chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, Ocular hyperaemia
Clinical narrative: A non-serious spontaneous report of "patient jerked and went into eye and eye somewhat red" has been received from a consumer concerning a 24-month-old male, subsequent to H1N1. The patient's past medical history and concomitant medications were not reported. The patient who is the reporter's son received H1N1 on 22-Oct-2009 at a large flu clinic. During vaccination, the first spray did not all go up the patient's nose. He jerked and some went into his eye. On 23-Oct-2009, the patient's eye was somewhat red. The outcome of the adverse events is unknown.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of a small amount of H1N1 mist got into his eye was received from a nurse practitioner concerning a 7-year-old male. On 26-Oct-2009, the patient received H1N1, intranasal. A small amount of the vaccine got into the patient's left eye and onto his cheek. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 69.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Rotator cuff repair, Rotator cuff syndrome
Clinical narrative: Initial report received from an investigator on 28 May 2010 under the reference number FUF16. A 69-year-old male subject experienced a rotator cuff injury - left shoulder 161 days after receiving an intramuscular left deltoid injection of H1N1, 3.8 mcg HA, lot number UD12414, reconstituted with PBS diluent, lot number UD12820, on 10 November 2009. The subject did not receive AF03 adjuvant. On 20 April 2010 he was admitted to the hospital for surgery to repair a left rotator cuff injury. He was treated with oxycodone and hydrocodone postoperatively for pain relief. The event was considered to be resolved on 21 April 2010. Medical records had been requested. According to the investigator, the event was not related to the study vaccine or the concomitant medications. Unblinding information was received on 28 May 2010. Follow-up information was received from an investigator on 13 July 2010 provided that there was no ongoing medical history and/or complementary investigations. There were no medical records available as of 13 July 2010. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Fatigue, Pain, Pyrexia, Throat irritation
Clinical narrative: A non-serious spontaneous report of scratchy throat, fatigue, fever and feels achy has been received from a nurse concerning a 30-year-old female, subsequent to H1N1, intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, intranasal on 24-Oct-2009 for unknown indication. Four days after receiving H1N1, intranasal, the patient developed scratchy throat, fatigue, fever and felt achy. The treatment for the events was not provided. The outcome for the reported adverse events was not reported.
Age: 43.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dysphonia, Fatigue, Nasal congestion
Clinical narrative: A non-serious, spontaneous report of very tired, hoarse throat, and stuffy nose has been received from a consumer concerning a 43-year-old female patient, subsequent to receiving H1N1, Intranasal. Medical history and concomitant medications were not reported. The patient received H1N1 on 24-Oct-2009. On 25-Oct-2009, the patient experienced very tired, hoarse throat, and stuffy nose. The events were ongoing at the time of the report.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of a fever has been received from a physician concerning a child, subsequent to H1N1, Intranasal. Medical history included two unvaccinated siblings tested positive for H1N1 on 23-Oct-2009. Concomitant medications were not reported. On 23-Oct-2009 the patient received H1N1, Intranasal. On 25-Oct-2009, the patient had a fever. Neither outcome nor causality have been reported for this event.
Age: 47.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: A non-serious spontaneous report of dizziness, nausea, and vomiting has been received from a nurse concerning a 47-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Oct-2009, the patient received a single dose of H1N1. On 28-Oct-2009, the patient developed dizziness, nausea, and vomiting. The outcome of the events was not reported.
Age: 9.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of "my daughter had sore throat and headache after H1N1 LAIV" has been received from a consumer, concerning a nine-year-old female, subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. The patient received H1N1, Intranasal on 24-Oct-2009 through a company's employee immunization event. On 28-Oct-2009, the patient complained of sore throat and headache. Her temperature was 98.9 degrees F. The outcome of the adverse events was unknown.
Age: 11.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of sore throat and headache has been received from a consumer, concerning an 11-year-old female, subsequent to H1N1. The patient's past medical history and concomitant medications were not reported. The patient received H1N1 on 24-Oct-2009 through a company's employee immunization event. On 27-Oct-2009, the patient developed sore throat and headache. The outcome of the adverse events was not reported.
