chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Full blood count, Laboratory test, Lumbar puncture, Pyrexia, Viral test
Clinical narrative: 6 hours after 4 month-old vaccines (incl. Hep B, PENTACEL, PREVNAR, oral ROTATEK), baby had fever and a 20 minute-long generalized seizure. Taken to the emergency and required x2 ATIVAN IV dose. Transferred to PICU after full work up.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Pt's mother reported pt had seizure after vaccine administration.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt described symptoms developing 2 days after vaccination of swelling, pain, itching, tenderness and warmth at injection site. Pt reported feeling lethargic and tired No fever or headache. Patient saw Dr at scheduled appt.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy
Clinical narrative: Pt described symptoms developing 2 days after vaccination of swelling, pain, itching, tenderness and warmth at injection site. Pt reported feeling lethargic and tired No fever or headache. Patient saw Dr at scheduled appt.
Age: 1.15
Sex: F
Vaccine: DTAP, HIBV, MMR, OPV, PNC, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Raised red rash all over body 2 days after receiving vax on 3-9-10.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Vitiligo
Clinical narrative: Initial literature received on 22 Mar 2010: This literature deals with vaccination against classic influenza in medical personnel: self-protection and patient protection. This patient was vaccinated with Influenza virus vaccine (manufature unk, batch no. unk) for immunisation on unspecified date. On an unspecified date, four weeks after the vaccination, the patient had presented with the vitilligo on both hands and the arms. The causality assessment was unknown. The outcome of the event was not reported.
Age: 52.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: 15-20min post incetion developed chills and high fever 105.3.  Resolved after 12 hours, pt states felt fine afterwards....Per review of records seasonal shot given at 0945am, patient seen by PCP at 10am (no complaints of above in PCP progress notes.  No active signs of infection.  Hep C liver enzymes mild elevated at visit 01/21/2010 08:59  PLASMA     SGOT(AST)             110 H  U/L         17 -  59 01/21/2010 08:59  PLASMA     SGPT(ALT)             113 H  U/L         21 -  72 ) and upon discharge was given H1N1 at 10:30.
Age: 0.36
Sex: M
Vaccine: RV5
Symptoms: Irritability
Clinical narrative: Patient was "fussy" per mother and did not want to take his naps during the day.  Fussiness resolved by 3/27/10 completely.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC
Symptoms: Haematochezia, Vaccine positive rechallenge
Clinical narrative: BM with blood again at 1:00 PM BM with blood (more blood then what occurred at 4 months of age). Initial report received on 29 March 2010 from a healthcare professional.  This case is linked to case 2010-01876.  A 6 month-old male patient received the following vaccine on 29 March 2010: an intramuscular injection in the right leg of PENTACEL (lot number C3565AA); an intramuscular injection in the left leg of FLUZONE SV 2009-2010 (lot number U3378AB); and an intramuscular injection in the left leg of PREVNAR, (Wyeth, lot number D93211).  Two hours post vaccination, the patient experienced a bloody bowel movement.  A second episode occurred 1/2 hour later.  The patient had a similar episode after vaccination at 4 months of age when he received PENTACEL, rotavirus vaccine and pneumococcal vaccine.  The patient also experienced hives after the 4 month vaccination.  These events are documented in case 2010-01876.  It was noted that there was more blood in the stool in the episode at 6 months of age compared to the event at 4 months of age.  No other history was noted and the patient was not ill at the time of vaccination.  The outcome was not reported.  List of documents held by sender: none
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site discharge, Injection site nodule, Injection site pain, Wound complication
Clinical narrative: PT STATES SHE HAD A Tdap ADMINISTERED IN LEFT ARM ON 2/25/10 AND EVER SINCE A SUBSTANCE HAS BEEN SECRETING FROM THE INJECTION SITE. DENIES REDNESS, BUT HAS A NODE AND PAIN. PER PATIENT THE SECRETION HAS A SMELL LIKE 'MOTOR OIL'.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Application site odour, Injection site discharge, Injection site nodule
Clinical narrative: PT STATES SHE HAD A Tdap ADMINISTERED IN LEFT ARM ON 2/25/10 AND EVER SINCE A SUBSTANCE HAS BEEN SECRETING FROM THE INJECTION SITE. DENIES REDNESS, BUT HAS A NODE AND PAIN. PER PATIENT THE SECRETION HAS A SMELL LIKE 'MOTOR OIL'.
Age: 56.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Condition aggravated, Rash
Clinical narrative: developed new rash over back and arms, started after cholecalciferol and hydroxyzine started.  continue to worsen after medications stopped
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Localized reaction, red, painful areas over injection site.
Age: 26.0
Sex: F
Vaccine: TTOX
Symptoms: Chills, Constipation, Dizziness, Injection site erythema, Injection site pain
Clinical narrative: She received vaccine at 8 PM on 3/26/2010. She noticed blotchy red at injection site, right deltoid. She also experienced chills, nausea, light headedness, irritability, constipation, pain at site of injection, pain level 6-7.
Age: 26.0
Sex: F
Vaccine: TTOX
Symptoms: Irritability, Nausea, Rash macular
Clinical narrative: She received vaccine at 8 PM on 3/26/2010. She noticed blotchy red at injection site, right deltoid. She also experienced chills, nausea, light headedness, irritability, constipation, pain at site of injection, pain level 6-7.
