chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: This case is serious since seizures were considered medically important. Follow up information received 26-AUG-2003, provided patient details, concomitant vaccines administered, event onset date and patient outcome (recovered). A nurse reported that a 15 month old male received his 3rd dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 15-APR-2003. On 15-APR-2003, post immunization, the patient developed a high fever and experienced a seizure. The child recovered. The child's mother reported this even on 06-AUG-2003, after the child had received his 4th dose of Prevnar. See related case:HQWYE957107AUG03 (adverse event, expedited).
Sex: M
Vaccine: OPV
Symptoms: Cardiac failure, Cardio-respiratory arrest, Dyspnoea, Lung disorder, Lung neoplasm malignant
Clinical narrative: Information regarding a polio vaccine was received from an attorney regarding a male patient who received a dose of unspecified date sometime in the 1950's. The patient was reportedly exposed to asbestos and asbestos containing products. Indication for the polio vaccine was immunization. Product was administered on an unspecified date sometime in the 1950's. Dose regimen was 1 dose. Concomitant medications were not reported. According to the legal complaint, the patient was diagnosed with mesothelioma on or about March 2002. Reportedly, the patient received a polio vaccination that was contaminated with the SV 40 virus which was a substantial factor in the decedent's contraction of mesothelioma. The legal complaint states that the decedent's exposure to asbestos, asbestos-containing products, and the SV 40 virus caused severe and permanent injury to the decedent, including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. On 6/23/03, the patient died. The cause of death stated in the legal complaint was acute cardio respiratory insufficiency and mesthelioma. No additional information was available at the time of this report.
Sex: M
Vaccine: OPV
Symptoms: Neoplasm malignant, Respiratory disorder, Respiratory failure
Clinical narrative: Information regarding a polio vaccine was received from an attorney regarding a male patient who received a dose of unspecified date sometime in the 1950's. The patient was reportedly exposed to asbestos and asbestos containing products. Indication for the polio vaccine was immunization. Product was administered on an unspecified date sometime in the 1950's. Dose regimen was 1 dose. Concomitant medications were not reported. According to the legal complaint, the patient was diagnosed with mesothelioma on or about March 2002. Reportedly, the patient received a polio vaccination that was contaminated with the SV 40 virus which was a substantial factor in the decedent's contraction of mesothelioma. The legal complaint states that the decedent's exposure to asbestos, asbestos-containing products, and the SV 40 virus caused severe and permanent injury to the decedent, including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. On 6/23/03, the patient died. The cause of death stated in the legal complaint was acute cardio respiratory insufficiency and mesthelioma. No additional information was available at the time of this report.
Age: 21.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Alopecia, Back pain, Blood urine, Epistaxis, Fatigue
Clinical narrative: Information received from subject's mother regarding 21 year old male received 1st dose Anthrax vaccine 6/7/01. Began noticing symptoms beginning around 10/01, including hair loss, nose bleeds at night, fatigue, and weight loss. The subject was sent overseas in October 2002 and was seen by a physician multiple times for symptoms including vomiting, excessive fatigue and possible sleep apnea. The subject returned home from vacation in May 2003. He received medical care for blood in his urine, back pain over the kidney area, feeling sick to his stomach, and stunned bowel. He was hospitalized and underwent surgery for gangrenous small intestine. The subject's kidneys stopped functioning properly, and he gained 55 pounds of fluid. On 6/1/03, the subject was sent to hospital and began dialysis 6/3/03. The subject was hospitalized for 4 months and discharged in September. He continued with dialysis for 9 months until 01/04. Currently he has a stent in one kidney, and both kidneys are functioning. The last creatinine was 3.2. By 6/13/03, the subject was diagnosed with Vasculitis Glomerulonephritis. He has since been diagnosed with Microscopic Polytonitis and Vasculitis Polynodosa. The subject has been seen by a urologist, rheumatologist, nephrologist, orthopedist in addition to his internist. He is now home and continues with medical care at least twice a week. Recently, he had a kidney infection. Current medications included: Prednisone, Lisinopril, Cellcept (on hold during kidney infection treatment), Toprol, Trotonix, Phoslo, Nephrovite, Folic Acid and Fosomax. Per annual follow up report: Son will always have glomerulonephritis for rest of his life. Also can not bend knees and has trouble with fingers and hands as well.
