chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Vomiting
Clinical narrative: A non-serious spontaneous report of extreme vomiting has been received from a consumer concerning a 37-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 02-Dec-2009, the patient received H1N1, Intranasal, for an unknown indication. On 03-Dec-2009, the patient experienced severe vomiting for one day. At the time of reporting patient had no symptom. The outcome for the reported adverse events was resolved on 04-Dec-2009.
Age: 30.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent eye administration of H1N1 was received from medical assistant/non-health professional concerning a 30-year-old male. The patient's medical history was not reported. On 05-Jan-2010, a portion of H1N1, Intranasal was inadvertently administered to the patient's eye. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
Age: 18.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: A non-serious spontaneous report of administration to pregnant female was received from a registered nurse/health professional concerning a 18-year-old female. No relevant medical history have been reported for this patient. The obstetrical history includes gravida two and para one. In Jan-2010, after the vaccination, pregnancy test was conducted and it came out to be positive. Her gestation age was six to eight weeks at the time of vaccination. Her EDD was approximately 03-Aug-2010 and LMP was at the end of Oct-2009. No concomitant medications have been reported for this patient. On 05-Jan-2010, the patient received H1N1, Intranasal. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments were not applicable. The outcome of this vaccine exposure during pregnancy was considered resolved. Additional information was received on 19-Jan-2010 and incorporated into the narrative: obstetrical history, gestation age, EDD, LMP and lab information. Other information obtained were reporter's address and title of the reporter.
Age: 39.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of 13 week pregnant woman received a dose of H1N1 LAIV was received from a physician concerning a 39-year-old female. The patient's medical history and obstetrical history was not reported. The patient was 13 weeks pregnant at the time of event. The expected delivery date was approximately 09-Jun-2010. Concomitant medications have not been reported. On 02-Dec-2009, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments were not applicable. The outcome of vaccine exposure during pregnancy was considered resolved. Additional information was received on 11-Jan-2010 and incorporated into the narrative: Expected Delivery Date. Other additional information received: reporter's address.
Age: 49.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Amphetamines, Amphetamines positive, Urine analysis abnormal
Clinical narrative: A non-serious spontaneous report of false positive for amphetamines has been received from a consumer concerning himself, 49-year-old male, subsequent to H1N1, Intranasal. The patient's past medical history was not reported and concomitant medications included ranitidine and other medications for blood pressure. The patient did not use methamphetamine. On 04-Jan-2010, the patient received H1N1, Intranasal, for an unknown indication. On 08-Jan-2010, the patient was tested positive on a urine test for amphetamines. The outcome for the reported adverse event was unknown at the time of reporting.
Age: 48.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Ear pain, Ear pruritus, Headache, Otorrhoea, Pain
Clinical narrative: A non-serious spontaneous report of ear itching, ear aching, fluid in ears, nose sore, aching and stinging over body and head hurting has been received from 48-year-old male patient concerning himself, subsequent to H1N1, Intranasal. Neither medical history nor concomitant medications have been reported for this patient. On an unknown date in Dec-2009, the patient received H1N1, Intranasal for an unknown indication. On 11-Jan-2010, the patient developed ear itching, ear aching. The patient went to hospital and they said that he had fluid in ears, aching and stinging over body, head hurting and nose sore. The outcome of the events was unknown.
Age: 48.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Rhinalgia
Clinical narrative: A non-serious spontaneous report of ear itching, ear aching, fluid in ears, nose sore, aching and stinging over body and head hurting has been received from 48-year-old male patient concerning himself, subsequent to H1N1, Intranasal. Neither medical history nor concomitant medications have been reported for this patient. On an unknown date in Dec-2009, the patient received H1N1, Intranasal for an unknown indication. On 11-Jan-2010, the patient developed ear itching, ear aching. The patient went to hospital and they said that he had fluid in ears, aching and stinging over body, head hurting and nose sore. The outcome of the events was unknown.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Wrong drug administered
Clinical narrative: A non-serious spontaneous report of inadvertently gave H1N1 to a patient who was recently diagnosed with asthma was received from a physician concerning a 33-month-old male. The patient was a known case of asthma. In Dec-2009, the patient was administered H1N1, Intranasal. Then the patient was diagnosed with asthma and on 11-Jan-2010, the patient received booster dose of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Nausea, Pain, Tremor
Clinical narrative: Pt received FLUZONE on 9-3-10 at approx 11 AM. By 6 pm same day pt suffered from severe nausea, shaking, chills, body aches, weakness. Sx subsided in overnight hours.
