chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Abscess bacterial, Fasciitis, Herpes zoster, Infection, Necrosis
Clinical narrative: Information has been received from a health professional concerning an approx. 8 year old female who was vaccinated with varicella virus vaccine live on an unknown date. She presented to her doctor's office with a severe looking rash on the inside of her thigh (side unknown) that was thought to be herpes zoster. When the child was examined, chickenpox lesions were found on the upper chest. It was noted that samples were taken to be sent to the CDC. It was noted that there was swelling at the site. The physician felt there was an infection and the child was admitted to the hospital. She was found to have "necrosis from a muscle abscess in her thigh". A drain was put into the leg to help drain pus that resulted from the necrotizing fasciitis. It was noted that the muscle abscess was thought to be a "reaction to the herpes zoster rash". Follow-up information has been received from a physician and a health professional who states this child was previously healthy with no known immunosuppression or on any medication within at least 30 days prior to these events. The pt's mother reported that vesicular lesions began on 5/8/01 on the child's thorax, legs and arms. On 5/13/01, the dermatomal lesions began to develop on the child's left leg. When the child was seen at the physician's office on 5/14/01, the lesions had scabbed over, but the child had a fever of 104F and complained of pain on the left groin. The child had a classic dermatomal zoster band approx. 4 X 6 along the L1-L2 dermatome. There was edema at the site. It was reported that the child "may have developed herpes zoster on the thigh after a possible case of mild breakthrough chickenpox rash". The child was treated with acyclovir. It was noted that during the week of 5/14/01, the child had received a kick to the groin. The child had begun to recover from the herpes zoster, but on 5/18/01, she developed a fever and pain. She was admitted to the hospital on 5/20/01. At the time of admission there was no zoster rash noted on the child's thigh. When the child continued to complain of pain, a groin CT scan was done which revealed a large abscess (14 X 13). The abscess required surgical intervention with an incision, drainage and placement of a Penrose drain. A culture from the drainage showed staphylococcus aureus and the pt was treated with IV oxacillin (manufacturer unknown). The child was discharged from the hospital on 5/24/01. It was suggested that the pt have repeat blood work done in 6 weeks. Recovery status was not reported. Additional information is expected. The follow-up states that it was noted that the rash healed in less than 4 weeks and that the child missed 14 days of school. Additional info is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a health professional concerning an approx. 8 year old female who was vaccinated with varicella virus vaccine live on an unknown date. She presented to her doctor's office with a severe looking rash on the inside of her thigh (side unknown) that was thought to be herpes zoster. When the child was examined, chickenpox lesions were found on the upper chest. It was noted that samples were taken to be sent to the CDC. It was noted that there was swelling at the site. The physician felt there was an infection and the child was admitted to the hospital. She was found to have "necrosis from a muscle abscess in her thigh". A drain was put into the leg to help drain pus that resulted from the necrotizing fasciitis. It was noted that the muscle abscess was thought to be a "reaction to the herpes zoster rash". Follow-up information has been received from a physician and a health professional who states this child was previously healthy with no known immunosuppression or on any medication within at least 30 days prior to these events. The pt's mother reported that vesicular lesions began on 5/8/01 on the child's thorax, legs and arms. On 5/13/01, the dermatomal lesions began to develop on the child's left leg. When the child was seen at the physician's office on 5/14/01, the lesions had scabbed over, but the child had a fever of 104F and complained of pain on the left groin. The child had a classic dermatomal zoster band approx. 4 X 6 along the L1-L2 dermatome. There was edema at the site. It was reported that the child "may have developed herpes zoster on the thigh after a possible case of mild breakthrough chickenpox rash". The child was treated with acyclovir. It was noted that during the week of 5/14/01, the child had received a kick to the groin. The child had begun to recover from the herpes zoster, but on 5/18/01, she developed a fever and pain. She was admitted to the hospital on 5/20/01. At the time of admission there was no zoster rash noted on the child's thigh. When the child continued to complain of pain, a groin CT scan was done which revealed a large abscess (14 X 13). The abscess required surgical intervention with an incision, drainage and placement of a Penrose drain. A culture from the drainage showed staphylococcus aureus and the pt was treated with IV oxacillin (manufacturer unknown). The child was discharged from the hospital on 5/24/01. It was suggested that the pt have repeat blood work done in 6 weeks. Recovery status was not reported. Additional information is expected. The follow-up states that it was noted that the rash healed in less than 4 weeks and that the child missed 14 days of school. Additional info is expected.
Sex: F
Vaccine: HEP
Symptoms: Erythema multiforme, Laboratory test abnormal, Sepsis
Clinical narrative: The pt was presented to the ER on 6/11/01. The pt developed erythema multiforme and to be tested to rule out sepsis. The pt was transferred to the hospital.  diagnosed with parainfluenzae
Age: 3.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site swelling
Clinical narrative: Swollen left arm. Sent to OHSU per taxi. Soft ice pack wrapped and applied to arm. Given 2 tsp Benadryl 12.5/5 given now (14:35).
