chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Laboratory test abnormal, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine unspecified (manufacturer unspecified). Subject's medical condition included systemic lupus erythematosus. On an unspecified date, the subject received an unspecified dose of influenza vaccine unspecified (unknown route and injection site, batch number not provided). 12 weeks after vaccination with influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 systemic lupus erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subjects' medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improvement management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators, using xMAP technology. SLE patients who exhibited disease flare and significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism of flare, therapeutic selection or development.
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Laboratory test abnormal, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 12 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date for prophylaxis. Subjects' medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism for flare, therapeutic selection or development.
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Laboratory test abnormal, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 12 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subject's medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2 and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism of flare, therapeutic selection or development.
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Laboratory test abnormal, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 12 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subject's medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism of flare, therapeutic selection or development.
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 12 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subject's medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2 and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism of flare, therapeutic selection or development.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram, Electrocardiogram normal, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 06 November 2013. A 21 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 14 days after he had received the following vaccines on 17 July 2013: 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 data included: an abnormal Troponin I with the highest recorded value of 02.67 and a normal ECG on 26 July 2013. Echocardiogram results were not available. A lumbar puncture 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: 1.52
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 217 cases solicited from the database during the surveillance period from 01 January 2010 to 23 October 2013. These 217 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 23 October 2013 from the investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a four year-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject had received four doses of PENTACEL; dose one on 30 October 2009, dose two received on 12 January 2010, dose three received on 18 March 2010 and dose four on 08 March 2011 (lot numbers, routes and sites of administration for all doses not reported). The subject developed cold-like symptoms on 09 September 2013, approximately 30 months after the last dose. On 09 September 2013, the subject developed a cough and paroxysmal cough on 12 September 2013 without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 17 October 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 October 2013 for five days. The subject was not hospitalized. At the time of final contact on 21 October 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 42 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.52
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 217 cases solicited from the database during the surveillance period from 01 January 2010 to 23 October 2013. These 217 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 23 October 2013 from the investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a four year-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject had received four doses of PENTACEL; dose one on 30 October 2009, dose two received on 12 January 2010, dose three received on 18 March 2010 and dose four on 08 March 2011 (lot numbers, routes and sites of administration for all doses not reported). The subject developed cold-like symptoms on 09 September 2013, approximately 30 months after the last dose. On 09 September 2013, the subject developed a cough and paroxysmal cough on 12 September 2013 without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 17 October 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 October 2013 for five days. The subject was not hospitalized. At the time of final contact on 21 October 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 42 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: This is one case out of a cumulative total of 215 cases solicited from a database during the surveillance period from 01 January 2010 to 15 October 2013. These 215 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 15 October 2013 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the state Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL; lot number C3294AB received on 13 July 2009, lot number C3378AA received on 15 September 2009, lot number C3365AB received on 16 November 2009 and lot number C3615AA received on 29 July 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms on 27 August 2013, approximately three years after the last dose. On 27 August 2013, the subject developed a cough and paroxysmal cough on 06 September 2013 with a whoop. The subject also experienced post-tussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 08 September 2013. Chest x-ray findings were unknown for pneumonia. Corrective treatments consisted of azithromycin starting on 06 September 2013 for 3 days. The subject was not hospitalized. At the time of final contact on 12 September 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 215 cases solicited from a database during the surveillance period from 01 January 2010 to 15 October 2013. These 215 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 15 October 2013 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the state Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL; lot number C3294AB received on 13 July 2009, lot number C3378AA received on 15 September 2009, lot number C3365AB received on 16 November 2009 and lot number C3615AA received on 29 July 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms on 27 August 2013, approximately three years after the last dose. On 27 August 2013, the subject developed a cough and paroxysmal cough on 06 September 2013 with a whoop. The subject also experienced post-tussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 08 September 2013. Chest x-ray findings were unknown for pneumonia. Corrective treatments consisted of azithromycin starting on 06 September 2013 for 3 days. The subject was not hospitalized. At the time of final contact on 12 September 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 36.0
Sex: F
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Bilateral nucal xantham well defined circular in nature. Intact, total of 7.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Full blood count, Vomiting
Clinical narrative: Vomiting/Diarrhea.
