chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Discomfort, Injection site rash, Irritability, Rash
Clinical narrative: 01/25/2011:  PC from mother. Child woke up with a "hive-like" rash this am around the injection site on the left leg, her mouth, on her chest, around her umbilicus, and behind her knees.  Mother says the rash looks like "chickenpox".   Mother called Dr. who instructed her to call here because client recieved her 2nd flu vaccine on 1-21-11.  Child received Flumist on 11-15-10 without any problems.  Child has been "whiny" this past weekend, but afebrile.  Denies itching to rash.  Rash is the "size of a pencil eraser to double that size and raised, but without a head."  Child has appt. to see Dr. at 10:45 today.  Mother thinks child has received flu shots in the past years, but knows that she did not receive any H1N1 or flu shot last year.  Denies any allergies for child.  Mother instructed to talk with Dr. to evaluate the rash and if child is to receive further flu shots in the future.  Mother v/u. 01/26/2011:  PC; child seen by Dr. yesterday; given prescription for Prelone 15 mg/5ml po daily x5 days.  Rash is better, except for mouth.  Rash extends down chin on both sides and child complains of discomfort under chin where she got 4 stitches on 12-18-10.  Child not drinking or eating any better today.   No previous flu shots at doctor's office. Reports medical resident said child's tonsils were enlarged.  Dr. said rash could be from a viral infection or from the flu injection.  Mother reports runny nose and croupy cough 2 days after Flumist; afebile; no rash.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Tonsillar hypertrophy, Urticaria
Clinical narrative: 01/25/2011:  PC from mother. Child woke up with a "hive-like" rash this am around the injection site on the left leg, her mouth, on her chest, around her umbilicus, and behind her knees.  Mother says the rash looks like "chickenpox".   Mother called Dr. who instructed her to call here because client recieved her 2nd flu vaccine on 1-21-11.  Child received Flumist on 11-15-10 without any problems.  Child has been "whiny" this past weekend, but afebrile.  Denies itching to rash.  Rash is the "size of a pencil eraser to double that size and raised, but without a head."  Child has appt. to see Dr. at 10:45 today.  Mother thinks child has received flu shots in the past years, but knows that she did not receive any H1N1 or flu shot last year.  Denies any allergies for child.  Mother instructed to talk with Dr. to evaluate the rash and if child is to receive further flu shots in the future.  Mother v/u. 01/26/2011:  PC; child seen by Dr. yesterday; given prescription for Prelone 15 mg/5ml po daily x5 days.  Rash is better, except for mouth.  Rash extends down chin on both sides and child complains of discomfort under chin where she got 4 stitches on 12-18-10.  Child not drinking or eating any better today.   No previous flu shots at doctor's office. Reports medical resident said child's tonsils were enlarged.  Dr. said rash could be from a viral infection or from the flu injection.  Mother reports runny nose and croupy cough 2 days after Flumist; afebile; no rash.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chromosome analysis normal, Drug exposure during pregnancy, Foetal heart rate abnormal, Intra-uterine death, Retained products of conception
Clinical narrative: 01/04/2011 12:45 PM: Visited OBGYN for 12 week pregnancy check up.  Heard baby's heartbeat.  All was good and healthy.  Instructed by Nurse Practioner to get flu shot.  01/04/2011 6:30pm I received the FLUZONE 2010-11 Vial .5ml.  On 01/05/2011 10:00 AM I had a standard ultrasound test and there was no heartbeat.  On 01/07/2011 I had a D and C.  As of 01/26/2011 the uterus is still bleeding.  An ultrasound was performed on 01/24/2011  at 1:40 PM and it was determined that there is blood, blood clots and remaining tissue.  A second D and C is scheduled for tomorrow 01/27/2011 at 2 PM.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Thrombosis, Ultrasound antenatal screen abnormal, Ultrasound uterus abnormal, Uterine dilation and curettage, Uterine haemorrhage
Clinical narrative: 01/04/2011 12:45 PM: Visited OBGYN for 12 week pregnancy check up.  Heard baby's heartbeat.  All was good and healthy.  Instructed by Nurse Practioner to get flu shot.  01/04/2011 6:30pm I received the FLUZONE 2010-11 Vial .5ml.  On 01/05/2011 10:00 AM I had a standard ultrasound test and there was no heartbeat.  On 01/07/2011 I had a D and C.  As of 01/26/2011 the uterus is still bleeding.  An ultrasound was performed on 01/24/2011  at 1:40 PM and it was determined that there is blood, blood clots and remaining tissue.  A second D and C is scheduled for tomorrow 01/27/2011 at 2 PM.
