chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTP, MMR
Symptoms: Cellulitis, Contusion, Ecchymosis, Injection site erythema, Injection site induration
Clinical narrative: Information has been received from an MA concerning a 5 year old female pt with a history of cellulitis and a recently broken arm and no known allergies who on 1/21/02 was vaccinated with MMRII. Concomitant therapy on 1/21/02 included a dose, in the right deltoid, of DPT. There were no other concomitant therapies. On 1/24/02, the pt presented to the physician's office with a bruised and red, 4 X 2cm, ecchymotic area (exact date of reaction onset not reported). There was also a dark purple blotch and an erythematous area that was firm. The pt was dx'd with cellulitis. The physician started the pt on Augmentin. The pt's mother stated that "this happened the last time she received these same shots". It was noted that this reaction was reported at another physician's office and could not be confirmed. The pt subsequently recovered. No further info is available.
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a health professional concerning a female employee who on 7/24/97 was vaccinated with a dose of MMRII. The pt was also vaccinated with a 1st dose of MMRII as a child. Subsequently, in approx. 1997, the pt failed to sero-convert. Unspecified medical attention was sought. Additional info has been requested.
Sex: U
Vaccine: MMR
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with 1 dose of MMRII. Subsequently, the pt experienced negative titer to measles and mumps. The pt sought unspecified medical attention. Additional info has been requested.
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Diarrhoea, Rash
Clinical narrative: Information has been received from a consumer concerning her son (DOB 1/20/01) with no known allergies and a history of ear infection who on an unspecified date was vaccinated with a single dose of MMRII. The day after vaccination, her son experienced a seizure. She brought her son to the ER. She was provided azithromycin (Zithromax) after the ER visit. Her son then developed a rash all over his body and diarrhea. Upon internal review, seizure was determined to be an "Other Important Medical Event". Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Dysphonia, Rash vesicular, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 4 year old female with no allergies and no past medical history who on 1/24/02 was vaccinated SC, in the left arm with a 0.5ml dose of MMRII. There was no concomitant medication. On 1/28/02, the pt developed hives on her face (predominantly on 1 side). The pt presented to the office on 1/29/02 and the rash had affected the whole face and the pt's voice became hoarse. The rash was described a s pruritic, red, blotchy and slightly raised and began to spread to the chest. The pt was administered Benadryl as needed. On 1/30/02, the rash had spread to her arms per the pt's mother. The rash on her arms was described as a white pimple-like rash. Additional info has been requested.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a male who in approx. 1/02, was vaccinated with 1 dose of MMRII (lot 640562/1374L). Concomitant therapy included 1 dose of varicella (lot 641151/1181L). On 1/15/02, the pt developed a temperature. This information was called in to the physician's office. The pt sought unspecified medical attention. The physician requested a lot check on the lots because there were "more phone calls than ever before", for MMRII (lot 640562/1374L) and varicella (lot 641151/1181L). It was found that, "The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. This lot complies with the standard of the Center for Biologics Evaluation and Research and was released." F/U info on 3/7/02, from a physician, noted there were no more adverse events to report other than those that were previously reported. The physician stated that the reason she used the phrase "more calls than ever", was because she has been in practice for a number of years and always gave pt/parents standard info on the benefits/risks of a vaccine before its administered, and also instructed them to call the office if the child experienced any problems, post vax. The physician reported that in her years of practice, it had been her experience that parents very rarely call their office to report a post vax reaction. It was very unusual for their office to receive as many calls as they did in 1/02, including this pt and other pts who were vaccinated and experienced similar events (WAES021USA03018, 0202USA00429, 0202USA00430, 0202USA00431 and 0202USA00432). The physician also thought it was unusual that several of the adverse events seemed to be occurring at day 10, post vax. It was noted that there were no additional cases reported and the increase in calls was just in the month of 1/02. They did not experience any unusual volume of calls in February or thus far in 3/02. Additional info has been requested.
