chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Lumbar puncture, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: This study case was received from the investigator on 12 November 2012. A 28 year-old male subject with no significant past medical history was found to have Acute pericarditis, unspecified, 18 days after the subject had received the following vaccines on 05 July 2012: an injection of 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 tests included an abnormal ECG on 11 July 2012 and a normal echocardiogram on 13 July 2012. Troponin I, MRI (brain, spinal cord and heart) and lumbar puncture results 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: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Nuclear magnetic resonance imaging spinal cord, Pericarditis, Troponin I
Clinical narrative: This study case was received from the investigator on 12 November 2012. A 28 year-old male subject with no significant past medical history was found to have Acute pericarditis, unspecified, 18 days after the subject had received the following vaccines on 05 July 2012: an injection of 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 tests included an abnormal ECG on 11 July 2012 and a normal echocardiogram on 13 July 2012. Troponin I, MRI (brain, spinal cord and heart) and lumbar puncture results 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: 55.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Asthenia, Cellulitis, Erythema, Fatigue, Pain
Clinical narrative: Client reports (R) arm pain and feeling achy, feverish, weak and fatigue by early AM 11/14/12. States by 11/16 had fever of 102.4 degrees F, went to E.D. and was admitted for four days. Client reports discharge diagnosis of "cellulitis (R) arm". Client denies any symptoms in (L) arm. Client states by 11/21/12 (R) arm has improved, slightly achy and some redness remain.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Client reports (R) arm pain and feeling achy, feverish, weak and fatigue by early AM 11/14/12. States by 11/16 had fever of 102.4 degrees F, went to E.D. and was admitted for four days. Client reports discharge diagnosis of "cellulitis (R) arm". Client denies any symptoms in (L) arm. Client states by 11/21/12 (R) arm has improved, slightly achy and some redness remain.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Acute myocardial infarction, Echocardiogram normal, Electrocardiogram abnormal, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: This study case was received from the investigator in a trial on 12 November 2012. A 23 year-old male subject with a history of headaches was found to have six days post vaccination an acute myocardial infarction, subendocardial infarction after the subject had received on 15 September 2012 an injection of ACAM2000 (lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I of 00.18, an abnormal ECG on 21 September 2012 and a normal Echocardiogram on 23 September 2012. Lumbar puncture and MRI of the brain, spinal cord and heart were not available. 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
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal cord, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 12 November 2012. A 23 year-old male subject with a history of headaches was found to have six days post vaccination an acute myocardial infarction, subendocardial infarction after the subject had received on 15 September 2012 an injection of ACAM2000 (lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I of 00.18, an abnormal ECG on 21 September 2012 and a normal Echocardiogram on 23 September 2012. Lumbar puncture and MRI of the brain, spinal cord and heart were not available. 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: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Pericarditis, Troponin I
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator on 12 November 2012. A 29-year-old male subject received the following vaccinations: On 23 July 2012 an injection of ACAM2000 (lot number not reported), on 18 July 2012 an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported) and ANTHRAX (manufacturer and lot number not reported), and on 13 July 2012 an intramuscular injection of JAPANESE ENCEPHALITIS VACCINE (manufacturer and lot number not reported). The subject had no significant medical history. On 13 August 2012, the subject had a normal electrocardiogram (ECG). Troponin I results were not available. On 12 August 2012, the subject was diagnosed with acute pericarditis, unspecified. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Lumbar puncture, Myocarditis, Nuclear magnetic resonance imaging
