chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Myelitis transverse, Neurological symptom, Nuclear magnetic resonance imaging abnormal, Paraesthesia
Clinical narrative: Began to feel numbness/tingling in extremities, fatigue, back pain, weakness/heaviness in limbs, slowed thinking and other strange neurological symptoms. This progressed to facial involvement so I went to the ER.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Sensation of heaviness
Clinical narrative: Began to feel numbness/tingling in extremities, fatigue, back pain, weakness/heaviness in limbs, slowed thinking and other strange neurological symptoms. This progressed to facial involvement so I went to the ER.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Humerus fracture, Hypertrophic osteoarthropathy, Immediate post-injection reaction, Joint effusion, Musculoskeletal pain
Clinical narrative: Patient complains of pain & soreness at injection site that has persisted since the vaccination.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, Synovitis, Tendon disorder, Tendonitis
Clinical narrative: Patient complains of pain & soreness at injection site that has persisted since the vaccination.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: Patient complains of pain & soreness at injection site that has persisted since the vaccination.
Age: 53.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia oral, VIIth nerve paralysis
Clinical narrative: Initial report was received from a health care professional on 20 February 2012 who also reported the event to the health authority and provided a temporary VAERS e-report number of E-60095. A 53 year-old male patient had received an intramuscular first dose injection in the right arm of ADACEL, sanofi pasteur Ltd. lot number C3990 (sanofi pasteur Inc. lot number U4137AA) on 06 December 2011 at 2:40 PM. About 2 hours later, the patient started having tingling of the upper lip and side of the mouth. On 13 December 2011, the patient had paralysis on the right side of the face without any slurred speech, other motor signs/symptoms (s/s), other weakness or neuro s/s. The reporter was unaware if the patient had any illness at time of vaccination or had any pre-existing conditions. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Abdominal pain upper, Haematology test, Headache, Laboratory test, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of upper abdominal pain in a 21-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included joint pain. Concurrent vaccination included GARDASIL (Merck) given on 1 March 2012. Concurrent medications included BACTRIM DS, KEFLEX, LEXAPRO and Ibuprofen (prn). On 1 March 2012 at 09:30 the subject received 2nd dose of ENGERIX B at 1.0 ml in the left arm. At 19:47 on 01 March 2012, the subject contacted the triage nurse with concerns about upper abdominal pain, diffuse rash and headache. It was not known, however, exactly what time the symptoms began (within hours of vaccination with ENGERIX B). The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was advised to go to the hospital emergency room and he did so. He was released from the emergency room at 22:50 with notes from the report stating that the subject felt better, had no rash, and his abdomen was soft and non-tender. The events were reported to have resolved. The subject did not experience any difficulty breathing or fever. Attribution of the events to vaccination with ENGERIX B was not known.
Age: 21.0
Sex: M
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Urine analysis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of upper abdominal pain in a 21-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included joint pain. Concurrent vaccination included GARDASIL (Merck) given on 1 March 2012. Concurrent medications included BACTRIM DS, KEFLEX, LEXAPRO and Ibuprofen (prn). On 1 March 2012 at 09:30 the subject received 2nd dose of ENGERIX B at 1.0 ml in the left arm. At 19:47 on 01 March 2012, the subject contacted the triage nurse with concerns about upper abdominal pain, diffuse rash and headache. It was not known, however, exactly what time the symptoms began (within hours of vaccination with ENGERIX B). The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was advised to go to the hospital emergency room and he did so. He was released from the emergency room at 22:50 with notes from the report stating that the subject felt better, had no rash, and his abdomen was soft and non-tender. The events were reported to have resolved. The subject did not experience any difficulty breathing or fever. Attribution of the events to vaccination with ENGERIX B was not known.
Age: 21.0
Sex: M
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Abdominal pain upper, Headache, Rash generalised
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of upper abdominal pain in a 21-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included joint pain. Concurrent vaccination included GARDASIL (Merck) given on 1 March 2012. Concurrent medications included BACTRIM DS, KEFLEX, LEXAPRO and Ibuprofen (prn). On 1 March 2012 at 09:30 the subject received 2nd dose of ENGERIX B at 1.0 ml in the left arm. At 19:47 on 01 March 2012, the subject contacted the triage nurse with concerns about upper abdominal pain, diffuse rash and headache. It was not known, however, exactly what time the symptoms began (within hours of vaccination with ENGERIX B). The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was advised to go to the hospital emergency room and he did so. He was released from the emergency room at 22:50 with notes from the report stating that the subject felt better, had no rash, and his abdomen was soft and non-tender. The events were reported to have resolved. The subject did not experience any difficulty breathing or fever. Attribution of the events to vaccination with ENGERIX B was not known.
