chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Brachial plexopathy, Burning sensation, Computerised tomogram, Contusion, Electrocardiogram
Clinical narrative: Initial report received from a healthcare professional on 29 March 2012. A (questionably) 47-year-old female received a (questionably) left arm injection of ADACEL, sanofi pasteur Ltd., (lot number, and route not reported) at the employee health office on a day (questionably in February) 2012. The patient's medical history, any concomitant medications, and any illnesses at the time of vaccination, and any adverse event following prior vaccinations were not reported. Sometime after injection (on a date not specified), the patient developed left arm numbness and weakness, which the patient has now had for seven weeks. The reporter did not have patient information or vaccination information at time of call. The patient's outcome was not recovered. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Haematoma, Hypoaesthesia, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Paraesthesia
Clinical narrative: Initial report received from a healthcare professional on 29 March 2012. A (questionably) 47-year-old female received a (questionably) left arm injection of ADACEL, sanofi pasteur Ltd., (lot number, and route not reported) at the employee health office on a day (questionably in February) 2012. The patient's medical history, any concomitant medications, and any illnesses at the time of vaccination, and any adverse event following prior vaccinations were not reported. Sometime after injection (on a date not specified), the patient developed left arm numbness and weakness, which the patient has now had for seven weeks. The reporter did not have patient information or vaccination information at time of call. The patient's outcome was not recovered. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Swelling, Ultrasound scan, X-ray
Clinical narrative: Initial report received from a healthcare professional on 29 March 2012. A (questionably) 47-year-old female received a (questionably) left arm injection of ADACEL, sanofi pasteur Ltd., (lot number, and route not reported) at the employee health office on a day (questionably in February) 2012. The patient's medical history, any concomitant medications, and any illnesses at the time of vaccination, and any adverse event following prior vaccinations were not reported. Sometime after injection (on a date not specified), the patient developed left arm numbness and weakness, which the patient has now had for seven weeks. The reporter did not have patient information or vaccination information at time of call. The patient's outcome was not recovered. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Initial report received from a healthcare professional on 29 March 2012. A (questionably) 47-year-old female received a (questionably) left arm injection of ADACEL, sanofi pasteur Ltd., (lot number, and route not reported) at the employee health office on a day (questionably in February) 2012. The patient's medical history, any concomitant medications, and any illnesses at the time of vaccination, and any adverse event following prior vaccinations were not reported. Sometime after injection (on a date not specified), the patient developed left arm numbness and weakness, which the patient has now had for seven weeks. The reporter did not have patient information or vaccination information at time of call. The patient's outcome was not recovered. Documents held by sender: None.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Dx with intussusception 2d after admin of ROTATEQ at 2 mo well care at PCP of. Dx at hospital.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema normal, Blood creatinine normal, Intussusception, Laboratory test normal, Ultrasound abdomen abnormal
Clinical narrative: Dx with intussusception 2d after admin of ROTATEQ at 2 mo well care at PCP of. Dx at hospital.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Ultrasound scan abnormal, Vomiting projectile
Clinical narrative: Dx with intussusception 2d after admin of ROTATEQ at 2 mo well care at PCP of. Dx at hospital.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site swelling, Pain, Rash macular, Skin warm
Clinical narrative: Red Blotch 3 inches in diameter.  Swelling of entire thigh.  Hot to the touch and painful.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Pt experienced redness, pain & swelling medial lower bicep after injection. Treated with antibiotic for cellulitis & BENADRYL seen in office 4/12.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt had a large amount of redness. Swelling, and itching at site of immunization. Pt did not have any trouble with breathing. Parents gave BENADRYL and brought pt in. They were instructed to continue BENADRYL.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh with blanching redness & warmth, swelling noted, painful - all symptoms were noted the day after vaccine given.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pallor
Clinical narrative: (L) thigh with blanching redness & warmth, swelling noted, painful - all symptoms were noted the day after vaccine given.
Sex: U
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Initial report was received from another manufacturer on 02 April 2012 (Service Request Number 1-5014135556). A patient (age, date of birth and gender not reported) had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, date, site and route of administration not reported) and several hours later experienced shortness of breath. Past medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Injection site reaction (erythema at site of injection approximately 4-5 cm in diameter).
