chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error, Syringe issue
Clinical narrative: A report has been received from a pharmacist concerning a 47 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 13-Oct-2013. It was reported that the clip was messed up on the FLUMIST syringe he used so he thought the entire dose went into one nostril which started on 18-oct-2013. The outcome of the event of the clip was messed up on the FLUMIST syringe I used so I think the entire dose went into one nostril is unknown. The report was considered to be non-serious.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A report has been received from a physician concerning a 7 year old female patient. Relevant medical history and concomitant disease were unknown. On 23-Oct-2013, patient received nasal FLUMIST QUADRIVALENT. On 18-Nov-2013, the patient developed the flu. She was treated with TAMIFLU. Patient was a healthy child-no medical issues. The outcome of the event of flu diagnosis after vaccination with FLUMIST was unknown. The reporter assessed the event of flu diagnosis after vaccination with FLUMIST to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Pharmacist concerning a Child, subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 16-Sep-2013. The patient received given full dose of FLUMIST into one nostril on 16-Sep-2013. The outcome of the event of given full dose of FLUMIST into one nostril is unknown. The report was considered to be non-serious.
Age: 62.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 62 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 02-Dec-2013. The patient who received FLUMIST is 62 years old. This was outside of the approved age indication for FLUMIST. The patient experienced PT who received FLUMIST is 62 years old. The outcome of the event of PT who received FLUMIST is 62 years old, is unknown. The report was considered to be non-serious by the reporter.
Sex: U
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A report has been received from a physician via sales representative concerning several patients of unknown gender. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patients received FLUMIST (Intranasal). on an unknown date. A doctor mentioned in passing that sometime last season (2012-2013) more than one patient (exact number unknown) showed up in the ER after receiving FLUMIST. The time frame after receiving FLUMIST was not provided. The patients were swabbed in the ER and tested positive for the flu. The physician could not provide an identification for these patients. The outcome of the event of flu was unknown. The reporter considered the event to be non-serious.
Age: 70.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 70 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 19-Sep-2013. The patient experienced gave FLUMIST quadrivalent to a patient who was 70 years of age which started on 19-Sep-2013. The outcome of the event of gave FLUMIST quadrivalent to a patient who was 70 years of age is unknown. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 08-Oct-2013: the patient age changed from 66 years to 70 years, so adverse event term was updated from gave FLUMIST quadrivalent to a patient who was 66 years of age to gave FLUMIST quadrivalent to a patient who was 70 years of age.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Muscle spasms, Myalgia, Pruritus
Clinical narrative: A consumer report has been received. The report concerns an 8 year old, Male consumer, who had been receiving FLUMIST quadrivalent (intranasal). The patient's concurrent disease(s) included allergic to eggs. FLUMIST quadrivalent (intranasal) started on 18-Sep-2013. The patient experienced leg cramping in left leg and itching both legs which started on 18-Sep-2013 and muscle pain. The patient recovered from the event of leg cramping in left leg and itching both legs on an unspecified date and the outcome of the event of muscle pain is unknown. The report was considered to be non-serious.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 07-Oct-2013. The patient experienced administration of expired dose which started on 07-Oct-2013. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
Age: 1.9
Sex: U
Vaccine: FLUN4
Symptoms: Epistaxis
Clinical narrative: A report has been received from a Physician concerning a 1 year old, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced NOSEBLEED. The outcome of the event of NOSEBLEED is unknown. The report was considered to be non-serious by the reporter.
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A report has been received from a Health Professional concerning, Female subject, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included CEREBRAL PALSY. FLUMIST started on an unknown date. A nurse told him that last season, when giving FLUMIST to a MS patient, the patient moved and was stabbed in the nose and it started bleeding. The outcome of the event of BLEEDING and PATIENT WAS STABBED IN THE NOSE DURING ADMINISTRATION OF FLUMIST is unknown. The report was considered to be non-serious. Follow-up information insignificant information received by AstraZeneca/MedImmune on 04-Oct-2013 from HCP: Last season for receiving FLUMIST was updated. Added the patient gender and concomitant diseases. Updated the reporter's information and narrative.