Age: 40.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Rash
Clinical narrative: A non-serious, spontaneous report of rash has been received from a registered nurse concerning a 40-year-old female, subsequent to receiving H1N1. The patient's medical history and concomitant medications was not reported. The patient received H1N1 on 06-Oct-2009. On the same day, the patient broke out in a rash that has lasted more than ten days and at the time of the report, she still had a rash on her face. The event was ongoing.
Age: 100.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of H1N1 administered by mistake to a 100-year-old male was received from a healthcare professional. The patient's medical history and concomitant medications were not provided. On 29-Oct-2009, the patient received H1N1. 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: 33.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Accidental exposure, Chills, Cough, Fatigue, Headache
Clinical narrative: A non-serious spontaneous report of accidental exposure, cough, chills, headache, fatigue, and nausea has been received from a consumer concerning herself, a 33-year-old female, involving H1N1. The patient's past medical history and concomitant medications were not reported. The patient was exposed to H1N1 on 22-Oct-2009. The patient did not receive the vaccine. On 22-Oct-2009, the patient's daughter was administered H1N1. The patient was holding her, and as the syringe was pulled from her daughter's nose, her daughter took a deep breath and blew it into the patient's face. The next day, 23-Oct-2009, the patient experienced a cough. That evening, the patient was "very ill" with chills, headache, fatigue, and nausea. The event of headache was resolved on 10/24/2009. The outcome for the other events was not reported. The patient indicated she did not receive the vaccine "but thinks the virus was transmitted from her daughter's vaccination".
Age: 33.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Malaise, Nausea
Clinical narrative: A non-serious spontaneous report of accidental exposure, cough, chills, headache, fatigue, and nausea has been received from a consumer concerning herself, a 33-year-old female, involving H1N1. The patient's past medical history and concomitant medications were not reported. The patient was exposed to H1N1 on 22-Oct-2009. The patient did not receive the vaccine. On 22-Oct-2009, the patient's daughter was administered H1N1. The patient was holding her, and as the syringe was pulled from her daughter's nose, her daughter took a deep breath and blew it into the patient's face. The next day, 23-Oct-2009, the patient experienced a cough. That evening, the patient was "very ill" with chills, headache, fatigue, and nausea. The event of headache was resolved on 10/24/2009. The outcome for the other events was not reported. The patient indicated she did not receive the vaccine "but thinks the virus was transmitted from her daughter's vaccination".
Age: 37.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a patient concerning a 37-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. 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: 0.65
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of H1N1 given to seven-month-old female was received from a registered nurse. The patient had no medical history and no concomitant medication was taken by the patient. The patient received H1N1, Intranasal on 28-Oct-2009. The child had no symptoms, no problems, has been doing very well, and was healthy. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved. Additional information was received on 17-Nov-2009 and incorporated in the narrative: Reporter's name changed, concomitant medication and medical history.
Age: 20.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 20-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. 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: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Rash generalised
Clinical narrative: A non-serious spontaneous report of "rash all over her body" has been received from a consumer concerning a 24-month-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received single dose H1N1, Intranasal on 28-Oct-2009. On the morning of 29-Oct-2009, the patient had developed a rash all over her body. The consumer was taking her daughter to the physician. The reporter stated the rash had not resolved.
Age: 45.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dysphagia, Eye pain, Feeling abnormal, Headache, Pain
Clinical narrative: A non-serious spontaneous report of "difficulty swallowing with some throat swelling," headache, spacey feeling, achy and "my eyes hurt" has been received from a 45-year-old physician regarding herself, subsequent to H1N1 2009 MONOVALENT Vaccine. The patient's past medical history and concomitant medications were not reported. The patient received both H1N1 2009 MONOVALENT Vaccine and the flu shot on 27-Oct-2009. Within minutes of vaccination, the patient had difficulty swallowing with some throat swelling. Later in the day, she had headache, spacey feeling, achy and "my eyes hurt." The outcome of the adverse events was unknown.
