chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Tremor
Clinical narrative: Patient called to report that after receiving ZOSTAVAX vaccine, his right arm was shaking while drinking a glass of water. It was isolated and occurred only once. His arm was also blackish/blue at injection site. No other adverse event reported.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Serum sickness
Clinical narrative: Serum sickness; onset with rash 1/25/2012 but she was also prescribed Amoxicillin, starting 1/18. She had previously taken Amox without incident; also placed on TMP/SMX on 1/25/2012; serum sickness dx 1/30/2012.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Glycosylated haemoglobin, Laboratory test, Rash, Swelling
Clinical narrative: Swelling on her arm & rash to the elbow. Treated with BENADRYL.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: 2 days after flu shot (L deltoid), pt got rash to chest & (R) flexor surface elbow.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Skin lesion
Clinical narrative: Rt arm mild swelling and tenderness in the deltoid area. Patient took Ibuprofen and it helped. 1/4 inch lesion on right arm.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Anion gap normal, Antibiotic resistant Staphylococcus test negative, Band neutrophil count, Band neutrophil percentage, Basophil percentage decreased
Clinical narrative: This female subject was enrolled in a study. On 16 August 2010 and 18 October 2010, she received the 1st and 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVENAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 17 January 2011, she received 3rd dose of HIBERIX, PEDIARIX and PREVENAR 13. On 09 December 2011, she received a booster of HIBERIX and a dose of INFANRIX. On 17 December 2011, 14 months after the 2nd dose of ROTARIX, 11 months after the 3rd dose of PEDIARIX, 11 months after the 3rd dose of PREVNAR 13, eight days after the 4th dose of HIBERIX, eight days after the 1st dose of INFANRIX, this 18-month-old subject developed traumatic head injury : cephalohematoma and traumatic subdural hemorrhage. The subject was hospitalised. The events resolved on 30 December 2011. The investigator considered that there was no reasonable possibility that the cephalohematoma and traumatic subdural hemorrhage may have been caused by ROTARIX, PEDIARIX, PREVNAR 13, HIBERIX and INFANRIX and that the events were possibly due to accidental fall. Investigator Comments : 20Dec2011-CT Head WO Contrast: Findings: Nonenhanced axial images obtained from skull base to vertex. CSF spaces and ventrioles remain normal without evidence of hydrocephalus. A tiny extra-axial hyperdense collection bordering the left temporal frontal lobe best noted on images 10-20/56 has a maximum diameter of 1.5mm. Allowing for slice thickness differences on comparison exam, finding has not significantly changed and compatible with a tiny extra-axial hematoma. Reidentified is the moderate sire left frontal temporal cephalohematoma. No calvarial fracture is appreciated. There is no evidence for new interval finding. Impression: Stable left temporal frontal extra-axial tiny hematoma, probably subdural. No calvarial fracture identified. A moderate left frontal temporal cephalohematoma is unchanged. No new interval finding. 18 month old brought to clinic for evaluation for enlarging lump to head. Pt was being carried by older sibling and fell approximately 3 feet onto concrete driveway 2 days prior. No loss of consciousness, cried immediately, no emesis/crankiness, with normal activity and appetite. Lump to left side of scalp noted to be increasing in size and softer. Medical findings: 9-10 cm left parietal cephalohematoma, tender to palpation: child alert/oriented, moving all extremities. DTRs 2+. Admitted to hospital for observation and neurosurgery consult 12/19/2011. CT scan confirmed left temporal frontal subdural hematoma. No skull fracture, no edema, no mass effect. Discharged 12/20/2011 asymptomatic. January 31, 2012 (First Follow Up) 01/10/2012 spoke with mom, reports hematoma all resolved 12/30/2011 when saw neurosurgery for follow up appointment.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood chloride increased, Blood creatinine decreased, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: This female subject was enrolled in a study. On 16 August 2010 and 18 October 2010, she received the 1st and 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVENAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 17 January 2011, she received 3rd dose of HIBERIX, PEDIARIX and PREVENAR 13. On 09 December 2011, she received a booster of HIBERIX and a dose of INFANRIX. On 17 December 2011, 14 months after the 2nd dose of ROTARIX, 11 months after the 3rd dose of PEDIARIX, 11 months after the 3rd dose of PREVNAR 13, eight days after the 4th dose of HIBERIX, eight days after the 1st dose of INFANRIX, this 18-month-old subject developed traumatic head injury : cephalohematoma and traumatic subdural hemorrhage. The subject was hospitalised. The events resolved on 30 December 2011. The investigator considered that there was no reasonable possibility that the cephalohematoma and traumatic subdural hemorrhage may have been caused by ROTARIX, PEDIARIX, PREVNAR 13, HIBERIX and INFANRIX and that the events were possibly due to accidental fall. Investigator Comments : 20Dec2011-CT Head WO Contrast: Findings: Nonenhanced axial images obtained from skull base to vertex. CSF spaces and ventrioles remain normal without evidence of hydrocephalus. A tiny extra-axial hyperdense collection bordering the left temporal frontal lobe best noted on images 10-20/56 has a maximum diameter of 1.5mm. Allowing for slice thickness differences on comparison exam, finding has not significantly changed and compatible with a tiny extra-axial hematoma. Reidentified is the moderate sire left frontal temporal cephalohematoma. No calvarial fracture is appreciated. There is no evidence for new interval finding. Impression: Stable left temporal frontal extra-axial tiny hematoma, probably subdural. No calvarial fracture identified. A moderate left frontal temporal cephalohematoma is unchanged. No new interval finding. 