chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ocular hyperaemia, Oculorespiratory syndrome, Oropharyngeal pain
Clinical narrative: Initial case received from a registered nurse on 16 October 2009. It was reported that another patient at the same facility experienced similar events after receiving FLUZONE from a different lot number (U3211AA). The events for the other patient are captured in case number 2009-04382. An adult male patient developed oculorespiratory syndrome after receiving an injection of FLUZONE (lot number U3213AA). At an unspecified time post-vaccination, the patient complained of red eyes, sore throat, and cough. He subsequently recovered. No additional information was provided. Additional information received on 21 December 2009 from a nurse practitioner. The patient, a 48 year old female (previously reported as a male) had received on 14 October 2009 an intramuscular left deltoid injection of FLUZONE. Event onset date was reported as 14 October 2009, five hours post-vaccination. She recovered on an unspecified date. The patient's medical history included a drug allergy to AUGMENTIN. She was taking Enalapril concomitantly. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ocular hyperaemia, Oculorespiratory syndrome, Oropharyngeal pain, Similar reaction on previous exposure to drug
Clinical narrative: Initial case received from a registered nurse on 16 October 2009. It was reported that two patients at the same facility experienced similar events after receiving FLUZONE from a different lot number (U3213AA). This case is regarding an adult male. The events for the other patient are captured in case number 2009-04383. An adult male patient developed occulorespiratory syndrome after receiving an injection of FLUZONE (lot number U3211AA). At an unspecified time post-vaccination, the patient complained of red eyes, sore throat, and cough. He subsequently recovered. No additional information was provided. Follow-up information received from a health care professional on 21 December 2009. The patient was a 40-year-old female patient, not adult male as previously reported. She had received the FLUZONE (lot number U3211AA) on 13 October 2009 at 12:30pm, intramuscular in the left deltoid. This was the first dose of FLUZONE the patient had received. Three hours post vaccination at 15:30 pm (also reported as 4 hours later), she developed occulorespiratory syndrome. No relevant diagnostic tests or laboratory data were completed/performed. The patient had no concurrent illnesses, pre-existing medical conditions, or use of other medications at the time of vaccination. She had not experienced any adverse events with prior vaccinations. The patient subsequently recovered (date not reported). Follow-up information was received 12 May 2010 from a health care professional who reported that no treatment was required for the event and that the patient recovered after 24 hours. Documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Oedema peripheral
Clinical narrative: Initial report received on 19 October 2009 from a health care professional. A female patient (age not specified) complained of arm and lymph node swelling after receiving FLUZONE (lot number U3200AA) intramuscularly (site and number of previous doses not reported). Recovery status was unknown. No further information was provided. The patient was 55 years old, and had not received any other vaccinations within four weeks of receiving FLUZONE. She was seen by her health care provider several days after vaccination; the health care provider did not feel that the symptoms were related to the vaccine. No treatment was given, and the patient recovered. List of Documents held by Sender: none. This case has the same reporter as case number 2009-04391.
Age: 1.75
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Initial report received 21 October 2009 from a health care professional.  A 21-month-old male patient with no pre-existing medical conditions had received a third dose intramuscular injection of FLUZONE SV 2009-2010 (lot number U3211AA) on 13 October 2009 at 18:00 hours, and 24 hours later (also reported as 14 October 2009 at 18:00 hours), he developed a non tender, irregular red area which extended from the left thigh to the groin.  The reporter indicated that the event required a doctor's visit or an emergency room visit.  The reporter also recorded the date 15 October 2009 in box 8 of the VAERS form; however it was unclear what this date represents.  No laboratory or diagnostic testing had been performed.  At the time of the report, the patient's recovery status was unknown.  Follow-up information received on 16 November 2009 from a healthcare professional.  On 15 October 2009, the patient was seen in the doctor's office with the symptoms of the reaction.  No treatment was prescribed.  The irregular red area persisted for five days.  The patient recovered on 20 October 2009.  Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Eye swelling, Pallor, Pruritus, Swollen tongue, Tachycardia
Clinical narrative: A non-serious spontaneous report of swollen tongue, tachycardia, pale on appearance, itching, swollen eyes and hives has been received from a nurse who is the patient concerning a 32-year-old female subsequent to H1N1 2009 Monovalent Vaccine.  The patient's past medical history includes allergies to naproxen, sulfa, bee and wasp stings (reaction anaphylaxis) and no allergies to eggs.  She carries an epinephrine injection.  Concomitant medications included venlafaxine and recent FLUMIST vaccination with no reported events.  The patient received H1N1 2009 Monovalent Vaccine on 23-Oct-2009 nasally.  On 23-Oct-2009 at 10:30 AM the patient received H1N1 2009 Monovalent Vaccine.  At noon, the patient noted hives on her trunk, itching and swelling in the back of her tongue.  She was seen by a local physician who also noted the patient was pale on appearance and experiencing tachycardia.  The patient took diphenhydramine 75 milligrams oral and went home.  The patient stated her symptoms improved but reoccurred at 7:00 PM and now she developed swelling of the eyes.  She took another 50 milligrams of diphenhydramine at 11:00 PM and went to bed.  The following morning on 24-Oct-2009 the symptoms remained but were not as severe.  By that evening all the symptoms has resolved.  On 24-Oct-2009 all the events had resolved.