Sex: M
Vaccine: MMR
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male who on 12/27/01 was vaccinated with one dose of MMR II (lot 640562/1374L). Subsequently in approximately January 2002, the physician's office was notified by telephone that the pt developed localized rash and temperature. The pt sought unspecified medical attention. The physician requested a lot check on the lot because there were "more phone calls than ever before." The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. This lot complies with the standard of the Center for Biologics Evaluation and Research and was released. Follow-up info on 3/7/02, from a physician noted there were no more adverse events to report other than those that were previously reported. The physician stated that the reason she used the phrase "more calls than ever," was because she has been in practice for a number of years, and always gave pt/parents standard info on the benefits/risks of a vaccine before its administration and also instructed them to call the office if the child experienced any problems post-vaccination. The physician reported that in her years of practice, it had been her experience that parents very rarely call their office to report a post-vaccination reaction. It was very unusual for their office to receive as many calls as they did in January 2002. Including this pt and other pts who were vaccinated and experienced similar events (WAES0202USA03018, 0202USA00428, 0202USA00429, 0202USA00430 and 0202USA00432). The physician also thought it was unusual that several of the adverse events seemed to be occurring at day 10 post-vaccination. It was noted that there were no additional cases reported and the increase in calls was just in the month of January 2002. They did not experience any unusual volume of calls in February or thus far in March 2002. Additional info has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site reaction, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a pt (gender unspecified) who on 1/18/02 was vaccinated with 1 dose of MMRII (lot 639615/0734L). On 1/28/02, the physician's office received a telephone call that the pt developed a temperature and localized rash. The pt sought unspecified medical attention. The physician requested a lot check on the lot because there were "more phone calls than ever before". The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. This lot complies with the standard of the Center for Biologics Evaluation and Research and was released. F/U info on 3/7/02, from a physician noted there were no more adverse events to report other than those that were previously reported. The physician stated that the reason she used the phrase "more calls than ever", was because she has been in practice for a number of years and always gave pt/parents standard information on the benefits/risks of a vaccine before its administration and also instructed them to call the office if the child experienced any problems post-vax. The physician reported that in her years of practice, it had been her experience that parents very rarely call their office to report a post vax reaction. It was very unusual for their office to receive as many calls as they did in 1/02, including this pt and other pts who were vaccinated and experienced similar events (WAES0201USA03018, 0202USA00428, 0202USA00429, 0202USA00430 and 0202USA00431). The physician also thought it was unusual that several of the adverse events seemed to be occurring at day 10, post vax. It was noted that there were no additional cases reported and the increase in calls was just in the month of January, 2002. They did not experience any unusual volume of calls in February or thus far in March, 2002. Additional info has been requested.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a health professional concerning a 20 year old female with no drug allergies who on 6/20/01 was vaccinated with a 2nd dose of MMRII. There was no concomitant medication. It was noted that she received a 1st dose in 1982. On 1/22/02, the pt's titer did no show seroconversion. Unspecified medical attention was sought. Additional info has been requested.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Information has been received from an RN concerning a 12 month old female pt with no known allergies and no concurrent medications who was vaccinated, SC, in the right arm with a 0.5ml dose of MMRII. Concomitant therapy included varicella in the leg and HIB + Hep-B  into the leg. Subsequently, the pt developed an immediate reaction at the injection site. The affected area was 0.72mm X 5.3mm in size and tender to the touch. The pt was observed for 30 minutes and was seen by the physician. The mother was instructed to observe the site and report any changes. She called to report the redness had resolved when the pt got home. Additional info has been requested.
Age: 7.0
Sex: U
Vaccine: MMR
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from an NP concerning a 7 year old child who was vaccinated with MMRII at the recommended age (approx. 1996). It was reported that "this past week, 2/11/02", the child was dx'd with mumps. Unspecified medical attention was sought. No further info was provided. Additional info has been requested.
Age: 9.0
Sex: U
Vaccine: MMR
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from an NP concerning a 9 year old child who was vaccinated with MMRII at the recommended age (approx. 1994). It was reported that "this past week, 2/11/02", the child was dx'd with mumps. Unspecified medical attention was sought. No further info was provided. Additional info has been requested.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from an RN concerning a 38 year old female with a history of mumps as a child who on 4/15/91 and 9/24/97 was vaccinated with MMRII. On 10/19/99, the pt had a mumps titer drawn which was "equivocal". Subsequently, a "recent" mumps titer was negative. Additional info has been requested.
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from an RN concerning a 15 month old pt with no known allergies who on 1/12/02 was vaccinated with MMRII (lot 639619/0594L). On 1/21/02, the pt developed a fever of 102F and widespread measles-like rash all over the body. The nurse requested a lot check of lot 639619/0954L. Unspecified medical attention was sought. The records of testing prior to release of this lot had been checked by Compliance and found to be satisfactory. The lot complied with the standards of the Center for Biological Evaluation and Research and was released. The nurse reported that another pt developed a fever and a measles-like rash, post vax, with MMRII. See (WAES0201USA02367). Additional info has been requested.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a health professional concerning a 19 year old female who on 11/10/83 and 9/26/96 was vaccinated with MMRII. On 2/15/02, the pt had a negative titer for rubella (0.94). Unspecified medical attention was sought. Additional info has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Injection site reaction
Clinical narrative: Information has been received from an RN concerning a female in her 30's who on 2/18/02 was vaccinated with a dose of MMRII, which was reconstituted with 0.5ml diluent instead of 0.7ml. The pt developed a bruise at the injection site, "but had no complaints". The pt did not seek medical attention. Additional info has been requested.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received on 2/21/02 from a health professional concerning a 31 year old female who "as a child" was vaccinated with a dose of MMRII. It was reported that there was "some controversy" if the pt ever received a 2nd dose. The pt was titered for measles, mumps and rubella and the results were reported to be "either equivocal or negative for protection. The pt received an additional dose on 2/21/02. It was noted that the pt had her titers checked because she was going to be a school teacher. There were no other details available. Additional info has been requested.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Viral infection
Clinical narrative: Information has been received from a Pharm D concerning her 19 year old son who was vaccinated with MMRII at 12 months of age and pre-kindergarten (in approx. 1988). It was reported on 2/22/02, that the pt "now" developed rubella. The pt did seek medical attention. Additional info has been requested.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information has been received from a mother concerning her son who was vaccinated with MMRII, at the age of 15 months. Subsequently, the pt developed a high fever, bumps and welts all over his body. The mother stated that "she no longer goes to the doctor that vaccinated her son". Unspecified medical attention was sought. Additional info has been requested.