Age: 49.0
Sex: M
Vaccine: FLUN4
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Fever, body aches, muscle aches.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia, Tremor, Withdrawal syndrome
Clinical narrative: Pt. states she woke up at 1:00am with severe shaking of her body, chills, and fever. Her son called an ambulance and she was taken to the ER. She states that the ER doc said she was having withdrawal from pain meds. Pt. denies this and states that these symptoms were from the quadrivalent flu vaccine. She had never had a reaction to the flu vaccine before.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth and itching at injection site.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arrhythmia, Extrasystoles, Heart rate irregular
Clinical narrative: Starting about 15 minutes after vaccine injected, began having a cardiac arrhythmia ... thumping in my chest ... irregular pulse (skipped beats palpated in radial pulse).  Lasted for 4 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Very swollen and red arm, radiating heat. Went to ER and got Benadryl, steroid, and other treatment per patient.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Off label use
Clinical narrative: Patient was inadvertently given adult trivalent flu 0.5ml dose instead of pediatric 0.25 ml dose.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Itching, redness, hives...obvious allergic reaction; escorted to ER by RN; treated by ER physician.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site joint pain, Malaise
Clinical narrative: Pain in upper left shoulder joint, malaise has lasted over one month, difficulty raising left arm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Arm swollen twice the size of other arm.
Age: 7.0
Sex: M
Vaccine: FLU4, IPV, MMRV, TDAP
Symptoms: Pyrexia, Skin warm, Swelling, Tenderness
Clinical narrative: SLIGHT FEVER, LEFT UPPER SHOULDER WARM, TENDER, AND SWOLLEN. MOM GAVE TYLENOL AND APPLIED COLD PACKS TO AREA.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Middle insomnia
Clinical narrative: Injection site pain and itching. Pain severe enough to disrupt sleep (pain scale 7-8).
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Insomnia
Clinical narrative: Injection site pain and itching. Pain severe enough to disrupt sleep (pain scale 7-8).
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Eye discharge, Eye irritation, Myalgia
Clinical narrative: Fever, muscle aches, weakness, eye irritation and thick discharge, throat irritation, difficulty breathing, wheezing on expiration. Took 2 Benadryl and respiration and eye issues went away. Body aches, fever, weakness persisted for two days.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Throat irritation, Wheezing
Clinical narrative: Fever, muscle aches, weakness, eye irritation and thick discharge, throat irritation, difficulty breathing, wheezing on expiration. Took 2 Benadryl and respiration and eye issues went away. Body aches, fever, weakness persisted for two days.
Age: 47.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Back pain, Fatigue, Gait disturbance, Grip strength decreased, Headache
Clinical narrative: Severe body aches, fever, weakness in hands and legs, fatigue, headache, pain in right leg, right arm, neck and lower back. Difficulty holding objects or walking.
Age: 47.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Influenza virus test negative, Muscular weakness, Neck pain, Pain, Pain in extremity
Clinical narrative: Severe body aches, fever, weakness in hands and legs, fatigue, headache, pain in right leg, right arm, neck and lower back. Difficulty holding objects or walking.
Age: 47.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Severe body aches, fever, weakness in hands and legs, fatigue, headache, pain in right leg, right arm, neck and lower back. Difficulty holding objects or walking.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Eye discharge, Eye pruritus, Eye swelling, Headache, Ocular hyperaemia
Clinical narrative: Swelling, redness, and itching of eyes with exudate; swelling of throat, severe headache.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Pharyngeal oedema
Clinical narrative: Swelling, redness, and itching of eyes with exudate; swelling of throat, severe headache.