Age: 28.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Feeling hot, Fibrin D dimer increased, Hypersensitivity, Laboratory test normal, Oropharyngeal pain
Clinical narrative: A serious report of allergic reaction has been received from a registered nurse concerning herself, a 28-year-old female subsequent to H1N1. The patient's past medical history included allergy to latex, penicillin, and clarithromycin. Concomitant medication was drospirenone (birth control). The patient received H1N1 on 10-Oct-2009. The patient received a total of one dose of H1N1 given on 10-Oct-2009. On 10-Oct-2009, the patient experienced the event of allergic reaction about four hours after receiving H1N1. Her face was tingling (hot and swollen) and subsequently, the sore throat and scratchy throat symptoms developed. She reported that it was an allergic reaction. At 9:00 pm on 10-Oct-2009, she drove herself to the emergency room. At the emergency room, she received diphenhydramine 25 mg and was started on four liters of oxygen. A complete blood count indicated elevated white blood count and elevated d-dimer. Her blood chemistry was normal. A ventilation perfusion scan to rule out pulmonary embolism was negative. She discharged from the emergency room at 5:00 am on 11-Oct-2009. The event of allergic reaction was resolved on an 11-Oct-2009 at 5:00 am. The sponsor assessed the event of allergic reaction to be an important medical event.
Age: 28.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Paraesthesia, Swelling face, Throat irritation, White blood cell count increased
Clinical narrative: A serious report of allergic reaction has been received from a registered nurse concerning herself, a 28-year-old female subsequent to H1N1. The patient's past medical history included allergy to latex, penicillin, and clarithromycin. Concomitant medication was drospirenone (birth control). The patient received H1N1 on 10-Oct-2009. The patient received a total of one dose of H1N1 given on 10-Oct-2009. On 10-Oct-2009, the patient experienced the event of allergic reaction about four hours after receiving H1N1. Her face was tingling (hot and swollen) and subsequently, the sore throat and scratchy throat symptoms developed. She reported that it was an allergic reaction. At 9:00 pm on 10-Oct-2009, she drove herself to the emergency room. At the emergency room, she received diphenhydramine 25 mg and was started on four liters of oxygen. A complete blood count indicated elevated white blood count and elevated d-dimer. Her blood chemistry was normal. A ventilation perfusion scan to rule out pulmonary embolism was negative. She discharged from the emergency room at 5:00 am on 11-Oct-2009. The event of allergic reaction was resolved on an 11-Oct-2009 at 5:00 am. The sponsor assessed the event of allergic reaction to be an important medical event.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Pt developed cellulitis to left upper arm closer to the Axilla. Pt had hx of radiation therapy to throat and lymph nodes (upper portion of body).
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Alanine aminotransferase increased, Anion gap, Anisocytosis, Antineutrophil cytoplasmic antibody positive, Aspartate aminotransferase increased
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Bacterial test positive, Basophil count normal, Basophil percentage decreased, Bilirubin conjugated normal, Bilirubin urine
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin, Blood calcium decreased, Blood chloride normal
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Blood creatinine increased, Blood culture negative, Blood culture positive, Blood glucose increased, Blood grouping
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Blood lactate dehydrogenase increased, Blood magnesium increased, Blood phosphorus decreased, Blood potassium decreased, Blood sodium normal
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Blood urea increased, Blood urine present, Carbon dioxide normal, Culture positive, Culture stool negative
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Culture urine positive, Eosinophil count decreased, Eosinophil percentage decreased, Escherichia test positive, Glucose urine present
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Haematocrit decreased, Haemoglobin decreased, Haemolysis, Haemolytic uraemic syndrome, Helicobacter test negative
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive, Influenza like illness, Laboratory test normal, Lymphocyte count increased
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Lymphocyte morphology abnormal, Lymphocyte percentage decreased, Macrocytosis, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Mean cell volume normal, Metamyelocyte percentage, Microcytosis, Monocyte count increased, Monocyte percentage