Age: 32.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Urticaria
Clinical narrative: A non-serious spontaneous report of swollen tongue, tachycardia, pale on appearance, itching, swollen eyes and hives has been received from a nurse who is the patient concerning a 32-year-old female subsequent to H1N1 2009 Monovalent Vaccine.  The patient's past medical history includes allergies to naproxen, sulfa, bee and wasp stings (reaction anaphylaxis) and no allergies to eggs.  She carries an epinephrine injection.  Concomitant medications included venlafaxine and recent FLUMIST vaccination with no reported events.  The patient received H1N1 2009 Monovalent Vaccine on 23-Oct-2009 nasally.  On 23-Oct-2009 at 10:30 AM the patient received H1N1 2009 Monovalent Vaccine.  At noon, the patient noted hives on her trunk, itching and swelling in the back of her tongue.  She was seen by a local physician who also noted the patient was pale on appearance and experiencing tachycardia.  The patient took diphenhydramine 75 milligrams oral and went home.  The patient stated her symptoms improved but reoccurred at 7:00 PM and now she developed swelling of the eyes.  She took another 50 milligrams of diphenhydramine at 11:00 PM and went to bed.  The following morning on 24-Oct-2009 the symptoms remained but were not as severe.  By that evening all the symptoms has resolved.  On 24-Oct-2009 all the events had resolved.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Initial report received on 16 November 2009 from a health care professional. A 7 year old male patient developed a red and "circumferentially swollen" arm from his shoulder to his elbow 24 hours after receiving a first time dose of H1N1 (lot number was unknown) on an unknown date. The reporter stated that the vaccine may have been given subcutaneously. The reporter declined to provide further information. The recovery status was unknown. Follow-up information received on 08 December 2009 from a health care professional. Patient demographics were provided including date of birth. The patient had no concurrent illnesses at time of vaccination, but was taking concomitant medication of Amoxicillin (indication not reported). Relevant medical conditions include Von Willebrand's bleeding disorder. The patient received the H1N1 in the left deltoid; however, the date of vaccination, lot number and route was not provided. Onset dates of adverse events were not provided. At the time of this report, the patient had recovered; however recovery date was not provided. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Rhinorrhoea, Urticaria
Clinical narrative: A non-serious spontaneous report of urticaria and sniffles has been received from a physician concerning a 17-year-old female, subsequent to H1N1. The patient's medical history included past inactivated flu vaccinations with no reactions. Concomitant medications were not provided. On 26-Oct-2009, the patient received H1N1. On 27-Oct-2009, the patient experienced the sniffles and mild urticaria. The events were ongoing.
Age: 52.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "a 52 year old was administered H1N1 LAIV" was received from a registered nurse concerning a 52-year-old female. The patient's medical history and concomitant medications were not reported. On 28-Oct-2009, the patient was administered H1N1. There was no adverse event associated with this vaccination error; therefore, treatment and causality assessments are not applicable, and the event is considered resolved.