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Hypotonia, Oral intake reduced, Pyrexia, Somnolence
Clinical narrative: 2 hours, post vax, child had decreased activity, would not eat, ran a fever and appeared limp for 2-3 hours.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Hypotonia, Lethargy, Listless, Pyrexia
Clinical narrative: Pt had fever of 101F-102F, listless, lethargic, moaning and hypotonia.
Age: 1.3
Sex: F
Vaccine: HEP, PNC
Symptoms: Cough, Ear disorder, Infection, Rhinorrhoea, Sleep disorder
Clinical narrative: 48 hours, post vax, daughter had a runny nose. By 96 hours, post vax, she had unproductive, persistent cough that disturbed sleep. One week, post vax, she was dx'd with ear infections.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Dyspnoea, Hypotonia, Pallor, Syncope
Clinical narrative: Syncopal episode, paleness and limp. Recovered completely within minutes. O2 was given by nasal cannula for 5-10 minutes. Observed pt for 30 minutes after symptoms.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Parent reports temperature of 107F, post vax. Denies other neurological symptoms. Seen today for exam. Temperature 99.4F. Vaccines not given at this site.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis
Clinical narrative: Knee pain in both knees approx. 3 months after last shot of series. Pain is an arthritis-like feeling in knees. (Series of 3 shots) 2nd on 5/19/99 and 3rd on 5/16/00.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Bacterial infection, Pyrexia, Rash maculo-papular, Vomiting
Clinical narrative: Pt began vomiting with a temperature of 100.7F. Pallor, appeared to have abdominal pain and rash developed on 6/15/01 PM; fine, maculo-papular diffuse rash. Pt saw another doctor concerning her abdomen and was treated with Ceftriaxone for possible bacteremia.
Age: 7.4
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Rash papular
Clinical narrative: Pt developed a vesicular papular rash in various stages of evolution, typical of varicella, plus pruritus. No fever and no known infection exposures. This vaccination was given in 1998.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Rash erythematous
Clinical narrative: Pt c/o rash & raised erythema on L triceps that continued to spread all over body (large erythematous plaquer) No SOB, No respiratory problems.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Local reaction to immunization DTaP - ? cellulitis R leg 6x8cm 2+ red, warm, indurated. Treatment: Augmentin 400mg/5ml 3cc po bid x 10 days and benadryl 1 tsp q6hrs prn.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The pt experienced pain, swelling at the injection site and warmth to the touch.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Approx. 1 1/2 hours ago from shot (Hep-B) in left deltoid, cleaned with alcohol. Pt developed diffuse pruritic urticarial rash over trunk and extremities. No cough, shortness of breath or edema. Prescribed Benadryl by mouth every 6 hours. Will submit Hep-B antibodies in the future.
Age: 1.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: On 6/1/01, temperature of 103.2F. Tylenol given and it went down to 100F. The next day, it was 102.2F and decreased to 99F with Tylenol. The next day, up again to 102.2F. Per mom, today is down to 99F-97F. "Torso was covered with rash and small red bumps."
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Respiratory disorder
Clinical narrative: Local left deltoid edema, erythema and had systemic affect, 2 days, post vax, of larynx.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash papular
Clinical narrative: New onset complaint of itching. Reported approx. 1 to 2 hours, post initial Hep-B vaccine, with scattered erythematous papules. Was treated with antihistamine. Further vaccine discontinued. Follow-up with primary doctor.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Large, red, hot and tender site to upper left thigh measuring 3.8cm X 7.6cm at 24 hours. Area appeared "hivish" with irregular border, raised. Follow-up call on 6/15/01, beginning to resolve with cold compresses.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: The 6th day, post vax, pt developed fever; 7th day, post vax, rash on face and then trunk; 10th day, post vax, rash on extremities. Saw doctor on 6/15/01. No treatment except Benadryl. Rash started clearing up on 6/17/01.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Rash vesicular
Clinical narrative: Red vesicles on left thigh.
Age: 1.08
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Left thigh with swelling, redness, 3" X 3" reddened, raised area and fever (unknown how high).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left leg with erythema 9cm X 14cm around injection sites of DTAP and IPV, puffy and warm to touch.
Age: 1.3
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt got varicella vaccine on 12/20/00 and today on 6/08/01, presents with lesions of varicella on face and chest. Sent pt to lab to draw varicella IgM titers. Informed on the phone that there was a questionable failure of vaccine.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Friday night left deltoid was red, swollen the size of a golf ball and warm to the touch. Next day was swollen down to the upper arm. Saw doctor was put on Keflex.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Hypersensitivity, Pyrexia, Rash, Viral infection
Clinical narrative: On 6/13/01, severe headache then a high fever with chills and rash from head to toe. Seen by MD and dx'd with viral infection vs allergic reaction.
