chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Polymerase chain reaction, Pyrexia, Red blood cells CSF positive, Somnolence, Tremor
Clinical narrative: This serious case was extracted from the VAERS database on 28 March 2009 (reference number 327552). A 12 year old male patient received ADACEL and MENACTRA (lot number not reported) intramuscularly on 26 September 2008. On 08 October 2008, the patient developed meningoencephalitis, altered mental status requiring intubation, fever, first time tonic clonic seizure, and was incontinent of urine. The patient required mechanical ventilation. Records stated that the patient had a fight at school, became more sleepy, fell off the couch with shaking movements observed, and foaming at the mouth. The patient was unresponsive to painful stimuli. CSF WBC 158, RBC 4, Protein 97, Glucose 83, Varicella PCR was pending. CT scan was negative. Lumbar puncture showed leukocytosis with lymphocytic predominance all consistent with viral meningoencephalitis. The patient was hospitalized from 05 October 2008 to 11 October 2008. The discharge diagnosis was viral encephalitis. Outcome was reported as life threatening.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Unresponsive to stimuli, Urinary incontinence
Clinical narrative: This serious case was extracted from the VAERS database on 28 March 2009 (reference number 327552). A 12 year old male patient received ADACEL and MENACTRA (lot number not reported) intramuscularly on 26 September 2008. On 08 October 2008, the patient developed meningoencephalitis, altered mental status requiring intubation, fever, first time tonic clonic seizure, and was incontinent of urine. The patient required mechanical ventilation. Records stated that the patient had a fight at school, became more sleepy, fell off the couch with shaking movements observed, and foaming at the mouth. The patient was unresponsive to painful stimuli. CSF WBC 158, RBC 4, Protein 97, Glucose 83, Varicella PCR was pending. CT scan was negative. Lumbar puncture showed leukocytosis with lymphocytic predominance all consistent with viral meningoencephalitis. The patient was hospitalized from 05 October 2008 to 11 October 2008. The discharge diagnosis was viral encephalitis. Outcome was reported as life threatening.
Age: 11.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Eye swelling, Injection site erythema, Streptococcal identification test negative, Swelling face, Urine analysis normal
Clinical narrative: Initial information was received on 03 November 2008 from the CDC (Center for Disease Control and Detection), under VAERS reference number 328059-1.  A 11 year old male patient with a history of asthma received an injection of FLUZONE (lot number U2784GA) and ADACEL (lot number UF452CA) on 08 October 2008.  On 10 October 2008 the patient had 8cm of redness around the injection sites the day after vaccines were administered.  Two days after he had swelling of the left side of the face and his eye was swollen shut.  His temperature was 98.7, blood pressure was 118/88.  A urinalysis was normal and a streptococcal identification test was negative.  Treatment included BENADRYL and ORAPRED.  The patient was not recovered at the time of the report.  List of Documents held by Sender:  None.
Age: 12.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP, VARCEL, FLUN3, MNQ, TDAP, VARCEL, FLUN3, HEPA, MNQ, TDAP
Symptoms: Dizziness, Heart rate normal, Nausea, Oxygen saturation normal, Vomiting
Clinical narrative: This non-serious case was received from a health professional in the United States on 13 October 2008. A 12-year old female patient, with no reported medical history, received the following vaccines on 13 October 2008: an intramuscular right deltoid injection of (lot number C2767AA), an intramuscular left deltoid injection of MENACTRA (lot number U2618AA), a subcutaneous right arm injection of VARIVAX (Merck, lot number 4051X/1140X), and FLUMIST (Medimmune, lot number 500545P) administered nasally. Additionally the patient's mother had requested that a lead test be performed, and so the patient underwent capillary phlebotomy. Approximately 10 minutes after vaccination, the patient complained of dizziness, lightheadedness, and nausea. She also had one episode of emesis. Pulse oximetry was 98%, and heart rate 78 beats per minute. The event recovered after 30 to 45 minutes, and the patient was able to ambulate to the car with her mother. She had no further complaints. Follow-up information received on 12 November 2008 from a health care professional. The patient had not experienced any adverse event with prior vaccinations. The episode of lightheadedness, nausea and emesis resolved with rest and fluids. The patient experienced no further sequelae. No further information is expected. Documents held by sender: None
Age: 12.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP, VARCEL, FLUN3, MNQ, TDAP, VARCEL, FLUN3, HEPA, MNQ, TDAP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: This non-serious case was received from a health professional in the United States on 13 October 2008. A 12-year old female patient, with no reported medical history, received the following vaccines on 13 October 2008: an intramuscular right deltoid injection of (lot number C2767AA), an intramuscular left deltoid injection of MENACTRA (lot number U2618AA), a subcutaneous right arm injection of VARIVAX (Merck, lot number 4051X/1140X), and FLUMIST (Medimmune, lot number 500545P) administered nasally. Additionally the patient's mother had requested that a lead test be performed, and so the patient underwent capillary phlebotomy. Approximately 10 minutes after vaccination, the patient complained of dizziness, lightheadedness, and nausea. She also had one episode of emesis. Pulse oximetry was 98%, and heart rate 78 beats per minute. The event recovered after 30 to 45 minutes, and the patient was able to ambulate to the car with her mother. She had no further complaints. Follow-up information received on 12 November 2008 from a health care professional. The patient had not experienced any adverse event with prior vaccinations. The episode of lightheadedness, nausea and emesis resolved with rest and fluids. The patient experienced no further sequelae. No further information is expected. Documents held by sender: None