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Myelocyte percentage, Neutrophil count increased, Neutrophil percentage increased, Neutrophil toxic granulation present, Nitrite urine present
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Nucleated red cells, Platelet count decreased, Poikilocytosis, Polychromasia, Protein urine present
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell anisocytes present, Red blood cell count decreased, Red blood cell schistocytes present, Red blood cells urine positive, Red cell distribution width increased
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Renal failure acute, Rhesus antibodies positive, Shift to the left, Specific gravity urine normal, Spherocytic anaemia
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: Transfusion, Urine abnormality, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 1.67
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count increased, White blood cell morphology abnormal, White blood cells urine negative, Yersinia test negative, pH urine normal
Clinical narrative: Flu like Symptoms, progressing to acute renal failure as a result of (HUS), only blood and urine samples cultured any trace of E. coli, stool samples have not grown any E. coli bacteria. Test POS for Influenza A.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Shoulder/upper arm pain around injection site.  Trouble with mobility, pain worsens if lying on that side.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspepsia, Erythema, Eye pruritus, Nausea, Oral pruritus
Clinical narrative: Have been intensely itching all over since later in the evening, the day I was administered the flu shot.  Feel nauseous and have had heartburn. Have had hives, and itchy red skin that seems to swell easily upon itching.  Sinuses feel as if they have swollen shut.  I am worried my throat will close-  I keep having the sensation of fullness in my throat. Very itchy mouth, throat, and deep inside my ears.  Eyes, scalp, and even the bottoms of my feet itch.  These symptoms have persisted over the last 2.5 days, and have been worsening and intensifying.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pruritus generalised, Sinus congestion, Swelling, Throat irritation
Clinical narrative: Have been intensely itching all over since later in the evening, the day I was administered the flu shot.  Feel nauseous and have had heartburn. Have had hives, and itchy red skin that seems to swell easily upon itching.  Sinuses feel as if they have swollen shut.  I am worried my throat will close-  I keep having the sensation of fullness in my throat. Very itchy mouth, throat, and deep inside my ears.  Eyes, scalp, and even the bottoms of my feet itch.  These symptoms have persisted over the last 2.5 days, and have been worsening and intensifying.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Urticaria
Clinical narrative: Have been intensely itching all over since later in the evening, the day I was administered the flu shot.  Feel nauseous and have had heartburn. Have had hives, and itchy red skin that seems to swell easily upon itching.  Sinuses feel as if they have swollen shut.  I am worried my throat will close-  I keep having the sensation of fullness in my throat. Very itchy mouth, throat, and deep inside my ears.  Eyes, scalp, and even the bottoms of my feet itch.  These symptoms have persisted over the last 2.5 days, and have been worsening and intensifying.
Age: 59.0
Sex: F
Vaccine: DTP, FLUX
Symptoms: Hypersensitivity, Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site haematoma
Clinical narrative: Injection site started itching as I exited Dr office.  Site was red, hot, swollen and itchy for four days after which I called Dr and was advised to use Benadryl to counter act the allergic reaction..injection site most resembled a gigantic hive...the size of a pancake.  immediate injection site indicated by firm nodule under skin that was tender and itchy.  Today nodule still remains however it is shrinking and no longer tender or itchy.  Welted hive has gone leaving discolored area resembling a bruise.
Age: 59.0
Sex: F
Vaccine: DTP, FLUX
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site started itching as I exited Dr office.  Site was red, hot, swollen and itchy for four days after which I called Dr and was advised to use Benadryl to counter act the allergic reaction..injection site most resembled a gigantic hive...the size of a pancake.  immediate injection site indicated by firm nodule under skin that was tender and itchy.  Today nodule still remains however it is shrinking and no longer tender or itchy.  Welted hive has gone leaving discolored area resembling a bruise.