Age: 45.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pharyngeal oedema
Clinical narrative: A non-serious spontaneous report of "difficulty swallowing with some throat swelling," headache, spacey feeling, achy and "my eyes hurt" has been received from a 45-year-old physician regarding herself, subsequent to H1N1 2009 MONOVALENT Vaccine. The patient's past medical history and concomitant medications were not reported. The patient received both H1N1 2009 MONOVALENT Vaccine and the flu shot on 27-Oct-2009. Within minutes of vaccination, the patient had difficulty swallowing with some throat swelling. Later in the day, she had headache, spacey feeling, achy and "my eyes hurt." The outcome of the adverse events was unknown.
Age: 23.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 23-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. 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: 45.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Body temperature increased, Diarrhoea, Influenza like illness, Malaise, Nausea
Clinical narrative: A non-serious spontaneous report of flu-like feeling - achy, malaise, nausea and diarrhea has been received from a consumer concerning a 45-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a single dose of H1N1 on 27-Oct-2009. On 27-Oct-2009, within one hour the patient felt symptoms of flu-like feeling - achy, and malaise. By day two, the patient's temperature was 100 degrees F. On an unknown date the patient had diarrhea and nausea as well. The patient reported she is feeling better, with some symptoms continuing. Additional information received 03-Nov-2009 and incorporated into narrative: new event terms and outcomes.
Age: 49.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Headache
Clinical narrative: A non-serious spontaneous report of headaches has been received from a consumer concerning a 49-year-old female, subsequent to H1N1, Intranasal. Medical history included diabetes. Concomitant medications included aspirin therapy. The patient received a single dose of H1N1 on 23-Oct-2009. On 23-Oct-2009, the patient started to experience headaches everyday since the vaccination. The first day the patient did not experience a headache was 29-Oct-2009. The outcome of the event was not reported.
Age: 0.5
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of six-month-old got H1N1 was received from a mother/consumer concerning her six-month-old daughter, subsequent to H1N1, Intranasal. The patient had no past medical history or concomitant medications. The patient received the vaccine on 23-Oct-2009 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 12-Nov-2009 and incorporated into the narrative: patient's medical history, concomitant medications and patient's demographics.
Age: 21.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 21-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. 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: 33.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Vaccination error
Clinical narrative: A non-serious report of "eye exposure to mist" was received from a licensed practical nurse concerning a 33-year-old female. The patient's medical history was not reported. On 30-Oct-2009, some of the administered H1N1, Intranasal went in the patient's eye. The eye was immediately flushed with water. 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 resolved.
Age: 49.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Hypoaesthesia oral
Clinical narrative: A non-serious spontaneous report of mouth numbness has been received from a registered nurse concerning a 49-year-old female subsequent to H1N1. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST intranasally on 28-Oct-2009. On 28-Oct-2009, after H1N1 administration, the patient experienced mouth numbness. On 28-Oct-2009, after several hours, the event of mouth numbness resolved.
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Underdose
Clinical narrative: A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 27-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. There was no adverse event associated with this vaccine underdose; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 55.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Vaccination error
Clinical narrative: A non-serious spontaneous report of "I got the H1N1 vaccine and should not have", was received from a consumer concerning himself, a 55-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 29-Oct-2009, this 55-year-old patient received H1N1, Intranasal. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 25.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Underdose
Clinical narrative: A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 25-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. 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: 43.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of sore throat, cough, fever of 102 F and muscle aches has been received from a pharmacist concerning a 43-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on unknown date. Two days after receiving H1N1, Intranasal, the patient developed sore throat, cough, fever of 102 and muscle aches. Treatment for the events was not provided. The patient's symptoms lasted for ten days.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain upper, Asthenia, Pyrexia, Vomiting
Clinical narrative: A non-serious spontaneous report of fever, vomiting, stomach aches, and weakness has been received from a pharmacist concerning a six-year-old female subsequent to H1N1. The patient's past medical history was not reported. The patient received H1N1 on 24-Oct-2009. On 30-Oct-2009, the patient experienced high fever, vomiting, stomach aches, and general weakness. The outcome of the events was not reported.