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 03 April 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 14-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance database. The subject had received 3 doses of PENTACEL; first dose received on 23 February 2011 (lot number unspecified), second dose received on 11 May 2011 (lot number C3590AA) and third dose received on 25 July 2011 (lot number C3633AA; routes and sites of administration not reported). The subject developed a cough on 01 March 2012, approximately seven months after the last dose. On 15 March 2012, patient developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 15 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 March 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 29 March 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 03 April 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 14-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance database. The subject had received 3 doses of PENTACEL; first dose received on 23 February 2011 (lot number unspecified), second dose received on 11 May 2011 (lot number C3590AA) and third dose received on 25 July 2011 (lot number C3633AA; routes and sites of administration not reported). The subject developed a cough on 01 March 2012, approximately seven months after the last dose. On 15 March 2012, patient developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 15 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 March 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 29 March 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 03 April 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 20-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance database. The subject had received 3 doses of PENTACEL; lot number C3670AA received on 05 August 2010, lot number C36585AA received on 04 October 2010 and lot number C3685AA received on 16 December 2010 and 1 dose of DAPTACEL; lot number C3957AA received on 29 September 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 13 February 2012, approximately four months after the last dose. On 21 February 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 24 February 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 February 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 07 March 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Pertussis, Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 03 April 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 20-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance database. The subject had received 3 doses of PENTACEL; lot number C3670AA received on 05 August 2010, lot number C36585AA received on 04 October 2010 and lot number C3685AA received on 16 December 2010 and 1 dose of DAPTACEL; lot number C3957AA received on 29 September 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 13 February 2012, approximately four months after the last dose. On 21 February 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 24 February 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 February 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 07 March 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: F
Vaccine: VARCEL
Symptoms: Erb's palsy, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a physician's assistant concerning a female infant. On 09-MAY-2011, the patient's mother was vaccinated with a dose of 0.5 mL VARIVAX (Merck) (Lot # 667480/1374Z). On 14-DEC-2011 the patient was born and experienced left arm erb's palsy. At the time of reporting, the patient's outcome was unknown. Upon internal review, left arm erb's palsy was determined to be an other important medical event. The mother's experience has been captured in WAES 1105USA01516. No further information is available.
Age: 46.0
Sex: M
Vaccine: HEPAB, MNQ, TYP, YF
Symptoms: Rash papular
Clinical narrative: Within 5 minutes of injection, a few red papules developed on both arms. They were not pruritic. Following diphenhydramine 50 mg IM, no further lesions occurred. The patient was sitting comfortably.
Age: 22.0
Sex: M
Vaccine: SMALL, TYP, SMALL, TYP
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericardial disease, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator on 04 April 2012. A 22-year-old male subject received the following vaccinations on 27 December 2011: an injection of ACAM2000 (lot number not reported) and TYPHIM VI, sanofi pasteur SA (lot number not reported). The subject had no significant medical history. On 09 January 2012, the subject had an abnormal troponin I of 11.05, an abnormal electrocardiogram (ECG) and an abnormal echocardiogram. On 08 January 2012, the subject was diagnosed with unspecified disease of pericardium and on 09 January 2012, the subject was diagnosed with acute pericarditis, unspecified. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 21.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram normal, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 04 April 2012. A 21-year-old female subject received the following vaccinations: On 09 November 2011: an injection of ACAM2000 (lot number not reported) and ANTHRAX 2 (manufacturer and lot number not reported) and on 11 October 2011: an injection of TYPHIM VI, sanofi pasteur, lot number not reported and an injection of ANTHRAX 1 (manufacturer and lot number not reported). The subject had no significant medical history. On 15 November 2011, the subject had a normal electrocardiogram (ECG). On 17 November 2011, the subject had a normal troponin I and on 21 November 2011, the subject had a normal echocardiogram. On 22 November 2011, the subject was diagnosed with other, chest pain. 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: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Positive erythema, redness positive swelling.