Sex: U
Vaccine: FLUN3
Symptoms: Upper respiratory tract infection
Clinical narrative: A report has been received from a Pharmacist concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced UPPER RESPIRATORY TRACT INFECTION. The outcome of the event of UPPER RESPIRATORY TRACT INFECTION is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A report has been received from a Health Professional concerning, female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient received nasal FLUMIST in August or September of 2012. It was reported that the employees tested positive for the flu during Oct-2012, after receiving FLUMIST. Action taken with FLUMIST was not applicable. The Flu lasted for about three days and all recovered. The reporter considered the event to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A report has been received from a Health Professional concerning, female patient. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. On an unknown date, the patient got nasal FLUMIST last season (2012-2013) and FLUMIST did not protect her from getting the flu. The patient tested positive for the flu and had the flu after receiving FLUMIST. Also it was reported that the patient received FLUMIST in Aug-2012 or Sep-2012 and became ill in October. Action taken with influenza virus vaccine live, intranasal was unknown and the outcome of the event of patient tested positive for flu after receiving FLUMIST and had the flu was recovered. The report was considered to be non-serious by the reporter.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A report has been received from a health professional via medical representative concerning a female patient. This case reports for one of the four patients from same reporter. No information regarding relevant history, concurrent disease and concomitant medications of the patient was provided. The patient was receiving FLUMIST (intranasal) started in Aug-2012 or Sep-2012. The reporter stated that he had an office that reported four employees who got FLUMIST last season and FLUMIST did not protect them from getting the flu. The employees tested positive for the flu after receiving FLUMIST. Further it was reported that the patient received FLUMIST in Aug-2012 or Sep-2012 and became ill in October. Reporter stated that flu lasted for about three days. Action taken with FLUMIST was unknown. The patient recovered from the event of patient tested positive for flu after receiving FLUMIST and had the flu on an unspecified date. The report was considered to be non-serious by company physician.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A report has been received from a Health Professional concerning, female patient. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. In the year 2012, the patient received FLUMIST (intranasal) and FLUMIST did not protect her from getting the flu. The patient tested positive for the flu and had the flu after receiving FLUMIST. Action taken with FLUMIST, intranasal was unknown and the patient recovered from the event of patient tested positive for flu after receiving FLUMIST and had the flu. The report was considered to be non-serious by the reporter.
Age: 0.8
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 9 month old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced INADVERTENTLY ADMINISTERED FLUMIST TO A 9-MONTH OLD BABY GIRL. The outcome of the event of INADVERTENTLY ADMINISTERED FLUMIST TO A 9-MONTH OLD BABY GIRL is unknown. The report was considered to be non-serious.
Age: 48.0
Sex: F
Vaccine: FLUN4
Symptoms: Chest discomfort, Nervousness
Clinical narrative: A report has been received from a Physician via a corporation concerning a 48 year old, Female subject, who had been received Nasal FLUMIST, 0.2 Milliliters, Once/Single administration for PREVENTION OF INFLUENZA. FLUMIST started on 14-Nov-2013 for PREVENTION OF INFLUENZA. The patient experienced CHEST DISCOMFORT and NERVOUS which started on 14-Nov-2013 and BLOOD PRESSURE WAS 140/80. FLUMIST was discontinued on 14-Nov-2013. At the time of reporting, the event of CHEST DISCOMFORT and NERVOUS was improving and the outcome of the event of BLOOD PRESSURE WAS 140/80 is unknown. The report was considered to be non-serious by the company physician.
Age: 58.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 58 year old, Female subject, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on 05-Nov-2013. The patient experienced inadvertently given to a 58 year old which started on 05-Nov-2013. The outcome of the event of inadvertently given to a 58 year old is unknown. The report was considered to be non-serious by the reporter.
Sex: F
Vaccine: FLUN4
Symptoms: Fatigue, Headache, Myalgia, Nasal congestion, Rhinorrhoea
Clinical narrative: A consumer report has been received. The report concerns, Female consumer, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on 05-Nov-2013. The patient experienced scratchy throat, muscle pain, headache, nasal congestion, fatigue, and running nose which started on 06-Nov-2013. FLUMIST (intranasal) was discontinued on 05-Nov-2013. At the time of reporting, the event of scratchy throat, muscle pain, headache, nasal congestion, fatigue and running nose was ongoing. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Throat irritation
Clinical narrative: A consumer report has been received. The report concerns, Female consumer, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on 05-Nov-2013. The patient experienced scratchy throat, muscle pain, headache, nasal congestion, fatigue, and running nose which started on 06-Nov-2013. FLUMIST (intranasal) was discontinued on 05-Nov-2013. At the time of reporting, the event of scratchy throat, muscle pain, headache, nasal congestion, fatigue and running nose was ongoing. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: A consumer report has been received. The report concerns a 3 year old, Female consumer, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. The patient experienced stuffy nose and runny nose. The outcome of the event of stuffy nose and runny nose is unknown. The report was considered to be non-serious.
