developed a rash on the right side of her back. It was described as small raised vesicular lesions about the size of a silver dollar. It was noted that there was no history of chickenpox, no recent exposure to chickenpox or herpes zoster and no lab tests were performed. It was also noted that a rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. On an unknown date , the patient recovered. Additional information has been requested.
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Bronchial obstruction, Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: This report describes joint pain in a male vaccinee of unspecified age who received Lyme disease vaccine recombinant LYMErix. this report was received as part of litigation proceedings, with forwarding of limited medical records. This report has not been verified by a physician or othe rhealthcare professional. The medical history included snoring, elongated uvule, partial upper airway obstruction, obstructive sleep apnea and chronic fatigue. In the winter of 1994, the vacciene injured his right shoulder while sledding. He experienced numbness and tingling radiating from the right shoulder to the right thumb and first finger "soon after the accident." The numbness and tingling persisted as of 05/17/1994, when was evaluated by a neurologist. The neurologist made a diagnosis of "mild thoracic outlet syndrome." Concurrent conditions and medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a statement of injuries, his attorney alleged that the vaccinee "suffers from joint pain, in particular in his shoulders and neck. He also experiences numbness in his hands and arms. In addition, he experiences fatigue." Time to onset following immunization, treatment and outcome of the alleged events were not reported. Reported on 05/17/2002: "The adverse events "joint pain" and "numbness" do not meet ICM serious criteria, but are being submitted as an expedited report by special FDA request per the June 28,2000 letter.
Sex: M
Vaccine: LYME, LYME
Symptoms: Sleep apnoea syndrome
Clinical narrative: This report describes joint pain in a male vaccinee of unspecified age who received Lyme disease vaccine recombinant LYMErix. this report was received as part of litigation proceedings, with forwarding of limited medical records. This report has not been verified by a physician or othe rhealthcare professional. The medical history included snoring, elongated uvule, partial upper airway obstruction, obstructive sleep apnea and chronic fatigue. In the winter of 1994, the vacciene injured his right shoulder while sledding. He experienced numbness and tingling radiating from the right shoulder to the right thumb and first finger "soon after the accident." The numbness and tingling persisted as of 05/17/1994, when was evaluated by a neurologist. The neurologist made a diagnosis of "mild thoracic outlet syndrome." Concurrent conditions and medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a statement of injuries, his attorney alleged that the vaccinee "suffers from joint pain, in particular in his shoulders and neck. He also experiences numbness in his hands and arms. In addition, he experiences fatigue." Time to onset following immunization, treatment and outcome of the alleged events were not reported. Reported on 05/17/2002: "The adverse events "joint pain" and "numbness" do not meet ICM serious criteria, but are being submitted as an expedited report by special FDA request per the June 28,2000 letter.
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: This report describes joint pain in a male vaccinee of unspecified age who received Lyme disease vaccine recombinant LYMErix. this report was received as part of litigation proceedings, with forwarding of limited medical records. This report has not been verified by a physician or othe rhealthcare professional. The medical history included snoring, elongated uvule, partial upper airway obstruction, obstructive sleep apnea and chronic fatigue. In the winter of 1994, the vacciene injured his right shoulder while sledding. He experienced numbness and tingling radiating from the right shoulder to the right thumb and first finger "soon after the accident." The numbness and tingling persisted as of 05/17/1994, when was evaluated by a neurologist. The neurologist made a diagnosis of "mild thoracic outlet syndrome." Concurrent conditions and medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a statement of injuries, his attorney alleged that the vaccinee "suffers from joint pain, in particular in his shoulders and neck. He also experiences numbness in his hands and arms. In addition, he experiences fatigue." Time to onset following immunization, treatment and outcome of the alleged events were not reported. Reported on 05/17/2002: "The adverse events "joint pain" and "numbness" do not meet ICM serious criteria, but are being submitted as an expedited report by special FDA request per the June 28,2000 letter.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: CSF test abnormal, Cognitive disorder, Headache, Muscle spasms, Muscular weakness
Clinical narrative: 8 weeks after shot, I had severe headaches, blurred vision, leg weakness and thought process not clear. This all continued until now. I am out of work at different times and have leg spasms most nights. I am on pain medication.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Vision blurred
Clinical narrative: 8 weeks after shot, I had severe headaches, blurred vision, leg weakness and thought process not clear. This all continued until now. I am out of work at different times and have leg spasms most nights. I am on pain medication.