Age: 21.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Fluid retention, Gastrointestinal disorder, Glomerulonephritis, Intestinal gangrene, Nausea
Clinical narrative: Information received from subject's mother regarding 21 year old male received 1st dose Anthrax vaccine 6/7/01. Began noticing symptoms beginning around 10/01, including hair loss, nose bleeds at night, fatigue, and weight loss. The subject was sent overseas in October 2002 and was seen by a physician multiple times for symptoms including vomiting, excessive fatigue and possible sleep apnea. The subject returned home from vacation in May 2003. He received medical care for blood in his urine, back pain over the kidney area, feeling sick to his stomach, and stunned bowel. He was hospitalized and underwent surgery for gangrenous small intestine. The subject's kidneys stopped functioning properly, and he gained 55 pounds of fluid. On 6/1/03, the subject was sent to hospital and began dialysis 6/3/03. The subject was hospitalized for 4 months and discharged in September. He continued with dialysis for 9 months until 01/04. Currently he has a stent in one kidney, and both kidneys are functioning. The last creatinine was 3.2. By 6/13/03, the subject was diagnosed with Vasculitis Glomerulonephritis. He has since been diagnosed with Microscopic Polytonitis and Vasculitis Polynodosa. The subject has been seen by a urologist, rheumatologist, nephrologist, orthopedist in addition to his internist. He is now home and continues with medical care at least twice a week. Recently, he had a kidney infection. Current medications included: Prednisone, Lisinopril, Cellcept (on hold during kidney infection treatment), Toprol, Trotonix, Phoslo, Nephrovite, Folic Acid and Fosomax. Per annual follow up report: Son will always have glomerulonephritis for rest of his life. Also can not bend knees and has trouble with fingers and hands as well.
Age: 21.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Renal impairment, Renal vasculitis, Sleep apnoea syndrome, Vomiting, Weight decreased
Clinical narrative: Information received from subject's mother regarding 21 year old male received 1st dose Anthrax vaccine 6/7/01. Began noticing symptoms beginning around 10/01, including hair loss, nose bleeds at night, fatigue, and weight loss. The subject was sent overseas in October 2002 and was seen by a physician multiple times for symptoms including vomiting, excessive fatigue and possible sleep apnea. The subject returned home from vacation in May 2003. He received medical care for blood in his urine, back pain over the kidney area, feeling sick to his stomach, and stunned bowel. He was hospitalized and underwent surgery for gangrenous small intestine. The subject's kidneys stopped functioning properly, and he gained 55 pounds of fluid. On 6/1/03, the subject was sent to hospital and began dialysis 6/3/03. The subject was hospitalized for 4 months and discharged in September. He continued with dialysis for 9 months until 01/04. Currently he has a stent in one kidney, and both kidneys are functioning. The last creatinine was 3.2. By 6/13/03, the subject was diagnosed with Vasculitis Glomerulonephritis. He has since been diagnosed with Microscopic Polytonitis and Vasculitis Polynodosa. The subject has been seen by a urologist, rheumatologist, nephrologist, orthopedist in addition to his internist. He is now home and continues with medical care at least twice a week. Recently, he had a kidney infection. Current medications included: Prednisone, Lisinopril, Cellcept (on hold during kidney infection treatment), Toprol, Trotonix, Phoslo, Nephrovite, Folic Acid and Fosomax. Per annual follow up report: Son will always have glomerulonephritis for rest of his life. Also can not bend knees and has trouble with fingers and hands as well.
Age: 21.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Abdominal pain upper, Alopecia, Blood urine, Epistaxis, Fluid retention
Clinical narrative: Information received from subject's mother regarding 21 year old male received 1st dose Anthrax vaccine 6/7/01. Began noticing symptoms beginning around 10/01, including hair loss, nose bleeds at night, fatigue, and weight loss. The subject was sent overseas in October 2002 and was seen by a physician multiple times for symptoms including vomiting, excessive fatigue and possible sleep apnea. The subject returned home from vacation in May 2003. He received medical care for blood in his urine, back pain over the kidney area, feeling sick to his stomach, and stunned bowel. He was hospitalized and underwent surgery for gangrenous small intestine. The subject's kidneys stopped functioning properly, and he gained 55 pounds of fluid. On 6/1/03, the subject was sent to hospital and began dialysis 6/3/03. The subject was hospitalized for 4 months and discharged in September. He continued with dialysis for 9 months until 01/04. Currently he has a stent in one kidney, and both kidneys are functioning. The last creatinine was 3.2. By 6/13/03, the subject was diagnosed with Vasculitis Glomerulonephritis. He has since been diagnosed with Microscopic Polytonitis and Vasculitis Polynodosa. The subject has been seen by a urologist, rheumatologist, nephrologist, orthopedist in addition to his internist. He is now home and continues with medical care at least twice a week. Recently, he had a kidney infection. Current medications included: Prednisone, Lisinopril, Cellcept (on hold during kidney infection treatment), Toprol, Trotonix, Phoslo, Nephrovite, Folic Acid and Fosomax. Per annual follow up report: Son will always have glomerulonephritis for rest of his life. Also can not bend knees and has trouble with fingers and hands as well.