Age: 23.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Underdose
Clinical narrative: A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 23-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. There was no adverse event associated with this vaccine underdose; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 30.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Underdose
Clinical narrative: A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 30-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. 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: Underdose
Clinical narrative: A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 22-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. There was no adverse event associated with this vaccine underdose; 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: Underdose
Clinical narrative: A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 22-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half dose was discarded by the person administering the vaccine. 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: 36.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Underdose
Clinical narrative: A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 36-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half dose was discarded by the person administering the vaccine. 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: 20.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Underdose
Clinical narrative: A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 20-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half dose was discarded by the person administering the vaccine. 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: 28.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Underdose
Clinical narrative: A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 28-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half dose was discarded by the person administering the vaccine. 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: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of a large portion of the dose was expelled and received a second dose in each nostril was received from the mother of a patient concerning a 24-year-old female. On 30-Oct-2009 a large portion of the H1N1, Intranasal dose was expelled from the nostril during administration, the patient then received a second dose in each nostril. 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: 38.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Movement disorder, Pain
Clinical narrative: A non-serious spontaneous report of body aches has been received from a consumer, patient's wife, concerning a 38-year-old male subsequent to H1N1, Intranasal. The patient's medical history and concomitant medications were not reported. The patient received H1N1, Intranasal on 23-Oct-2009. On 22-Oct-2009, the night before receiving H1N1, Intranasal, the patient had body aches. After vaccine administration, on 24-Oct-2009, the patient "could barely move." The reporter was not sure if her husband experienced adverse reaction to the H1N1, Intranasal or if he was infected with the circulating novel H1N1 strain. The outcome of the event was unknown. On 09-Sep-2010 this is a corrected report to the previous report: MedDRA coding of the event was changed from myalgia to pain.
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Influenza A virus test positive, Pyrexia, Sneezing
Clinical narrative: A non-serious spontaneous report of positive influenza A test has been received from a pharmacist concerning an adult female, subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. The patient received H1N1, Intranasal on 16-Oct-2009. On 30-Oct-2009, the patient developed symptoms of fever, cough, sneezing and had a positive influenza A rapid test. The outcome of the event of positive influenza A test was not reported.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Condition aggravated, Cough, Headache, Influenza, Influenza A virus test positive
Clinical narrative: A non-serious spontaneous report of "tested positive for influenza A has been received from a consumer, patient's mother, concerning a five-year-old female subsequent to H1N1.  The patient's medical history and concomitant medications were not reported.  The patient received H1N1 on 23-Oct-2009.  On 22-Oct-2009, the night before receiving H1N1, the patient had a headache.  After receiving the vaccine, on 23-Oct-2009, the patient "was in tears because her headache was so bad."  On 23-Oct-2009, the patient also experienced a fever of 100.4F, and it went up to 102.8F on 25-Oct-2009.  On 25-Oct-2009, the patient also vomited a few times, had a cough and nasal discharge.  The reporter stated that she thought her daughter had a sinus infection.  On 26-Oct-2009, the patient tested positive for Influenza A.  The reporter was not sure if her daughter experienced adverse reactions to the H1N1 or if she was infected with the circulating novel H1N1 strain.  The outcome of the event was not provided.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia, Rhinorrhoea, Tearfulness, Vomiting
Clinical narrative: A non-serious spontaneous report of "tested positive for influenza A has been received from a consumer, patient's mother, concerning a five-year-old female subsequent to H1N1.  The patient's medical history and concomitant medications were not reported.  The patient received H1N1 on 23-Oct-2009.  On 22-Oct-2009, the night before receiving H1N1, the patient had a headache.  After receiving the vaccine, on 23-Oct-2009, the patient "was in tears because her headache was so bad."  On 23-Oct-2009, the patient also experienced a fever of 100.4F, and it went up to 102.8F on 25-Oct-2009.  On 25-Oct-2009, the patient also vomited a few times, had a cough and nasal discharge.  The reporter stated that she thought her daughter had a sinus infection.  On 26-Oct-2009, the patient tested positive for Influenza A.  The reporter was not sure if her daughter experienced adverse reactions to the H1N1 or if she was infected with the circulating novel H1N1 strain.  The outcome of the event was not provided.
