chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Throat tightness
Clinical narrative: A spontaneous report has been received from a consumer concerning a 17 year old, female patient. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving nasal FLUMIST started on 11-JAN-2013. The reporter stated that the patient received FLUMISTS and 17 days later she had an anaphylaxis reaction on 28-JAN-2013. Her face and body broke out into a rash, throat closed, eyes swollen eyes shut, and blood pressure dropped. The reporter also reported that daughter was having exercise class the day the reaction occurred. The reporter stated that doctor did not feel like the reaction was attributed to FLUMIST. The patient recovered from the event of anaphylaxis reaction on an unspecified date. The company physician considered the event of anaphylaxis reaction to be serious with criteria of important medical event. Corrected report 29-MAY-2014; the key ingredient changed from QLAIV to FLUMIST. The product is reported changed from FLUMIST Quadrivalent to FLUMIST.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A report has been received from a Physician concerning an 11 year old, Female subject, who had been receiving FLUMIST. FLUMIST started on 19-Sep-2012. On 19-Sep-2012, the patient received 2 doses of FLUMIST five minutes apart. The physician stated that the child did receive 2 full doses of FLUMIST but experienced no side effects. He indicated that after the FLUMIST was ordered for the child a nurse gave a full dose but did not sign that it was given, a second nurse noted FLUMIST needed to be given and gave a full second dose. The outcome of the event of 2 doses of FLUMIST given 5 minutes apart is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 05-Dec-2012 from physician: Reporter confirmed that patient was given two full dose inadvertently and no adverse event occurred, narrative updated. Corrected report 17-Dec-2012: Reporter details corrected, route, second lot number and expiration date of FLUMIST, coding of event '2 doses of FLUMIST given 5 minutes apart' changed to extra dose administered. Corrected Report on 10-Apr-2014: Ethnic origin added. Second lot number and expiration date added of the suspect drug. Coding of event of 2 doses of FLUMIST given 5 minutes apart changed to inappropriate dose of vaccine administered. Title of the reporter added. Narrative added.
Sex: U
Vaccine: FLUN3
Symptoms: Nausea
Clinical narrative: A report has been received from a literature source concerning an adult, subject of unknown gender, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. The patient experienced nausea. The outcome of the event nausea is unknown. The report was considered to be non-serious.
Age: 47.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Hypoaesthesia, Pyrexia, Tremor
Clinical narrative: A report has been received from a pharmacist concerning a 47 year old, female subject who had been receiving nasal FLUMIST.  The patients medical history included FLU vaccination. The patient experienced moderate numbness from nose down to chin, moderate fevers up to 37.5 degrees Celsius and severe headaches which started on 05-JAN-2014. The patient recovered from the event of numbness from nose down to chin, moderate shaking,  fevers up to 37.5 degrees Celsius and severe headaches on an unspecified date. The report was considered to be non-serious. The reporter considered casual relationship between all the reported events and suspect drug/FLUMIST.
Sex: U
Vaccine: FLUN3
Symptoms: Gastrointestinal disorder
Clinical narrative: A report has been received from a literature source concerning an adult subject of unknown gender, who had been receiving nasal FLUMIST started on an unknown date. The patient experienced gastrointestinal symptoms. The outcome of the event of gastrointestinal symptoms is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Exposure via direct contact, Underdose
Clinical narrative: A report has been received from a health professional concerning a 6 year old, male patient. Concomitant medications and medical history were not reported. On 10-OCT-2012, the patient received FLUMIST. The health professional reported that they have inadvertently gotten FLUMIST in a patient's eye may have been given. The patient was examined next morning and his eye looked fine. At the time of the reporting the outcome of the events of inadvertently got FLUMIST into the patient's eye and partial dose may have been given was unknown.  The event of inadvertently got FLUMIST into patient's eye was considered to be non-serious by the reporter. The event of partial dose may have been given was identified by company physician from the source document and it was added as non serious event. Corrected report 06-DEC-2012 the coding of inadvertently got FLUMIST into patient eye was changed from wrong route of administration dispensed to drug administration error. Corrected report 10-APR-2014 full narrative, initials added, route corrected to ophthalmic.