Age: 8.0
Sex: U
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning an 8 year old, subject of unknown gender, who had been receiving FLUMIST  quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The patient experienced fever. The outcome of the event of fever is unknown. The report was considered to be non-serious by the reporter.
Age: 34.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a 34 year old, Female subject, Height: 5.0 Inches; Weight: 169.0 Pounds, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 07-Oct-2013. The patient experienced administration to pregnant female which started on 07-Oct-2013. FLUMIST quadrivalent (intranasal) was continued. The outcome of the event of administration to pregnant female is unknown. The date of the patient's last menstruation was Mar-2013. The estimated date of delivery is 04-Dec-2013. The report was considered to be non-serious.
Age: 0.62
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Physician concerning a 7 month old, Male subject, who had been receiving FLUMIST (intranasal), 0.2 milliliters. Once/Single administration. FLUMIST (intranasal) started on 16-Nov-2013. The doctor reported an off label use after administration which started on 16-Nov-2013. FLUMIST (intranasal) was discontinued on 16-Nov-2013. The outcome of the event of off label use is unknown. The report was considered to be non-serious by the company physician.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, Female subject, who had been received FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. Medical Assistant reported that the patient received expired FLUMIST quadrivalent on 02-Dec-2013 and did not reported any symptoms. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Physician concerning a 35 years old, female patient. The relevant history and concurrent diseases of patient were not reported. The concomitant medications included ascorbic acid, biotin, minerals NOS, Nicotinic acid, retinol, tocopherol, vitamin B NOS, vitamin D NOS. The patient had been receiving FLUMIST which was started on 17-Jan-2013. The physician reported that one of their pregnant patients received FLUMIST at her child's pediatrician's office which on 17-Jan-2013. The outcome of the reported event was unknown. The outcome of pregnancy was unknown. The reporter considered the event of one of our pregnant patients received FLUMIST to be non-serious. Summary of follow up information received by AstraZeneca/MedImmune on 04-Oct-2013 from Physician: Form completed date added. The coding of the event one of our pregnant patients received FLUMIST changed from drug exposure during pregnancy to vaccine exposure during pregnancy. Reporter as responsible physician added.
Age: 47.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 47 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 11-Nov-2013. The patient experienced administration of only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The nurse reported, that they gave FLUMIST quadrivalent for a patient, then later it was found that she was pregnant. The outcome of the event of pregnancy is unknown. The estimated date of delivery is 16-May-2014. The report was considered to be non-serious by the reporter.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza, Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: A report has been received from a Health Professional an adult, subject of unknown gender, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient experienced nasal culture positive for flu type B and nasal culture for positive for flu type A which started on 24-Sep-2013. The outcome of the event of nasal culture positive for flu type A and B and nasal culture positive for flu type A is unknown. The report was considered to be non-serious by the reporter.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Lacrimation increased, Nasopharyngitis, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: A consumer report has been received. The report concerns a 13 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced RUNNY NOSE, WATERY EYES, HEAD COLD and CONGESTION which started on 01-Oct-2013. At the time of reporting, the event of RUNNY NOSE, WATERY EYES, HEAD COLD and CONGESTION was ongoing. The report was considered to be non-serious.
Age: 44.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A consumer report has been received. The report concerns a patient, Male consumer, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. It was reported that consumer was administered FLUMIST quadrivalent and only received half the dose in one nostril on 02-Oct-2013. The outcome of the event of received half the dose is unknown. The report was considered to be non-serious.