Age: 20.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Human chorionic gonadotropin positive, Maternal exposure before pregnancy
Clinical narrative: Patient was vacinated with Smallpox vaccine on 21 Feb 2012.  Patient had positive pregnancy test on 06 Mar 2012.  Patient denies having sex between vacination and positive pregnancy test.  Patient reports previous sexual encounter was prior to vaccination.  Pregnancy test was performed at time of vaccination.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Abnormal behaviour, Feeling abnormal, Syncope
Clinical narrative: Fainted after receiving flu & HPV #1. Felt foggy and had some odd behavior and ? mental status changes. Being worked up by neurologist.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Oedema peripheral, Pruritus
Clinical narrative: Itching. Burning. Swelling in arm of injection. Patient took a BENADRYL and it has helped with symptoms.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site swelling
Clinical narrative: (L) leg swollen hip to knee. Non stop crying x 2 hrs. TYLENOL given.
Age: 45.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Echocardiogram, Electrocardiogram normal, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012. A 45 year-old male subject with a past medical history of elevated cholesterol and diabetes (Type I or Type II) was found to have on 23 April 2009 "other, chest pain" three days after the subject had received on 20 April 2009 the following vaccines: ACAM2000 (lot number, route and site of administration not reported), an injection of TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I on 24 April 2009 and a normal ECG on 27 April 2009. Echocardiogram, lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Nuclear magnetic resonance imaging brain, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012. A 45 year-old male subject with a past medical history of elevated cholesterol and diabetes (Type I or Type II) was found to have on 23 April 2009 "other, chest pain" three days after the subject had received on 20 April 2009 the following vaccines: ACAM2000 (lot number, route and site of administration not reported), an injection of TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I on 24 April 2009 and a normal ECG on 27 April 2009. Echocardiogram, lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Echocardiogram, Electrocardiogram normal, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012. A 45 year-old male subject with a past medical history of elevated cholesterol and diabetes (Type I or Type II) was found to have on 23 April 2009 "other, chest pain" three days after the subject had received on 20 April 2009 the following vaccines: ACAM2000 (lot number, route and site of administration not reported), an injection of TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I on 24 April 2009 and a normal ECG on 27 April 2009. Echocardiogram, lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Nuclear magnetic resonance imaging spinal cord, Nuclear magnetic resonance imaging thoracic, Troponin I, Troponin normal
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012. A 45 year-old male subject with a past medical history of elevated cholesterol and diabetes (Type I or Type II) was found to have on 23 April 2009 "other, chest pain" three days after the subject had received on 20 April 2009 the following vaccines: ACAM2000 (lot number, route and site of administration not reported), an injection of TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I on 24 April 2009 and a normal ECG on 27 April 2009. Echocardiogram, lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Sex: U
Vaccine: SMALL
Symptoms: Chest pain
Clinical narrative: This study case was received from the investigator on 22 February 2012. A subject (age, date of birth and gender not reported) had received an injection of ACAM2000 (lot number, route, site and date not reported). The subject was diagnosed with other, chest pain on 02 August 2011. Medical history was not reported. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Sex: U
Vaccine: SMALL
Symptoms: Chest pain
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012. A subject (age, date of birth and gender not reported) had received an injection of ACAM2000 (lot number, route, site and date not reported). The subject was diagnosed with other, chest pain on 03 October 2011. Medical history was not reported. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Sex: U
Vaccine: SMALL
Symptoms: Pericardial disease
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012. A subject (age, date of birth and gender not reported) had received an injection of ACAM2000 (lot number, route, site and date not reported). The subject was diagnosed with unspecified disease of pericardium on 08 December 2011. Medical history was not reported. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein, Alpha 1 foetoprotein normal, Cytogenetic analysis normal, Hand fracture, Maternal exposure during pregnancy
