chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Flushing, Injection site discolouration, Neuralgia, Pyrexia
Clinical narrative: This spontaneous report as received from a 57 years old female consumer with allergy to Sulfa and cortisone, no pain medications or anti-inflammatories. The patient's concurrent condition included heart flutters and asthma, medical history "last July" (July, 2012), she had a rash on her ribs on one side of her body and her dermatologist told her that it was shingles, but her PCP, said it wasn't shingles. On 15-JAN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number not provided). Concomitant therapies included XANAX. She still had a purple area of 3X3 inches around the injection site. Since the injection she has been sick. She had had a fever on and off and got the chills a lot. She had horrible stomach and back pain and digestive problems. She felt like she had seizure (had tremors in her pain). Her face got really red and flushed. She had nerve pain throughout her body. Blood work was performed and results were unknown. KEFLEX (manufacture unspecified) for one week was put as treatment for adverse event. The outcome of adverse events was reported as not recovered. The patient saw the HCP for seeking medical attention. Her PCP thought that she was just having an allergic reaction to the vaccine. Upon internal review, convulsion was considered to be medically significant event. This is one of several reports received from the same source. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Seizure like phenomena, Tremor
Clinical narrative: This spontaneous report as received from a 57 years old female consumer with allergy to Sulfa and cortisone, no pain medications or anti-inflammatories. The patient's concurrent condition included heart flutters and asthma, medical history "last July" (July, 2012), she had a rash on her ribs on one side of her body and her dermatologist told her that it was shingles, but her PCP, said it wasn't shingles. On 15-JAN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number not provided). Concomitant therapies included XANAX. She still had a purple area of 3X3 inches around the injection site. Since the injection she has been sick. She had had a fever on and off and got the chills a lot. She had horrible stomach and back pain and digestive problems. She felt like she had seizure (had tremors in her pain). Her face got really red and flushed. She had nerve pain throughout her body. Blood work was performed and results were unknown. KEFLEX (manufacture unspecified) for one week was put as treatment for adverse event. The outcome of adverse events was reported as not recovered. The patient saw the HCP for seeking medical attention. Her PCP thought that she was just having an allergic reaction to the vaccine. Upon internal review, convulsion was considered to be medically significant event. This is one of several reports received from the same source. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Aphagia, Autoimmune thyroiditis, Biopsy thyroid gland, Blood thyroid stimulating hormone, Feeling abnormal
Clinical narrative: I took the last of the 3 GARDASIL shots between Feb and March 2010. That June I noticed significant issues. My throat was swollen, I could not eat anything. Long story short, I now have Hashimoto's thyroiditis. My doctors thought it was allergies then chalked it up to plain old crazy. I am in debt because of all these medical bills of specialists telling me I am crazy, depressed, or just plain neurotic. When they finally did diagnose me, I asked them hey, could it be because of the GARDASIL shot? I never had any issues with my health other than asthma. I now have to live with the fact that my thyroid is dying. I did not think at the time, since I trusted my doctors, that it could have been from the shots or that I could have told my story and other people would have been in the same boat as me. I feel like crap every day. I took it upon myself to research this auto immune disorder online and found what I should and should not eat, and scan all these other stories just like mine.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngeal oedema, Scan, Scan thyroid gland, Thyroxine, Tri-iodothyronine
Clinical narrative: I took the last of the 3 GARDASIL shots between Feb and March 2010. That June I noticed significant issues. My throat was swollen, I could not eat anything. Long story short, I now have Hashimoto's thyroiditis. My doctors thought it was allergies then chalked it up to plain old crazy. I am in debt because of all these medical bills of specialists telling me I am crazy, depressed, or just plain neurotic. When they finally did diagnose me, I asked them hey, could it be because of the GARDASIL shot? I never had any issues with my health other than asthma. I now have to live with the fact that my thyroid is dying. I did not think at the time, since I trusted my doctors, that it could have been from the shots or that I could have told my story and other people would have been in the same boat as me. I feel like crap every day. I took it upon myself to research this auto immune disorder online and found what I should and should not eat, and scan all these other stories just like mine.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Back pain, Discomfort, Hypoaesthesia, Insomnia, Musculoskeletal chest pain