Age: 1.31
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: This is one case out of a cumulative total of 216 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 18 October 2013. These 216 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 18 October 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot numbers not reported received on 07 June 2011, 13 September 2011 and 13 December 2011 and lot number C4194AA received on 26 July 2012 (routes and sites of administration not reported). The subject developed a cough on 23 August 2013, approximately one year after the last dose and paroxysmal cough on 23 August 2013 with a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 07 September 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 September 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 08 October 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 46 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.31
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 216 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 18 October 2013. These 216 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 18 October 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot numbers not reported received on 07 June 2011, 13 September 2011 and 13 December 2011 and lot number C4194AA received on 26 July 2012 (routes and sites of administration not reported). The subject developed a cough on 23 August 2013, approximately one year after the last dose and paroxysmal cough on 23 August 2013 with a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 07 September 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 September 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 08 October 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 46 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Pt started with redness and itching at injection site. Then developed anaphylactic symptoms, Pt was given Diphenhydramine and SOLU-MEDROL inj.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site urticaria, Pruritus
Clinical narrative: Reported itching immediately after injection. 15 minutes after vaccine hives around injection site.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacterial infection, Erythema, Induration, Local swelling, Nodule
Clinical narrative: Next day red, arm swollen, hard knot appeared (looked like blood under skin) - turned black and warm - went to MD within one week (express care) and went to current MD today 11/12/13 told her she had bacterial infection got cream and oral abx.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin discolouration, Skin warm
Clinical narrative: Next day red, arm swollen, hard knot appeared (looked like blood under skin) - turned black and warm - went to MD within one week (express care) and went to current MD today 11/12/13 told her she had bacterial infection got cream and oral abx.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Upper (R) arm swollen and red and warm to the touch; s/s started on 11/5/13 at approx 4 pm; s/s have not gotten worse today; pt advised to take ibuprofen, BENADRYL et ice packs for 24 hrs; RTC if s/s persist or worsen.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Axillary pain, Chills, Flushing, Immediate post-injection reaction, Lymphadenitis
Clinical narrative: 11/11/13 Patient started feeling flush immediately after inj. 11/12/13 Next day high fever T 102, rigors, general malaise exquisitely tender with axillary pain. DURICEF 500mg 2 PO now then one twice daily. 11/13/13 Swollen, more painful, fever down sent for MRI to R/O subcutaneous abscess. She was admitted 11/13/13 in the evening.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Malaise, Nuclear magnetic resonance imaging, Pyrexia, Tenderness
Clinical narrative: 11/11/13 Patient started feeling flush immediately after inj. 11/12/13 Next day high fever T 102, rigors, general malaise exquisitely tender with axillary pain. DURICEF 500mg 2 PO now then one twice daily. 11/13/13 Swollen, more painful, fever down sent for MRI to R/O subcutaneous abscess. She was admitted 11/13/13 in the evening.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Feeling abnormal, Injection site erythema, Injection site swelling
Clinical narrative: 11/11/13 Patient started feeling flush immediately after inj. 11/12/13 Next day high fever T 102, rigors, general malaise exquisitely tender with axillary pain. DURICEF 500mg 2 PO now then one twice daily. 11/13/13 Swollen, more painful, fever down sent for MRI to R/O subcutaneous abscess. She was admitted 11/13/13 in the evening.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Malaise, Nuclear magnetic resonance imaging abnormal, Pyrexia, Tearfulness
Clinical narrative: 11/11/13 Patient started feeling flush immediately after inj. 11/12/13 Next day high fever T 102, rigors, general malaise exquisitely tender with axillary pain. DURICEF 500mg 2 PO now then one twice daily. 11/13/13 Swollen, more painful, fever down sent for MRI to R/O subcutaneous abscess. She was admitted 11/13/13 in the evening.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 11-NOV-2013 the patient was vaccinated with M-M-R II injection (dose, lot and expiry date unknown). The  M-M-R II doses were exposed to 52 Fahrenheit since 07-NOV-2013. No adverse effect was reported. This is 2 of 2 reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation
Clinical narrative: This spontaneous report  has been received from a male consumer of unknown age reporting on himself with history of shingles. None drug reactions/allergies. On approximately 14-OCT-2013 reproted as 2 weeks ago, the patient was vaccinated with ZOSTAVAX refrigerated vial 19400 PUF, (dose, lot # and route not reported). None concomitant medication. In October 2013, the patient has developed a burning sensation in his back and little white blisters. The patient did not receive any treatment at the time of the report and did not seek medical attention. The action taken for ZOSTAVAX was not applicable. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Arm soar directly under injection site and red/swollen for a day too. Now 6 weeks later arm still hurts and seems to spread slightly. Currently not warm to touch or red. When press spot hurts and on fingers tingling. Not debilitating and relieved by APAP.