Clinical narrative: Initial report received on 13 July 2011 from a health professional. A female patient, whose medical history, obstetrical history, and concomitant medications were not reported, received an intramuscular injection of ADACEL (lot number C3828AA) on an unspecified date. The patient was pregnant. She had no risk factors. The date of her last menstrual period was unknown. The estimated date of delivery is 07 September 2011. The patient had no adverse event following vaccination. Follow-up information was received on 24 February 2012 from a health care professional. Based upon the new information provided (hospitalization), this case has been upgraded to serious. The patient was 27-year-old and received the injection of ADACEL on 29 March 2011. The patient was hospitalized from 29 March 2011 to 30 March 2011 with right hand fifth metacarpal fracture and acute postoperative pain. On 30 March 2011 the patient had an open reduction of fracture with internal fixation, carpals and metacarpals surgery. On 31 March 2011, the patient had an MS triple screen. Neural tube defect, down syndrome and trisomy-18 were all negative screens. The patient had no illness at the time of vaccination. The patient had a history of iron deficiency anemia and an allergy of swelling of the hands and right foot with acetaminophen and ibuprofen. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Open reduction of fracture, Procedural pain
Clinical narrative: Initial report received on 13 July 2011 from a health professional. A female patient, whose medical history, obstetrical history, and concomitant medications were not reported, received an intramuscular injection of ADACEL (lot number C3828AA) on an unspecified date. The patient was pregnant. She had no risk factors. The date of her last menstrual period was unknown. The estimated date of delivery is 07 September 2011. The patient had no adverse event following vaccination. Follow-up information was received on 24 February 2012 from a health care professional. Based upon the new information provided (hospitalization), this case has been upgraded to serious. The patient was 27-year-old and received the injection of ADACEL on 29 March 2011. The patient was hospitalized from 29 March 2011 to 30 March 2011 with right hand fifth metacarpal fracture and acute postoperative pain. On 30 March 2011 the patient had an open reduction of fracture with internal fixation, carpals and metacarpals surgery. On 31 March 2011, the patient had an MS triple screen. Neural tube defect, down syndrome and trisomy-18 were all negative screens. The patient had no illness at the time of vaccination. The patient had a history of iron deficiency anemia and an allergy of swelling of the hands and right foot with acetaminophen and ibuprofen. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Initial report was received on 29 September 2011 from a consumer, who was also the patient, at which time this case was assessed as non-serious listed. Based upon follow-up information was received on 29 February 2012 from a consumer, who was also the patient, on 29 February 2012, it was determined this case now meets seriousness criteria (Other-Medically Significant) and this case has been upgraded from non-serious to serious. This narrative includes information reported on both dates. A female patient had received an injection of influenza vaccine (manufacturer, lot number, date, route and site of vaccination not reported) over 30 years ago and an unspecified amount of time later had a seizure. The patient's past medical history was originally reported as an allergy to flu shot, seizure (fractured her skull twice by her husband which caused her to have seizures), smoker for 63 years, measles, mumps, gun shot wound, rabies from gun shot before 12-years-old, hospitalized 5 times at age 42 due to seizures, low blood pressure, weight loss, heart attack on 15 May 2011, stent placement for clogged artery and spot on her lung. Concomitant medication included furosemide, potassium chloride, atenolol, phenytoin, ZOCOR, PLAVIX and will restart baby aspirin after biopsy. The reporter clarified that the patient did not have an allergy to the flu shot, she had a seizure after receiving the flu shot. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Sex: U
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site induration
Clinical narrative: Information has been received from a hospital pharmacist concerning a patient who on unknown date, were vaccinated with a dose of PNEUMOVAX 23 (lot number, dose and route not reported). It was reported that on unknown date, the patient had "sensitivity reactions" to PNEUMOVAX 23 at the injection site, one of them "was bad and got really hard". It was also reported that on unknown date, the patient was "on the floor" at the hospital (date, duration and location unspecified). The patient's outcome was unknown at the time of report. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Pharyngeal hypoaesthesia, Pruritus generalised
Clinical narrative: 11:15 - presents c/o "itching all over", no rash or hives noted. Denies shortness of air. Administered BENADRYL 25mg PO observed x15 min. 11:35 - student remembered getting vaccine this a.m. States itching is getting worse, throat feels numb. Red raised circular areas , approx. 5cm ea, hive like rash noted to right upper arm. Administered oxygen at 4L face mask. 11:40 - administered epinephrine 1:1000 0.5ml IM. 11:58 - transported to hospital via EMS.