Age: 27.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cough, Ocular hyperaemia, Pruritus, Throat irritation, Urticaria
Clinical narrative: This serious case was extracted from the VAERS database via QSCAN on 24 February 2009 (VAERS identification number 329066). A 27-year-old female patient, whose past medical history was not provided, had received on 15 October 2008 a first intramuscular injection of ADACEL (lot number C2689AA); and an intramuscular injection of FLUZONE SV 2008-2009 (lot number U2756AA). The sites of administration for both vaccines were not provided. Approximately 10 minutes post-vaccination (also reported as 31 days post-vaccination on 15 November 2008), the patient developed hives, red eyes, itching, cough and scratchy throat. The patient presented to the emergency room and was administered 0.2 mL of Epinephrine 1:1000 at 11:21am, and BENADRYL 25mg (IV) at 11:25am, and oral BENADRYL 50mg at 11:50am. The patient's vital signs were stable throughout and she was discharged to home at 12:20am in stable condition. The patient recovered (date not provided). Documents held by sender: None.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary mass, Injected limb mobility decreased, Local swelling
Clinical narrative: Initial report received from a health care professional on 02 December 2008. A 37-year-old patient, with history of swelling in arm pit following a flu vaccination, received an intramuscular left arm injection of ADACEL (lot number C3031AA) on 23 November 2008 and the following day, his arm was stiff. Gradually, a lump in his axilla area developed. As of 27 November 2008, there was swelling to his chest area (on the same side of injection). Patient outcome was not reported. Follow up information was received on 08 January 2009 from a health care professional. The patient did not receive any prior doses of ADACEL. The patient reported having had a "reaction to a flu vaccine" in the past. No other details were provided. The reporter confirmed that the lump in the axilla and the stiffness occurred in the vaccinated limb. The axillary lump appeared one day post vaccination. The patient was treated with MOTRIN 800 mg orally three times a day. The patient made a full recovery. No other information was provided. The reporter of this case is the same as case 2008-03860. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Antinuclear antibody, Burning sensation, Chest X-ray, Full blood count, Headache
Clinical narrative: Initial report received on 10 November 2008 from a consumer. A 41-year-old female patient, with no concurrent illnesses, and a history of sinusitis and allergy to sulfa, had received a first 0.5 mL intramuscular left deltoid injection of ADACEL (lot number "unknown") on 29 October 2008. The patient had received the ADACEL vaccine for post-exposure to a child who had pertussis. Within 24 hours post-vaccination, on 30 October 2008, the patient developed a "knot" on the left deltoid that was the sized of a quarter. The left arm was sore and painful to raise. The patient also had a headache for one week after receiving the ADACEL. The following day on 31 October 2008, the patient developed a "knot" on the left clavicle as well. The knot at the injection site and the knot on the left clavicle still persists. No relevant diagnostic tests or laboratory data were performed. It was not reported whether the patient received any corrective treatment. The patient is scheduled to be evaluated by a physician the week of 10 November 2008. At the time of this report, the patient had not recovered. Follow up information was received on 08 December 2008 from a health care professional. The lot number for ADACEL was C2720AA. An assessment and ultrasound was completed for a lymph node located in the clavicle area. The results revealed a benign appearing solid nodule consistent with a lymph node (date of the ultrasound was not provided). A new nodule was present in the left axilla (onset date was not provided). No further information was provided. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Induration, Lymphadenopathy, Mass, Pain, Pain in extremity
Clinical narrative: Initial report received on 10 November 2008 from a consumer. A 41-year-old female patient, with no concurrent illnesses, and a history of sinusitis and allergy to sulfa, had received a first 0.5 mL intramuscular left deltoid injection of ADACEL (lot number "unknown") on 29 October 2008. The patient had received the ADACEL vaccine for post-exposure to a child who had pertussis. Within 24 hours post-vaccination, on 30 October 2008, the patient developed a "knot" on the left deltoid that was the sized of a quarter. The left arm was sore and painful to raise. The patient also had a headache for one week after receiving the ADACEL. The following day on 31 October 2008, the patient developed a "knot" on the left clavicle as well. The knot at the injection site and the knot on the left clavicle still persists. No relevant diagnostic tests or laboratory data were performed. It was not reported whether the patient received any corrective treatment. The patient is scheduled to be evaluated by a physician the week of 10 November 2008. At the time of this report, the patient had not recovered. Follow up information was received on 08 December 2008 from a health care professional. The lot number for ADACEL was C2720AA. An assessment and ultrasound was completed for a lymph node located in the clavicle area. The results revealed a benign appearing solid nodule consistent with a lymph node (date of the ultrasound was not provided). A new nodule was present in the left axilla (onset date was not provided). No further information was provided. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Red blood cell sedimentation rate, Ultrasound scan, X-ray