Age: 1.08
Sex: F
Vaccine: DTP, HBHEPB, MMR, VARCEL
Symptoms: Rash macular
Clinical narrative: Information has been received from an RN concerning a teething 13 month old Caucasian female with no known allergies and no past medical history who on 2/21/02 was vaccinated with the 1st dose of MMRII (lot 635180/0737L), SC, in the right vastus lateralis. Concomitant therapy that day included the 3rd dose of Hib + Hep-b (lot 634237/0289K), IM, in the right vastus lateralis, the 1st dose of varicella (lot 641151/1181L), SC, in the left vastus lateralis and the 4th dose of DPT, IM, in the left vastus lateralis. It was noted that the vaccinations were administered between 09:30 AM and 11:30 AM. There was no illness at the time of vaccination. On 2/22/02, in the AM, the pt's mother reported to the nurse, that her daughter developed a rash described as non-raised, "blotchy red, with white skin in between". It was noted that the pt was afebrile. The pt sought unspecified medical attention. The rash was completely resolved by the time the pt was seen in the physician's office on 2/25/02. Follow-up information reported that the symptoms resolved in approx. 1 day. No further info is expected.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Parotid gland enlargement, Viral infection
Clinical narrative: Information has been received from an LPN concerning a 26 year old female co-worker who was "unsure" whether as a child, was vaccinated with a dose of MMRII. On 3/4/02, the pt presented with a swollen parotid gland, one side only. It was noted that the pt did not have a sore throat. The pt saw a physician who was unsure of the cause of her swollen parotid glands. It was reported that the physician did not order any lab tests, including a strept test. A possible dx of mumps was noted. The physician ordered an antibiotic and the pt recovered approx. 10 days later. No further info is expected.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Eye movement disorder
Clinical narrative: Information has been received from the mother of a 4 year old male with allergies to wheat, cow's milk, yeast, fungus, corn, carrots and mangos and no other medical history who on 3/29/01 was vaccinated with the 2nd dose of MMRII. Prior to vaccination, included Hep-B on 9/19/96, 10/28/96 and 5/30/97. On approx. 4/1/01, the mother reported that her son had strange episodes of where his eyes would roll back in his head. The mother reported that she was having problems with her son now. No further information is available.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Lymphadenopathy, Neck pain
Clinical narrative: Information has been received from an NP concerning a 44 year old Caucasian female with no past medical history and no illness at the time of vaccination, who on 2/13/02, was vaccinated, SC, in the left arm, with a dose of MMRII (lot 639695/0902L). There was no concomitant medication. On 2/23/02, the pt experienced increased fatigue. On 2/25/02, the pt noticed neck swelling with palpable, slightly tender, anterior cervical nodes bilaterally and tender palpable posterior cervical nodes. The pt was afebrile, with a temperature of 98.2F on 2/26/02, when seen in the employee health. Additional info has been requested.  Reported on 06/04/2003: "Follow-up information indicated that the patient subsequently recovered.  Additional information has been requested. "
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Breast infection
Clinical narrative: Information has been received from a physician concerning a 31 year old female with a history of breast prosthesis implantation in 1999 who on 2/25/02 was vaccinated with MMRII. On approx. 3/4/02, the pt developed an infection in her breast implant. The pt told the reporting physician that the surgeon who performed the breast implant procedure, felt that vaccination with MMRII was the cause of the infection. The administering physician reported that she did not think that the vaccination with MMRII could have caused the infection in the pt's breast. The pt sought unspecified medical attention. At the time of this report, the outcome of the pt's infection was not reported. Additional info has been requested. A 15-day follow up report received 6/4/2003 adds: Follow-up info was received from the physician. Laboratory evaluations performed on 01/31/2002 revealed rubella virus IgG antibody test was 0.61, no rubella antibodies were detected. The outcome of the pt's infection was unknown. No additional info is expected.