18 month old brought to clinic for evaluation for enlarging lump to head. Pt was being carried by older sibling and fell approximately 3 feet onto concrete driveway 2 days prior. No loss of consciousness, cried immediately, no emesis/crankiness, with normal activity and appetite. Lump to left side of scalp noted to be increasing in size and softer. Medical findings: 9-10 cm left parietal cephalohematoma, tender to palpation: child alert/oriented, moving all extremities. DTRs 2+. Admitted to hospital for observation and neurosurgery consult 12/19/2011. CT scan confirmed left temporal frontal subdural hematoma. No skull fracture, no edema, no mass effect. Discharged 12/20/2011 asymptomatic. January 31, 2012 (First Follow Up) 01/10/2012 spoke with mom, reports hematoma all resolved 12/30/2011 when saw neurosurgery for follow up appointment.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood urea normal, Carbon dioxide decreased, Cephalhaematoma, Computerised tomogram abnormal, Computerised tomogram head
Clinical narrative: This female subject was enrolled in a study. On 16 August 2010 and 18 October 2010, she received the 1st and 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVENAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 17 January 2011, she received 3rd dose of HIBERIX, PEDIARIX and PREVENAR 13. On 09 December 2011, she received a booster of HIBERIX and a dose of INFANRIX. On 17 December 2011, 14 months after the 2nd dose of ROTARIX, 11 months after the 3rd dose of PEDIARIX, 11 months after the 3rd dose of PREVNAR 13, eight days after the 4th dose of HIBERIX, eight days after the 1st dose of INFANRIX, this 18-month-old subject developed traumatic head injury : cephalohematoma and traumatic subdural hemorrhage. The subject was hospitalised. The events resolved on 30 December 2011. The investigator considered that there was no reasonable possibility that the cephalohematoma and traumatic subdural hemorrhage may have been caused by ROTARIX, PEDIARIX, PREVNAR 13, HIBERIX and INFANRIX and that the events were possibly due to accidental fall. Investigator Comments : 20Dec2011-CT Head WO Contrast: Findings: Nonenhanced axial images obtained from skull base to vertex. CSF spaces and ventrioles remain normal without evidence of hydrocephalus. A tiny extra-axial hyperdense collection bordering the left temporal frontal lobe best noted on images 10-20/56 has a maximum diameter of 1.5mm. Allowing for slice thickness differences on comparison exam, finding has not significantly changed and compatible with a tiny extra-axial hematoma. Reidentified is the moderate sire left frontal temporal cephalohematoma. No calvarial fracture is appreciated. There is no evidence for new interval finding. Impression: Stable left temporal frontal extra-axial tiny hematoma, probably subdural. No calvarial fracture identified. A moderate left frontal temporal cephalohematoma is unchanged. No new interval finding. 18 month old brought to clinic for evaluation for enlarging lump to head. Pt was being carried by older sibling and fell approximately 3 feet onto concrete driveway 2 days prior. No loss of consciousness, cried immediately, no emesis/crankiness, with normal activity and appetite. Lump to left side of scalp noted to be increasing in size and softer. Medical findings: 9-10 cm left parietal cephalohematoma, tender to palpation: child alert/oriented, moving all extremities. DTRs 2+. Admitted to hospital for observation and neurosurgery consult 12/19/2011. CT scan confirmed left temporal frontal subdural hematoma. No skull fracture, no edema, no mass effect. Discharged 12/20/2011 asymptomatic. January 31, 2012 (First Follow Up) 01/10/2012 spoke with mom, reports hematoma all resolved 12/30/2011 when saw neurosurgery for follow up appointment.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Craniocerebral injury, Crying, Eosinophil percentage, Fall, Glomerular filtration rate
Clinical narrative: This female subject was enrolled in a study. On 16 August 2010 and 18 October 2010, she received the 1st and 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVENAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 17 January 2011, she received 3rd dose of HIBERIX, PEDIARIX and PREVENAR 13. On 09 December 2011, she received a booster of HIBERIX and a dose of INFANRIX. On 17 December 2011, 14 months after the 2nd dose of ROTARIX, 11 months after the 3rd dose of PEDIARIX, 11 months after the 3rd dose of PREVNAR 13, eight days after the 4th dose of HIBERIX, eight days after the 1st dose of INFANRIX, this 18-month-old subject developed traumatic head injury : cephalohematoma and traumatic subdural hemorrhage. The subject was hospitalised. The events resolved on 30 December 2011. The investigator considered that there was no reasonable possibility that the cephalohematoma and traumatic subdural hemorrhage may have been caused by ROTARIX, PEDIARIX, PREVNAR 13, HIBERIX and INFANRIX and that the events were possibly due to accidental fall. Investigator Comments : 20Dec2011-CT Head WO Contrast: Findings: Nonenhanced axial images obtained from skull base to vertex. CSF spaces and ventrioles remain normal without evidence of hydrocephalus. A tiny extra-axial hyperdense collection bordering the left temporal frontal lobe best noted on images 10-20/56 has a maximum diameter of 1.5mm. Allowing for slice thickness differences on comparison exam, finding has not significantly changed and compatible with a tiny extra-axial hematoma. Reidentified is the moderate sire left frontal temporal cephalohematoma. No calvarial fracture is appreciated. There is no evidence for new interval finding. Impression: Stable left temporal frontal extra-axial tiny hematoma, probably subdural. No calvarial fracture identified. A moderate left frontal temporal cephalohematoma is unchanged. No new interval finding. 