Age: 0.25
Sex: M
Vaccine: DTP
Symptoms: Catatonia, Kawasaki's disease
Clinical narrative: Catatonic Reaction to DPT later was diagnosed with Kawasaki Disease 4 1/2 years later at age 5. No other DPTs given
Age: 44.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: R arm swelling and pain
Age: 1.05
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site induration, Injection site rash
Clinical narrative: Induration, rash at injection site one week after vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Chest X-ray, Chest pain, Immediate post-injection reaction
Clinical narrative: Information has been received from a 73 year old always very healthy female consumer with an allergy to SUPREX who in July 2009, was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included vitamins (unspecified) and minerals (unspecified) which were recommended by doctors. The patient experienced pain like being on fire which started immediately after having taken the ZOSTAVAX (Merck) injection. The pain was on the left side of her chest which had affected her entire breast bone. The doctor was having more tests run since she had pain for such a long time to make sure that this had not spread to her heart. After the pain started, the patient got 2 areas (like 2 little blisters) located on upper left shoulder blade these 2 areas were treated with a topical cream. The patient stated that could not even wear a bra. The patient sought unspecified medical attention. In December 2009, the patient had several tests, included 2 mammograms, 2 chest x-rays, echo/stress cardiogram test, and echo ultrasound. The results were not reported. At the time of the report, the patient had not recovered from these events. These events were considered to be disabling by the reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Mammogram, Stress echocardiogram, Ultrasound scan
Clinical narrative: Information has been received from a 73 year old always very healthy female consumer with an allergy to SUPREX who in July 2009, was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included vitamins (unspecified) and minerals (unspecified) which were recommended by doctors. The patient experienced pain like being on fire which started immediately after having taken the ZOSTAVAX (Merck) injection. The pain was on the left side of her chest which had affected her entire breast bone. The doctor was having more tests run since she had pain for such a long time to make sure that this had not spread to her heart. After the pain started, the patient got 2 areas (like 2 little blisters) located on upper left shoulder blade these 2 areas were treated with a topical cream. The patient stated that could not even wear a bra. The patient sought unspecified medical attention. In December 2009, the patient had several tests, included 2 mammograms, 2 chest x-rays, echo/stress cardiogram test, and echo ultrasound. The results were not reported. At the time of the report, the patient had not recovered from these events. These events were considered to be disabling by the reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLUN(H1N1), FLU(H1N1), FLUX(H1N1)
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Leg weakness arm weakness to the point of not being able to stand or dress self admitted to hospital 2/1/10 treated with iv igg
Age: 55.0
Sex: F
Vaccine: FLUN(H1N1), FLU(H1N1), FLUX(H1N1)
Symptoms: Back pain, Inappropriate schedule of drug administration, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Leg weakness arm weakness to the point of not being able to stand or dress self admitted to hospital 2/1/10 treated with iv igg
Age: 55.0
Sex: F
Vaccine: FLUN(H1N1), FLU(H1N1), FLUX(H1N1)
Symptoms: Activities of daily living impaired, Computerised tomogram, Dysstasia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Leg weakness arm weakness to the point of not being able to stand or dress self admitted to hospital 2/1/10 treated with iv igg
Age: 55.0
Sex: F
Vaccine: FLUN(H1N1), FLU(H1N1), FLUX(H1N1)
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Leg weakness arm weakness to the point of not being able to stand or dress self admitted to hospital 2/1/10 treated with iv igg
Age: 64.0
Sex: U
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1), FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Got H1N1 vaccine Nov. 12 2009. Within hours arm began hurting. Eventually couldn't move it, it felt like muscle was involve. Drs. couldn't tell if it involved muscle or nerve. 4 months later, no better. Arm is excruciating.
Age: 64.0
Sex: U
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1), FLUX
Symptoms: Ultrasound scan
Clinical narrative: Got H1N1 vaccine Nov. 12 2009. Within hours arm began hurting. Eventually couldn't move it, it felt like muscle was involve. Drs. couldn't tell if it involved muscle or nerve. 4 months later, no better. Arm is excruciating.
Age: 64.0
Sex: U
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1), FLUX
Symptoms: Asthenia, Nuclear magnetic resonance imaging normal, Pain in extremity, Ultrasound scan normal
Clinical narrative: Got H1N1 vaccine Nov. 12 2009. Within hours arm began hurting. Eventually couldn't move it, it felt like muscle was involve. Drs. couldn't tell if it involved muscle or nerve. 4 months later, no better. Arm is excruciating.
Age: 64.0
Sex: U
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1), FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Ultrasound scan
Clinical narrative: Got H1N1 vaccine Nov. 12 2009. Within hours arm began hurting. Eventually couldn't move it, it felt like muscle was involve. Drs. couldn't tell if it involved muscle or nerve. 4 months later, no better. Arm is excruciating.
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Decreased appetite, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient was given a TDAP (ADACEL) immunization on 3-01-10. Parent reports the student had fever and nausea all day 3-2-10. He also had pain at the injection site, redness and swelling, and a headache. His temperature was 100.2 degrees F in the morning of 3-2-10 then was controlled with TYLENOL the rest of the day. Student returned to school 3-3-10 but still complained of a lack of appetite.