Age: 1.0
Sex: F
Vaccine: IPV, UNK
Symptoms: Convulsion, Electroencephalogram abnormal, Gait disturbance, Postictal state, Pyrexia
Clinical narrative: On 1/15/02, the pt received 2 shots on her pediatric visit. On 1/28/02, she began running a low-grade temperature of 99-102F daily. On 2/13/02, her fever went to 103F and nothing could break the fever. (Cold compresses or a cool bath). Pediatrician advised to give Tylenol 15 minutes before her seizure. At 16:00 on 2/13/02, her temperature rose to 104F and she lapsed into a seizure. We called 911 and they transported her to the hospital. Her seizure lasted 13-15 minutes. In the ER, she went into a post-ictal state, which lasted for over 1/2 hour. She was given Ativan to control the seizure activity. Post seizure paralysis remained until 2/15/02 and she was very unstable in her gait and abilities. She was discharged on 2/15/02. On 3/3/02, she was fine all day. She ate, played and acted normal. She took a nap at 14:30 and woke up at 14:50 with a 103F temperature (Ax). She was given Tylenol and Motrin at 14:55 and put her in a tub to cool down. The seizure started at 15:05, called 911 and they transported her immediately at 15:10 and administered a prescribed 50mg of Diastat and her respirations slowed. The seizure lasted 13 minutes; ER stabilized her and moved her to PICU. PICU attending ordered and performed a spinal tap, which was negative. 6/25/02 Hospital discharge summary states child had episodes of vomiting and slight cough prior to onset of seizure and developed a rash while in hospital after being started on Amoxicillin for possible OM.
Age: 1.0
Sex: F
Vaccine: IPV, UNK
Symptoms: Rash, Respiratory rate decreased
Clinical narrative: On 1/15/02, the pt received 2 shots on her pediatric visit. On 1/28/02, she began running a low-grade temperature of 99-102F daily. On 2/13/02, her fever went to 103F and nothing could break the fever. (Cold compresses or a cool bath). Pediatrician advised to give Tylenol 15 minutes before her seizure. At 16:00 on 2/13/02, her temperature rose to 104F and she lapsed into a seizure. We called 911 and they transported her to the hospital. Her seizure lasted 13-15 minutes. In the ER, she went into a post-ictal state, which lasted for over 1/2 hour. She was given Ativan to control the seizure activity. Post seizure paralysis remained until 2/15/02 and she was very unstable in her gait and abilities. She was discharged on 2/15/02. On 3/3/02, she was fine all day. She ate, played and acted normal. She took a nap at 14:30 and woke up at 14:50 with a 103F temperature (Ax). She was given Tylenol and Motrin at 14:55 and put her in a tub to cool down. The seizure started at 15:05, called 911 and they transported her immediately at 15:10 and administered a prescribed 50mg of Diastat and her respirations slowed. The seizure lasted 13 minutes; ER stabilized her and moved her to PICU. PICU attending ordered and performed a spinal tap, which was negative. 6/25/02 Hospital discharge summary states child had episodes of vomiting and slight cough prior to onset of seizure and developed a rash while in hospital after being started on Amoxicillin for possible OM.
Age: 3.5
Sex: F
Vaccine: YF
Symptoms: Crying, Hallucination, visual
Clinical narrative: On 4/24/02, in the night, she woke up screaming and said she saw spiders coming at her and she tried to wipe them off her hands. This lasted about 2 hours. Pediatrician called. No treatment. Told if it continued, to go to MD. The next night it quit and then the she saw spiders the following night. On 4/8/02, she had her 1st Hep-A at PMD. She was started on Suprax for UTI for 10 days.
Age: 0.7
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site induration, Injection site reaction
Clinical narrative: Induration on right thigh the size of a softball.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Seen back on 5/2/02. Mother came with the infant which had swelling and redness at the site of DTAP and Comvax. There was an indurated area about 1.5cm mainly on the upper leg than lower thigh. Lump was noted. Will be followed.
Age: 1.2
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Rash erythematous
Clinical narrative: On 3/30/01 at 15:25, had a red, raised rash (patches) one on left upper anterior thigh and lower leg, left forearm and on each buttock. Clear runny nose. Seen by PA. HR-124; Resp-24; temperature 96.6 (Ax); O2 sat-95%. Observed for 1 hour, Rx'd with Benadryl susp. given to be filled. On 3/30/01, Pediatrician consulted by PA and told to go to ER if condition worsens. No respiratory distress (vital signs ok). Pt is to return on Monday. Called on 4/1/02 X 2 with no answer. Called on 4/1/01 at 15:00 and child is fine; rash is gone.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: 5cm inflammed/red area around injection site X 4 days (DTAP site). Fever X 2 days.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Influenza like illness, Sinus congestion
Clinical narrative: Minor flu-like symptoms (ie: fatigue, aches in joints and sinus pressure).