Age: 34.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Health Professional concerning a 34 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. It was reported that patient accidentally received full FLUMIST dose in one nostril which started on 02-Oct-2013. The outcome of the event of received full FLUMIST dose in one nostril is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Chills, Headache, Influenza, Pneumonia bacterial
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old, Female subject, Height: 48.0 Inches; Weight: 53.0 Pounds, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included THROMBOCYTOPENIA and ADHD. Concomitant medications included AMOXICILLIN, CLAVULANIC ACID for PARONCHIA TOE. FLUMIST started on 27-Sep-2013. The patient experienced WORSENING OF BACTERIAL PNEUMONIA which started on 16-Oct-2013, VITAL SYNDROME which started on 14-Oct-2013, VOMITING which started on 04-Oct-2013, STOMACH ACHE, CHILLS, POSITIVE FOR FLU TYPE B and FEVER which started on 27-Sep-2013 and HEADACHE. At the time of reporting, the event of STOMACH ACHE, CHILLS, POSITIVE FOR FLU TYPE B and FEVER was improving. At the time of reporting, the event of WORSENING OF BACTERIAL PNEUMONIA, VIRAL SYNDROME and VOMITING was ongoing and the outcome of the event of HEADACHE is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 29-Oct-2013 from Health Professional: E-mail id for primary reporter added. Ethnic origin and siblings information were added, indication for FLUMIST was added. New non serious events of vomiting, viral syndrome, WORSENING OF BACTERIAL PNEUMONIA and headache were added. Concomitant medication Augmentin was added. Medical history was also updated. Vaccinate at and Vaccine purchased with information was added.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia, Viral infection, Vomiting
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old, Female subject, Height: 48.0 Inches; Weight: 53.0 Pounds, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included THROMBOCYTOPENIA and ADHD. Concomitant medications included AMOXICILLIN, CLAVULANIC ACID for PARONCHIA TOE. FLUMIST started on 27-Sep-2013. The patient experienced WORSENING OF BACTERIAL PNEUMONIA which started on 16-Oct-2013, VITAL SYNDROME which started on 14-Oct-2013, VOMITING which started on 04-Oct-2013, STOMACH ACHE, CHILLS, POSITIVE FOR FLU TYPE B and FEVER which started on 27-Sep-2013 and HEADACHE. At the time of reporting, the event of STOMACH ACHE, CHILLS, POSITIVE FOR FLU TYPE B and FEVER was improving. At the time of reporting, the event of WORSENING OF BACTERIAL PNEUMONIA, VIRAL SYNDROME and VOMITING was ongoing and the outcome of the event of HEADACHE is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 29-Oct-2013 from Health Professional: E-mail id for primary reporter added. Ethnic origin and siblings information were added, indication for FLUMIST was added. New non serious events of vomiting, viral syndrome, WORSENING OF BACTERIAL PNEUMONIA and headache were added. Concomitant medication Augmentin was added. Medical history was also updated. Vaccinate at and Vaccine purchased with information was added.
Age: 50.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 50 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 12-Sep-2013. The reporter inadvertently administered FLUMIST quadrivalent to a gentleman who was 50 years old on 12-Sep-2013. The outcome of the event of administered FLUMIST quadrivalent to a 50 YO is unknown. The report was considered to be non-serious.