Clinical narrative: Initial report received on 10 November 2008 from a consumer. A 41-year-old female patient, with no concurrent illnesses, and a history of sinusitis and allergy to sulfa, had received a first 0.5 mL intramuscular left deltoid injection of ADACEL (lot number "unknown") on 29 October 2008. The patient had received the ADACEL vaccine for post-exposure to a child who had pertussis. Within 24 hours post-vaccination, on 30 October 2008, the patient developed a "knot" on the left deltoid that was the sized of a quarter. The left arm was sore and painful to raise. The patient also had a headache for one week after receiving the ADACEL. The following day on 31 October 2008, the patient developed a "knot" on the left clavicle as well. The knot at the injection site and the knot on the left clavicle still persists. No relevant diagnostic tests or laboratory data were performed. It was not reported whether the patient received any corrective treatment. The patient is scheduled to be evaluated by a physician the week of 10 November 2008. At the time of this report, the patient had not recovered. Follow up information was received on 08 December 2008 from a health care professional. The lot number for ADACEL was C2720AA. An assessment and ultrasound was completed for a lymph node located in the clavicle area. The results revealed a benign appearing solid nodule consistent with a lymph node (date of the ultrasound was not provided). A new nodule was present in the left axilla (onset date was not provided). No further information was provided. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Axillary mass, Headache, Injection site mass, Nodule, Pain
Clinical narrative: Initial report received on 10 November 2008 from a consumer. A 41-year-old female patient, with no concurrent illnesses, and a history of sinusitis and allergy to sulfa, had received a first 0.5 mL intramuscular left deltoid injection of ADACEL (lot number "unknown") on 29 October 2008. The patient had received the ADACEL vaccine for post-exposure to a child who had pertussis. Within 24 hours post-vaccination, on 30 October 2008, the patient developed a "knot" on the left deltoid that was the sized of a quarter. The left arm was sore and painful to raise. The patient also had a headache for one week after receiving the ADACEL. The following day on 31 October 2008, the patient developed a "knot" on the left clavicle as well. The knot at the injection site and the knot on the left clavicle still persists. No relevant diagnostic tests or laboratory data were performed. It was not reported whether the patient received any corrective treatment. The patient is scheduled to be evaluated by a physician the week of 10 November 2008. At the time of this report, the patient had not recovered. Follow up information was received on 08 December 2008 from a health care professional. The lot number for ADACEL was C2720AA. An assessment and ultrasound was completed for a lymph node located in the clavicle area. The results revealed a benign appearing solid nodule consistent with a lymph node (date of the ultrasound was not provided). A new nodule was present in the left axilla (onset date was not provided). No further information was provided. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, Ultrasound scan abnormal
Clinical narrative: Initial report received on 10 November 2008 from a consumer. A 41-year-old female patient, with no concurrent illnesses, and a history of sinusitis and allergy to sulfa, had received a first 0.5 mL intramuscular left deltoid injection of ADACEL (lot number "unknown") on 29 October 2008. The patient had received the ADACEL vaccine for post-exposure to a child who had pertussis. Within 24 hours post-vaccination, on 30 October 2008, the patient developed a "knot" on the left deltoid that was the sized of a quarter. The left arm was sore and painful to raise. The patient also had a headache for one week after receiving the ADACEL. The following day on 31 October 2008, the patient developed a "knot" on the left clavicle as well. The knot at the injection site and the knot on the left clavicle still persists. No relevant diagnostic tests or laboratory data were performed. It was not reported whether the patient received any corrective treatment. The patient is scheduled to be evaluated by a physician the week of 10 November 2008. At the time of this report, the patient had not recovered. Follow up information was received on 08 December 2008 from a health care professional. The lot number for ADACEL was C2720AA. An assessment and ultrasound was completed for a lymph node located in the clavicle area. The results revealed a benign appearing solid nodule consistent with a lymph node (date of the ultrasound was not provided). A new nodule was present in the left axilla (onset date was not provided). No further information was provided. Documents held by sender: None.