Age: 10.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Erythema, Rash
Clinical narrative: Information has been received from an RN concerning a 10 year old female who on 1/19/93 was vaccinated with MMRII, 1st dose on 1/19/93 and a re-vaccination dose on 3/12/02 from (lot 640561/1086L). On 3/12/02, the pt was also vaccinated with Hep-B and had a TB skin test (results unknown). On 3/14/02, the pt developed a fine red rash on her legs and lower trunk. The pt did seek medical attention. Further info has been requested. A 15-day follow up report received on 6/4/2003 adds: Initial and follow up info has been received from a registered nurse concerning a 10 year old female who on 01/19/1993 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation), first dose on 01/19/1993 and a revaccination dose on 03/12/2002 from lot #640561/1086L. On 03/12/2002 the pt was also vaccinated with hepatitis B vaccine recombinant (yeast) (MSD) and had a TB skin test (results unknown). On 03/14/2002 the pt developed a fine red rash on her legs and lower trunk. The pt's mother stated that the pediatrician told her that the rash was the fifth disease. Subsequently, the pt recovered from the rash. The pt did not seek medical attention. Further info is not expected.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 15 month old male who on 1/28/90 was vaccinated with a dose of MMRII. On 2/7/92, the pt developed a rash. The pt sought unspecified medical attention. Additional info has been requested.  Received on 06/04/2003: "Follow-up information received from the physician stated that he consulted an Immunologist who did not feel there was a "problem."  He also noted that the patient may receive another dose of the vaccine "this summer".  No further information is available.
Age: 1.4
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Information has been received from a woman in social services concerning a 17 month old male with no past medical history and no known allergies who was vaccinated with MMRII. There was no concomitant medication. Subsequently, the pt experienced fever. Unspecified medical attention was sought. Addition info has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Injection site pain, Laboratory test abnormal, Pruritus, Pyrexia
Clinical narrative: Information has been received from a 30 year old female consumer who is a pediatric ICU nurse with no known allergies who in 1/02, had a MMRII titer done and she was not immune to rubella, therefore, on 3/14/02 was vaccinated with a dose of MMRII (lot 636400/1276K). There was no concomitant medication. On the day of vaccination, her arm was sore. On 3/21/02, the pt experienced a high fever, raised rash all over the body and joint pain. On 3/22/02, she reported that "she is still feeling this now". Her doctor had her on Benadryl for the rash and itching and Tylenol for the pain. Her doctor feels that it "was a serum reaction". The pt reported that she "needs documentation that she called in for work and she is unable to return until her rash clears up". It was reported that the pt was vaccinated with the MMR vaccine in 12/72, mumps vaccine in 1975 and the 1st and 2nd dose of the rubella vaccine in 9/75 and 3/82, respectively. Additional info has been requested.  Received on 06/04/2003: "Follow-up information has been received from a registered nurse.  The nurse reported that the patient had allergies to iodine and shellfish (conflicting information).  On 03/20/2002, the patient developed fatigue, fever and chills, joint pain, headache, and an itchy, fine papular rash over her whole body.  On 03/21/2002, the patient was "feeling batter."  The patient was treated with ibuprofen and diphenhydramine (BENADRYL).  On 03/25/2002, the patient's rash and fever resolved.  No additional information is expected.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a 30 year old female consumer who is a pediatric ICU nurse with no known allergies who in 1/02, had a MMRII titer done and she was not immune to rubella, therefore, on 3/14/02 was vaccinated with a dose of MMRII (lot 636400/1276K). There was no concomitant medication. On the day of vaccination, her arm was sore. On 3/21/02, the pt experienced a high fever, raised rash all over the body and joint pain. On 3/22/02, she reported that "she is still feeling this now". Her doctor had her on Benadryl for the rash and itching and Tylenol for the pain. Her doctor feels that it "was a serum reaction". The pt reported that she "needs documentation that she called in for work and she is unable to return until her rash clears up". It was reported that the pt was vaccinated with the MMR vaccine in 12/72, mumps vaccine in 1975 and the 1st and 2nd dose of the rubella vaccine in 9/75 and 3/82, respectively. Additional info has been requested.  Received on 06/04/2003: "Follow-up information has been received from a registered nurse.  The nurse reported that the patient had allergies to iodine and shellfish (conflicting information).  On 03/20/2002, the patient developed fatigue, fever and chills, joint pain, headache, and an itchy, fine papular rash over her whole body.  On 03/21/2002, the patient was "feeling batter."  The patient was treated with ibuprofen and diphenhydramine (BENADRYL).  On 03/25/2002, the patient's rash and fever resolved.  No additional information is expected.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Information has been received from a healthcare professional concerning a 1 year old male who on 3/8/02 was vaccinated with a dose of MMRII. On 3/16/02, the pt developed a fever and generalized "maculopapular rash". Unspecified medical attention was sought. He was treated with Benadryl. On 3/22/02, the nurse reported that the pt "is now fine". Additional info has been requested.  Received on 06/04/2003: "Information has been received from a health professional concerning a 14 month old Hispanic male with no known allergies who on 03/08/2002 was vaccinated SC with a first dose of MMRII (Lot # 639694/1212L).  