Age: 66.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a pharmacist concerning a 66 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 24-Sep-2013. They inadvertently gave FLUMIST to a 66 yo on 24-sep-2013. The outcome of the event of administered FLUMIST to a 66 yo is unknown. The report was considered to be non-serious.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Atypical pneumonia, Bronchitis, Cough, Diarrhoea, Influenza virus test positive
Clinical narrative: A report has been received from a health professional concerning a 5 year old male patient. The patients concurrent disease(s) included PDD spectrum disorder, reactive airway disease and candidal skin rash. Concomitant medications included nystatin for rash. The patient had been received FLUMIST quadrivalent (intranasal) started on 27-Sep-2013. The patient was positive for flu type B and positive for RSV which started on 03-Oct-2013. The patient also had congestion. Patient presented with cough, nasal congestion, and fever of 100.3 on 01-Oct-2013. Diagnosed with fever and acute bronchitis. Patient presents with cough and wheezing on 04-Oct-2013. Diagnosed with acute bronchitis vs atypical pneumonia and purulent rhinitis. Patient presents with vomiting and loose stools on 09-Oct-2013. Diagnosed with vomiting and question of immunocompromised. Action taken with FLUMIST quadrivalent was not applicable. The outcome of the event of positive for flu type B, positive for RSV, cough, congestion, loose stools, nasal congestion and question of immunocompromised was unknown, at the time of reporting, the event of fever, acute bronchitis, wheezing, atypical pneumonia and purulent rhinitis was ongoing and the patient recovered from the event of vomiting on 11-Oct-2013. The reporter considered all the events to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 29-Oct-2013 from health professional: Added new events of acute bronchitis and wheezing and atypical pneumonia and purulent rhinitis and vomiting and loose stools and nasal congestion and question of immunocompromised. Added indication and concomitant medications. Added relevant history and lab details. Reporters detail updated.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Nasal congestion, Pyrexia, Respiratory syncytial virus test positive, Respiratory tract congestion, Rhinitis
Clinical narrative: A report has been received from a health professional concerning a 5 year old male patient. The patients concurrent disease(s) included PDD spectrum disorder, reactive airway disease and candidal skin rash. Concomitant medications included nystatin for rash. The patient had been received FLUMIST quadrivalent (intranasal) started on 27-Sep-2013. The patient was positive for flu type B and positive for RSV which started on 03-Oct-2013. The patient also had congestion. Patient presented with cough, nasal congestion, and fever of 100.3 on 01-Oct-2013. Diagnosed with fever and acute bronchitis. Patient presents with cough and wheezing on 04-Oct-2013. Diagnosed with acute bronchitis vs atypical pneumonia and purulent rhinitis. Patient presents with vomiting and loose stools on 09-Oct-2013. Diagnosed with vomiting and question of immunocompromised. Action taken with FLUMIST quadrivalent was not applicable. The outcome of the event of positive for flu type B, positive for RSV, cough, congestion, loose stools, nasal congestion and question of immunocompromised was unknown, at the time of reporting, the event of fever, acute bronchitis, wheezing, atypical pneumonia and purulent rhinitis was ongoing and the patient recovered from the event of vomiting on 11-Oct-2013. The reporter considered all the events to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 29-Oct-2013 from health professional: Added new events of acute bronchitis and wheezing and atypical pneumonia and purulent rhinitis and vomiting and loose stools and nasal congestion and question of immunocompromised. Added indication and concomitant medications. Added relevant history and lab details. Reporters detail updated.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Vomiting, Wheezing
Clinical narrative: A report has been received from a health professional concerning a 5 year old male patient. The patients concurrent disease(s) included PDD spectrum disorder, reactive airway disease and candidal skin rash. Concomitant medications included nystatin for rash. The patient had been received FLUMIST quadrivalent (intranasal) started on 27-Sep-2013. The patient was positive for flu type B and positive for RSV which started on 03-Oct-2013. The patient also had congestion. Patient presented with cough, nasal congestion, and fever of 100.3 on 01-Oct-2013. Diagnosed with fever and acute bronchitis. Patient presents with cough and wheezing on 04-Oct-2013. Diagnosed with acute bronchitis vs atypical pneumonia and purulent rhinitis. Patient presents with vomiting and loose stools on 09-Oct-2013. Diagnosed with vomiting and question of immunocompromised. Action taken with FLUMIST quadrivalent was not applicable. The outcome of the event of positive for flu type B, positive for RSV, cough, congestion, loose stools, nasal congestion and question of immunocompromised was unknown, at the time of reporting, the event of fever, acute bronchitis, wheezing, atypical pneumonia and purulent rhinitis was ongoing and the patient recovered from the event of vomiting on 11-Oct-2013. The reporter considered all the events to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 29-Oct-2013 from health professional: Added new events of acute bronchitis and wheezing and atypical pneumonia and purulent rhinitis and vomiting and loose stools and nasal congestion and question of immunocompromised. Added indication and concomitant medications. Added relevant history and lab details. Reporters detail updated.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Accidental exposure to product
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The reporter stated that when FLUMIST was administered, the patient pulled back and FLUMIST sprayed in the patient's left eye on 02-Oct-2013. The outcome of the event of WHEN ADMINISTERING FLUMIST THE PATIENT PULLED BACK AND IT SPRAYED IN THE LEFT EYE is unknown. The report was considered to be non-serious.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Health Professional concerning a patient. Male subject, who had been receiving FLUMIST (Intranasal). The patient's concurrent disease(s) included hypogammaglobulinemia. Concomitant medications included immunoglobulin human normal. FLUMIST (Intranasal) started on 11-Oct-2013. It was reported that a child with hypogammaglobulinemia accidentally received FLUMIST on the morning of 11-Oct-2013. The outcome of the event of a child with hypogammaglobulinemia accidentally received FLUMIST this morning is unknown. The report was considered to be non-serious.