Age: 76.0
Sex: M
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Angioedema, Blood culture negative, Complement factor C3, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old male who on 27-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 664320/0560Y), subcutaneously in the back of one of his arms (unspecified which one). Postvaccination on 16-JUN-2009 the patient developed welts, rash all over the body and angioedema. The patient was hospitalized on 16-JUN-2009, he was inpatient for 2 days, then released from the hospital. The patient was treated with p10/20/09:  Manufacturer adverse drug event report received.rednisone, hydroxyzine and ranitidine. The pharmacist believed that the patient had recovered. The pharmacist considered the events to be serious and other important medical events. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Angioedema, Rash generalised, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old male who on 27-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 664320/0560Y), subcutaneously in the back of one of his arms (unspecified which one). Postvaccination on 16-JUN-2009 the patient developed welts, rash all over the body and angioedema. The patient was hospitalized on 16-JUN-2009, he was inpatient for 2 days, then released from the hospital. The patient was treated with p10/20/09:  Manufacturer adverse drug event report received.rednisone, hydroxyzine and ranitidine. The pharmacist believed that the patient had recovered. The pharmacist considered the events to be serious and other important medical events. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Angioedema, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old male who on 27-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 664320/0560Y), subcutaneously in the back of one of his arms (unspecified which one). Postvaccination on 16-JUN-2009 the patient developed welts, rash all over the body and angioedema. The patient was hospitalized on 16-JUN-2009, he was inpatient for 2 days, then released from the hospital. The patient was treated with p10/20/09:  Manufacturer adverse drug event report received.rednisone, hydroxyzine and ranitidine. The pharmacist believed that the patient had recovered. The pharmacist considered the events to be serious and other important medical events. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Dyspnoea, Erythema, Eyelid oedema, Tachycardia
Clinical narrative: Coughing, shortness of breath edema of eyelids, erythema, tachycardia.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Allergy to vaccine, Blood test, Body temperature increased, Convulsion
Clinical narrative: Imun given Thursday - 6/18/09 approx. 9:30 AM. Mother reports Friday 6/19/09 AM - had increase temp of 100.8 - never went higher then that - gave OTC med's. At approx. 6:45 pm. 6/19/09 - child had a seizure. Was taken to hospital ER. At that time hospital did a work-up. Mother reports did blood work-up and a spinal tap. Was transferred to hosp ICU at approx. 3:00 AM Sat. 6/20/09. Was discharged from ICU at approx. 1:00 pm Sat. 6/20/09. Dx with Pertussis allergic reaction. Admitted to hosp with extreme agitation and vomiting on 06/22/09. Discharged 6/23/09 with Dx: Dehydration. Mother reported that with 1st and 2nd set of Imun's within 2 weeks child had issues with Resp. illness -was eval. per PMD and that neither one was Imun related.  7/15/09 MR received for DOS 6/20/09 with D/C DX:  Possible seizure 2' to DPT. Pt presented after episode of eye deviation and vomiting with low grade fever (100.8'F) and irritability. Admitted for observation with no further episodes.  7/21/09 MR received for DOS 6/23-23/09 with D/C DX: mild isonatremic dehydration, treated, resolved.  Acute gastroenteriitis. Fussiness due to same, resolved.  Pt presented with 2 day hx of vomiting, diarrhea, decreased urine output and activity and inconsolability.  Lethargic and fatigued-looking on PE. Improved with IVF.  ICD9: 276.51, 558.9, 530.81
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Dehydration, Intensive care, Lumbar puncture, Vomiting
Clinical narrative: Imun given Thursday - 6/18/09 approx. 9:30 AM. Mother reports Friday 6/19/09 AM - had increase temp of 100.8 - never went higher then that - gave OTC med's. At approx. 6:45 pm. 6/19/09 - child had a seizure. Was taken to hospital ER. At that time hospital did a work-up. Mother reports did blood work-up and a spinal tap. Was transferred to hosp ICU at approx. 3:00 AM Sat. 6/20/09. Was discharged from ICU at approx. 1:00 pm Sat. 6/20/09. Dx with Pertussis allergic reaction. Admitted to hosp with extreme agitation and vomiting on 06/22/09. Discharged 6/23/09 with Dx: Dehydration. Mother reported that with 1st and 2nd set of Imun's within 2 weeks child had issues with Resp. illness -was eval. per PMD and that neither one was Imun related.  7/15/09 MR received for DOS 6/20/09 with D/C DX:  Possible seizure 2' to DPT. Pt presented after episode of eye deviation and vomiting with low grade fever (100.8'F) and irritability. Admitted for observation with no further episodes.  7/21/09 MR received for DOS 6/23-23/09 with D/C DX: mild isonatremic dehydration, treated, resolved.  Acute gastroenteriitis. Fussiness due to same, resolved.  Pt presented with 2 day hx of vomiting, diarrhea, decreased urine output and activity and inconsolability.  Lethargic and fatigued-looking on PE. Improved with IVF.  ICD9: 276.51, 558.9, 530.81
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Intussusception, Surgery
Clinical narrative: Intussusception requiring surgical reduction.  12/10/2009 Received ED records for 6/16-6/18/2009, DC DX Intussusception which was successively reduced. ICD-9 560.0   patient with c/o's nausea/vomiting, fever, lethargy, progressive sx x 3 days. Blood per rectum,  Tx: IVF, IV ABX, Telemetry. Air enema partially reduced IS & patient transfered to higher level of care.  Repeat air enema done.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Cough, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Daughter has adverse reaction to Gardasil, she has had continuous fever 104 07/10/09 nausea Dr thought might be strep, however strep test negative.  Continues to have high fever, no appetite, sore throat, cough.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcal identification test negative
Clinical narrative: Daughter has adverse reaction to Gardasil, she has had continuous fever 104 07/10/09 nausea Dr thought might be strep, however strep test negative.  Continues to have high fever, no appetite, sore throat, cough.