Concomitant vaccination the same day included a first dose of varicella virus vaccine live (Lot # 639489/0573L) given SC.  There was no illness at the time of vaccination, the patient was seen for a well child visit.  On 03/18/2002 (previously reported as 03/16/2002) the patient developed a fever of 101 F and generalized "maculopapular rash".  The patient's fever lasted for 4 days.  Unspecified medical attention was sought.  He was treated with diphendydramine hydrochloride (BENADRYL) every 4-6 hours.  On 03/22/2002, the nurse reported that the patient "is now fine" and subsequently he recovered.  No further information is available.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning his 18 month old son who on 3/15/02 was vaccinated with a dose of MMRII. Eleven days later, on 3/26/02, the pt experienced a rash on his face and trunk. Unspecified medical attention was sought. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain, Dehydration, Eosinophilia, Glycosuria, Hyperglycaemia
Clinical narrative: Information has been received from a health professional concerning a 4 year old male who on 3/14/02 was vaccinated with a 2nd dose of MMRII (lot 636663/0020L). The 1st dose was given on 9/11/98 and no problems were experienced. On 3/25/02, in the evening, the pt's mother contacted the physician's office and reported that the pt was complaining of increased urination, abdominal pain and nausea. She was instructed to take the pt to the ER and the physician saw the pt. Lab tests were done and he had an accucheck of 220 and glucose in his urine. The pt was dehydrated and had an elevated WBC and an increased eosinophil value. The pt had IV fluids administered and recurrent accuchecks and serum samples were done. The pt's blood sugar returned to normal and he was released from the ER the same evening on 3/25/02. The physician ruled out Diabetes and felt that this event could have been a reaction to the MMRII due to the eosinophila. The week of 4/3/02, the pt's mother had telephone follow-up with the physician's office and it was reported that the pt has not experienced any further problems. The plan was for the pt to have lab work done at the end of 4/02 and was scheduled for a doctor's visit on 4/26/02. It was reported that another child (WAES0203USA02975), in the pt's nursery school, had a similar experience following exposure to MMRII. Additional info has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Nausea, Pollakiuria, White blood cell count increased
Clinical narrative: Information has been received from a health professional concerning a 4 year old male who on 3/14/02 was vaccinated with a 2nd dose of MMRII (lot 636663/0020L). The 1st dose was given on 9/11/98 and no problems were experienced. On 3/25/02, in the evening, the pt's mother contacted the physician's office and reported that the pt was complaining of increased urination, abdominal pain and nausea. She was instructed to take the pt to the ER and the physician saw the pt. Lab tests were done and he had an accucheck of 220 and glucose in his urine. The pt was dehydrated and had an elevated WBC and an increased eosinophil value. The pt had IV fluids administered and recurrent accuchecks and serum samples were done. The pt's blood sugar returned to normal and he was released from the ER the same evening on 3/25/02. The physician ruled out Diabetes and felt that this event could have been a reaction to the MMRII due to the eosinophila. The week of 4/3/02, the pt's mother had telephone follow-up with the physician's office and it was reported that the pt has not experienced any further problems. The plan was for the pt to have lab work done at the end of 4/02 and was scheduled for a doctor's visit on 4/26/02. It was reported that another child (WAES0203USA02975), in the pt's nursery school, had a similar experience following exposure to MMRII. Additional info has been requested.
Age: 0.9
Sex: M
Vaccine: DTP, OPV
Symptoms: Cerebral palsy, Dyskinesia, Encephalopathy, Neurodevelopmental disorder, Somnolence
Clinical narrative: Patient sleepy after shot at 2 months of age.  Birth apgar 9, although development delayed after 3 months of age and diagnosed with mild form of cerebral palsy by Dr., neurologist, at 9 months of age. At that time (2 months of age), we did not see a pertussis connection because were told that a bona-fide reaction was marked only by fever.  However, at 11 1/2 months of age, Dr. argued with patient's mother over administration of Pertussis vaccine as mother had learned from other parents of cp victims that Pertussis should never be given to children with neurological problems.  Dr. argued that neurologist said it was safe because pt had non-progressive encephalopathy. Another dose of Pertussis was then administered two weeks before patient's 1st birthday.  Pt developed jerking spells within the week after shot and taken to neurologist and diagnosed with infantile spasms.  EEG showed no seizure disorder present before the shot was given.  Pt could suddenly no longer scoot on floor or smile.  He became lethargic and dull in reflexes and cognitive ability.  His cerebral palsy immediately became severe, with mental retardation, and remained so until his death at age 17.  Since the last pertussis shot, his jerking spasms were uncontrollable by any anti seizure medication on the market.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site reaction
Clinical narrative: very large local reaction right thigh. Had ER and clinic visit as consequence.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Apnoea, Cyanosis, Gastrointestinal disorder, Hypotonia
Clinical narrative: appx 48 hrs after the vaccine, he had several episodes of cyanosis, (perioral and oral) and hypotonia,with possible post ictel periods (total duration per episode 20 sec) witness initially by the parents and in an emergency room x3.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Received 2nd pneumovax 7/23/02 in left deltoid area at the clinic. Developed redness (5.5"x5.5"), swelling and warmth left deltoid area. Cold compresses, Benadryl 25mg 4 a day. Ex. Tylenol 2 QID.