Clinical narrative: This study case was received from the investigator in a trial on 12 November 2012. A 21 year-old male subject with no significant past medical history was found to have unspecified disease of the pericardium and non-specific myocarditis 14 and 10 days respectively after the subject had received on 16 July 2012 an injection of ACAM2000 (lot number, route and site of administration not reported). Relevant laboratory tests included an abnormal Troponin I recorded highest value of 01.91 on 28 July 2012, an abnormal ECG on 26 July 2012 and an abnormal echocardiogram on 27 July 2012. A Lumbar puncture and MRI of the brain, spinal cord and heart results 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: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal cord, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 12 November 2012. A 21 year-old male subject with no significant past medical history was found to have unspecified disease of the pericardium and non-specific myocarditis 14 and 10 days respectively after the subject had received on 16 July 2012 an injection of ACAM2000 (lot number, route and site of administration not reported). Relevant laboratory tests included an abnormal Troponin I recorded highest value of 01.91 on 28 July 2012, an abnormal ECG on 26 July 2012 and an abnormal echocardiogram on 27 July 2012. A Lumbar puncture and MRI of the brain, spinal cord and heart results 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: 25.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator on 12 November 2012. A 25-year-old female subject received the following vaccinations: On 25 July 2012 an injection of ACAM2000 (lot number not reported), an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported) and ANTHRAX (manufacturer and lot number not reported). The subject previously received a dose of ANTHRAX (manufacturer and lot number not reported) on 26 June 2012. The subject had no significant medical history. On 06 August 2012, the subject had an abnormal troponin I of 00.99, a abnormal electrocardiogram (ECG) and a normal echocardiogram. On 06 August 2012, the subject was diagnosed with other and unspecified acute pericarditis. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Pericardial disease
Clinical narrative: This study case was received from the investigator in a trial on 12 November 2012. A 33-year-old male subject received an injection of ACAM2000 (lot number not reported) on 14 June 2012. Medical history and laboratory data were not available. On 20 June 2012, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema
Clinical narrative: Pt's arm (R) had redness and erythema following pneumonia vaccine injection. Pt used BENADRYL and compresses. Symptoms resolved by the next day.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Laboratory test
Clinical narrative: This study case was received from the investigator on 12 November 2012. A 33-year-old male subject received an injection of ACAM2000 (lot number not reported) on 11 July 2012. Medical history was not available. On 24 July 2012, the subject was diagnosed with chest pain, unspecified. Laboratory testing was not available. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 43.0
Sex: F
Vaccine: SMALL
Symptoms: Encephalitis post immunisation, Laboratory test
Clinical narrative: This study case was received from the investigator on 12 November 2012. A 43-year-old female subject received the following vaccinations: On 21 June 2012 an injection of ACAM2000 (lot number not reported) and on 29 May 2012 an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported) and ANTHRAX (manufacturer and lot number not reported). The subject had a past medical history of headaches and meningitis. On 03 July 2012, the subject was diagnosed with encephalitis following immunization procedures. Laboratory testing was not available. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator on 12 November 2012. A 19-year-old male subject received the following vaccinations: On 01 August 2012 an injection of ACAM2000 (lot number not reported), on 30 July 2012 an injection of ANTHRAX (manufacturer and lot number not reported), and an injection of TWINRIX (manufacturer and lot number not reported). The subject had no significant medical history. On 31 August 2012, the subject had an abnormal troponin I of 00.67 and a normal echocardiogram. On 30 August 2012, the subject was diagnosed with non-specific myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Encephalitis post immunisation, Lumbar puncture abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Troponin I, Troponin normal
Clinical narrative: This study case was received from the investigator in a trial on 12 November 2012. A 19-year-old male subject received the following vaccinations on 30 August 2012: an injection of ACAM2000 (lot number not reported), an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported), ANTHRAX (manufacturer and lot number not reported), and a intranasal dose of INFLUENZA, LIVE (manufacturer and lot number not reported). The subject had no significant medical history. On 09 September 2012, the subject had an abnormal lumbar puncture (spinal tap). On 13 September 2012, the subject had a normal troponin I and an abnormal MRI (spinal cord). On 08 September 2012, the subject was diagnosed with encephalitis following immunization procedures. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood culture negative, Chest X-ray normal, Computerised tomogram normal, Nausea, Pyrexia
Clinical narrative: Nausea Vomiting Day 1, fever started 11:30 PM, Hives began Day 3, Respiratory Distress night of Day 3, Nausea now subsiding, Hives and Respiratory distress are still going on.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Respiratory distress, Urine analysis normal, Urticaria, Vomiting
Clinical narrative: Nausea Vomiting Day 1, fever started 11:30 PM, Hives began Day 3, Respiratory Distress night of Day 3, Nausea now subsiding, Hives and Respiratory distress are still going on.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chest discomfort, Oedema mouth, Pyrexia, Swelling face, Swollen tongue
