chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.03
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Urticaria
Clinical narrative: 10 minutes after the administration of vaccines child developed erythema & hives around the site where varicella was administered.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hypotension, Loss of consciousness, Nausea
Clinical narrative: Dizziness and nausea, loss consciousness, lowered patient to floor, and patient regained consciousness, BP initially low and returned to 118/60 with standing
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Inadvertently gave 0.5 ml influenza vaccine to a 2 yr old. Dosage should have been 0.25 ml.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: Right anterior thigh with bruising and patchy erythema 3x4cm raised lesion.
Age: 4.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Erythema, Induration, Rash
Clinical narrative: 4cm red rash, erythema and induration.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Thinking abnormal, Vertigo
Clinical narrative: Extreme vertigo - thought process impairment.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Ataxia, Encephalitis, Thinking abnormal, Vertigo
Clinical narrative: Extreme vertigo - thought process impairment.
Age: 6.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: localized redness, swelling, and warmth to the touch at injection sight
Age: 23.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP, FLU3, HEPA, MNQ, TDAP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: 15 MINS AFTER RECEIVING THE VACCINES THE RECRUIT C/O RASH REDNESS, DENIES ANY THROAT TIGHTNESS OR SHORTNESS OF BREATH, MILD ITCHING.
Age: 23.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP, FLU3, HEPA, MNQ, TDAP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: 15 MINS AFTER RECEIVING THE VACCINES THE RECRUIT C/O RASH REDNESS, DENIES ANY THROAT TIGHTNESS OR SHORTNESS OF BREATH, MILD ITCHING.
Age: 5.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Bacterial test negative, C-reactive protein normal, Epstein-Barr virus antibody negative, Full blood count normal, Injection site pain
Clinical narrative: fever for two days, leg pain starting 2/15/2011
Age: 5.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Metabolic function test normal, Parvovirus B19 test negative, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: fever for two days, leg pain starting 2/15/2011
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Injection site cellulitis, Nausea, Pyrexia, Vaccination complication
Clinical narrative: Localized area of cellulitis - R upper arm, fevers, nausea after PNEUMOVAX administration. Pt was treated for other problems (as well as for reaction to PNEUMOVAX) with Clindamycin, Vancomycin.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count normal
Clinical narrative: Localized area of cellulitis - R upper arm, fevers, nausea after PNEUMOVAX administration. Pt was treated for other problems (as well as for reaction to PNEUMOVAX) with Clindamycin, Vancomycin.
Age: 38.0
Sex: M
Vaccine: TYP
Symptoms: Rash erythematous
Clinical narrative: Red raised rash under both arms
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Convulsion, Dyskinesia, Electroencephalogram abnormal, Myoclonic epilepsy, Nuclear magnetic resonance imaging normal
Clinical narrative: Started having jerks (later found out they were seizures). Were around 15 at a time.
Age: 14.0
Sex: M
Vaccine: HPV2
Symptoms: Drug administration error
Clinical narrative: none-misadministered
Age: 55.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Within 2-3 hrs, developed red, itchy, induration 6 cm in diameter @ varicella injection site.  Within 36 hrs swelling, redness & induration increased to include soft tissue from deltoid to elbow.  Complains of itching - intense.  Mild relief achieved by frequent application of topical corticosteroids.  Area affected was sore to touch for 3 days.  Symptoms began to subside day 4.  Area returning to normal with only slight redness & swelling @ site - day 6.