Age: 25.0
Sex: F
Vaccine: DTP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: I realized while at work the next day (1/25/11) that my arm, where the shot was administered, was swollen in the shape of a band aid.  I kept taking Tylenol & even took Advil that night to ease the pain, and applied an ice pack that night, but I could not sleep on my right side due to the swelling and pain. I realized the next morning (1/26/11) that the area was red and swollen even higher and wider than it was before. I then called the PCP's office to see if this was normal, or if I needed to be seen again.  I went to the dr's office and saw Dr. who advised I may have an infection and prescribed antibiotics and hot compresses.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Crying, Pyrexia
Clinical narrative: Inconsolable crying for 3 hours fever 101.7 for 24 hours.
Age: 1.33
Sex: M
Vaccine: FLU3, HIBV, PNC13
Symptoms: Blood test normal, Culture negative, Febrile convulsion, Heart rate increased, Heart rate irregular
Clinical narrative: Patient was a healthy 16 month old boy when he went in for his 'well baby' visit to his pediatrician on Friday, January 14th, 2011. At 9:30am he was healthy and fever free, so he has his 15 month shots and the flu shot, as recommended by the doctor. 12 hours later he developed a fever of 105.1,had a febrile seizure & was rushed to the ER in an ambulance. His heart rate was over 250 bpm!!!!! The fever was treated with MOTRIN & TYLENOL, and about 2 hours later he was 101f, however his heart rate was still irregular and much too fast -approx 180 - at rest. He was admitted to the hospital, for 2 days. He had many, many test done -urine, blood, 24 and 48 hours cultures, flu test, etc but all tests were negative. We went home on Sunday despite no diagnosis. I saw the doctor on Monday & Wed but no symptoms of illness since the fever and heart rate went down in the hospital. I am very concerned that my son had an adverse reaction to the flu shot.
Age: 1.33
Sex: M
Vaccine: FLU3, HIBV, PNC13
Symptoms: Influenza virus test negative, Laboratory test normal, Pyrexia, Urine analysis normal
Clinical narrative: Patient was a healthy 16 month old boy when he went in for his 'well baby' visit to his pediatrician on Friday, January 14th, 2011. At 9:30am he was healthy and fever free, so he has his 15 month shots and the flu shot, as recommended by the doctor. 12 hours later he developed a fever of 105.1,had a febrile seizure & was rushed to the ER in an ambulance. His heart rate was over 250 bpm!!!!! The fever was treated with MOTRIN & TYLENOL, and about 2 hours later he was 101f, however his heart rate was still irregular and much too fast -approx 180 - at rest. He was admitted to the hospital, for 2 days. He had many, many test done -urine, blood, 24 and 48 hours cultures, flu test, etc but all tests were negative. We went home on Sunday despite no diagnosis. I saw the doctor on Monday & Wed but no symptoms of illness since the fever and heart rate went down in the hospital. I am very concerned that my son had an adverse reaction to the flu shot.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac enzymes normal, Cardioactive drug level decreased, Chest X-ray normal, Computerised tomogram normal, Dizziness
Clinical narrative: September 11, 2010: Patient reports to hospital with fatigue and lower extremity weakness and numbness. He had been having headache and felt lightheaded for "the past couple days." It was reported that patient received the flu vaccine two weeks prior at a pharmacy. Neuro ordered IVIG and plasmapheresis. Pt received two treatments of IVIG and deteriorated then plateaued. Pt was discharged with a diagnosis of HTN with treatment.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram normal, Fatigue, Haematocrit decreased, Haemoglobin normal, Headache
Clinical narrative: September 11, 2010: Patient reports to hospital with fatigue and lower extremity weakness and numbness. He had been having headache and felt lightheaded for "the past couple days." It was reported that patient received the flu vaccine two weeks prior at a pharmacy. Neuro ordered IVIG and plasmapheresis. Pt received two treatments of IVIG and deteriorated then plateaued. Pt was discharged with a diagnosis of HTN with treatment.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, International normalised ratio increased, Laboratory test normal, Muscular weakness, Neurological examination
Clinical narrative: September 11, 2010: Patient reports to hospital with fatigue and lower extremity weakness and numbness. He had been having headache and felt lightheaded for "the past couple days." It was reported that patient received the flu vaccine two weeks prior at a pharmacy. Neuro ordered IVIG and plasmapheresis. Pt received two treatments of IVIG and deteriorated then plateaued. Pt was discharged with a diagnosis of HTN with treatment.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Platelet count normal, Scan brain, Troponin, Ultrasound Doppler
Clinical narrative: September 11, 2010: Patient reports to hospital with fatigue and lower extremity weakness and numbness. He had been having headache and felt lightheaded for "the past couple days." It was reported that patient received the flu vaccine two weeks prior at a pharmacy. Neuro ordered IVIG and plasmapheresis. Pt received two treatments of IVIG and deteriorated then plateaued. Pt was discharged with a diagnosis of HTN with treatment.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: White blood cell count increased
Clinical narrative: September 11, 2010: Patient reports to hospital with fatigue and lower extremity weakness and numbness. He had been having headache and felt lightheaded for "the past couple days." It was reported that patient received the flu vaccine two weeks prior at a pharmacy. Neuro ordered IVIG and plasmapheresis. Pt received two treatments of IVIG and deteriorated then plateaued. Pt was discharged with a diagnosis of HTN with treatment.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site pain
Clinical narrative: On Jan 15, 2011 pt exhibited severe dizziness and she was prescribed Meclizine. Also arm began to hurt where shot was given and it still hurts today 21 days later.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Breast swelling, Chest pain, Dyspnoea, Injection site erythema, Oedema peripheral
Clinical narrative: Chest pain, short of breath, axillary swelling, (L) breast swelling, erythema at injection site x 4 days.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Started next day, lg red, hard, warm area to (L) upper arm.