Age: 4.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough, Influenza, Influenza A virus test positive, Pyrexia, Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of tested positive for influenza A with symptoms of fever, runny nose, congestion and cough has been received from a mother/consumer concerning her son, a four-year-old male subsequent to H1N1, Intranasal. The patient's medical history included breathing issues. Concomitant medications have not been reported. The patient first dose of H1N1, Intranasal on 23-Oct-2009 and second dose of on H1N1, Intranasal on 25-Nov-2009. On 28-Oct-2009, five days after first dose, the patient had symptoms of fever, runny nose and congestion. On 29-Oct-2009, the patient was tested positive for Influenza A, the patient was experiencing a cough and fever of 100.5 F. The patient was treated with acetaminophen and ibuprofen. The reporter took him to the clinic at 10 pm. On 30-Oct-2009, the patient began treatment with oseltamivir phosphate. The reporter was not sure if her son experienced adverse reactions to the H1N1, Intranasal or if he was infected with the circulating novel H1N1 strain. The outcome of reported event was unknown. Additional information was received on 23-Dec-2009 and incorporated into the narrative: adverse event, event description and outcome.
Age: 4.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of tested positive for influenza A with symptoms of fever, runny nose, congestion and cough has been received from a mother/consumer concerning her son, a four-year-old male subsequent to H1N1, Intranasal. The patient's medical history included breathing issues. Concomitant medications have not been reported. The patient first dose of H1N1, Intranasal on 23-Oct-2009 and second dose of on H1N1, Intranasal on 25-Nov-2009. On 28-Oct-2009, five days after first dose, the patient had symptoms of fever, runny nose and congestion. On 29-Oct-2009, the patient was tested positive for Influenza A, the patient was experiencing a cough and fever of 100.5 F. The patient was treated with acetaminophen and ibuprofen. The reporter took him to the clinic at 10 pm. On 30-Oct-2009, the patient began treatment with oseltamivir phosphate. The reporter was not sure if her son experienced adverse reactions to the H1N1, Intranasal or if he was infected with the circulating novel H1N1 strain. The outcome of reported event was unknown. Additional information was received on 23-Dec-2009 and incorporated into the narrative: adverse event, event description and outcome.
Age: 17.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough
Clinical narrative: A non-serious spontaneous report of coughing has been received from a physician concerning a 17-year-old male, subsequent to H1N1, Intranasal. The patient has a past medical history of asthma and has not had any problem with his asthma for years. On 29-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 29-Oct-2009, night, the patient experienced a lot of coughing which lasted up to the morning of 30-Oct-2009. The outcome of the event was resolved.
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Accidental exposure, Joint swelling
Clinical narrative: A non-serious spontaneous report of accidental exposure and swelling of her knees had been received from a immunization coordinator concerning an adult female subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. The patient is a nurse who administered H1N1, Intranasal to patients starting on 01-Oct-2009. The patient did not receive the vaccine. Within the past three weeks in October 2009, the patient has experienced swelling of her knees. The outcome of the event was not reported.
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Accidental exposure, Oedema peripheral
Clinical narrative: A non-serious spontaneous report of accidental exposure and swelling of her hands has been received from an immunization coordinator concerning an adult female subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. The patient is a nurse who administered H1N1, Intranasal to patients starting 01-Oct-2009. The patient did not receive the vaccine. Within the past three weeks in October 2009, the patient has experienced swelling of her hands. The outcome of the event was not reported.
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Accidental exposure, Aphonia
Clinical narrative: A non-serious spontaneous report of accidental exposure and lost her voice has been received from an immunization coordinator concerning an adult female subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. The patient is a nurse who administered H1N1, Intranasal to patients starting 01-Oct-2009. The patient did not receive the vaccine. Within the past three weeks in October 2009, the patient has experienced a loss of her voice for three weeks. The outcome of the event was not reported.
Age: 63.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of gave H1N1 to a 63-year-old person was received from a nurse concerning a 63-year-old male. On 29-Oct-2009, the patient received Influenza A (H1N1) 2009 MONOVALENT Vaccine Live, Intranasal. 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: 54.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: No adverse event
Clinical narrative: A non-serious spontaneous report of "gave the H1N1 vaccine to a 54-year-old" was received from a health care professional concerning a 54-year-old female. On 29-Oct-2009, the patient received single dose H1N1, Intranasal. There is 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: 56.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of a 56-year-old got H1N1 was received from a nurse concerning a 56-year old male. On 29-Oct-2009, the patient received single dose H1N1, Intranasal. There is 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: 59.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of gave H1N1 LAIV to a 59-year-old was received from a nurse concerning a 59-year-old female. On 29-Oct-2009, the patient received single dose H1N1 2009 MONOVALENT Vaccine Live, Intranasal. There is 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: 59.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: No adverse event
Clinical narrative: A non-serious report of administration of H1N1 to a patient over 50 was received from a consumer concerning a 59-year-old female subsequent to the administration of H1N1. Relevant medical history and concomitant medications were not reported. On 30-Oct-2009, the patient received H1N1. There was no adverse event reported with this vaccination error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.
