chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Injection site swelling, Rash erythematous, Skin burning sensation, Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 31 year old female who on 09/19/01 was vaccinated with MMRII. On 09/29/01, the patient developed a lump behind her left ear. On 10/01/01, she developed a lump behind her right ear, swelling and burning at the hair line, and a lump on her collarbone. On 10/01/01, the patient was treated with penicillin 500 mg four times daily. On 10/03/01, the patient developed a red rash on her face which spread to her body during the day. The patient had sought medical attention for her experience. Additional information has two requested.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old female patient who on 09/21/01 was vaccinated SC in the left arm with the first dose of MMRII. On 10/01/01, the patient developed a diffuse,fine, pinpoint,red rash. Unspecified medical attention was sought. FOLLOW-UP information from a registered  nurse reported that per phone conversation with the patient, she described the rash as fine, pinpoint and located all over the body. When she was seen in the clinic "later the same day", the rash was not as it was described by the patient but rather clusters of 3-4 papules (mosquito bite size) all over her body. The patient also complained of intense itching. The patient recovered approximately 2 weeks later. No further information is available.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Skin nodule
Clinical narrative: Information has been received from a pharmacist concerning a 15 month old white male with a milk allergy who on 09/26/01 was vaccinated with a first dose of MMR II IM in the leg (lot 639617/0739L). Concomitant therapy on an unknown date included diphtheria toxoid/pertussis/tetanus toxoid (manuf unk) and haemophilus B conjugate (manuf unk). There was no illness at the time of vaccination. On 10/04/01, the pt developed two "pea sized" knots on the back of each side of his head near the neck area. The pt had received medical attention for his experience. The pharmacist reported that the knots didn't get any larger and were still noticeable but smaller at 2 weeks. No additional info is expected.
Age: 0.08
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Screaming, Vomiting
Clinical narrative: Information has been received from the mother of an approximately 8 week old female with a penicillin allergy who on 04/19/94 was vaccinated with MMR II. On approximately 05/03/94, two weeks after the vaccination, the pt developed a rash behind her ears and on the back of her neck, a high fever, vomiting and had bouts of screaming which lasted for about 9 days. The pt had received medical attention for her experience. The pt subsequently recovered. Additional info received from a physician indicated that he had no records on the pt. No additional info is expected.
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: Blood alkaline phosphatase increased, Faeces discoloured, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 month old pt who in approximately February 1998, was vaccinated with a first dose of MMR II. Ten to fourteen days post vaccination, the pt experienced temperature of 104, an elevated alkaline phosphatase and clay colored stools. It was noted that the clay colored stool persisted for weeks. The symptoms have resolved. Unspecified medical attention was sought. Additional info has been requested.
Age: 43.0
Sex: M
Vaccine: MMR
Symptoms: Infection, Pyrexia, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 43 year old male who on 09/24/01 was revaccinated with a dose of MMR II in the left arm (lot 635180/0737L). On 10/04/01, the pt developed a rash and fever. On 10/09/01, the pt developed a diffuse maculopapular rash and "vaccine induced" measles rash. The pt sought unspecified medical attention. The pt had only a physical exam. Subsequently, the pt recovered. No additional info is expected.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 28 year old female who on 10/08/01 was vaccinated with MMR II (lot 637837/0373L). On 10/09/2001, the pt experienced malaise and nausea. The pt had sought medical attention for her experience. Additional info has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning an adult female who was vaccinated with MMRII. The pharmacist reported that the patient broke out in a rash 14 days post vaccination. The patient had sought medical attention for her experience. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR
Symptoms: Cellulitis, Difficulty in walking, Infection, Injection site swelling, Pain
Clinical narrative: Information has been received from a consumer concerning a 5 year old female with a slight fever and no known drug allergies who on 8/14/01 was vaccinated in the thigh with a 2nd dose of MMRII. Concomitant therapy included vaccination on the same day with poliovirus vaccine and DPT. The consumer reported that the pt's fever continued and she experienced severe swelling at the injection site on her thigh. The next day in school, on 8/14/01, was sent home from school because she fell asleep on the playground and complained that she could not walk. By the next day, on 8/15/01, the swelling got worse and 2 red lines traveled up her leg. She went to the ER and was admitted for 2 days with an infection. The pt was treated with an unspecified antibiotic, Benadryl and ibuprofen (Motrin) and sent home (date unknown). The pt still complains of pain and have a hard time walking. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR
Symptoms: Pyrexia, Somnolence
Clinical narrative: Information has been received from a consumer concerning a 5 year old female with a slight fever and no known drug allergies who on 8/14/01 was vaccinated in the thigh with a 2nd dose of MMRII. Concomitant therapy included vaccination on the same day with poliovirus vaccine and DPT. The consumer reported that the pt's fever continued and she experienced severe swelling at the injection site on her thigh. The next day in school, on 8/14/01, was sent home from school because she fell asleep on the playground and complained that she could not walk. By the next day, on 8/15/01, the swelling got worse and 2 red lines traveled up her leg. She went to the ER and was admitted for 2 days with an infection. The pt was treated with an unspecified antibiotic, Benadryl and ibuprofen (Motrin) and sent home (date unknown). The pt still complains of pain and have a hard time walking. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Laboratory test abnormal, Upper respiratory tract infection
Clinical narrative: Information has been received from a 30 year old pregnant female with allergies to eggs and perfume who on 4/6/01 was vaccinated with a 1st dose of MMRII. Concomitant therapy included verapamil HC1 (Calan), unspecified prenatal vitamins and amoxicillin 250mg BID times 10 days. The pt reported that within the 1st week, her arm began to swell and she developed a red lump. The pt reported that on 10/18/01, she had a small red bump and the muscle in her arm was sore. She states that follow-up blood work revealed that she was not immune and would need to be re-vaccinated. She indicated that she would wait until the birth of her baby to be re-vaccinated. Additional information has been received from the pt's physician. She had a history of 2 previous pregnancies, 0 live births. One pregnancy ended in a miscarriage at 19 weeks and the 2nd pregnancy ended in fetal demise at 21 weeks in 2/01. The date of the pt's last menstrual period was 7/29/01. Her estimated delivery date was determined to be 5/5/02. The pt's pregnancy was confirmed by a pregnancy test. The physician reported that the pt was not pregnant at the time of vaccination with MMRII. The physician reported that the pt had an upper respiratory infection at 6 weeks. On approx. 11/18/01, the pt had an ultrasound at 16 weeks. It was reported that the pt is still pregnant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with MMRII. The physician reported that the patient developed a rash, 10 days post vaccination. The patient sought medical attention for the experience. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on 10/15/01 was vaccinated IM with a 0.5 ml dose of MMRII. On 10/16/01, the physician's offices was notified of inflammation, burning and swelling at the injection site. The patient was instructed to ice the area. On 10/26/01, the patient presented to the physician's office with an infection at the injection's site . The nurse noted that the patient had a pre-exisiting bump that was the result of a prior immunization. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of MMRII. Subsequently,2-3 days after vaccination, the patient developed a fever and  rash. The patient sought unspecified medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician's assistant concerning an approximately 25 year old female who was vaccinated with the first and second dose of MMRII. It was reported on 11/01/01 that a recent titer showed that the patient did not seroconvert.  The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a registered nurse and a health care professional concerning a  13 month of old white male who on 10/26/01 was vaccinated with a dose of MMRII. Concomitant vaccination the same day included Varivax. On 11.01.01, the patient was seen for a rash diagnosed as rash secondary to MMRII, also described as hives reaction. The RN reported that the patient has no systemic symptoms. No therapy was prescribed. Subsequently on 11/06/01, the patient recovered from the hives. No further information is expected.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: Information has been received from a health care professional at a physician's office concerning a 4 year old Hispanic female child who on 10/23/01 at 17:00 was vaccinated in the left thigh with the second dose of MMRII. Comcomitant vaccinations  included Infanrix in the left thigh, IPOL in the right thigh and Havrix in the right thigh. Illnesses at the time of vaccination included an upper respiratory infection and reactive cough. On 10/24/01 at 17:30,the child presented with an 18 x 17 cm area of erythema, warmth and induration at the left thigh and cellulitis of the left anterior thigh. It was also reported that the site was tender and swollen. The child was given Keflex and Motrin and was instructed to use coool compresses. It was reported that on 10/29/01, the child had recovered from all the events. No further information is expected. the health Care Professional also reported that a 13 month old female developed injection site erythema, swelling, induration, tenderness and warmth (see WAES01112249) and that a 12 month old female developedaskin lesion,and injectionsite swelling and tenderness (see WAES01112258)