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash erythematous, Rash morbilliform
Clinical narrative: Measles rash - fine red raised rash to bilat. cheeks et posterior trunk.
Age: 48.0
Sex: F
Vaccine: MMR, TD
Symptoms: Burning sensation, Rash erythematous, Skin discolouration
Clinical narrative: Shots given noon a couple hours later arm felt burning that evening arm developed red rashy areas. Applied cortisone cream next morning blackened areas appeared on left arm and (L) lateral torso.
Age: 1.83
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Incorrect dose administered, Urticaria, Vaccination complication
Clinical narrative: Child received 0.5cc dose of FLUZONE instead of 0.25cc appropriate for age. Mother informed of vaccine error at time of visit on 12/2/10. On 12/3/10 at 5:30pm red welts began on legs and then hives on top of them. Used hydrocortisone but hives spread to arms, hands, neck within 30 minutes. Went to Emergency. Doctor told mother it was an allergic reaction to vaccine. Prescribed Prednisone & BENADRYL for 3 days. Symptoms gone after 4th dose of meds.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Pt developed severe pain 10/10 and swelling at injection site, pt states pain started soon after injection and got much worse from day of injection. Pt given Methylprednisolone Pak and TYLENOL #3.
Age: 0.94
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Body temperature increased, Erythema, Rash erythematous
Clinical narrative: 1-24-11 Vaccinated approx 11am. Taken home and after nap woke with temp approx 102 degrees. Reduces after med. Fluctuating temps (highest 102 degrees) but fine red rash appeared on stomach. Contacted health dept: report filed.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh with redness and swelling. Warm to the touch.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Rash, Rash generalised
Clinical narrative: Within 5 minutes of VARIVAX subcut -> 10 cm splotchy red area on thigh with hot center - given BENADRYL & observed rash continued to spread to trunk & face.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash macular
Clinical narrative: Within 5 minutes of VARIVAX subcut -> 10 cm splotchy red area on thigh with hot center - given BENADRYL & observed rash continued to spread to trunk & face.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: Patients mother called office to report pain/swelling at injection site. States golf ball size area of redness. Instructed to ice 20 min. on/20 min. off 6-8 times a day and take Ibuprofen as directed on bottle. If no improvement in 24hrs to call family doctor.
Age: 56.0
Sex: F
Vaccine: FLU3, PNC, TDAP, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Approx. 5 hrs after imms she began experiencing severe pain in (R) arm from shoulder all the way down to the tip of her fingers. Is unable to lift arm above her head. Denies redness or swelling at inj. sites. Advised to see MD for f/u. Pt agrees to plan of care.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Right leg red to touch swollen & itchy.