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Headache, Hypokinesia, Nausea
Clinical narrative: I felt sick to my stomach and couldn't get off the couch; had a headache and felt "off" for about a week and a half. Lost appetite. Had similar reaction to 1st shot but only for an hour or two.
Age: 1.4
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: 4 1/2" of redness and swelling at the injection site, 48 hours, post vax. Pt sought evaluation from PMD. PMD dx'd with cellulitis and Rx'd antibiotics.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Flushing, Insomnia, Myalgia, Nausea
Clinical narrative: Flushed, low fever, hands shaking, continuous nausea, muscle aches, spacing out, decreased appetite (now no appetite), sleep twitches, sleeplessness (no sleep), stomach pain for 5 months and ongoing. Since 11/01, been to doctor 15 times and he is now on meds to help bring him up, meds for nausea and meds for sleep.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Oral intake reduced, Pyrexia, Stupor, Tremor
Clinical narrative: Flushed, low fever, hands shaking, continuous nausea, muscle aches, spacing out, decreased appetite (now no appetite), sleep twitches, sleeplessness (no sleep), stomach pain for 5 months and ongoing. Since 11/01, been to doctor 15 times and he is now on meds to help bring him up, meds for nausea and meds for sleep.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Mom did not call us when she noticed the swelling the next day. Redness resolved over the next 48 hours but lump has persisted. She mentioned it to us when she came on 5/1/02 for a visit.
Age: 4.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hypotonia, Injection site erythema, Injection site swelling, Injection site warmth, Somnolence
Clinical narrative: Left arm became slightly warm with erythema and swelling. Dad called on 5/9/02 and stated that child had been quiet, less playful and sleeping more. Gave Cefzil 250 bid X 10 days.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Fever X 5 days
Age: 0.9
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site induration, Injection site reaction
Clinical narrative: Induration on right thigh the size of a nickel.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt was given TD vaccine in left deltoid on 4/24/02 and was into the clinic on 5/1/02 with left arm 4 3/4" X 3/18" area of redness and swollen at deltoid site. Temperature was 99.4F. Pt was seen by PA and given Tylenol and Benadryl 25mg tid X 10 days.
Age: 70.0
Sex: M
Vaccine: TYP
Symptoms: Dyspnoea, Flushing, Pain in jaw
Clinical narrative: On 5/13/02, took 1st oral typhoid at 07:30 and by 11:00, had SOB and flushed face. Went to PMD. Also started to get jaw tightness. Reports on 5/10/02 started Hytrin for BP. Monitored by PMD for 2-3 hours and symptoms subsided. Instructed not to continue with oral typhoid.
Age: 4.9
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site mass, Injection site reaction
Clinical narrative: Softball-sized lump at the injection site. Instructed to try compresses and antihistamine. F/U phone call on 5/13/02; pt's leg is doing fine.
Age: 21.0
Sex: F
Vaccine: TTOX
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: 26 hours, post vax, the pt developed a fever of 101F, body aches and fatigue lasting 48 hours. Fever and fatigue X 72 hours, possibly more.
Age: 20.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Red, 4cm wide and 4cm long with welt.
Age: 1.4
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Swelling of the whole left thigh after 24 hours of injection.
Age: 67.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 17cm X 9cm area of erythema on left deltoid area. Treated with Tylenol and warm compresses q 3-4h X 2 days. Chief complaint: skin tenderness. Skin has redness, swelling and pain in left upper arm. Assessment: Allergic reaction, new. Treated with Benadryl 50mg, q6, 30 tablets and warm soaks tid
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom brought child in. Thigh was swollen and red about 4" X 4". Parent advised to put cool compresses on site; take Tylenol and if not better, take to MD. On 3/27/02, called X 2 to pt's home with no response; left message X 2. No response. Last call on 3/29/02; unable to reach parent. Talked to grandmother. No knowledge of problem. Told her to have daughter call health dept.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Swelling
Clinical narrative: Client stated she got TD in 1986. Left arm swollen and injection site swollen since Friday. Swollen went down since Friday. Client stated she took Goody body pain medication from Friday until today at 16:00.