Age: 69.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Arthropathy, Joint stiffness
Clinical narrative: I received 3 vaccinations: (4/29/99; 6/8/99 and 5/9/00). Shortly after the 1st vaccination, I started with joint pain and stiffness and it is still getting worse. I tried physical therapy, Celebrex and Vioxx without results. I have been in excellent health before. Information received on 10/10/02 in a 60 days follow up report states, "Severe joint pain and inflam, arthritis."  Annual follow up on 08/05/03 reports : "Patient did not recover from adverse events.  Severe arthritis-like pain like I'm paralyzed."
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Right thigh swelling, redness, tenderness.
Age: 0.6
Sex: F
Vaccine: DTP, HBHEPB, IPV, PNC
Symptoms: Cerebral infarction, Hemiparesis
Clinical narrative: Hemiparesis of right side of body.  Brain infarct. Follow uP: Deaf
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Infection, Injection site reaction, Rash papular
Clinical narrative: Pt had DTaP, IPOL, MMR on 07/15/02. Back to office 07/22/02-broke out in pustules. 07/23/02 dx. chicken pox-vesicular red papules. Rt leg around injection site-other similar lesions on body. 07/22/02 parent called and reported local reaction to DTaP site right thigh-parent reports multiple lesions itch lasting at injection site spread to generalized.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Visual disturbance
Clinical narrative: "Could not see" and dizziness for 3 hours.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis, Hypoacusis, Hypotension, Pallor
Clinical narrative: Skin color pale, lips pale. Complained of "feeling funny". Diminished hearing; diaphoretic. No SOB. RAS 106/50; 10 minutes later, RAS 104/56. P-60 R; 10 minutes later, P 64 Reg. Lasted 10 minutes. Client had eaten.
Age: 7.0
Sex: F
Vaccine: DTAP, MMR, OPV, VARCEL
Symptoms: Pain, Pruritus, Rash vesicular
Clinical narrative: Multiple (about 15) vesicular lesions up to 5mm, pain and itching.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Contusion, Joint swelling, Polyarthritis
Clinical narrative: Caused severe arthritis in most of joints of body. Pain moving throughout the body. Include pain and swelling and slight bruising of joints.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 7/17/02, early morning, complained of painful, red and swollen in left deltoid with large red area around DTAP immunization site. Per MD, can take Motrin for pain/temperature and apply ice to area.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Malaise, Nausea, Rash maculo-papular, Rhinorrhoea
Clinical narrative: Malaise, rhinorrhea, nausea, cough and maculo-papular eruption on face, trunk (mostly anterior) and extremities. Duration-7 days. Treatment-rest, supportive care.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm swelling, erythema 2" X 2" at site of IPV shot.
Age: 10.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Pyrexia
Clinical narrative: Child was given Hep-B and varicella vaccines on 7/16/02 AM. Generalized fever in the afternoon while at the beach between 10:00 and 13:00. On and off up to 7/18/02.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Pruritus, Rash
Clinical narrative: Administered vaccine within 3 minutes of receiving vaccine, patient came back to the clinic with several bumps and redness above the injection site and complaining about itching and soreness.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Pain
Clinical narrative: Patient complained of headache, nausea, joint pain, low grade fever, fatigue, arm pain. Instructions - Advil, Tylenol, fluids, rest, follow up FMD.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Patient complained of headache, nausea, joint pain, low grade fever, fatigue, arm pain. Instructions - Advil, Tylenol, fluids, rest, follow up FMD.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Drug administration error, Injection site rash, Rash
Clinical narrative: Information has been received from a physician concerning  17 month old Caucasian female with a history of partial onycholysis of some distal fingernails and no other past medical history and no allergies who on 09/26/96 in the AM was vaccinated with the first dose of varicella virus vaccine live (lot 0389D-invalid for this product), which had expired. There was no concomitant medication. There were no adverse events noted at that time. Follow-up reported that "late addendum: pt did develop rash at vaccine stie and on face at 2-3 weeks."
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Onseto f hives within five minutes on bilateral legs, progressing to back and posterior scalp.  Some diminished within 30 minutes others remained. No respiratory distress, lungs remained clear to auscultation bilaterally throughout observation.  Observed 30 minutes prior to discharge.  Private physician contacted.No treatment necessary in this office.  Child had no further difficulties after going home.