Sex: U
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a pharmacist concerning a subject of unknown gender, who had been receiving nasal FLUMIST started on an unknown date. The patient experienced received partial dose. The outcome of the event of received partial dose is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A report has been received from a physician concerning a female patient (her daughter). Medical history, concurrent diseases and concomitant medication of the patient were not reported. On 06-Sep-2012, FLUMIST was administered to the patient as a single dose in one nostril. The action taken with FLUMIST was unknown. The outcome of the event of full dose administered in one nostril was unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 03-Oct-2012: vaccination date added. Corrected report 06-Dec-2012: Coding of event 'full dose administered in one nostril' changed from intentional drug misuse to drug administration error, narrative updated. Corrected report on 18-Apr-2014: reporter's details updated, full narrative added.
Sex: U
Vaccine: FLUN3
Symptoms: Anosmia
Clinical narrative: A report has been received from a Physician concerning, subject of unknown gender, who had been receiving FLUMIST, 0.2 milliliters, yearly. FLUMIST started on an unknown date. The patient experienced loss of smell. The outcome of the event of loss of smell is unknown. The report was considered to be non-serious. 02-Dec-2011: Corrected report 02-Dec-2011: Case was suppressed.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event
Clinical narrative: A report has been received from a health professional and a consumer concerning a 10 years old female patient. No medical history and concurrent diseases provided. Concomitant medications were not reported. On 26-Sep-2012 the patient was vaccinated with FLUMIST. She was administered the full dose of FLUMIST in just one nostril. It rolled out of her nose all the way to her chin. The outcome of the event of administration of full dose in one nostril was unknown. The report was considered to be non-serious by the reporter. Corrected report on 08-Nov-2012: First reporter is HCP, case is now medically confirmed. Corrected report on 14-Dec-2012: Coding of administration of full dose in one nostril was changed from circumstance or information capable of leading to medication error to drug administration error. The patient had no symptoms. Corrected report on 22-Apr-2014: Manufacturer, received last season and reporter details added. The case has been updated with full data due to term additional for FLUMIST / Q/Laiv.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Circumstance or information capable of leading to medication error, Exposure via direct contact
Clinical narrative: The report had been received from a registered nurse. The report concerns a 12 years old male patient. Concomitant medications, concurrent diseases and medical history were not reported. On 28-Aug-2012, the patient received FLUMIST but the child pulled back while the nurse was trying to administer FLUMIST. A minimal amount of the FLUMIST was sprayed into his eye. He was not revaccinated with FLUMIST. The outcome of the event of FLUMIST sprayed in eye is unknown. The event was considered to be non-serious by the reporter. The reporter and the company physician both considered the causality between the event and the suspect product to be unrelated. Summary of follow-up information received by AstraZeneca/MedImmune 29-Oct-2012 from Health Care professional: Ethnic origin updated. Corrected report 06-Nov-2012: Reporter entered as Health Care professional and case became medically confirmed. Additional reporter added. Corrected report 06-Dec-2012: Coding of event 'FLUMIST sprayed in eye' correct from inappropriate route of vaccination to drug administration error, narrative updated. Corrected report on 11-Apr-2014: The case has been updated with full data due to term additions for FLUMIST /Q/Laiv. For reference, source document can be found at case 2012SE70762.
Sex: U
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A report has been received from a pharmacist concerning four children of unknown age or gender. This report concerns one of the four patients. No concomitant medication or relevant history was provided. The patient had been receiving FLUMIST, started on an unknown date. The patient was accidentally administered both doses into a single nostril. The outcome of the event of accidentally administered both doses into a single nostril in 4 children was unknown. The report was considered to be non-serious by a company physician. Corrected report 15-Apr-2014: case category amended, narrative updated, additional report added.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event
Clinical narrative: A report has been received from a health professional concerning a male patient. The patient's concomitant diseases and concomitant medications were unknown. On an unknown date, receiving FLUMIST. The patient was administered of complete FLUMIST dose in one nostril. The action taken of FLUMIST was not applicable. The outcome of the event was unknown. The report was considered to be non-serious by  the reporter. Corrected report 16-Oct-2012: Case has been suppressed due to medication with no AE. Corrected report 06-Dec-2012: Coding of event 'administration of complete FLUMIST dose in one nostril' changed from circumstance or information capable of leading to medication error to drug administration error, narrative updated, reporter details corrected. Corrected report 14-Apr-2014: The has been updated with full data due to term additions for FLUMIST /Q/Laiv. For reference, source document can be found at case 2012SE70762.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A report has been received from a health professional concerning a 7 year old male patient. The patient's concomitant diseases and concomitant medications were unknown. On an unknown date the patient started to receiving nasal FLUMIST. The patient was administered of complete FLUMIST dose in one nostril which started on 23-SEP-2012. The action taken of FLUMIST was not applicable. The outcome of the event was unknown. The report was considered to be non-serious by the reporter. Corrected report 15-APR-2013. The case has been updated with full data due to KUR term additions for FLUMIST/Q/Laiv. Additional reporter added as patient.