Age: 30.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to pregnant female was received from a physician concerning a 39-year-old female. The patient has no past medical history was not reported and the obstetrical history included gravida three and para two. The patient was 24 weeks pregnant at the time of vaccination. The patient's last menstrual period was 23-Apr-2009 and estimated date of delivery was 28-Jan-2010. Concomitant medications included vitamins. On 26-Oct-2009, the patient received H1N1, Intranasal. The patient delivered vaginally a healthy and normal nine-pound baby boy on 23-Jan-2010. His apgar scores were; seven at one-minute, and ten at five minutes. Both mother and baby remain fine and healthy with no problems. There was no adverse event associated with this pregnancy therefore, treatment and reporter causality assessments are not applicable, and the event of vaccine exposure during pregnancy was resolved. Additional information was received on 11-Nov-2009 and incorporated into the narrative: Gravida, para, last menstrual period, estimated date of delivery was incorporated in the narrative. Additional information was received on 10-Feb-2010 and incorporated into the narrative: EOP date, apgar scores, child weight, gender of child and the outcome of pregnancy.
Age: 39.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of 37 week pregnant woman received vaccine was received from a physician concerning a 39-year-old female. The patient had a history of coccygodynia. Acetaminophen PO, PRN and ibuprofen PO, PRN were prescribed for this condition. During the pregnancy prior to the vaccination the patient had an elevated blood pressure from 33 weeks until the time of her delivery but did not require treatment. Lab tests and urine protein level were within normal limits. The patient received H1N1 vaccine, intranasal on 30-Oct-2009. The estimated date of delivery was 29-Oct-2009. On 04-Nov-2009 the patient delivered a healthy baby boy of normal weight vaginally. At the first week check-up the baby was well, had no problems and was doing great. Post delivery the patient was gravida 8, para 6-0-6-2. 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 resolved. Additional information was received on 11-Nov-2009 and incorporated into the narrative: Medical history, concomitant medication, gravida, para, expected delivery date, actual delivery date, outcome of the pregnancy, type of delivery, condition of newborn. Additional information was received on Reporter's address, phone and fax number.
Age: 28.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Arthralgia
Clinical narrative: A non-serious spontaneous report of joint pain in lower legs, arms and shoulder has been received from a registered nurse concerning a 28-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 26-Oct-2009, the patient received H1N1, Intranasal for an unspecified indication. On 31-Oct-2009, the patient developed symptoms of joint pain in lower legs, arms and shoulder. Patient was seen by physician and prescribed acetaminophen around the clock. At the time of report, the patient was still having pain. The outcome of the reported events was not resolved.
Age: 35.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Caesarean section, Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of gave H1N1 mist to 16 week pregnant patient was received from a registered nurse/health professional concerning a 35-year-old female, subsequent to H1N1, Intranasal. The patient had no prior medical history and was not ill at the time of vaccination. She had received no other vaccinations. The patient's obstetrical history included gravida four and para four. The patient's LMP date was 10-Jun-2009 and EDD date was 23-Apr-2010. She was 16 weeks pregnant at the time of report. No concomitant medications have been reported for this patient. On 12-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. From 09-Apr-2010 to 12-Apr-2010, she applied terconazole vaginal cream for an unknown indication. On 14-Apr-2010, she gave live birth to a normal female child. The mode of delivery was cesarean. Resuscitation was not necessary. The patient did not experience any medical complication during pregnancy. The child's gestational age was 39 weeks, wt: 8 lbs 7 oz, length: 22 inch, Head circumference: 14 inch, Apgar score at one minute: eight and Apgar score at five minute: nine. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The outcome of the event of vaccine exposure during pregnancy was considered to be resolved. Additional information was received on 28-Apr-2010 and incorporated into the narrative: Medical and obstetrical history, other  medication taken, LMP and EDD dates, Pregnancy outcome and child information. Other information was received on 28-Apr-2010: reporter name and address, vaccinated at and vaccine purchased with.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Blood product transfusion, CSF protein increased, Condition aggravated, Differential white blood cell count abnormal, Dizziness