Age: 1.78
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Abasia, Crying, Injected limb mobility decreased, Injection site pain
Clinical narrative: Recd IZ on 1/25/11. 5 hrs. later MOC reports he couldn't move legs or walk. Painful, cried all night better 1/26, still sore to touch - (R) leg.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth over large area of right deltoid
Age: 29.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Cellulitis, Chills, Erythema, Injected limb mobility decreased, Malaise
Clinical narrative: Initial report was received on 19 January 2011 from another manufacturer, report number WAES 1010USA01329. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information had been received from a Registered Nurse concerning a 29 year old female patient with asthma, seasonal allergy and codeine allergy who on 27-Sep-2010 was vaccinated in the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665707-1407Y) (Expiration date: 12-Jun-2011). On 27-Sep-2010, the patient also received a dose of BOOSTRIX in the left deltoid and a dose of FLUZONE in the right deltoid. The nurse reported that on 29-Sep-2010, the patient reported sore left arm, which was difficult to raise, area of arm was red, warm and tender. She had a fever, chills and malaise (reported as mailse). The patientwas seen by physician on 29-Sep-2010, on30-Sep-2010 and on 01-Oct-2010. Physician gave patient 1 gram of REOCEPHIN at each visit. Physician also prescribed patient AUGMENTIN to be taken orally for 10 days. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from the registered nurse. It was reported that on 07-Sep-2010 the patient with no birth defects was vaccinated with the first dose of PNEUMOVAX 23 (Lot# 665707-1407Y) in the left deltoid. On the same date the patient received a dose BOOSTRIX into the left deltoid and a dose of influenza virus vaccine (unspecified) into the right arm. At the time of vaccination the patient presented asthma. On 28-Sep-2010 the patient developed red, warm and very sore left arm after the injections. The patient was diagnosed with cellulitis. The patient required 3 daily doses of ROCEPHIN 1 gram IM and AUGMENTIN 85 mg BID for 10 days to resolve. On an unspecified the date the patient recovered. Cellulitis was considered to be other important medical event by the registered nurse. Follow up information has been received from a registered nurse who indicated that the patient was a 29 year old housewife with allergic rhinitis who on 27-Sep-2010 was vaccinated IM with the first dose of BOOSTRIX (lot # AC52BO51AB) in the left deltoid and a dose of FLUZONE (lot # UF201AA) in the right deltoid. On 28-Sep-2010, the patient's left arm became red, warm and very tender. A diagnosis of cellulitis of the left arm was done. An IM dose of ROCEPHIN and AUGMENTIN oral were given on 29-Sep-2010. A second dose of ROCEPHIN was given on 30-Sep-2010 cellulitis had increased. On 01-Oct-2010, the patient was feeling better, a third dose of ROCEPHIN was given. The patient recovered on 02-Oct-2010. The patient required doctor visit. No further information is available. Note: The reported lot number is invalid for a sanofi pasteur FLUZONE product. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Pain in extremity, Pyrexia, Skin warm, Tenderness
Clinical narrative: Initial report was received on 19 January 2011 from another manufacturer, report number WAES 1010USA01329. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information had been received from a Registered Nurse concerning a 29 year old female patient with asthma, seasonal allergy and codeine allergy who on 27-Sep-2010 was vaccinated in the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665707-1407Y) (Expiration date: 12-Jun-2011). On 27-Sep-2010, the patient also received a dose of BOOSTRIX in the left deltoid and a dose of FLUZONE in the right deltoid. The nurse reported that on 29-Sep-2010, the patient reported sore left arm, which was difficult to raise, area of arm was red, warm and tender. She had a fever, chills and malaise (reported as mailse). The patientwas seen by physician on 29-Sep-2010, on30-Sep-2010 and on 01-Oct-2010. Physician gave patient 1 gram of REOCEPHIN at each visit. Physician also prescribed patient AUGMENTIN to be taken orally for 10 days. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from the registered nurse. It was reported that on 07-Sep-2010 the patient with no birth defects was vaccinated with the first dose of PNEUMOVAX 23 (Lot# 665707-1407Y) in the left deltoid. On the same date the patient received a dose BOOSTRIX into the left deltoid and a dose of influenza virus vaccine (unspecified) into the right arm. At the time of vaccination the patient presented asthma. On 28-Sep-2010 the patient developed red, warm and very sore left arm after the injections. The patient was diagnosed with cellulitis. The patient required 3 daily doses of ROCEPHIN 1 gram IM and AUGMENTIN 85 mg BID for 10 days to resolve. On an unspecified the date the patient recovered. Cellulitis was considered to be other important medical event by the registered nurse. Follow up information has been received from a registered nurse who indicated that the patient was a 29 year old housewife with allergic rhinitis who on 27-Sep-2010 was vaccinated IM with the first dose of BOOSTRIX (lot # AC52BO51AB) in the left deltoid and a dose of FLUZONE (lot # UF201AA) in the right deltoid. On 28-Sep-2010, the patient's left arm became red, warm and very tender. A diagnosis of cellulitis of the left arm was done. An IM dose of ROCEPHIN and AUGMENTIN oral were given on 29-Sep-2010. A second dose of ROCEPHIN was given on 30-Sep-2010 cellulitis had increased. On 01-Oct-2010, the patient was feeling better, a third dose of ROCEPHIN was given. The patient recovered on 02-Oct-2010. The patient required doctor visit. No further information is available. Note: The reported lot number is invalid for a sanofi pasteur FLUZONE product. Documents held by sender: none.
Age: 1.42
Sex: M
Vaccine: FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: On the day of the vaccine, patient spiked a fever (104.7). He had a temperature on and off until 10/08/10. On 10/08/10, patient had a 2 min. seizure, and was brought by ambulance to Hospital, where they diagnosed him with a febrile seizure. He had had high fevers prior to 10/08/10 and has had high fevers since that time, but had never had a seizure prior to 10/08/10 and has not had another one since.