Age: 28.0
Sex: F
Vaccine: FLUN4
Symptoms: Local swelling, Sneezing
Clinical narrative: A report has been received from a Health Professional concerning a 28 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 07-Oct-2013. The patient experienced swollen left hand which started on 11-Oct-2013 and sneezing which started on 08-Oct-2013. At the time of reporting, the event of swollen left hand and sneezing was improving. The report was considered to be non-serious.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Lip swelling, Urticaria
Clinical narrative: A report has been received from a physician concerning a 10 year old, male patient. No relevant history or concomitant medication was reported. On an unknown date the patient received FLUMIST. On 05-Oct-2013 the patient who received FLUMIST experienced hives and swelling on lips 12 hours later. The patient did not have Egg allergy and the reporter also stated that the patient received FLUMIST before with no problems. At the time of reporting, the event of hives was ongoing. The report was consideer3ed to be non-serious by the reporter.
Age: 59.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 59 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 25-Sep-2013. Pharmacist reported that they had one staff member who received FLUMIST who was over 50 years of age on 25-Sep-2013. The outcome of the event of administration to a person over 50 years of age is unknown. The report was considered to be non-serious.
Age: 55.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 55 year old, female subject, who had been receiving FLUMIST. Concomitant medications included Tolterodine L-Tartrate, Alprazolam, Acyclovir and Sertraline. FLUMIST started on 06-Oct-2013. It was reported that the FLUMIST was administered to a 55 year old on 06-Oct-2013. FLUMIST was discontinued on 06-Oct-2013. The outcome of the event of we administered FLUMIST to a 55 year old is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning, a subject to unknown gender, who had been receiving FLUMIST. FLUMIST started on an unknown date. Pharmacist reported that they had one staff member who received FLUMIST who was over 50 years of age. The outcome of the event of administration to a person over 50 years of age is unknown. The report was considered to be non-serious.
Age: 39.0
Sex: F
Vaccine: FLUN4
Symptoms: Bronchitis, Chills, Pyrexia, Respiratory tract congestion
Clinical narrative: A report has been received from a Health Professional who is a patient herself of 39 years old, who had been receiving FLUMIST. FLUMIST started on 09-Sep-2013. The patient experienced fever, chills, bronchitis and congestion which started on 09-Sep-2013. FLUMIST was discontinued on 09-Sep-2013. The patient recovered from the event of fever, chills, bronchitis, and congestion on 23-Sep-2013. The report was considered to be non-serious.
Age: 1.94
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 05-Oct-2013. The Nurse Practitioner reported that they had inadvertently given FLUMIST to a 23 month old patient on 05-Oct-2013. No symptoms and side effects were observed after administration. The patient recovered from the event of we inadvertently gave FLUMIST to a 23 month old on an unspecified date. The report was considered to be non-serious.
Age: 57.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 57 year old, male subject, who had been receiving FLUMIST. The patient's concurrent disease(s) included egg allergy. FLUMIST started on 05-Nov-2013. It was reported that patient was administered FLUMIST to a 57 year old which started on 05-Nov-2013. The outcome of the event of administered FLUMIST to a 57 year old is unknown. The report was considered to be non-serious.
Age: 52.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 52 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The medical assistant reported that they did notice the patient's age that it was out of the window and inadvertently gave FLUMIST quadrivalent to a patient who was 52 years old on 06-Nov-2013 and were not reporting any symptoms. The outcome of the event of administered FLUMIST quadrivalent to a 52 year old is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 20-Nov-2013 from health professional: Narrative update.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Epistaxis, Face injury, Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 13-Nov-2013. The reporter stated that the patient's nose was bumped during the administration and started the nose bleed after that he did not let us do the second side which started on 13-Nov-2013. The patient recovered form the event of nose bleed on 13-Nov-2013. The patient recovered from the event of nose was bumped during the administration on an unspecified date and the outcome of the event of not let us do the second side is unknown. The event of nose bleed was considered to be non-serious by the reporter. The events of not let us do the second side and nose was bumped during the administration have been identified by the company physician from the source documents and added as non-serious adverse events. Summary of follow-up information received by AstraZeneca/MedImmune on 20-Nov-2013 from a Health Professional: New reporter was added (patient). The outcome of the event of nose bleed was changed from unknown to recovered. Corrected report on 29-Nov-2013: The event onset date of the event of nose bleed was added. Two new events were added (not let us do the second side and nose was bumped during the administration).