Age: 21.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Gastrointestinal disorder, Glomerulonephritis, Intestinal gangrene, Renal failure, Ureteric obstruction
Clinical narrative: Information received from subject's mother regarding 21 year old male received 1st dose Anthrax vaccine 6/7/01. Began noticing symptoms beginning around 10/01, including hair loss, nose bleeds at night, fatigue, and weight loss. The subject was sent overseas in October 2002 and was seen by a physician multiple times for symptoms including vomiting, excessive fatigue and possible sleep apnea. The subject returned home from vacation in May 2003. He received medical care for blood in his urine, back pain over the kidney area, feeling sick to his stomach, and stunned bowel. He was hospitalized and underwent surgery for gangrenous small intestine. The subject's kidneys stopped functioning properly, and he gained 55 pounds of fluid. On 6/1/03, the subject was sent to hospital and began dialysis 6/3/03. The subject was hospitalized for 4 months and discharged in September. He continued with dialysis for 9 months until 01/04. Currently he has a stent in one kidney, and both kidneys are functioning. The last creatinine was 3.2. By 6/13/03, the subject was diagnosed with Vasculitis Glomerulonephritis. He has since been diagnosed with Microscopic Polytonitis and Vasculitis Polynodosa. The subject has been seen by a urologist, rheumatologist, nephrologist, orthopedist in addition to his internist. He is now home and continues with medical care at least twice a week. Recently, he had a kidney infection. Current medications included: Prednisone, Lisinopril, Cellcept (on hold during kidney infection treatment), Toprol, Trotonix, Phoslo, Nephrovite, Folic Acid and Fosomax. Per annual follow up report: Son will always have glomerulonephritis for rest of his life. Also can not bend knees and has trouble with fingers and hands as well.
Age: 21.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Vasculitis, Weight decreased
Clinical narrative: Information received from subject's mother regarding 21 year old male received 1st dose Anthrax vaccine 6/7/01. Began noticing symptoms beginning around 10/01, including hair loss, nose bleeds at night, fatigue, and weight loss. The subject was sent overseas in October 2002 and was seen by a physician multiple times for symptoms including vomiting, excessive fatigue and possible sleep apnea. The subject returned home from vacation in May 2003. He received medical care for blood in his urine, back pain over the kidney area, feeling sick to his stomach, and stunned bowel. He was hospitalized and underwent surgery for gangrenous small intestine. The subject's kidneys stopped functioning properly, and he gained 55 pounds of fluid. On 6/1/03, the subject was sent to hospital and began dialysis 6/3/03. The subject was hospitalized for 4 months and discharged in September. He continued with dialysis for 9 months until 01/04. Currently he has a stent in one kidney, and both kidneys are functioning. The last creatinine was 3.2. By 6/13/03, the subject was diagnosed with Vasculitis Glomerulonephritis. He has since been diagnosed with Microscopic Polytonitis and Vasculitis Polynodosa. The subject has been seen by a urologist, rheumatologist, nephrologist, orthopedist in addition to his internist. He is now home and continues with medical care at least twice a week. Recently, he had a kidney infection. Current medications included: Prednisone, Lisinopril, Cellcept (on hold during kidney infection treatment), Toprol, Trotonix, Phoslo, Nephrovite, Folic Acid and Fosomax. Per annual follow up report: Son will always have glomerulonephritis for rest of his life. Also can not bend knees and has trouble with fingers and hands as well.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Anaphylactoid reaction, Angioneurotic oedema, Stridor
Clinical narrative: Patient developed angioedema and stridor. Given 0.15ml Epinephrine with relief of stridor and reduction of edema. Discharged home in stable condition. Medical record on 04/29/04 states: anaphylactoid reaction.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Cough, Crying, Swelling, Swelling face, Urticaria
Clinical narrative: Wheals developed at each injection site of varicella and MMR. Hives at injection site, neck, facial swelling, ears swollen within 10 minutes of injections. 25mg IM Benadryl given; icepacks applied to injection site. Child transferred to ER; distressed crying, cough. Follow up: Child was placed on oral Benadryl and Prednisone dose pack. 4/23/04 Mom states hives gone, wheals gone and appears recovered.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Brain oedema, Cerebral infarction, Convulsion, Encephalitis, Febrile convulsion
Clinical narrative: 7 days after receiving vaccine, patient ran high fever, resulting in seizures. Results of seizures caused his brain to swell, causing permanent disability. Doctors said if he survived at all, he would be a total vegetable. Through prayer, and a lot of therapy, he is doing well and is close to being normal again. Doctors say he probably never be completely normal, but they are happy with progress. He is on numerous seizure medications to prevent a recurrence. ER record & Discharge summary on 05/06/04 states: febrile seizure, acute upper respiratory infection, pharyngitis, otitis media, gastritis, viral exanthema. Medical record on 05/06/04 states: afebrile seizures.  Nurse follow up on 06/03/04 states: "ADD: status epilepticus, papilledema, encephalitis, cerebral infarcts, cortical visual impairment (convuls grand mal, papilledema, encephalitis, infarct cerebr, vision abnorm)."  Per annual follow up report: 05/01/05 to date patient continues on seizure meds and continues therapy OT, pt speech, early Ed w/ develoopmental delays also receives neurodevelopmental therapy, has significant speech delays, pt is very small for age, has not grown significantly since original injury. Age 3yrs 8 months weight 25 lbs, height 36 inches.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Gastritis, Grand mal convulsion, Growth retardation, Otitis media, Papilloedema
