chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 12 year old, Female patient, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, unknown. FLUMIST QUADRIVALENT was given on 06-Jan-2016. The patient received expired dose of FLUMIST QUADRIVALENT which started on 06-Jan-2016. The outcome of the event of expired dose of FLUMIST QUADRIVALENT administered was unknown. The report was considered to be non-serious by the company physician.
Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product 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), 0.2 Millilitres. FLUMIST Quadrivalent (Intranasal) started on 06-Jan-2016. It was reported that a dose of expired FLUMIST was administered. FLUMIST Quadrivalent (Intranasal) was continued. The outcome of the event of expired FLUMIST was administered-medication error is unknown. The report was considered to be non-serious.
Age: 5.0
Sex: M
Vaccine: DTP, FLUN4, IPV
Symptoms: Erythema, Eyelid oedema, Mass
Clinical narrative: A consumer report has been received concerning a 5 year old, male patient, Height: 43.0 inches. Patient's relevant history and concomitant disease were not reported. Patient's concomitant medications included Diphtheria toxoid, Tetanus toxoid, whole cell pertussis vaccine and poliovirus vaccine live oral. Patient reported that 5 y/o son received FLUMIST QUADRIVALENT (intranasal) vaccination along with DTP and Polio vaccines on 22-Dec-2015. Consumer reports son's weight to be 43.5 lbs. Consumer reported that 3 hours after son received FLUMIST, DTP and Polio vaccines, on 22-Dec-2015, son had a red lump on his left cheek. Patient reported that the following morning, on 23-Dec-2015, son had another red bump on his right cheek and his right eye had a bigger lump that looked like a swollen eye on his upper eyelid all they way up to his eyebrow. The action taken with suspect drug was unknown. The outcome of the events of big lump on right eye, red lump on cheek and swollen eye was unknown. The company physician assessed the events of big lump on right eye, red lump on cheek and swollen eye to be non serious.
Age: 3.0
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, subject of unknown gender, who had been receiving Nasal FLUMIST (Intranasal), 0.2 Millilitres, Once/Single administration on 15-Mar-2016 for influenza prevention. FLUMIST EXPIRED on 07-MAR-2016 was GIVEN TO PATIENT on 15-Mar-2016. No adverse event was reported. The outcome of the event of FLUMIST EXPIRED on 07-MAR-2016 GIVEN TO PATIENT is unknown. The report was considered to be non-serious by company physician.
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A consumer report has been received. The report concerns a, Female consumer, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres. FLUMIST Quadrivalent (Intranasal) started on an unknown date. The patient has taken FLUMIST when she was pregnant. The outcome of taken FLUMIST when she was pregnant is unknown. The report was considered to be non-serious.
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, Male subject, who had been receiving Nasal FLUMIST QUADRILVALENT, 0.2 Millilitres, Once/Single administration. FLUMIST QUADRILVALENT started on 23-Dec-2015. The vaccine was inadvertent administration to wrong age group which started on 23-Dec-2015. FLUMIST QUADRIVALENT was discontinued on 23-Dec-2015. The outcome of the event of inadvertent administration to wrong age group is unknown. The report was considered to be non-serious.
Age: 75.0
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 75 year old, Male patient, who had been receiving FLUMIST QUADRIVALENT (Intranasal), 0.2 Millilitres. FLUMIST QUADRIVALENT (intranasal) was started on 23-Dec-2015. The patient experienced FLUMIST QUAD given to an adult over 49 years old which started on 23-Dec-2015. The outcome of the event of FLUMIST QUAD given to an adult over 49 years old was unknown. The report was considered to be non-serious.
Age: 72.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered
Clinical narrative: A spontaneous report has been received from a Health Professional concerning 72 year old, Female patient who had been administered Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Unknown. FLUMIST QUADRIVALENT started on 23-Dec-2015. It was reported that the patient was given FLUMIST QUADRIVALENT, full adult dose, up each nostril on 23-Dec-2015. It was also reported that the nurse accidentally was given the vaccine that was administered to an adult older than the 49 years old which started during 23-Dec-2015. FLUMIST QUADRIVALENT was discontinued on 23-Dec-2015. The outcome of the event of FLUMIST QUAD administered to a consumer over 49 years and full adult dose given up each nostril was unknown. The report was considered to be non-serious by company physician.