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient was given a TDAP (ADACEL) immunization on 3-01-10. Parent reports the student had fever and nausea all day 3-2-10. He also had pain at the injection site, redness and swelling, and a headache. His temperature was 100.2 degrees F in the morning of 3-2-10 then was controlled with TYLENOL the rest of the day. Student returned to school 3-3-10 but still complained of a lack of appetite.
Age: 1.34
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Decreased appetite, Depressed mood, Dyskinesia, Irritability, Listless
Clinical narrative: Started getting restless even in father's arms. At 4:45 started SCREAMING hysterically for an hour and a half. Could not be comforted by mom or dad. Since then has had almost no appetite, will barely even drink. Repetitive head motions. Staring. Not responding to name. Cranky. Fever for two days. Seems depressed and listless.
Age: 1.34
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Pyrexia, Restlessness, Screaming, Staring, Unresponsive to stimuli
Clinical narrative: Started getting restless even in father's arms. At 4:45 started SCREAMING hysterically for an hour and a half. Could not be comforted by mom or dad. Since then has had almost no appetite, will barely even drink. Repetitive head motions. Staring. Not responding to name. Cranky. Fever for two days. Seems depressed and listless.
Age: 1.34
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Headache, Irritability, Lethargy, Pyrexia
Clinical narrative: Started getting restless even in father's arms. At 4:45 started SCREAMING hysterically for an hour and a half. Could not be comforted by mom or dad. Since then has had almost no appetite, will barely even drink. Repetitive head motions. Staring. Not responding to name. Cranky. Fever for two days. Seems depressed and listless.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cardiac enzymes normal, Chest pain, Electrocardiogram normal, Injection site vesicles, Musculoskeletal chest pain
Clinical narrative: The patient had the smallpox vaccine prior to deployment on 5 Feb 2010 and on 12 Feb reported pleuritic discomfort - chest pain that was brought on by inspiration and by movement.  He otherwise was well without any constitutional symptoms.  The site formed a normal blister.  He was referred to the ED for evaluation.  Cardiac enzymes were negative, ECG was reported as normal, he was diagnosis with musculoskeletal chest pain.  Upon review on 26 Feb 2010 he was feeling well.  The case was discussed with the Vaccine Healthcare Center who recommended a VAERS submission.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pleuritic pain
Clinical narrative: The patient had the smallpox vaccine prior to deployment on 5 Feb 2010 and on 12 Feb reported pleuritic discomfort - chest pain that was brought on by inspiration and by movement.  He otherwise was well without any constitutional symptoms.  The site formed a normal blister.  He was referred to the ED for evaluation.  Cardiac enzymes were negative, ECG was reported as normal, he was diagnosis with musculoskeletal chest pain.  Upon review on 26 Feb 2010 he was feeling well.  The case was discussed with the Vaccine Healthcare Center who recommended a VAERS submission.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pain, Painful respiration, Pleuritic pain
Clinical narrative: The patient had the smallpox vaccine prior to deployment on 5 Feb 2010 and on 12 Feb reported pleuritic discomfort - chest pain that was brought on by inspiration and by movement.  He otherwise was well without any constitutional symptoms.  The site formed a normal blister.  He was referred to the ED for evaluation.  Cardiac enzymes were negative, ECG was reported as normal, he was diagnosis with musculoskeletal chest pain.  Upon review on 26 Feb 2010 he was feeling well.  The case was discussed with the Vaccine Healthcare Center who recommended a VAERS submission.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Dyspnoea, Urticaria
Clinical narrative: Returned about 1 hour after imms with hives, cough, difficulty breathing.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Expired drug administered
Clinical narrative: No adverse reactions. PEDIARIX given on 3-29-10 had expired on 3/26/10 Lot # AC2161B149AA. Reported to provider.
Age: 0.26
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: No adverse reactions. PEDIARIX given on 3/29/10 had expired on 3/26/10 Lot# ACB149AA. Reported to provider.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood culture negative, Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: 20 minutes after vaccine administration, patient had nausea and 10-12 episodes of emesis (green, non-bloody). No diarrhea occurred. About 1-2 hours later had fever of 102 degrees Fahr. Presented to hospital for blood culture, IV ceftriaxone, and admission. Nausea and emesis had resolved at this point (8:00PM on 3/23/10). The blood culture grew no organisms. He was discharged on 3/25/10 with no fevers or emesis. He did develop loose bowel movements on the date of discharge.