Age: 1.25
Sex: F
Vaccine: MEA
Symptoms: Rash papular
Clinical narrative: Rash on face, chest, back and arms. Small vesicles and fine papules.
Age: 4.0
Sex: M
Vaccine: DT
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Deltoid of left arm very red with edema over whole upper arm.
Age: 2.8
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: It was reported that a 2 year old male pt received a TriHibit (a combination of Act-Hib and Tripedia) vaccination on 8/15/00 at 16:30. Reportedly, the day after, the pt his mother called the physician's office and stated that the pt had a reaction. The pt was seen by the physician and the pt's right thigh was red and swollen. Treatment of Elocon and Histex was prescribed. Reportedly, the pt recovered from this experience.
Age: 12.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Arthralgia, Hyperhidrosis, Joint effusion, Leukocytosis, Pyrexia
Clinical narrative: On 4/20/01, pt complained of flu-like symptoms, increased fever to 103F, body aches (full body) and headache. Needed to miss school. On 4/21/01, pt was taken to doctor and dx'd as "serum sickness" and was told that symptoms would subside and to treat with Aleve and rest. On 4/22/01 to the present time, continues to complain of joint discomfort, especially of the feet, making it difficult to walk or run. "Just doesn't feel right", stated by her dad. Continues to have "flare-ups".
Age: 12.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Arthralgia, Difficulty in walking, Headache, Influenza like illness, Pain
Clinical narrative: On 4/20/01, pt complained of flu-like symptoms, increased fever to 103F, body aches (full body) and headache. Needed to miss school. On 4/21/01, pt was taken to doctor and dx'd as "serum sickness" and was told that symptoms would subside and to treat with Aleve and rest. On 4/22/01 to the present time, continues to complain of joint discomfort, especially of the feet, making it difficult to walk or run. "Just doesn't feel right", stated by her dad. Continues to have "flare-ups".
Age: 12.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pyrexia, Serum sickness
Clinical narrative: On 4/20/01, pt complained of flu-like symptoms, increased fever to 103F, body aches (full body) and headache. Needed to miss school. On 4/21/01, pt was taken to doctor and dx'd as "serum sickness" and was told that symptoms would subside and to treat with Aleve and rest. On 4/22/01 to the present time, continues to complain of joint discomfort, especially of the feet, making it difficult to walk or run. "Just doesn't feel right", stated by her dad. Continues to have "flare-ups".
Age: 0.25
Sex: F
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Dermatitis contact, Rash
Clinical narrative: This report is concerning a 11 week old female with no illness at time of vaccination and who was vaccinated with Hep-B at birth on 3/1/01 and had no adverse reaction who on 5/17/01 at 14:15 was vaccinated IM in the left thigh, with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (lot 637764/1409K). Concomitant therapy include a 1st dose, IM in the left thigh, of streptococcus pneumoniae vaccine (Prevnar) (batch 475384), a dose, IM in the right thigh, of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Infanrix) (batch DTPA994B2) and a dose in the right thigh of poliovirus vaccine (Aventis Pasteur) (batch T0697). On 5/17/01, at 18:30, the pt screamed, went limp and was not arousable. The pt's mother put the pt in their car and drove to a local ER. The pt remained non-arousable for the 10-15 minute car ride, but she opened her eyes when transferred to a table within the ER. The pt was transferred and admitted to another facility where as of 5/18/01, she remained. It was noted that "the pt was eating, drinking and playing at this time". Results of the EEG are pending. This was originally reported by a physician. Follow-up information from a hospital receptionist indicated that the discharge dx was hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available.
Age: 0.25
Sex: F
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Coma, Hypotonia, Screaming, Stupor
Clinical narrative: This report is concerning a 11 week old female with no illness at time of vaccination and who was vaccinated with Hep-B at birth on 3/1/01 and had no adverse reaction who on 5/17/01 at 14:15 was vaccinated IM in the left thigh, with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (lot 637764/1409K). Concomitant therapy include a 1st dose, IM in the left thigh, of streptococcus pneumoniae vaccine (Prevnar) (batch 475384), a dose, IM in the right thigh, of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Infanrix) (batch DTPA994B2) and a dose in the right thigh of poliovirus vaccine (Aventis Pasteur) (batch T0697). On 5/17/01, at 18:30, the pt screamed, went limp and was not arousable. The pt's mother put the pt in their car and drove to a local ER. The pt remained non-arousable for the 10-15 minute car ride, but she opened her eyes when transferred to a table within the ER. The pt was transferred and admitted to another facility where as of 5/18/01, she remained. It was noted that "the pt was eating, drinking and playing at this time". Results of the EEG are pending. This was originally reported by a physician. Follow-up information from a hospital receptionist indicated that the discharge dx was hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available.