Age: 34.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Flushing, Migraine, Muscle spasms, Tremor
Clinical narrative: Flushing, Migraine occurred almost immediately after injection. Within 24 hours, severe muscle spasms, tremors, weakness, and continued migraine.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Lip swelling, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever to 103, subjectively swollen lips, coughing and wheezing resolving without treatment, myalgias, malaise.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Fever to 103, subjectively swollen lips, coughing and wheezing resolving without treatment, myalgias, malaise.
Age: 0.76
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, C-reactive protein increased, Electroencephalogram normal, Febrile convulsion, Nuclear magnetic resonance imaging normal
Clinical narrative: 1530-infant experienced a seizure. 1630-brought to health unit, temp 103.1 axillary. Hospitalized 1/14/11-1/18/11 diagnosed with febrile seizure. No further incident reported.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Dizziness, Feeling abnormal, Heart rate increased, Pallor
Clinical narrative: rapid heart beat, pale, weak, dizzy, just didn't feel right
Age: 1.25
Sex: M
Vaccine: DTAP, DTAPIPVHIB, FLU3
Symptoms: Chest X-ray, Convulsion, Febrile convulsion, Full blood count, Pyrexia
Clinical narrative: Fever of 103.7 and seizure Ambulance to hospital diagnosed with febrile seizure - gave Tylenol and Motrin
Age: 70.0
Sex: F
Vaccine: TD
Symptoms: Muscle mass, Myalgia
Clinical narrative: Pt. states that she developed a "muscle" in her arm. She states it feels like a knot. Pt. states the knot feels it is about 2 inches. Pt. states it feels sore but not painful. Pt. denies redness or it being hot to the touch.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; time unknown - wife called provider to inform of reaction
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome
Clinical narrative: Progressive ascending weakness two wks after receiving flu shot per hospital records (GUILLAIN BARRE).
Age: 44.0
Sex: M
Vaccine: HEPAB
Symptoms: Migraine
Clinical narrative: 1/24/11 TC from pt c/o severe migraine H/A's taking ADVIL with relief. Pt stated he never had this H/A's before & it started after injection. Pt stated he went online & read possible adverse reaction is severe H/A's.
Age: 5.0
Sex: M
Vaccine: FLU3, IPV
Symptoms: Abasia, Confusional state, Dysstasia, Encephalitis viral, Gaze palsy
Clinical narrative: blurred vision, confusion, room spinning  fever  excessive sweating  left side facial drooping  glazed eyes (rolling up ) altered mental status, unable to stand/walk vomiting
Age: 5.0
Sex: M
Vaccine: FLU3, IPV
Symptoms: Hyperhidrosis, Mental status changes, Pyrexia, VIIth nerve paralysis, Vertigo
Clinical narrative: blurred vision, confusion, room spinning  fever  excessive sweating  left side facial drooping  glazed eyes (rolling up ) altered mental status, unable to stand/walk vomiting
Age: 5.0
Sex: M
Vaccine: FLU3, IPV
Symptoms: Vision blurred, Vomiting
Clinical narrative: blurred vision, confusion, room spinning  fever  excessive sweating  left side facial drooping  glazed eyes (rolling up ) altered mental status, unable to stand/walk vomiting
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Developed hives on the upper bilateral cheeks and bilateral face, temple area, forehead.  Had red, raised blotchy spots.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth in the upper arm where the injection was administered. The arm is also sore. Patient also experienced head and body aches starting the day after receiving the vaccine. She had a temperature of 99.3 degrees the evening after receiving the vaccine, but no fever since.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Redness, swelling and warmth in the upper arm where the injection was administered. The arm is also sore. Patient also experienced head and body aches starting the day after receiving the vaccine. She had a temperature of 99.3 degrees the evening after receiving the vaccine, but no fever since.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: redness and warmth at site of injection, rash in a circular pattern
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient has a raised red bump on her right deltoid about the size of a normal plantar wart.  Area around the bump did not appear to be infected.  Patient said yesterday was the first time the patient noticed any signs. Patient said the bump did not hurt, was not hot, and did not irritate her in any way.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Pain to injection site and pain with movement. Went to Er. Was given pain medication.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1), TDAP
Symptoms: Arthralgia, Arthritis, Blood test, Carpal tunnel decompression, Joint stiffness
Clinical narrative: I received the following: Tdap-09/09/09, then seasonal flu on 09/17/09, then H1N1 on 10/26/09. I began having stiffness in both wrists in November, excruciating pain by January 2010 in both wrists and hands, carpal tunnel surgery x2, March all large joints became stiff, inflamed, and swollen. Being treated with methotrexate and prednisone for possible seronegative RA.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1), TDAP
Symptoms: Joint swelling, Neurological examination, Nuclear magnetic resonance imaging, Pain in extremity, Surgery