18 month old brought to clinic for evaluation for enlarging lump to head. Pt was being carried by older sibling and fell approximately 3 feet onto concrete driveway 2 days prior. No loss of consciousness, cried immediately, no emesis/crankiness, with normal activity and appetite. Lump to left side of scalp noted to be increasing in size and softer. Medical findings: 9-10 cm left parietal cephalohematoma, tender to palpation: child alert/oriented, moving all extremities. DTRs 2+. Admitted to hospital for observation and neurosurgery consult 12/19/2011. CT scan confirmed left temporal frontal subdural hematoma. No skull fracture, no edema, no mass effect. Discharged 12/20/2011 asymptomatic. January 31, 2012 (First Follow Up) 01/10/2012 spoke with mom, reports hematoma all resolved 12/30/2011 when saw neurosurgery for follow up appointment.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematocrit normal, Haemoglobin normal, International normalised ratio, Lymphocyte percentage increased, Mass
Clinical narrative: This female subject was enrolled in a study. On 16 August 2010 and 18 October 2010, she received the 1st and 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVENAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 17 January 2011, she received 3rd dose of HIBERIX, PEDIARIX and PREVENAR 13. On 09 December 2011, she received a booster of HIBERIX and a dose of INFANRIX. On 17 December 2011, 14 months after the 2nd dose of ROTARIX, 11 months after the 3rd dose of PEDIARIX, 11 months after the 3rd dose of PREVNAR 13, eight days after the 4th dose of HIBERIX, eight days after the 1st dose of INFANRIX, this 18-month-old subject developed traumatic head injury : cephalohematoma and traumatic subdural hemorrhage. The subject was hospitalised. The events resolved on 30 December 2011. The investigator considered that there was no reasonable possibility that the cephalohematoma and traumatic subdural hemorrhage may have been caused by ROTARIX, PEDIARIX, PREVNAR 13, HIBERIX and INFANRIX and that the events were possibly due to accidental fall. Investigator Comments : 20Dec2011-CT Head WO Contrast: Findings: Nonenhanced axial images obtained from skull base to vertex. CSF spaces and ventrioles remain normal without evidence of hydrocephalus. A tiny extra-axial hyperdense collection bordering the left temporal frontal lobe best noted on images 10-20/56 has a maximum diameter of 1.5mm. Allowing for slice thickness differences on comparison exam, finding has not significantly changed and compatible with a tiny extra-axial hematoma. Reidentified is the moderate sire left frontal temporal cephalohematoma. No calvarial fracture is appreciated. There is no evidence for new interval finding. Impression: Stable left temporal frontal extra-axial tiny hematoma, probably subdural. No calvarial fracture identified. A moderate left frontal temporal cephalohematoma is unchanged. No new interval finding. 18 month old brought to clinic for evaluation for enlarging lump to head. Pt was being carried by older sibling and fell approximately 3 feet onto concrete driveway 2 days prior. No loss of consciousness, cried immediately, no emesis/crankiness, with normal activity and appetite. Lump to left side of scalp noted to be increasing in size and softer. Medical findings: 9-10 cm left parietal cephalohematoma, tender to palpation: child alert/oriented, moving all extremities. DTRs 2+. Admitted to hospital for observation and neurosurgery consult 12/19/2011. CT scan confirmed left temporal frontal subdural hematoma. No skull fracture, no edema, no mass effect. Discharged 12/20/2011 asymptomatic. January 31, 2012 (First Follow Up) 01/10/2012 spoke with mom, reports hematoma all resolved 12/30/2011 when saw neurosurgery for follow up appointment.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Mean cell volume decreased, Monocyte percentage, Neutrophil count, Neutrophil percentage decreased, Platelet count increased
Clinical narrative: This female subject was enrolled in a study. On 16 August 2010 and 18 October 2010, she received the 1st and 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVENAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 17 January 2011, she received 3rd dose of HIBERIX, PEDIARIX and PREVENAR 13. On 09 December 2011, she received a booster of HIBERIX and a dose of INFANRIX. On 17 December 2011, 14 months after the 2nd dose of ROTARIX, 11 months after the 3rd dose of PEDIARIX, 11 months after the 3rd dose of PREVNAR 13, eight days after the 4th dose of HIBERIX, eight days after the 1st dose of INFANRIX, this 18-month-old subject developed traumatic head injury : cephalohematoma and traumatic subdural hemorrhage. The subject was hospitalised. The events resolved on 30 December 2011. The investigator considered that there was no reasonable possibility that the cephalohematoma and traumatic subdural hemorrhage may have been caused by ROTARIX, PEDIARIX, PREVNAR 13, HIBERIX and INFANRIX and that the events were possibly due to accidental fall. Investigator Comments : 20Dec2011-CT Head WO Contrast: Findings: Nonenhanced axial images obtained from skull base to vertex. CSF spaces and ventrioles remain normal without evidence of hydrocephalus. A tiny extra-axial hyperdense collection bordering the left temporal frontal lobe best noted on images 10-20/56 has a maximum diameter of 1.5mm. Allowing for slice thickness differences on comparison exam, finding has not significantly changed and compatible with a tiny extra-axial hematoma. Reidentified is the moderate sire left frontal temporal cephalohematoma. No calvarial fracture is appreciated. There is no evidence for new interval finding. Impression: Stable left temporal frontal extra-axial tiny hematoma, probably subdural. No calvarial fracture identified. A moderate left frontal temporal cephalohematoma is unchanged. No new interval finding. 