Sex: U
Vaccine: PPV
Symptoms: Injection site hypersensitivity
Clinical narrative: Information has been received from a hospital pharmacist concerning a patient who on unknown date, were vaccinated with a dose of PNEUMOVAX 23 (lot number, dose and route not reported). It was reported that on unknown date, the patient had "sensitivity reactions" to PNEUMOVAX 23 at the injection site. It was also reported that on unknown date, the patient was "on the floor" at the hospital (date, duration and location unspecified). The patient's outcome was unknown at the time of report. This is one of several reports from the same source. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Altered state of consciousness, Dry skin, Pallor, Skin warm, Syncope
Clinical narrative: 3/5/12 Mother brought child in for partial imm. - this was 2nd time to bring child for imm. Mom reported no problems with 1st round - child healthy. After injection - child became faint - pale. Laid flat, elevated legs. No complete loss consciousness. Skin warm & dry. Adm. sugar, observed 45 min. P - 88 reg. Left under own power. Mom reports both parents "do this". Advised to report event to her physician. Always start child out lying flat fro procedures. Child had eaten previously. 3/6/12 - spoke with mom today - child recovered - eating/drinking - normal activity.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dysphonia, Emotional disorder, Pain, Pain in extremity, Somnolence
Clinical narrative: Throat became slightly tight & voice started to crack within 1 hour of receiving vaccine. Emotional breakdown (crying for no reason) the next night with arm very painful. She slept all day also. Body aches 2 days after vaccine. By the 3rd day at night all symptoms resolved.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Throat tightness
Clinical narrative: Throat became slightly tight & voice started to crack within 1 hour of receiving vaccine. Emotional breakdown (crying for no reason) the next night with arm very painful. She slept all day also. Body aches 2 days after vaccine. By the 3rd day at night all symptoms resolved.
Age: 32.0
Sex: M
Vaccine: MU, SMALL, VARCEL
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram normal, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012. A 32 year-old male subject whose medical history was not available was found to have "other, chest pain" 14 days after the subject had received the following vaccines on 24 February 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), Mumps (manufacturer, lot number, route and site of administration not reported) and Varicella (manufacturer, lot number, route and site of administration not reported). On 25 January 2009, the subject had Anthrax 2 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I on 09 March 2009, a normal ECG and a normal Echocardiogram on 11 March 2009. Lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 32.0
Sex: M
Vaccine: MU, SMALL, VARCEL
Symptoms: Nuclear magnetic resonance imaging brain, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012. A 32 year-old male subject whose medical history was not available was found to have "other, chest pain" 14 days after the subject had received the following vaccines on 24 February 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), Mumps (manufacturer, lot number, route and site of administration not reported) and Varicella (manufacturer, lot number, route and site of administration not reported). On 25 January 2009, the subject had Anthrax 2 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I on 09 March 2009, a normal ECG and a normal Echocardiogram on 11 March 2009. Lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: As per Medicine Admission note 1/12/12: 60 years old male with PMHx of hypertension, Hyperlipidemia, COPD/Emphesyma, GERD, gout and depression. He presented to the ER with cc of feeling dizzy. He was visiting his PCP for general exam and he got the flu shot. When he went back to work, he started to feel dizzy and lightheaded, he never lost his consciousness, he also had nausea, abdominal pain and one episode of watery diarrhea with no blood, this feeling lasted for about 2 hours till he came to the ER. He report having SOB, denies any chest pain, palpitation, orthopnea, PND, headache, blurred vision. He attributed his symptoms to allergy to flu shot, since he had similar episode in the past after having flu shot in 2008. A/P: #) Dizziness and lightheadedness: unclear etiology, could be related to reaction from flu vaccine. Blood pressure on admission was 60/36, improved with IV fluids. - No evidence of cardiac etiology, EKG showed sinus rhythm. - Will continue to monitor blood pressure.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: As per Medicine Admission note 1/12/12: 60 years old male with PMHx of hypertension, Hyperlipidemia, COPD/Emphesyma, GERD, gout and depression. He presented to the ER with cc of feeling dizzy. He was visiting his PCP for general exam and he got the flu shot. When he went back to work, he started to feel dizzy and lightheaded, he never lost his consciousness, he also had nausea, abdominal pain and one episode of watery diarrhea with no blood, this feeling lasted for about 2 hours till he came to the ER. He report having SOB, denies any chest pain, palpitation, orthopnea, PND, headache, blurred vision. He attributed his symptoms to allergy to flu shot, since he had similar episode in the past after having flu shot in 2008. A/P: #) Dizziness and lightheadedness: unclear etiology, could be related to reaction from flu vaccine. Blood pressure on admission was 60/36, improved with IV fluids. - No evidence of cardiac etiology, EKG showed sinus rhythm. - Will continue to monitor blood pressure.