Clinical narrative: I received a Shingles vaccine on Friday, Jan. 27, 2013, at my doctor's office. The next day my hands were both numb as if LANACAINE had been applied. A sharp pain in my right arm began shortly afterwards. The pain got progressively worse and travelled to a sharp pain in the area between my shoulder blades. It got so bad that I went to the emergency room. They sent me home with pain medication, saying it was a reaction to the vaccine. I spent the next 7 days in bed in agony as the pain moved to the outside of my legs and around my rib cage. I could not sleep as I couldn't get comfortable. My only comfort was numerous hot whirlpool baths. I was given Gabapentin and finally started getting some relief. People should be warned about these life altering reactions to the vaccine.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: I received a Shingles vaccine on Friday, Jan. 27, 2013, at my doctor's office. The next day my hands were both numb as if LANACAINE had been applied. A sharp pain in my right arm began shortly afterwards. The pain got progressively worse and travelled to a sharp pain in the area between my shoulder blades. It got so bad that I went to the emergency room. They sent me home with pain medication, saying it was a reaction to the vaccine. I spent the next 7 days in bed in agony as the pain moved to the outside of my legs and around my rib cage. I could not sleep as I couldn't get comfortable. My only comfort was numerous hot whirlpool baths. I was given Gabapentin and finally started getting some relief. People should be warned about these life altering reactions to the vaccine.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram abnormal, Troponin I, Troponin normal
Clinical narrative: This study case was received from the investigator on 05 February 2013. A 31-year-old male subject received an injection of ACAM2000 (lot number not reported) on 31 October 2012. The subject has no significant medical history. On 12 November 2012, the subject was diagnosed with Other, chest pain. Diagnostic testing on 15 November 2012 included: normal Troponin I, abnormal ECG, normal echocardiogram. 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: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Acute myocardial infarction, Cardiomyopathy, Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis
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 in a trial on 05 February 2013. A 27 year-old male subject with no significant past medical history was found to have acute pericarditis, unspecified 14 days after the subject had received on 19 November 2012: an injection of ACAM2000 (lot number, route and site of administration not reported). On 01 December 2012, the subject was diagnosed with acute myocardial infarction, unspecified site (reported as ICD-9 code 410.9 Unspecified site) and other and unspecified acute myocarditis. On 30 November 2012, the subject was diagnosed with other primary cardiomyopathies and non-specific myocarditis. Relevant laboratory data on 30 November 2012 included: an abnormal Troponin I recorded highest value of 16.75, an abnormal ECG and an abnormal Echocardiogram. Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. 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: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Pericarditis, Troponin I increased
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 in a trial on 05 February 2013. A 27 year-old male subject with no significant past medical history was found to have acute pericarditis, unspecified 14 days after the subject had received on 19 November 2012: an injection of ACAM2000 (lot number, route and site of administration not reported). On 01 December 2012, the subject was diagnosed with acute myocardial infarction, unspecified site (reported as ICD-9 code 410.9 Unspecified site) and other and unspecified acute myocarditis. On 30 November 2012, the subject was diagnosed with other primary cardiomyopathies and non-specific myocarditis. Relevant laboratory data on 30 November 2012 included: an abnormal Troponin I recorded highest value of 16.75, an abnormal ECG and an abnormal Echocardiogram. Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. 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: ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram normal, Pericardial disease, Troponin I, Troponin normal
Clinical narrative: This study case was received from the investigator in a trial on 05 February 2013. A 25-year-old male subject received the following vaccinations on 05 December 2012: an injection of ACAM2000 (lot number, route, site and date not reported), TYPHIM VI, sanofi pasteur SA, (lot number, route, site and date not reported), and anthrax (Manufacturer, lot number, route, site and date not reported). The subject had a medical history of myocarditis, pericarditis, chest pain, and chest pressure. On 14 December 2012, the subject had a normal Troponin I, normal electrocardiogram, and normal echocardiogram. On 19 December 2012, the subject was diagnosed with unspecified disease of the pericardium. No further information was available at the time of the report. The subject's 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: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram, Guillain-Barre syndrome, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: This study case was received from the investigator in a trial on 05 February 2013. A 24-year-old male subject, who had a past medical history of asthma (included exercise induced), developed Guillain-Barre syndrome, 20 days after receiving a injection of ACAM2000 (lot number not reported) on 18 October 2012. On 07 November 2012, 20 days post vaccination, the subject was diagnosed with Guillain-Barre Syndrome. On 14 December 2012: a magnetic resonance imaging (MRI) of the brain was reported as abnormal and an MRI of the spinal cord was reported as abnormal. Troponin I result was reported as not performed; an ECG and echocardiogram were reported as not available. Magnetic resonance imaging (MRI) heart and lumbar puncture (spinal tap) were reported as not performed. Treatments and hospitalization were not reported. The subject's 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.