Age: 0.5
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of H1N1 2009 MONOVALENT Vaccine Live, Intranasal to a six-month old was received from a nurse involving a six-month-old subsequent to administration of H1N1 2009 MONOVALENT Vaccine Live, Intranasal. The patient did not have any past medical history and was not taking any concomitant medications. On 30-Oct-2009, the patient received H1N1 2009 MONOVALENT Vaccine Live, 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 to be resolved. Additional information was received 01-Dec-2009 and incorporated into the narrative medical history and concomitant medication confirmed; no adverse event reported.
Age: 12.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Nausea, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of fever, sore throat, cough, runny nose, and nausea has been received from a consumer/mother concerning her 12-year-old daughter, subsequent to H1N1, Intranasal. The patient's medical history and concomitant medications were not reported. On 27-Oct-2009, the patient received H1N1, Intranasal. On 30-Oct-2009, the patient experienced a fever, sore throat, cough, nausea and runny nose. The patient's mother has reported the events to the doctor. The outcome was unknown.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever and stuffy nose has been received from a physician concerning a six-year-old female, subsequent to H1N1. The patient's medical history and concomitant medications were not reported. On 31-Oct-2009, the patient received H1N1. Fourteen hours after receiving H1N1, the patient experienced a fever of 102 degrees Fahrenheit and a stuffy nose. The outcome was unknown.
Age: 76.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Balance disorder
Clinical narrative: A non-serious spontaneous report of "I got H1N1 and I am 76 years old" and "equilibrium has been off 2 or 3 times since receiving vaccine" has been received from a consumer concerning a 76-year-old male, subsequent to H1N1, intranasal. Medical history includes presence of a pacemaker; no concomitant medications have been reported. The patient received H1N1, intranasal on 24-Oct-2009 for unknown indication. On 24-Oct-2009, a 76-year-old patient received H1N1, intranasal and later reported that his equilibrium has been off 2 or 3 time since receiving the vaccine (exact dates of occurrence not provided). The outcomes for the events were not provided.
Age: 18.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), FLUN(H1N1)
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of pregnant 18-year-old got H1N1 LAIV was received from a consumer/mother concerning her daughter, a 18-year-old pregnant female. The patient's medical history included seasonal allergies and depression. Obstetrical history included gravida one and para zero. The patient was six month pregnant (second trimester) at the time of vaccination. The EDD was in between the 4th to the 9th February 2010 and LMP was uncertain. The concomitant medications included regular flu vaccine received on the same day of H1N1 vaccination, prenatal vitamins during pregnancy and venlafaxine for depression, when she realized about the pregnancy she weaned herself off this drug over several weeks (all occurred during the first trimester). On 26-Oct-2009, the patient received H1N1 Vaccine, Intranasal for an unknown indication. On 27-Jan-2010, the patient gave birth vaginally to a 7 lb 8 ozs, healthy baby boy who measured 19.5 inches long. Both were well and healthy. The patient did very well with the vaginal delivery and had no complications. 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 23-Feb-2010 and incorporated into the narrative: Medical history, concomitant medications, obstetrical history, EDD, information about delivery and status of baby, weight and length of baby.