Clinical narrative: Nausea Vomiting Day 1, fever started 11:30 PM, Hives began Day 3, Respiratory Distress night of Day 3, Nausea now subsiding, Hives and Respiratory distress are still going on.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Urticaria
Clinical narrative: Nausea Vomiting Day 1, fever started 11:30 PM, Hives began Day 3, Respiratory Distress night of Day 3, Nausea now subsiding, Hives and Respiratory distress are still going on.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Tendonitis
Clinical narrative: Stabbing pain posterior L shoulder decreased range of motion x last 2 1/2 weeks no erythema, no fever.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: When Prevnar 13 was given, the patient's left thigh immediately begin to swell and bleed profusely.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Temp of 100.4F, localized pain at injection site. On 11/20/12 he complained of increased arm pain and fatigue. Temp increased to 102.8F. Mom noted swelling and redness at site of injection. After calling our office at 7pm on 11/20/12 he was started on a burst of prednisolone (15mg twice daily for 3 days). He was evaluated in our office at 9:45am on 11/21/12. He was playful, alert, and non-toxic appearing in the office. Exam normal except for erythematous posterior oropharynx and 3 x 5.5cm area of erythema, induration, warmth, and tenderness over left deltoid.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Pharyngeal erythema
Clinical narrative: Temp of 100.4F, localized pain at injection site. On 11/20/12 he complained of increased arm pain and fatigue. Temp increased to 102.8F. Mom noted swelling and redness at site of injection. After calling our office at 7pm on 11/20/12 he was started on a burst of prednisolone (15mg twice daily for 3 days). He was evaluated in our office at 9:45am on 11/21/12. He was playful, alert, and non-toxic appearing in the office. Exam normal except for erythematous posterior oropharynx and 3 x 5.5cm area of erythema, induration, warmth, and tenderness over left deltoid.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Redness, and blistering at injection site approx 3cm in length.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Syncope
Clinical narrative: Patient stood up to leave the room because she did not want to see her sister get a shot. As she walked out the door she fainted. Came to quickly. No treatement required.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Woke up very dizzy, headache, fever. Lasted two days.
Age: 34.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Activities of daily living impaired, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Client received vaccine on 10/26/12.  Started having shoulder & arm pain that night.  Saw MD on 11/11/12, given steroid injection.  Has not been able to work-out or use arm in normal capacity.  There was no redness or rash associated at site.  Pain improved with steroid but now returning as steroid is wearing off.  Still having arm pain - not able to move arm to full extent.
Age: 34.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Client received vaccine on 10/26/12.  Started having shoulder & arm pain that night.  Saw MD on 11/11/12, given steroid injection.  Has not been able to work-out or use arm in normal capacity.  There was no redness or rash associated at site.  Pain improved with steroid but now returning as steroid is wearing off.  Still having arm pain - not able to move arm to full extent.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Chills, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Fast heart beat, a little bit of difficulty of breathing, paleness, possible fever, chills, headache, body ache, anxiety.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pallor
Clinical narrative: Fast heart beat, a little bit of difficulty of breathing, paleness, possible fever, chills, headache, body ache, anxiety.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Headache
Clinical narrative: Severe headache, took Advil several times every 4 hours. Chills and upset stomach ache, diarrhea.
Age: 19.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Induration, Injected limb mobility decreased, Injection site pain
Clinical narrative: After getting the shot it was sore then around 830p.m. right arm started having pain took some Tylenol and at 200 a.m the pain still there cannot lift the arm and having the chill, headache, nausea then taking Tylenol and Motrin alternate to relieve the pain and still there cannot lift the arm still having headache continously and chills at night time. The headache and fever won't go away and not be able to lift the arm too painful and firm/swollen no redness warm to touch. Went to the DR yesterday and they order some blood work waiting for result. On the order it says meningococcal vaccine but she got pneumococcal vaccine. She is 19 years old and not smoking or had asthma. Not sure why she got pnemo vaccine instead of meningicoccal vaccine. She got pneumo vaccine and flu vaccine on her right arm the same time. The reaction is still the same for 3 days now, warm to touch not be able to lift the arm without help by other other arm and medication continously and continously bad headache and fever.