Age: 0.7
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Health Professional concerning a 7 month old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The health professional reported that they inadvertently gave a half dose of FLUMIST to seven month old on 13-Nov-2013. The outcome of the event of gave half dose of FLUMIST to seven month old is unknown. The report was considered to be non-serious.
Age: 71.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 71 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 09-Nov-2013. PharmD stated: another Pharmacist gave QUAD to a 71 year old male. The patient experienced  FLUMIST given to 71 year old male which started on 09-Nov-2013. The outcome of the event of FLUMIST given to 71 year old male is unknown. The report was considered to be non-serious by the reporter.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 02-May-2004, male subject who had been receiving FLUMIST. FLUMIST started on 28-Sep-2013. Registered nurse reported that a patient received FLUMIST twice, one and one half months apart. The outcome of the event of patient received FLUMIST twice is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a physician concerning a female patient of unknown age. No medical history, concurrent diseases and concomitant medications were reported. On an unspecified date, the patient received FLUMIST. Dosing and frequency were not reported. Patient received FLUMIST and found out she was pregnant. The outcome of the event of patient received FLUMIST and found out she was pregnant is unknown. The report was considered to be non-serious by the reporter. Summary of follow-up information received on 21-Jun-2013 from physician. New reporter and patient initials added.
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 17 year old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. Pharmacist reported that the patient received only a half dose of FLUMIST in one nostril which started on 11-Nov-2013 at a mobile clinic. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 16.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 16 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The reporter stated that the patient was administered only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 38.0
Sex: M
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 38 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The reporter stated that the patient had administration of only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 11 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. It was reported that the consumer was administered only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 38.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 38 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The reporter stated that the patient was administered only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 13 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient was administered only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 7 year old, male subject who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. Pharmacist reported that the patient received only a half dose FLUMIST in one nostril started on 11-Nov-2013 at a mobile clinic. The out outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 48.0
Sex: M
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 4 month old, male subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The reporter stated that the patient had administration of only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious. Correct report 10-Dec-2013. They key ingredient of the suspect product was corrected from FLUMIST to Q/LAIV.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning an 11 year old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. Pharmacist reported that the patient received only a half dose FLUMIST in one nostril which started on 11-Nov-2013 at one of the mobile clinics. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 13 year old, female subject,  who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. It was reported that patient was administered half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 14.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Health Professional concerning a 14 year old, male subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The nurse reported that the son of one of the nurses received full dose of FLUMIST in one nostril which started on 25-Nov-2013. The outcome of the event of the son of one of our nurses received full dose of FLUMIST is unknown. The report was considered to be non-serious.
Age: 20.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 20 year old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. Pharmacist reported that the patient received only a half dose FLUMIST in one nostril on 11-Nov-2013 at a mobile clinic. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 31.0
Sex: U
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 31 year old, subject of unknown gender, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient was administered only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 44.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 44 year old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The reporter reported that on 11-Nov-2013 multiple patients received only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious. Corrected report 10-Dec-2013: The key ingredient of the suspect product was corrected from FLUMIST to Q/LAIV.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a patient born on 20-Dec-2004, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. It was reported by the pharmacist that patient had administration of only a half dose of FLUMIST in one nostril. The outcome of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 51.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 51 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 01-Nov-2013. The nurse reported they inadvertently gave FLUMIST to a person over 49 years of age on 01-Nov-2013. The outcome of the event of we inadvertently gave FLUMIST to a person over 49 years is unknown. The report was considered to be non-serious.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning an 8 year old, female subject, who had been receiving FLUMIST. FLUMIST was started on 11-Nov-2013. The patient received only a half dose FLUMIST in one nostril, which was started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious by the reporter.