Age: 46.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Body temperature increased, Fatigue, Oropharyngeal pain, Pain, Rash generalised
Clinical narrative: Friday noon 3/30/12 complain sore throat, generalized rashes from neck down to legs front and back, tired and body aches. Low grade temperature.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Myocarditis, Pericardial disease, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 04 April 2012. A 24-year-old male subject received the following vaccinations: On 24 January 2012: an injection of ACAM2000 (lot number not reported) and on 04 January 2012: an injection of anthrax 2 (manufacturer and lot number not reported). The subject had no significant medical history. On 04 February 2012, the subject had an abnormal Troponin I of 06.89 and a normal electrocardiogram (ECG). On 04 February 2012, the subject was diagnosed with acute pericarditis, unspecified, unspecified disease of pericardium and non-specific myocarditis. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocardial infarction, Troponin I increased
Clinical narrative: This study case was received from the investigator on 04 April 2012. A 31-year-old male subject received the following vaccinations: On 06 January 2012: an injection of ACAM2000 (lot number not reported) and on 14 December 2011: an injection of TYPHIM VI, sanofi pasteur SA, lot number not reported, an injection of ANTHRAX 1 (manufacturer and lot number not reported) and an injection of Hep B Adult (manufacturer and lot number not reported). The subject had a history of elevated cholesterol. On 19 January 2012, the subject had an abnormal troponin I of 00.52, an abnormal electrocardiogram (ECG) and a normal echocardiogram. On 24 January 2012, the subject was diagnosed with subendocardial infarction. 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: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocardial infarction, Troponin I, Troponin I increased
Clinical narrative: This study case was received from the investigator on 04 April 2012. A 31-year-old male subject received the following vaccinations: On 06 January 2012: an injection of ACAM2000 (lot number not reported) and on 14 December 2011: an injection of TYPHIM VI, sanofi pasteur SA, lot number not reported, an injection of ANTHRAX 1 (manufacturer and lot number not reported) and an injection of Hep B Adult (manufacturer and lot number not reported). The subject had a history of elevated cholesterol. On 19 January 2012, the subject had an abnormal troponin I of 00.52, an abnormal electrocardiogram (ECG) and a normal echocardiogram. On 24 January 2012, the subject was diagnosed with subendocardial infarction. 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: 69.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site joint pain, Injection site pain, Pain, Pruritus
Clinical narrative: Extreme pain in deltoid (right arm) also into a right elbow. Painful to use right arm with great (or any) degree of movement. This area was where flu shot was given. Right arm had minimal use due to pain. Yes itch. Need help relief.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Vaccination site inflammation
Clinical narrative: The patient presented to the pharmacy on 3-31-12 with a sore upper arm. In the location of the vaccination, there was redness and inflammation.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Convulsion
Clinical narrative: Patient began having seizures. Presented to ER was given IO ATIVAN. Admitted to the Hospital.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Mother called office 4-5 12 stating arm had red, hard lump > silver dollar at inj site. 4-6-12 Pt. developed temp 102 with chills, aches & pain. Seen in office 4-7-12 - arm felt better swelling 8x12 cm noted - Temp 97.6 no wheezing noted.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Oedema peripheral, Pain
Clinical narrative: Mother called office 4-5 12 stating arm had red, hard lump > silver dollar at inj site. 4-6-12 Pt. developed temp 102 with chills, aches & pain. Seen in office 4-7-12 - arm felt better swelling 8x12 cm noted - Temp 97.6 no wheezing noted.
Age: 0.59
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Cough, Influenza virus test positive, Lobar pneumonia, Mechanical ventilation, Pneumonia respiratory syncytial viral
Clinical narrative: On 3-17-12 pt developed fever 103.5, cough, wheezing. She tested positive for RSV and flu. She was treated at hospital. She was on ventilator for weeks. She was in hospital for 18 days. Dx her RUL pneumonia. Severe respiratory distress.
Age: 0.59
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Pyrexia, Respiratory distress, Respiratory syncytial virus test positive, Rhinovirus infection, Wheezing
Clinical narrative: On 3-17-12 pt developed fever 103.5, cough, wheezing. She tested positive for RSV and flu. She was treated at hospital. She was on ventilator for weeks. She was in hospital for 18 days. Dx her RUL pneumonia. Severe respiratory distress.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm - reddened, warm to the touch, area swollen - advised, ibuprofen, ice to area and rest arm. Patient stated symptoms started 2 hrs. after vaccination.