Age: 19.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Laboratory test, Nausea, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: After getting the shot it was sore then around 830p.m. right arm started having pain took some Tylenol and at 200 a.m the pain still there cannot lift the arm and having the chill, headache, nausea then taking Tylenol and Motrin alternate to relieve the pain and still there cannot lift the arm still having headache continously and chills at night time. The headache and fever won't go away and not be able to lift the arm too painful and firm/swollen no redness warm to touch. Went to the DR yesterday and they order some blood work waiting for result. On the order it says meningococcal vaccine but she got pneumococcal vaccine. She is 19 years old and not smoking or had asthma. Not sure why she got pnemo vaccine instead of meningicoccal vaccine. She got pneumo vaccine and flu vaccine on her right arm the same time. The reaction is still the same for 3 days now, warm to touch not be able to lift the arm without help by other other arm and medication continously and continously bad headache and fever.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Ache/pain in shoulder - still occurring 11/21/2012 - I thought the shot was given higher up on my arm than usual.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported redness, swelling, itchiness, hard to touch tissue, and burning in arm that vaccine was administered and for 3 days after.  She self administered Benadryl, she says that helped with the swelling and is not having any complications currently.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Breakthrough pain, Injection site pain, Injection site swelling, Musculoskeletal pain, Skin warm
Clinical narrative: Mother reports that child experienced pain and swelling in the arm of the influenza vaccination administration (LD).  Child was see by Dr. on 11/05/2012 for left arm pain.  Per physician report "left shoulder pain; s/p flu shot. Plan Motrin, local heat.  Probably self limiting but could involve deltoid nerve.  Will give it time and tx as described.  If Sx persist we can do an EMG w/Peds Neurology.  Tylenol ok for breakthrough pain.  Call or Return if symptoms worsen or persist.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Fungal infection, Nausea, Vaginal discharge, Vulvovaginal burning sensation
Clinical narrative: Yeast infection. Itching, burning and vaginal discharge. Yeast infection has since cleared. Feeling of nausea, stomach pains a cramps that continue as  of 11/21/12.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Vulvovaginal pruritus
Clinical narrative: Yeast infection. Itching, burning and vaginal discharge. Yeast infection has since cleared. Feeling of nausea, stomach pains a cramps that continue as  of 11/21/12.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Eye pain, Fatigue, Headache, Nausea
Clinical narrative: Headache, chills, neck pain, eyes hurt and vision was odd, nausea, fever (104.1 Peak), body aches, exhausted. Took ibuprofen every 3 to 4 hours, but it didn't bring the fever all the way down or stop the pain. Had to seek medical care on Thursday. Was prescribed prednisone and medication for nausea. I am still fatigued and vision is still off compared to what it usually is. The fever lasted even with the meds until Sunday off and on. Still not feeling "normal" yet.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Neck pain, Pain, Pyrexia, Visual impairment
Clinical narrative: Headache, chills, neck pain, eyes hurt and vision was odd, nausea, fever (104.1 Peak), body aches, exhausted. Took ibuprofen every 3 to 4 hours, but it didn't bring the fever all the way down or stop the pain. Had to seek medical care on Thursday. Was prescribed prednisone and medication for nausea. I am still fatigued and vision is still off compared to what it usually is. The fever lasted even with the meds until Sunday off and on. Still not feeling "normal" yet.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Heart rate increased, Sinus tachycardia
Clinical narrative: Stated rapid heart rate, sinus tachycardia 105/min.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool, Haematochezia, Mucous stools
Clinical narrative: Mucus in stool followed by blood in stool.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Dizziness, Headache
Clinical narrative: Symptoms began w/HA at 1:45 pm, then some lightheadness, and chest pressure rated at 2-3 of 10.At 2:54 pm P-85, BP-138/81. EMS called, pt. declined transport.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Fatigue, Influenza like illness, Muscle spasms, Myalgia
Clinical narrative: Initially high temperature, muscle aches, flu-like feeling.  By 11 PM severe back spasms from shot site to spine. By 4 AM considered going to ER. Fever and extreme muscle pain continued for 2 days, then fatigue and lesser aches for 2 more days. Missed 1 1/2 days of work after weekend. Have never reacted this way to vaccine before. Not allergic to eggs.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: Initially high temperature, muscle aches, flu-like feeling.  By 11 PM severe back spasms from shot site to spine. By 4 AM considered going to ER. Fever and extreme muscle pain continued for 2 days, then fatigue and lesser aches for 2 more days. Missed 1 1/2 days of work after weekend. Have never reacted this way to vaccine before. Not allergic to eggs.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itching on torso and upper extremities.