Age: 51.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Dizziness, Dyspnoea, Dysuria, Injection site pain, Lymphadenopathy
Clinical narrative: Pain in (R) arm from armpit to wrist - swollen lymph nodes under arm. Flat red rash on face - neck - (rash resolved 11/8/13). Dizzy, blurred vision - problems with urination - Had S.O.B x 2 days - resolved 11/7/13 fever.
Age: 51.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash, Rash erythematous, Vision blurred
Clinical narrative: Pain in (R) arm from armpit to wrist - swollen lymph nodes under arm. Flat red rash on face - neck - (rash resolved 11/8/13). Dizzy, blurred vision - problems with urination - Had S.O.B x 2 days - resolved 11/7/13 fever.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dosing information and route were not provided) lot # J003727, expiry date 07-NOV-2015. GARDASIL was improperly stored. This information was stated on a vaccination list of improperly stored vaccines. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema
Clinical narrative: Angioedema 4 hours later which resolved on its own.
Age: 0.75
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a registered nurse regarding an unknown number of patients. The unknown number of patients were inadvertently administered GARDASIL, and PEDVAXHIB (dosages and routes of administration not provided) on 30-OCT-2013 and 31-OCT-2013, that had been improperly stored. No adverse effects reported. The nurse was unable to confirm the exact number of identifies of the patients at the time of this report. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report has been received from a licensed practical nurse concerning to a 65 year old male patient. Current conditions, medical history and drug reactions/allergies were not provided. On 07-OCT-2013, the patient's father-in-law was vaccinated with ZOSTAVAX, 0.65ml, (lot # and route not reported). Concomitant medication was not reported. On approximately 11-OCT-2013 reported as 4-5 days after receiving ZOSTAVAX, the patient (son-in-law) developed a rash on his left hip diagnosed as shingles. At the time of the report, the outcome of shingles/a rash on his left hip and secondary transmission was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Myalgia
Clinical narrative: Received PPV-23 on 10/31/13. 11-2-13 induration, pain, redness at site. Approximately 11-4/5-13 developed myalgia, fatigue. 11-9-13 generalized itching.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus generalised
Clinical narrative: Received PPV-23 on 10/31/13. 11-2-13 induration, pain, redness at site. Approximately 11-4/5-13 developed myalgia, fatigue. 11-9-13 generalized itching.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 81 year old female patient. Medical history was not provided. On an unknown date in the recent past the patient was vaccinated with ZOSTAVAX (route of administration was not provided, lot H1021459 (determined to be not valid). No information on concomitant medications was reported. On an unknown date the patient experienced "developed a red arm". The patient's arm was not sore, did not itch and the patient was fine now. No treatment was provided. The red arm lasted one week and then went away. The outcome of patient developed a red arm was recovered/resolved. No action taken with ZOSTAVAX was provided. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: ZOSTAVAX given (R) arm proper placement on 11/12/13 8 x 10 cm hard, red, blistered area started on 11/13/13 hot to touch, swollen.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Vomiting
Clinical narrative: This spontaneous report as received from a registered pharmacist via field representative, refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with PNEUMOVAX23 injection (dose, route and lot number were not reported). Other suspect therapies included influenza virus vaccine (manufacturer unknown) (dose, route, date of administration and lot number were not provided).  No concomitant medications were reported. On an unknown date, the patient experienced vomiting and had swelling at the injection site. The patient did not seek medical attention. The outcome of swelling at the injection site and vomiting was unknown.  Additional information has been requested.