Age: 0.25
Sex: F
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Depressed level of consciousness, Hypotonia, Stupor
Clinical narrative: This report is concerning a 11 week old female with no illness at time of vaccination and who was vaccinated with Hep-B at birth on 3/1/01 and had no adverse reaction who on 5/17/01 at 14:15 was vaccinated IM in the left thigh, with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (lot 637764/1409K). Concomitant therapy include a 1st dose, IM in the left thigh, of streptococcus pneumoniae vaccine (Prevnar) (batch 475384), a dose, IM in the right thigh, of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Infanrix) (batch DTPA994B2) and a dose in the right thigh of poliovirus vaccine (Aventis Pasteur) (batch T0697). On 5/17/01, at 18:30, the pt screamed, went limp and was not arousable. The pt's mother put the pt in their car and drove to a local ER. The pt remained non-arousable for the 10-15 minute car ride, but she opened her eyes when transferred to a table within the ER. The pt was transferred and admitted to another facility where as of 5/18/01, she remained. It was noted that "the pt was eating, drinking and playing at this time". Results of the EEG are pending. This was originally reported by a physician. Follow-up information from a hospital receptionist indicated that the discharge dx was hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available.
Age: 0.25
Sex: F
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Coma, Hypotonia
Clinical narrative: This report is concerning a 11 week old female with no illness at time of vaccination and who was vaccinated with Hep-B at birth on 3/1/01 and had no adverse reaction who on 5/17/01 at 14:15 was vaccinated IM in the left thigh, with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (lot 637764/1409K). Concomitant therapy include a 1st dose, IM in the left thigh, of streptococcus pneumoniae vaccine (Prevnar) (batch 475384), a dose, IM in the right thigh, of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Infanrix) (batch DTPA994B2) and a dose in the right thigh of poliovirus vaccine (Aventis Pasteur) (batch T0697). On 5/17/01, at 18:30, the pt screamed, went limp and was not arousable. The pt's mother put the pt in their car and drove to a local ER. The pt remained non-arousable for the 10-15 minute car ride, but she opened her eyes when transferred to a table within the ER. The pt was transferred and admitted to another facility where as of 5/18/01, she remained. It was noted that "the pt was eating, drinking and playing at this time". Results of the EEG are pending. This was originally reported by a physician. Follow-up information from a hospital receptionist indicated that the discharge dx was hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available.
Age: 0.25
Sex: F
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Hypotonia, Hypoventilation, Screaming, Somnolence
Clinical narrative: This report is concerning a 11 week old female with no illness at time of vaccination and who was vaccinated with Hep-B at birth on 3/1/01 and had no adverse reaction who on 5/17/01 at 14:15 was vaccinated IM in the left thigh, with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (lot 637764/1409K). Concomitant therapy include a 1st dose, IM in the left thigh, of streptococcus pneumoniae vaccine (Prevnar) (batch 475384), a dose, IM in the right thigh, of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Infanrix) (batch DTPA994B2) and a dose in the right thigh of poliovirus vaccine (Aventis Pasteur) (batch T0697). On 5/17/01, at 18:30, the pt screamed, went limp and was not arousable. The pt's mother put the pt in their car and drove to a local ER. The pt remained non-arousable for the 10-15 minute car ride, but she opened her eyes when transferred to a table within the ER. The pt was transferred and admitted to another facility where as of 5/18/01, she remained. It was noted that "the pt was eating, drinking and playing at this time". Results of the EEG are pending. This was originally reported by a physician. Follow-up information from a hospital receptionist indicated that the discharge dx was hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available.
Age: 0.25
Sex: F
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Hypotonia, Stupor
Clinical narrative: This report is concerning a 11 week old female with no illness at time of vaccination and who was vaccinated with Hep-B at birth on 3/1/01 and had no adverse reaction who on 5/17/01 at 14:15 was vaccinated IM in the left thigh, with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (lot 637764/1409K). Concomitant therapy include a 1st dose, IM in the left thigh, of streptococcus pneumoniae vaccine (Prevnar) (batch 475384), a dose, IM in the right thigh, of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Infanrix) (batch DTPA994B2) and a dose in the right thigh of poliovirus vaccine (Aventis Pasteur) (batch T0697). On 5/17/01, at 18:30, the pt screamed, went limp and was not arousable. The pt's mother put the pt in their car and drove to a local ER. The pt remained non-arousable for the 10-15 minute car ride, but she opened her eyes when transferred to a table within the ER. The pt was transferred and admitted to another facility where as of 5/18/01, she remained. It was noted that "the pt was eating, drinking and playing at this time". Results of the EEG are pending. This was originally reported by a physician. Follow-up information from a hospital receptionist indicated that the discharge dx was hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available.