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a health care professional at a physician's office concerning a 4 year old Hispanic female child who on 10/23/01 at 17:00 was vaccinated in the left thigh with the second dose of MMRII. Comcomitant vaccinations  included Infanrix in the left thigh, IPOL in the right thigh and Havrix in the right thigh. Illnesses at the time of vaccination included an upper respiratory infection and reactive cough. On 10/24/01 at 17:30,the child presented with an 18 x 17 cm area of erythema, warmth and induration at the left thigh and cellulitis of the left anterior thigh. It was also reported that the site was tender and swollen. The child was given Keflex and Motrin and was instructed to use coool compresses. It was reported that on 10/29/01, the child had recovered from all the events. No further information is expected. the health Care Professional also reported that a 13 month old female developed injection site erythema, swelling, induration, tenderness and warmth (see WAES01112249) and that a 12 month old female developedaskin lesion,and injectionsite swelling and tenderness (see WAES01112258)
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Abasia, Convulsion, Drug ineffective, Dysarthria, Encephalitis
Clinical narrative: Information has been received from a newspaper reporter concerning an 11 year old female who in approx. 1991, at the age of 1, was vaccinated with a 1st dose of MMRII and in approx. 1995, at the age of 5, was vaccinated with a 2nd dose of MMRII. It was reported that in approx. 6/01, the pt started having trouble in school. Prior to that she was a good student. She developed some seizures in 6/01. She was dx'd with epilepsy and placed on therapy. The pt did well for several months. In approx. 9/01, she started getting sleepy, her speech became slurred and she did not respond very well. She was hospitalized for approx. 1 week with no dx being made. She was then transferred to another hospital where she had a 1 month hospitalization. Her work-up included a brain biopsy from which a dx of subacute sclerosing panencephalitis (SSPE) was made. It was reported that the pt's physician indicated the SSPE could have been due to an old measles infection or the the vaccine. At the time of this report, the pt was on experimental medication and was unable to walk, talk and feed herself. Additional information has been requested. A 15-day follow up report received 10/10/2002 adds: Follow-up received on 08/02/2002 reported that the brain biopsy tissue evaluated for measles virus. RTPCR and subsequent sequencing of the amplified region indicated that the child was infected with wild type measles virus. It was noted that this represents a case of wild type measles infection after primary vaccine failure. It was reported on 08/02/2002 that the pt expired "a few months ago". Additional info has been requested.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Mental disorder due to a general medical condition, Somnolence
Clinical narrative: Information has been received from a newspaper reporter concerning an 11 year old female who in approx. 1991, at the age of 1, was vaccinated with a 1st dose of MMRII and in approx. 1995, at the age of 5, was vaccinated with a 2nd dose of MMRII. It was reported that in approx. 6/01, the pt started having trouble in school. Prior to that she was a good student. She developed some seizures in 6/01. She was dx'd with epilepsy and placed on therapy. The pt did well for several months. In approx. 9/01, she started getting sleepy, her speech became slurred and she did not respond very well. She was hospitalized for approx. 1 week with no dx being made. She was then transferred to another hospital where she had a 1 month hospitalization. Her work-up included a brain biopsy from which a dx of subacute sclerosing panencephalitis (SSPE) was made. It was reported that the pt's physician indicated the SSPE could have been due to an old measles infection or the the vaccine. At the time of this report, the pt was on experimental medication and was unable to walk, talk and feed herself. Additional information has been requested. A 15-day follow up report received 10/10/2002 adds: Follow-up received on 08/02/2002 reported that the brain biopsy tissue evaluated for measles virus. RTPCR and subsequent sequencing of the amplified region indicated that the child was infected with wild type measles virus. It was noted that this represents a case of wild type measles infection after primary vaccine failure. It was reported on 08/02/2002 that the pt expired "a few months ago". Additional info has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a  12 month old Caucasian female patient who was was vaccinated with the MMRII in the right leg and the first dose of Varivax in the left leg concomitantly. On10/31/01, the patient developed a rash all over and fever of 99.2 to 102 degrees F. The nurse reported that the outcome was unknown. No further information is available.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a PA concerning an approx. 17 or 18 year old female who was vaccinated with "at least 2 doses" of MMRII "in the past". On 11/9/1, it was reported that "a recent titer does not show sero-conversion". The pt sought unspecified medical attention. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from an RN concerning a 17 month old white female who on 10/29/01 was vaccinated with a 1st dose of MMRII, IM, in the left thigh (lot 636393/0016L). On 11/9/01, the pt developed lymph node enlargement in the groin area. The pt had 2 enlarged lymph nodes in the left groin. One of the lymph nodes was 1 to 1 1/2cm in diameter and the other was about 8mm in diameter. There was a single enlarged node in the right groin about 1cm. The pt sought unspecified medical attention. Subsequently, the pt recovered. The date of recovery was reported to be unknown. No additional information is expected.