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A consumer report had been received concerning a 10 years old female patient. No medical history and concurrent diseases provided. Concomitant medications were not reported. On 17-Oct-2012 the patient was vaccinated with nasal FLUMIST and appeared to have little in the first nostril and a huge blast in the second nostril. The patient told that she didn't feel any in her first nostril. The action taken with FLUMIST was unknown. The report was considered to be non-serious by the reporter. Corrected report 15-Dec-2012: Event 'patient didn't feel any FLUMIST in first nostril' replaced with 'little in the first nostril and a huge blast in the second nostril', narrative updated, reporter details corrected. Corrected report on 16-Apr-2014: Drug and event start date added. The case has been updated with full data due to KUR term additions for FLUMIST/Q/Laiv.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 20-Dec-2013. The office manager reported that they gave expired FLUMIST QUADRIVALENT (preferred term: expired drug administered) which started on 20-Dec-2013. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a health professional concerning an 8 year old, subject of unknown gender, who had been receiving nasal FLUMIST started on an unknown date. The nurse reported that they inadvertently administered expired FLUMIST to the patient, which started on 14-JAN-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Age: 5.0
Sex: U
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, subject of unknown gender. who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The nurse reported that they inadvertently administered expired FLUMIST QUADRIVALENT to the patient which started on 14-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Age: 16.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 16 year old male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 24-Jan-2014. It was reported that nurse had administered expired FLUMIST QUADRIVALENT. (Preferred Term: Expired drug administered) to student which started on 24-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
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 started on 03-Dec-2013. It was reported that patient was given expired FLUMIST QUADRIVALENT inadvertently to forty-two patients on 03-Dec-2013. The outcome of the event of gave expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 13 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 06-Dec-2013. It was reported that patient was given an expired FLUMIST QUADRIVALENT which started on 06-Dec-2013. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 12 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 20-Jan-2014. It was reported that expired FLUMIST QUADRIVALENT was given to 42 patients which started on 20-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 16-Jan-2014. The reporter stated inadvertently gave expired FLUMIST QUADRIVALENT which started on 16-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 07-Jan-2014. It was reported that forty two patients were administered with expired FLUMIST QUADRIVALENT which was started on 07-Jan-2014. The outcome of the event gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A consumer report has been received. The report concerns a 4 year old, Male consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The patient inadvertently administered expired FLUMIST QUADRIVALENT given on 21-Jan-2014. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient received expired FLUMIST QUADRIVALENT. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
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 started on an unknown date. The patient received expired FLUMIST. The outcome of the event of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a non-medically confirmed source concerning a 13 year old female patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 03-Jan-2014 the patient received nasal FLUMIST QUADRIVALENT, but the vaccine was expired (Preferred Term: expired drug administered) on 02-Dec-2013. At the time of reporting, the outcome of the event of gave expired FLUMIST QUADRIVALENT was unknown. The report was considered to be non-serious by the reporter.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 9 year old, Female subject who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The patient experienced gave expired FLUMIST which started on 14-Dec-2013. The outcome of the event of gave expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
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 QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 17-Jan-2014. It was reported that expired FLUMIST QUADRIVALENT was administered to forty two patients which started on 17-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT 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 Pharmacist concerning a 7 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 14-Dec-2013. The patient was inadvertently administered expired FLUMIST QUADRIVALENT on 14-Dec-2013. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 14 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 21-Jan-2014. The patient was inadvertently administered expired FLUMIST QUADRIVALENT. No adverse experiences have been reported. The patient experienced gave expired FLUMIST QUADRIVALENT which started on 21-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter. Corrected report 05-Feb-2014: Case medically confirmed box ticked.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 20-Jan-2014. The patient was inadvertently give expired FLUMIST. The patient experienced gave expired FLUMIST QUADRIVALENT which started on 20-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A report has been received from a physician concerning a 4 year old female patient. Concomitant medications and concomitant diseases were not reported. During 2011 the patient started receiving FLUMIST (intranasal). The patient experienced hives which started on 11-Nov-2011. The action taken with FLUMIST was unknown. The outcome of the event of hives was unknown. The report was considered to be non-serious by the reporter.