Age: 55.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pruritus
Clinical narrative: Within 2-3 hrs, developed red, itchy, induration 6 cm in diameter @ varicella injection site.  Within 36 hrs swelling, redness & induration increased to include soft tissue from deltoid to elbow.  Complains of itching - intense.  Mild relief achieved by frequent application of topical corticosteroids.  Area affected was sore to touch for 3 days.  Symptoms began to subside day 4.  Area returning to normal with only slight redness & swelling @ site - day 6.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Decreased activity, Decreased appetite, Insomnia, Irritability, Lethargy
Clinical narrative: By 5:00 PM on date of administration, child was extremely and uncharacteristically irritable.  From 2/24/11 - 3/4/11 a few mild fevers were experienced along with continued irritability.  On 3/6/11 child suffered severe rash which became worse and spread over entire body and face.  On this date child began to experience trouble sleeping. Reduction in appetite occurred, sores are present inside of throat, fevers and continued irritability.  Child has become less active and much more lethargic since vaccine administration.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Stomatitis
Clinical narrative: By 5:00 PM on date of administration, child was extremely and uncharacteristically irritable.  From 2/24/11 - 3/4/11 a few mild fevers were experienced along with continued irritability.  On 3/6/11 child suffered severe rash which became worse and spread over entire body and face.  On this date child began to experience trouble sleeping. Reduction in appetite occurred, sores are present inside of throat, fevers and continued irritability.  Child has become less active and much more lethargic since vaccine administration.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Body temperature increased, Chills, Headache, Injected limb mobility decreased
Clinical narrative: Woke up in early AM 2/16/11 - shivering and left arm hurt. At 3:30PM - can't raise arm overhead, tender to touch, red & warm site about size 50 cent piece. Temp 101.6, headache. No appetite. Nephrologist referred her to E.R., blood cultures x2 done, advised to take TYLENOL for temp. Referred to ER if increased temp. On 2/17 - reports malaise, severe headache - over eyes, (L) arm still sore. Temp 99.8 with TYLENOL.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Woke up in early AM 2/16/11 - shivering and left arm hurt. At 3:30PM - can't raise arm overhead, tender to touch, red & warm site about size 50 cent piece. Temp 101.6, headache. No appetite. Nephrologist referred her to E.R., blood cultures x2 done, advised to take TYLENOL for temp. Referred to ER if increased temp. On 2/17 - reports malaise, severe headache - over eyes, (L) arm still sore. Temp 99.8 with TYLENOL.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Rash
Clinical narrative: Pt reported developing a rash 2 days after vaccine administration, as well as swelling on the inner upper left arm. Recommended that pt take OTC BENADRYL for the rash, & to contact PCP if swelling doesn't resolve by the following day.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Erythema, induration, tenderness at the site of injection. Myalgias and low grade fever.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling & redness 10 to 12cm area.
Age: 73.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, painful on RUE at site of injection.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal pain, Myalgia, Paraesthesia, Sensory disturbance
Clinical narrative: Deep shoulder pain; sensation of shoulder being dislocated; radiating pain w/ tingling down through arm; muscle soreness in forearm & deltoid; weakness when lifting above shoulder level.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Patient came in with (B) arms red and hot no fevers but blisters on (B) arms.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, redness, tenderness.
Age: 0.6
Sex: M
Vaccine: DTAPIPV, HIBV, PPV, RVX
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of fever in a 6-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included HIB (manufacturer unspecified), live attenuated human rotavirus vaccine (manufacturer unspecified) and pneumococcal vaccine (manufacturer unspecified) all given on 18 January 2011. There were no concurrent medications. In the late morning on 18 January 2011 the subject inadvertently received a dose of KINRIX in an unknown thigh. On 18 January 2011, less than one day after vaccination with KINRIX, in the evening, the subject experienced slight fever. The fever resolved the same day. Administration of KINRIX was also a maladministration (asymptomatic/child too young) and wrong vaccine administered. The child should have received his 3rd dose of PEDIARIX. He received hepatitis B vaccine recombinant (manufacturer unspecified) the following day, 19 January 2011, to complete his coverage. Attribution of fever to treatment with KINRIX was not known.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Brachial plexopathy, Hypoaesthesia, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Flu vaccine received IM deltoid, left arm on 2/3/11. 2/15/11 began onset of symptoms consistent with brachial plexus neuropathy/neuritis including: significant pain to shoulder & scapula, weakness when lifting items above shoulder height, constant tingling/numb sensation from scapula to elbow, significant stiffness when not using arm.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Radiculitis brachial