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Autism, Speech disorder developmental
Clinical narrative: Initial report received from a consumer, who is also the patient's parent, on 22 February 2012. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of sanofi pasteur. A male patient had received an injection of hib vaccine, poliomyelitis vaccine inactivated and DTAP (manufacturers, lot numbers, dates, routes and sites of administration not reported). The patient was behind in speech (approximately 6-12 months behind) when he turned two years of age. The patient was evaluated in February of 2011 and diagnosed with autism. At the time of the report, the patient was showing improvement, and his condition was very mild now. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injected limb mobility decreased, Injection site swelling, Oedema peripheral, Paraesthesia
Clinical narrative: Marked swelling of his right arm from shoulder to fingertips his third dose of AVA in 2007. 8 hours after receiving AVA his arm was swollen as above with his hand "10 times bigger than the other". His fingertips were red and tingling. There was some difficulty with movement; his arm felt heavy. No systemic symptoms; well otherwise. The symptoms lasted 24 hours then totally resolved.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Sensation of heaviness
Clinical narrative: Marked swelling of his right arm from shoulder to fingertips his third dose of AVA in 2007. 8 hours after receiving AVA his arm was swollen as above with his hand "10 times bigger than the other". His fingertips were red and tingling. There was some difficulty with movement; his arm felt heavy. No systemic symptoms; well otherwise. The symptoms lasted 24 hours then totally resolved.
Sex: U
Vaccine: TDAP
Symptoms: Swelling, Tachycardia
Clinical narrative: Initial report was received from another manufacturer, who received the report from a health care professional on 22 February 2012 (Service Request Number 1-4889096556). A patient (age, date of birth and gender not reported) had received an injection of ADACEL, sanofi pasteur Ltd. (lot number, date, site and route of administration not reported) and an unspecified amount of time later developed tachycardia and swelling. Past medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Pityriasis rosea, Rash
Clinical narrative: Rashes.  Dr. diagnosed said it was Pityriasis Rosea.
Age: 33.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Cough
Clinical narrative: Right side chest pain, dry cough.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Asthma, Croup infectious, Dyspnoea, Respiratory disorder
Clinical narrative: At 4 weeks old she began to have breathing problems. We took her to the ER and she was diagnosed with croup. She was given breathing treatments and oral steroids. Since that time she has been diagnosed with asthma and continues to suffer from respiratory illnesses.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Arm swollen approx 3-4 inches in diameter, painful and warm to touch.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site haematoma, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient returned to clinic with complaints of arm pain and limited range of motion. Patient was assessed by Dr. no acute distress, no respiratory difficulty, arm ender to direct palpation, slight amount of bruising around the injection site without swelling or redness. Range of motion is somewhat limited due to pain in the left shoulder but overall good range of motion and handgrip is normal. Patient advised to use Tylenol/Ibuprofen as needed for the discomfort. Return to the clinic as needed.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Patient returned to clinic with complaints of arm pain and limited range of motion. Patient was assessed by Dr. no acute distress, no respiratory difficulty, arm ender to direct palpation, slight amount of bruising around the injection site without swelling or redness. Range of motion is somewhat limited due to pain in the left shoulder but overall good range of motion and handgrip is normal. Patient advised to use Tylenol/Ibuprofen as needed for the discomfort. Return to the clinic as needed.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Muscular weakness, Myalgia
Clinical narrative: Swollen red arm from shoulder to 2-3 inches above elbow, itching, muscle soreness, joint pain, arm weakness.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus
Clinical narrative: Swollen red arm from shoulder to 2-3 inches above elbow, itching, muscle soreness, joint pain, arm weakness.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site papule, Injection site pruritus, Injection site vesicles, Vaccination site pain, Vaccination site swelling
Clinical narrative: ITCH IN VACCINE SITE, THEN SWELLING AND PAIN WITH DEVELOPMENT OF PAPULES AND VESICLES IN AREA ON 3/4/12.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Lymph node pain, Malaise, Pyrexia, Rash papular
Clinical narrative: Patient received smallpox vaccination on left shoulder approximately two weeks before presenting.  On the morning of March 6, 2012 he noted a papular rash on his chest, abdomen, neck and back.  No rash on arms or hands.  Prior to the rash he had typical symptoms associated with smallpox vaccination: axillary lymph node tenderness, intermittent fevers and malaise.  Considering mild presentation will defer treatment at this time. Will continue to follow.  (Comments provided by Doctor).