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 93 year old female patient with no drug reaction and allergies and with no medical history. On 26-OCT-2013, the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneously (lot number: J006828, expiration date 14-SEP-2014) for shingles prevention. Concomitant therapies included losartan potassium (manufacturer unknown), NASONEX, SINGULAIR, PLAVIX and LONOX. The patient who received a dose of ZOSTAVAX on 26-OCT-2013 in the morning, developed rash on her back later that evening. No lab diagnostic studies were performed. There was no treatment given for the rash on her back. The patient spoke to pharmacist (reported as patient seek medical attention). No intervention to prevent serious criteria was taken, no PQC was involved. The outcome of rash on her back was reported as not recovered/not resolved. The relatedness between ZOSTAVAX and rash on her back was not reported. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Injection site erythema, Injection site inflammation, Irritability
Clinical narrative: Post vaccine administration pt. developed red inflammation on (L) thigh and excessive crying and irritability.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pressure when receiving, sore that evening. No apparent swelling. Pain on moving arm forward and backward denies numbness or tingling, no weakness.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. 13-OCT-2011 the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and indication were not reported), and on 04-NOV-2013 the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number and indication were not reported). Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pruritus
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a 57 year old female patient. On 08-AUG-2013 the patient was vaccinated with ZOSTAVAX, (dose, lot number and expiration date not reported) intramuscular for vaccination. There was no concomitant medication reported. The nurse reported that the patient was inadvertently administered ZOSTAVAX intramuscularly on 08-AUG-2013. The patient developed localized itching immediately after receiving the vaccine. The itching lasted a few days (exact length of time unspecified). The patient sought for medical attention and spoke to the nurse. No treatment was given for the event. The localized itching recovered on an unknown date in 2013. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: General symptom, Tic
Clinical narrative: Acute onset motor tic. General sx's - entire body. Sx's resolved after 3 months.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Musculoskeletal pain, Neck pain, Vertigo
Clinical narrative: 10/24/2013 Mild other At noon the day of the immunization, patient said things were "spinning" for a few seconds and he felt dizzy. He said he felt like it was Meniere's disease but without the ringing in his ears he had a sore neck and shoulders, and felt light headed for the next two weeks. Client feels much better now (11/13/2013). Was instructed to follow up with his doctor.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 28-OCT-2013, the patient was vaccinated with a first dose of ROTATEQ, orally, (Lot number not provided), which expired on 27-OCT-2013. Co-suspect therapies and concomitant medications were not provided. No adverse events were reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Swelling
Clinical narrative: Difficulty swallowing. Swolled jaw.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on both legs within 24 hours of shot. 3rd and 4th day - hives up back and elbows.
Age: 16.0
Sex: M
Vaccine: FLUN4
Symptoms: Activities of daily living impaired, C-reactive protein normal, Condition aggravated, Cyanosis, Fatigue
Clinical narrative: Given FLUMIST at 2pm on 11/7 - had prolonged seizure and taken to ER 4pm. Had more seizures in ER. Patient is a 16 y.o. male w/history of viral encephalitis in 2009, and known seizure disorder who presented on 11/7 with prolonged seizure. Per Dr's note (peds neuro): Mom reports that over the past 4-5 days patient has been complaining of extreme fatigue and myalgias. On day of admission he stayed home from school due to fatigue. Around 4pm yesterday mom reports patient had a seizure with unknown duration (mom feels approximately 2-3 minutes) described as generalized tonic-clonic with cyanosis. She called 911 - patient had stopped seizing by time EMS arrived. Patient had 2-3 more seizures in the ER described as bilateral arm stiffening with right leg drawn up, each lasting 1-2 minutes. Also had periods of retching/nausea in ER. Patient has had fevers with tmax of 38.1, normal CBC, CMP and CRP. ED course: VPA 1 gram load and ATIVAN 0.1 mg/kg IV x1 while in the ER. Last seizure was in December 2012 (also while ill with a virus). Prior to arrival he was taking VPA 750 mg BID. Previously taken KEPPRA but was discontinued due to side effects of anxiety and nausea.