Clinical narrative: Flu vaccine received IM deltoid, left arm on 2/3/11. 2/15/11 began onset of symptoms consistent with brachial plexus neuropathy/neuritis including: significant pain to shoulder & scapula, weakness when lifting items above shoulder height, constant tingling/numb sensation from scapula to elbow, significant stiffness when not using arm.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness & itchiness at site of injection.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 28 February 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 10 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 29 June 2010. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 00.78, an abnormal ECG and a normal Echocardiogram. 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: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocardial infarction, Myocarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 28 February 2011. A 37 year-old male subject with a history of chest pain was found to have a subendocardial infarction and a non-specific myocarditis 11 and 26 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 17 April 2010. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 02.68, an abnormal ECG and a normal Echocardiogram. 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: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Encephalitis, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: This study case was received from the investigator on 02 March 2011. A 28-year-old male subject was found to have unspecified cause of encephalitis 29 days after receiving an injection (route and site not reported) of ACAM2000, lot number not reported, on 23 February 2010. The subject had a history of elevated cholesterol, headaches and numbness or paralysis. On 24 March 2010, the subject was diagnosed with unspecified cause of encephalitis. The subject's magnetic resonance imaging (MRI) of the brain and lumbar puncture (spinal tap) results were not available. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: SMALL, ANTH, SMALL
Symptoms: Chest pain, Dyspnoea, Fatigue
Clinical narrative: This study case was received from the investigator in a trial on 02 March 2011. A 23 year-old male subject with a medical history of headaches was found to have idiopathic myocarditis and unspecified secondary cardiomyopathy 10 and 15 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 2 (manufacturer, lot number, route and site of administration not reported) on 10 June 2010. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 22.15, an abnormal ECG and an abnormal Echocardiogram. 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: 23.0
Sex: M
Vaccine: SMALL, ANTH, SMALL
Symptoms: Cardiomyopathy, Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 02 March 2011. A 23 year-old male subject with a medical history of headaches was found to have idiopathic myocarditis and unspecified secondary cardiomyopathy 10 and 15 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 2 (manufacturer, lot number, route and site of administration not reported) on 10 June 2010. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 22.15, an abnormal ECG and an abnormal Echocardiogram. 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: 37.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood glucose increased, Condition aggravated, Ejection fraction decreased, Electrocardiogram ST segment elevation, Hyperlipidaemia
Clinical narrative: This study case was received from the investigator in the trial on 02 March 2011. A 37-year-old male subject was found to have on 09 July 2010 acute pericarditis (17 days after vaccine) and was found to have on 16 July 2010 other and unspecified acute myocarditis 24 days after receiving an injection (route and site not reported) of ACAM2000, lot number not reported, on 22 June 2010. The subject received an injection (route and site not reported) of ANTHRAX, lot number not reported, on 01 June 2010. The subject had a history of elevated cholesterol and dizziness and fainting spells. On 05 July 2010 the subject had an electrocardiogram performed which was reported as abnormal. On 09 July 2010, the subject was diagnosed with acute pericarditis and on 16 July 2010 he was diagnosed with other and unspecified acute myocarditis. The subject's troponin I of 00.12 from the 22 July 2010 was reported as abnormal. On 22 July 2010, the subject had an echocardiogram performed which was normal. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Left ventricular dysfunction, Loss of consciousness, Myopericarditis, Pericarditis, Syncope
Clinical narrative: This study case was received from the investigator in the trial on 02 March 2011. A 37-year-old male subject was found to have on 09 July 2010 acute pericarditis (17 days after vaccine) and was found to have on 16 July 2010 other and unspecified acute myocarditis 24 days after receiving an injection (route and site not reported) of ACAM2000, lot number not reported, on 22 June 2010. The subject received an injection (route and site not reported) of ANTHRAX, lot number not reported, on 01 June 2010. The subject had a history of elevated cholesterol and dizziness and fainting spells. On 05 July 2010 the subject had an electrocardiogram performed which was reported as abnormal. On 09 July 2010, the subject was diagnosed with acute pericarditis and on 16 July 2010 he was diagnosed with other and unspecified acute myocarditis. The subject's troponin I of 00.12 from the 22 July 2010 was reported as abnormal. On 22 July 2010, the subject had an echocardiogram performed which was normal. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in the trial on 02 March 2011. A 37-year-old male subject was found to have on 09 July 2010 acute pericarditis (17 days after vaccine) and was found to have on 16 July 2010 other and unspecified acute myocarditis 24 days after receiving an injection (route and site not reported) of ACAM2000, lot number not reported, on 22 June 2010. The subject received an injection (route and site not reported) of ANTHRAX, lot number not reported, on 01 June 2010. The subject had a history of elevated cholesterol and dizziness and fainting spells. On 05 July 2010 the subject had an electrocardiogram performed which was reported as abnormal. On 09 July 2010, the subject was diagnosed with acute pericarditis and on 16 July 2010 he was diagnosed with other and unspecified acute myocarditis. The subject's troponin I of 00.12 from the 22 July 2010 was reported as abnormal. On 22 July 2010, the subject had an echocardiogram performed which was normal. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator in the above mentioned trial on 28 February 2011.  A 25 year-old male subject with a history of dizziness/fainting spells was found to have an unspecified disease of the pericardium and a non-specific myocarditis 17 and 20 days, respectively, after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 02 July 2010.  Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 00.65, an abnormal ECG and an abnormal Echocardiogram.  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: 25.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Axillary pain, Blood creatine phosphokinase MB increased, Cardiac enzymes increased, Cardiomyopathy, Catheterisation cardiac abnormal
Clinical narrative: This study case was received from the investigator on 28 February 2011. A 25 year-old male subject with no significant medical history was found to have acute pericarditis, an unspecified disease of the pericardium and a non-specific myocarditis 19, 14 and 17 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 04 June 2010. He also received on 03 June 2010 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: an abnormal Troponin I with the highest recorded value of 08.23, an abnormal ECG and an abnormal Echocardiogram. 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: 25.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Chest discomfort, Chest pain, Computerised tomogram, Computerised tomogram normal, Dizziness
Clinical narrative: This study case was received from the investigator on 28 February 2011. A 25 year-old male subject with no significant medical history was found to have acute pericarditis, an unspecified disease of the pericardium and a non-specific myocarditis 19, 14 and 17 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 04 June 2010. He also received on 03 June 2010 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: an abnormal Troponin I with the highest recorded value of 08.23, an abnormal ECG and an abnormal Echocardiogram. 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: 25.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Dyspnoea, Echocardiogram, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram ST segment elevation
Clinical narrative: This study case was received from the investigator on 28 February 2011. A 25 year-old male subject with no significant medical history was found to have acute pericarditis, an unspecified disease of the pericardium and a non-specific myocarditis 19, 14 and 17 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 04 June 2010. He also received on 03 June 2010 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: an abnormal Troponin I with the highest recorded value of 08.23, an abnormal ECG and an abnormal Echocardiogram. 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: 25.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Fatigue, Fibrin D dimer normal, Hyperhidrosis, Injection site erythema, Left ventricular dysfunction
Clinical narrative: This study case was received from the investigator on 28 February 2011. A 25 year-old male subject with no significant medical history was found to have acute pericarditis, an unspecified disease of the pericardium and a non-specific myocarditis 19, 14 and 17 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 04 June 2010. He also received on 03 June 2010 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: an abnormal Troponin I with the highest recorded value of 08.23, an abnormal ECG and an abnormal Echocardiogram. 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: 25.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Lymphadenopathy, Myocarditis, Myoglobin blood increased, Painful respiration, Red blood cell sedimentation rate normal
Clinical narrative: This study case was received from the investigator on 28 February 2011. A 25 year-old male subject with no significant medical history was found to have acute pericarditis, an unspecified disease of the pericardium and a non-specific myocarditis 19, 14 and 17 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 04 June 2010. He also received on 03 June 2010 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: an abnormal Troponin I with the highest recorded value of 08.23, an abnormal ECG and an abnormal Echocardiogram. 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: 25.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Troponin I increased, Ventricular hypokinesia
Clinical narrative: This study case was received from the investigator on 28 February 2011. A 25 year-old male subject with no significant medical history was found to have acute pericarditis, an unspecified disease of the pericardium and a non-specific myocarditis 19, 14 and 17 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 04 June 2010. He also received on 03 June 2010 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: an abnormal Troponin I with the highest recorded value of 08.23, an abnormal ECG and an abnormal Echocardiogram. 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: 25.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Pericardial disease, Pericarditis