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No Preservative 2009-2010 (lot number U3173CA) and H1N1 2009 Monovalent Vaccine - Preservative (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, hypothyroidism, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following events were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, lips, and tongue. Diagnostic laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96 (H), CBC/WBC 11.0 Thous (H), MPV 11.0 FL (H), Neut 82.5% (H), Lymph 15.3% (L), Mono 1.2% (L), Eos 0.7% (L), Neut ABS 9.1 (H), Chemistry (result not reported). The patient was diagnosed with Guillain-Bare syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exotosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Dysaesthesia, Dysarthria, Dysgeusia, Eosinophil percentage decreased, Exostosis
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No Preservative 2009-2010 (lot number U3173CA) and H1N1 2009 Monovalent Vaccine - Preservative (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, hypothyroidism, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following events were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, lips, and tongue. Diagnostic laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96 (H), CBC/WBC 11.0 Thous (H), MPV 11.0 FL (H), Neut 82.5% (H), Lymph 15.3% (L), Mono 1.2% (L), Eos 0.7% (L), Neut ABS 9.1 (H), Chemistry (result not reported). The patient was diagnosed with Guillain-Bare syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exotosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Headache, Hypertension, Hypoaesthesia
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No Preservative 2009-2010 (lot number U3173CA) and H1N1 2009 Monovalent Vaccine - Preservative (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, hypothyroidism, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following events were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, lips, and tongue. Diagnostic laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96 (H), CBC/WBC 11.0 Thous (H), MPV 11.0 FL (H), Neut 82.5% (H), Lymph 15.3% (L), Mono 1.2% (L), Eos 0.7% (L), Neut ABS 9.1 (H), Chemistry (result not reported). The patient was diagnosed with Guillain-Bare syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exotosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Laboratory test, Lymphocyte count decreased, Mean platelet volume increased, Monocyte percentage decreased, Neutrophil count increased
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No Preservative 2009-2010 (lot number U3173CA) and H1N1 2009 Monovalent Vaccine - Preservative (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, hypothyroidism, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following events were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, lips, and tongue. Diagnostic laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96 (H), CBC/WBC 11.0 Thous (H), MPV 11.0 FL (H), Neut 82.5% (H), Lymph 15.3% (L), Mono 1.2% (L), Eos 0.7% (L), Neut ABS 9.1 (H), Chemistry (result not reported). The patient was diagnosed with Guillain-Bare syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exotosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Neutrophil percentage increased, Nuclear magnetic resonance imaging abnormal, Oral dysaesthesia, Paraesthesia, Thyroxine free increased
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No Preservative 2009-2010 (lot number U3173CA) and H1N1 2009 Monovalent Vaccine - Preservative (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, hypothyroidism, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following events were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, lips, and tongue. Diagnostic laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96 (H), CBC/WBC 11.0 Thous (H), MPV 11.0 FL (H), Neut 82.5% (H), Lymph 15.3% (L), Mono 1.2% (L), Eos 0.7% (L), Neut ABS 9.1 (H), Chemistry (result not reported). The patient was diagnosed with Guillain-Bare syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exotosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: CSF protein increased, Condition aggravated, Dizziness, Dysaesthesia, Dysarthria
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No Preservative 2009-2010 (lot number U3173CA) and H1N1 2009 Monovalent Vaccine - Preservative (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, hypothyroidism, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following events were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, lips, and tongue. Diagnostic laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96 (H), CBC/WBC 11.0 Thous (H), MPV 11.0 FL (H), Neut 82.5% (H), Lymph 15.3% (L), Mono 1.2% (L), Eos 0.7% (L), Neut ABS 9.1 (H), Chemistry (result not reported). The patient was diagnosed with Guillain-Bare syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exotosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Dysgeusia, Eosinophil percentage decreased, Full blood count abnormal, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No Preservative 2009-2010 (lot number U3173CA) and H1N1 2009 Monovalent Vaccine - Preservative (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, hypothyroidism, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following events were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, lips, and tongue. Diagnostic laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96 (H), CBC/WBC 11.0 Thous (H), MPV 11.0 FL (H), Neut 82.5% (H), Lymph 15.3% (L), Mono 1.2% (L), Eos 0.7% (L), Neut ABS 9.1 (H), Chemistry (result not reported). The patient was diagnosed with Guillain-Bare syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exotosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Headache, Hypertension, Hypoaesthesia, Immunoglobulin therapy, Laboratory test