Age: 1.0
Sex: F
Vaccine: FLUX, HEP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Pyrexia, Rash
Clinical narrative: Broke out in hives across upper arms, torso, and thighs. Clustered hives around injection site on RLE. Low grade fever for over 1 week (11/09/2012-11/19/2012) ranging from 99.8*F to 100.8*F. As of 11/21/2012, injection site is still red with cluster of hives/bumps, and still has several bumps on face, neck, and stomach.
Age: 1.0
Sex: F
Vaccine: FLUX, HEP, HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: Broke out in hives across upper arms, torso, and thighs. Clustered hives around injection site on RLE. Low grade fever for over 1 week (11/09/2012-11/19/2012) ranging from 99.8*F to 100.8*F. As of 11/21/2012, injection site is still red with cluster of hives/bumps, and still has several bumps on face, neck, and stomach.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain in arm where vaccine administered; extreme chills; fever; nausea. Redness; swelling from injection site (shoulder) to elbow; affected area very hot and painful to touch. Went back to doctor (11/21/2012) who diagnosed problem to be reaction to pneumonia vaccine; told to elevate arm to reduce swelling and apply cold compresses to relieve soreness; instructed to call if situation worsens.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Pain in arm where vaccine administered; extreme chills; fever; nausea. Redness; swelling from injection site (shoulder) to elbow; affected area very hot and painful to touch. Went back to doctor (11/21/2012) who diagnosed problem to be reaction to pneumonia vaccine; told to elevate arm to reduce swelling and apply cold compresses to relieve soreness; instructed to call if situation worsens.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Crying, Disturbance in social behaviour, Fear, Speech disorder
Clinical narrative: Sudden behavior change.  Decrease in speech and interaction.  More fearful with more crying for past month.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Influenza like illness, Pyrexia
Clinical narrative: Patient reported joint ache, low-grade fever up to 100 F, and "flu-like" symptoms starting from the day when she received the vaccine and lasted until the day patient reported the problem to the pharmacy (11/23/2012).
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: After approximately 3 min of receiving the flu shot. Patient had dizzy spell & fainted. Paramedics were then called. According to paramedic personnel pt's vitals checked out ok.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Abnormal behaviour, Anaphylactic reaction, Breath sounds abnormal, Urticaria, Vomiting
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as office administrator) refers to a 4 years old male patient with cerebral ventricular shunt, cleft palate, asthma and prophylaxis and a medical history of history of brain tumor and no drug reactions or allergies. On 09-JUN-2009, dose 1 M-M-R II (dose, route and lot # not reported) and on 15-NOV-2012, dose 2 M-M-R II (lot # H011907 exp: 03-JUL-2014) (dose and route not reported). Other suspect therapies included, on 09-JUN-2009, the patient was vaccinated subcutaneously with dose 1 VARIVAX (Merck) (dose and lot # not reported). On 15-NOV-2012, the patient was vaccinated subcutaneously with dose 2 VARIVAX (Merck) (lot # H013182 exp: 05-JUL-2014) (dose not reported), and on 15-NOV-2012 influenza virus vaccine (unspecified) (Manufacturer by Sanofi). No concomitant medications were reported. The office administrator stated that on 15-NOV-2012, a patient had an anaphylaxis reaction. The patient's mother and patient left the office and was in the parking lot when the patient's mother called to say the patient was not acting correct. The patient was brought back into the office and had multiple episodes of vomiting, broke out in urticaria, and experienced diminished breath sounds bilateral. The patient was sent to the emergency room by ambulance. The patient received VARIVAX (Merck), M-M-R II and influenza virus vaccine (unspecified) (Manufacturer by Sanofi) in the past with no problems. The patient ate eggs on the morning of 15-NOV-2012 with no problems. The patient was put on treatment with intramuscular EPIPEN; BENADRYL; nebulizer of albuterol and supplemental oxygen. The outcome of anaphylaxis reaction was reported as recovered/resolved on 15-NOV-2012. The relatedness for all adverse events was unknown for M-M-R II, influenza virus vaccine (unspecified) and VARIVAX (Merck). All events were considered to be disabling and life threatening and medically significant by the reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, HIBV, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.8