Age: 0.2
Sex: F
Vaccine: DTAP, RV5
Symptoms: Vomiting
Clinical narrative: At 2 mo, child was given her 1st dose of ROTATEQ.  She immediately vomited.  It was repeated within minutes, + she vomited again.  Today, she was again given ROTATEQ, + after administering the 1st 1/2, she vomited, + when 2nd 1/2 was given, she vomited a large amt. of stomach contents.  On both occasions, child had had a well child exam with very normal findings + no history of frequent vomiting.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Electrocardiogram normal, Grand mal convulsion, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female patient who on 18-JUN-2009 was vaccinated with 0.65 ml of the first dose of GARDASIL (Lot:661766/0652X). There was no concomitant medication. Immediately after vaccination the patient had a seizure. They called an ambulance, and by the time the ambulance got there the patient was fine and laughing and did not need to leave in the ambulance. Additional information has been received from an office person who stated that the patient's DOB was 13-MAY-1992. After the 17 year old female patient received GARDASIL she began to shake, became unconscious and had a tonic- clonic seizure that lasted for 15 seconds. An Ambulance was called to take the patient to the hospital. The patient "came to and was fine". The patient was not postictal, had no rash and had no difficulty breathing. The patient's blood pressure and EKG were normal. The patient's mother did not want the patient to go to the Emergency Room. The physician evaluated the patient and recommended that the patient have a CT scan of the brain and an EEG. The patient was approved for both diagnostic tests. The patient's mother took the patient home. Upon internal review, tonic-clonic seizure was considered to be an Other Important Medical Event. Additional information has been requested.  7/16/09 PCP recs rec'd.  WCC 6/18/09 with normal exam except hematoma under 2 toe nails.  HPV#1 given. Pt immediately devloped pallor and syncope with tonic/clonic seizure activity lasting 5-10 sec.  EMS called but parent declined transport.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female patient who on 18-JUN-2009 was vaccinated with 0.65 ml of the first dose of GARDASIL (Lot:661766/0652X). There was no concomitant medication. Immediately after vaccination the patient had a seizure. They called an ambulance, and by the time the ambulance got there the patient was fine and laughing and did not need to leave in the ambulance. Additional information has been received from an office person who stated that the patient's DOB was 13-MAY-1992. After the 17 year old female patient received GARDASIL she began to shake, became unconscious and had a tonic- clonic seizure that lasted for 15 seconds. An Ambulance was called to take the patient to the hospital. The patient "came to and was fine". The patient was not postictal, had no rash and had no difficulty breathing. The patient's blood pressure and EKG were normal. The patient's mother did not want the patient to go to the Emergency Room. The physician evaluated the patient and recommended that the patient have a CT scan of the brain and an EEG. The patient was approved for both diagnostic tests. The patient's mother took the patient home. Upon internal review, tonic-clonic seizure was considered to be an Other Important Medical Event. Additional information has been requested.  7/16/09 PCP recs rec'd.  WCC 6/18/09 with normal exam except hematoma under 2 toe nails.  HPV#1 given. Pt immediately devloped pallor and syncope with tonic/clonic seizure activity lasting 5-10 sec.  EMS called but parent declined transport.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Induration, Joint swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Shot Saturday, swollen knot on right wrist Monday - painful. Swollen clavicular node and cervical nodes Wednesday- painful (Right). Swollen tissue in right shoulder and chest. Headaches almost everyday clouded thinking and slowed memory function.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Memory impairment, Pain, Swelling, Thinking abnormal
Clinical narrative: Shot Saturday, swollen knot on right wrist Monday - painful. Swollen clavicular node and cervical nodes Wednesday- painful (Right). Swollen tissue in right shoulder and chest. Headaches almost everyday clouded thinking and slowed memory function.
Age: 0.4
Sex: F
Vaccine: DTAP, RV5
Symptoms: Vomiting
Clinical narrative: At 2 mo. well child visit, pt. was given Live Oral ROTAVIRUS vaccine & she vomited soon thereafter.  It was repeated within minutes, & she again vomited.  At her 4 mo. well child visit, she was given 1/2 the dose of Oral ROTAVIRUS vaccine & she vomited promptly.  She was given the 2nd 1/2 & again vomited.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 13x8 cm region of erythema and edema, on left buttock began only 60-90 minutes after vaccine administered, BENADRYL, ice, CORTAID cream.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Herpes simplex, Herpes zoster
Clinical narrative: On 6/12/2009 MMR, Varicella, PCV7, and Hep A given on 6/22/2009 pt seen in office Dx with herpes simplex without mention of complication. Then on 7/7/09 pt RTC for Re-eval DX with herpes zoster w/o complications.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: MMR + Varicella given in (L) upper/outer thigh.  19th +- cm raised, red + hot to touch area around w/ bruising injection sights 2-3 days after receiving the injections.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Hypoaesthesia, Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: Per client, 30 minutes after vaccine, felt numbness and pain in Lt arm. Stated after vaccine also felt numbness from Lt shoulder to hip. 2 weeks following vaccine, developed rash in Lt arm with some swelling and this was in area of vaccine. Current complaint now is that she has pain from middle of her back to lower back, said this occurs when she lays in bed to watch TV.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Pyrexia, Screaming
Clinical narrative: After last immunization pt had fever 102- 103 and screaming x 2 hrs increased x 2 days. Parents very concerned. No tx was given by our office.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Erythema, Injection site swelling, Skin tightness
Clinical narrative: Vaccine given 5-26- AM.  Symptoms noticed 5-27-AM after taking shower.  Left upper arm became reddened from shoulder to elbow.  Skin had a burning sensation but no pain.  Slight swelling at injection site.  Skin felt tight when bending arm.  No fever.  No generalized aches or pains.