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Arthralgia, Fatigue, Increased upper airway secretion, Injection site joint pain, Injection site pruritus
Clinical narrative: This study case was received from the investigator of a trial on 08 February 2013. A male subject had received the following vaccinations on 30 January 2013: ACAM2000 (lot number and route not reported) in the left arm, typhoid vaccine (manufacturer, lot number, route and site not reported) and anthrax vaccine (lot number, route and site not reported). The subject reported local site symptoms, productive cough, fatigue and joint pain at V2 but no clear cardiac/pulmonary symptoms. Rapid troponin was normal but lab troponin was 0.3 ng/mL. The subject was instructed for repeat troponin, ECG and referral but indicated he may not. Suspect possible myopericarditis, subclinical. Details of the subject's symptoms included: the same day the subject experienced itching at the smallpox vaccination (SPV) site. On 01 February 2013, the subject experienced coughing up phlegm and fatigue. On 03 February 2013, the subject experienced bubbling at the SPV site. On 05 February 2013, the subject experienced bilateral shoulder pain and bilateral elbow pain. On 07 February 2013, the subject had elevated troponin HC 0.30 ng/mL. The subject had irrelevant past medical history. No further information was available at the time of the report. The subject's outcome was not recovered. According to the investigator, the event of elevated Troponin was considered another important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Injection site reaction, Injection site vesicles, Local reaction, Musculoskeletal pain, Productive cough
Clinical narrative: This study case was received from the investigator of a trial on 08 February 2013. A male subject had received the following vaccinations on 30 January 2013: ACAM2000 (lot number and route not reported) in the left arm, typhoid vaccine (manufacturer, lot number, route and site not reported) and anthrax vaccine (lot number, route and site not reported). The subject reported local site symptoms, productive cough, fatigue and joint pain at V2 but no clear cardiac/pulmonary symptoms. Rapid troponin was normal but lab troponin was 0.3 ng/mL. The subject was instructed for repeat troponin, ECG and referral but indicated he may not. Suspect possible myopericarditis, subclinical. Details of the subject's symptoms included: the same day the subject experienced itching at the smallpox vaccination (SPV) site. On 01 February 2013, the subject experienced coughing up phlegm and fatigue. On 03 February 2013, the subject experienced bubbling at the SPV site. On 05 February 2013, the subject experienced bilateral shoulder pain and bilateral elbow pain. On 07 February 2013, the subject had elevated troponin HC 0.30 ng/mL. The subject had irrelevant past medical history. No further information was available at the time of the report. The subject's outcome was not recovered. According to the investigator, the event of elevated Troponin was considered another important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Troponin increased
Clinical narrative: This study case was received from the investigator of a trial on 08 February 2013. A male subject had received the following vaccinations on 30 January 2013: ACAM2000 (lot number and route not reported) in the left arm, typhoid vaccine (manufacturer, lot number, route and site not reported) and anthrax vaccine (lot number, route and site not reported). The subject reported local site symptoms, productive cough, fatigue and joint pain at V2 but no clear cardiac/pulmonary symptoms. Rapid troponin was normal but lab troponin was 0.3 ng/mL. The subject was instructed for repeat troponin, ECG and referral but indicated he may not. Suspect possible myopericarditis, subclinical. Details of the subject's symptoms included: the same day the subject experienced itching at the smallpox vaccination (SPV) site. On 01 February 2013, the subject experienced coughing up phlegm and fatigue. On 03 February 2013, the subject experienced bubbling at the SPV site. On 05 February 2013, the subject experienced bilateral shoulder pain and bilateral elbow pain. On 07 February 2013, the subject had elevated troponin HC 0.30 ng/mL. The subject had irrelevant past medical history. No further information was available at the time of the report. The subject's outcome was not recovered. According to the investigator, the event of elevated Troponin was considered another important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Electrocardiogram normal, Laboratory test normal, Troponin