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No Preservative 2009-2010 (lot number U3173CA) and H1N1 2009 Monovalent Vaccine - Preservative (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, hypothyroidism, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following events were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, lips, and tongue. Diagnostic laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96 (H), CBC/WBC 11.0 Thous (H), MPV 11.0 FL (H), Neut 82.5% (H), Lymph 15.3% (L), Mono 1.2% (L), Eos 0.7% (L), Neut ABS 9.1 (H), Chemistry (result not reported). The patient was diagnosed with Guillain-Bare syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exotosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Lymphocyte percentage decreased, Mean platelet volume increased, Monocyte percentage decreased, Neutrophil count increased, Neutrophil percentage increased
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No Preservative 2009-2010 (lot number U3173CA) and H1N1 2009 Monovalent Vaccine - Preservative (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, hypothyroidism, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following events were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, lips, and tongue. Diagnostic laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96 (H), CBC/WBC 11.0 Thous (H), MPV 11.0 FL (H), Neut 82.5% (H), Lymph 15.3% (L), Mono 1.2% (L), Eos 0.7% (L), Neut ABS 9.1 (H), Chemistry (result not reported). The patient was diagnosed with Guillain-Bare syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exotosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Oral dysaesthesia, Paraesthesia, Thyroxine free increased, White blood cell count increased
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No Preservative 2009-2010 (lot number U3173CA) and H1N1 2009 Monovalent Vaccine - Preservative (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, hypothyroidism, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following events were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, lips, and tongue. Diagnostic laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96 (H), CBC/WBC 11.0 Thous (H), MPV 11.0 FL (H), Neut 82.5% (H), Lymph 15.3% (L), Mono 1.2% (L), Eos 0.7% (L), Neut ABS 9.1 (H), Chemistry (result not reported). The patient was diagnosed with Guillain-Bare syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exotosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased. Documents held by sender: None.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Adenoidal hypertrophy, Basophil percentage, Blood bicarbonate normal, Blood calcium normal, Blood chloride normal
Clinical narrative: A serious spontaneous report of seizures questionable tonic-clonic and non-serious report of slightly irritable was received from a non-health professional concerning a 26-month-old male, subsequent to H1N1, Intranasal. The patient had heart murmur when he was born. The patient never received flu vaccine before and never experienced seizure. No concomitant medications was taken by the patient. The patient's mother had pituitary tumor and father had a history of colon CA. On the mother's side, the grandfather had intracranial tumor and spinal cancer. There was no family history of seizures. On 25-Oct-2009, the patient received first dose of H1N1, intranasal for an unknown indications. On 27-Oct-2009, the patient was laying on pillow and was shaking from his waist up, it lasted for two minutes and he was out of it. No cyanosis was there. Then patient had another short seizure with five head twitches. The child was taken to the emergency room for evaluation and testing. On 27-Oct-2009, WBC was 11.6 (high) and RBC was 4.26 (low) neutrophils was 24.9 (low) and lymphocytes was 61.2 (high); in basic metabolic panel creatinine was 0.2 (low); chest x-ray was normal; influenza serology test was negative for both A and B and the CT scan of brain without contrast noted the intracranial structures were normal. There was no hemorrhage identified. The lateral ventricles were normal in size. There was no midline displacement. The paranasal sinuses were clear and adenoid hypertrophy was noted. The patient denies any nausea, vomiting or diarrhea, fever or chills, any shortness of breath, respiratory distress or abdominal pain. The patient has had normal urine output and bowel movements. At the time of this report, the patient has had no further seizures. The child has not undergone an electroencephalogram (EEG) at the time of report, because the child was to see the neurologist first, and that appointment was scheduled for an unspecified date in mid Jan-2010. The details of physical examination are attached in the source document. The outcome of the seizures questionable tonic-clonic was resolved and for slightly irritable it was unknown. Additional information was received on 11-Nov-2009 and incorporated into the narrative. Additional information about further evaluation of progression, frequency and outcome of the event and additional scheduled investigation was included. Following additional information was received on 10-Dec-2009 and incorporated into the narrative: patient history and patient's family history, additional adverse event and lab details
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Blood creatinine decreased, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal
Clinical narrative: A serious spontaneous report of seizures questionable tonic-clonic and non-serious report of slightly irritable was received from a non-health professional concerning a 26-month-old male, subsequent to H1N1, Intranasal. The patient had heart murmur when he was born. The patient never received flu vaccine before and never experienced seizure. No concomitant medications was taken by the patient. The patient's mother had pituitary tumor and father had a history of colon CA. On the mother's side, the grandfather had intracranial tumor and spinal cancer. There was no family history of seizures. On 25-Oct-2009, the patient received first dose of H1N1, intranasal for an unknown indications. On 27-Oct-2009, the patient was laying on pillow and was shaking from his waist up, it lasted for two minutes and he was out of it. No cyanosis was there. Then patient had another short seizure with five head twitches. The child was taken to the emergency room for evaluation and testing. On 27-Oct-2009, WBC was 11.6 (high) and RBC was 4.26 (low) neutrophils was 24.9 (low) and lymphocytes was 61.2 (high); in basic metabolic panel creatinine was 0.2 (low); chest x-ray was normal; influenza serology test was negative for both A and B and the CT scan of brain without contrast noted the intracranial structures were normal. There was no hemorrhage identified. The lateral ventricles were normal in size. There was no midline displacement. The paranasal sinuses were clear and adenoid hypertrophy was noted. The patient denies any nausea, vomiting or diarrhea, fever or chills, any shortness of breath, respiratory distress or abdominal pain. The patient has had normal urine output and bowel movements. At the time of this report, the patient has had no further seizures. The child has not undergone an electroencephalogram (EEG) at the time of report, because the child was to see the neurologist first, and that appointment was scheduled for an unspecified date in mid Jan-2010. The details of physical examination are attached in the source document. The outcome of the seizures questionable tonic-clonic was resolved and for slightly irritable it was unknown. Additional information was received on 11-Nov-2009 and incorporated into the narrative. Additional information about further evaluation of progression, frequency and outcome of the event and additional scheduled investigation was included. Following additional information was received on 10-Dec-2009 and incorporated into the narrative: patient history and patient's family history, additional adverse event and lab details
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Chest X-ray normal, Computerised tomogram normal, Convulsion, Eosinophil percentage increased, Glomerular filtration rate increased
Clinical narrative: A serious spontaneous report of seizures questionable tonic-clonic and non-serious report of slightly irritable was received from a non-health professional concerning a 26-month-old male, subsequent to H1N1, Intranasal. The patient had heart murmur when he was born. The patient never received flu vaccine before and never experienced seizure. No concomitant medications was taken by the patient. The patient's mother had pituitary tumor and father had a history of colon CA. On the mother's side, the grandfather had intracranial tumor and spinal cancer. There was no family history of seizures. On 25-Oct-2009, the patient received first dose of H1N1, intranasal for an unknown indications. On 27-Oct-2009, the patient was laying on pillow and was shaking from his waist up, it lasted for two minutes and he was out of it. No cyanosis was there. Then patient had another short seizure with five head twitches. The child was taken to the emergency room for evaluation and testing. On 27-Oct-2009, WBC was 11.6 (high) and RBC was 4.26 (low) neutrophils was 24.9 (low) and lymphocytes was 61.2 (high); in basic metabolic panel creatinine was 0.2 (low); chest x-ray was normal; influenza serology test was negative for both A and B and the CT scan of brain without contrast noted the intracranial structures were normal. There was no hemorrhage identified. The lateral ventricles were normal in size. There was no midline displacement. The paranasal sinuses were clear and adenoid hypertrophy was noted. The patient denies any nausea, vomiting or diarrhea, fever or chills, any shortness of breath, respiratory distress or abdominal pain. The patient has had normal urine output and bowel movements. At the time of this report, the patient has had no further seizures. The child has not undergone an electroencephalogram (EEG) at the time of report, because the child was to see the neurologist first, and that appointment was scheduled for an unspecified date in mid Jan-2010. The details of physical examination are attached in the source document. The outcome of the seizures questionable tonic-clonic was resolved and for slightly irritable it was unknown. Additional information was received on 11-Nov-2009 and incorporated into the narrative. Additional information about further evaluation of progression, frequency and outcome of the event and additional scheduled investigation was included. Following additional information was received on 10-Dec-2009 and incorporated into the narrative: patient history and patient's family history, additional adverse event and lab details
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Haematocrit decreased, Haemoglobin normal, Influenza A virus test negative, Influenza virus test negative, Irritability