Sex: M
Vaccine: FLU3
Symptoms: Cardiovascular disorder, Guillain-Barre syndrome, Impaired work ability
Clinical narrative: Initial consumer report via article received on 26 Mar 2010: The patient was vaccinated with Influenza virus vaccine (batch no. unknown), unknown dose, on an unspecified date. The patient experienced Guillain Barre Syndrome and was unable to work for two months (date not specified). The patient was hospitalized and would undergo surgery for a cardio-vascular disorder on unspecified date. The outcomes of events were not reported.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Lip swelling, Oedema mouth, Rash generalised, Swelling face
Clinical narrative: Within 30 minutes of receiving vaccines the child developed face, lip and mouth swelling, full body rash.  Went immediately to the ER (which is in the same building as the Dr. Office) received IV Benadryl, IV Decadron IM epinephrine, HHN Albuterol observed until 8pm, swelling decreased and discharged with Decadron and Benadryl po for 24 hours.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Bacterial infection, Band neutrophil count decreased, Blood culture positive, Haemoglobin normal
Clinical narrative: A serious clinical trial report of Grade 3 osteomyelitis was received from a physician concerning a five-year-old female, who was enrolled in a study. The subject's past medical history included born at 35 weeks gestational age, ear infection, and no hospitalization. Her family history included arthritis, skin cancer and Sjogren's disease (all maternal grandmother). The subject has three siblings and the subject is one in a set of triplets. Her concomitant medication included amoxicillin approximately 1 month prior for treatment of an ear infection. The subject received one dose of MEDI3414 on 19-Aug-2009 intranasally, and the second dose of MEDI3414 was administered intranasally on 16-Sep-2009. The subject's mother reported progressive right leg pain for 2 days that resulted in the subject becoming unable to bear weight on the leg. The subject had several days of fevers (up to 102 F) at home prior to being evaluated in the Emergency Room. The mother reported that her daughter had a slight scratch by pet on 15-Jan-2010. Two siblings at home experienced fever, diarrhea and vomiting, and her older sister had a streptococcal infection of the throat which was treated approximately 2 weeks prior. On 28-Jan-2010, the subject presented to the Emergency Room with fever and pain in the right-knee-region. Blood work was performed, and she was sent home. The blood work revealed staphylococcus infection, and the subject was recalled to return to the hospital. On 29-Jan-2010, she was admitted to the hospital. Her vital signs were within normal limits with the exception of a fever of 39.4C. The subject was in no acute distress, and had no tenderness to palpation along the entire leg and specifically in the hip, greater trochanter, knee joint, and ankle. She had painless active and passive range of motion of the hip and ankle. The right knee was slightly warm to touch, and there was no clear effusion on examination, but was described as slightly puffy in the knee region. The subject was started on intravenous antibiotics. On 29-Jan-2010, magnetic resonance imaging (MRI) of the right lower extremity was done. The results of MRI were following: abnormal signal and enhancement of involving the distal femur and adjacent soft tissues, no focal bony lesion, and normal femorotibial alignment. On 02-Feb-2010, ultrasound and fluoroscopic guided placement of a four-French-single-lumen peripherally ventral catheter were performed successfully. on 02-Feb-2010, the subject was discharged from the hospital. The event of osteomyelitis was reported as recovered on 12-Feb-2010. The Study Investigator reported the causality of the osteomyelitis to MEDI3414 as none. Alternative etiology provided was bacterial infection. The sponsor assessed the causality of the osteomyelitis to MEDI-3414 as none. Follow-up information, changed onset date, was received on 24-Feb-2010. Follow-up information, subject's medical records, was received on 15-Mar-2010.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Joint swelling, Lymphocyte count decreased, Lymphocyte percentage decreased, Mean cell haemoglobin concentration, Monocyte percentage increased
Clinical narrative: A serious clinical trial report of Grade 3 osteomyelitis was received from a physician concerning a five-year-old female, who was enrolled in a study. The subject's past medical history included born at 35 weeks gestational age, ear infection, and no hospitalization. Her family history included arthritis, skin cancer and Sjogren's disease (all maternal grandmother). The subject has three siblings and the subject is one in a set of triplets. Her concomitant medication included amoxicillin approximately 1 month prior for treatment of an ear infection. The subject received one dose of MEDI3414 on 19-Aug-2009 intranasally, and the second dose of MEDI3414 was administered intranasally on 16-Sep-2009. The subject's mother reported progressive right leg pain for 2 days that resulted in the subject becoming unable to bear weight on the leg. The subject had several days of fevers (up to 102 F) at home prior to being evaluated in the Emergency Room. The mother reported that her daughter had a slight scratch by pet on 15-Jan-2010. Two siblings at home experienced fever, diarrhea and vomiting, and her older sister had a streptococcal infection of the throat which was treated approximately 2 weeks prior. On 28-Jan-2010, the subject presented to the Emergency Room with fever and pain in the right-knee-region. Blood work was performed, and she was sent home. The blood work revealed staphylococcus infection, and the subject was recalled to return to the hospital. On 