Age: 11.0
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning an 11 year old, subject of unknown gender, Height: 57.5 Inches, Weight: 80.0 Pounds, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres, Once/Single administration. FLUMIST Quadrivalent (Intranasal) started on 05-Jan-2016. The patient received an expired FLUMIST Quadrivalent on 04-Jan-2016. No adverse event was reported. The outcome of the event of given an expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious by the company physician. Summary of follow-up information received by Medimmune on 01-Feb-2016 from a health professional: event term changed from caller reported giving FLUMIST Quadrivalent with an expiration date of 30-DEC-2015 today 5-JAN-2016 to given an expired FLUMIST Quadrivalent. Narrative updated. Corrected report: new report added, manufacturer added, action taken changed from none to not applicable.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning three children of unknown gender, who had been receiving FLUMIST, 0.2 Millilitres, once/single administration. FLUMIST started on an unknown date. It was reported that the patients were administered expired dose which started on 13-Jan-2016. The outcome of the event of expired dose is unknown. The reporter's description of the events was as follows: No pertinent medical history for any of the 3 children. The report was considered to be non-serious by the company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning an infant, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Once/Single administration. FLUMIST QUADRIVALENT started on 12-Jan-2016. The FLUMIST vaccine that was given on 12-Jan-2016 to the patient had expired on 07-Jan-2016. The vaccine was not expired when it was received at the HCP office. The outcome of the event of received a dose of expired FLUMIST-medication error is unknown. The report was considered to be non-serious by the company physician.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A health professional report has been received. The report concerns 4 year old, Female consumer, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 milliliters, Unknown for Influenza. FLUMIST Quadrivalent (Intranasal) started on 15-JAN-2016 for Influenza. Reporter stated that FLUMIST that expired on January13, 2016 was administered today to a 4 year girl. FLUMIST Quadrivalent (Intranasal) was continued. The outcome of the event of administered an expired drug is unknown. The report was considered to be non-serious.
Age: 18.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning an 18 year Female patient, who was prescribed Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, started on an unknown date. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced expired dose. The outcome of the event of expired dose was unknown. The reporter's description of the event was as follows: None reported. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a, patient of unknown gender, who had been receiving FLUMIST, once/single administration. FLUMIST started on an unknown date. The HCP stated it was approximately 6 days post-expiration and had been administered to the patient. The outcome of the event of administered expired FLUMIST to patient was unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a subject, of unknown gender who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 milliliters. FLUMIST Quadrivalent (Intranasal) started on unknown date for Influenza. Nurse reported 5 or 6 doses of expired FLUMIST 1/4/16 were given since the expiration. The outcome of the event of 5 or 6 doses of expired FLUMIST were given since the expiration is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 17-Feb-2007, female subject, who had been receiving FLUMIST, 0.2 millilitres, unknown. FLUMIST started on an unknown date. It was reported that expired FLUMIST Lot FJ2073 was given to patient 5 days after expiration date. The outcome of the event of expired dose is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal) 0.2 Millilitres, Total. FLUMIST Quadrivalent (Intranasal) started on an unknown date. The reporter stated patient was administered expired dose which started on 13-Jan-2016. The outcome of the event of expired dose is unknown. The reporter's description of the event(s) was as follows: No pertinent medical history for any of the 3 children. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a Child, patient of unknown gender, who had received Nasal FLUMIST Quadrivalent (Intranasal), was started on an unknown date. FLUMIST administered to patient outside the approved age indication. Child came into doctor's office today to receive the second dose of FLUMIST. The doctor covering realized that the child had just turned 2 years old on January 14th 2016. This meant that the first dose was administered back in Dec 2015 when the child was not 2 years old yet. The outcome of inadvertent administration to child less than 2 years of age was unknown. The report was considered to be non-serious. The reporter and the company physician both considered inadvertent administration to child less that 2 years of age to be unrelated to FLUMIST Quadrivalent.