Clinical narrative: 7 days after receiving vaccine, patient ran high fever, resulting in seizures. Results of seizures caused his brain to swell, causing permanent disability. Doctors said if he survived at all, he would be a total vegetable. Through prayer, and a lot of therapy, he is doing well and is close to being normal again. Doctors say he probably never be completely normal, but they are happy with progress. He is on numerous seizure medications to prevent a recurrence. ER record & Discharge summary on 05/06/04 states: febrile seizure, acute upper respiratory infection, pharyngitis, otitis media, gastritis, viral exanthema. Medical record on 05/06/04 states: afebrile seizures.  Nurse follow up on 06/03/04 states: "ADD: status epilepticus, papilledema, encephalitis, cerebral infarcts, cortical visual impairment (convuls grand mal, papilledema, encephalitis, infarct cerebr, vision abnorm)."  Per annual follow up report: 05/01/05 to date patient continues on seizure meds and continues therapy OT, pt speech, early Ed w/ develoopmental delays also receives neurodevelopmental therapy, has significant speech delays, pt is very small for age, has not grown significantly since original injury. Age 3yrs 8 months weight 25 lbs, height 36 inches.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Pharyngitis, Pyrexia, Rash, Speech disorder, Upper respiratory tract infection
Clinical narrative: 7 days after receiving vaccine, patient ran high fever, resulting in seizures. Results of seizures caused his brain to swell, causing permanent disability. Doctors said if he survived at all, he would be a total vegetable. Through prayer, and a lot of therapy, he is doing well and is close to being normal again. Doctors say he probably never be completely normal, but they are happy with progress. He is on numerous seizure medications to prevent a recurrence. ER record & Discharge summary on 05/06/04 states: febrile seizure, acute upper respiratory infection, pharyngitis, otitis media, gastritis, viral exanthema. Medical record on 05/06/04 states: afebrile seizures.  Nurse follow up on 06/03/04 states: "ADD: status epilepticus, papilledema, encephalitis, cerebral infarcts, cortical visual impairment (convuls grand mal, papilledema, encephalitis, infarct cerebr, vision abnorm)."  Per annual follow up report: 05/01/05 to date patient continues on seizure meds and continues therapy OT, pt speech, early Ed w/ develoopmental delays also receives neurodevelopmental therapy, has significant speech delays, pt is very small for age, has not grown significantly since original injury. Age 3yrs 8 months weight 25 lbs, height 36 inches.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Visual disturbance
Clinical narrative: 7 days after receiving vaccine, patient ran high fever, resulting in seizures. Results of seizures caused his brain to swell, causing permanent disability. Doctors said if he survived at all, he would be a total vegetable. Through prayer, and a lot of therapy, he is doing well and is close to being normal again. Doctors say he probably never be completely normal, but they are happy with progress. He is on numerous seizure medications to prevent a recurrence. ER record & Discharge summary on 05/06/04 states: febrile seizure, acute upper respiratory infection, pharyngitis, otitis media, gastritis, viral exanthema. Medical record on 05/06/04 states: afebrile seizures.  Nurse follow up on 06/03/04 states: "ADD: status epilepticus, papilledema, encephalitis, cerebral infarcts, cortical visual impairment (convuls grand mal, papilledema, encephalitis, infarct cerebr, vision abnorm)."  Per annual follow up report: 05/01/05 to date patient continues on seizure meds and continues therapy OT, pt speech, early Ed w/ develoopmental delays also receives neurodevelopmental therapy, has significant speech delays, pt is very small for age, has not grown significantly since original injury. Age 3yrs 8 months weight 25 lbs, height 36 inches.
Age: 34.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Nausea, Pain
Clinical narrative: 34 year old military man presented to our urgent care 04/16/04 with complaints of right shoulder and right sided neck pains and nausea.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: 1400 Mom called, said left thigh swollen, red, warm from hip to 1/2 inch above knee.  Rec: ice to site, Tylenol
Age: 1.25
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Within 8 hours pt experienced redness and swelling of left thigh (DTaP site), after 24 hours swelling increased to a 4" diameter, raised like a welt with redness. Advised to use ice and Benadryl.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia, Rash erythematous
Clinical narrative: Lo grade temp with a 20 raised fld filled red area on trunk and legs. Benadryl and Hydrocort. prn
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash erythematous, Skin ulcer
Clinical narrative: 20-30 raised red fld filled lesions. Afebrile.
Sex: F
Vaccine: SMALL
Symptoms: Hypertension
Clinical narrative: 3/26 HTN at MD of c- No preexisting SOB
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness of upper arm at site given, left arm. Patient seen 4 days after injection.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Laboratory test abnormal, Meningitis
Clinical narrative: Follow up received from the physician on 5/28/03 provided information regarding the patient's medical history. A physician reported via a company representative that a 23 month old male received his third dose of Prevnar on 1/16/02 at 9 months of age. The physician indicated that the child had no illness at time of vaccination and no pre-existing medical conditions at the time of the event. On 3/11/03, the child developed  pneumococcal meningitis and was subsequently hospitalized. Treatment medications included unspecified IV antibiotics. Serotyping revealed one of the pneumococcal serotypes found in Prevnar; however, the specific serotype was not reported. The child recovered.