29-Jan-2010, she was admitted to the hospital. Her vital signs were within normal limits with the exception of a fever of 39.4C. The subject was in no acute distress, and had no tenderness to palpation along the entire leg and specifically in the hip, greater trochanter, knee joint, and ankle. She had painless active and passive range of motion of the hip and ankle. The right knee was slightly warm to touch, and there was no clear effusion on examination, but was described as slightly puffy in the knee region. The subject was started on intravenous antibiotics. On 29-Jan-2010, magnetic resonance imaging (MRI) of the right lower extremity was done. The results of MRI were following: abnormal signal and enhancement of involving the distal femur and adjacent soft tissues, no focal bony lesion, and normal femorotibial alignment. On 02-Feb-2010, ultrasound and fluoroscopic guided placement of a four-French-single-lumen peripherally ventral catheter were performed successfully. on 02-Feb-2010, the subject was discharged from the hospital. The event of osteomyelitis was reported as recovered on 12-Feb-2010. The Study Investigator reported the causality of the osteomyelitis to MEDI3414 as none. Alternative etiology provided was bacterial infection. The sponsor assessed the causality of the osteomyelitis to MEDI-3414 as none. Follow-up information, changed onset date, was received on 24-Feb-2010. Follow-up information, subject's medical records, was received on 15-Mar-2010.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Muscular weakness, Neutrophil percentage, Nuclear magnetic resonance imaging abnormal, Osteomyelitis, Pain in extremity
Clinical narrative: A serious clinical trial report of Grade 3 osteomyelitis was received from a physician concerning a five-year-old female, who was enrolled in a study. The subject's past medical history included born at 35 weeks gestational age, ear infection, and no hospitalization. Her family history included arthritis, skin cancer and Sjogren's disease (all maternal grandmother). The subject has three siblings and the subject is one in a set of triplets. Her concomitant medication included amoxicillin approximately 1 month prior for treatment of an ear infection. The subject received one dose of MEDI3414 on 19-Aug-2009 intranasally, and the second dose of MEDI3414 was administered intranasally on 16-Sep-2009. The subject's mother reported progressive right leg pain for 2 days that resulted in the subject becoming unable to bear weight on the leg. The subject had several days of fevers (up to 102 F) at home prior to being evaluated in the Emergency Room. The mother reported that her daughter had a slight scratch by pet on 15-Jan-2010. Two siblings at home experienced fever, diarrhea and vomiting, and her older sister had a streptococcal infection of the throat which was treated approximately 2 weeks prior. On 28-Jan-2010, the subject presented to the Emergency Room with fever and pain in the right-knee-region. Blood work was performed, and she was sent home. The blood work revealed staphylococcus infection, and the subject was recalled to return to the hospital. On 29-Jan-2010, she was admitted to the hospital. Her vital signs were within normal limits with the exception of a fever of 39.4C. The subject was in no acute distress, and had no tenderness to palpation along the entire leg and specifically in the hip, greater trochanter, knee joint, and ankle. She had painless active and passive range of motion of the hip and ankle. The right knee was slightly warm to touch, and there was no clear effusion on examination, but was described as slightly puffy in the knee region. The subject was started on intravenous antibiotics. On 29-Jan-2010, magnetic resonance imaging (MRI) of the right lower extremity was done. The results of MRI were following: abnormal signal and enhancement of involving the distal femur and adjacent soft tissues, no focal bony lesion, and normal femorotibial alignment. On 02-Feb-2010, ultrasound and fluoroscopic guided placement of a four-French-single-lumen peripherally ventral catheter were performed successfully. on 02-Feb-2010, the subject was discharged from the hospital. The event of osteomyelitis was reported as recovered on 12-Feb-2010. The Study Investigator reported the causality of the osteomyelitis to MEDI3414 as none. Alternative etiology provided was bacterial infection. The sponsor assessed the causality of the osteomyelitis to MEDI-3414 as none. Follow-up information, changed onset date, was received on 24-Feb-2010. Follow-up information, subject's medical records, was received on 15-Mar-2010.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Scratch, Skin warm, Staphylococcal infection, Weight bearing difficulty
Clinical narrative: A serious clinical trial report of Grade 3 osteomyelitis was received from a physician concerning a five-year-old female, who was enrolled in a study. The subject's past medical history included born at 35 weeks gestational age, ear infection, and no hospitalization. Her family history included arthritis, skin cancer and Sjogren's disease (all maternal grandmother). The subject has three siblings and the subject is one in a set of triplets. Her concomitant medication included amoxicillin approximately 1 month prior for treatment of an ear infection. The subject received one dose of MEDI3414 on 19-Aug-2009 intranasally, and the second dose of MEDI3414 was administered intranasally on 16-Sep-2009. The subject's mother reported progressive right leg pain for 2 days that resulted in the subject becoming unable to bear weight on the leg. The subject had several days of fevers (up to 102 F) at home prior to being evaluated in the Emergency Room. The mother reported that her daughter had a slight scratch by pet on 15-Jan-2010. Two siblings at home experienced