Clinical narrative: This study case was received from the investigator on 28 February 2011. A 25 year-old male subject with no significant medical history was found to have acute pericarditis, an unspecified disease of the pericardium and a non-specific myocarditis 19, 14 and 17 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 04 June 2010. He also received on 03 June 2010 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: an abnormal Troponin I with the highest recorded value of 08.23, an abnormal ECG and an abnormal Echocardiogram. 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: 25.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator on 28 February 2011. A 25 year-old male subject with no significant medical history was found to have acute pericarditis, an unspecified disease of the pericardium and a non-specific myocarditis 19, 14 and 17 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 04 June 2010. He also received on 03 June 2010 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: an abnormal Troponin I with the highest recorded value of 08.23, an abnormal ECG and an abnormal Echocardiogram. 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: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure abnormal, Body temperature increased, Diarrhoea, Dizziness, Feeling abnormal
Clinical narrative: Combined initial and follow up reports received from Pharmacy family of companies via Novartis legal department on 31 Jan 2011: This patient was vaccinated with FLUVIRIN (batch number 111776P1) on an unspecified date. 2 hours post vaccination, the patient experienced symptoms like nausea, dizziness and achiness. The patient had to spend a night in hospital because of these symptoms. The outcome of the event was not reported. Follow-up report received from a consumer on 24 Feb 2011: The patient was vaccinated on 13 Sep 2010 at 18:00 hours. Following administration of the vaccine at 20:00 hours, the patient was in worst possible shape he had ever been and experienced vomiting, diarrhea, vicious headache and felt very foggy like he was on a different planet. On 14 Sep 2010 at around 04:00 hours, the patient was taken to a hospital where and he was shaking uncontrollably and had a temperature of 102. The patient was shifted to another hospital, wherein tests were performed and his blood pressure went to 90/52. The patient was in emergency room for 8 hours before being admitted to hospital. Gradually he got better, the temperature went down and blood pressure back to normal. According to the physician, flu shot was responsible for the patient's condition. The outcome of the events was not reported.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Laboratory test, Nausea, Pain, Tremor
Clinical narrative: Combined initial and follow up reports received from Pharmacy family of companies via Novartis legal department on 31 Jan 2011: This patient was vaccinated with FLUVIRIN (batch number 111776P1) on an unspecified date. 2 hours post vaccination, the patient experienced symptoms like nausea, dizziness and achiness. The patient had to spend a night in hospital because of these symptoms. The outcome of the event was not reported. Follow-up report received from a consumer on 24 Feb 2011: The patient was vaccinated on 13 Sep 2010 at 18:00 hours. Following administration of the vaccine at 20:00 hours, the patient was in worst possible shape he had ever been and experienced vomiting, diarrhea, vicious headache and felt very foggy like he was on a different planet. On 14 Sep 2010 at around 04:00 hours, the patient was taken to a hospital where and he was shaking uncontrollably and had a temperature of 102. The patient was shifted to another hospital, wherein tests were performed and his blood pressure went to 90/52. The patient was in emergency room for 8 hours before being admitted to hospital. Gradually he got better, the temperature went down and blood pressure back to normal. According to the physician, flu shot was responsible for the patient's condition. The outcome of the events was not reported.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Combined initial and follow up reports received from Pharmacy family of companies via Novartis legal department on 31 Jan 2011: This patient was vaccinated with FLUVIRIN (batch number 111776P1) on an unspecified date. 2 hours post vaccination, the patient experienced symptoms like nausea, dizziness and achiness. The patient had to spend a night in hospital because of these symptoms. The outcome of the event was not reported. Follow-up report received from a consumer on 24 Feb 2011: The patient was vaccinated on 13 Sep 2010 at 18:00 hours. Following administration of the vaccine at 20:00 hours, the patient was in worst possible shape he had ever been and experienced vomiting, diarrhea, vicious headache and felt very foggy like he was on a different planet. On 14 Sep 2010 at around 04:00 hours, the patient was taken to a hospital where and he was shaking uncontrollably and had a temperature of 102. The patient was shifted to another hospital, wherein tests were performed and his blood pressure went to 90/52. The patient was in emergency room for 8 hours before being admitted to hospital. Gradually he got better, the temperature went down and blood pressure back to normal. According to the physician, flu shot was responsible for the patient's condition. The outcome of the events was not reported.