Age: 0.25
Sex: F
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Coma
Clinical narrative: This report is concerning a 11 week old female with no illness at time of vaccination and who was vaccinated with Hep-B at birth on 3/1/01 and had no adverse reaction who on 5/17/01 at 14:15 was vaccinated IM in the left thigh, with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (lot 637764/1409K). Concomitant therapy include a 1st dose, IM in the left thigh, of streptococcus pneumoniae vaccine (Prevnar) (batch 475384), a dose, IM in the right thigh, of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Infanrix) (batch DTPA994B2) and a dose in the right thigh of poliovirus vaccine (Aventis Pasteur) (batch T0697). On 5/17/01, at 18:30, the pt screamed, went limp and was not arousable. The pt's mother put the pt in their car and drove to a local ER. The pt remained non-arousable for the 10-15 minute car ride, but she opened her eyes when transferred to a table within the ER. The pt was transferred and admitted to another facility where as of 5/18/01, she remained. It was noted that "the pt was eating, drinking and playing at this time". Results of the EEG are pending. This was originally reported by a physician. Follow-up information from a hospital receptionist indicated that the discharge dx was hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: A grandmother reported that her 4 month old grandson received his first dose of Prevnar on 5/21/01. On 6/3/01 he died of sudden infant death syndrome. He was seen earlier in the day by the physician and "everything was normal".
Age: 0.08
Sex: M
Vaccine: DTP, HEP, HIBV, IPV
Symptoms: Coma, Constipation, Convulsion, Faeces pale, Injection site erythema
Clinical narrative: This report is concerning an approx. 6 week old male who in 7/98, was vaccinated with a dose of Hep-B vaccine recombinant (yeast). Concomitant therapy included a dose of Hib conjugate vaccine, a dose of poliovirus vaccine (IPOL) and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. He reportedly, developed injection site reactions characterized by hard lumps, redness and warmth. He later, experienced a "high fever". His mother notified the physician. The pt became irritable and inconsolable. He experienced high pitch screaming for several hours and arching of his back. The pt became chronically constipated, needing help to pass hard, clay-like lumps which often made him bleed. Shortly following his immunizations, he experienced a series of "vague seizure activity". His entire body would twitch and he would seem unresponsive. The physician was notified. He experienced a few more episodes and recovered. It was reported that the pt's experiences of seizures are considered an "Important Medical Event". This was originally reported by the pt's mother. No further information is available.
Age: 0.08
Sex: M
Vaccine: DTP, HEP, HIBV, IPV
Symptoms: Injection site mass, Injection site warmth, Irritability, Muscle twitching, Opisthotonus
Clinical narrative: This report is concerning an approx. 6 week old male who in 7/98, was vaccinated with a dose of Hep-B vaccine recombinant (yeast). Concomitant therapy included a dose of Hib conjugate vaccine, a dose of poliovirus vaccine (IPOL) and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. He reportedly, developed injection site reactions characterized by hard lumps, redness and warmth. He later, experienced a "high fever". His mother notified the physician. The pt became irritable and inconsolable. He experienced high pitch screaming for several hours and arching of his back. The pt became chronically constipated, needing help to pass hard, clay-like lumps which often made him bleed. Shortly following his immunizations, he experienced a series of "vague seizure activity". His entire body would twitch and he would seem unresponsive. The physician was notified. He experienced a few more episodes and recovered. It was reported that the pt's experiences of seizures are considered an "Important Medical Event". This was originally reported by the pt's mother. No further information is available.
Age: 0.08
Sex: M
Vaccine: DTP, HEP, HIBV, IPV
Symptoms: Pyrexia, Rectal haemorrhage, Screaming
Clinical narrative: This report is concerning an approx. 6 week old male who in 7/98, was vaccinated with a dose of Hep-B vaccine recombinant (yeast). Concomitant therapy included a dose of Hib conjugate vaccine, a dose of poliovirus vaccine (IPOL) and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. He reportedly, developed injection site reactions characterized by hard lumps, redness and warmth. He later, experienced a "high fever". His mother notified the physician. The pt became irritable and inconsolable. He experienced high pitch screaming for several hours and arching of his back. The pt became chronically constipated, needing help to pass hard, clay-like lumps which often made him bleed. Shortly following his immunizations, he experienced a series of "vague seizure activity". His entire body would twitch and he would seem unresponsive. The physician was notified. He experienced a few more episodes and recovered. It was reported that the pt's experiences of seizures are considered an "Important Medical Event". This was originally reported by the pt's mother. No further information is available.
Age: 36.0
Sex: F
Vaccine: LYME
Symptoms: Abasia, Arthralgia
Clinical narrative: Long term pain in hips, joint pain and loss of mobility. (2nd Lymerix given on 9/10/99 and 3rd on 10/10/99).
Age: 53.0
Sex: F
Vaccine: LYME
Symptoms: Muscle atrophy, Muscle contractions involuntary, Muscle spasms, Muscular weakness, Neuropathy peripheral
Clinical narrative: Cramping in 1 finger in 8/99, progressed to cramping, muscle weakness, fasiculations and atrophy of both hands and forearms by 11/99 causing progressive disability. Treatment with Doxycycline and occupational therapy, did no improve. Extensive testing resulted in dx in 7/00 of motor neuropathy with nerve conduction block on auto-immune response. IV immunoglobulin therapy initiated on 11/27/00 with unknown results; may have to be continued indefinitely.