Age: 0.6
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Laboratory test abnormal, Sepsis
Clinical narrative: Additional information received on 5/12/03 from the reporting physician provided medical history. A physician reported via a company representative that a 7 month old male received his second dose of Prevnar on 1/14/03. Medical history included hypospadias. The reporter indicated that the child was not ill at the time of vaccination. On 3/17/03, at the age of 10 months, he developed pneumococcal sepsis and was subsequently hospitalized. A blood culture was performed; the results of the subtype is pending. He was treated with Rocephin and Clindamyacin. He recovered. The reporter considered this event to be life threatening.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Bacterial infection, Drug ineffective, Sepsis
Clinical narrative: Follow up information received 9/2/03 from the physician provided additional patient details and concomitant vaccines administered. A nurse reported that an 11 month old female received her 3rd dose of Prevnar on 12/12/02, at the age of 6 months. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 2/11/03. Dose regimen was 1 dose (IM). Concomitant therapy included 3rd doses of Tripedia and ActHIB. On 7/12/03, the child developed pneumococcal pneumonia and sepsis, and was hospitalized. Initial treatment included IV and IM ceftraixone, followed by oral amoxicillin. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Febrile convulsion
Clinical narrative: A physician reported that a 2 year old male received his fourth dose of Prevnar on an unspecified date. One day post immunization, he experienced a febrile seizure. He was hospitalized. He recovered. No further information was available at the date of this report.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Convulsion, Pyrexia, Tremor, Viral infection
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse regarding a 12-month-old female who experienced generalized seizure, tremors and fever. At 12 months of age, the patient received a dose on 22-Dec-2003. The patient also received a dose of MMR II (measles, mumps and rubella vaccine) and Varivax (varicella virus vaccine live) vaccines on 22-Dec-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 22-Dec-2003. Dose regiment was 1 dose. Concomitant Therapy: Concomitant medications were not reported. Event Details: On 25-Dec-2003, three days post vaccination, the patient developed a fever ranging from 99.7 deg. F. to 102.6 deg. F (pyrexia). At 10:00 PM that same day, she developed tremors (tremor) and generalized seizure (convulsion). She was seen in an emergency room. The diagnosis at that time was febrile seizure, viral illness versus reaction to the immunizations. This reported was received from manufacturer. No additional information was available at the date of this report. (OMIC)
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Tremor
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse regarding a 12-month-old female who experienced generalized seizure, tremors and fever. At 12 months of age, the patient received a dose on 22-Dec-2003. The patient also received a dose of MMR II (measles, mumps and rubella vaccine) and Varivax (varicella virus vaccine live) vaccines on 22-Dec-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 22-Dec-2003. Dose regiment was 1 dose. Concomitant Therapy: Concomitant medications were not reported. Event Details: On 25-Dec-2003, three days post vaccination, the patient developed a fever ranging from 99.7 deg. F. to 102.6 deg. F (pyrexia). At 10:00 PM that same day, she developed tremors (tremor) and generalized seizure (convulsion). She was seen in an emergency room. The diagnosis at that time was febrile seizure, viral illness versus reaction to the immunizations. This reported was received from manufacturer. No additional information was available at the date of this report. (OMIC)
Sex: U
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Meningitis
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 3 month old infant who experienced pneumococcal meningitis. The infant received the first done on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. The infant was hospitalized with pneumococcal meningitis on an unspecified date. No additional information was available at the time of this report.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Hyperhidrosis, Irritability, Myalgia, Pallor
Clinical narrative: The event "rectal temperature of 103 deg. F" was considered medically important. Follow-up information received from the patient's physician on 22-Sep-2003 provided a family history, vaccines given within four weeks (none), and verified that the information contained in this report is correct. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a consumer regarding a 4-month-old male patient who patient received the second dose on 19-Aug-2003 along with Tripedia, IPOL, Act-HIB, Recombivax vaccines. Medical History: The patient's concurrent illness includes "reflux." The physician indicated that tehre is a strong family history of "unusual allergic reactions" to medications and vaccines. Product Details: Indication for Prevnar was immunization. Product was administered on 19-Aug-2003. Concomitant Therapy: Concomitant therapy included Zantac (ranitidine hydrochloride and Tylenol (parecetamol). Dose regimen was one dose (intramuscular). Event Details: On the morning of 19-Aug-2003, the infant received a dropperful of Tylenol (paracetamol) prior to receiving the vaccines. This was repeated at 2:30 pm that afternoon. He then started