Age: 13.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Body temperature, Injection site pain, Injection site warmth
Clinical narrative: Painful arms at inj. site - warm to touch.  T. 98.3 Rx with pain mid - ice.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: The child had an episode of dizziness after receiving GARDASIL and VARIVAX #2 fainted for <1 minute (20 seconds) but recovered well right away.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV
Symptoms: Cellulitis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of cellulitis in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). The subject's medical history included asthma. Previous and/or concurrent vaccination included Hib (non-gsk); Merck; unknown given on 19 June 2009. On 19 June 2009, the subject received 1st dose of KINRIX (.5 ml, unknown left thigh). On 21 June 2009, 2 days after vaccination with KINRIX, the subject experienced cellulitis. The subject went to the emergency room and was given an antibiotic and PRELONE. The subject was not hospitalized overnight. This case was assessed as medically serious by GSK. The subject was treated with Antibiotic unknown and PRELONE. On 24 June 2009, the event was resolved. The healthcare professional considered the event was probably related to vaccination with KINRIX.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Blood product transfusion, Body temperature increased, Diarrhoea, Echocardiogram, Full blood count
Clinical narrative: 6/22/09 - ER Hospital for elevated temp/ generalized rash, cathed urine negative/chest x-ray negative/ Influenza A negative. 6/23/09- MD's office. vomiting/ diarrhea x 1/ sclera pink/ temp 101 1/2 / macular rash- generalized > admitted to Hospital. (CBC-32.3 with 65 polys) 6-24-09 - seen by ID - Dx - Kawasaki. Echo done / IVIG given. 9/24/09 Medical records received for date of service 6/22/09. Presented to ER with fever 100.2F, generalized rash, discharge from eyes, cough, diarrhea.  DX: Urinary tract infection
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Influenza serology negative, Rash generalised, Rash macular, Scleritis, Urine analysis normal
Clinical narrative: 6/22/09 - ER Hospital for elevated temp/ generalized rash, cathed urine negative/chest x-ray negative/ Influenza A negative. 6/23/09- MD's office. vomiting/ diarrhea x 1/ sclera pink/ temp 101 1/2 / macular rash- generalized > admitted to Hospital. (CBC-32.3 with 65 polys) 6-24-09 - seen by ID - Dx - Kawasaki. Echo done / IVIG given. 9/24/09 Medical records received for date of service 6/22/09. Presented to ER with fever 100.2F, generalized rash, discharge from eyes, cough, diarrhea.  DX: Urinary tract infection
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Vomiting
Clinical narrative: 6/22/09 - ER Hospital for elevated temp/ generalized rash, cathed urine negative/chest x-ray negative/ Influenza A negative. 6/23/09- MD's office. vomiting/ diarrhea x 1/ sclera pink/ temp 101 1/2 / macular rash- generalized > admitted to Hospital. (CBC-32.3 with 65 polys) 6-24-09 - seen by ID - Dx - Kawasaki. Echo done / IVIG given. 9/24/09 Medical records received for date of service 6/22/09. Presented to ER with fever 100.2F, generalized rash, discharge from eyes, cough, diarrhea.  DX: Urinary tract infection
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Pt became light headed. Blood pressure 70/40 but elevated to 90/60 within 15 minutes. No other adverse effects observed. Remained alert and oriented.
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Exposure to communicable disease, Lip swelling, Paraesthesia, Similar reaction on previous exposure to drug
Clinical narrative: Patient presented today to emergency department approx 12 hours after her Day 3 RabAvert dose complaining mostly of feeling anxious, having subjective sensation of swelling in her lower lips, and feeling "pins and needles" in her lower extremities. She states having a similar reaction to her Day 0 treatment which did include 1200units of hyperRab, but these resolved within 24hrs, and certainly prior to the second RabAvert. I appreciate no rash, no erythema and no swelling. By the time I evaluated her she had had resolution of her symptoms which started about 4 hours after injection and continued during the day and into the evening, lasting until about 10 hours after injection today. I advised the patient to continue her injections, but she wished to know how protected she would be if she stopped the series. 1) Is this likely related to the vaccine? 2)Would she be covered for her current exposure (no bite but unknown contact from sleeping in cabin and finding bat in am)?