18 month old brought to clinic for evaluation for enlarging lump to head. Pt was being carried by older sibling and fell approximately 3 feet onto concrete driveway 2 days prior. No loss of consciousness, cried immediately, no emesis/crankiness, with normal activity and appetite. Lump to left side of scalp noted to be increasing in size and softer. Medical findings: 9-10 cm left parietal cephalohematoma, tender to palpation: child alert/oriented, moving all extremities. DTRs 2+. Admitted to hospital for observation and neurosurgery consult 12/19/2011. CT scan confirmed left temporal frontal subdural hematoma. No skull fracture, no edema, no mass effect. Discharged 12/20/2011 asymptomatic. January 31, 2012 (First Follow Up) 01/10/2012 spoke with mom, reports hematoma all resolved 12/30/2011 when saw neurosurgery for follow up appointment.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Platelet morphology, Prothrombin time prolonged, Red blood cell count normal, Red blood cell elliptocytes present, Red blood cell microcytes present
Clinical narrative: This female subject was enrolled in a study. On 16 August 2010 and 18 October 2010, she received the 1st and 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVENAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 17 January 2011, she received 3rd dose of HIBERIX, PEDIARIX and PREVENAR 13. On 09 December 2011, she received a booster of HIBERIX and a dose of INFANRIX. On 17 December 2011, 14 months after the 2nd dose of ROTARIX, 11 months after the 3rd dose of PEDIARIX, 11 months after the 3rd dose of PREVNAR 13, eight days after the 4th dose of HIBERIX, eight days after the 1st dose of INFANRIX, this 18-month-old subject developed traumatic head injury : cephalohematoma and traumatic subdural hemorrhage. The subject was hospitalised. The events resolved on 30 December 2011. The investigator considered that there was no reasonable possibility that the cephalohematoma and traumatic subdural hemorrhage may have been caused by ROTARIX, PEDIARIX, PREVNAR 13, HIBERIX and INFANRIX and that the events were possibly due to accidental fall. Investigator Comments : 20Dec2011-CT Head WO Contrast: Findings: Nonenhanced axial images obtained from skull base to vertex. CSF spaces and ventrioles remain normal without evidence of hydrocephalus. A tiny extra-axial hyperdense collection bordering the left temporal frontal lobe best noted on images 10-20/56 has a maximum diameter of 1.5mm. Allowing for slice thickness differences on comparison exam, finding has not significantly changed and compatible with a tiny extra-axial hematoma. Reidentified is the moderate sire left frontal temporal cephalohematoma. No calvarial fracture is appreciated. There is no evidence for new interval finding. Impression: Stable left temporal frontal extra-axial tiny hematoma, probably subdural. No calvarial fracture identified. A moderate left frontal temporal cephalohematoma is unchanged. No new interval finding. 18 month old brought to clinic for evaluation for enlarging lump to head. Pt was being carried by older sibling and fell approximately 3 feet onto concrete driveway 2 days prior. No loss of consciousness, cried immediately, no emesis/crankiness, with normal activity and appetite. Lump to left side of scalp noted to be increasing in size and softer. Medical findings: 9-10 cm left parietal cephalohematoma, tender to palpation: child alert/oriented, moving all extremities. DTRs 2+. Admitted to hospital for observation and neurosurgery consult 12/19/2011. CT scan confirmed left temporal frontal subdural hematoma. No skull fracture, no edema, no mass effect. Discharged 12/20/2011 asymptomatic. January 31, 2012 (First Follow Up) 01/10/2012 spoke with mom, reports hematoma all resolved 12/30/2011 when saw neurosurgery for follow up appointment.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Red blood cell morphology abnormal, Red blood cell poikilocytes present, Red cell distribution width normal, Subdural haematoma, Subdural haemorrhage
Clinical narrative: This female subject was enrolled in a study. On 16 August 2010 and 18 October 2010, she received the 1st and 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVENAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 17 January 2011, she received 3rd dose of HIBERIX, PEDIARIX and PREVENAR 13. On 09 December 2011, she received a booster of HIBERIX and a dose of INFANRIX. On 17 December 2011, 14 months after the 2nd dose of ROTARIX, 11 months after the 3rd dose of PEDIARIX, 11 months after the 3rd dose of PREVNAR 13, eight days after the 4th dose of HIBERIX, eight days after the 1st dose of INFANRIX, this 18-month-old subject developed traumatic head injury : cephalohematoma and traumatic subdural hemorrhage. The subject was hospitalised. The events resolved on 30 December 2011. The investigator considered that there was no reasonable possibility that the cephalohematoma and traumatic