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram, Differential white blood cell count, Electrocardiogram, Full blood count, Injection site reaction
Clinical narrative: Pt received Adacel on 2/23/12, called office on 3/2/12 with "nerve type pain" in arm where she received injection. C/O pain getting worse radiating down arm and into neck. Unable to sleep due to pain. Seen 3/3/12 and 3/5/12 at Emergency room. Treated with Prednisone and "pain meds".
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Metabolic function test, Neck pain, Neuralgia, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Pt received Adacel on 2/23/12, called office on 3/2/12 with "nerve type pain" in arm where she received injection. C/O pain getting worse radiating down arm and into neck. Unable to sleep due to pain. Seen 3/3/12 and 3/5/12 at Emergency room. Treated with Prednisone and "pain meds".
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder, Troponin, Ultrasound scan, X-ray limb
Clinical narrative: Pt received Adacel on 2/23/12, called office on 3/2/12 with "nerve type pain" in arm where she received injection. C/O pain getting worse radiating down arm and into neck. Unable to sleep due to pain. Seen 3/3/12 and 3/5/12 at Emergency room. Treated with Prednisone and "pain meds".
Age: 42.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Abdominal pain upper, Headache, Heart rate increased, Pharyngeal oedema, Trismus
Clinical narrative: Rapid heart rate, throat swelled, jaw locked, stomach pain, headache, vomiting.
Age: 42.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Vomiting
Clinical narrative: Rapid heart rate, throat swelled, jaw locked, stomach pain, headache, vomiting.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Rash papular, Viral test
Clinical narrative: Papulovesicular vaccinia reaction, onset in morning of 03 Mar 2012.  Rash worsened and led to emergency department evaluation and subsequent hospital admission on 04 Mar 2012.  Patient was discharged on 05 Mar 2012.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Culture, Rash papular, Vaccination complication
Clinical narrative: Papulovesicular vaccinia reaction, onset in morning of 03 Mar 2012.  Rash worsened and led to emergency department evaluation and subsequent hospital admission on 04 Mar 2012.  Patient was discharged on 05 Mar 2012.
Age: 53.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Back pain, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Nerve injury
Clinical narrative: Pain and stiffness in my neck and shoulders and back.  After suffering for months, thinking it was just a stiff neck, I then was diagnosed and began physical therapy.
Age: 53.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pain and stiffness in my neck and shoulders and back.  After suffering for months, thinking it was just a stiff neck, I then was diagnosed and began physical therapy.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abasia, Asthenia, Blood test, Dizziness, Gait disturbance
Clinical narrative: THE FIRST "SEVERE" EPISODE WAS ON THE DATE ABOVE, PATIENT WAS EXTREMELY WEAK AND UNSTEADY ON HER FEET. SHE HAD BEEN FEELING ILL FOR A COUPLE WEEKS PRIOR TO THIS, SHE WAS SORE, HEADACHE AND DIZZY. THE NEXT DAY 12/21/10 SHE COULD NOT WALK AT ALL AND THIS WAS THE FIRST PARALYSIS. SHE WAS ADMITTED TO THE HOSPITAL, A NEUROLOGIST WAS CALLED IN, SHE HAD MRI AND BLOOD WORK.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Malaise, Nuclear magnetic resonance imaging, Pain, Paralysis
Clinical narrative: THE FIRST "SEVERE" EPISODE WAS ON THE DATE ABOVE, PATIENT WAS EXTREMELY WEAK AND UNSTEADY ON HER FEET. SHE HAD BEEN FEELING ILL FOR A COUPLE WEEKS PRIOR TO THIS, SHE WAS SORE, HEADACHE AND DIZZY. THE NEXT DAY 12/21/10 SHE COULD NOT WALK AT ALL AND THIS WAS THE FIRST PARALYSIS. SHE WAS ADMITTED TO THE HOSPITAL, A NEUROLOGIST WAS CALLED IN, SHE HAD MRI AND BLOOD WORK.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electroencephalogram, Electromyogram, Muscle twitching, Muscular weakness, Nerve conduction studies