Age: 53.0
Sex: F
Vaccine: LYME
Symptoms: Sjogren's syndrome
Clinical narrative: Cramping in 1 finger in 8/99, progressed to cramping, muscle weakness, fasiculations and atrophy of both hands and forearms by 11/99 causing progressive disability. Treatment with Doxycycline and occupational therapy, did no improve. Extensive testing resulted in dx in 7/00 of motor neuropathy with nerve conduction block on auto-immune response. IV immunoglobulin therapy initiated on 11/27/00 with unknown results; may have to be continued indefinitely.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Infantile spasms, Pyrexia
Clinical narrative: Fever, unresponsive to Tylenol, seizures/infantile spasms.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Anaphylactic reaction, Bradyphrenia, Diarrhoea, Dyspnoea
Clinical narrative: General paralysis, cloudiness of mind, breathing difficulties, bloating, chronic colds, flu, runny nose, phlegm, aches, pains in muscles, excessive diarrhea, nervousness, headaches, fever, anaphylaxis and more, etc.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Electrolyte depletion, Headache, Influenza, Nasopharyngitis, Nervousness
Clinical narrative: General paralysis, cloudiness of mind, breathing difficulties, bloating, chronic colds, flu, runny nose, phlegm, aches, pains in muscles, excessive diarrhea, nervousness, headaches, fever, anaphylaxis and more, etc.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paralysis, Pyrexia, Rhinorrhoea
Clinical narrative: General paralysis, cloudiness of mind, breathing difficulties, bloating, chronic colds, flu, runny nose, phlegm, aches, pains in muscles, excessive diarrhea, nervousness, headaches, fever, anaphylaxis and more, etc.
Age: 1.0
Sex: M
Vaccine: HBHEPB, IPV, MMR, PNC, HBHEPB, IPV, MMR, PNC
Symptoms: Condition aggravated, Face oedema, Hypersensitivity, Oedema peripheral
Clinical narrative: The pt experienced facial swelling hours post vax, the worsening of eczema 24 hours post vax, the swelling of hands, feet 24 hours post vax. Diagnosed with an egg allergy.
Age: 1.0
Sex: M
Vaccine: HBHEPB, IPV, MMR, PNC, HBHEPB, IPV, MMR, PNC
Symptoms: Condition aggravated, Eczema, Hypersensitivity, Oedema peripheral, Swelling face
Clinical narrative: The pt experienced facial swelling hours post vax, the worsening of eczema 24 hours post vax, the swelling of hands, feet 24 hours post vax. Diagnosed with an egg allergy.
Sex: U
Vaccine: HEPA
Symptoms: Vasculitis
Clinical narrative: This report described cutaneous leukocytoplastic vasculitis in a vaccinee of unspecified age and gender who received Hep-A vaccine, inactivated (Havrix). Allergies, medical history and concomitant medications were not specified. On an unspecified date, the pt received the 1st dose of Havrix. Two weeks, post vax, he experienced cutaneous leukocytoplastic vasculitis. This report is considered to be "Medically Serious". As of 6/16/01, the outcome of the event was unknown. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: On 6/13/01 patient noted to have a baseball sized knot at site. It was red in color and she had a fever at the site. Patient also had a fever to the touch. The area was very tender to the touch. On 6/14/01, the site was 3.5" by 3" and much better. The patient was treated with Motrin, ice and Benadryl cream.
Age: 1.08
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient developed a fever the day after vaccines that measured 103. Tylenol was given, and the temperature dropped to 101. Patient was seen by physician for follow-up on 6/21/01.
Age: 0.7
Sex: M
Vaccine: HEP, PNC, HEP, PNC
Symptoms: Cold sweat, Hypertension, Lethargy, Pallor, Vomiting
Clinical narrative: Within 1 hour after vaccine administration, the patient had sudden onset of severe vomiting, pallor and lethargy. The patient was clammy. He was observed in the office and received oral hydration for 5 hours.
Age: 0.7
Sex: M
Vaccine: HEP, PNC, HEP, PNC
Symptoms: Lethargy, Pallor, Vomiting
Clinical narrative: Within 1 hour after vaccine administration, the patient had sudden onset of severe vomiting, pallor and lethargy. The patient was clammy. He was observed in the office and received oral hydration for 5 hours.
Age: 4.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Injection site erythema, Rash erythematous, Rash papular
Clinical narrative: Patient developed redness which started at Prevnar site. She developed erythematous papules on left upper arm, left fingers and face. She was treated with Atarax.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Patient developed a fever and rash. She was seen in the ER and treated with Calamine.
