chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from an office manager concerning a 3 year old, female patient who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) was administered on 13-Jan-2014. The office manager reported that they gave EXPIRED FLUMIST QUADRIVALENT to patient which occurred on 13-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: 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 an unknown date. It was reported, they gave expired FLUMIST QUADRIVALENT to the patient (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: 1.03
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 1 year old, Male subject, who had been receiving Nasal FLUMIST QUARIVALENT(Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 17-Jan-2014. It was reported that FLUMIST QUADRIVALENT was administered to 12 months old which started on 17-Jan-2014. The outcome of the event of administered FLUMIST QUADRIVALENT to a 1 yo is unknown. The report was considered to be non-serious.
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from an office manager concerning a 15 year old, male patient who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) was administered on 15-Jan-2014. The office manager reported that they gave expired FLUMIST QUADRIVALENT which occurred 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.
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 30-Dec-2009, male subject, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. It was reported, they gave expired FLUMIST QUADRIVALENT to the patient (Preferred Term: Expired drug administered).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 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 16-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: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a health professional concerning a 10 year old, female subject who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 11-Dec-2013. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 1.04
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 1 year old male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 22-Jan-2014, the patient was received nasal FLUMIST QUADRIVALENT. The patient experienced inadvertently administered FLUMIST QUADRIVALENT to a 1 year old (preferred term: drug administered to patient of inappropriate age) which started on 23-Jan-2014. The outcome of the event of inadvertently administered FLUMIST QUADRIVALENT to a 1 year old is unknown. The report was considered to be non-serious by the company physician.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a non-medically confirmed source concerning a 3 year old female patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 17-Dec-2014 the patient was 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: 10.0
Sex: F
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 16-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.
Sex: F
Vaccine: FLUN4
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Physician via medical representative concerning, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started during Oct-2013. The patient experienced tested positive for Influenza A over the holidays. The outcome of the event of tested positive for Influenza A over the holidays is unknown. The report was considered to be non-serious. Corrected report: 05-Feb-2014: Key Ingredient corrected. Postal code added.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 19-Dec-2013. The reporter stated that inadvertently expired FLUMIST QUADRIVALENT administered which stared on 19-Dec-2013. The outcome os the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious by the reporter.
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). FLUMIST QUADRIVALENT (INTRANASAL) started on 20-Dec-2013. The medical assistant reported that on 20-Dec-2013, two patients received expired FLUMIST QUADRIVALENT. The outcome of the event of ADMINISTRATION OF EXPIRED DOSE is unknown. The report was considered to be non-serious by reporter.
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 20-Dec-2013. The reporter mentioned that patient was administered expired dose of FLUMIST (preferred term: expired drug administered) on 20-Dec-2013. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A report has been received from a Health Professional concerning male patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient had been received nasal FLUMIST QUADRIVALENT on 04-Oct-2013. It was reported that the patient had influenza A. The outcome of the event of Influenza A was unknown. The reporter considered the event 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 17-Dec-2013. It was reported that patient  was inadvertently administered an expired FLUMIST QUADRIVALENT which started on 17-Dec-2013. The outcome of the event of inadvertently administered of 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 nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 17-Dec-2013. The health professional reported that they inadvertently gave three doses of expired FLUMIST (preferred term: expired drug administered) on 17-Dec-2013. The outcome of the event of administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 29.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 29 year old, Male subject who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 17-Dec-2013. It was reported that patient was administered an expired FLUMIST QUADRIVALENT which started on 17-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a health professional concerning a 12 year old, male subject, who had been receiving nasal FLUMIST QUADRIVALENT. The patient's medical history, concurrent diseases and concomitant medications were not reported. FLUMIST QUADRIVALENT started on 19-Dec-2013. The patient experienced expired FLUMIST QUADRIVALENT administered (preferred term: expired drug administered) on 19-Dec-2013. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, female subject, who has been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 26-Oct-2013. The patient experienced FLU A which started on 14-Dec-2013. The outcome of the event of FLU A is unknown. The report was considered to be non-serious by the reporter.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: A spontaneous report has been received from Health Professional reporting for 5 patients and this report is concerning a 07 years old male patient. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving Nasal FLUMIST started on 27-Aug-2013. The patient received FLUMIST of lot BH2174. He tested positive on Flu A on 19-Dec-2013, he was not hospitalized but was treated with TAMIFLU. The action taken with FLUMIST was not applicable. The outcome of the event of Flu A was unknown. The reporter considered the event of Flu A to be non-serious.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: A report has been received from a health professional concerning a female patient. Medical history and concomitant medications of the patient was not reported. The patient had received FLUMIST (intranasal) on 05-Nov-2013. It was reported that the patient was tested positive for Flu A. Patient was not hospitalized and was treated with TAMIFLU. Action taken with FLUMIST was not applicable. The outcome of the event of flu was unknown. The reporter considered the event Flu A to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, female patient. The relevant history and concomitant drugs of patient were not reported. The patient had been receiving nasal FLUMIST QUADRIVALENT (intranasal) started on 27-Sep-2013. The patient was tested for Flu A on 19-Dec-2013. She was not hospitalized, but was treated with TAMIFLU. It was reported that 5 patients were tested positive for Flu. This patient was one among them. The outcome of the event of flu A was unknown. The reporter considered event of flu A to be non-serious. Laboratory values are available.