Age: 17.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Abdominal pain upper, Headache, Malaise, Pyrexia
Clinical narrative: 90 minutes after receiving vaccine client experienced headache.  She took ibuprofen but didn't receive any relief until second dose taken 4 hours later.  Symptoms progressed to fever of 102 degrees F, stomache and general malaise. Took additional ibuprofen this morning at 8:00 am. At 9:30 am temperature is currently 99.8 degreees F.  General malaise continues. Has private physician.  Advised to consult with him and monitor for progression or worsening of symptoms. Mother is declining further doses of vaccine for daughter.
Age: 17.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Abdominal pain upper, Dizziness, Headache, Hyperacusis, Malaise
Clinical narrative: 90 minutes after receiving vaccine client experienced headache.  She took ibuprofen but didn't receive any relief until second dose taken 4 hours later.  Symptoms progressed to fever of 102 degrees F, stomache and general malaise. Took additional ibuprofen this morning at 8:00 am. At 9:30 am temperature is currently 99.8 degreees F.  General malaise continues. Has private physician.  Advised to consult with him and monitor for progression or worsening of symptoms. Mother is declining further doses of vaccine for daughter.
Age: 17.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Muscle spasms, Myalgia, Pyrexia, Vomiting
Clinical narrative: 90 minutes after receiving vaccine client experienced headache.  She took ibuprofen but didn't receive any relief until second dose taken 4 hours later.  Symptoms progressed to fever of 102 degrees F, stomache and general malaise. Took additional ibuprofen this morning at 8:00 am. At 9:30 am temperature is currently 99.8 degreees F.  General malaise continues. Has private physician.  Advised to consult with him and monitor for progression or worsening of symptoms. Mother is declining further doses of vaccine for daughter.
Age: 17.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Abdominal pain upper, Headache, Malaise, Pyrexia
Clinical narrative: sensitivity to noise within 1/2 hour;  severe headace within 1 1/2 hour;  uncorrected by ibuprofen;  fever within 5 hours 101.9, lowered to 99.8 by two doses of ibuprofen; muscle aches over all body; leg cramps; stomach ache; vomitting x 2; generalized feeling sick all over; lightheaded
Age: 17.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Abdominal pain upper, Dizziness, Headache, Hyperacusis, Malaise
Clinical narrative: sensitivity to noise within 1/2 hour;  severe headace within 1 1/2 hour;  uncorrected by ibuprofen;  fever within 5 hours 101.9, lowered to 99.8 by two doses of ibuprofen; muscle aches over all body; leg cramps; stomach ache; vomitting x 2; generalized feeling sick all over; lightheaded
Age: 17.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Muscle spasms, Myalgia, Pyrexia, Vomiting
Clinical narrative: sensitivity to noise within 1/2 hour;  severe headace within 1 1/2 hour;  uncorrected by ibuprofen;  fever within 5 hours 101.9, lowered to 99.8 by two doses of ibuprofen; muscle aches over all body; leg cramps; stomach ache; vomitting x 2; generalized feeling sick all over; lightheaded
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site pain
Clinical narrative: Soreness at injection site and severe fatigue lasting two days post vaccine.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: 4 inch redness, bumpy, warm, itching area around injection site
Age: 23.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased
Clinical narrative: Client stated that she experienced chest tightnes accompanied by shortness of breath and acelerated heart rate on Tuesday morning 6/09/09. She received the vaccine 6/8/09@ 1:35pm She left the clinic without complaints. 9/23/09 Medical records received for date of service 6/11/09 to 6/13/09. Presented in ED with c/o shortness of breath, wheezing, fever, nausea/vomiting, diarrhea. ED DX: Asthma exacerbation, fever. Findings: Diminished breath sounds at base of lungs, wheezing, irregular heart rhythem, tachycardia.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: On 7/8/09 patient received Prevnar, Hib, Varicella, and MMR vaccinations.  On 7/10/09 patient mother reported that the child has been taken to the ER for a temperature of 104.0.  Patient was sent home same day. On 7/13/09 patient's mother called our office requesting an office visit for fever of 101. Patient was offered an appointment with our extended care office but refused.  Patient's mom did not call back that day.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Contusion, Rash generalised, Skin discolouration, Swelling, Urticaria
Clinical narrative: STARTED WITH A RASH ALL OVER BODY, IT SWELLED, HE HAD WHELPS ON FACE, BRUISING, AND A PURPLISH RASH.  WAS SEEN AT URGENT CARE AND ER.  DIAGNOSED WITH EM-MINOR.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: SEVERE GENERALIZED RASH AND URTICARIAL REACTION INVOLVING FACE WITH PRURITUS
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Urticaria Mom noticed rash upon awakening on the 14th of July after vaccine administered on the 13th of July. Pt. given Prelone x 3 days and Zyrtec
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Flat, red rash and spots on chest; increased in 24 hours; resolved without treatment
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site cellulitis, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Shingles vaccination 7/1/09; 7/2/09 the patient reports fever, chills, muscle aches, then red tender sore arm at injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Shingles vaccination 7/1/09; 7/2/09 the patient reports fever, chills, muscle aches, then red tender sore arm at injection site.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: VACCINE WAS ADMINISTERED AT 6 MONTHS OLD.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: 6month term previously healthy female received her 6 month shots on 06/02/09 exactly 12 weeks after her 4month rota vaccine.  On 07/6/09 the patient had an intussusceptive event that was successfully reduced with barium enema. Recovered with no additional events to this date.  7/30/09 Clinic records received DOS 6/2/09 and 7/6/09 Well child visit. Later child presents with bilious vomiting, dehydration. Tired, inactive, lost weight, not crying. Cough, blood in diaper. Sunken anterior fontanelle. Transferred to another facility for surgical consult.   9/9/09 MR received from transfer hospital for DOS 7/6-8/2009 with D/C DX:  Intussusception. Arrived listless and dehydrated with emesis and bloody stools. Reduced by barium enema and d/c after taking po well.  ICD9 560.0  IS.