Clinical narrative: Initial report was received 05 February 2013 from the investigator for a trial. A 20-year-old male subject (medical history and concomitant medications not reported), had received ACAM2000 on 16 May 2012 and a previous dose of ANTHRAX vaccine on 02 May 2012 (routes and sites of administration not reported). On 22 May 2012 at 04:00 hours, six days after receiving ACAM2000, the subject developed chest pain described as twisting in the middle of his chest (mid-sternum) rated 5/10 on pain scale which resolved that same day at 12:00 hours. He had no other associated cardiac symptoms. No further episodes occurred and no treatment was sought. On 28 May 2012, troponin level was drawn (results <0.10 ng/mL) and rapid test was negative at that visit. He also had an ECG performed with normal findings and was released back to duty. Medical notes indicated possible follow-up for a stress test upon return to base. On 16 June 2012, medical notes indicated the subject was assessed properly with appropriate follow-up and no further action was required. The event was reported as recovered/resolved on 28 May 2012. According to the investigator, the event of chest pain was possibly related to the study vaccine. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Condition aggravated, Diaphragmalgia, Injection site pain, Mobility decreased
Clinical narrative: Initial case was received from a consumer on 08 February 2013. A 64-year-old female patient received an injection of ADACEL, sanofi pasteur Ltd., (lot number, route, site, side and dose in series not reported) on 28 January 2013. The next morning on 29 January 2013, the patient woke up with aching in her neck, spine and diaphragm and could not turn her head side to side. Injection site was still very sore. The following day, she experienced low grade fever, and weakness. She visited her doctor. According to the report, the patient describes Arthus reaction per her doctor. On 08 February 2013, the date of report, the patient stated she had low grade fever and neck pain, but had good energy. The patient had a past medical history of arthus reaction and "tons" of allergies to unspecified: drugs, foods, pets and hay fever. She had no illness at time of vaccination. She had received a shingles vaccine on an unspecified date four or five weeks prior to vaccination. Concomitant medications were not reported. Laboratory or diagnostic testing and treatments were not reported. The patient's outcome was reported as not recovered (also reported as recovered, date not specified). Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pyrexia, Spinal pain, Type III immune complex mediated reaction
Clinical narrative: Initial case was received from a consumer on 08 February 2013. A 64-year-old female patient received an injection of ADACEL, sanofi pasteur Ltd., (lot number, route, site, side and dose in series not reported) on 28 January 2013. The next morning on 29 January 2013, the patient woke up with aching in her neck, spine and diaphragm and could not turn her head side to side. Injection site was still very sore. The following day, she experienced low grade fever, and weakness. She visited her doctor. According to the report, the patient describes Arthus reaction per her doctor. On 08 February 2013, the date of report, the patient stated she had low grade fever and neck pain, but had good energy. The patient had a past medical history of arthus reaction and "tons" of allergies to unspecified: drugs, foods, pets and hay fever. She had no illness at time of vaccination. She had received a shingles vaccine on an unspecified date four or five weeks prior to vaccination. Concomitant medications were not reported. Laboratory or diagnostic testing and treatments were not reported. The patient's outcome was reported as not recovered (also reported as recovered, date not specified). Documents held by sender: None.
Age: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Drug administered to patient of inappropriate age, Erythema, Injection site discolouration, Oedema peripheral
Clinical narrative: Initial case was received from a consumer on 08 February 2013 and involves a case misuse due to inappropriate age at vaccine administration. An 84-year-old female patient received an injection in the arm (side unspecified) of a second dose of ADACEL, sanofi pasteur Ltd., (lot number, and route not reported) on an unspecified date (exact date of injection was not given). The patient came in a week later, on an unspecified date, for a routine blood pressure check, and the nurse noticed the arm where the ADACEL was given was very swollen and red. The area around the injection site was yellowish in color. According to the reporter, the physician diagnosed cellulitis. Laboratory or diagnostic testing and treatments were not reported. The nurse stated that the patient had already received Tdap vaccine years ago (unspecified date) and was incorrectly given a second dose. The patient's outcome was not reported. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Chest pain, Cold sweat, Electrocardiogram normal, Troponin normal