fever, diarrhea and vomiting, and her older sister had a streptococcal infection of the throat which was treated approximately 2 weeks prior. On 28-Jan-2010, the subject presented to the Emergency Room with fever and pain in the right-knee-region. Blood work was performed, and she was sent home. The blood work revealed staphylococcus infection, and the subject was recalled to return to the hospital. On 29-Jan-2010, she was admitted to the hospital. Her vital signs were within normal limits with the exception of a fever of 39.4C. The subject was in no acute distress, and had no tenderness to palpation along the entire leg and specifically in the hip, greater trochanter, knee joint, and ankle. She had painless active and passive range of motion of the hip and ankle. The right knee was slightly warm to touch, and there was no clear effusion on examination, but was described as slightly puffy in the knee region. The subject was started on intravenous antibiotics. On 29-Jan-2010, magnetic resonance imaging (MRI) of the right lower extremity was done. The results of MRI were following: abnormal signal and enhancement of involving the distal femur and adjacent soft tissues, no focal bony lesion, and normal femorotibial alignment. On 02-Feb-2010, ultrasound and fluoroscopic guided placement of a four-French-single-lumen peripherally ventral catheter were performed successfully. on 02-Feb-2010, the subject was discharged from the hospital. The event of osteomyelitis was reported as recovered on 12-Feb-2010. The Study Investigator reported the causality of the osteomyelitis to MEDI3414 as none. Alternative etiology provided was bacterial infection. The sponsor assessed the causality of the osteomyelitis to MEDI-3414 as none. Follow-up information, changed onset date, was received on 24-Feb-2010. Follow-up information, subject's medical records, was received on 15-Mar-2010.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: X-ray limb normal, X-ray of pelvis and hip normal
Clinical narrative: A serious clinical trial report of Grade 3 osteomyelitis was received from a physician concerning a five-year-old female, who was enrolled in a study. The subject's past medical history included born at 35 weeks gestational age, ear infection, and no hospitalization. Her family history included arthritis, skin cancer and Sjogren's disease (all maternal grandmother). The subject has three siblings and the subject is one in a set of triplets. Her concomitant medication included amoxicillin approximately 1 month prior for treatment of an ear infection. The subject received one dose of MEDI3414 on 19-Aug-2009 intranasally, and the second dose of MEDI3414 was administered intranasally on 16-Sep-2009. The subject's mother reported progressive right leg pain for 2 days that resulted in the subject becoming unable to bear weight on the leg. The subject had several days of fevers (up to 102 F) at home prior to being evaluated in the Emergency Room. The mother reported that her daughter had a slight scratch by pet on 15-Jan-2010. Two siblings at home experienced fever, diarrhea and vomiting, and her older sister had a streptococcal infection of the throat which was treated approximately 2 weeks prior. On 28-Jan-2010, the subject presented to the Emergency Room with fever and pain in the right-knee-region. Blood work was performed, and she was sent home. The blood work revealed staphylococcus infection, and the subject was recalled to return to the hospital. On 29-Jan-2010, she was admitted to the hospital. Her vital signs were within normal limits with the exception of a fever of 39.4C. The subject was in no acute distress, and had no tenderness to palpation along the entire leg and specifically in the hip, greater trochanter, knee joint, and ankle. She had painless active and passive range of motion of the hip and ankle. The right knee was slightly warm to touch, and there was no clear effusion on examination, but was described as slightly puffy in the knee region. The subject was started on intravenous antibiotics. On 29-Jan-2010, magnetic resonance imaging (MRI) of the right lower extremity was done. The results of MRI were following: abnormal signal and enhancement of involving the distal femur and adjacent soft tissues, no focal bony lesion, and normal femorotibial alignment. On 02-Feb-2010, ultrasound and fluoroscopic guided placement of a four-French-single-lumen peripherally ventral catheter were performed successfully. on 02-Feb-2010, the subject was discharged from the hospital. The event of osteomyelitis was reported as recovered on 12-Feb-2010. The Study Investigator reported the causality of the osteomyelitis to MEDI3414 as none. Alternative etiology provided was bacterial infection. The sponsor assessed the causality of the osteomyelitis to MEDI-3414 as none. Follow-up information, changed onset date, was received on 24-Feb-2010. Follow-up information, subject's medical records, was received on 15-Mar-2010.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Encephalitis, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Diagnosis: encephalitis Symptoms: confusion, possible seizure
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Memory impairment, Pain
Clinical narrative: He completed his first series of six injections in Jan 2000. Other than slight soreness, he denied problems with previous immunizations. It was at 6-10 months following AVA #6 that he began to notice problems with his short term memory to include difficulty with recall, learning new information, where he placed things and birthdays, states family has commented on his memory. He reports that he continues to notice difficulty with memory and has not had it formally evaluated. He stated he did mention it to his PCM when he first noticed it approx 9yrs ago. He denies any other symptoms.