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a lawyer regarding a male consumer who on 01OCT10 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 0866Z Expiration date 14JUL11) and developed a fever and arm pain shortly after receiving the vaccination and went to the hospital the same day. Outcome was not reported. Additional information is expected.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Dyspnoea, Echocardiogram abnormal, Electrocardiogram normal, Myopericarditis
Clinical narrative: Acute myopericarditis.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Pericardial effusion, Pyrexia, Troponin increased
Clinical narrative: Acute myopericarditis.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Electrocardiogram ST segment elevation, Myopericarditis, Troponin increased
Clinical narrative: Acute myopericarditis.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Apparent life threatening event, Chest pain, Dyspnoea, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: Acute myopericarditis.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Myopericarditis, Pericardial effusion, Pyrexia, Troponin increased
Clinical narrative: Acute myopericarditis.
Sex: U
Vaccine: PPV, PPV
Symptoms: Asthenia, Dysstasia, Fatigue, Joint swelling, Pain
Clinical narrative: None stated.
Sex: U
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Respiratory tract congestion
Clinical narrative: None stated.
Sex: U
Vaccine: PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Differential white blood cell count abnormal, Erythema, Full blood count abnormal, Oedema peripheral, Skin warm
Clinical narrative: Patient complained of having left anterolateral arm with marked swelling, erythema and mild warmth noted by school nurse on 1-24-11.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Conversion disorder, Crying, Hypotension, Loss of consciousness
Clinical narrative: Patient was hysterical and crying during administration of vaccinations. After the vaccinations were administered she was informed to sit in the chair for 10-15 minutes, but she insisted sitting on the floor. A few minutes later she began to lose consciousness. She was laid to floor and regained consciousness immediately. Blood pressure was slightly low 90/50 and slowly increased to 108/90 from lying, to sitting, to sitting in chair, to standing, to walking.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Musculoskeletal pain, Neck pain, Rash, X-ray limb
Clinical narrative: Moderate pain in neck; by morning pain in shoulder; mid day 3/5/11 rash began to appear; severe pain in upper back and shoulder, rash spread to right arm; right arm is inoperable
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Crying, Herpes zoster, Joint sprain, Joint stiffness
Clinical narrative: Moderate pain in neck; by morning pain in shoulder; mid day 3/5/11 rash began to appear; severe pain in upper back and shoulder, rash spread to right arm; right arm is inoperable
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Rash pustular, X-ray abnormal
Clinical narrative: Moderate pain in neck; by morning pain in shoulder; mid day 3/5/11 rash began to appear; severe pain in upper back and shoulder, rash spread to right arm; right arm is inoperable
Age: 3.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Erythema, Rash, Scratch, Urticaria
Clinical narrative: Father in clinic with client, requesting vaccinations--father denied that child had been seriously ill or febrile in the past week that she had been in his custody---he also stated that she had NKA, was not immuno-compromised, that she was not currently taking any medications, and that she had no history of seizures--There were no contraindications to any vaccinations--Vaccines were administered at 2:23 PM--At 2:25 PM, after administration while data was being put into the computer, the child's father noted that she was scratching and had began to "break out"--This nurse noted small welts and redness bilaterally to child's lower jaw area---her temperature was 99.8, her apical pulse was 108, her respirations were 24, her lungs were clear upon auscultation and she weighed 29 lbs---She showed no signs/symptoms of acute distress---At 2:30 PM, the child was administered 6.5ml of Diphenhydramine PO---the child's father was instructed to take the child to her pediatrician or an acute care facility immediately after leaving the Health Department---the father agreed to follow the instructions---At 2:44 PM, the child left the facility ambulatory, holding her father's hand--no signs/symptoms of distress were noted upon child's exit---I called the child's father at 10:00 AM on 03/04/2011 and he stated that he had taken the child to an acute care facility and that they told him to treat the child with Benadryl---He also stated that she had another "break out" later that evening and that he gave her more Benadryl---He stated that she was doing "fine".