Clinical narrative: This study case was received from the investigator in a trial on 05 February 2013. A 20 year-old male subject (date of birth not reported) with no reported past medical history had received on 16 May 2012 in the right arm a ACAM2000, (lot number and route of administration not reported) and 8 days later was found to have on 24 May 2012 chest pain. The subject also received on 03 May 2012 Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 28 May 2012, the subject was evaluated where he reported chest pain with cold sweats. The subject described the chest pain was like a pressure that lasted a few minutes on and off throughout the day. He also reported vision disturbance of speckled vision. The subject rested for about five minutes the events subsided shortly after on 24 May 2012. The subject had no other signs or symptoms of myopericarditis. He did not seek medical attention. A Troponin level was drawn, rapid test was negative and the level was normal. The subject had an ECG which was normal. No further information was available at the time of the report. The subject's outcome was recovered/resolved on 28 May 2012. According to the investigator the event of chest pain was considered to be possibly related. Documents held by sender: progress notes.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Visual impairment
Clinical narrative: This study case was received from the investigator in a trial on 05 February 2013. A 20 year-old male subject (date of birth not reported) with no reported past medical history had received on 16 May 2012 in the right arm a ACAM2000, (lot number and route of administration not reported) and 8 days later was found to have on 24 May 2012 chest pain. The subject also received on 03 May 2012 Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 28 May 2012, the subject was evaluated where he reported chest pain with cold sweats. The subject described the chest pain was like a pressure that lasted a few minutes on and off throughout the day. He also reported vision disturbance of speckled vision. The subject rested for about five minutes the events subsided shortly after on 24 May 2012. The subject had no other signs or symptoms of myopericarditis. He did not seek medical attention. A Troponin level was drawn, rapid test was negative and the level was normal. The subject had an ECG which was normal. No further information was available at the time of the report. The subject's outcome was recovered/resolved on 28 May 2012. According to the investigator the event of chest pain was considered to be possibly related. Documents held by sender: progress notes.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Cough, Electrocardiogram normal, Troponin I, Troponin normal
Clinical narrative: This study case was received on 07 February 2013 from the investigator in the trial. A male subject (age and birth date not reported) with a past medical history of smoking since unspecified date in 2012, experienced a dry cough, four days after the subject received the following vaccines on 23 January 2013: a left arm injection of ACAM2000 (SP Biologics Co., (lot number and route not reported); typhoid vaccine, manufacturer unknown; and anthrax, other manufacturer, (lot numbers, routes and sites not reported). On 27 January 2013, four days post vaccination; the subject reported four episodes of new onset, mild, dry cough, lasting two to three minutes, which resolved without intervention. The subject had no other symptoms and no clear etiology. The dry cough was reported as not resolved. The subject took no concomitant medications. Rapid and laboratory Troponin I were both reported as normal; and an electrocardiogram (ECG) was reported as normal. Treatments were reported as unknown. The subject was referred for care, but was unable to be reached for follow-up. According to the investigator, although unlikely, myopericarditis could not be excluded. The subject's outcome was reported as not recovered (not resolved) and also reported as lost to follow-up. According to the investigator, the events of dry cough and potential myopericarditis were considered possibly related to trial product. Documents held by sender: Medical Records.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Back pain, Condition aggravated, Fatigue, Headache
Clinical narrative: A consumer report has been received. The report concerns a 43 year old, Female patient. The patient's concurrent diseases included chronic neck pain and chronic lower back pain. Concomitant medications included cetirizine for allergies. The patient received nasal FLUMIST of Lot no. AJ2141, 0.2 millilitres, once/single administration on 23-Oct-2012. Patient received FLUMIST in Nov 2010 and 18-Oct-2011 with no adverse event/effect. The patient experienced moderate nausea, moderate overall weakness, moderate muscle ache and moderate tiredness which started on 28-Oct-2012, moderate headaches which started on 24-Oct-2012. The patient also experienced neck pain and back pain. At the time of reporting the events of nausea, headaches overall weakness, muscle ache and tiredness were recovering. The outcome of the events of neck pain and back pain was unknown. The company physician assessed the events of headaches, to be serious due to disability. The company physician assessed the events of overall weakness, muscle ache and tiredness to be serious with seriousness criteria of important medical event. The events of neck pain and back pain assessed to be non serious.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Myalgia, Nausea, Neck pain