Age: 59.0
Sex: F
Vaccine: DTP, FLUX
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Injection site started itching as I exited Dr office.  Site was red, hot, swollen and itchy for four days after which I called Dr and was advised to use Benadryl to counter act the allergic reaction..injection site most resembled a gigantic hive...the size of a pancake.  immediate injection site indicated by firm nodule under skin that was tender and itchy.  Today nodule still remains however it is shrinking and no longer tender or itchy.  Welted hive has gone leaving discolored area resembling a bruise.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 40 mm area of redness at injection site, pain to touch
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Flushing, Palpitations, Peripheral coldness
Clinical narrative: racing heart AP 142. skin cold, flushed, chest pain.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Chest X-ray, Dizziness, Electromyogram
Clinical narrative: Original complaint of dizziness/vertigo symptoms on 10/7/10.  Was administered flu shot that day.  Conditions continued to worsen over the next several days.  Returned to physician office on 10/22/10.  Symptoms worse.  Doctor prescribed meclizine for dizziness.  Conditions worsened over next few days.  Prompted another physician visit on 10/26/2010 after being changed over to scopolomine.  10/26 symptoms included headache, tingling feeling in fingers and toes.  Loss of strength in legs and arms.  Numbness in extremities.  MRI of brain was ordered and taken.  Referred to neurologist.  First possible appt was 2/1/2011.  Tuesday, Nov 2 there was a cancellation at neurologist.  I visited him at 9:45am and was subsequently admitted to hospital later that morning.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging brain, Paraesthesia
Clinical narrative: Original complaint of dizziness/vertigo symptoms on 10/7/10.  Was administered flu shot that day.  Conditions continued to worsen over the next several days.  Returned to physician office on 10/22/10.  Symptoms worse.  Doctor prescribed meclizine for dizziness.  Conditions worsened over next few days.  Prompted another physician visit on 10/26/2010 after being changed over to scopolomine.  10/26 symptoms included headache, tingling feeling in fingers and toes.  Loss of strength in legs and arms.  Numbness in extremities.  MRI of brain was ordered and taken.  Referred to neurologist.  First possible appt was 2/1/2011.  Tuesday, Nov 2 there was a cancellation at neurologist.  I visited him at 9:45am and was subsequently admitted to hospital later that morning.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Original complaint of dizziness/vertigo symptoms on 10/7/10.  Was administered flu shot that day.  Conditions continued to worsen over the next several days.  Returned to physician office on 10/22/10.  Symptoms worse.  Doctor prescribed meclizine for dizziness.  Conditions worsened over next few days.  Prompted another physician visit on 10/26/2010 after being changed over to scopolomine.  10/26 symptoms included headache, tingling feeling in fingers and toes.  Loss of strength in legs and arms.  Numbness in extremities.  MRI of brain was ordered and taken.  Referred to neurologist.  First possible appt was 2/1/2011.  Tuesday, Nov 2 there was a cancellation at neurologist.  I visited him at 9:45am and was subsequently admitted to hospital later that morning.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Dizziness, Headache
Clinical narrative: Felt light-headed which then became a headache, lots of joint pain in the hips, knees, and hands. Also had a cough.  No treatment, symptoms disappeared in the morning after night sleep.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Antinuclear antibody, Antiphospholipid antibodies, Blood immunoglobulin G, Blood test, Borrelia test
Clinical narrative: Slight fever, muscles sore, headache, mild red rash on cheeks and neck, feeling tired and sleepy.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Computerised tomogram, Fatigue, Full blood count, Headache, Mononucleosis heterophile test
Clinical narrative: Slight fever, muscles sore, headache, mild red rash on cheeks and neck, feeling tired and sleepy.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Myalgia, Pyrexia, Rash erythematous, Somnolence, Streptococcus test
Clinical narrative: Slight fever, muscles sore, headache, mild red rash on cheeks and neck, feeling tired and sleepy.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: White blood cell count
Clinical narrative: Slight fever, muscles sore, headache, mild red rash on cheeks and neck, feeling tired and sleepy.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Area of injection hurt for about 2 weeks.  Approx. a week after injection, shoulder pain began and worsened over time.  Can't raise arm above shoulder level.  Very painful to move.  Can't reach behind back, or high overhead.
Age: 49.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Pruritus generalised, Rash, Rash generalised
Clinical narrative: skin rash and itching entire body
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pain in extremity, Pruritus generalised, Pyrexia, Rash
Clinical narrative: Very sore arm at first; 12 hours later fever, chills, red rash and itching over the entire body, Benadryl administered 24 hours after shot received.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Eye discharge, Headache, Hiccups, Insomnia
Clinical narrative: Headache, Fever, Body Aches, Drainage from eyes, dry cough, hard to lift left arm where shot was given. These symptoms went away the next day (Friday 11/12/2010), but a lymph node has now swelled in my neck on the left side, same side the shot was given on.  Also, had strange hiccups, like no other, wake me during the night Friday 11/12/2010.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy, Mobility decreased, Pain, Pyrexia
Clinical narrative: Headache, Fever, Body Aches, Drainage from eyes, dry cough, hard to lift left arm where shot was given. These symptoms went away the next day (Friday 11/12/2010), but a lymph node has now swelled in my neck on the left side, same side the shot was given on.  Also, had strange hiccups, like no other, wake me during the night Friday 11/12/2010.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Palpitations, Panic attack
Clinical narrative: Almost like a panic attack. Heart racing and light headed. Did not contact doctor until today but have not gotten phone call back.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Dizziness, Vomiting
Clinical narrative: Dizziness and repeated vomiting lasting 6 hours
Age: 1.01
Sex: M
Vaccine: FLUX, HEPA, UNK
Symptoms: Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: Our Child had a 103 degree fever at 7 PM.  Took over 17 hours to reduce to normal.  Treated with Acetaminophen every 4 hours and with Ibuprofen every 6 hours.  At injection site on arm is red and inflamed 27 hours later.