fussing and screaming. He was taken back to the physician an hour later; his temperature at that time was 98.9 deg. F. The infant fell asleep at 4:00 pm until 8:00 pm, when he woke up sweating with a rectal temperature of 103 deg. F. He was seen in an emergency room. He "looked grey/white," and was vomiting, fussy, and crying. The reporter stated that laboratory tests revealed his "urine, blood, and liver were normal." He was treated with Feverall (paracetamol) suppositories and released at 2:00 am on 20-Aug-2003. As of 25-Aug-2003, all events have resolved except "some soreness at the thigh injection sites." Related case(s): See related case(s): HQWYE363526AUG03 (The infant didn't feel well, had a gurgling stomach, didn't sleep, eat or drink, looked grey white, was vomiting, and had abnormal urine and abnormal liver enzymes following receipt of his first dose of Prevnar, Tripedia, IPOL, ActHIB, and Recombivax HB vaccines on 16-June-2003 at 2 months of age).  Manufacturer Comment: Information regarding these events has been forwarded to the manufacturers of the concomitantly administered vaccines. (OMIC)
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pyrexia, Screaming, Vomiting
Clinical narrative: The event "rectal temperature of 103 deg. F" was considered medically important. Follow-up information received from the patient's physician on 22-Sep-2003 provided a family history, vaccines given within four weeks (none), and verified that the information contained in this report is correct. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a consumer regarding a 4-month-old male patient who patient received the second dose on 19-Aug-2003 along with Tripedia, IPOL, Act-HIB, Recombivax vaccines. Medical History: The patient's concurrent illness includes "reflux." The physician indicated that tehre is a strong family history of "unusual allergic reactions" to medications and vaccines. Product Details: Indication for Prevnar was immunization. Product was administered on 19-Aug-2003. Concomitant Therapy: Concomitant therapy included Zantac (ranitidine hydrochloride and Tylenol (parecetamol). Dose regimen was one dose (intramuscular). Event Details: On the morning of 19-Aug-2003, the infant received a dropperful of Tylenol (paracetamol) prior to receiving the vaccines. This was repeated at 2:30 pm that afternoon. He then started fussing and screaming. He was taken back to the physician an hour later; his temperature at that time was 98.9 deg. F. The infant fell asleep at 4:00 pm until 8:00 pm, when he woke up sweating with a rectal temperature of 103 deg. F. He was seen in an emergency room. He "looked grey/white," and was vomiting, fussy, and crying. The reporter stated that laboratory tests revealed his "urine, blood, and liver were normal." He was treated with Feverall (paracetamol) suppositories and released at 2:00 am on 20-Aug-2003. As of 25-Aug-2003, all events have resolved except "some soreness at the thigh injection sites." Related case(s): See related case(s): HQWYE363526AUG03 (The infant didn't feel well, had a gurgling stomach, didn't sleep, eat or drink, looked grey white, was vomiting, and had abnormal urine and abnormal liver enzymes following receipt of his first dose of Prevnar, Tripedia, IPOL, ActHIB, and Recombivax HB vaccines on 16-June-2003 at 2 months of age).  Manufacturer Comment: Information regarding these events has been forwarded to the manufacturers of the concomitantly administered vaccines. (OMIC)
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Laboratory test abnormal, Meningitis
Clinical narrative: Additional information received on 6/23/03 from the reporting physician provided patient demographics, vaccination information, medication, concurrent illness at the time of vaccination, and recovery status. A physician reported that a 4 year old male received his first dose of Prevnar on 11/6/00, at the age of 25 months. Medical history included a cerebrospinal fluid leak/shunt. Concurrent medical history included convulsions. Concomitant medication included phenobarbital. On 1/26/03, the child was hospitalized. A cerebrospinal fluid culture revealed Streptococcus pneumoniae, serotype 23F. An anti-pneumococcal antibody test was low for serotype 23F at 2.63. A diagnosis of pneumococcal meningitis was made. On 2/28/03, he was discharged from the hospital. He recovered.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Infection, Laboratory test abnormal
Clinical narrative: Additional information was received from the reported on 17-Sep-2003 providing diagnosis, duration of hospitalization and treatment therapy. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare profession regarding a 29-month-old male patient who experienced drug ineffective, streptococcal pneumonia and streptococcal bacteremia. At 25 months of age, the patient received the first dose of Prevnar on an unspecified date. Medical History: The physician stated that the "child had no underlying medical conditions." Product Details: Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was one dose. Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient experienced drug ineffective (drug ineffective), streptococcal pneumonia (pneumonia streptococcal) and streptococcal bacteremia (streptococcal bacteraemia) in June 2003. The child was hospitalized for 2 days and diagnosed with right lower lobe pneumonia and bacteremia. He was treated with Rocephin and Augmentin. Test results: Blood culture (results: Positive for streptococcal pneumonia) was done on 02-June-2003. Note: the physician reported this event to the CDC and completed a VAERS form.