Age: 14.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Dysphemia, Speech disorder
Clinical narrative: Speech. Abnormal stuttering.  Follow up:  Change to non-serious, disregard report-parents don't want to pursue; normal boy.
Age: 37.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Symptoms are mainly-shooting pains and aching in both of my shoulders and upper arms. Symptoms are constant. Shortly after receiving my 3rd dose of the Lymerix vaccine, I started getting shooting pains and aching in both of my shoulders and both of my upper arms. I went to see the doctor and told him that it all started after receiving the lyme vaccine. Doctor did not know what was causing the pain and aching, so he recommended that I see a doctor at Orthopedic Surgeons. That doctor could not determine what was causing the pain and aching. He thought that it might be bicepetal tendenitious. The pain and aching have not disappeared and they are constant, but sometimes it is more severe than others. I have not had any other treatment since then. Dates that I saw the doctors regarding the pain and aching are on or about 03/08/2000 and 03/22/2000.
Age: 4.08
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: 6x7.5cmhyperedemas and mild induration right deltoid x 3 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Red, swollen and hot. Fever 100 given Motrin q 4hrs with cool clothes applied. Also pain in right upper leg.
Age: 4.6
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Right arm swelling, redness, tenderness.
Age: 1.08
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Had varicella vaccine 11/13/01 and developed the disease 07/11/02, had aprox. 30 spots.
Age: 1.25
Sex: F
Vaccine: HBHEPB
Symptoms: Erythema, Oedema, Subcutaneous nodule
Clinical narrative: Red, swollen, lump under skin. 3cm.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Dyskinesia, Myoclonus
Clinical narrative: 06/03/02 myoclonic jerks during sleep. Started out occurring every few seconds for several hours. Over the course of about a week, the occurred less and less frequently and eventually stopped.
Age: 72.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: On 07/18/02, pt came to unit for scheduled dialysis with c/o "rash all over and soles of feet and palms of Hands itch". She states the itching on her feet started on 07/11/02 and that the rash started on 07/16/02she denies going to the hospital of physician's office. The responsible physicians was notified on 07/17/02.
Age: 4.8
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left arm swelling 2" above elbow no central skin breakdown-warm to the touch-some erythema.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Diarrhoea, Faeces pale
Clinical narrative: Within couple hours of vaccination felt weak. Was seen at clinic 05/09/02. She had light colored loose stools which were negative for pathogens. Liver enzymes were transiently elevated to peak of ALT 115 and AST 60. Liver enzymes returned to normal 05/24/02.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Lacrimation increased, Urticaria
Clinical narrative: Cough, watery eyes, hives 15 minutes after varicella vaccine. Similar reaction to MMR. Eats eggs. Rx Benadryl-rash gone in 24 hours.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Arthralgia, Erythema, Feeling hot, Swelling
Clinical narrative: Vaccine given on 7/17/02, DTaP on right anterior lateral thigh. Patient awakened at 02:00 on 7/18/02 complaining of pain, by 7:00am right thigh and right knee were moderately swollen and could not bend knee as per mother. Applied cold compresses every 30 mintues, as per Dr's instructions. Dr told mother to wait one more day. Leg continued to swell with redness and warm to touch. No fever at any time. Child's behavior was normal except for pain to leg. Mother took child to pediatrician on 7/19/02. Doctor prescribed Motrin for pain. Gave mother form. On 7/20/02, swelling down, no pain to leg on a little when bends knee. No longer warm to touch and no longer redness at site of injection.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus
Clinical narrative: Redness on left upper arm expanded towards the inside of the arm. No fever, no reported pain. Complaints of itching.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Headache, Lethargy, Nightmare, Visual disturbance
Clinical narrative: symptoms day of vaccine: dizziness, lethargy, visual changes ("white flashes"), headache, nightmares  symptoms a problem for about 24 - 36 hours
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site induration, Injection site mass, Injection site reaction, Oedema
Clinical narrative: 7-18-02 CLIENT CAME INTO OFFICE REQUESTING TETANUS - CLIENT HAD SUSTAINED DOG SCRATCH - DOCTOR'S OFFICE REQUESTED THAT WE GIVE TETANUS BUT MS. REPORTED THAT WE CURRENTLY DO NOT STOCK TT - DT WAS OFFERED - CLIENT STATED HAD A PREVIOS REACTION FROM SAME - MS. SENT CLIENT BACK TO DOCTOR'S OFFICE TO GET ORDER PRIOR TO GIVING VACCINE - CLIENT RETURNED WITH ORDER FOR TT - ORDER WAS CLIPPED TO THE BACK OF THE IMMUNIZATION RECORD - TD ADULT WAS GIVEN - CLIENT SUSTAINED CELLULITIS LEFT DELTOID AND COMPLAINS OF PAIN, SWELLING, AND REDNESS AT INJECTION SITE - CLIENT IS TAKING DARVOCET N100 FOR PAIN AND KEFLEX 500MG BID FOR PRIOR DOG SCRATCH - ADVISED CLIENT TO APPLY WARM COMPRESSES TO SITE PER DR. - TO RETURN FOR RECHECK ON MONDAY, 7-29-02. The 60 day follow-up states that the "pt reported hard knot in arm. Instructed to use warm compresses per physician. Was seen in office x 2 post "trauma" of receiving injection. Pt incurred loss of work time and has been upset. We have furnished her with copies of her records at her request."