Age: 12.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Nodule, Swelling
Clinical narrative: Phone call from mom. Daughter has red swollen bump to left arm - knotty - size bigger than 50 cent piece. Mom gave her BENADRYL. RN suggested TYLENOL or MOTRIN as indicated on VIS - cool cloths & go to Dr. if any big changes. Offered support.
Age: 19.0
Sex: F
Vaccine: JEV1
Symptoms: Chest discomfort, Throat irritation
Clinical narrative: Pt. c/o "scratchy" throat and tightness in her chest, about 5 minutes after receiving the Japanese Encephalitis vaccine. BENADRYL PO 50mg given. Pt's B/P 100/60. States feeling better after 10 minutes of lying down (about 10 mins after taking med.).
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Central nervous system inflammation, Convulsion, Electroencephalogram abnormal, Hemiparesis, Lumbar puncture normal
Clinical narrative: Diffuse inflammation of right hemisphere of the brain resulting in left hemiparesis. Symptoms began within 12 hours of vaccine admin. Multiple seizures.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Nuclear magnetic resonance imaging brain
Clinical narrative: Diffuse inflammation of right hemisphere of the brain resulting in left hemiparesis. Symptoms began within 12 hours of vaccine admin. Multiple seizures.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, CSF protein increased, Computerised tomogram head normal, Dysgeusia, Guillain-Barre syndrome
Clinical narrative: Severe pain on March 9, 2011; foul taste in mouth. Visited ER 3 times over 3 days. Admitted to hospital March 13, 2011 with loss of sensation from head to calves, severe facial paralysis, blurred vision inability to walk without support. Diagnosed with Guillain Barre Syndrome & treated with 5 day course of IVIG. Still recovering 1 year later - continue to have facial paralysis.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Nuclear magnetic resonance imaging brain normal, Pain, Sensory loss, VIIth nerve paralysis
Clinical narrative: Severe pain on March 9, 2011; foul taste in mouth. Visited ER 3 times over 3 days. Admitted to hospital March 13, 2011 with loss of sensation from head to calves, severe facial paralysis, blurred vision inability to walk without support. Diagnosed with Guillain Barre Syndrome & treated with 5 day course of IVIG. Still recovering 1 year later - continue to have facial paralysis.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred, Walking aid user
Clinical narrative: Severe pain on March 9, 2011; foul taste in mouth. Visited ER 3 times over 3 days. Admitted to hospital March 13, 2011 with loss of sensation from head to calves, severe facial paralysis, blurred vision inability to walk without support. Diagnosed with Guillain Barre Syndrome & treated with 5 day course of IVIG. Still recovering 1 year later - continue to have facial paralysis.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Hypertension, Hypoaesthesia, Tachycardia
Clinical narrative: Guillain-Barre Syndrome onset progressive numbness/weakness about 2wks after influenza vacc. Characterized as mild/moderate by dr (neurologist). Currently resolving weakness with HTN & tachycardia.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Burning sensation, Eye irritation, Eye pruritus, Nerve stimulation test
Clinical narrative: Eyes-itching, scratching, hands burning & pinching; wrist weak. Top of hands freezing cold. Continually still burning gone to rheumatologist - under (Eyes itching - drs appt for eye drops) done nerve tests. - given gabapentin 3 x day. Some relief. Rheumatologist made appointment with neurologist in March 2012. Need help relief.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral coldness
Clinical narrative: Eyes-itching, scratching, hands burning & pinching; wrist weak. Top of hands freezing cold. Continually still burning gone to rheumatologist - under (Eyes itching - drs appt for eye drops) done nerve tests. - given gabapentin 3 x day. Some relief. Rheumatologist made appointment with neurologist in March 2012. Need help relief.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Severe localized pain, swelling, erythema - tx w/po BENADRYL/steroids.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Hyperhidrosis, Palmar erythema, Throat tightness
Clinical narrative: Within 12 minutes of injection noted, dull HA/dizziness, feeling sweaty, palms both hands were slightly reddened. Within a couple more minutes throat feeling full - taken to Emergency Dpt at this point for evaluation/treatment.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: Cellulitis, local reaction - most likely location of MMR.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Skin lesion
Clinical narrative: Erythematous indurated lesion (L) thigh.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Developed vaccine-related varicella zoster (R) arm C-8 dermatome.
