chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Dry skin, Skin warm, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 13 years old female patient with allergies to pollen, allergies to animal dander and NKDA. The patient was vaccinated IM with dose 1 GARDASIL (lot # 671994/1537AA) on right arm on 30-MAY-2012. No other co-suspects were reported. Concomitant medications included MENACTRA (lot # U3778AA, IM, dose 1, on left arm), HAVRIX (lot # AHAVB550AA, IM, dose 1, on left arm) and fexofenadine hydrochloride. On 30-MAY-2012 the patient experienced syncopal episode approximately 2 minutes after last immunisation administration, episode lasting only a few seconds, vital signs stable-BP 120/80 and pulse 84, skin warm and dry. 1 day after onset of therapy. No treatment information was reported. At the time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site papule
Clinical narrative: Information has been received from a physician concerning a 5 year old male patient who on an unknown date was vaccinated SC with a 0.5 mL dose of MMR II (lot # not provided) and a dose of VARIVAX (route, dose and lot # not provided) administered in the same arm. The physician stated that the patient developed a dramatic rash "itchy and red" at the injection site. At the time of the report, the patient was recovering from the events. The patient sought unspecified medical attention. Follow-up information from the physician revealed that the patient (birth weight 8 lb 13 oz, 1 sibling) was a 5 year old male with no significant medical history, no known drug allergies, birth defects or medical conditions, no illness at time of vaccination and no adverse events following prior vaccination who on 18-MAY-2012 was vaccinated at the private doctor's office/hospital with the first dose of M-M-R II in his left arm (lot # 1571AA) and the first dose of VARIVAX (Merck) in his left arm (lot # 1909AA). The physician indicated that on 22-MAY-2012, the patient developed erythema, swelling, itching and rash. On 22-MAY-2012, the patient was seen with small erythema area at vaccine site. On 25-MAY-2012, the patient was seen with increase size of rash 8 cm x 8 cm, erythema, oedema, itchy. No laboratory tests were performed. On an unknown date, the patient recovered from the events. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 5 year old male patient who on an unknown date was vaccinated SC with a 0.5 mL dose of MMR II (lot # not provided) and a dose of VARIVAX (route, dose and lot # not provided) administered in the same arm. The physician stated that the patient developed a dramatic rash "itchy and red" at the injection site. At the time of the report, the patient was recovering from the events. The patient sought unspecified medical attention. Follow-up information from the physician revealed that the patient (birth weight 8 lb 13 oz, 1 sibling) was a 5 year old male with no significant medical history, no known drug allergies, birth defects or medical conditions, no illness at time of vaccination and no adverse events following prior vaccination who on 18-MAY-2012 was vaccinated at the private doctor's office/hospital with the first dose of M-M-R II in his left arm (lot # 1571AA) and the first dose of VARIVAX (Merck) in his left arm (lot # 1909AA). The physician indicated that on 22-MAY-2012, the patient developed erythema, swelling, itching and rash. On 22-MAY-2012, the patient was seen with small erythema area at vaccine site. On 25-MAY-2012, the patient was seen with increase size of rash 8 cm x 8 cm, erythema, oedema, itchy. No laboratory tests were performed. On an unknown date, the patient recovered from the events. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Abdominal pain upper, Back pain, Blindness, Convulsion, Gene mutation identification test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Abnormal behaviour, Alanine aminotransferase increased, Alpers' disease
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Aspartate aminotransferase increased, Asthenia, Aura, Back pain, Biopsy brain abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Biopsy muscle abnormal, Blindness, Blindness cortical, Blood calcium decreased, Blood chloride increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: CSF protein increased, Clostridium difficile colitis, Confusional state, Convulsion, Disturbance in social behaviour
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Dyskinesia, Encephalitis autoimmune, Encephalopathy, Endotracheal intubation, Epistaxis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Erythema, Gait disturbance, Gaze palsy, Gene mutation, Gene mutation identification test positive
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Hallucination, Head injury, Headache, Hemiplegia, Hyperpyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Hypertension, Hyporesponsive to stimuli, Hypotonia, Illiteracy, Immunoglobulin therapy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Intensive care, Labile blood pressure, Lethargy, Lymphocyte percentage decreased, MELAS syndrome
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Mechanical ventilation, Mental status changes, Mood swings, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Myoclonus, Nausea, Neutrophil percentage increased, Nystagmus, Pancreatitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Partial seizures, Photopsia, Pneumonia, Protein total decreased, Restriction fragment-length polymorphism analysis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Retching, Seizure cluster, Somnolence, Speech disorder, Status epilepticus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Tic, Tracheostomy, Unresponsive to stimuli, Visual impairment, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, chronic abdominal pain, heart murmurs, persistent cough, environmental allergies and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 05-DEC-2007. Other suspect therapies included FLUMIST with dose information as (UNK) on 05-DEC-2007. No concomitant medications were reported. ORA-01489: result of string concatenation is too long. No treatment information was reported. The outcome of abdominal pain, vomiting, visual impairment, unresponsive to stimuli, tracheostomy, tic, status epilepticus, speech disorder, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hyporesponsive to stimuli, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour and abdominal pain upper is unknown. The relatedness for abdominal pain, somnolence, seizure cluster, retching, pneumonia, photopsia, partial seizures, pancreatitis, nystagmus, nausea, myoclonus, musculoskeletal stiffness, muscle twitching, mood swings, mental status change, mechanical ventilation, MELAS syndrome, lethargy, labile blood pressure, intensive care, immunoglobulin therapy, illiteracy, hypotonia, hypertension, hyperpyrexia, hemiplegia, headache, head injury, hallucination, gaze palsy, gait disturbance, erythema, epistaxis, enteral nutrition, endotracheal intubation, encephalopathy, encephalitis autoimmune, dyskinesia, disturbance in social behaviour, convulsion, confusional state, clostridium difficile colitis, blindness cortical, blindness, biopsy muscle, back pain, aura, asthenia, Alpers disease, abnormal behaviour, abdominal pain upper and hyporesponsive to stimuli is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Malaise, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old male patient with Attention deficit/hyperactivity disorder (ADHD) was vaccinated IM on the right arm with the first dose of GARDASIL (lot # 671994/1537AA) on 30-MAY-2012. Concomitant medications included: VYVANSE. On 30-MAY-2012 the patient experienced Malaise and vomiting. The patient became ill with vomiting almost immediately after receiving vaccine. The patient was put in an exam room to lie down, blood pressure (BP) was taken (ok). Advised to remain at office for observation (which is routine after this vaccine, for 15 minutes) and wait for a second blood pressure (BP). The patient left before being released by the Medical Assistant. Follow up phone call a few hours later revealed that the patient continued to vomit for a few hours after leaving the office. Home to rest and push fluids, Mom was advised to call the next day if still any symptoms. The outcome of vomiting and became ill was unknown. The original reporting source was not provided. Additional information is not expected.