Age: 0.02
Sex: M
Vaccine: FLUN4
Symptoms: Injection site erythema
Clinical narrative: A Consumer report has been received. The report concerns a 1 month old, male consumer, who had been receiving intramuscular SYNAGIS, 15.0 Milligrams per kilogram, Unknown and Nasal FLUMIST QUAD. Concomitant medications included Furosemide, Levothyroxine sodium and Acetylsalicylic Acid. SYNAGIS started on 22-Nov-2013 and FLUMIST QUADRIVALENT started on an unknown date. The patient experienced red spot on right leg (Preferred term: injections site erythema) which started on 22-Nov-2013. The patient recovered from the event of red spot on right leg on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/Medimmune on 03-Jan-2013 from consumer: new suspect drug FLUMIST was added. Corrected report 15-Jan-2014: Event onset date added. Reported details updated Concomitant drugs added.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a health professional, concerning a female patient. Patient was a twin. No relevant history, concomitant disease or concomitant medications of the patient were reported. The patient had received nasal FLUMIST QUADRIVALENT (Intranasal) on 05-Nov-2013, of lot number BJ2014. It was reported that the patient tested positive for FLU A sometime between 14-Dec-2013. Patient was not hospitalized and was treated with TAMIFLU. The outcome of the event of flu A was unknown. The reporter assessed the event to be non-serious.
Age: 29.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional via medical representative concerning, a female patient. The reporter for four patients and this case relates to one of the four patients. The patient's medical history and concurrent diseases were not provided. The patient's concomitant medications were not provided. The patient received FLUMIST (intranasal) started on 08-Nov-2013. The reporter said there were 6 patients with 1 doctor who tested positive for influenza A. She thought that 3 of those patients had FLUMIST, the other 3 received a different product. After review of the files from that day, there were only 2 patients who received FLUMIST and 2 employees who received FLUMIST and tested positive for influenza A. On unspecified date, the patient experienced Influenza A. It was reported that there were positive tests for influenza A in the past few weeks. Patients were not hospitalized due to event. It was also reported that none of the patients/employees were treated. All of the other patients diagnosed with the flu on Monday had either the shot or no flu prophylaxis. The outcome of the event of Influenza A was unknown. The reporter considered the event to be non-serious.
Age: 32.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning male patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient had been received nasal FLUMIST QUADRIVALENT (intranasal) on 10-Sep-2013. The reporter stated there were 6 patients with 1 doctor who tested positive for influenza A. She thought that 3 of those patients had FLUMIST QUADRIVALENT, the other 3 received a different product. After review of the files from that day, there were only 2 patients who received FLUMIST QUADRIVALENT and 2 employees who received FLUMIST QUADRIVALENT and tested positive for influenza A. On unspecified date, the patient experienced influenza A. The outcome of the event of Influenza A was unknown. The reporter considered the event to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: A report has been received from a health professional concerning a male patient born on 19-Jun-2009. The relevant history and concomitant drugs of patient were not reported. The patient had been receiving nasal FLUMIST QUADRIVALENT started on 28-Aug-2013. A Registered Nurse in a doctor's office reported that they have had six cases of influenza A in individuals who had received FLUMIST QUADRIVALENT.  She did not have patient demographics, information of the FLUMIST used, or MD information. She stated the Registered Nurse told her that two individuals were staff members of the clinic. Registered Nurse said the positive tests were in the past few weeks. He was tested positive on Monday, not treatment. The outcome of the event of Influenza A was unknown. The reporter considered the event of influenza A to be non-serious. Laboratory values are available.