Clinical narrative: I received the following: Tdap-09/09/09, then seasonal flu on 09/17/09, then H1N1 on 10/26/09. I began having stiffness in both wrists in November, excruciating pain by January 2010 in both wrists and hands, carpal tunnel surgery x2, March all large joints became stiff, inflamed, and swollen. Being treated with methotrexate and prednisone for possible seronegative RA.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1), TDAP
Symptoms: X-ray
Clinical narrative: I received the following: Tdap-09/09/09, then seasonal flu on 09/17/09, then H1N1 on 10/26/09. I began having stiffness in both wrists in November, excruciating pain by January 2010 in both wrists and hands, carpal tunnel surgery x2, March all large joints became stiff, inflamed, and swollen. Being treated with methotrexate and prednisone for possible seronegative RA.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Eye pruritus, Headache, Ocular hyperaemia
Clinical narrative: Coughing, shortness of breath, eyes itch, red, and goopy, mouth tingling, throat feeling swollen, tongue little swollen, headache, body aches, sore all over.  Doctor said to take Benadryl now and at bedtime.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia oral, Pharyngeal oedema, Swollen tongue
Clinical narrative: Coughing, shortness of breath, eyes itch, red, and goopy, mouth tingling, throat feeling swollen, tongue little swollen, headache, body aches, sore all over.  Doctor said to take Benadryl now and at bedtime.
Age: 2.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. 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. The subject's vaccine history included 4 doses of TRIPEDIA: lot number U1751BA received on 20 April 2007, lot number U1751BA received on 20 June 2007, lot number U2290BA received on 21 August 2007, and lot number U2470BA received on 10 March 2009 (route and site of administration not reported). Approximately 21 months after the last dose, the subject developed a paroxysmal cough on 25 November 2010. The subject also developed symptoms of cold-like illness, posttussive vomiting, apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 07 December 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 14 December 2010. The subject was not hospitalized. At the time of final contact on 20 December 2010, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. 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. The subject's vaccine history included 4 doses of TRIPEDIA: lot number U1751BA received on 20 April 2007, lot number U1751BA received on 20 June 2007, lot number U2290BA received on 21 August 2007, and lot number U2470BA received on 10 March 2009 (route and site of administration not reported). Approximately 21 months after the last dose, the subject developed a paroxysmal cough on 25 November 2010. The subject also developed symptoms of cold-like illness, posttussive vomiting, apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 07 December 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 14 December 2010. The subject was not hospitalized. At the time of final contact on 20 December 2010, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. 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. The subject's vaccine history included 4 doses of TRIPEDIA: lot number U1751BA received on 20 April 2007, lot number U1751BA received on 20 June 2007, lot number U2290BA received on 21 August 2007, and lot number U2470BA received on 10 March 2009 (route and site of administration not reported). Approximately 21 months after the last dose, the subject developed a paroxysmal cough on 25 November 2010. The subject also developed symptoms of cold-like illness, posttussive vomiting, apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 07 December 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 14 December 2010. The subject was not hospitalized. At the time of final contact on 20 December 2010, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. 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. The subject's vaccine history included 4 doses of TRIPEDIA: lot number U1751BA received on 20 April 2007, lot number U1751BA received on 20 June 2007, lot number U2290BA received on 21 August 2007, and lot number U2470BA received on 10 March 2009 (route and site of administration not reported). Approximately 21 months after the last dose, the subject developed a paroxysmal cough on 25 November 2010. The subject also developed symptoms of cold-like illness, posttussive vomiting, apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 07 December 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 14 December 2010. The subject was not hospitalized. At the time of final contact on 20 December 2010, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC
Symptoms: Influenza
Clinical narrative: Initial report received from a health care professional on 18 January 2011. A 6 month-old male patient with no known allergies, and current medical condition of GERD for which he takes ZANTAC, had received on 20 December 2010 a first left thigh dose of FLUZONE (lot number UT3619AA), and a dose of PENTACEL, HEP B (manufacturer unknown), PREVNAR (Wyeth) and ROTATEQ (Merck), lot numbers not reported. At the end of the week of January 14 2011, the patient was diagnosed with Influenza B. The patient required a physician visit, however treatments received were not reported. Recovery status was not reported. Documents held by sender: None.