subdural hemorrhage may have been caused by ROTARIX, PEDIARIX, PREVNAR 13, HIBERIX and INFANRIX and that the events were possibly due to accidental fall. Investigator Comments : 20Dec2011-CT Head WO Contrast: Findings: Nonenhanced axial images obtained from skull base to vertex. CSF spaces and ventrioles remain normal without evidence of hydrocephalus. A tiny extra-axial hyperdense collection bordering the left temporal frontal lobe best noted on images 10-20/56 has a maximum diameter of 1.5mm. Allowing for slice thickness differences on comparison exam, finding has not significantly changed and compatible with a tiny extra-axial hematoma. Reidentified is the moderate sire left frontal temporal cephalohematoma. No calvarial fracture is appreciated. There is no evidence for new interval finding. Impression: Stable left temporal frontal extra-axial tiny hematoma, probably subdural. No calvarial fracture identified. A moderate left frontal temporal cephalohematoma is unchanged. No new interval finding. 18 month old brought to clinic for evaluation for enlarging lump to head. Pt was being carried by older sibling and fell approximately 3 feet onto concrete driveway 2 days prior. No loss of consciousness, cried immediately, no emesis/crankiness, with normal activity and appetite. Lump to left side of scalp noted to be increasing in size and softer. Medical findings: 9-10 cm left parietal cephalohematoma, tender to palpation: child alert/oriented, moving all extremities. DTRs 2+. Admitted to hospital for observation and neurosurgery consult 12/19/2011. CT scan confirmed left temporal frontal subdural hematoma. No skull fracture, no edema, no mass effect. Discharged 12/20/2011 asymptomatic. January 31, 2012 (First Follow Up) 01/10/2012 spoke with mom, reports hematoma all resolved 12/30/2011 when saw neurosurgery for follow up appointment.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Tenderness, White blood cell count normal
Clinical narrative: This female subject was enrolled in a study. On 16 August 2010 and 18 October 2010, she received the 1st and 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVENAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 17 January 2011, she received 3rd dose of HIBERIX, PEDIARIX and PREVENAR 13. On 09 December 2011, she received a booster of HIBERIX and a dose of INFANRIX. On 17 December 2011, 14 months after the 2nd dose of ROTARIX, 11 months after the 3rd dose of PEDIARIX, 11 months after the 3rd dose of PREVNAR 13, eight days after the 4th dose of HIBERIX, eight days after the 1st dose of INFANRIX, this 18-month-old subject developed traumatic head injury : cephalohematoma and traumatic subdural hemorrhage. The subject was hospitalised. The events resolved on 30 December 2011. The investigator considered that there was no reasonable possibility that the cephalohematoma and traumatic subdural hemorrhage may have been caused by ROTARIX, PEDIARIX, PREVNAR 13, HIBERIX and INFANRIX and that the events were possibly due to accidental fall. Investigator Comments : 20Dec2011-CT Head WO Contrast: Findings: Nonenhanced axial images obtained from skull base to vertex. CSF spaces and ventrioles remain normal without evidence of hydrocephalus. A tiny extra-axial hyperdense collection bordering the left temporal frontal lobe best noted on images 10-20/56 has a maximum diameter of 1.5mm. Allowing for slice thickness differences on comparison exam, finding has not significantly changed and compatible with a tiny extra-axial hematoma. Reidentified is the moderate sire left frontal temporal cephalohematoma. No calvarial fracture is appreciated. There is no evidence for new interval finding. Impression: Stable left temporal frontal extra-axial tiny hematoma, probably subdural. No calvarial fracture identified. A moderate left frontal temporal cephalohematoma is unchanged. No new interval finding. 18 month old brought to clinic for evaluation for enlarging lump to head. Pt was being carried by older sibling and fell approximately 3 feet onto concrete driveway 2 days prior. No loss of consciousness, cried immediately, no emesis/crankiness, with normal activity and appetite. Lump to left side of scalp noted to be increasing in size and softer. Medical findings: 9-10 cm left parietal cephalohematoma, tender to palpation: child alert/oriented, moving all extremities. DTRs 2+. Admitted to hospital for observation and neurosurgery consult 12/19/2011. CT scan confirmed left temporal frontal subdural hematoma. No skull fracture, no edema, no mass effect. Discharged 12/20/2011 asymptomatic. January 31, 2012 (First Follow Up) 01/10/2012 spoke with mom, reports hematoma all resolved 12/30/2011 when saw neurosurgery for follow up appointment.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Dyspnoea, Hypoxia, Influenza virus test positive, Pneumonia, Polymerase chain reaction
Clinical narrative: ONSET SNEEZING 8/28. FEVER 102 DEGREES 8/30 AND 8/31. PRESENTED TO PEDIATRICIAN 9/1, TREATED WITH SHOT OF ROCEPHIN, ORAL STERIOD, XOPENEX Q 2 HRS AND GAVE HIM A BREATHING MACHINE. PRESENTED TO VIA ER WITH DIFFICULTY BREATHING 9/2, DX WITH PNEUMONIA AND HYPOXIA. TREATED WITH ROCEPHIN, VANCOMYCIN, SOLUMEDROL, PEPCID, ATROVENT, ALBUTEROL, TAMIFLU OVER 3 DAY HOSPITAL COURSE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Pyrexia, Sneezing
Clinical narrative: ONSET SNEEZING 8/28. FEVER 102 DEGREES 8/30 AND 8/31. PRESENTED TO PEDIATRICIAN 9/1, TREATED WITH SHOT OF ROCEPHIN, ORAL STERIOD, XOPENEX Q 2 HRS AND GAVE HIM A BREATHING MACHINE. PRESENTED TO VIA ER WITH DIFFICULTY BREATHING 9/2, DX WITH PNEUMONIA AND HYPOXIA. TREATED WITH ROCEPHIN, VANCOMYCIN, SOLUMEDROL, PEPCID, ATROVENT, ALBUTEROL, TAMIFLU OVER 3 DAY HOSPITAL COURSE.