Age: 0.79
Sex: F
Vaccine: MMR, YF
Symptoms: Rash morbilliform
Clinical narrative: Morbilliform rash starting on forehead and then becoming generalized by 13NOV2010.
Age: 33.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Adverse reaction, Arthralgia, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Body aches, joint pain, soreness at site, small red spot (size of a nickel) beginning around 8-10pm.  Temp of 100.1F next morning (11/10) at 8am.  Severe pain in arm in morning of 11/10 with continued body aches.  Redness at site approximately 2 inches in diameter.  Notified doctor and she told me what to be on the lookout for.  Still in severe pain all over body through the night.  Morning of 11/11, redness at site now covers the entire width of upper arm.  Fever of 102.5F at 8am.  Notified doctor.  She called in prescription for cephalexin 250mg and took first pill at 4pm.  Patient also had a previously scheduled CT Scan on 11/11 and pre medicates with Prednisone to combat a sensitivity to contrast dye.  The Prednisone taken at 12pm actually helped alleviate symptoms from vaccine reaction.  Cephalexin taken every 8 hrs along with Advil 600mg.  Still sore during 11/12.  Now it is 2:45pm on Saturday, 11/13.  Pain somewhat less. Site is still red across the width of upper arm.  Redness has been warm to the touch ever since symptoms began.
Age: 33.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Body aches, joint pain, soreness at site, small red spot (size of a nickel) beginning around 8-10pm.  Temp of 100.1F next morning (11/10) at 8am.  Severe pain in arm in morning of 11/10 with continued body aches.  Redness at site approximately 2 inches in diameter.  Notified doctor and she told me what to be on the lookout for.  Still in severe pain all over body through the night.  Morning of 11/11, redness at site now covers the entire width of upper arm.  Fever of 102.5F at 8am.  Notified doctor.  She called in prescription for cephalexin 250mg and took first pill at 4pm.  Patient also had a previously scheduled CT Scan on 11/11 and pre medicates with Prednisone to combat a sensitivity to contrast dye.  The Prednisone taken at 12pm actually helped alleviate symptoms from vaccine reaction.  Cephalexin taken every 8 hrs along with Advil 600mg.  Still sore during 11/12.  Now it is 2:45pm on Saturday, 11/13.  Pain somewhat less. Site is still red across the width of upper arm.  Redness has been warm to the touch ever since symptoms began.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Similar reaction on previous exposure to drug, Syncope
Clinical narrative: Patient left from behind screen and went to sit in the waiting area and immediately became dizzy then she fainted.  At this time her mother said she has passed out before after receiving a vaccination.  We called 911 and she refused to go to the hospital.  When she left, she had regained her color and could stand and sit without being dizzy.  Both mother and patient said she was fine.