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: Fatigue, Immediate post-injection reaction, Injection site pain, Musculoskeletal stiffness, Nervousness
Clinical narrative: Flu shot & Hep A given in L deltoid; Gardasil given in R deltoid.  Immediately after Gardasil injection, patient stated "that one hurt"; started getting pale and as RN laid him back on exam table, patient stiffened arms and legs.  No LOC.  Elevated legs and applied cool rag to face and neck.  After about 5 minutes, patient was able to sit up and drink a couple ounces of orange juice and ate a few pretzels.  Patient had not eaten any breakfast this AM.  Patient remained alert and oriented, but continued to be shaky for several more minutes.  By 9:20 AM, all s/s were gone but patient stated that he felt tired.  BP=108/70 and HR=88.  PCP was called for any further recommendations for the patient.  PCP states that patient OK to return to school if BP OK.  Mom to call HD and/or PCP for further questions or concerns.
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: Pallor
Clinical narrative: Flu shot & Hep A given in L deltoid; Gardasil given in R deltoid.  Immediately after Gardasil injection, patient stated "that one hurt"; started getting pale and as RN laid him back on exam table, patient stiffened arms and legs.  No LOC.  Elevated legs and applied cool rag to face and neck.  After about 5 minutes, patient was able to sit up and drink a couple ounces of orange juice and ate a few pretzels.  Patient had not eaten any breakfast this AM.  Patient remained alert and oriented, but continued to be shaky for several more minutes.  By 9:20 AM, all s/s were gone but patient stated that he felt tired.  BP=108/70 and HR=88.  PCP was called for any further recommendations for the patient.  PCP states that patient OK to return to school if BP OK.  Mom to call HD and/or PCP for further questions or concerns.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Meningism, Meningitis meningococcal, Neisseria test positive
Clinical narrative: Developed symptoms of meningitis,  Dx 2/12/2011 with Neisseria meningitidis group Y. Discharged from hospital and has returned home to further recover.  No known disease sequelae identified.
Age: 24.0
Sex: F
Vaccine: FLU3, HPV4, IPV, TDAP
Symptoms: Arthralgia, Dizziness, Pain
Clinical narrative: Joint pain, dizziness, body aches.
Age: 29.0
Sex: F
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Drug exposure during pregnancy, Neonatal disorder, Pregnancy test positive
Clinical narrative: Information has been received from a obstetrics registered nurse and a physician via medical records for VARIVAX (Merck), a Pregnancy Registry product, concerning a female baby patient whose 29 year old mother was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (lot # 664355/0655Y) on 07-OCT-2009. Concomitant medications included vitamins. The patient's mother was subsequently discovered to be pregnant on a serum pregnancy test on 21-OCT-2009 (WAES # 0910USA02803). The patient was born on 21-JUN-2010 via normal spontaneous vaginal delivery, her weight was 8 pounds 7 ounces. APGAR score was pending at the time of dictation but the initial APGAR was quoted as 8. The pediatric team was called because of the patient's baby particulate meconium aspiration, and although the baby had a spontaneous and vigorous cry, oxygen supplementation was necessary to keep the pulse oximeter reading appropriate. Because the reading was borderline, the decision was made to take the baby to the special care nursery. The baby was hospitalized for 4 days in the neonatal ICU due to meconium aspiration. On an unspecified date, the patient was sent home with her mother. At the time of the patient's mother postpartum visit in August 2010, no problems were reported with the healthy patient. Additional information has been requested. All available medical records will be provided upon request.