Age: 12.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Approximately 24 hours following injection pt developed erythema, warmth, itchy and swelling to LUE approximately 5 x 2 in dimension. No drainage. No tenderness & no other sx.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Injection site swelling, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to touch per mom on day 1. On 04/05/12 at MD's office significant swelling noted from mid thigh to knee joint. Redness and warmth resolved.
Age: 51.0
Sex: M
Vaccine: DTAP, PPV, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: (R) arm is red, itching, is afebrile. No numbness or tingling. Monitor, apply ice prn, TYLENOL 650 mg q 4 hours, BENADRYL 25-50 mg q 6 hours prn. Follow up if temp over 101 degrees or increased sxs.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Chills, Ear lobe infection, Exposure to communicable disease, Headache, Hyperhidrosis
Clinical narrative: VARIVAX vaccine x 2. Exposed to aunt with shingles 1 month ago. Seen 4/2/12 - headache, fever all night, chills, sweats, on OMNICEF (3/28/12) for infected earlobes. Earlobes healed / viral illness - symptomatic Rx. Seen 4/3/12 - papular rash, (not pustulant or vesicular) getting new spots every few hours - consistent with mild chicken pox.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash papular, Varicella, Viral infection
Clinical narrative: VARIVAX vaccine x 2. Exposed to aunt with shingles 1 month ago. Seen 4/2/12 - headache, fever all night, chills, sweats, on OMNICEF (3/28/12) for infected earlobes. Earlobes healed / viral illness - symptomatic Rx. Seen 4/3/12 - papular rash, (not pustulant or vesicular) getting new spots every few hours - consistent with mild chicken pox.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: Erythema surrounding area of injection site  up to 6 cm. No other symptoms.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Computerised tomogram thorax, Dyspnoea, Electrocardiogram, Hypersensitivity
Clinical narrative: Allergic reaction to TDAP rash, shortness of breath, wheezing chest tightness.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Wheezing
Clinical narrative: Allergic reaction to TDAP rash, shortness of breath, wheezing chest tightness.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Local reaction. Redness, itching right upper arm. Warm without vesicles.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: A few hours following vaccines patient developed a diffused urticarial rash/lesions throughout the body. Patient treated with BENADRYL and referred to an allergist.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmth erythema over 11 x 10 cm area on (L) thigh which was 2 cm greater in diameter than right.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Received ZOSTAVAX vaccine 2-22-12 at pharmacy. Wife called pharmacy 2-24-12 and reported a 5 inch blister at vaccine site, which she thought was shingles.
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Information has been received from a healthcare worker concerning a 61 day old female patient with no pertinent medical history who on 27-MAY-2011 was vaccinated orally with the first dose of ROTATEQ (lot # 668124/0520Z, expiration: 31-MAR-2012) (dose not reported). There was no concomitant medication. The healthcare worker reported that the patient vomited administration of the first dose of ROTATEQ. No treatment was given for the adverse event. No lab diagnostics studies were performed. At the time of reporting, the patient's status was unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Erythema, Pyrexia, Swelling
Clinical narrative: Redness, swelling, fever, chills. Given Benadryl and a prescription for Bactrim.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: MUSCLE PAIN PERSISTING SINCE IMMUNIZATION, DENIES WEAKNESS. CLIENT REPORTED EVENT TODAY 4/12/2012: ALSO REPORTED THAT SHE HAD INJURED LEFT BODY 1 YEAR AGO.  CLIENT SAID THAT SHE HAD SEEN HER DOCTOR.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Full blood count, Induration, Inflammation, Pyrexia
Clinical narrative: Local inflammatory reaction with induration, this increased over the course of 48 hours to be the size of an "orange."  She also had a fever as high as 101 (measured at home).  She was advised to move the arm frequently, apply ice packs x20 minutes several times a day, and take Ibuprofen PRN.  On 4/12 she presented to office with complaint of extreme fatigue. Checked CBC/ESR.  Local reaction significantly better.  Advised she continue fluids/rest and NSAIDs.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Local inflammatory reaction with induration, this increased over the course of 48 hours to be the size of an "orange."  She also had a fever as high as 101 (measured at home).  She was advised to move the arm frequently, apply ice packs x20 minutes several times a day, and take Ibuprofen PRN.  On 4/12 she presented to office with complaint of extreme fatigue. Checked CBC/ESR.  Local reaction significantly better.  Advised she continue fluids/rest and NSAIDs.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Started with a *really* itchy thumb.  Itching kept up & would not dissipate.  Rash started & looked like tiny welts/boils, etal. As of this date I still have the rash (4/12/2012)... As one area 'heals' you can look and see another row of the bumps already having formed; the rash radiates outward and has taken up about half of my palm; has only gone up to the base of the pointer finger; has covered my entire thumb and destroyed my thumbnail.  I've had a nurse friend tell me it sounds like eczema but the doctors office not tell me a thing except that I must have come in contact with *something* - I am not allergic to anything and have never had eczema in my life and was healthy when I went in for the checkup/shot...