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 43 year old female pt who on 11/1/01 was vaccinated with a dose of MMRII (lot 640234/1091L). On 11/12/01, the pt developed a fever, subsequently visited another physician and azithromycin (Zithromax) was prescribed. On approx. 11/13/01, the pt developed a non-pruritic rash. Follow-up information from a physician indicated that the pt developed a rash 10 days after the vaccination. The physician stated that "I told her to follow-up with me if it did not resolve. It did." No further information was available.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received on 11/15/01 from a physician concerning a 33 year old Hispanic female who "since 1995" was vaccinated with a 1st, 2nd and 3rd dose of MMRII. The pt received the 1st 2 doses from her physician "around 1995". A measles titer was done in 12/98 and was found to be negative. It was reported that another immunization was given on 2/1/99. A titer was drawn in 8/99 which again revealed lack of sero-conversion. It was noted that the pt did sero-convert on mumps and rubella. The pt sought unspecified medical attention. It was reported that the reporting physician opted not to give the pt a 4th dose. No further information is expected.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a health professional concerning a 38 year old female who on 9/28/01 was vaccinated with 1 dose of MMRII (lot 633815/0893L). Concomitant therapy included hormonal contraceptives (unspecified). The pt has not had a menstrual period since. The pt's last menstrual period date was 9/3/01. The pt had urine pregnancy tests on 10/8/01 and 11/27/01 which were negative. The pt sought medical attention. Follow-up information from the health professional noted that the pt was not willing to sign a consent form to release information. No further information is available.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 16 month old male who on 7/29/98 was vaccinated with MMRII (lot 627427/0792H). Concomitant therapy (date unspecified) included the 1st dose of HIB (ActHib), IM in the left thigh (lot 0919800), the 3rd dose of oral poliovirus vaccine (Orimune) (lot 0786M4) and the 1st dose of DPT (Tripedia), IM in the left thigh (lot 0920770). On 8/7/98, the pt developed a maculo-papular rash. On 08/10/98, the pt was seen by his physician and some loose stool was noted. The physician indicated that the pt had an otherwise normal exam, was asymptomatic and that the rash could have been viral. No lab or diagnostic testing was done and the pt subsequently recovered. Additional information is not expected.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash papular
Clinical narrative: Information has been received on 11/28/01 from a RPh concerning a 24 year old male with no past medical history and no known allergies who "approx. 2 weeks ago" was vaccinated with a dose of MMRII. On 11/28/01, it was reported that "a few days ago" the pt "broke out" in generalized rash, papular-vesicular, all over the body and had a fever. The pt sought unspecified medical attention. There was no other information provided. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Laboratory test abnormal, Lymphadenopathy, Pyrexia, Viral infection
Clinical narrative: Information has been received from an RN concerning an approx. 40 year old male health center employee who was vaccinated with MMRII as a child. Recently, the pt had a negative rubella titer (WAES0112USA02042) and on 11/16/01, received a dose of MMRII. Six days later, on 11/22/01, the pt developed lymphadenopathy at the neck and behind the ears. No rash was noted and the pt was afebrile. The dx from a family physician was mild rubella. The pt was scheduled to see "ENT" during the week of 12/3/01. On 11/28/01, the pt developed a fever and arthritic symptoms, which persisted. Unspecified medical attention was sought. Follow-up information received from the RN indicated that her office did not administer the pt's vaccine or evaluate the pt after the event. No further information is available.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Dyspnoea, Hypersensitivity, Sneezing, Swelling face
Clinical narrative: Information has been received from a health care professional concerning a 36 month old male with a history of asthma and an allergy to gelatin who on 9/26/01 was vaccinated with the 2nd dose of MMRII (lot 637837/0373L) which is contraindicated in pt's with an allergy to gelatin. There was no concomitant medication. It was reported that approx. 20 minutes after vaccination, the child developed wheezing, shortness of breath, facial swelling and hives and was dx'd with having an allergic reaction. The child was treated by his father who is a physician (treatment not specified). The child also complained that his throat felt funny and he experienced coughing and sneezing. At the time of this report, the outcome of the events was unknown. It was also reported that the child did not experience any problems following vaccination on 9/23/99 with the 1st dose of MMRII. Upon internal review, the allergic reaction was determined to be an "Other Medical Event". Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Throat tightness, Urticaria, Wheezing