Age: 55.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Patient developed general joint pain after first dose of LYMErix. On 3/8/00, the patient received her second dose of LYMErix. As of 6/20/01, the patient continued to have general joint pain. Additional information has been requested. The follow-up states that the vaccinee had gastroesophageal reflux disease and hypertension. On 02/04/2000, the vaccinee received her first dose of LYMErix. That day after the vaccine had been administered, she began to experinece eneral joint pain. The reporter stated that the adverse event was of moderate intensity. she was treated with ibuprofen. Follow up states that she had no history of gout, psoriasis, Crohn's disease, or Lyme disease. She had no family history of rheumatoid arthritis or lupus. The joint pain persisted. The vaccinee's joint complaints have not been evaluated by a physician. No swollen or warm joints have been noted on physican examination. No joint fluid was obtained. Erythrocyte sedimentation rate, measured on an unspecified date was within normal limits. Antinuclear antibody titer, measured on an unspecified date was negative. The reporter stated that the LYMErix immunization series was to be completed on the recomendation of the centers for disease control and prevention. The vaccinee was to receive her third injection of LYMErix on her next visit. Outcome of the joint pain was not provided. The follow-up states allerigies and concomitant medications were not specified. The vaccinee had gastroesophageal reflux disease and hypertension. On 02/04/2000, the vaccinee received her first dose of LYMErix. That day, after the vaccine had been administered, she began to experience "general joint pain." The reporter stated that the adverse event was of moderate intensity. She was treated with ibuprofen. 07/26/2001, the vaccinee continued to have "general joint pain." Additional info has been requested.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hypokinesia, Influenza like illness, Myalgia, Pain
Clinical narrative: Patient developed pain in his right arm and had difficulty lifting his arm. He felt that he got flu symptoms, including muscular pain and weakness. He took Advil.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed localized swelling and redness in left leg measuring 2" by 2.5".
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Oedema peripheral, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Within 24 hours of receiving vaccine, patient had the onset of a fever of 101-102, sore throat, arm swelling and local erythema.
Age: 2.75
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Patient developed varicella infection starting 4/27/01.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Flushing, Urticaria
Clinical narrative: Hives occurred 1/2 hour, post vax. Pt also had blood drawn with latex gloves right after shots. Sites with satellite hives on arms, hands, legs and red face. None on trunk. Received 12.5 mg, IM Benadryl.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Anorexia, Fatigue, Headache, Lymphadenopathy, Sleep disorder
Clinical narrative: On 6/13/01, mom reported child, in her opinion, had a reaction to varicella. Headache, swollen glands and went to doctor. Also had fatigue, disturbed sleep and loss of appetite. Treatment occurred on Thursday.
Age: 1.25
Sex: F
Vaccine: DT
Symptoms: Balance disorder, Crying, Lethargy, Sleep disorder
Clinical narrative: Uncontrollable crying for 3 months. Disturbed sleep for 5 months. Falling over sideways, like a drunk person and lethargic as though drugged.
Age: 8.0
Sex: F
Vaccine: DTAP, MMR, OPV, VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Pyrexia
Clinical narrative: Broke out in typical varicella rash on 6/9/01. Mild with fewer than 50 lesions, minimal itching and no fever.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: It was reported that a male pt received an Act-Hib and a Tripedia vaccination on 5/18/00. Reportedly, that same day, the pt developed a local reaction of redness and swelling. Further information requested.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Contusion, Erythema multiforme, Injection site mass, Purpura, Urticaria
Clinical narrative: It was reported that a 2 year old male pt received a TriHibit (a combination of Act-Hib and Tripedia) and a MMR (Merck) vaccination on 7/11/00 at 11:00. By that evening, the pt developed a lump the size of a tennis ball on his right lateral thigh with an erythema multiform type rash. The pt also developed hives that progressed to bruising and purpura on his chest, back and thighs. Treatment of Benadryl was given.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, IPV, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Irritability
Clinical narrative: It was reported that a 16 month old female pt received an Act-Hib and Tripedia (combined as TriHibit) vaccination along with an IPOL and a Varivax vaccination on 8/2/00. Reportedly, 4 hours, post vax, the pt became fussy and the injection site was red and warm to the touch. By the next day, the reddened area had increased 1" in diameter (3" X 3" area). Further information requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site reaction
Clinical narrative: It was reported that a female pt received an Act-Hib and an Acel-Imune vaccination on 5/9/00 and again on 7/20/00. Reportedly, after both vaccinations, the pt developed a large local reaction from knee to hip. No specifics were provided. Further information is being requested. From additional correspondence received on 1/31/01, additional pt, vaccine and responsible physician information is expected for this report. Case is closed.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema
Clinical narrative: From initial report received on 1/8/01, it was reported that an 18 month old male was given TriHibit (a combination of Act-Hib and Tripedia) and IPOL vaccines on 1/5/01. Pt reportedly, experienced "within 24 hours" a 5cm X 8cm red area at the injection site radiating to inner thigh. From additional correspondence received on 2/21/01, additional pt, vaccine, vaccine administration and responsible physician information was provided.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: It was reported that a female pt received a TriHibit (combination of Tripedia and Act-Hib), Prevnar and IPOL vaccinations on 1/24/01. Reportedly, that same day, the pt developed a local reaction of redness and swelling. Further information is requested. Insufficient reporter information was provided, several attempts have been made to contact the reporter. As of 3/7/01, no further information has been received for this case. This case is closed.