Age: 0.17
Sex: M
Vaccine: PNC
Symptoms: Drug ineffective, Infection, Pyrexia, Sepsis, Viral infection
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 5-month-old male patient who received a dose at 2 months of age, in September, 2003. Medical History: The patient's concurrent illnesses include wheezing and respiratory syncytial virus infection. Product Details: Indication for Prevnar was immunization. Product was administered in September, 2003. Dose regimen was not provided. Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient developed pneumococcal bacteremia (pneumococcal bactermeia (drug ineffective) on December 5, 2003. It was reported by a healthcare professional that, at two months of age, in September 2003, a male infant received a single dose of Prevnar. At 5 months of age, in December 2003, the reporter indicated a history of wheezing, and that the patient was admitted to the hospital with a diagnosis of Respiratory Syncytial Virus. During this hospitalization, he developed a fever. A blood culture was obtained on December 5. 2003 and repeated on December 7, 2003 which documented pneumococcal bacteremia. As of 17-Dec-2003, the patient remains hospitalized and is currently receiving Ceftriaxone intravenously. Serotype identification of the isolates is pending. This case is considered medically important. Test Results: Blood cultures (results: streptococcus pneumoniae isolated) were performed on December 5, and December 7, 2003. No additional information was available at the time of this report. (OMIC)
Age: 0.17
Sex: M
Vaccine: PNC
Symptoms: Wheezing
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 5-month-old male patient who received a dose at 2 months of age, in September, 2003. Medical History: The patient's concurrent illnesses include wheezing and respiratory syncytial virus infection. Product Details: Indication for Prevnar was immunization. Product was administered in September, 2003. Dose regimen was not provided. Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient developed pneumococcal bacteremia (pneumococcal bactermeia (drug ineffective) on December 5, 2003. It was reported by a healthcare professional that, at two months of age, in September 2003, a male infant received a single dose of Prevnar. At 5 months of age, in December 2003, the reporter indicated a history of wheezing, and that the patient was admitted to the hospital with a diagnosis of Respiratory Syncytial Virus. During this hospitalization, he developed a fever. A blood culture was obtained on December 5. 2003 and repeated on December 7, 2003 which documented pneumococcal bacteremia. As of 17-Dec-2003, the patient remains hospitalized and is currently receiving Ceftriaxone intravenously. Serotype identification of the isolates is pending. This case is considered medically important. Test Results: Blood cultures (results: streptococcus pneumoniae isolated) were performed on December 5, and December 7, 2003. No additional information was available at the time of this report. (OMIC)
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Infection, Sepsis
Clinical narrative: Follow-up information received from the patient's physician on 08-May-2003 included the pneumococcal isolate serotype and the patient's health status. Information was received from a nurse regarding a male child who received his fourth dose of Prevnar on 19-Nov-2002 at 12 months of age. On 14-Apr-2003, when the child was 17 months of age, a blood culture was performed; Streptococcus pneumoniae was isolated. Other laboratory test results included a WBC count of 38.7. A blood sample was sent to the CDC for serotyping; the pneumococcal isolate was identified as 33F. The child reportedly was not hospitalized. The physician reported that the child is "doing well." Streptococcus pneumoniae bacteremia was considered medically important (OMIC).
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Bacterial infection, Cough, Drug ineffective, Laboratory test abnormal, Pneumonia
Clinical narrative: A medical student reported that a 6 month old female received her third dose of Prevnar (lot # 474730) on 9/11/01. On 2/7/03, at 23 months of age, the child was seen by the physician for temperature and cough. She was seen again on 2/12/03, with rapid respirations and was sent to the hospital. Lab tests were performed and a bacterial blood culture obtained on 2/11/03 yielded strep pneumonia, serotype 19. The child was diagnosed with pneumonia and empyema. The reporter indicated that the patient came down with the serotype infection that was contained in the vaccine. The child was discharged to home taking ampicillin for three additional weeks and recovered. At present the child is being followed by an infectious disease specialist.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Pyrexia, Respiratory rate increased
Clinical narrative: A medical student reported that a 6 month old female received her third dose of Prevnar (lot # 474730) on 9/11/01. On 2/7/03, at 23 months of age, the child was seen by the physician for temperature and cough. She was seen again on 2/12/03, with rapid respirations and was sent to the hospital. Lab tests were performed and a bacterial blood culture obtained on 2/11/03 yielded strep pneumonia, serotype 19. The child was diagnosed with pneumonia and empyema. The reporter indicated that the patient came down with the serotype infection that was contained in the vaccine. The child was discharged to home taking ampicillin for three additional weeks and recovered. At present the child is being followed by an infectious disease specialist.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Laboratory test abnormal
Clinical narrative: A physician reported that a 30 month old female received her first dose of Prevnar on 1/3/03, at 24 months of age. The child had no underlying medical conditions. On 6/20/03, the child developed unspecified symptoms of illness. On 6/25/03, the child was seen in an emergency room. A blood culture was taken, S. pneumoniae was isolated. That same day, the child was transferred to anothe hospital facility and admitted. Treatment medications included cefotaxime, clindamycin and gentamycin. On 6/26/03, the child was again transferred to another hospital facility and admitted to the ICU. A pleural fluid culture was taken, S. pneumoniae was isolated. Treatment medications included cefotaxime, clindamycin, and vancomycin for about a day. On 7/1/03, she had surgery for empyema decortication. As of 7/2/03, the child remained in the ICU and was receiving penicillin. The physician indicated that the S. pneumoniae isolates were sent for serotyping; serotype 3 was isolated. No further information was available at the date of this report.