Clinical narrative: Information has been received from a health care professional concerning a 36 month old male with a history of asthma and an allergy to gelatin who on 9/26/01 was vaccinated with the 2nd dose of MMRII (lot 637837/0373L) which is contraindicated in pt's with an allergy to gelatin. There was no concomitant medication. It was reported that approx. 20 minutes after vaccination, the child developed wheezing, shortness of breath, facial swelling and hives and was dx'd with having an allergic reaction. The child was treated by his father who is a physician (treatment not specified). The child also complained that his throat felt funny and he experienced coughing and sneezing. At the time of this report, the outcome of the events was unknown. It was also reported that the child did not experience any problems following vaccination on 9/23/99 with the 1st dose of MMRII. Upon internal review, the allergic reaction was determined to be an "Other Medical Event". Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Information has been received from an RN concerning a 4 year old male who was vaccinated on 9/15/98 with a dose of MMRII (628003/1172H). Subsequently, 1 week later, the pt developed a fever of 105F. No medical attention was sought. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a 32 year old female RN with a negative titer for rubella and subsequently experienced a lack of response. The nurse reported that she was unsure if she was vaccinated as a child and was also unsure if she was again vaccinated while in National Guard. In approx. 9/01, the pt was vaccinated with a dose of MMRII. The pt had a repeat titer drawn "at 90 days". The pt's titer was now borderline for the rubella titer. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus
Clinical narrative: Information has been received from a physician concerning a 28 year old male who on 11/28/01 (also reported as 11/23/01) was vaccinated with a dose of MMRII. There was no illness at the time of vaccination. On 11/28/01, later that night, the pt experienced generalized, persistent itching which was worse at night. At the time of this report, the pt had not recovered from itching. Follow-up information indicated that the pt's persistent pruritus lasted for 21 days and the pt subsequently recovered. It was reported that the pt's history was unknown, however the pt denied one. A CBC and SMA were done with normal results. No further information is available.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from an NP concerning a 15 month old white female who on 12/3/01 was vaccinated SC, in the right with the 1st dose of MMRII (lot 640962/1095L). The child had no noted adverse events following prior vaccinations. Concomitant therapy included azithromycin (Zithromax) for the treatment of an ear infection since 11/13/01. On 12/8/01, the child developed a severe "measles rash". The was described as being macular/papular and very red. It was also reported that some of the rash was raised and there was some "halos". In follow-up, the NP reported that the child had a left otitis media at the time of vaccination with no fever, which had been improving on therapy with amoxicillin trihydrate (+) clavulanate potassium (Augmentin). The child was seen on 12/12/01 for the rash and left otitis media and at that time had no fever. At the time of this report, the outcome of the rash was unknown. No further information is expected. The NP also reported that a 12 month old child developed a morbilliform rash, otitis media and a fever following vaccination with MMRII (lot 639514/0601L) (see WAES 0112USA02178).
Age: 1.4
Sex: F
Vaccine: MMR
Symptoms: Insomnia, Irritability, Otitis media, Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from a consumer concerning her 17 month old daughter with no past medical history, a dairy allergy and an antibiotic allergy who on 3/19/01 was vaccinated with MMRII (lot 00150-invalid lot). Concomitant therapy included hyoscyamine (Levsin). In approx. 3/01, the pt developed a fever of 105F, a rash, an ear infection, irritability and insomnia. It was noted that the rash looked like measles and rubella. She went on antibiotics and the effects disappeared within 2 weeks. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 15 month old female who on 12/7/01 was vaccinated with MMRII (lot 639916/0903L). The LVN reported that in approx. 12/01, the pt subsequently experienced a rash "all over". Unspecified medical attention was sought. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Lymphadenopathy, Mouth ulceration, Pruritus, Rash papular
Clinical narrative: Information has been received from 2 physicians concerning a 5 year old white male with no known allergies and no prior medical history who on 11/30/01 was vaccinated with the 2nd dose of MMRII (lot 640634/1093L). There was no concomitant medication. On 12/18/01, the pt developed a pruritic rash on his face and trunk and a papular, erythematous rash on his arms, palms and soles bilaterally. He did not have a fever. The physician also reported that the pt developed a "target lesion" on a foot and lesions on his posterior pharynx and buccal areas. On 12/19/01, the pt presented to the physician's office with a pruritic and papular rash on his face and trunk; red areas on his buccal mucosa and pharynx and his post/anterior nodes behind his ears were enlarged. The pt was treated with Benadryl, 2 teaspoons 3 X daily for 8 days. Subsequently, in 12/01, the pt recovered from the papular erythematous and pruritic rash, pharyngeal and buccal lesions and target lesion on the foot. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Skin ulcer