Age: 50.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Ph call from client who states she received MMR and Tdap on 3/5/10. 1 wk after receiving the vaccines her chin and glands on side of her neck became swollen. A fine rash appeared on face & arms 3-4 days ago. Symptoms are still present. No treatment yet.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Alpha 1 globulin increased, Alpha 2 globulin normal, Beta globulin normal, Blood albumin normal, Blood glucose normal
Clinical narrative: The pt received seasonal influenza IM right arm on 12/1/09 and H1N1 mist on 12/8/09 without immediate adverse reaction. The pt was healthy at the time of the vaccinations. On 12/20/09 the pt awoke and noted right lower facial weakness (drooping and the sensation of being stretched) and difficulty speaking which lasted several seconds. She reported having similar episodes each day, increasing in frequency (2-4 episodes/day) and continuing to last a few seconds. Beginning 12/23/09 the pt also noted right arm weakness and numbness associated with the facial symptoms. On 12/30/09 she noted that the episodes increased to about 6/7 per day and lasted 45-60 seconds. She was evaluated by a neurosurgeon who is a family friend. She was treated with anti-inflammatory medication and vitamin B complex IM (without improvement in the pt's symptoms). On 1/11/10 the pt experienced about 22 episodes of right sided facial weakness and right arm weakness. Additionally, the pt experienced facial pain (10/10). The pt was seen in the ER. Evaluation included a CT of the head and MRI of the brain (see below). The pt was evaluated by neurology on 1/12/10 and had a normal PE except for 1+ DTRs UE. EEG and LP performed (see below). IV SOLU-MEDROL 1gm qd for 3 days initiated without impact on the pt's symptoms. Per neurology on 1/21/10: "The MRI is more suggestive of MS than ADEM/post vaccinial encephalomyelitis considering the involvement of the corpus callosum as well as the presence of other nonenhancing lesions and overall mild symptomatology. The lack of possible presenting symptom of the underlying demyelinating disorder." Rebif initiated on 1/25/10. Pt had resolution of facial and arm symptoms within 2 weeks. Symptoms: disturbance of skin sensation, symptom, facial weakness, disturbance, speech NEC, paralysis, transient, limb.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Borrelia test negative, CSF test abnormal
Clinical narrative: The pt received seasonal influenza IM right arm on 12/1/09 and H1N1 mist on 12/8/09 without immediate adverse reaction. The pt was healthy at the time of the vaccinations. On 12/20/09 the pt awoke and noted right lower facial weakness (drooping and the sensation of being stretched) and difficulty speaking which lasted several seconds. She reported having similar episodes each day, increasing in frequency (2-4 episodes/day) and continuing to last a few seconds. Beginning 12/23/09 the pt also noted right arm weakness and numbness associated with the facial symptoms. On 12/30/09 she noted that the episodes increased to about 6/7 per day and lasted 45-60 seconds. She was evaluated by a neurosurgeon who is a family friend. She was treated with anti-inflammatory medication and vitamin B complex IM (without improvement in the pt's symptoms). On 1/11/10 the pt experienced about 22 episodes of right sided facial weakness and right arm weakness. Additionally, the pt experienced facial pain (10/10). The pt was seen in the ER. Evaluation included a CT of the head and MRI of the brain (see below). The pt was evaluated by neurology on 1/12/10 and had a normal PE except for 1+ DTRs UE. EEG and LP performed (see below). IV SOLU-MEDROL 1gm qd for 3 days initiated without impact on the pt's symptoms. Per neurology on 1/21/10: "The MRI is more suggestive of MS than ADEM/post vaccinial encephalomyelitis considering the involvement of the corpus callosum as well as the presence of other nonenhancing lesions and overall mild symptomatology. The lack of possible presenting symptom of the underlying demyelinating disorder." Rebif initiated on 1/25/10. Pt had resolution of facial and arm symptoms within 2 weeks. Symptoms: disturbance of skin sensation, symptom, facial weakness, disturbance, speech NEC, paralysis, transient, limb.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Calcium ionised decreased, Computerised tomogram head, Demyelination, Electroencephalogram, Electrophoresis protein normal
Clinical narrative: The pt received seasonal influenza IM right arm on 12/1/09 and H1N1 mist on 12/8/09 without immediate adverse reaction. The pt was healthy at the time of the vaccinations. On 12/20/09 the pt awoke and noted right lower facial weakness (drooping and the sensation of being stretched) and difficulty speaking which lasted several seconds. She reported having similar episodes each day, increasing in frequency (2-4 episodes/day) and continuing to last a few seconds. Beginning 12/23/09 the pt also noted right arm weakness and numbness associated with the facial symptoms. On 12/30/09 she noted that the episodes increased to about 6/7 per day and lasted 45-60 seconds. She was evaluated by a neurosurgeon who is a family friend. She was treated with anti-inflammatory medication and vitamin B complex IM (without improvement in the pt's symptoms). On 1/11/10 the pt experienced about 22 episodes of right sided facial weakness and right arm weakness. Additionally, the pt experienced facial pain (10/10). The pt was seen in the ER. Evaluation included a CT of the head and MRI of the brain (see below). The pt was evaluated by neurology on 1/12/10 and had a normal PE except for 1+ DTRs UE. EEG and LP performed (see below). IV SOLU-MEDROL 1gm qd for 3 days initiated without impact on the pt's symptoms. Per neurology on 1/21/10: "The MRI is more suggestive of MS than ADEM/post vaccinial encephalomyelitis considering the involvement of the corpus callosum as well as the presence of other nonenhancing lesions and overall mild symptomatology. The lack of possible presenting symptom of the underlying demyelinating disorder." Rebif initiated on 1/25/10. Pt had resolution of facial and arm symptoms within 2 weeks. Symptoms: disturbance of skin sensation, symptom, facial weakness, disturbance, speech NEC, paralysis, transient, limb.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Facial pain, Facial palsy, Facial paresis, Hyperreflexia, Hypoaesthesia