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Pain
Clinical narrative: 7-18-02 CLIENT CAME INTO OFFICE REQUESTING TETANUS - CLIENT HAD SUSTAINED DOG SCRATCH - DOCTOR'S OFFICE REQUESTED THAT WE GIVE TETANUS BUT MS. REPORTED THAT WE CURRENTLY DO NOT STOCK TT - DT WAS OFFERED - CLIENT STATED HAD A PREVIOS REACTION FROM SAME - MS. SENT CLIENT BACK TO DOCTOR'S OFFICE TO GET ORDER PRIOR TO GIVING VACCINE - CLIENT RETURNED WITH ORDER FOR TT - ORDER WAS CLIPPED TO THE BACK OF THE IMMUNIZATION RECORD - TD ADULT WAS GIVEN - CLIENT SUSTAINED CELLULITIS LEFT DELTOID AND COMPLAINS OF PAIN, SWELLING, AND REDNESS AT INJECTION SITE - CLIENT IS TAKING DARVOCET N100 FOR PAIN AND KEFLEX 500MG BID FOR PRIOR DOG SCRATCH - ADVISED CLIENT TO APPLY WARM COMPRESSES TO SITE PER DR. - TO RETURN FOR RECHECK ON MONDAY, 7-29-02. The 60 day follow-up states that the "pt reported hard knot in arm. Instructed to use warm compresses per physician. Was seen in office x 2 post "trauma" of receiving injection. Pt incurred loss of work time and has been upset. We have furnished her with copies of her records at her request."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 4 cm mild induration and erythema surrounding injection site on right upper thigh. Parent directed to apply Benadryl cream and call if worsen.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cyanosis, Hypotonia, Respiratory arrest, Staring
Clinical narrative: At about 7:30 pm on July 26, 2002 I found my son laying on the floor in a stare. His body was limp.I immediately picked him up trying to figure out what was wrong. My husband noticed that his lips were blue and that he was not breathing. My husband reached into his mouth to see if he was choking on something.My son started to breathe again. He was acting very tired and was moving slowly, but seemed better.I sat downed and nursed him while I called my pediatrician. I got a hold of another physician in the practice Dr. I explained to him what happened and he said that he would allow something like that to happen once, but if it happened again to take him to the E.R. My son seems fine today (July 27 2002).
Age: 0.29
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Amino acid level normal, Autism, Convulsion, Dyskinesia
Clinical narrative: Noticed abnormal fussiness and nursing problems beginning in early June.  Jerky seizure movements and abnormal fussiness which was later diagnosed as infantile spasms.  Spasms first noted on June 20, 1997 and diagnosed on June 27,1997.  Treatment began on June 27, 1997.  Treatment included valproic acid and vigabatrin followed by ACTH which was followed by Cortef.  Cortef was tapered until September 15, 1997. The 60 day follow-up states "seizures, severe mental retardation, autism, and visual disturbances." Also diagnosed with Autism and severely mentally retarded.
Age: 0.29
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Electroencephalogram normal, Feeding disorder, Full blood count normal, Infantile spasms, Laboratory test normal
Clinical narrative: Noticed abnormal fussiness and nursing problems beginning in early June.  Jerky seizure movements and abnormal fussiness which was later diagnosed as infantile spasms.  Spasms first noted on June 20, 1997 and diagnosed on June 27,1997.  Treatment began on June 27, 1997.  Treatment included valproic acid and vigabatrin followed by ACTH which was followed by Cortef.  Cortef was tapered until September 15, 1997. The 60 day follow-up states "seizures, severe mental retardation, autism, and visual disturbances." Also diagnosed with Autism and severely mentally retarded.
Age: 0.29
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Mental retardation severity unspecified, Metabolic function test normal, Nuclear magnetic resonance imaging abnormal, Thyroid function test normal, Visual disturbance
Clinical narrative: Noticed abnormal fussiness and nursing problems beginning in early June.  Jerky seizure movements and abnormal fussiness which was later diagnosed as infantile spasms.  Spasms first noted on June 20, 1997 and diagnosed on June 27,1997.  Treatment began on June 27, 1997.  Treatment included valproic acid and vigabatrin followed by ACTH which was followed by Cortef.  Cortef was tapered until September 15, 1997. The 60 day follow-up states "seizures, severe mental retardation, autism, and visual disturbances." Also diagnosed with Autism and severely mentally retarded.