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician refers to a 10 months old male patient with a history of short bowel syndrome enrolled in a study. On 07-FEB-2012, the patient was vaccinated with first dose, ROTATEQ oral. On unknown date, the patient was vaccinated with second dose, ROTATEQ oral. On 05-JUL-2012, the patient was vaccinated with third dose, ROTATEQ oral. No other co-suspects were reported. No concomitant medications were reported. On 23-OCT-2012, the patient experienced vomiting and diarrhea. The patient had 3 episodes of vomiting, followed by one day of diarrhea. On 24-OCT-2012, the patient recovered from vomiting and diarrhea without treatment. This was an expected event in the normal course of childhood. The events of vomiting and diarrhea were not related to ROTATEQ. The events of vomiting and diarrhea were considered medically significant by the reporting investigator. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Injection site pain, Nausea, Vomiting
Clinical narrative: 12 hours after receiving vaccine, c/o joint pain, ankle, knee and hip. C/O soreness at injection site; c/o N/V/headache for 24 hours.
Age: 53.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blood test, Rash, Scratch, Skin lesion
Clinical narrative: This spontaneous report as received from a consumer and a nurse practitioner refers to a 53 years old female patient with diabetes, abnormal cholesterol, high blood pressure, mental illness and drug hypersensitivity to TYLENOL with codeine #3. The patient's medical history included shingles. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) in September 2012. Other suspect therapies included a dose of Influenza Virus Vaccine (manufacturer unknown) (lot #, dose and route not reported) on the same day in September 2012. Concomitant medications included benztropine mesylate, lamotrigine, lovastatin, aspirin, lisinopril (manufacturer unknown), ziprasidone hydrochloride, metformin and venlafaxine hydrochloride. The consumer reported that five days after receiving the ZOSTAVAX shot, she broke out in a rash. She indicated she scratched so hard, sores came up. She stated she received the ZOSTAVAX and the Influenza Virus Vaccine (manufacturer unknown) shot on the same day at the pharmacy. She indicated she was treated for poison ivy and scabies. The nurse practitioner asked what could be done with the patient. The patient sought unspecified medical attention. Blood work was performed on 16-OCT-2012 and 24-OCT-2012 (results not provided). The outcome of she broke out in a rash and scratched so hard sores came out was reported as not recovered/not resolved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC
Symptoms: Drug hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: 6cm x 8cm red, erythematous skin over (L) deltoid area where PREVNAR given. Min. tender to palpation. No skin breakdown.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Pain in extremity
Clinical narrative: Patient complains on knot in injection site & arm pain lasting since 9/28/12.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Syncopal episode, convulsions (rule out seizure disorder). Patient was sent to ER via ambulance.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Electrocardiogram normal, Electroencephalogram, Hypotonia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Upon administration of HPV, pt had immediate loss of muscle tone and then had tremors on (L) side & LOC x 10-15 sec. Pt could respond to verbal instruction to squeeze hand but unable to verbalize. After resting 2-3 min moved pt from chair to reclining bed and pt fainted. Pt was carried to bed sitting upright and felt better. Paramedics arrived on scene at 3:48pm.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Speech disorder, Syncope, Tremor
Clinical narrative: Upon administration of HPV, pt had immediate loss of muscle tone and then had tremors on (L) side & LOC x 10-15 sec. Pt could respond to verbal instruction to squeeze hand but unable to verbalize. After resting 2-3 min moved pt from chair to reclining bed and pt fainted. Pt was carried to bed sitting upright and felt better. Paramedics arrived on scene at 3:48pm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Erythema, Fatigue, Oedema peripheral, Urticaria
Clinical narrative: Swelling & redness in arm, hives over entire body, fatigue, persistent non-productive cough/wheezing as per PCP 11/8 office visit note. Treated with prednisone, VENTOLIN HFA, Guaifenesin-codeine syrup.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Swelling & redness in arm, hives over entire body, fatigue, persistent non-productive cough/wheezing as per PCP 11/8 office visit note. Treated with prednisone, VENTOLIN HFA, Guaifenesin-codeine syrup.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Head injury, Syncope
Clinical narrative: Syncopal episode few minutes after administration, sustained head injury and sent to ER for evaluation & management.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site vesicles, Local reaction
Clinical narrative: Local adverse reaction to injection site. Injection site redness, purple colored bruise with small fluid filled blister. Pt reported pain and burning to Lt upper arm (deltoid area).