Clinical narrative: THE FIRST "SEVERE" EPISODE WAS ON THE DATE ABOVE, PATIENT WAS EXTREMELY WEAK AND UNSTEADY ON HER FEET. SHE HAD BEEN FEELING ILL FOR A COUPLE WEEKS PRIOR TO THIS, SHE WAS SORE, HEADACHE AND DIZZY. THE NEXT DAY 12/21/10 SHE COULD NOT WALK AT ALL AND THIS WAS THE FIRST PARALYSIS. SHE WAS ADMITTED TO THE HOSPITAL, A NEUROLOGIST WAS CALLED IN, SHE HAD MRI AND BLOOD WORK.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: THE FIRST "SEVERE" EPISODE WAS ON THE DATE ABOVE, PATIENT WAS EXTREMELY WEAK AND UNSTEADY ON HER FEET. SHE HAD BEEN FEELING ILL FOR A COUPLE WEEKS PRIOR TO THIS, SHE WAS SORE, HEADACHE AND DIZZY. THE NEXT DAY 12/21/10 SHE COULD NOT WALK AT ALL AND THIS WAS THE FIRST PARALYSIS. SHE WAS ADMITTED TO THE HOSPITAL, A NEUROLOGIST WAS CALLED IN, SHE HAD MRI AND BLOOD WORK.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abasia, Asthenia, Blood test, Dizziness, Gait disturbance
Clinical narrative: The patient has been experiencing periodic episodes of paralysis, muscle weakness and muscle twitching. She has had an extensive work up that has not been conclusive.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Malaise, Nuclear magnetic resonance imaging, Pain, Paralysis
Clinical narrative: The patient has been experiencing periodic episodes of paralysis, muscle weakness and muscle twitching. She has had an extensive work up that has not been conclusive.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electroencephalogram, Electromyogram, Muscle twitching, Muscular weakness, Nerve conduction studies
Clinical narrative: The patient has been experiencing periodic episodes of paralysis, muscle weakness and muscle twitching. She has had an extensive work up that has not been conclusive.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: The patient has been experiencing periodic episodes of paralysis, muscle weakness and muscle twitching. She has had an extensive work up that has not been conclusive.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Balance disorder, Blindness, Deafness, Loss of consciousness, Syncope
Clinical narrative: Became faint, blacked out, ringing in ears, loss of hearing and vision, loss of balance.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Tinnitus
Clinical narrative: Became faint, blacked out, ringing in ears, loss of hearing and vision, loss of balance.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient began developing a red rash at site of injection. Over the period of several hours the rash spread to cover the majority of her upper arm.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Right leg pain. Swelling and redness where immunization was given. Fever. Seen in ER and admitted antibiotic treatment on 2/19/12.
Age: 4.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Eyelid oedema, Pyrexia, Urticaria, Vaccination complication
Clinical narrative: Day of Vaccine 102 fever followed by 100 for 4 days.  On Sunday 3/4 severe hives eyes swollen shut. The hives returned 2 hours post Benadryl on 7 occasions through the next day. Saw allergist on Monday after seeing ped. on Sunday. Allergist believed it was a vaccine reaction. Zyrtec resolved symptoms.
Age: 1.12
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Crying, Dermatitis acneiform, Disorientation, Injection site erythema, Injection site rash
Clinical narrative: Sudden crying, blank staring, seizure like symptoms, spiked fever, disorientation, throwing up multiple times, pimple like rash over belly and back. Child was also seen by Pediatric facility on 2/29 and on 3/2. Developed 4 chicken pox like marks on lower back area after emergency room visit and redness and hard bumps at site where injection was given.
Age: 1.12
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash vesicular, Seizure like phenomena, Staring, Vomiting
Clinical narrative: Sudden crying, blank staring, seizure like symptoms, spiked fever, disorientation, throwing up multiple times, pimple like rash over belly and back. Child was also seen by Pediatric facility on 2/29 and on 3/2. Developed 4 chicken pox like marks on lower back area after emergency room visit and redness and hard bumps at site where injection was given.
Age: 2.0
Sex: F
Vaccine: FLU3, HIBV, PNC13, FLU3, HIBV, PNC13
Symptoms: Febrile convulsion, Musculoskeletal stiffness, Pyrexia, Vaccine positive rechallenge, Vomiting
Clinical narrative: 10/13/2009 - Febrile Seizure after vaccination 03/17/2010 - Febrile Seizure after vaccination 04/25/2011 - Febrile Seizure after vaccination 02/28/2012 - Febrile Seizure after vaccination  ** High fever, stiffness during seizure, vomit *** During the previous incidents, we took our daughter to the emergency room. This latest one 02/28/2012, we did not.