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 (Intranasal). FLUMIST (Intranasal) started on an unknown date. Reporter indicated that the patent received expired FLUMIST and did not report ant adverse events. The patient experienced EXPIRED FLUMIST ADMINISTERED. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The report was considered to be non-serious by the company physician.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A consumer report has been received. The report concerns an 11 year old, male consumer, who had been received nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated that a patient received a dose of expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered) which started on 20-Jan-2014. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious by the reporter.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a licensed practical nurse concerning a 4 year old, female patient, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT had been provided on 15-Jan-2014. It was reported that the patient had been administered expired FLUMIST QUADRIVALENT (Preferred Term: expired drug administered) on 15-Jan-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a physician concerning an 8 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The reporter stated that they accidentally gave a dose of expired FLUMIST which started on 17-Jan-2014. The outcome of the event of gave a dose of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Age: 39.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Pharmacist concerning a 39 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (INTRANASAL) started on 07-Jan-2014. The pharmacist reported that they accidentally gave a dose of expired FLUMIST which started on 07-Jan-2014. The outcome of the event of EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 17.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 17 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 21-Jan-2014. Office manager reported that on 21-Jan-2014, they inadvertently gave expired FLUMIST QUADRIVALENT to two patients. Not reporting any symptoms. The outcome of the event of INADVERTENTLY ADMINISTERED EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by reporter.
Sex: M
Vaccine: FLUN4
Symptoms: Influenza virus test positive
Clinical narrative: A report has been received from a Physician concerning, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 30-Sep-2013. The patient experienced tested positive for Flu (Preferred term: Influenza virus test positive) which started on 13-Jan-2014. The outcome of the event of tested positive for Flu is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Exposure during breast feeding
Clinical narrative: A report was received from a consumer concerning a patient with unknown gender and age. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unknown date, the patient administered with transmammary FLUMIST. The reporter stated that she was administered FLUMIST and she were nursing. At the time of reporting the outcome of the event of was administered FLUMIST and she was nursing was unknown. According to the reporter the report was considered to be non-serious. Corrected report on 25-Feb-2014: coding of the event of was administered FLUMIST and she is nursing changed from maternal exposure timing unspecified to exposure during breast feeding, narrative updated.
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been reported from a Health Professional concerning, male subject, who had been receiving FLUMIST (INTRANASAL), once for FLU VACCINE. FLUMIST (INTRANASAL) started on 23-Jan-2014 for FLU VACCINE. The nurse reported that she gave expired product which started on 23-Jan-2014. FLUMIST (INTRANASAL) was discontinued on 23-Jan-2014. The outcome of the event of GAVE EXPIRED PRODUCT is unknown. The report was considered to be non-serious.
Age: 53.0
Sex: F
Vaccine: FLUN4
Symptoms: Blood blister
Clinical narrative: A report has been received from a Pharmacist concerning a 53 year old, Female subject, who had been receiving Nasal FLUMIST ( Intranasal), 0.2 milliliters, Daily for flu vaccination. The patients concurrent disease(s) included diabetes. Concomitant medication included Indapamide, Perindopril erbumine for hypertension, ENTERCAVIR for hepatitis B and Rosuvastatin for hypercholesteremia. FLUMIST (Intranasal) started on 08-Jan-2014 for flu vaccination. The patient experienced mild blood blisters on the arm which started on 13-Jan-2014. FLUMIST (Intranasal) was discontinued on 08-Jan-2014. The patient recovered from the event of blood blisters on the arm on 20-Jan-2014. The report was considered to be non-serious. Reporter assessed the event was related to suspect drug. Summary of follow-up information received by AstraZeneca/Medimmune 04-Feb-2014 from pharmacist: Patients demography was added. Reporter causality was added. Concomitant medicine and disease were added. Outcome for the event was also updated.
Age: 1.0
Sex: U
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, subject of unknown gender, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. It was reported by Health Professional that inadvertently administered FLUMIST to a 12 month old child. The outcome of the event of nurse inadvertently administered FLUMIST to a 12 month old child 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, No adverse event
Clinical narrative: A report has been received from a Physician concerning a 66 year old, male subject, who had been receiving FLUMIST (INTRANASAL). The patient's medical history included CHEMOTHERAPY. The patient's concurrent disease(s) included CANCER, DIABETIC and HYPERTENSION. FLUMIST (INTRANASAL) started on 08-Jan-2014. The patient experienced no AE, only inadvertent administration of vaccine. FLUMIST was discontinued on 08-Jan-2014. The outcome of the event of NO AE, ONLY INADVERTENT ADMINISTRATION is unknown. The report was considered to be non-serious.