Age: 7.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Activated partial thromboplastin time, Blood creatine phosphokinase, Blood culture, Blood fibrinogen, Body fluid analysis
Clinical narrative: 1-27-2012 About 4 hours after the vaccine was received patient was having very bad pain in her leg. She was having trouble bending her leg. She started to develop a fever.   1-28-2012 Patient's leg had pink welts on her upper thigh. She could not bend her leg. She continued having fevers. She was still in moderate pain. In the evening I called Dr. office to find out if I should do anything for her. They told me to give her Tylenol and use cold compress. 1-29-2012 Patient's leg is very swollen, the welts have become darker pink, she is in more pain and does not bend her knee at all. I called Dr. office to ask what I should do and they said I should take her to the Urgent care. 1-29-2012 I took patient to Hospital instead of the Urgent Care. 1-29-2012 At hospital they ran blood test and performed a knee joint aspiration. They admitted her. In that time they ran more blood work, did an Xray and a MRI. 2-1-2012 Patient was discharged with a diagnosis of adverse reaction to PPSV23.
Age: 7.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein, Culture, Differential white blood cell count, Erythema, Full blood count
Clinical narrative: 1-27-2012 About 4 hours after the vaccine was received patient was having very bad pain in her leg. She was having trouble bending her leg. She started to develop a fever.   1-28-2012 Patient's leg had pink welts on her upper thigh. She could not bend her leg. She continued having fevers. She was still in moderate pain. In the evening I called Dr. office to find out if I should do anything for her. They told me to give her Tylenol and use cold compress. 1-29-2012 Patient's leg is very swollen, the welts have become darker pink, she is in more pain and does not bend her knee at all. I called Dr. office to ask what I should do and they said I should take her to the Urgent care. 1-29-2012 I took patient to Hospital instead of the Urgent Care. 1-29-2012 At hospital they ran blood test and performed a knee joint aspiration. They admitted her. In that time they ran more blood work, did an Xray and a MRI. 2-1-2012 Patient was discharged with a diagnosis of adverse reaction to PPSV23.
Age: 7.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Gram stain, International normalised ratio, Joint stiffness, Metabolic function test, Oedema peripheral
Clinical narrative: 1-27-2012 About 4 hours after the vaccine was received patient was having very bad pain in her leg. She was having trouble bending her leg. She started to develop a fever.   1-28-2012 Patient's leg had pink welts on her upper thigh. She could not bend her leg. She continued having fevers. She was still in moderate pain. In the evening I called Dr. office to find out if I should do anything for her. They told me to give her Tylenol and use cold compress. 1-29-2012 Patient's leg is very swollen, the welts have become darker pink, she is in more pain and does not bend her knee at all. I called Dr. office to ask what I should do and they said I should take her to the Urgent care. 1-29-2012 I took patient to Hospital instead of the Urgent Care. 1-29-2012 At hospital they ran blood test and performed a knee joint aspiration. They admitted her. In that time they ran more blood work, did an Xray and a MRI. 2-1-2012 Patient was discharged with a diagnosis of adverse reaction to PPSV23.
Age: 7.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia, Red blood cell sedimentation rate, Skin warm, Urticaria
Clinical narrative: 1-27-2012 About 4 hours after the vaccine was received patient was having very bad pain in her leg. She was having trouble bending her leg. She started to develop a fever.   1-28-2012 Patient's leg had pink welts on her upper thigh. She could not bend her leg. She continued having fevers. She was still in moderate pain. In the evening I called Dr. office to find out if I should do anything for her. They told me to give her Tylenol and use cold compress. 1-29-2012 Patient's leg is very swollen, the welts have become darker pink, she is in more pain and does not bend her knee at all. I called Dr. office to ask what I should do and they said I should take her to the Urgent care. 1-29-2012 I took patient to Hospital instead of the Urgent Care. 1-29-2012 At hospital they ran blood test and performed a knee joint aspiration. They admitted her. In that time they ran more blood work, did an Xray and a MRI. 2-1-2012 Patient was discharged with a diagnosis of adverse reaction to PPSV23.
Age: 7.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Activated partial thromboplastin time, Aspiration joint, Blood creatine phosphokinase, Blood culture, Blood fibrinogen
Clinical narrative: 1-27-2012 About 4 hours after the vaccine was received patient was having very bad pain in her leg. She was having trouble bending her leg. She started to develop a fever.   1-28-2012 Patient's leg had pink welts on her upper thigh. She could not bend her leg. She continued having fevers. She was still in moderate pain. In the evening I called Dr. office to find out if I should do anything for her. They told me to give her Tylenol and use cold compress. 1-29-2012 Patient's leg is very swollen, the welts have become darker pink, she is in more pain and does not bend her knee at all. I called Dr. office to ask what I should do and they said I should take her to the Urgent care. 1-29-2012 I took patient to Hospital instead of the Urgent Care. 1-29-2012 At hospital they ran blood test and performed a knee joint aspiration. They admitted her. In that time they ran more blood work, did an Xray and a MRI. 2-1-2012 Patient was discharged with a diagnosis of adverse reaction to PPSV23.
Age: 7.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Body fluid analysis, C-reactive protein, Culture, Differential white blood cell count, Erythema
Clinical narrative: 1-27-2012 About 4 hours after the vaccine was received patient was having very bad pain in her leg. She was having trouble bending her leg. She started to develop a fever.   1-28-2012 Patient's leg had pink welts on her upper thigh. She could not bend her leg. She continued having fevers. She was still in moderate pain. In the evening I called Dr. office to find out if I should do anything for her. They told me to give her Tylenol and use cold compress. 1-29-2012 Patient's leg is very swollen, the welts have become darker pink, she is in more pain and does not bend her knee at all. I called Dr. office to ask what I should do and they said I should take her to the Urgent care. 1-29-2012 I took patient to Hospital instead of the Urgent Care. 1-29-2012 At hospital they ran blood test and performed a knee joint aspiration. They admitted her. In that time they ran more blood work, did an Xray and a MRI. 2-1-2012 Patient was discharged with a diagnosis of adverse reaction to PPSV23.