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient reports pain upon movement, specifically lifting up arm since date of administration (receiving) of vaccine. Patient was seen by worker's comp MD on 11-13-12 & was prescribed six visits of physical therapy. Has received 3 sessions of P.T.
Age: 0.72
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 21.0
Sex: U
Vaccine: FLU3
Symptoms: Flushing, Heart rate decreased, Hypotension, Syncope
Clinical narrative: Patient fainted, flushed paramedics came low BP & pulse relaxing gave water.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain
Clinical narrative: Reports pain with lifting of (Lt) arm since date of receiving vaccine. Approx. 3 hrs. after receiving vaccine, had severe pain x 5 days, has since diminished but still feels dull pain which radiates to elbow. No treatment sought.
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Returned to clinic approx. 15 minutes after receiving IM flu shot - c/o paleness, mild dizziness, mild nausea and sweating. No respiratory or skin complaints. VSS -> seated, provided H2O & 25 mg p.o. BENADRYL. No further symptoms or complaints after 15 min. Monitored VS Q5min x3, then at 35 minutes s/p episode. All WNL discharged from clinic with flu instructions.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chest discomfort, Chills, Cough, Pyrexia
Clinical narrative: Fever, chills, cough, heavy feeling chest, joint pain in wrists, knees, elbows, runny nose. Took MOTRIN. Pt states (11-21-12) he began feeling better about 6am this morning.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Fever, chills, cough, heavy feeling chest, joint pain in wrists, knees, elbows, runny nose. Took MOTRIN. Pt states (11-21-12) he began feeling better about 6am this morning.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Lyme disease
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 27 years old female patient. The patient was vaccinated (intramuscularly) with lot # (0101AE) (expiry date 10-OCT-2014) dose 1, 0.5 ml GARDASIL on 14-SEP-2012. No other co-suspects were reported. Concomitant medications included CYMBALTA, TRILEPTAL, gabapentin, ATIVAN and ZYRTEC. The patient was diagnosed with Lyme disease by another unspecified healthcare facility 2 weeks ago, 43 days after onset of therapy. The patient was treated with unspecified medications to treat Lyme disease. The lab diagnostic studies performed where unspecified by the reporter. The outcome of Lyme disease was reported as not recovered/not resolved. The relatedness for Lyme disease was unknown for GARDASIL. Additional information is not expected.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting, diarrhea (moderately severe) 3d after vaccine managed conservatively.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Hot, swelling rash at injection site; extended down arm. Pt went to see his PCP & was prescribed cephalexin.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, achiness.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Nerve injury
Clinical narrative: Right arm pneumonia shot. Smarted upon injection Pain and numbness grew intolerance within hours, E.R. doc. prescribed PERCOCET for pain. That was almost 4 weeks ago!