Age: 32.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 32 year old, female patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 15-Jan-2014 the patient received nasal FLUMIST QUADRIVALENT, but the vaccine was expired on November 25, 2013. At the time of reporting, the outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Age: 56.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood blister
Clinical narrative: A report has been received from a Pharmacist concerning an Adult, male subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST(INTRANASAL) started on 08-Jan-2013. The patient experienced BLOOD BLISTER ON THE ARM which started on 12-Jan-2014. FLUMIST (INTRANASAL) was discontinued on 08-Jan-2014. The patient recovered from the event of BLOOD BLISTER ON THE ARM on 16-Jan-2014. The report was considered to be non-serious by the reporter. The reported case causality was considered between the event of BLOOD BLISTER ON THE ARM and the suspect drug of FLUMIST to be Yes. Summary of follow-up information received by AstraZeneca/MedImmune 04-Feb-2014 from a Pharmacist dose and frequency added, lot number, patient's initials and date of birth added, medical history and reported case causality added.
Sex: F
Vaccine: FLUN3
Symptoms: Hypersensitivity, Rash pruritic
Clinical narrative: A report has been received from a pharmacist via the Regulatory Authority concerning a female patient. No concomitant drugs or relevant history was provided. The patient had been receiving FLUMIST, (intranasal), 0.2 millilitres started on an unknown date. The patient experienced hypersensitivity and rash pruritic. Action taken with the suspect drug was unknown. The patient recovered from the events of hypersensitivity and rash pruritic on an unspecified date. The report was considered to be non-serious by the reporter.
Age: 65.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 65 year old, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The reporter mentioned that he inadvertently administered FLUMIST to 65 year old. The outcome of the event of inadvertent administration to 65 yr old is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: A report has been received from a Physician via medical representative, then follow-up received from a health professional. The report concerns concerning a 4 years old male patient. Concomitant medications, concurrent diseases and medical history were not provided. On an unknown date, the patient received nasal FLUMIST QUADRIVALENT. On 08-Jan-2014 the patient tested positive for flu A, after receiving FLUMIST QUADRIVALENT. The patient recovered from the event on an unspecified date. The report was considered to be non-serious by company physician. Summary of follow-up information received by AstraZeneca/MedImmune on 04-Feb-2014 from health professional: patient identifier were reported, event term changed to tested positive from flu A from twelve to fifteen patients developed fairly severe flu A after receiving FLUMIST QUADRIVALENT, event start date added, lot and expiration date for the suspect product added, case became valid, narrative updated.
Age: 57.0
Sex: M
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 57 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The registered nurse reported that a 57 year old received FLUMIST on 26-Nov-2013. Patient had not reported any adverse effects. The outcome of the event 57 year old received FLUMIST is unknown. The report was considered to be non-serious.
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 FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 29-Nov-2013. It was the patient was administered expired FLUMIST on 29-Nov-2013. Patient had reported any symptoms. The outcome of the event of ADMINISTERED EXPIRED FLUMIST is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 10-Dec-2013 from Health Professional: Lot number of FLUMIST added. Start date of event and state date of FLUMIST updated to 29-Nov-2013. Patient details added.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 09-Dec-2013. The Licensed Practical Nurse reported that they accidentally gave a patient a dose of expired FLUMIST on 09-Dec-2013. The patient had not experienced any adverse symptoms. The outcome of the event of gave patient a dose of expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been received Nasal FLUMIST QUADRIVALENT (INTRANASAL) started on 04-Dec-2013. The nurse reported that patient was given expired FLUMIST which started on 04-Dec-2013. The outcome of the event of PATIENT WAS GIVEN EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 15 year old, male subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The reporter mentioned that patient was accidentally given expired FLUMIST on 04-Dec-2013. The outcome of the event of WE ACCIDENTALLY GAVE EXPIRED FLUMIST TO A PATIENT is unknown. The report was considered to be non-serious.
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 had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The reporter mentioned that patient experienced administration of expired FLUMIST on 09-Dec-2013. The outcome of the event of administration of expired FLUMIST 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, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The reporter stated that on 10-Dec-2013 there was administration of expired FLUMIST in error to the patient. The outcome of the event of administration is unknown. The report was considered to be non-serious.