Age: 0.58
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Meningitis, Sepsis
Clinical narrative: Follow-up information received from the physician on 07-Aug-2003 provided additional patient demographics, birth date, vaccination date, vaccine lot number, vaccines given within four weeks, medical history (negative), and culture results. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 10-month-old male patient who developed "strep pneumo meningitis." At 7 moths of age, the patient received the first dose on 11-Mar-2003. Medical History: patient had no relevant medical history. Product Details: Indication for Prevnar was immunization. Product was administered on 11-Mar-2003. Dose regimen was one dose. Concomitant Therapy: The patient was receiving concomitant mediation. Event Details: The patient experienced "strep pneumo meningitis" (meningitis pneumococcal) (drug ineffective) on 13-June-2003, and was subsequently hospitalized in the pediatric intensive care unit for 15 days duration. Treatment medications included unspecified antibiotics. He recovered. The physician indicated that she did not consider this an adverse event because the infant only received one dose of Prevnar.  Test Results: CSF culture (results: positive, S. pneumoniae isolated) and blood culture (results: Postive, S. pneumoniae isolated.) were done on an unspecified date.
Age: 0.5
Sex: U
Vaccine: PNC
Symptoms: Rash
Clinical narrative: A physician reported that an unidentified 6 month old infant received a first dose of Prevnar (pneumococcal 7 valent conjugate vaccine ) vaccine (date not identified). Subsequent to vaccine administration, the child developed a rash. No further information was available at the time of this report.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Injection site vesicles, Skin exfoliation, Skin ulcer
Clinical narrative: Follow up information from the pediatrician provided the site of the reaction as the injection site. A pediatrician reported that a nine month old female received her first dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 08-MAY-2003. On 09-2003, one day post immunization, she developed a quarter sized water blister lesion at the injection site. The lesion ruptured ad skin peeled for two weeks. Treatment included supportive care for two weeks. The child recovered.
Age: 1.25
Sex: F
Vaccine: PNC, PNC
Symptoms: Crying, Otitis media
Clinical narrative: Information has been received from a mother regarding her 23 month old daughter with a past medical history of unilateral and bilateral ear infections. On 07-MAR-2003, she experienced another incident of bilateral ear infection. The mother also reported that her daughter was crying. Reporter indicated that no cultures were done. No further information was available at the date of this report.
Age: 1.25
Sex: F
Vaccine: PNC, PNC
Symptoms: Otitis media
Clinical narrative: Information has been received from a mother regarding her 23 month old daughter with a past medical history of unilateral and bilateral ear infections. On 07-MAR-2003, she experienced another incident of bilateral ear infection. The mother also reported that her daughter was crying. Reporter indicated that no cultures were done. No further information was available at the date of this report.
Age: 1.25
Sex: F
Vaccine: PNC, PNC
Symptoms: Crying, Otitis media
Clinical narrative: Information has been received from a mother regarding her 23 month old daughter with a past medical history of unilateral ear infection. On 28-JUN-2002, at 15 months of age, she received her fourth dose of Prevnar. On 27-JAN-2003, she developed a bilateral ear infection. No further information was available at the date of this report.
Age: 1.25
Sex: F
Vaccine: PNC, PNC
Symptoms: Otitis media
Clinical narrative: Information has been received from a mother regarding her 23 month old daughter with a past medical history of unilateral ear infection. On 28-JUN-2002, at 15 months of age, she received her fourth dose of Prevnar. On 27-JAN-2003, she developed a bilateral ear infection. No further information was available at the date of this report.
Age: 0.5
Sex: F
Vaccine: PNC
Symptoms: Injection site induration, Injection site rash, Injection site reaction, Rash erythematous, Rash maculo-papular
Clinical narrative: Follow up information received from the pediatrician on 03-JUN-2003 provided additional vaccination details, including vaccination dates and vaccines given within four weeks, patient date of birth, concomitant medications, illness at the time of vaccination, event onset date and recovery status. A pediatrician reported that a six month old female received her third dose of Prevnar on 22-APR-2003. The infant had bronchitis that was improving at the time of vaccination. Concomitant medications included Pulmicort (budesonide) and Xopenex (levalbuterol). Vaccines administered within 4 weeks of Prevnar included the infant's third doses of Tripedia (Aventis) and IPOL (Aventis ) on 14-APR-2003. On 26-APR-2003, the infant developed an injection site reaction on her thigh at the site of Prevnar administration characterized by a "knot". The knot resolved 4 days post vaccination; however, a rash at the Prevnar injection site then appeared. She was treated iwth Benadryl (dephenhyddramine). She recovered. The infant developed a generalized, erythematous, maular-papular rash following receipt of her second doses of Prevnar, Tripedia (Aventis), IPOL (Aventis and Comvax (Merck) accines at 4 months of age  (se MCN HQWYE036305MAY03). The physician indicat4ed that there were "no problems" following receipt of the infant's first doses. Informatin regarding this event has been forwarded to Aventis.