Age: 29.0
Sex: F
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received from a obstetrics registered nurse and a physician via medical records for VARIVAX (Merck), a Pregnancy Registry product, concerning a female baby patient whose 29 year old mother was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (lot # 664355/0655Y) on 07-OCT-2009. Concomitant medications included vitamins. The patient's mother was subsequently discovered to be pregnant on a serum pregnancy test on 21-OCT-2009 (WAES # 0910USA02803). The patient was born on 21-JUN-2010 via normal spontaneous vaginal delivery, her weight was 8 pounds 7 ounces. APGAR score was pending at the time of dictation but the initial APGAR was quoted as 8. The pediatric team was called because of the patient's baby particulate meconium aspiration, and although the baby had a spontaneous and vigorous cry, oxygen supplementation was necessary to keep the pulse oximeter reading appropriate. Because the reading was borderline, the decision was made to take the baby to the special care nursery. The baby was hospitalized for 4 days in the neonatal ICU due to meconium aspiration. On an unspecified date, the patient was sent home with her mother. At the time of the patient's mother postpartum visit in August 2010, no problems were reported with the healthy patient. Additional information has been requested. All available medical records will be provided upon request.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Condition aggravated, Rash, Rash macular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient with the medical history of high blood pressure who on 14-FEB-2011 was vaccinated intramuscularly with the first dose of GARDASIL (Lot# 662529/1317Y, Expiration: 30-May-2011).  Concomitant therapy included MICARDIS for her high blood pressure and ethinyl estradiol (+) etonogestrel (MSD).  The physician reported that the patient had a rash and increased blood pressure.  On 23-FEB-2011 the patient went back to the physician because of the onset of the rash which started on 16-FEB-2011.  It was on her arm and leg and it was itchy and blotchy.  One thing to note about the increased blood pressure, she was on MICARDIS (manufacturer unspecified).  She was also on ethinyl estradiol (+) etonogestrel (MSD) prior to getting the GARDASIL vaccine.  One thing her primary doctor added after the AE was the metoprolol 50mg (manufacturer unspecified).  She did visit her primary care physician and that's who prescribed it.  At time of report, the patient's status was unknown.  Blood pressure increased was considered to be another important medical event by the reporter.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Erythema multiforme, Urticaria
Clinical narrative: Erythema multiforme rash started as hives on feet, then spread to heels & elbows, then knees. Topical steroids & OTC antihistamine.
Age: 44.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Activated partial thromboplastin time normal, Arthralgia, Culture throat negative, Joint range of motion decreased, Liver function test normal
Clinical narrative: A few days after getting varicella and Tdap vaccine, she noticed itching in different places of her body and when she scratched, would get hives.  Then, on 3/4 she woke up with pain in her left middle finger MCP joint could not bend it.  The pain migrated then to different joints in right thumb, wrist, and then in her knees.  Has been moving around.
Age: 44.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Platelet count decreased, Prothrombin time normal, Pruritus, Streptococcus test negative, Urticaria
Clinical narrative: A few days after getting varicella and Tdap vaccine, she noticed itching in different places of her body and when she scratched, would get hives.  Then, on 3/4 she woke up with pain in her left middle finger MCP joint could not bend it.  The pain migrated then to different joints in right thumb, wrist, and then in her knees.  Has been moving around.
Age: 44.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Viral test
Clinical narrative: A few days after getting varicella and Tdap vaccine, she noticed itching in different places of her body and when she scratched, would get hives.  Then, on 3/4 she woke up with pain in her left middle finger MCP joint could not bend it.  The pain migrated then to different joints in right thumb, wrist, and then in her knees.  Has been moving around.