Clinical narrative: A consumer report has been received. The report concerns a 43 year old, Female patient. The patient's concurrent diseases included chronic neck pain and chronic lower back pain. Concomitant medications included cetirizine for allergies. The patient received nasal FLUMIST of Lot no. AJ2141, 0.2 millilitres, once/single administration on 23-Oct-2012. Patient received FLUMIST in Nov 2010 and 18-Oct-2011 with no adverse event/effect. The patient experienced moderate nausea, moderate overall weakness, moderate muscle ache and moderate tiredness which started on 28-Oct-2012, moderate headaches which started on 24-Oct-2012. The patient also experienced neck pain and back pain. At the time of reporting the events of nausea, headaches overall weakness, muscle ache and tiredness were recovering. The outcome of the events of neck pain and back pain was unknown. The company physician assessed the events of headaches, to be serious due to disability. The company physician assessed the events of overall weakness, muscle ache and tiredness to be serious with seriousness criteria of important medical event. The events of neck pain and back pain assessed to be non serious.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram abnormal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 05 February 2013. A 21-year-old female subject, who had a past medical history of headaches, developed chest pain, unspecified, nine days after receiving a injection of ACAM2000, SP Biologics Co., (lot number not reported) on 26 September 2012; TYPHIM VI, sanofi pasteur SA, (lot number not reported) on 24 September 2012; ANTHRAX, other manufacturer, (lot number not reported) on 24 September 2012; and intranasal INFLUENZA, LIVE, other manufacturer, (lot number not reported) on 11 September 2012. On 05 October 2012, the subject was diagnosed with chest pain unspecified. On 05 October 2012, laboratory and diagnostic testing was reported as: Troponin I result abnormal, with highest value 06.29 (no unit for reference range reported); an abnormal electrocardiogram (ECG) and a normal Echocardiogram. Magnetic resonance imaging, (MRI) of brain, MRI of spinal cord, MRI of heart and lumbar puncture (spinal tap) were not performed. The subject's 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: 41.0
Sex: F
Vaccine: SMALL
Symptoms: Angina pectoris, Echocardiogram normal, Electrocardiogram normal, 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 in a trial on 05 February 2013. A 41-year-old female subject, who had a past medical history of: high blood pressure, chest pain, chest pressure, abnormal electrocardiogram (ECG), dizziness or fainting spells, shortness of breath, eczema, headaches and numbness or paralysis, developed other and unspecified angina pectoris, eleven days after receiving a injection of ACAM2000, SP Biologics Co., (lot number not reported) on 18 October 2012. On 29 October 2012, eleven days post vaccination, the subject was diagnosed with other and unspecified angina pectoris (ICD-9 Code 413.9). Troponin I result was reported as not available. On 21 November 2012: an ECG was reported as normal and an echocardiogram was reported as normal. Magnetic resonance imaging, (MRI) of brain, MRI of spinal cord, MRI of heart and lumbar puncture (spinal tap) were reported as not performed. The subject's 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: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Abasia, Asthenia, Condition aggravated, Malaise, Multiple sclerosis relapse
Clinical narrative: This spontaneous report as received via Teva Pharmaceuticals from a consumer refers to a 54 year old female patient with multiple sclerosis. On an unknown date in approximately June 2012, reported as eight months ago (reporting date 06-FEB-2013) the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (route, dose, lot number unknown). Other suspect therapies included COPAXONE which was started on 15-FEB-2000 for multiple sclerosis. No concomitant medication reported. The patient shares that on an unspecified date in approximately June 2012, reported as eight months ago (reporting date 06-FEB-2013) she had a "mini flare up" (medically significant by reporting manufacturer) after her physician advised her to get a Shingles vaccine. The evening after the vaccine injection, she became achy, didn't feel well and very weak. She could barely walk. She went to the ER for 4 hours and they didn't do anything to help her, told her to 'go home and let it wear off'. The patient got to a point in which she couldn't walk and thought she was paralyzed for a few days. It took her 1.5 months to feel better. She believes the vaccine caused an MS flare up and was disappointed that the nurse at the clinic didn't discuss potential side effects with her. The nurse at the clinic told her she was having a 'secondary reaction' (medically significant by reporting manufacturer) to the vaccine. The outcome of MS flare up and secondary reaction to shingles vaccine was reported as recovered/resolved. Action taken with varicella virus vaccine live (manufacturer unknown) was not applicable. The patient considered MS flare up and secondary reaction to shingles vaccine to be related to varicella virus vaccine live (manufacturer unknown). Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: This spontaneous report as received via Teva Pharmaceuticals from a consumer refers to a 54 year old female patient with multiple sclerosis. On an unknown date in approximately June 2012, reported as eight months ago (reporting date 06-FEB-2013) the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (route, dose, lot number unknown). Other suspect therapies included COPAXONE which was started on 15-FEB-2000 for multiple sclerosis. No concomitant medication reported. The patient shares that on an unspecified date in approximately June 2012, reported as eight months ago (reporting date 06-FEB-2013) she had a "mini flare up" (medically significant by reporting manufacturer) after her physician advised her to get a Shingles vaccine. The evening after the vaccine injection, she became achy, didn't feel well and very weak. She could barely walk. She went to the ER for 4 hours and they didn't do anything to help her, told her to 'go home and let it wear off'. The patient got to a point in which she couldn't walk and thought she was paralyzed for a few days. It took her 1.5 months to feel better. She believes the vaccine caused an MS flare up and was disappointed that the nurse at the clinic didn't discuss potential side effects with her. The nurse at the clinic told her she was having a 'secondary reaction' (medically significant by reporting manufacturer) to the vaccine. The outcome of MS flare up and secondary reaction to shingles vaccine was reported as recovered/resolved. Action taken with varicella virus vaccine live (manufacturer unknown) was not applicable. The patient considered MS flare up and secondary reaction to shingles vaccine to be related to varicella virus vaccine live (manufacturer unknown). Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Computerised tomogram head normal, Febrile convulsion, Full blood count normal, Influenza virus test negative, Laboratory test normal
Clinical narrative: Febrile seizure following immunization (2 month, routine) approximately 12 hours later.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Respiratory syncytial virus test negative
Clinical narrative: Febrile seizure following immunization (2 month, routine) approximately 12 hours later.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 06-Dec-2012. The patient experienced INADVERTENTLY GAVE PATIENT EXPIRED FLUMIST which started on 06-Dec-2012, the patient received today and it expired on 03-Dec-2012. The outcome of the event of INADVERTENTLY GAVE PATIENT EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Fourth dose of Hepatitis B vaccine administered on 02/18/2013 at 1500Hrs. Rash started later that evening on face & back. First 3 vaccines received elsewhere. Sent to ER-rash worse on 2/19/13.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper thigh developed an erythemic, warm to touch swelling on 2/16/2013. Was treated for cellulitis with an antibiotic. Mom also gave BENADRYL. Left upper thigh mostly clear 2/18/13.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Erythema, Headache, Rash erythematous
Clinical narrative: A consumer report has been received. The report concerns a 10 year old, Male consumer, who had been receiving Nasal FLUMIST .2 Millilitres, Once/Single administration. FLUMIST started on 13-Oct-2012. The patient experienced RED CHEEKS, HEADACHE and RED SPOTS which 14-Oct-2012. The patient recovered from the event of RED CHEEKS, HEADACHE and RED SPOTS on 20-Oct-2012. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 09-Nov-2012 from consumer: Events stop date added and Outcome changed from not recovered to recovered.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Lip swelling, Oral discomfort, Rash
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, Female subject, who had been receiving Nasal FLUMIST, 0.2 Millilitres, Once/Single administration. FLUMIST started on 15-Oct-2012. The patient experienced SWELLED, LIPS WERE BURNING and FACIAL RASH which started on 15-Oct-2012. The outcome of the event of SWELLED, LIPS WERE BURNING and FACIAL RASH is unknown. The report was considered to be non-serious by reporter.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest discomfort, Palpitations
Clinical narrative: A report has been received from a Pharmacist concerning a 9 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced RACING HEART and HEAVY CHEST which started on 15-Oct-2012. The patient recovered from the event of RACING HEART and HEAVY CHEST on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by Astrazeneca/MedImmune 01-Nov-2012 from Physician via Pharmacist: Reporter's details added. Corrected Report 12-Nov-2012: Additional reporter of Physician and Administered by added.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Convulsion, Gaze palsy, Pyrexia, Skin warm, Tremor
Clinical narrative: Overnight was seen to have 2 episodes with legs shaking and eyes looking up. Second time Mom noticed was very warm with fever. Only other time he had seizure was after MMR and VARIVAX given 4/7/10 and had seizure-febrile 4/12/10. (Fine by AM).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Febrile convulsion, Gaze palsy, Pyrexia, Skin warm, Tremor
Clinical narrative: Overnight was seen to have 2 episodes with legs shaking and eyes looking up. Second time Mom noticed was very warm with fever. Only other time he had seizure was after MMR and VARIVAX given 4/7/10 and had seizure-febrile 4/12/10. (Fine by AM).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Gaze palsy, Pyrexia, Tremor
Clinical narrative: Overnight was seen to have 2 episodes with legs shaking and eyes looking up. Second time Mom noticed was very warm with fever. Only other time he had seizure was after MMR and VARIVAX given 4/7/10 and had seizure-febrile 4/12/10. (Fine by AM).