Age: 1.26
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: Systemic varicella-like illness, with wide-spread rash and high fever.
Age: 1.26
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: Varicella-like illness, wide-spread rash and high fever.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: Varicella-like illness, wide-spread rash and high fever.
Age: 1.21
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: Systemic Varicella-like illness, wide-spread rash and high fever.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue
Clinical narrative: Very fatigued for about five days.
Age: 21.0
Sex: M
Vaccine: HEPAB, TYP, YF
Symptoms: Feeling abnormal, Hyperhidrosis, Nausea, Pulse pressure decreased
Clinical narrative: Patient in to receive immunizations for international travel. About 10 minutes past receipt patient c/o nausea, sweating, feeling bad. Patient drank a little coke without relief of s/s. V/O 60/ weak radial pulse - ammonia under patient's nose; started IV of N?S in right arm.  911 called.  Patient more alert and walked to ambulance stretcher.  Patient using phone; transported to Medical Center.  Pateint d/c from ER on 4/6 when checked on him at 4:30 p.m.  Spoke with patient 4/12/2012.  States completely recovered.  States ER gave him Rx for nausea (Phenergan) although he has not taken in a few days.  Still plans to travel in June.  Will visit private provider for f/u and Rx for Maleria medication.
Age: 41.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Chills, Headache, Insomnia, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Headache, fever/chills, unable to sleep, stiffness shoulders and neck that has not resolved.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Mother called at 4pm & said baby had red dots all over her that she noted 1/2 hr ago. Denied itching.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain, Pain in extremity, Vomiting
Clinical narrative: Left arm swollen at inj. site & red yesterday. Slightly improved today, achy & vomiting today. Arm was painful yesterday, but improved today. Rx given for ZOFRAN & return if worse.
Age: 0.57
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Body temperature increased, Chest X-ray normal, Crying, Injection site erythema
Clinical narrative: Infant began with inconsolable crying when at ER found to have temperature 103.8. CXR, Lab, and UA were reported as normal by mother. Given Motrin and discharge home. Returned to another ER at 4PM with behavior changes, staring and local erythema to right thigh was noted. 4/12/12 Erythema now 10mm X35 mm on lateral thigh. Temp 98.8 and infant happy and smiling.