Clinical narrative: Information has been received from 2 physicians concerning a 5 year old white male with no known allergies and no prior medical history who on 11/30/01 was vaccinated with the 2nd dose of MMRII (lot 640634/1093L). There was no concomitant medication. On 12/18/01, the pt developed a pruritic rash on his face and trunk and a papular, erythematous rash on his arms, palms and soles bilaterally. He did not have a fever. The physician also reported that the pt developed a "target lesion" on a foot and lesions on his posterior pharynx and buccal areas. On 12/19/01, the pt presented to the physician's office with a pruritic and papular rash on his face and trunk; red areas on his buccal mucosa and pharynx and his post/anterior nodes behind his ears were enlarged. The pt was treated with Benadryl, 2 teaspoons 3 X daily for 8 days. Subsequently, in 12/01, the pt recovered from the papular erythematous and pruritic rash, pharyngeal and buccal lesions and target lesion on the foot. Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash on arms, back and trunk.  Took benadryl but did not help.  Went to ER and received an oinment
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Report 2001026324-1 described a 3 month old male who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) and subsequently died. This report was received from a manufacturer, who received it from the FDA. This report has been forwarded to an an institute. Medical history, concurrent conditions, and concurrent medications were not specified. On 9/6/01, the infant received his second injection of Infanrix. On that date, he also received his second injections of 7-valent pneumococcal conjugate vaccine (Prevnar), combination Haemophilus influenzae type b conjugate/hepatitis B vaccine (Comvax), and inactivated poliomyelitis virus vaccine (IPOL). On an unspecified date, the infant developed an unevaluable reaction. The infant died as a results of the adverse event.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Coma
Clinical narrative: Report 2001028496 describes a 3 month old female who died following receipt of Infanrix. Medical history was not specified. At the time of immunization, the infant had otitis media, which was being treated with amoxicillin, pseudoephedrine and paracetamol. On 05/14/01, the infant received her second injection of Infanrix. On that date, she also received her second injections of Prevnar, Hib-Titer, and IPOL. On 05/18/01, four days post vaccination, the infant was found unresponsive and blue. Attempts at cardiopulmonary resuscitation were unsuccessful, and the infant died.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Diarrhoea, Fatigue, Mouth haemorrhage, Pyrexia
Clinical narrative: Report 2001028498 describes a 4 month old male who died following receipt of an injection of Infanrix. Medical history included premature birth (six weeks premature), hypospadias, an asymmetric head, and gastroesophageal reflux disease. Concurrent conditions were not specified. There were no concurrent medications. On 10/15/01, the infant received his third injection of Infanrix. On that date, he also received his second injection of hepatitis B vaccine (Recombivax-HB) and his third injection of Prevnar and Act-HIb. On 10/16/01, one day post-immunization, he developed a fever, was more tired than usual, and experienced three or four episodes of diarrhea. In the evening of 10/16/01, his father found him with blood from his mouth (considered medically serious). He was not breathing. The infant died; cause of death was not reported.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: Report 2001028498 describes a 4 month old male who died following receipt of an injection of Infanrix. Medical history included premature birth (six weeks premature), hypospadias, an asymmetric head, and gastroesophageal reflux disease. Concurrent conditions were not specified. There were no concurrent medications. On 10/15/01, the infant received his third injection of Infanrix. On that date, he also received his second injection of hepatitis B vaccine (Recombivax-HB) and his third injection of Prevnar and Act-HIb. On 10/16/01, one day post-immunization, he developed a fever, was more tired than usual, and experienced three or four episodes of diarrhea. In the evening of 10/16/01, his father found him with blood from his mouth (considered medically serious). He was not breathing. The infant died; cause of death was not reported.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Report 2002001711-1 describes a 2 month old female who died following receipt of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). This report was received from manufacturer who received it from the FDA. This report has also been forwarded to an institute. Medical history included premature birth at 31 weeks gestational age. Concurrent conditions were not specified. There were no concurrent medications. On 11/30/01, the infant received her first injection of Infanrix. On that date, she also received her first injections of 7-valent pneumococcal influenzae type B conjugate/hepatitis B vaccine (Comvax), and inactivated poliomyelitis virus vaccine (IPOL). On 12/3/01, three days post immunization, the infant was found dead in her crib.  Emergency personnel were summoned; attempts at resuscitation were unsuccessful. An autopsy was performed; results were not available at the time the report was submitted.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea
Clinical narrative: Report 2002001697 describes a 2 month old male who died following receipt of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). This report was received from manufacturer who received it from an agency. This report has also been forwarded to an institute. Medical history, concurrent conditions, and concurrent medications were not specified. On 6/13/01, the infant received his first injection of Infanrix. On that date, he also received his first injections of 7-valent pneumococcal conjugate vaccine (Prevnar), combination Haemophilus influenzae type B conjugate/heaptitis B vaccine (Comvax), and inactivated poliomyelitis virus vaccine (IPOL). Approximately 1 hour after being put to bed that evening, he was found not breathing. He died.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Coma
Clinical narrative: Report 2002001662 describes a 3 month old male who died following receipt of Infanrix. Medical history included an upper respiratory tract infection and conjunctivitis. Approximately two or three weeks prior to immunization, the infant was taken to an emergency facility, where the diagnoses of upper respiratory tract infection and conjunctivitis were made. The infant was treated with an unspecified antibiotic; antibiotic therapy ended one week prior to immunization. There were reportedly no other pre-existing illnesses and no concurrent medications. On 11/27/01, the infant received his first injection of Infanrix. On that date, he also received his first injections of Prevnar, Act-Hib, and IPOL. He also recieved his second injection of hepatitis B vaccine.  At approximately 10:00 in the morning of 12/12/01, 15 days post-immunization, the infant was fed a bottle of infant formula. He was found unresponsive and was taken to the local hospital, where he was pronounced dead on arrival at 11:41. An autopsy was performed; results were not available at the time of the report was submitted.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Anorexia, Coma, Hypertonia, Rhinitis, Somnolence
Clinical narrative: Report 2002001685 describes a 2 month old male who died following receipt of Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. Family history was significant for vomiting in other family members two or three days prior to the infant's death. On 11/28/01, the infant received his first injection of Infanrix. On that date, he also received his first injections of Prevnar, Act-Hib, and IPOL. On 11/28/01, he also received his second injection of hepatitis B vaccine. An unspecified time post-immunization, the infant developed anorexia, hypertonia, rhinitis, somnolence and stupor. Treatment and outcomes of these events were not provided. At 20:15 on 12/12/01, the infant was put to sleep in his crib, on his abdomen. He was found unresponsive at 21:15. He was taken to the local hospital, where he was pronounced dead on arrival at 00:20 on 12/13/2001. An autopsy was performed; results were not available at the time the report was submitted.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Stupor
Clinical narrative: Report 2002001685 describes a 2 month old male who died following receipt of Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. Family history was significant for vomiting in other family members two or three days prior to the infant's death. On 11/28/01, the infant received his first injection of Infanrix. On that date, he also received his first injections of Prevnar, Act-Hib, and IPOL. On 11/28/01, he also received his second injection of hepatitis B vaccine. An unspecified time post-immunization, the infant developed anorexia, hypertonia, rhinitis, somnolence and stupor. Treatment and outcomes of these events were not provided. At 20:15 on 12/12/01, the infant was put to sleep in his crib, on his abdomen. He was found unresponsive at 21:15. He was taken to the local hospital, where he was pronounced dead on arrival at 00:20 on 12/13/2001. An autopsy was performed; results were not available at the time the report was submitted.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Abnormal sleep-related event, Feeding disorder neonatal, Feeling cold, Lung disorder, Nervous system disorder
Clinical narrative: Report A0361877A describes the death of a 2 month old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). This report was received from manufacturer, who received it from the FDA. This report has also been forwarded to an institute. Medical history included prematurity, apnea, and bradycardia.Concurrent conditions were not specified. Concurrent medications included ferrous sulfate, multivitamin solution, and palivizumab. On 12/26/01, the infant received her first dose of Infanrix. On that date, she also received her first injections of 7 valent pneumococcal conjugate vaccine, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. At midnight on 12/27/01, the infant fed poorly. The infant's mother subsequently took the infant into bed with her. Upon awakening, the mother noticed that the infant was cold. The infant was taken to an emergency room via ambulance. Resuscitation was attempted; however, the infant was pronounced dead on arrival at the emergency room.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Premature baby