Age: 59.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Blood pressure increased, Feeling abnormal, Nausea, Tremor
Clinical narrative: Pt RTC 4/17/02, approx. 10:35, complaining of nausea, weakness and vomiting to the point of dry heaves. He states, I took my last rabies shot yesterday and about 2 hours later, I began to feel real bad with nausea and vomiting. I drank 2 beers and thought I would feel better but I continued to feel bad with mild tremors noted. BP 132/80, P-74. Referred to MD.
Age: 59.0
Sex: M
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Pt RTC 4/17/02, approx. 10:35, complaining of nausea, weakness and vomiting to the point of dry heaves. He states, I took my last rabies shot yesterday and about 2 hours later, I began to feel real bad with nausea and vomiting. I drank 2 beers and thought I would feel better but I continued to feel bad with mild tremors noted. BP 132/80, P-74. Referred to MD.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Swollen glands behind the neck accompanied with pain.
Age: 1.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration of left lateral thigh.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 28 year old male who was vaccinated with varicella vaccine on 03/02/2001 and on 04/10/2001. There was no illness at the time of vaccination. Subsequently on 05/10/2001 the pt experienced lack of response with a negative titer. The varicella zoster IGG was 1.01 negative. The pt had no adverse effects from the vaccine. Additional info is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, OPV, VARCEL
Symptoms: Blister, Pruritus, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no known medical history who on 12/29/1998 was vaccinated with varicella. Concomitant vaccination included a fifth dose of DTaP given IM and a third dose poliovirus vaccine given orally. There was no illness at the time of vaccination. On 04/15/2001 the pt developed 25-10 red water filled vesicules that were itchy at times and a fever. Unspecified medical attention was sought. No further info is available.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old pt who in January 1997, was vaccinated with varicella vaccine. In January/February the pt was "exposed to a severe breakout at school." In approximately February 2001, the pt developed greater then 100 lesions all over. Unspecified medical attention was sought. The pt's sibling had a similar experience. Addiitional info has been requested.
Age: 1.0
Sex: M
Vaccine: DTPIPV, MMR, TTOX, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 12-month-old male who on 02/15/2001 was vaccinated with then first dose of varicella virus vaccinee live SC in the left thigh. concomitant therapy included the first dose of measles  virus vacine live (second generation) SC in the left thigh, diphtheria toxoids/ pertussis vaccine/tetanus IM into the upper left thigh and poliovirus inactivated SC in the left upper thigh. On 02/28/01, the patient developed a "small red bumpy rash from head to toe. Many , many red spots" it was also noted that the pt was fussy and had a low grade fever prior to eruption. On 03/21/01, the pt developed a "small red bump on the tip of nose, mom says it had been there for x 1 wk. now looks crusting-scabbing- has smaller red spot on back of lower area, back of head, on upper back and top of foot. No temperature or fussiness at the time of the report. it was noted it was unknown if the patient recovered. it was noted that the patient had no adverse reaction following previous vaccinations, and no illness at the time of vaccination.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male who on 06/11/1998 was vaccinated with a first dose of Varicella virus vaccine live SC in the left arm. On 04/03/01, the patient experienced Varicella that included 16 to 18 lesions on the face, back chest and extremities. The patient was treated with acetaminophen (Tylenol), diphenhydramine (Benadryl), and calamine lotion. Unspecified medical attention was sought. No further information is expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9-year-old white female with an allergy to amoxicillin who on 08/22/1996 was vaccinated with a first dose of Varicella virus vaccine live in the first arm. On 04/16/01, the patient developed 10-15 vesicular lesions on her trunk. On 04/17/01, the patient reported to the doctor's office and was diagnosed with chicken pox. According to licensed practical nurse, no other symptoms were noted. It was noted that the patient recovered. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6 year old male with ceclor allergy who on 03/27/1996 was vaccinated with a first dose of varicella virus vaccine SC . On 04/03/2001 the pt developed chicken pox with 67 small raised lumps over a 3 day period and a fever of 101 deg. F for one day. On 04/09/2001 the pt recovered. Unspecified medical attention was sought. No further info is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a consumer concerning a 9 year old male who in 1995 was vaccinated with varicella vaccine. On 04/17/2001 the pt experienced 400-500 lesions all over his body, except face and arms. The pt has no fever and no itching. The pt sought medical attention. It was also noted that the pt's sibling had a similar experience. Additional info has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a health professional concerning a 6 year old black female who on 06 APR 2001 was vaccinated SQ in the left arm with a second dose of varicella virus vaccine live (Lot #637671/1609K). On 13 APR 2001, the patient developed typical varicella lesions. Additional information has been requested.