Age: 7.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Full blood count, Gram stain, International normalised ratio, Metabolic function test, Mobility decreased
Clinical narrative: 1-27-2012 About 4 hours after the vaccine was received patient was having very bad pain in her leg. She was having trouble bending her leg. She started to develop a fever.   1-28-2012 Patient's leg had pink welts on her upper thigh. She could not bend her leg. She continued having fevers. She was still in moderate pain. In the evening I called Dr. office to find out if I should do anything for her. They told me to give her Tylenol and use cold compress. 1-29-2012 Patient's leg is very swollen, the welts have become darker pink, she is in more pain and does not bend her knee at all. I called Dr. office to ask what I should do and they said I should take her to the Urgent care. 1-29-2012 I took patient to Hospital instead of the Urgent Care. 1-29-2012 At hospital they ran blood test and performed a knee joint aspiration. They admitted her. In that time they ran more blood work, did an Xray and a MRI. 2-1-2012 Patient was discharged with a diagnosis of adverse reaction to PPSV23.
Age: 7.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nuclear magnetic resonance imaging, Oedema peripheral, Pain in extremity, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: 1-27-2012 About 4 hours after the vaccine was received patient was having very bad pain in her leg. She was having trouble bending her leg. She started to develop a fever.   1-28-2012 Patient's leg had pink welts on her upper thigh. She could not bend her leg. She continued having fevers. She was still in moderate pain. In the evening I called Dr. office to find out if I should do anything for her. They told me to give her Tylenol and use cold compress. 1-29-2012 Patient's leg is very swollen, the welts have become darker pink, she is in more pain and does not bend her knee at all. I called Dr. office to ask what I should do and they said I should take her to the Urgent care. 1-29-2012 I took patient to Hospital instead of the Urgent Care. 1-29-2012 At hospital they ran blood test and performed a knee joint aspiration. They admitted her. In that time they ran more blood work, did an Xray and a MRI. 2-1-2012 Patient was discharged with a diagnosis of adverse reaction to PPSV23.
Age: 7.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Urticaria, Vaccination complication, X-ray
Clinical narrative: 1-27-2012 About 4 hours after the vaccine was received patient was having very bad pain in her leg. She was having trouble bending her leg. She started to develop a fever.   1-28-2012 Patient's leg had pink welts on her upper thigh. She could not bend her leg. She continued having fevers. She was still in moderate pain. In the evening I called Dr. office to find out if I should do anything for her. They told me to give her Tylenol and use cold compress. 1-29-2012 Patient's leg is very swollen, the welts have become darker pink, she is in more pain and does not bend her knee at all. I called Dr. office to ask what I should do and they said I should take her to the Urgent care. 1-29-2012 I took patient to Hospital instead of the Urgent Care. 1-29-2012 At hospital they ran blood test and performed a knee joint aspiration. They admitted her. In that time they ran more blood work, did an Xray and a MRI. 2-1-2012 Patient was discharged with a diagnosis of adverse reaction to PPSV23.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Headache, Injected limb mobility decreased, Injection site reaction, Injection site swelling
Clinical narrative: SEVERE PAIN IN ARM - UNABLE TO USE SEVERE SWELLING AT INJECTION SITE RED RASH AT INJECTION SITE WARM SKIN AT INJECTION SITE FEVER OF 100.7 SEVERE HEADACHE - FATIGUE
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: SEVERE PAIN IN ARM - UNABLE TO USE SEVERE SWELLING AT INJECTION SITE RED RASH AT INJECTION SITE WARM SKIN AT INJECTION SITE FEVER OF 100.7 SEVERE HEADACHE - FATIGUE
Age: 1.34
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Profound vomiting without other symptoms and no sick contacts.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site mass, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site lump in a 4-year-old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX in an unknown leg. At an unspecified time after vaccination with KINRIX, the subject experienced injection site lump (golf-ball size knot at the injection site) described as a "bad reaction." At the time of reporting the outcome of the event was unspecified. Follow up received from the healthcare professional on 03 February 2012. Concurrent medical conditions included asthma. On 20 December 2011 the female subject received a dose of KINRIX as the 1st dose in series (.5 unknown, unknown, right thigh) in the series and experienced wrong vaccine administered. KINRIX is indicated as the 5th dose in the DTaP series and the 4th dose in the IPV series. The reporter noted that this was the 1st dose of KINRIX administered to the 4-year-old subject. also on 20 December 2011, the subject received unspecified dose of MMR vaccine (Non-GSK) (details unknown), 1st dose of PREVNAR 13 (.5 unknown, unknown, right thigh), unspecified dose of VARIVAX (details unknown). On 22 December 2011, 2 days after vaccination with KINRIX, MMR vaccine (Non-GSK), PREVNAR 13 and VARIVAX, the subject experienced injection site lump. The healthcare professional noted that the events could have been associated with KINRIX, MMR vaccine, PREVNAR 13 and VARIVAX as all were given at the same time, but left relationship to GSK product as unknown. The healthcare professional considered the events were clinically significant (or requiring intervention). On 20 January 2012, the events were resolved.