Age: 32.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Chills, Cough, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: sore throat, cough, high fever with violent chills, muscle aches, headache
Age: 32.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Pyrexia
Clinical narrative: sore throat, cough, high fever with violent chills, muscle aches, headache
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Epistaxis, Myalgia, Pyrexia, Vomiting
Clinical narrative: Epistaxis, and 8 days of fever, myalgia, cough, and, emesis, concerning for actual contraction of Influenza, versus concomitant flu-like illness by coincidence.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Croup infectious, Pyrexia, Rhinorrhoea, Streptococcus test negative
Clinical narrative: Fever of 102 Croup cough Runny nose
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Aphonia, Cough, Pyrexia, Rhinorrhoea, Streptococcus test negative
Clinical narrative: Swollen tonsills  Fever of 102 Runny nose Cough Loss of voice
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Tonsillar disorder
Clinical narrative: Swollen tonsills  Fever of 102 Runny nose Cough Loss of voice
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Back pain, Body temperature increased, Cellulitis, Chills
Clinical narrative: On Wed 11/3/2010 received pneumonia vaccination in left arm and flu vaccination in right arm. The flu vaccine was drawn up in front of me.  However, the pneumonia vaccination was not, but already drawn. Assistant came in room and gave injection.  Woke up Thursday morning with 103.2 fever, chills, mild ache in arm, lower back ache, weakness, dizziness. Started ibuprofen.  Was in bed Thursday afternoon through Saturday am. Saturday work up with pain in injection site, redness and hardness in site and patches of red hot skin on my arm with temp of 101.8. Injection site and bicep area became worse, spreading to elbow area.  Called her on call physician called me back at 3:43 pm.    Explained all signs and symptoms.  Advised to use warm compresses/ibuprofen.  If worse on the next day I was to go to walk in clinic or ER.  Sunday am went to Urgent Care who gave me an antibiotic injection (? name) and prescribed Bactrim DS po bid.  Started Bactrim DS Sunday night.  Much worse on Monday evening.  Went to Medical Center, admitted that evening for Advanced cellulitis and infected hematoma at injection site.  Treated with Rocephin IV and then vancomycin IV in emergency room. Received vancomycin IV two times day, with last dose on Friday, 11/12/2010 approx 11am.    Discharged on Friday, 11/12/2010.  Treated by Dr. in hospital.  Now taking Bactrim DS bid for a ten day course.   Still have hematoma, sore site area, fatigue.   Have follow up apt with Dr on 11/24.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Erythema, Fatigue, Injection site erythema, Injection site haematoma
Clinical narrative: On Wed 11/3/2010 received pneumonia vaccination in left arm and flu vaccination in right arm. The flu vaccine was drawn up in front of me.  However, the pneumonia vaccination was not, but already drawn. Assistant came in room and gave injection.  Woke up Thursday morning with 103.2 fever, chills, mild ache in arm, lower back ache, weakness, dizziness. Started ibuprofen.  Was in bed Thursday afternoon through Saturday am. Saturday work up with pain in injection site, redness and hardness in site and patches of red hot skin on my arm with temp of 101.8. Injection site and bicep area became worse, spreading to elbow area.  Called her on call physician called me back at 3:43 pm.    Explained all signs and symptoms.  Advised to use warm compresses/ibuprofen.  If worse on the next day I was to go to walk in clinic or ER.  Sunday am went to Urgent Care who gave me an antibiotic injection (? name) and prescribed Bactrim DS po bid.  Started Bactrim DS Sunday night.  Much worse on Monday evening.  Went to Medical Center, admitted that evening for Advanced cellulitis and infected hematoma at injection site.  Treated with Rocephin IV and then vancomycin IV in emergency room. Received vancomycin IV two times day, with last dose on Friday, 11/12/2010 approx 11am.    Discharged on Friday, 11/12/2010.  Treated by Dr. in hospital.  Now taking Bactrim DS bid for a ten day course.   Still have hematoma, sore site area, fatigue.   Have follow up apt with Dr on 11/24.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site infection, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: On Wed 11/3/2010 received pneumonia vaccination in left arm and flu vaccination in right arm. The flu vaccine was drawn up in front of me.  However, the pneumonia vaccination was not, but already drawn. Assistant came in room and gave injection.  