Clinical narrative: Report A0361877A describes the death of a 2 month old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). This report was received from manufacturer, who received it from the FDA. This report has also been forwarded to an institute. Medical history included prematurity, apnea, and bradycardia.Concurrent conditions were not specified. Concurrent medications included ferrous sulfate, multivitamin solution, and palivizumab. On 12/26/01, the infant received her first dose of Infanrix. On that date, she also received her first injections of 7 valent pneumococcal conjugate vaccine, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. At midnight on 12/27/01, the infant fed poorly. The infant's mother subsequently took the infant into bed with her. Upon awakening, the mother noticed that the infant was cold. The infant was taken to an emergency room via ambulance. Resuscitation was attempted; however, the infant was pronounced dead on arrival at the emergency room.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Feeling cold
Clinical narrative: Report A0361877A describes the death of a 2 month old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). This report was received from manufacturer, who received it from the FDA. This report has also been forwarded to an institute. Medical history included prematurity, apnea, and bradycardia.Concurrent conditions were not specified. Concurrent medications included ferrous sulfate, multivitamin solution, and palivizumab. On 12/26/01, the infant received her first dose of Infanrix. On that date, she also received her first injections of 7 valent pneumococcal conjugate vaccine, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. At midnight on 12/27/01, the infant fed poorly. The infant's mother subsequently took the infant into bed with her. Upon awakening, the mother noticed that the infant was cold. The infant was taken to an emergency room via ambulance. Resuscitation was attempted; however, the infant was pronounced dead on arrival at the emergency room.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Report A0363108A describes sudden infant death syndrome in a 3 month old male who received Infanrix. Medical history and concurrent conditions were not specified. There were no concurrent medications. On 11/28/2001, the infant received his first injection of Infanrix. On that date, he also received injections of Prevnar, IPOL and Comvax. At 8:38 on 12/17/01, 19 days post-immunization, the infant died of sudden infant death syndrome. The reporter noted that the infant experienced no other adverse events post-immunization. An autopsy was performed; results were not available at the time this report was submitted.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Respiratory arrest
Clinical narrative: The pt was dx'd with cystic encephalomalacia associated with seizures and global developmental delay. The child's MD stated that the child would most likely live only 3 to 4 months due to this severe dx. On 1/16/2002, 5 days post vax, the infant was found in his crib not breathing. His mother called an ambulance; attempts to resuscitate him were unsuccessful.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Encephalopathy
Clinical narrative: The pt was dx'd with cystic encephalomalacia associated with seizures and global developmental delay. The child's MD stated that the child would most likely live only 3 to 4 months due to this severe dx. On 1/16/2002, 5 days post vax, the infant was found in his crib not breathing. His mother called an ambulance; attempts to resuscitate him were unsuccessful.
Age: 0.25
Sex: M
Vaccine: MMR, MMR
Symptoms: Rash
Clinical narrative: Information has been received from a relative of a 15 week old male with no past medical history and no known allergies who on01/23/01 was vaccinated with the first dose of MMR II. There was no concomitant medication. On the next day, 01/24/01, the pt broke out with a rash around the groin which then moved up to his neck and legs. The pt sought unspecified medical attention. Additional info has been requested.
Age: 1.2
Sex: F
Vaccine: IPV, MMR, MMR
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Information has been received from a health professional concerning a 14 month old female with no known drug allergies who on 1/14/02 was vaccinated with a dose of MMRII (lot 637837/0373L). There was no concomitant medication. On 1/21/02, the pt developed a fever of 104F (ax). On 1/22/02, the pt developed a widely dispersed pink, non-raised rash and swollen glands in her neck and axillary area. Unspecified medical attention was sought. Additional info has been requested.  Reported on 06/04/2003: "Information has been received from a registered nurse concerning a 14 month old white female (birth weight 6lb 2oz) with two siblings, no known drug allergies and a history of asthma who on 01/14/2002, at 14:30, was vaccinated with her first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 637837/0373L), subcutaneously, in the left leg.  There was no concomitant medication.  The patient had no illness at the time of the vaccination.  On 01/21/2002, at 04:00, the patient developed a fever of 104 F axillary.  On 01/22/2002 the patient developed a sparse, non-itchy, widely dispersed pink/red non-raised rash.  The rash first appeared on the stomach and back then progressed to the arms and legs, and then to the hairline.  On 01/22/2002, the patient also developed swollen glands in her neck and axillary area and was fussy and fatigued. On 01/24/2002, lab results reported: rubeola IgG <10 (10-640), rubeola IgM <10 (<10), rubella IgG 5.6 IU/ml (>9.9 IU/ml=immunity) and rubella IgM negative (negative).  The registered nurse reported that on 01/26/2002, the patient had 15-20 spots still present.  The registered nurse reported that on 01/28/2002, the patient recovered.  Unspecified medical attention was sought.  No additional information is expected.