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Skin lesion
Clinical narrative: Has red blister like lesion on (R) arm & (R) thigh. Lesions are in different phases.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Altered state of consciousness, Clonus, Dizziness, Fall, Immediate post-injection reaction
Clinical narrative: The child received #1 Tdap, #2 Influenza vacc in (L) arm, #3 MENACTRA on (L) arm. As 3rd needle was being removed, he fell forward across his knees, had moderate clonic movements, brief loss of awareness x < 30 sec with mild shaking of upper ext. - then came to with slight dizziness.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Tremor
Clinical narrative: The child received #1 Tdap, #2 Influenza vacc in (L) arm, #3 MENACTRA on (L) arm. As 3rd needle was being removed, he fell forward across his knees, had moderate clonic movements, brief loss of awareness x < 30 sec with mild shaking of upper ext. - then came to with slight dizziness.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood glucose, Convulsion, Metabolic function test
Clinical narrative: Pt came in on 11-19-12 for 6 mo WCV and received vaccinations. On 11-20-12 parents took child to ED for a seizure we had or was having.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Arm sore, slightly red on 11/19/12 pm. After lunch on 11/20/12 redness increased & area increased swelling.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Fainted after receiving vaccinations. Rested and drank water. Patient left with mother at approximately 11:10.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Injection site discolouration, Injection site haemorrhage, Injection site warmth
Clinical narrative: After the vaccine arm was stiff. The next morning rash present arm was hot touch. Took an ibuprofen and put ice. Next day arm turned yellow & redness moved down now a burning sensation in elbow for seconds also with red on above. Part 2 the arm has yellow skin where the injection was given like old ecchymosis it is warm to touch. The redness it at the elbow & warm to touch she is taking BENADRYL.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Rash, Skin discolouration, Skin warm
Clinical narrative: After the vaccine arm was stiff. The next morning rash present arm was hot touch. Took an ibuprofen and put ice. Next day arm turned yellow & redness moved down now a burning sensation in elbow for seconds also with red on above. Part 2 the arm has yellow skin where the injection was given like old ecchymosis it is warm to touch. The redness it at the elbow & warm to touch she is taking BENADRYL.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of patients. Case 5 of 6 of the same reporter (related cases 1211USA005695, 1211USA005837, 1211USA005838, 1211USA005839 and 1211USA005841). The patient was vaccinated with GARDASIL in 2012. No other co-suspects were reported. No concomitant medications were reported. The patients were administered vaccines that had been improperly stored for the last six months. No treatment information was reported. No adverse was reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Ageusia
Clinical narrative: This spontaneous report as received from a physician refers to a 14 years old male patient with no drug reactions or allergies and no pertinent medical history. On 15-NOV-2012, the patient was vaccinated with dose 1 GARDASIL (dose, route and lot # not provided). Other suspect therapies included on 15-NOV-2012 Influenza Virus Vaccine (manufacturer unknown). No concomitant medications were reported. The physician stated that on 15-NOV-2012, a patient, who was administered his first dose of GARDASIL as well as Influenza Virus Vaccine (manufacturer unknown), developed loss of taste on 16-NOV-2012. No treatment has been prescribed at the time of the report. The patient sought medical attention by physician office visit. No treatment for the adverse event was given. Laboratory and diagnostics were not performed. The outcome of loss of taste was reported as not recovered/not resolved. The relatedness for loss of taste was unknown for GARDASIL and Influenza Virus Vaccine (manufacturer unknown). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 18 years old female patient. The patient was vaccinated with dose 1, .5 ml GARDASIL on 16-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 19-NOV-2012 the patient experienced fever of 102F, 4 days after onset of therapy and severe headache. No treatment information was reported. The outcome of fever of 102F and severe headache was reported as not recovered/not resolved. The relatedness for fever of 102F and severe headache is unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with dose 1, .5 ml GARDASIL on 19-APR-2012 and with dose 2 on 15-NOV-2012. No adverse event was reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (dose, lot # not reported) on 12-NOV-2012 but had a needle leakage. The patient got less than the recommended dose. The patient was readministering another full dose at the time of reporting. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to a child patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of VARIVAX (lot # not reported) dose and route not reported. No concomitant medications were reported. The reporter received the information form a nurse at physician's office. A small child presented to the physician's office on 08-NOV-2012 with a case of disseminated varicella. The patient may or may not have received VARIVAX (merck) in the past. The patient had not recovered from the event. The patient sought medical attention for the event. No further information is available. Additional information has been requested.