Woke up Thursday morning with 103.2 fever, chills, mild ache in arm, lower back ache, weakness, dizziness. Started ibuprofen.  Was in bed Thursday afternoon through Saturday am. Saturday work up with pain in injection site, redness and hardness in site and patches of red hot skin on my arm with temp of 101.8. Injection site and bicep area became worse, spreading to elbow area.  Called her on call physician called me back at 3:43 pm.    Explained all signs and symptoms.  Advised to use warm compresses/ibuprofen.  If worse on the next day I was to go to walk in clinic or ER.  Sunday am went to Urgent Care who gave me an antibiotic injection (? name) and prescribed Bactrim DS po bid.  Started Bactrim DS Sunday night.  Much worse on Monday evening.  Went to Medical Center, admitted that evening for Advanced cellulitis and infected hematoma at injection site.  Treated with Rocephin IV and then vancomycin IV in emergency room. Received vancomycin IV two times day, with last dose on Friday, 11/12/2010 approx 11am.    Discharged on Friday, 11/12/2010.  Treated by Dr. in hospital.  Now taking Bactrim DS bid for a ten day course.   Still have hematoma, sore site area, fatigue.   Have follow up apt with Dr on 11/24.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Skin warm
Clinical narrative: On Wed 11/3/2010 received pneumonia vaccination in left arm and flu vaccination in right arm. The flu vaccine was drawn up in front of me.  However, the pneumonia vaccination was not, but already drawn. Assistant came in room and gave injection.  Woke up Thursday morning with 103.2 fever, chills, mild ache in arm, lower back ache, weakness, dizziness. Started ibuprofen.  Was in bed Thursday afternoon through Saturday am. Saturday work up with pain in injection site, redness and hardness in site and patches of red hot skin on my arm with temp of 101.8. Injection site and bicep area became worse, spreading to elbow area.  Called her on call physician called me back at 3:43 pm.    Explained all signs and symptoms.  Advised to use warm compresses/ibuprofen.  If worse on the next day I was to go to walk in clinic or ER.  Sunday am went to Urgent Care who gave me an antibiotic injection (? name) and prescribed Bactrim DS po bid.  Started Bactrim DS Sunday night.  Much worse on Monday evening.  Went to Medical Center, admitted that evening for Advanced cellulitis and infected hematoma at injection site.  Treated with Rocephin IV and then vancomycin IV in emergency room. Received vancomycin IV two times day, with last dose on Friday, 11/12/2010 approx 11am.    Discharged on Friday, 11/12/2010.  Treated by Dr. in hospital.  Now taking Bactrim DS bid for a ten day course.   Still have hematoma, sore site area, fatigue.   Have follow up apt with Dr on 11/24.
Age: 67.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Cough, Dermatitis allergic, Dysphonia, Fatigue, Headache
Clinical narrative: Coughing, tightness in throat, headache, hoarness, heavy phlegm production and fatigue and a fever and on Sat 10/30/2010 I went to Dr. with an Allergic Rash reaction. Dr. prescribed Methylprednisolone. Had a fever of 100.6f. Rash started to lighten within 2 hrs of taking Prednisone Flu symptoma lasted until 11/13/2010.
Age: 67.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Hypersensitivity, Increased upper airway secretion, Influenza, Pyrexia, Throat tightness
Clinical narrative: Coughing, tightness in throat, headache, hoarness, heavy phlegm production and fatigue and a fever and on Sat 10/30/2010 I went to Dr. with an Allergic Rash reaction. Dr. prescribed Methylprednisolone. Had a fever of 100.6f. Rash started to lighten within 2 hrs of taking Prednisone Flu symptoma lasted until 11/13/2010.
Age: 57.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Erythema, Nasopharyngitis, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: I got my flu vaccine at the pharmacy dept of a grocery store. I left right away & before I got out of the door my arm started itching. By the time I got home my arm was swollen & very painful. I had a large swollen area of about 3" by 5" an my arm was red & hot to the touch.  The pain & swelling lasted about 10 days. On 10/14 about 6 p.m. I started running a fever and had cold symptoms for 48 hrs. After that I felt better.
Age: 57.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Pyrexia, Skin warm
Clinical narrative: I got my flu vaccine at the pharmacy dept of a grocery store. I left right away & before I got out of the door my arm started itching. By the time I got home my arm was swollen & very painful. I had a large swollen area of about 3" by 5" an my arm was red & hot to the touch.  The pain & swelling lasted about 10 days. On 10/14 about 6 p.m. I started running a fever and had cold symptoms for 48 hrs. After that I felt better.