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Dark circles under eyes, Rash pruritic
Clinical narrative: A report has been received from registered nurse concerning a 6 year old, Female patient, who had been receiving Nasal FLUMIST. FLUMIST started on 17-Oct-2012. The patient experienced PURPLE CIRCLES UNDER THE CHILD'S EYES and ITCHY RASH which started on 18-Oct-2012. The outcome of the event of PURPLE CIRCLES UNDER THE CHILD'S EYES and ITCHY RASH is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/Medimmune 09-Nov-2012: The outcome of the events changed from not recovered to recovered. Patient name provided and added to the reporter page. 'Administered by' reporter field completed. LOT number of FLUMIST added. Corrected report 21-Nov-2012: The outcome of both events corrected from unknown to not recovered. Start date of the events and start date of the drug were amended.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Respiratory tract congestion
Clinical narrative: A report has been received from a Physician concerning a 7 year old, Female subject, who had been receiving Nasal FLUMIST, 0.2 Millilitres, Once/Single administration and Unknown NOSTRIL. FLUMIST started on 14-Sep-2012 and NOSTRIL started on an unknown date. The patient experienced CONGESTION which started on 14-Sep-2012. The outcome of the event of CONGESTION is unknown. The report was considered to be non-serious. Summary of insignificant follow-up information received by AstraZeneca/MedImmune on 24-Oct-2012: new primary reporter added, details of Administered by and Responsible physician reporter details updated. Corrected Report 24-Oct-2012: patient and responsible physician reporter records added, Have you reported this adverse event previously field amended, Form Completed by and Relation to Patient fields completed, start date of FLUMIST added, action taken corrected, event onset date added, narrative updated.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Spoke with mom & she reports the day after vaccines got a red-raised rash on bil thighs. Denies fever. Also had rash after 2nd set of vaccines.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Vaccine was administered on (R) deltoid on 2/18/13. That night pt started with swelling , red & soreness, and painful. Sx still going on today.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: A consumer report has been received. The report concerned a five year-old female patient. No concomitant medication or relevant medical history has been reported. the patient had been receiving nasal FLUMIST on 13-Sep-2012. The patient experienced flu-like symptoms for 10 days started on 13-Sep-2012. The flu-like symptoms resolved on 24-Sep-2012. The report was considered to be non-serious by the reporter. Summary of follow-up information received on 25-Sep-2012 from the reporter: the outcome of the event added as recovered. The patient's details added. Start date and stop date of the adverse event added. Narrative updated. The start date of the suspect drug added. Corrected report: have you reported this adverse event previously and form completed by and relation to patient added to the first reporter instead of the second reporter. Fever added to lab page. The reporter's phone number added.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Pyrexia, Rhinorrhoea
Clinical narrative: A report has been received from a Physician concerning a 2 year old, Female subject, Height: 39.5 IN; Weight: 38.5 LB, who had been receiving Nasal FLUMIST, 2.0 Millilitres, Once/Single administration. FLUMIST started on 05-Sep-2012. The patient experienced HEADACHE, FEVER and RUNNY NOSE which started on 09-Sep-2012. The patient recovered from the event of HEADACHE, FEVER and RUNNY NOSE on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 03-Oct-2012: new reporter, vaccinated by reporter; patient details; vaccine details; outcome of the adverse event added.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A report has been received from a physician concerning a 6 year old, male patient. No medical history, concurrent diseases and concomitant medications were provided. On 17-Sep-2012 the patient received nasal FLUMIST. The patient developed hives which started on 19-Sep-2012. Action taken with FLUMIST was unknown. The outcome of the event of hives was unknown. The report was considered to be non-serious by the reporter.
Sex: M
Vaccine: FLUN3
Symptoms: Asthma
Clinical narrative: A report has been received from a physician concerning a male patient. No medical history, concurrent diseases and concomitant medications were provided. On an unknown date the patient received nasal FLUMIST. The patient experienced acute asthmatic episode. Action taken with FLUMIST was unknown. The outcome of the event was unknown. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 06-Sep-2012 from the physician: patient's gender was added.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Exposure to vaccinated person
Clinical narrative: A consumer report has been received. The report concerned a four year-old female patient. No medical history, concomitant medications were provided. The patient had leukemia. The reporter stated that after on an unknown date, her daughter's first nasal FLUMIST administration, the patient had flu like symptoms for the following 10 days. Five of those days she had a fever over 104 F. The reporter added that, they unknowingly put their neighbor at risk who had leukemia. The reporter stated, her daughter did not have direct contact with the patient. Action taken with FLUMIST was unknown. The outcome of the event was unknown. The report was considered to be non-serious by company physician. Summary to follow-up information received AstraZeneca/MedImmune 25-Sep-2012 from the reporter: The event of flu like symptoms was deleted. The patient's initials and age added. Narrative updated. Corrected report 05-Sep-2012: relationship to patient field was corrected to other. Summary paragraph updated.