Age: 0.15
Sex: M
Vaccine: HIBV
Symptoms: Agitation, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Two hours post vax, the pt developed a large swollen, red, hard area at the injection site engaged whole leg, unconsolable crying for seven hours. Resolved in 48 hours. Seen in physicians office. From follow-up #1 correspondence received on 1-MAY-2001, the correct vaccination and adverse event onset dates (10-Nov-2000) as well as additional patient, vaccine and the reporter's phone number where provided.  -TS 23-Apr-2001. This case is closed.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Ecchymosis, Epistaxis, Petechiae, Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: Idiopathic Thrombocytopenic Purpura with symptoms of bruise, petechiae, nose and mouth bleed. Treatment with IV immunoglobulin X 2, so far.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Contusion, Epistaxis, Hypochromic anaemia, Mouth haemorrhage, Petechiae
Clinical narrative: Idiopathic Thrombocytopenic Purpura with symptoms of bruise, petechiae, nose and mouth bleed. Treatment with IV immunoglobulin X 2, so far.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: Idiopathic Thrombocytopenic Purpura with symptoms of bruise, petechiae, nose and mouth bleed. Treatment with IV immunoglobulin X 2, so far.
Age: 3.08
Sex: M
Vaccine: HEPA, PNC, HEPA, PNC
Symptoms: Abasia, Arthropathy, Fluid retention
Clinical narrative: Information has been received from a health professional concerning a healthy 37 month old male child with no known drug allergies and no past medical history who on 5/17/01 was vaccinated in the upper thigh with Hep-A virus vaccine inactivated (lot 635145/0680K). Concomitant vaccines on 5/17/01, included a dose in the other upper thigh of streptococcus pneumoniae vaccine (Prevnar). It was unknown which thigh received which vaccine. There were no other concomitant therapies or concurrent diseases. On 5/25/01, the child was unable to walk and was seen by a physician. The physician did a right hip X-ray that was negative. On 5/25/01, the child was sent to an orthopedic clinic and evaluated by an orthopedic surgeon. The orthopedic surgeon ordered a right hip ultrasound and reported a right hip effusion was related to the vaccinations but the orthopedic surgeon thought the effusion was a result of the vaccine, not necessarily the injection or technique of administration. It was noted that the child was treated and released from the hospital on 5/25/01. During a phone follow-up with the mother of the child, it was reported that the child recovered from his inability to walk. It was unknown if medication was ordered after the procedure. Upon internal review right hip effusion was determined to be an "Other Important Medical Event". Additional information has been requested.
Age: 3.08
Sex: M
Vaccine: HEPA, PNC, HEPA, PNC
Symptoms: Abasia, Joint effusion
Clinical narrative: Information has been received from a health professional concerning a healthy 37 month old male child with no known drug allergies and no past medical history who on 5/17/01 was vaccinated in the upper thigh with Hep-A virus vaccine inactivated (lot 635145/0680K). Concomitant vaccines on 5/17/01, included a dose in the other upper thigh of streptococcus pneumoniae vaccine (Prevnar). It was unknown which thigh received which vaccine. There were no other concomitant therapies or concurrent diseases. On 5/25/01, the child was unable to walk and was seen by a physician. The physician did a right hip X-ray that was negative. On 5/25/01, the child was sent to an orthopedic clinic and evaluated by an orthopedic surgeon. The orthopedic surgeon ordered a right hip ultrasound and reported a right hip effusion was related to the vaccinations but the orthopedic surgeon thought the effusion was a result of the vaccine, not necessarily the injection or technique of administration. It was noted that the child was treated and released from the hospital on 5/25/01. During a phone follow-up with the mother of the child, it was reported that the child recovered from his inability to walk. It was unknown if medication was ordered after the procedure. Upon internal review right hip effusion was determined to be an "Other Important Medical Event". Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Anaemia, Brain oedema, Infection, Pulmonary congestion, Pulmonary oedema
Clinical narrative: Mother did not report any adverse events of anything out of the ordinary. She states that she "went to check on baby, the next morning and found baby dead in her bed". Also, stated baby was active and acted in usual manner, at bedtime, the night before. Autopsy gives cause of death as pulmonary and brain congestion/edema. Death certificate states cause of death as multiple infections (bacterial and viral) in a low resistant anemic baby.