Age: 45.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Pharmacist concerning a 45 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 03-Dec-2013. The patient was administered expired FLUMIST on 03-Dec-2013. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 40.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 40 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 5-Dec-2013. It was reported that four patients were inadvertently administered expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered) which started on 05-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST QUADRAVALENT to four patients is unknown. The report was considered to be non-serious. Corrected report 06-Jan-2013; Formulation corrected. Start date added to FLUMIST.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 9 year old, male subject, who has been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 05-Dec-2013. It was reported that four patients were inadvertently administered with expired FLUMIST QUADRIVALENT which started on 05-Dec-2013. The outcome od the event of inadvertently administered expired FLUMIST QUADRIVALENT to four patients is unknown. The report was considered to be non-serious.
Age: 38.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 38 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on unknown date. It was reported that four patients were inadvertently administered expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered) which started on 05-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST QUADRAVALENT to four patients is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A report has been received from a Health Professional via medical representative concerning, a patient of an unknown age and unknown gender. The patient's medical history and concurrent diseases were not provided. The patient concomitant medications were not provided. The patient has received nasal FLUMIST QUADRIVALENT started during Oct-2013. It was reported that patient received FLUMIST in October this year and contracted the flu over thanksgiving (Preferred Term: Influenza). Action taken on suspect drug was unknown. The outcome of the event was unknown. The reporter assessed the event of patient received FLUMIST in/ RN reported to me that patient received FLUMIST in October this year and contracted the flu over thanksgiving/ flu to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning afemale patient, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced expired FLUMIST QUADRIVALENT administration. The outcome od the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious by the reporter.
Age: 3.0
Sex: U
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Pharmacist concerning a 3 year old, subject of unknown gender, who had been receiving Nasal FLUMIST (Intranasal). FLUMIST (Intranasal) started on 11-Feb-2014. The patient experienced FLUMIST was administered on FEB 11th however the vaccine expired FEB 10th which started on 11-Feb-2014. The outcome of the event of FLUMIST was administered on FEB 11th however the vaccine expired FEB 10th is unknown. The report was considered to be non-serious.
Age: 34.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A Consumer report has been received concerning Vaccine exposure during pregnancy in a 34 year old, female consumer, who has been receiving nasal FLUMIST, 0.2 Millilitres, Once/Single administration. FLUMIST started during Dec-2013. The mother reporting that her daughter-in-law had the FLUMIST vaccine in Dec-2013 and found out recently that she was 8 weeks pregnant (Preferred Term: Exposure during pregnancy) (and was pregnant when she had the vaccine). Wondering what possible effect this might have on the baby. Pregnancy outcome was unknown. Pregnancy outcome was unknown. The outcome of the event of took the FLUMIST and found out she's pregnant is unknown. The report was considered to be non-serious.
Age: 1.36
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 1 year old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 17-Jan-2014. The reporter FLUMIST given by mistake to 18 month old (Preferred Term: Drug administered to patient of inappropriate age) which started on 17-Jan-2014. The outcome of the event of FLUMIST given by mistake to 18 month old is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: F
Vaccine: FLU3, FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old female patient. The relevant history and concomitant drugs of patient were not reported. The patient had been receiving nasal FLUMIST started on 19-Feb-2013. The  reporter stated that the patient received both FLUZONE and FLUMIST in the same season. FLUZONE was administered on 08-Jan-2013 and FLUMIST was administered on 19-Feb-2013. The mom denied that the patient received both FLUMIST and FLUZONE, bu they have record of the patient receiving both vaccines at the office. The outcome od the event of receives both FLUZONE and FLUMIST in the same seasonal was unknown. The reporter considered event of receives both FLUZONE and FLUMIST in the same season to be non-serious. Corrected report 30-Apr-2014: Dose of FLUMIST was added. Relation to patient was corrected. The case has been updated with full data due to KUR term additions for FLUMIST/Q/Laiv.
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 patient born on 07-Sep-2012, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 07-Jan-2014. The reporter stated FLUMIST given by mistake to 18 month old (Preferred Term: Drug administered to patient of inappropriate age). The outcome of the event of FLUMIST given by mistake to 18 month old is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis, Rhinorrhoea
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old female patient. The relevant history and concomitant disease of the patient were not reported. Concomitant medications included AGRIFLU. Patient has been receiving Nasal FLUMIST started on an unknown date for unknown indication. It was reported that patient had a blood clot with nasal mucous coming from nose (preferred term: epistaxis). The patient recovered from the event of blood clot with nasal mucous coming from nose on an unspecified date. The report was considered to be non-serious by reporter.