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Computerised tomogram, Gait disturbance, Hypoaesthesia, Laboratory test, Lumbar puncture
Clinical narrative: Pt going overseas, had typhoid inj. 27Jan12, felt fine, 2 days later while standing at sink numbness in face, tingling in fingers, & unsteady, legs went out from underneath him - went to - then to med ctr. Admitted MRI, CT scan, Labs, & LP - sx resolved & D/C from hospital - Pt had typhoid inj. in 2005 without difficulties.
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Pt going overseas, had typhoid inj. 27Jan12, felt fine, 2 days later while standing at sink numbness in face, tingling in fingers, & unsteady, legs went out from underneath him - went to - then to med ctr. Admitted MRI, CT scan, Labs, & LP - sx resolved & D/C from hospital - Pt had typhoid inj. in 2005 without difficulties.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema
Clinical narrative: Redness developed 2/7, on 2/10. Redness measured 9x7 cm.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site oedema, Injection site swelling, Urticaria
Clinical narrative: Swelling - edema of Lt upper deltoid. Improved in 48-72h. Followed by acute urticaria. Treatment - BENADRYL po.
Age: 0.09
Sex: M
Vaccine: HEP
Symptoms: Endotracheal intubation, Intensive care, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
Clinical narrative: Pt preemie received SYNAGIS 12/16/11 in NICU. Pt developed RSV, was admitted to PICU, intubated for 14 days, and finally discharged after 18 days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 5 in diameter of redness inferior to site of administration. Red/swollen/painful/warm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: 2/4/12 redness at site, swelling. 2/4/12 E.R. visit Rx Cephalexin Dx cellulitis. 2/5/12 E.R. visit 2 shots antibiotic & Rx another antibiotic. Dx - Cellulitis. Fu with PMD today 2/6 seems "a little better" & hydrocortisone cream for itchiness.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema multiforme, Oedema peripheral
Clinical narrative: Pt. received vaccines 1/27/12, developed rash 2 days after receiving vaccines. Rash was erythema multiforme, associated with edemas of hands & feet.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, and pain to injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Autoimmune thrombocytopenia, Haematochezia, Haematuria, Packed red blood cell transfusion
Clinical narrative: Initial case was retrieved from the scientific literature on 03 February 2012. Verbatim from abstract: "BACKGROUND: The risk of immune thrombocytopenic purpura (ITP) after childhood vaccines other than MMR is unknown. METHODS: Using data from 5 managed care organizations from 2000 to 2009, we identified a cohort of 1.8 million children ages 6 weeks to 17 years. Potential ITP cases were identified by using diagnostic codes and platelet counts. All cases were verified by chart review. Incidence rate ratios were calculated comparing the risk of ITP in risk (1 to 42 days after vaccination) and control periods. RESULTS: There were 197 chart-confirmed ITP cases out of 1.8 million children in the cohort. There was no elevated risk of ITP after any vaccine in early childhood other than MMR in the 12- to 19-month age group. There was a significantly elevated risk of ITP after hepatitis A vaccine at 7 to 17 years of age, and for varicella vaccine and Tdap vaccine at 11 to 17 years of age. For hepatitis A, varicella, and Tdap vaccines, elevated risks were based on one to two vaccine-exposed cases. Most cases were acute and mild with no long-term sequelae. CONCLUSIONS: ITP is unlikely after early childhood vaccines other than MMR. Because of the small number of exposed cases and potential confounding, the possible association or ITP with hepatitis A, varicella, and Tdap vaccines in older children requires further investigation." Verbatim from the article: "Of the 6 cases of serious adverse events, only one was a vaccine-exposed case, a 4-year-old girl who developed Immune Thrombocytopenic Purpura (ITP), complicated by hematochezia and hematuria requiring a packed red blood cell transfusion 4 weeks after receiving DTaP, MMR, and IPV". Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Haematochezia, Haematuria, Packed red blood cell transfusion, Thrombocytopenic purpura
Clinical narrative: Initial case was retrieved from the scientific literature on 03 February 2012. Verbatim from abstract: "BACKGROUND: The risk of immune thrombocytopenic purpura (ITP) after childhood vaccines other than MMR is unknown. METHODS: Using data from 5 managed care organizations from 2000 to 2009, we identified a cohort of 1.8 million children ages 6 weeks to 17 years. Potential ITP cases were identified by using diagnostic codes and platelet counts. All cases were verified by chart review. Incidence rate ratios were calculated comparing the risk of ITP in risk (1 to 42 days after vaccination) and control periods. RESULTS: There were 197 chart-confirmed ITP cases out of 1.8 million children in the cohort. There was no elevated risk of ITP after any vaccine in early childhood other than MMR in the 12- to 19-month age group. There was a significantly elevated risk of ITP after hepatitis A vaccine at 7 to 17 years of age, and for varicella vaccine and Tdap vaccine at 11 to 17 years of age. For hepatitis A, varicella, and Tdap vaccines, elevated risks were based on one to two vaccine-exposed cases. Most cases were acute and mild with no long-term sequelae. CONCLUSIONS: ITP is unlikely after early childhood vaccines other than MMR. Because of the small number of exposed cases and potential confounding, the possible association or ITP with hepatitis A, varicella, and Tdap vaccines in older children requires further investigation." Verbatim from the article: "Of the 6 cases of serious adverse events, only one was a vaccine-exposed case, a 4-year-old girl who developed Immune Thrombocytopenic Purpura (ITP), complicated by hematochezia and hematuria requiring a packed red blood cell transfusion 4 weeks after receiving DTaP, MMR, and IPV". Documents held by sender: None.