Age: 50.0
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 50 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's concurrent disease(s) included Type 2 diabetes, hypercholesterolemia, GERD and obesity. Concomitant medications included atorvastatin, lisinopril, metformin and ranitidine. FLUMIST QUADRIVALENT (Intranasal) started on 05-Nov-2013. The patient over 50 years of age received FLUMIST QUADRIVALENT which started on 05-Nov-2013. The outcome of the event of received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by AstraZeneca/MedImmune on 17-Dec-2013 from Health Professional: Concomitant disease and concomitant drugs were added.
Age: 50.0
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 51 year old, female subject, who had been receiving FLUMIST (INTRANASAL) 0.5 mg 1m. The patient's medical history included EXCESSIVE MENSTRUATION. The patients concurrent disease(s) included TYPE 2 DIABETES and ANEMIA. Concomitant medications included trazodone hydrochloride, metformin, glipizide and ferrous sulfate. FLUMIST (INTRANASAL) started on 05-Nov-2013. The patient over 50 years of age received FLUMIST on 05-nov-2013. The outcome of the event of RECEIVED FLUMIST is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 17-Dec-2013 from Health Professional:  A dosing regimen added: Concomitant drugs and concomitant diseases added.
Age: 52.0
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 52 year old, Male subject, who had been receiving FLUMIST, (intranasal). The patient's concurrent disease(s) included Type 2 Diabetes, Hypertension and Hypercholesterolemia. Concomitant medications included metformin, lisinopril, hydrochlorothiazide, amlodipine and pravastatin. FLUMIST started on 01-Nov-2013. It was reported that the patient over 50 years of age patient received FLUMIST which started on 01-Nov-2013. The outcome of the event of over 50 years of age patient received FLUMIS is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 17-Dec-2013 from Health professional: Form completed date was updated. Action taken was updated. Dechallenge rechallenge was updated. Concomitant drugs were added. Concomitant diseases added. Reporter tab updated.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 11-Dec-2013. The reporter mentioned that patient had received expired FLUMIST on 11-Dec-2013. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: U
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Pharmacist concerning a 2 year old, subject of unknown gender, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The pharmacist reported that on 11-Dec-2013 patient received expired FLUMIST. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Physician concerning a 15 year old, male subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The patient received FLUMIST on 10-Dec-2013 that expired on 09-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST 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 (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 12-Dec-2013. Licensed vocational nurses (LVN) reported that they had administered FLUMIST QUADRIVALENT that expired on Dec 02, 2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 32.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 32 year old, Female subject who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST started on an unknown date. The registered nurse reported that they gave a patient expired FLUMIST which started on 11-Dec-2013. The patient has not reported any adverse symptoms. The outcome of the event of GAVE A PATIENT EXPIRED FLUMIST is unknown. The report was considered to be non-serious by reporter.
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. FLUMIST QUADRIVALENT (Intranasal) started on 11-Dec-2013. The reporter mentioned that patient had received expired FLUMIST on 11-Dec-2013. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Health Professional concerning, 10 years old female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. It was reported that patient with that has some mental/cognitive defects, she would not allow us to administer the 2nd half of her FLUMIST dose which started on 12-Dec-2013. The outcome of the event of would not allow us to administer the 2nd half of her FLUMIST dose is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Back pain, Dizziness, Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning an 11 year old, female subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 06-Dec-2013. The patient experienced FEVER, LOW BACK PAIN and DIZZINESS which started on 12-Dec-2013. The patient recovered from the event of FEVER, LOW BACK PAIN and DIZZINESS on an unspecified date. The report was considered to be non-serious. The reporter considered that there was no causal relationship between FEVER and FLUMIST, LOW BACK PAIN and FLUMIST and DIZZINESS and FLUMIST. The Company Physician considered the events of fever, low back pain and dizziness to be causally unrelated with suspect drug of FLUMIST.
Age: 0.31
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 4 month old, Male subject, who had been receiving FLUMIST (intranasal). FLUMIST started on 13-Dec-2013. It was reported that FLUMIST was given to four months old which started on 13-Dec-2013. The outcome of the event of FLUMIST given to a 4 month old is unknown. The report was considered to be non-serious.