Age: 18.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), FLUN(H1N1)
Symptoms: Delivery, Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of pregnant 18-year-old got H1N1 LAIV was received from a consumer/mother concerning her daughter, a 18-year-old pregnant female. The patient's medical history included seasonal allergies and depression. Obstetrical history included gravida one and para zero. The patient was six month pregnant (second trimester) at the time of vaccination. The EDD was in between the 4th to the 9th February 2010 and LMP was uncertain. The concomitant medications included regular flu vaccine received on the same day of H1N1 vaccination, prenatal vitamins during pregnancy and venlafaxine for depression, when she realized about the pregnancy she weaned herself off this drug over several weeks (all occurred during the first trimester). On 26-Oct-2009, the patient received H1N1 Vaccine, Intranasal for an unknown indication. On 27-Jan-2010, the patient gave birth vaginally to a 7 lb 8 ozs, healthy baby boy who measured 19.5 inches long. Both were well and healthy. The patient did very well with the vaginal delivery and had no complications. 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 23-Feb-2010 and incorporated into the narrative: Medical history, concomitant medications, obstetrical history, EDD, information about delivery and status of baby, weight and length of baby.
Age: 18.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), FLUN(H1N1)
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of "H1N1 LAIV to a women who was in her 26 week of pregnancy" was received from a health professional concerning a 18-year-old pregnant female. Relevant medical history was not reported. The patient was in her 26 weeks of pregnancy at the time of vaccination. Obstetrical history included gravida one and para zero. The LMP was 23-Apr-2009 and EDD was 29-Jan-2010. The concomitant medications have not been reported for this patient. On 28-Oct-2009, the patient received the H1N1, Intranasal for an unknown indication. The patient was very healthy all through her pregnancy and never became ill or developed the flu post vaccination. The patient delivered vaginally on 27-Jan-2010 without complications. The baby was a normal healthy male who weighed 7 lbs 8 oz and was 19 1/2 inches long at birth. At the time of report, the baby was well and healthy. 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 18-Feb-2010 and incorporated into the narrative: Obstetrical history, LMP, EDD, information about delivery and status of baby, weight and length of baby.
Age: 18.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), FLUN(H1N1)
Symptoms: Delivery, Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of "H1N1 LAIV to a women who was in her 26 week of pregnancy" was received from a health professional concerning a 18-year-old pregnant female. Relevant medical history was not reported. The patient was in her 26 weeks of pregnancy at the time of vaccination. Obstetrical history included gravida one and para zero. The LMP was 23-Apr-2009 and EDD was 29-Jan-2010. The concomitant medications have not been reported for this patient. On 28-Oct-2009, the patient received the H1N1, Intranasal for an unknown indication. The patient was very healthy all through her pregnancy and never became ill or developed the flu post vaccination. The patient delivered vaginally on 27-Jan-2010 without complications. The baby was a normal healthy male who weighed 7 lbs 8 oz and was 19 1/2 inches long at birth. At the time of report, the baby was well and healthy. 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 18-Feb-2010 and incorporated into the narrative: Obstetrical history, LMP, EDD, information about delivery and status of baby, weight and length of baby.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Vomiting
Clinical narrative: A non-serious, spontaneous report of vomiting has been received from a consumer concerning a six-year-old female patient, subsequent to receiving H1N1, Intranasal. The patient's medical history and concomitant medications were not reported. The patient received H1N1, Intranasal on 15-Oct-2009. On 02-Nov-2009, the patient experienced vomiting. The event outcome is unknown.
Age: 15.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: A non-serious, spontaneous report of sore throat and cough has been received from a registered nurse concerning a 15-year-old female patient, subsequent to receiving H1N1, intranasal. The patient's medical history included an inhaler for exercise-induced asthma four years ago and hypothyroidism. Concomitant medications included levothyroxine sodium. The patient received H1N1, intranasal on 30-Oct-2009. On 31-Oct-2009, the patient experienced a sore throat and cough. The events of sore throat and cough resolved.
Age: 0.79
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of H1N1 administered to 9 month old male was received from a consumer.  The patient was not having any relevant medical history and concomitant medication.  The patient received H1N1, Intranasal on 03-Nov-2009.  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 17-Nov-2009 and incorporated into the narrative: Age of the patient and information on medical history, concomitant medications was included.
Age: 41.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Vaccination error
Clinical narrative: A non-serious spontaneous report of "inadvertently gave H1N1 to a patient with asthma" was received from a nurse practitioner concerning a 41-year-old female. Medical history included asthma. Concomitant medications included budesonide and formoterol. On 03-Nov-2009, the nurse practitioner inadvertently administered H1N1, intranasal to the patient. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.