Clinical narrative: A serious spontaneous report of seizures questionable tonic-clonic and non-serious report of slightly irritable was received from a non-health professional concerning a 26-month-old male, subsequent to H1N1, Intranasal. The patient had heart murmur when he was born. The patient never received flu vaccine before and never experienced seizure. No concomitant medications was taken by the patient. The patient's mother had pituitary tumor and father had a history of colon CA. On the mother's side, the grandfather had intracranial tumor and spinal cancer. There was no family history of seizures. On 25-Oct-2009, the patient received first dose of H1N1, intranasal for an unknown indications. On 27-Oct-2009, the patient was laying on pillow and was shaking from his waist up, it lasted for two minutes and he was out of it. No cyanosis was there. Then patient had another short seizure with five head twitches. The child was taken to the emergency room for evaluation and testing. On 27-Oct-2009, WBC was 11.6 (high) and RBC was 4.26 (low) neutrophils was 24.9 (low) and lymphocytes was 61.2 (high); in basic metabolic panel creatinine was 0.2 (low); chest x-ray was normal; influenza serology test was negative for both A and B and the CT scan of brain without contrast noted the intracranial structures were normal. There was no hemorrhage identified. The lateral ventricles were normal in size. There was no midline displacement. The paranasal sinuses were clear and adenoid hypertrophy was noted. The patient denies any nausea, vomiting or diarrhea, fever or chills, any shortness of breath, respiratory distress or abdominal pain. The patient has had normal urine output and bowel movements. At the time of this report, the patient has had no further seizures. The child has not undergone an electroencephalogram (EEG) at the time of report, because the child was to see the neurologist first, and that appointment was scheduled for an unspecified date in mid Jan-2010. The details of physical examination are attached in the source document. The outcome of the seizures questionable tonic-clonic was resolved and for slightly irritable it was unknown. Additional information was received on 11-Nov-2009 and incorporated into the narrative. Additional information about further evaluation of progression, frequency and outcome of the event and additional scheduled investigation was included. Following additional information was received on 10-Dec-2009 and incorporated into the narrative: patient history and patient's family history, additional adverse event and lab details
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Lymphocyte percentage increased, Mean cell haemoglobin concentration, Mean cell haemoglobin normal, Mean cell volume normal, Muscle twitching
Clinical narrative: A serious spontaneous report of seizures questionable tonic-clonic and non-serious report of slightly irritable was received from a non-health professional concerning a 26-month-old male, subsequent to H1N1, Intranasal. The patient had heart murmur when he was born. The patient never received flu vaccine before and never experienced seizure. No concomitant medications was taken by the patient. The patient's mother had pituitary tumor and father had a history of colon CA. On the mother's side, the grandfather had intracranial tumor and spinal cancer. There was no family history of seizures. On 25-Oct-2009, the patient received first dose of H1N1, intranasal for an unknown indications. On 27-Oct-2009, the patient was laying on pillow and was shaking from his waist up, it lasted for two minutes and he was out of it. No cyanosis was there. Then patient had another short seizure with five head twitches. The child was taken to the emergency room for evaluation and testing. On 27-Oct-2009, WBC was 11.6 (high) and RBC was 4.26 (low) neutrophils was 24.9 (low) and lymphocytes was 61.2 (high); in basic metabolic panel creatinine was 0.2 (low); chest x-ray was normal; influenza serology test was negative for both A and B and the CT scan of brain without contrast noted the intracranial structures were normal. There was no hemorrhage identified. The lateral ventricles were normal in size. There was no midline displacement. The paranasal sinuses were clear and adenoid hypertrophy was noted. The patient denies any nausea, vomiting or diarrhea, fever or chills, any shortness of breath, respiratory distress or abdominal pain. The patient has had normal urine output and bowel movements. At the time of this report, the patient has had no further seizures. The child has not undergone an electroencephalogram (EEG) at the time of report, because the child was to see the neurologist first, and that appointment was scheduled for an unspecified date in mid Jan-2010. The details of physical examination are attached in the source document. The outcome of the seizures questionable tonic-clonic was resolved and for slightly irritable it was unknown. Additional information was received on 11-Nov-2009 and incorporated into the narrative. Additional information about further evaluation of progression, frequency and outcome of the event and additional scheduled investigation was included. Following additional information was received on 10-Dec-2009 and incorporated into the narrative: patient history and patient's family history, additional adverse event and lab details