Age: 11.0
Sex: F
Vaccine: HEPA, HPVX, MNQ, TDAP
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: severe headache,soreness in arms nausea.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Within 5 min of vaccines being given, patient presented with bilateral erythema with single urticarial lesion at sites of injection.  Dose of BENADRYL given in office, patient was monitored for 30 minutes.  Patient demonstrated no signs/ symptoms of a systemic reaction, only localized reaction noted.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Oedema, Skin warm, Tenderness
Clinical narrative: Edema, Tenderness (L) Deltoid, warm + Red + Tender, firmness also noted.  (L) arm circumference 31.5 cm (R) arm circumference 31 cm.  Given Hydroxyzine HCL 25mg Tab omnicef 300mg caps.  Cool compresses to area 3x day.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Hard, warm to touch, red area stated by mom left thigh.
Age: 20.0
Sex: F
Vaccine: TYP, YF
Symptoms: Dizziness, Dyspnoea, Headache, Sleep disorder
Clinical narrative: Developed headache p.m. of 7/2/09 - 7/6/09 with relief from ADVIL.  Awakened during sleep on 7/6/09 with continued headache, lightheaded + little difficulty when breathing (inspiration).  Denies shortness of breath @ rest, denies nausea + vomiting.  Nurse returned client to PCP.  7/7/09 - client still complains of symptoms but they're mild.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Vaccine administered 7-10-09, pt reported swelling the size of a grapefruit and pain on 7-11-09 in pm. Pt did not seek treatment.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Lip swelling, Local swelling, Swelling face
Clinical narrative: Vaccine administered 9/10/08 and noticed swelling of face, neck, nose and lips next day. Reports that she had difficulty breathing. Reports that she went to local Emergency Room was given a shot and placed on steroids and she improved.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mom stated that she took client to PMD because her arm was red and swollen. Dr stopped client from taking TYLENOL. Continue to use cold packs then warm. Dr started client on BENADRYL OID d/T itching at site.
Age: 18.0
Sex: M
Vaccine: HEP, MMR, MNQ, TDAP
Symptoms: Cold sweat, Hypotonia, Unresponsive to stimuli
Clinical narrative: Pt was given MMR II, RECOMBIVAX HB, BOOSTRIX, MENACTRA injections. Pt was talking with nurse and mother when he slumped over to the left side laying on counter and non responsive to questions - Mother became hysterical - nurse tried to talk to pt, who is now clammy and cold and had a questionable seizure. Nurse called for help, then pt
Age: 0.4
Sex: U
Vaccine: DTAPIPVHIB, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Crying, Irritability, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Fever 103, crying, fussy, red rash over entire body - Maculopapular rash.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tenderness on left thigh at site of vaccine that was noticed 2 days after receiving vaccine.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (B) legs - 5-10 min after vax bright red + hot both legs top to foot - lasted 1/2 to sevl hrs.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site papule
Clinical narrative: Per Grandma- patient got a "pimple like" mark on arm where Tdap was given.  Patient was swimming in a pool and at the beach.  Bump gone 2 days later.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Anxiety, Dizziness, Orthostatic hypotension, Oxygen saturation normal
Clinical narrative: About 20 seconds after administering HPV in R delt pt felt "dizzy" pulse 58 and BP 98/52 w/anxiety and orthostatic hypotension.  After 30 min pt felt much better B/P 110/72 and was able to walk out unassisted.  Pulse OX 98-99%.  After lying down.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Gait disturbance, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Mom noted red knot on arm and leg on 7-1-9 - C/o sore, hot to touch and can't walk good - Warm compress tid, BENADRYL, ELOCON cream
Age: 57.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Body temperature increased, Diarrhoea, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Injection site was red, tender, itchy. Had high temperature, some diarrhea. Little rash around site. S/S persisted about 1-2 hrs, resolved.
Age: 57.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site rash
Clinical narrative: Injection site was red, tender, itchy. Had high temperature, some diarrhea. Little rash around site. S/S persisted about 1-2 hrs, resolved.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: 7/10/09 Pt. presented to doctor with (R)axillary swelling. Area felt boggy. No warmth or redness.