Age: 17.0
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, (intranasal). FLUMIST started on an unknown date. The patient was inadvertently administered expired FLUMIST on 13-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 53.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 53 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. Concomitant medications included Simvastatin. FLUMIST QUADRIVALENT (Intranasal) started on 14-Dec-2013. The Pharmacist reported that they inadvertently administered FLUMIST QUADRIVALENT to person over 49 on 14-Dec-2013. The outcome of the event of inadvertently administered FLUMIST QUADRIVALENT to person over 49 is unknown. The report was considered to be non-serious.
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 had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The licensed practical nurse reported that on 10-Dec-2013, they inadvertently administered an expired dose of FLUMIST to the patient. The outcome of the event of EXPIRED FLUMIST ADMINISTERED/INADVERTENTLY ADMINISTERED AN EXPIRED DOSE OF FLUMIST is unknown. The report was considered to be non-serious by reporter.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: A consumer report has been received. The report concerns a 14 year old, female consumer, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 10-Dec-2013. The patient experienced headache and sore throat which started on 10-Dec-2013. The outcome of the event of headache and sore throat is unknown. The report was considered to be non-serious.
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 (Intranasal) started on 17-Dec-2013. The patient reported that they gave three expired doses of FLUMIST QUADRIVALENT which started on 17-Dec-2013. The outcome of the event of gave expired doses of FLUMIST is unknown. The report was considered to be non-serious.
Age: 17.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Health Professional concerning a 17 year old, male patient. No information regarding relevant history, concomitant disease and concomitant disease and concomitant medications were provided. The patient received FLUMIST (intranasal) started on 18-Dec-2013. The reporting nurse inadvertently administered the entire dose in one nostril on 18-Dec-2013. Not reporting any symptoms. The outcome of the event of entire dose in one nostril was unknown. The report was considered to be non-serious by the reporter. Corrected report 06-May-2014. The case has been updated with full date to KUR term additions for FLUMIST/ Q/Laiv.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza, Influenza A virus test positive, Vaccine breakthrough infection
Clinical narrative: A report has been received from a Health Professional concerning patients of unknown gender. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patients had been receiving nasal FLUMIST QUADRIVALENT which was started on an unknown date. An office nurse reported that they have had over 12 breakthrough cases of FLUMIST QUADRIVALENT recipients testing positive for flu. Every patient tested positive for Flu A. The outcome of the event of testing positive for flu A was unknown. The reporter considered the event to be non-serious.
Age: 44.0
Sex: U
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 44 year old, subject of unknown gender, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 17-Dec-2013. It was reported that one of the nurses gave FLUMIST to a 44 year old patient which started o 17-Dec-2013 which was expired on 25-Nov-2013. The outcome of the event of GAVE EXPIRED VACCINE is unknown. The report was considered to be non-serious.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 28-Oct-2013. The patient experienced tested positive for flu A which started on 16-Dec-2013. The outcome of the event of tested positive for flu A is unknown. The report was considered to be non-serious.
Age: 16.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 16 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 19-Dec-2013. The patient experienced expired FLUMIST QUADRIVALENT administered which started on 19-Dec-2013. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old. Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). The patient's medical history, concurrent diseases and concomitant medications were not reported. FLUMIST QUADRIVALENT (INTRANASAL) started on 26-Dec-2013. The patient experienced EXPIRED FLUMIST QUADRIVALENT ADMINISTERED which started on 26-Dec-2013. The patient used EXPIRED FLUMIST QUADRIVALENT which started on 26-Dec-2013. The outcome of the event of EXPIRED FLUMIST QUADRIVALENT ADMINISTERED is unknown. The report was considered to be non-serious by the reporter.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, male subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 26-Dec-2013. The health professional reported that they inadvertently administered expired FLUMIST which started on 26-Dec-2013. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The report was considered to be non-serious.
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 (Intranasal) started on 19-Dec-2013. Office Manager reported that they inadvertently administered expired FLUMIST QUADRIVALENT to a patient on 19-Dec-2013. Not reported symptoms. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 12-Dec-2013. The medical assistant reported that they inadvertently gave expired FLUMIST QUADRIVALENT to the patient on 12-Dec-2013. Not reported any symptoms. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious. Corrected report 30-Dec-2013: Key ingredient of FLUMIST QUADRIVALENT corrected from FLUMIST to Q/LAIV.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning an 11 year old, male subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. Reporter reported that she ADMINISTRATION of EXPIRED FLUMIST which started on 16-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.