Age: 2.0
Sex: F
Vaccine: FLU3, HIBV, PNC13, FLU3, HIBV, PNC13
Symptoms: Febrile convulsion, Gaze palsy, Musculoskeletal stiffness, Pyrexia
Clinical narrative: 10/13/2009 - Febrile Seizure after vaccination 03/17/2010 - Febrile Seizure after vaccination 04/25/2011 - Febrile Seizure after vaccination 02/28/2012 - Febrile Seizure after vaccination  ** High fever, stiffness during seizure, vomit *** During the previous incidents, we took our daughter to the emergency room. This latest one 02/28/2012, we did not.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Dysphagia
Clinical narrative: Severe abdominal cramps, difficulty swallowing.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Onset erythema, tenderness, swelling (R) deltoid day after injection. Tx- cold compresses, OTC ADVIL.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to injection site.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: Dx Guillain-Barre Syndrome. Tx Hospitalized at hospital from 2/2 to 2/8/2012. Received 5 days of IVIG. Discharged home stable.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Electrocardiogram ambulatory abnormal, Full blood count normal, Headache, Injection site pain
Clinical narrative: Received Tdap on 2/14. A few hours later felt headache, lightheadedness, malaise. Symptoms chronic, recurred. Also has noted intermittent palpitations, temperature around 99 degrees and left arm soreness (near site).
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Metabolic function test normal, Palpitations, Tenderness, Ventricular extrasystoles
Clinical narrative: Received Tdap on 2/14. A few hours later felt headache, lightheadedness, malaise. Symptoms chronic, recurred. Also has noted intermittent palpitations, temperature around 99 degrees and left arm soreness (near site).
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Blood creatine phosphokinase increased, Metabolic function test normal, Oedema peripheral, Pain in extremity, Rhabdomyolysis
Clinical narrative: Patient noticed left arm swelling & pain day following immunization. 2 days after immunization, swelling began in right arm. Patient seen by ER on day 3, with bilateral upper extremity pain & swelling. Admitted to hospital to treat for presumptive rhabdomyolysis and to monitor for compartment syndrome.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Urine analysis normal
Clinical narrative: Patient noticed left arm swelling & pain day following immunization. 2 days after immunization, swelling began in right arm. Patient seen by ER on day 3, with bilateral upper extremity pain & swelling. Admitted to hospital to treat for presumptive rhabdomyolysis and to monitor for compartment syndrome.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Abnormal behaviour, Fear, Irritability, Laboratory test normal
Clinical narrative: Initial report received from a health care professional on 03 November 2010. A 4-year-old child, with no medical history or concomitant medications, received on 29 September 2010 an injection (route and site not reported) of DAPTACEL, lot number C3142AA, an injection  (route and site not reported) of TUBERSOL 5 TU, lot number C3589AA, and an injection (route and site not reported) of MMR II, Merck lot number MS05322. The patient developed behavior changes on an unknown date after the vaccines in 2010. The patient's mother reported that the child became difficult in the morning, clings and cries at school and also now was afraid of the wind. The symptoms were reported first to the health care provider on 01 November 2010. The outcome was reported as not recovered. Follow-up information was received from the health care professional on 10 January 2011. The DAPTACEL was given intramuscularly in the left deltoid, the TUBERSOL 5TU intradermally in the left forearm.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: FLUZONE vaccine administered 10/31/2011. On 11/8/2011, noted left foot slap, tingling in feet/hands. Admitted to Hospital on 11/10/2011 with progressive weakness, numbness ultimately progressed to full paralysis, respiratory failure. EMG consistent with Guillain-Barre Syndrome. Received IVIG and plasmapheresis. Ultimately received Trach. Transferred to Rehab 01/13/2012.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Paralysis, Peroneal nerve palsy, Plasmapheresis, Respiratory failure
Clinical narrative: FLUZONE vaccine administered 10/31/2011. On 11/8/2011, noted left foot slap, tingling in feet/hands. Admitted to Hospital on 11/10/2011 with progressive weakness, numbness ultimately progressed to full paralysis, respiratory failure. EMG consistent with Guillain-Barre Syndrome. Received IVIG and plasmapheresis. Ultimately received Trach. Transferred to Rehab 01/13/2012.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Tracheostomy
Clinical narrative: FLUZONE vaccine administered 10/31/2011. On 11/8/2011, noted left foot slap, tingling in feet/hands. Admitted to Hospital on 11/10/2011 with progressive weakness, numbness ultimately progressed to full paralysis, respiratory failure. EMG consistent with Guillain-Barre Syndrome. Received IVIG and plasmapheresis. Ultimately received Trach. Transferred to Rehab 01/13/2012.