Age: 68.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Cyanosis, Fatigue, Hypoaesthesia, Injection site pain, Nausea
Clinical narrative: Other company reference number: WAES 1012USA03034. Initial information received from another company on 19 January 2011. The following information is verbatim from the other company's report: "Information has been received from a pharmacist concerning a 68 year old male patient who on approximately 06 December 2010 ("last week") was vaccinated with a a dose of flu vaccine (manufacturer unknown) in the right arm, and zoster vaccine live (Merck) in the left arm. On the same day the patient experienced radiating pain on the right side where the flu vaccine (manufacturer unknown) had been administered. Then it became pain all over the body. The patient called his pharmacist, explained the pain and stated that his extremities became blue. The pharmacist advised the patient to call 911. The 911 team provided the patient with oxygen and from then on he was feeling better. The patient decided not to go to the hospital. On the same day the patient recovered. Radiating pain on the right side/pain all over the body and extremities became blue were considered to be important medical events by the reporter. Follow-up information received from the pharmacist stated that the patient's concomitant medications were the following: MICARDIS and metoprolol for hypertension, simvastatin for cholesterol and vitamin D (unspecified). The patient also had implantable defibrillator. On 13 December 2010, the patient received zoster vaccine live (Merck) (lot number 665525/0695Z) and virus split virion 3v vaccine inactivated), lot # 43631AA). In the evening of 13 December 2010, the patient reported to the pharmacy that he had tingling and numbness. On 14 December 2010, the patient reported that he was nauseous and his hands turned "purple". Emergency services, (911) was notified and the patient was administered oxygen. The patient refused to go to the hospital. On 15 December 2010, the pharmacy contacted the patient by telephone. The patient stated that he felt better but felt 'run down'. This is one of several reports from the same source. Additional information has been requested." List of documents held by sender: none.
Age: 68.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: Other company reference number: WAES 1012USA03034. Initial information received from another company on 19 January 2011. The following information is verbatim from the other company's report: "Information has been received from a pharmacist concerning a 68 year old male patient who on approximately 06 December 2010 ("last week") was vaccinated with a a dose of flu vaccine (manufacturer unknown) in the right arm, and zoster vaccine live (Merck) in the left arm. On the same day the patient experienced radiating pain on the right side where the flu vaccine (manufacturer unknown) had been administered. Then it became pain all over the body. The patient called his pharmacist, explained the pain and stated that his extremities became blue. The pharmacist advised the patient to call 911. The 911 team provided the patient with oxygen and from then on he was feeling better. The patient decided not to go to the hospital. On the same day the patient recovered. Radiating pain on the right side/pain all over the body and extremities became blue were considered to be important medical events by the reporter. Follow-up information received from the pharmacist stated that the patient's concomitant medications were the following: MICARDIS and metoprolol for hypertension, simvastatin for cholesterol and vitamin D (unspecified). The patient also had implantable defibrillator. On 13 December 2010, the patient received zoster vaccine live (Merck) (lot number 665525/0695Z) and virus split virion 3v vaccine inactivated), lot # 43631AA). In the evening of 13 December 2010, the patient reported to the pharmacy that he had tingling and numbness. On 14 December 2010, the patient reported that he was nauseous and his hands turned "purple". Emergency services, (911) was notified and the patient was administered oxygen. The patient refused to go to the hospital. On 15 December 2010, the pharmacy contacted the patient by telephone. The patient stated that he felt better but felt 'run down'. This is one of several reports from the same source. Additional information has been requested." List of documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Dysgeusia, Hypoaesthesia facial, Lip swelling, Oedema peripheral
Clinical narrative: Initial report was received on 18 and 20 January 2011 from a health care professional. This case represents one of a cluster of 4 patients from the same reporter, same vaccine, same lot number, and who experienced adverse events requiring emergency room visits after receiving FLUZONE HIGH-DOSE on different dates. One patient was hospitalized. Information regarding the patient who was hospitalized is reported in case number 2010-01674; information regarding the other 2 patients are reported in cases 2011-00251, and 2011-00252. A 48 year-old female patient, who had concurrent illnesses of malaise and anemia had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE (lot number U3726AA) on 13 October 2010. At an unspecified amount of time later, she experienced extremely strong metallic taste, a scratchy throat, face felt a little numb, lips were tingling, she was "swelly", bottom of lip looked swollen, and her face was swelling. The patient required a doctor visit only (emergency room visit was not mentioned) and was advised to get evaluation for allergic reaction to flu shot. Treatment received was not reported. The patients medical history included: no known drug allergies, active menorrhagia, rheumatoid arthritis, major depressive disorder, recurrent episode, unspecified degree, fibromyalgia, fatigue and malaise, and hyperlipidemia (NOS). Patient had post-operative OBGYN appointment on 11 January 2011 (reason not identified). Patient stated she had 5 prior influenza vaccinations in the past with no reactions. The patient recovered, but a recovery date was not provided. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Postoperative care, Swelling face, Throat irritation