Age: 0.57
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Laboratory test normal, Staring, Urine analysis normal
Clinical narrative: Infant began with inconsolable crying when at ER found to have temperature 103.8. CXR, Lab, and UA were reported as normal by mother. Given Motrin and discharge home. Returned to another ER at 4PM with behavior changes, staring and local erythema to right thigh was noted. 4/12/12 Erythema now 10mm X35 mm on lateral thigh. Temp 98.8 and infant happy and smiling.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red, itchy, warm spot at injection site, local and generalized. No rash reported, nor shortness of breath, nor rapid heart rate. No systemic side effects reported. Advised to monitor and seek physician advice or hospital if condition worsens or other symptoms present. Benadryl suggested for itch.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Patient received 0.5 ml Anthrax IM in left deltoid on 10APR2012 at 0915. On 11APR2012, patient began to notice swelling and itchiness at 12 noon. The left deltoid increased in redness, swelling, itchiness, and tenderness throughout the day. Patient reported on 12APR2012 at 0845 with the prior listed signs and symptoms. Medical staff notified. Patient given heat pack, ACE Bandage, and 25 mg Benadryl PO. Patient will continue to be monitored by hospital personnel for any signs of resolution.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: Patient received 0.5 ml Anthrax IM in left deltoid on 10APR2012 at 0915. On 11APR2012, patient began to notice swelling and itchiness at 12 noon. The left deltoid increased in redness, swelling, itchiness, and tenderness throughout the day. Patient reported on 12APR2012 at 0845 with the prior listed signs and symptoms. Medical staff notified. Patient given heat pack, ACE Bandage, and 25 mg Benadryl PO. Patient will continue to be monitored by hospital personnel for any signs of resolution.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Generalised erythema, Lip swelling
Clinical narrative: Redness all over body, swelling to lips. Presents to ED 1 hour after vaccine administration.  Treated with Prednisone, diphenhydramine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Blister, Erythema, Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: ONSET SLOWLY PROGRESSIVE REDNESS AND LOCAL HEAT STARTED 04/11/12; FEW VESICLES NOTED BUT NOW RESOLVED, SOME SUBJECTIVE COMPLAINTS OF SORENESS/TENDERNESS - ON EXAM 6.5CM X 5CM AREA OF MILD INDURATION AND ERYTHEMA LEFT ARM BELOW DELTOID.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Pain, Tenderness
Clinical narrative: ONSET SLOWLY PROGRESSIVE REDNESS AND LOCAL HEAT STARTED 04/11/12; FEW VESICLES NOTED BUT NOW RESOLVED, SOME SUBJECTIVE COMPLAINTS OF SORENESS/TENDERNESS - ON EXAM 6.5CM X 5CM AREA OF MILD INDURATION AND ERYTHEMA LEFT ARM BELOW DELTOID.
Age: 1.29
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Pyrexia, Rash, Rash erythematous
Clinical narrative: Patient's mother noticed rash within 5 minutes of vaccination.  RN noted red rash to abdomen and left thigh.  Mother states patient did not have rash prior to vaccination.  Patient remained in clinic for 25 minutes after vaccination with no further events noted.  Call to mother placed 4/12/12 at 2:40 pm.  Mother reports rash better and patient had low grade fever.
Age: 28.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: Started itching at extremities, no visible rash; felt feverish and achy the following night.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Eczema, Hypersensitivity, Infection, Injection site nodule, Mobility decreased
Clinical narrative: Patient ran a high fever and did NOT get out of bed for 2 days following her 4 year child immunizations. She also had really hard knots at the injection site. Since those vaccinations she has suffered from hives, rashes, severe eczema, recurrent infections and allergies. None of these were present prior to the shots.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Patient ran a high fever and did NOT get out of bed for 2 days following her 4 year child immunizations. She also had really hard knots at the injection site. Since those vaccinations she has suffered from hives, rashes, severe eczema, recurrent infections and allergies. None of these were present prior to the shots.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Diplegia, Electroencephalogram, Electromyogram, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillain-Barre Syndrome; hospitalized twice for 5 days requiring 15 units of IV GAMUNEX-C (IgG). Requiring PT/wheelchair -- both legs remain paralyzed from knees down.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Wheelchair user
Clinical narrative: Guillain-Barre Syndrome; hospitalized twice for 5 days requiring 15 units of IV GAMUNEX-C (IgG). Requiring PT/wheelchair -- both legs remain paralyzed from knees down.