Sex: U
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A report has been received from a health professional (nurse practitioner) concerning two patients of unknown gender. This report refers to one them. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unspecified date, the patient started receiving a treatment with nasal FLUMIST. The patient developed bloody nose. The action taken with the suspect drug was unknown. The patient recovered from the event of bloody nose on an unspecified date. The report was considered to be non-serious by the reporter.
Sex: U
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a, subject of unknown gender, who had been receiving Nasal FLUMIST (Intranasal). FLUMIST (Intranasal) started on 14-Mar-2014. The patient was administered FLUMIST on March 14th, 2014, past expiry date which started on 14-Mar-2014. The outcome of the event of a patient was administered FLUMIST on March 14th, 2014, past expiry date is unknown. the report was considered to be non-serious.
Sex: M
Vaccine: FLUN3
Symptoms: Influenza virus test positive, Pyrexia
Clinical narrative: A spontaneous report has been received from a Health Professional concerning a 02 year old, male patient. No information regarding medical history, concomitant disease or concomitant medication was provided. The patient was receiving Nasal FLUMIST (intranasal) started on an unknown date. The reporter stated that one their patients had a fever 102 Degree Fahrenheit on and tested positive for the flu which started on 27-Nov-2012 a few weeks after receiving FLUMIST. The outcome of the events of fever and tested positive for the flu was unknown.  The reporter considered the events fever and tested positive for the flu as non-serious.
Age: 29.0
Sex: M
Vaccine: FLUN3
Symptoms: Chest discomfort, Cough, Wheezing
Clinical narrative: A report has been received from a Health Professional via medical representative concerning a 29 year old male patient. The follow up was received from consumer via spontaneous source. The patient's medical history included wheezing in Jan-2009 and the patient was treated for borderline bronchitis in Jan-2009. The patient's concomitant medications were not provided. The patient received nasal FLUMIST started during Dec-2011. It was reported that the patient was treated for wheezing in Jan-2009, he received FLUMIST in Dec-2011 and Jan-2012 he experienced wheezing (Preferred Term: Wheezing) two weeks later. It was also reported that there have been at least 5 elementary aged patients in the past two years and have come into the office to get treated for wheezing after having received the FLUMIST. The patient's wife submitted the questionnaire. It was reported that the patient had coughing and chest tightness during the event. He was medically attended and the episode was managed by breathing treatments 3-4 daily for 1 week. The patient had given antibiotics and robitussin AC. The event lasted for 1 week. The symptoms resolved with the treatment. The patient recovered from the event of wheezing on an unspecified date. The reporter assessed the event of wheezing to be non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Autoimmune neutropenia, Incomplete course of vaccination, Neutrophil count decreased, Pyrexia
Clinical narrative: A report has been received from health professional via MHRA concerning, a 10 month old, female patient. The reporter was also received from consumer via spontaneous source. The patient's medical history was not provided. The patient's concomitant medications were not reported. The patient received influenza virus vaccine, 1 df started on an unknown date. The route of administration and formulation information was unknown. It was reported that the patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal Influenza vaccine) on an unknown date. One to two weeks post vaccination the patient had high fever. Doctors concluded that she had neutropenia. Her neutrophil counts were so low that she was hospitalized for a couple of days. It took five months for her count to return to normal range. She had not had an event since then. The doctors thought it was autoimmune neutropenia. Her mother refused to administer a second dose of vaccine. The patient recovered from the events of autoimmune neutropenia, fever and neutrophil count decreased on an unspecified date. The reporter assessed the events of autoimmune neutropenia, fever and neutrophil count decreased to be serious with the criteria of hospitalization.
Age: 53.0
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 53 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 18-Nov-2013. It was reported they inadvertently gave FLUMIST QUADRIVALENT to a patient over 49 years of age. The outcome of the event of inadvertently gave FLUMIST QUADRIVALENT to a patient over 49 years of age is unknown. The report was considered to be non-serious. Corrected report 20-Jan-2014: Key ingredient and formulation corrected.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The reporter stated that on 21-Jan-2014, the patient was inadvertently administered FLUMIST QUADRIVALENT which expired on 20-Jan-2014 and also stated that no other details are available. The outcome of the event of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by reporter.
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient received expired FLUMIST QUADRIVALENT. She did not experience any adverse events. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious by the reporter.