Clinical narrative: The pt received seasonal influenza IM right arm on 12/1/09 and H1N1 mist on 12/8/09 without immediate adverse reaction. The pt was healthy at the time of the vaccinations. On 12/20/09 the pt awoke and noted right lower facial weakness (drooping and the sensation of being stretched) and difficulty speaking which lasted several seconds. She reported having similar episodes each day, increasing in frequency (2-4 episodes/day) and continuing to last a few seconds. Beginning 12/23/09 the pt also noted right arm weakness and numbness associated with the facial symptoms. On 12/30/09 she noted that the episodes increased to about 6/7 per day and lasted 45-60 seconds. She was evaluated by a neurosurgeon who is a family friend. She was treated with anti-inflammatory medication and vitamin B complex IM (without improvement in the pt's symptoms). On 1/11/10 the pt experienced about 22 episodes of right sided facial weakness and right arm weakness. Additionally, the pt experienced facial pain (10/10). The pt was seen in the ER. Evaluation included a CT of the head and MRI of the brain (see below). The pt was evaluated by neurology on 1/12/10 and had a normal PE except for 1+ DTRs UE. EEG and LP performed (see below). IV SOLU-MEDROL 1gm qd for 3 days initiated without impact on the pt's symptoms. Per neurology on 1/21/10: "The MRI is more suggestive of MS than ADEM/post vaccinial encephalomyelitis considering the involvement of the corpus callosum as well as the presence of other nonenhancing lesions and overall mild symptomatology. The lack of possible presenting symptom of the underlying demyelinating disorder." Rebif initiated on 1/25/10. Pt had resolution of facial and arm symptoms within 2 weeks. Symptoms: disturbance of skin sensation, symptom, facial weakness, disturbance, speech NEC, paralysis, transient, limb.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Immunoglobulins normal, Laboratory test, Lumbar puncture, Monoclonal immunoglobulin present, Multiple sclerosis
Clinical narrative: The pt received seasonal influenza IM right arm on 12/1/09 and H1N1 mist on 12/8/09 without immediate adverse reaction. The pt was healthy at the time of the vaccinations. On 12/20/09 the pt awoke and noted right lower facial weakness (drooping and the sensation of being stretched) and difficulty speaking which lasted several seconds. She reported having similar episodes each day, increasing in frequency (2-4 episodes/day) and continuing to last a few seconds. Beginning 12/23/09 the pt also noted right arm weakness and numbness associated with the facial symptoms. On 12/30/09 she noted that the episodes increased to about 6/7 per day and lasted 45-60 seconds. She was evaluated by a neurosurgeon who is a family friend. She was treated with anti-inflammatory medication and vitamin B complex IM (without improvement in the pt's symptoms). On 1/11/10 the pt experienced about 22 episodes of right sided facial weakness and right arm weakness. Additionally, the pt experienced facial pain (10/10). The pt was seen in the ER. Evaluation included a CT of the head and MRI of the brain (see below). The pt was evaluated by neurology on 1/12/10 and had a normal PE except for 1+ DTRs UE. EEG and LP performed (see below). IV SOLU-MEDROL 1gm qd for 3 days initiated without impact on the pt's symptoms. Per neurology on 1/21/10: "The MRI is more suggestive of MS than ADEM/post vaccinial encephalomyelitis considering the involvement of the corpus callosum as well as the presence of other nonenhancing lesions and overall mild symptomatology. The lack of possible presenting symptom of the underlying demyelinating disorder." Rebif initiated on 1/25/10. Pt had resolution of facial and arm symptoms within 2 weeks. Symptoms: disturbance of skin sensation, symptom, facial weakness, disturbance, speech NEC, paralysis, transient, limb.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Neurological examination abnormal, Neutrophil count abnormal, Nuclear magnetic resonance imaging brain abnormal, Pleocytosis
Clinical narrative: The pt received seasonal influenza IM right arm on 12/1/09 and H1N1 mist on 12/8/09 without immediate adverse reaction. The pt was healthy at the time of the vaccinations. On 12/20/09 the pt awoke and noted right lower facial weakness (drooping and the sensation of being stretched) and difficulty speaking which lasted several seconds. She reported having similar episodes each day, increasing in frequency (2-4 episodes/day) and continuing to last a few seconds. Beginning 12/23/09 the pt also noted right arm weakness and numbness associated with the facial symptoms. On 12/30/09 she noted that the episodes increased to about 6/7 per day and lasted 45-60 seconds. She was evaluated by a neurosurgeon who is a family friend. She was treated with anti-inflammatory medication and vitamin B complex IM (without improvement in the pt's symptoms). On 1/11/10 the pt experienced about 22 episodes of right sided facial weakness and right arm weakness. Additionally, the pt experienced facial pain (10/10). The pt was seen in the ER. Evaluation included a CT of the head and MRI of the brain (see below). The pt was evaluated by neurology on 1/12/10 and had a normal PE except for 1+ DTRs UE. EEG and LP performed (see below). IV SOLU-MEDROL 1gm qd for 3 days initiated without impact on the pt's symptoms. Per neurology on 1/21/10: "The MRI is more suggestive of MS than ADEM/post vaccinial encephalomyelitis considering the involvement of the corpus callosum as well as the presence of other nonenhancing lesions and overall mild symptomatology. The lack of possible presenting symptom of the underlying demyelinating disorder." Rebif initiated on 1/25/10. Pt had resolution of facial and arm symptoms within 2 weeks. Symptoms: disturbance of skin sensation, symptom, facial weakness, disturbance, speech NEC, paralysis, transient, limb.