Clinical narrative: Initial report was received on 18 and 20 January 2011 from a health care professional. This case represents one of a cluster of 4 patients from the same reporter, same vaccine, same lot number, and who experienced adverse events requiring emergency room visits after receiving FLUZONE HIGH-DOSE on different dates. One patient was hospitalized. Information regarding the patient who was hospitalized is reported in case number 2010-01674; information regarding the other 2 patients are reported in cases 2011-00251, and 2011-00252. A 48 year-old female patient, who had concurrent illnesses of malaise and anemia had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE (lot number U3726AA) on 13 October 2010. At an unspecified amount of time later, she experienced extremely strong metallic taste, a scratchy throat, face felt a little numb, lips were tingling, she was "swelly", bottom of lip looked swollen, and her face was swelling. The patient required a doctor visit only (emergency room visit was not mentioned) and was advised to get evaluation for allergic reaction to flu shot. Treatment received was not reported. The patients medical history included: no known drug allergies, active menorrhagia, rheumatoid arthritis, major depressive disorder, recurrent episode, unspecified degree, fibromyalgia, fatigue and malaise, and hyperlipidemia (NOS). Patient had post-operative OBGYN appointment on 11 January 2011 (reason not identified). Patient stated she had 5 prior influenza vaccinations in the past with no reactions. The patient recovered, but a recovery date was not provided. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Developed erythematous, pruritic swelling to L arm which started 2 hours after injection.  Area was 2 inches in diameter.  Cold pack and Ibuprofen for relief.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Hypoaesthesia, Pain, Swelling
Clinical narrative: SWELLING, REDNESS, NUMBNESS, PAIN
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Neuralgia, Pain, Paralysis, VIIth nerve paralysis
Clinical narrative: Patient states he woke up on 11/26/10 with left side of face paralyzed. Called 911 thinking of stroke. Brought to Hospital via rescue. Worked up for stroke. Final diagnosis Bell's Palsy (Neuralgia). Started on Acyclovir and Prednisone, later developed severe pain and was started on Lyrica.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Rash, Tachycardia
Clinical narrative: Allergic reaction - tachycardia, weakness, rash.  Patient sent to outside clinic for further evaluation.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Acne, Anxiety, Blood prolactin increased, Blood testosterone increased, Cardiac stress test normal
Clinical narrative: Out of body, heart palpitation, extreme depression & anxiety. Chills/sweats. Fear of dying. Feeling that I'm on a mind altering drug. Feel the need to urinate, but didn't need to. Doctors say I had a panic attack for bout 30 mins. The next 3 months I had these episodes on a daily basis, doctors were calling them panic attacks. I have no history of panic attacks or anything mentioned above. The attacks stopped after 3 months but the palpitations never stopped, I have them all day everyday.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Depression, Dissociation, Electrocardiogram normal, Fear of death
Clinical narrative: Out of body, heart palpitation, extreme depression & anxiety. Chills/sweats. Fear of dying. Feeling that I'm on a mind altering drug. Feel the need to urinate, but didn't need to. Doctors say I had a panic attack for bout 30 mins. The next 3 months I had these episodes on a daily basis, doctors were calling them panic attacks. I have no history of panic attacks or anything mentioned above. The attacks stopped after 3 months but the palpitations never stopped, I have them all day everyday.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Micturition urgency, Nuclear magnetic resonance imaging brain normal, Palpitations, Panic attack
Clinical narrative: Out of body, heart palpitation, extreme depression & anxiety. Chills/sweats. Fear of dying. Feeling that I'm on a mind altering drug. Feel the need to urinate, but didn't need to. Doctors say I had a panic attack for bout 30 mins. The next 3 months I had these episodes on a daily basis, doctors were calling them panic attacks. I have no history of panic attacks or anything mentioned above. The attacks stopped after 3 months but the palpitations never stopped, I have them all day everyday.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan normal, Ventricular extrasystoles
Clinical narrative: Out of body, heart palpitation, extreme depression & anxiety. Chills/sweats. Fear of dying. Feeling that I'm on a mind altering drug. Feel the need to urinate, but didn't need to. Doctors say I had a panic attack for bout 30 mins. The next 3 months I had these episodes on a daily basis, doctors were calling them panic attacks. I have no history of panic attacks or anything mentioned above. The attacks stopped after 3 months but the palpitations never stopped, I have them all day everyday.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Pain in extremity, Paraesthesia
Clinical narrative: subjective feeling of weakness tingling of anterior leg thigh and dorsa of foot  pain in thighs
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: sore throat, fever, chills, body aches, cough, fatigue
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Macule, Temperature intolerance, Tenderness
Clinical narrative: Red macules, induration and tenderness without fluctuance, uncomfortable with heat per patient.