Sex: M
Vaccine: FLU3
Symptoms: Cough, Decreased appetite, Fatigue, Influenza like illness, Malaise
Clinical narrative: This case was reported by a physician (also the subject and a GSK employee) and described the occurrence of influenza like illness in a male subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 October 2011 the subject received a dose of FLUARIX (details unknown). On 23 February 2012, 4 months after vaccination with FLUARIX, the subject experienced influenza like illness, not feeling well, fever, myalgia, fatigue, nausea and decreased appetite and on 26 February 2012, the subject experienced cough, sneezing and "slight" rhinorrhea. At the time of the report, the physician reported having "3 days of fever to 100". At the time of reporting the outcome of the events was unspecified. Follow up received from the physician, also the subject and GSK employee, on 03 April 2012. The physician reported that the events were resolved and noted that they were not serious. The physician stated that the events could have been associated with a lack of efficacy. According to the physician, he was diagnosed with influenza, but the diagnosis was not laboratory confirmed so he could not be certain (possible influenza). The physician stated that if it was influenza, he did not know the strain. This case was assessed as medically serious by GlaxoSmithKline due to the vaccination failure.
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: This case was reported by a physician (also the subject and a GSK employee) and described the occurrence of influenza like illness in a male subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 October 2011 the subject received a dose of FLUARIX (details unknown). On 23 February 2012, 4 months after vaccination with FLUARIX, the subject experienced influenza like illness, not feeling well, fever, myalgia, fatigue, nausea and decreased appetite and on 26 February 2012, the subject experienced cough, sneezing and "slight" rhinorrhea. At the time of the report, the physician reported having "3 days of fever to 100". At the time of reporting the outcome of the events was unspecified. Follow up received from the physician, also the subject and GSK employee, on 03 April 2012. The physician reported that the events were resolved and noted that they were not serious. The physician stated that the events could have been associated with a lack of efficacy. According to the physician, he was diagnosed with influenza, but the diagnosis was not laboratory confirmed so he could not be certain (possible influenza). The physician stated that if it was influenza, he did not know the strain. This case was assessed as medically serious by GlaxoSmithKline due to the vaccination failure.
Sex: M
Vaccine: FLU3
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a physician (also the subject and a GSK employee) and described the occurrence of influenza like illness in a male subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 October 2011 the subject received a dose of FLUARIX (details unknown). On 23 February 2012, 4 months after vaccination with FLUARIX, the subject experienced influenza like illness, not feeling well, fever, myalgia, fatigue, nausea and decreased appetite and on 26 February 2012, the subject experienced cough, sneezing and "slight" rhinorrhea. At the time of the report, the physician reported having "3 days of fever to 100". At the time of reporting the outcome of the events was unspecified. Follow up received from the physician, also the subject and GSK employee, on 03 April 2012. The physician reported that the events were resolved and noted that they were not serious. The physician stated that the events could have been associated with a lack of efficacy. According to the physician, he was diagnosed with influenza, but the diagnosis was not laboratory confirmed so he could not be certain (possible influenza). The physician stated that if it was influenza, he did not know the strain. This case was assessed as medically serious by GlaxoSmithKline due to the vaccination failure.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Disturbance in attention, Fatigue, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: (L) upper arm - redness around entire upper arm - swollen - pt. is tired, unable to concentrate and leg pain bilaterally.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatinine increased, Chills, Headache, Myalgia, Neck pain
Clinical narrative: 11-6-11 Fever/chills, myalgias, neck pain, H/A went to ED on 11-8-11 for evaluation, UTI, increased creat. prerenal (viral syndrome) 11-10-11 admitted to hospital after returned to the ED with acute renal failure/Flu vaccine stimulus for symptoms was indicated, Rx IVP, plasmapheresis, discharged 11-17-11.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Plasmapheresis, Prerenal failure, Pyrexia, Renal failure acute, Urinary tract infection
Clinical narrative: 11-6-11 Fever/chills, myalgias, neck pain, H/A went to ED on 11-8-11 for evaluation, UTI, increased creat. prerenal (viral syndrome) 11-10-11 admitted to hospital after returned to the ED with acute renal failure/Flu vaccine stimulus for symptoms was indicated, Rx IVP, plasmapheresis, discharged 11-17-11.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Urogram, Viral infection
Clinical narrative: 11-6-11 Fever/chills, myalgias, neck pain, H/A went to ED on 11-8-11 for evaluation, UTI, increased creat. prerenal (viral syndrome) 11-10-11 admitted to hospital after returned to the ED with acute renal failure/Flu vaccine stimulus for symptoms was indicated, Rx IVP, plasmapheresis, discharged 11-17-11.