Age: 43.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Pharmacist concerning a 43 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 21-jan-2014. The pharmacist reported that we inadvertently administered expired FLUMIST QUADRIVALENT to a patient on 21-Jan-2014. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Physician concerning a male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. On 21-Jan-2014, patient received expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered). The outcome of the event of administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL) started on 14-Jan-2014. The patient experienced FEVER and COUGH which started on 21-Jan-2014. At the time of reporting, the event of FEVER and COUGH was ongoing. The report was considered to be non-serious by the reporter. The reporter considered that there was no causal relationship between FEVER and FLUMIST QUADRIVALENT and COUGH and FLUMIST QUADRIVALENT. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the events fever and cough to be unrelated to the investigational product FLUMIST QUADRIVALENT. Corrected report 04-Feb-2014: Company causality added.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza, Vaccine breakthrough infection
Clinical narrative: A report has been received from physician via medical representative, concerning patients of unknown age and gender. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. Physician reported to her that she has had a lot of breakthrough influenza cases this season with nasal FLUMIST QUADRIVALENT (Intranasal) at her pediatric practice. She vaccinated children with FLUMIST for ages 6months to 5 years. She did not have exact number of breakthrough cases or any information on which patients. The outcome for the events of breakthrough influenza and vaccinates children with FLUMIST for ages 6 months to 5 years was unknown.  The reporter assessed the event of breakthrough influenza to be non-serious. The company physician added the event of vaccinates children with FLUMIST for ages 6 months to 5 years from the source document as non-serious adverse event.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza virus test positive
Clinical narrative: A report has been received from a Health Professional concerning, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced tested positive for flu (Preferred term: influenza virus test positive). The outcome of the event of tested positive for flu is unknown. The report was considered to be non-serious by the reporter.
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A health professional report has been received. The report concerning the 6th patient of 42 patients born on 25-Jan-1999, Male consumer, who had been receiving Nasal FLUMIST. FLUMIST (INTRANASAL) started on 17-Jan-2014. No adverse experiences have been reported. The patient was inadvertently EXPIRED FLUMIST QUADRIVALENT GIVEN. The outcome of the event of GAVE EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 22-Feb-1999, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started 21-Jan-2014. Office manager reported that they inadvertently administered expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered) to forty two patients. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by reporter.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 09-Jan-2003, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 18-Dec-2013. It was reported that expired FLUMIST QUADRIVALENT was administered to 42 patients on 18-Dec-2013. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A health professional report has been received. The report concerns a 10 year old, Female consumer who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on an unknown date. The reporter stated inadvertently GAVE EXPIRED FLUMIST QUADRIVALENT which started on 15-Dec-2013. The outcome of the event of GAVE EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A health professional report has been received. The report concerns a 10 year old, female consumer, who had been received nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated inadvertently gave expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered) which started on 12-Dec-2013. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
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 nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 22-Jan-2014. The office manager reported that they gave expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered) on 22-Jan-2014. No adverse experiences had been reported. The outcome of the event of gave expired FLUMIST QUADRIVALENT in unknown. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 20-Dec-2013. The patient was inadvertently given expired FLUMIST QUADRIVALENT. The patient experienced GAVE EXPIRED FLUMIST QUADRIVALENT which started on 20-Dec-2013. The outcome of the event of GAVE EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter. Corrected report 05-Feb-2014: Case medically confirmed box ticked.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning an 8 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal) started on 21-Jan-2014. It was reported that forty two patients were administered with expired FLUMIST QUADRIVALENT which started in 21-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A health professional report has been received. The report concerns a 10 year old, female consumer, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated inadvertently gave expired FLUMIST QUADRIVALENT (Preferred Term: expired drug administered) which started on 15-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 17 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 20-Jan-2014. Inadvertently was given expired FLUMIST QUADRIVALENT to the patient. The patient experienced GAVE EXPIRED FLUMIST QUADRIVALENT which started on 20-Jan-2014. The outcome of the event of GAVE EXPIRED FLUMIST QUADRIVALENT is unknown. The reporter was considered to be non-serious by the reporter.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, Female subject who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT started on 22-Jan-2014. It was reported that forty two patients were administered with expired FLUMIST QUADRIVALENT which started on 22-Jan-2014. The outcome of the event of GAVE EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 30-Dec-2013. It was reported that forty two patients were administered with expired FLUMIST QUADRIVALENT on 30-Dec-2013. The outcome of the event of GAVE EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, male subject, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 12-Dec-2013. It was reported that forty two patients were administered with expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered) which started on 12-Dec-2013. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 16-Jan-2014. The patient was inadvertently given expired FLUMIST QUADRIVALENT. The patient experienced gave expired FLUMIST QUADRIVALENT which started on 16-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered  toe non-serious by the reporter. Corrected report 05-feb-2014: Case medically confirmed box ticked.