Age: 35.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Headache, Influenza like illness, Pain, Pyrexia, Upper respiratory tract infection
Clinical narrative: Within two hours of the shot I started getting flu like symptoms which progressed from headache to body aches to fever to a week long severe upper respiratory infection.  One week later I am still feverish and am still experiencing flu like symptoms.  My husband and children who have been very close to me since the time of the shot have no symptoms at all.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Eye swelling, Ocular hyperaemia, Pruritus, Rash
Clinical narrative: Woke up w/red swollen eyes.  After shower began scratching and notices raised skin.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Anxiety, Injection site induration, Injection site pain, Pruritus
Clinical narrative: My mind just feels like it's in a state of constant anxiety.  I know where I am but it doesn't feel real. I am afraid to drive anywhere. My arm hurt really bad at the injection site on Wed. and improved on Thursday.  Today is Sat. 11/13 and my upper arm has a hard lump underneath the skin and gets itchy but not bad.  I still feel really unsettled though.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Dehydration, Diarrhoea, Lethargy, Pyrexia, Rash
Clinical narrative: Suffered from what seemed like a stomach virus with vomiting and diarrhea. Symptoms would stop and then high fever started (102.8). Fever subsided. Vomiting and diarrhea came back. Next day a raised red rash appeared over face and arms. Went away during the day, came back at night. Next night it was itchy. He's lethargic and dehydrated. No one will deal with the rash or discuss the possibility that it is connected to the vaccine. Given at the same time as a Hep A vaccine. As of today, six days later he still has the rash reappearing at night.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash erythematous, Rash pruritic, Vomiting
Clinical narrative: Suffered from what seemed like a stomach virus with vomiting and diarrhea. Symptoms would stop and then high fever started (102.8). Fever subsided. Vomiting and diarrhea came back. Next day a raised red rash appeared over face and arms. Went away during the day, came back at night. Next night it was itchy. He's lethargic and dehydrated. No one will deal with the rash or discuss the possibility that it is connected to the vaccine. Given at the same time as a Hep A vaccine. As of today, six days later he still has the rash reappearing at night.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of congestion and running fever was received from a consumer concerning a five-year-old female patient subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 03-Oct-2009. On 04-Oct-2009 the patient began experiencing congestion and on 05-Oct-2009 was running a fever. No further information was provided. The events of congestion and running a fever were ongoing.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: A non-serious, spontaneous report of fever, headaches and threw up multiple times has been received from a consumer concerning a 40-month-old female, subsequent to H1N1, Intranasal. Neither medical history nor concomitant medications were reported. The patient received H1N1, Intranasal on 02-Oct-2009 at 4:30 PM. On 03-Oct-2009 between eight and nine AM the patient experienced fever, headaches and threw up multiple times. The vomit was described as thick, yellow liquid. The patient did not require medical attention and on an unknown date the patient recovered from the symptoms of fever, headache and throwing up.
Age: 61.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious, spontaneous report of 61 Year Old was inadvertently administered novel H1N1 was received from a nurse regarding a 61-year-old female patient following H1N1, Intranasal. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Age: 22.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: A non-serious spontaneous report of gave the full dose in just one nostril was received from a patient/health professional concerning herself who is a 22-years-old female. Patient had no relevant medical history. The patient was taking oral contraceptive pills. On 12-Oct-2009 the patient received 0.2ml of H1N1, Intranasal in a single nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved. Additional information was received on 16-Dec-2009 and incorporated into the narrative : Reporter's status, medical history, concomitant medication, patient's health status, no adverse events, update facility address and name.
Age: 54.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of man over 49 years of age got nasal pandemic influenza 2009 was received from a registered nurse concerning a 54-year-old male, subsequent to H1N1, Intranasal. The patient neither had past medical history nor was on any concomitant medications. On 13-Oct-2009, the patient received the vaccine for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 17-Dec-2009 and incorporated into the narrative: reporter information, patient's medical history, concomitant medications and confirmation of other adverse event occurrence besides vaccination error.
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of H1N1 over 49 year of age was received from a registered nurse/health professional concerning a male adult patient. The patient did not have any medical history and was not on any concomitant medications. On 13-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved. Additional information was received on 17-Dec-2009 and incorporated into the narrative: medical history, concomitant medications and reporter's type.
Age: 57.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of H1N1 to a 58-year-old female patient has been received from a pharmacist concerning a 57-year-old female. The patient did not have any medical history and was not taking any concomitant medications. On 13-Oct-2009, the patient received H1N1, Intranasal, for an unknown indication. Since the vaccination the patient has remained healthy and well. She never developed any adverse symptoms or flu-like illness. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved. Additional information was received on 16-Dec-2009 and incorporated into the narrative: date of birth (age), medical history and concomitant medications and current health status of the patient. Also received information on name and contact number of the vaccine administrator.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of two doses of the H1N1 Intranasal vaccine has been received from a physician concerning a seven-year-old female subsequent to the administration of H1N1. Relevant medical history and concomitant medications were not reported. On 04-Oct-2009, the patient received H1N1. On 09-Oct-2009, she received a second dose of H1N1. According to the clinic, the patient's mother had checked "no" on the item for "received vaccine within the last 30 days". The patient's nose was irrigated by the clinic physician after the second dose. There was no adverse event associated with this vaccination error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.