Age: 8.0
Sex: U
Vaccine: FLUN4
Symptoms: Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: A consumer report has ben received. The report concerns an 8 year old, consumer of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Unknown. FLUMIST QUADRIVALENT started on 28-Dec-2015. The patient experienced high fever, fatigue and running nose. The patient recovered from the event of high fever, fatigue and running nose on an unspecified date. The report was considered to be non-serious.
Age: 46.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Influenza virus test positive, Malaise
Clinical narrative: Spontaneous report has been received from a Health Professional concerning a 46 years 35 weeks 5 days old, Female patient. Patient relevant history, concurrent diseases and concomitant drugs were not reported. On an unspecified date, patient received nasal FLUMIST QUADRIVALENT, 0.2 millilitres, once/single administration. Reporter stated that after receiving FLUMIST vaccine, flu confirmed via nasal swab and rapid test to patient. Patient became ill on 06-Mar-2016. The outcome of after receiving  FLUMIST vaccine, flu confirmed via nasal swab and rapid test was unknown. Company physician considered after receiving FLUMIST vaccine, flu confirmed via nasal and rapid test was unknown. Company physician considered after receiving FLUMIST vaccine, flu confirmed via nasal swab and rapid to be non serious.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 6 years old male patient, who had been receiving FLUMIST. FLUMIST started on an unknown date. It was reported that a FLUMIST that expired on 04-Jan-2016 was administered to a patient on 12-Jan-2016. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious. The reporter and the company physician considered that there was no causal relationship between received expired FLUMIST and FLUMIST Quadrivalent.
Sex: U
Vaccine: FLUN4
Symptoms: Malaise
Clinical narrative: A consumer report has been received. The report concerns a child, consumer of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL), 0.2 ml. FLUMIST (INTRANASAL) started on 19-Dec-2015. The patient experienced BEEN SICK AFTER RECEIVING FLUMIST. The outcome of the event of BEEN SICK AFTER RECEIVING FLUMIST is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning an 11 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. It was reported that the patient received expired FLUMIST which started on 07-JAN-2016. The outcome of the event of received expired FLUMIST was unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no causal relationship between received expired FLUMIST and FLUMIST QUADRIVALENT.
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, Male subject, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal). FLUMIST Quadrivalent (Intranasal) started on an unknown date. The FLUMIST Quadrivalent was administered to patient outside of indicated age which started on 28-Mar-2016. The outcome of the event of FLUMIST administered to patient outside of indicated age is unknown. The reporter's description of the event(s) was as follows: unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no causal relationship between FLUMIST administered to patient outside of indicated age and FLUMIST Quadrivalent.
Sex: M
Vaccine: FLUN4
Symptoms: Wheezing
Clinical narrative: A report has been received from a Health Professional concerning a male patient. No information regarding the relevant history, concomitant disease and concomitant drug was provided. HCP reported that patient took Nasal FLUMIST (intranasal), 0.2 milliliter, started last week in Mar-2016 on an unknown date. HCP reported patient experienced wheezing same day they got the dose in Mar-2016 on an unknown date. The outcome of wheezing was unknown. Company physician assessed the wheezing as non serious.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report received from a Health Professional concerning a 4 year old, female patient. The patient medical history and concomitant medication were not provided. The patient had received nasal FLUENZ TETRA (intranasal) on 12-Feb-2016. Caller stated she had given a FLUENZ vaccine which was out of date to a child. Action taken with FLUENZ TETRA was unknown. The outcome of the event of given FLUENZ vaccine which was out of date was unknown. The company physician assessed the event given a FLUENZ which was out of date to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning, who had had been receiving FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres. FLUMIST Quadrivalent (Intranasal) started on an unknown date. HCP reports that a patient received expired FLUMIST vaccine. The patient experienced patient received expired vaccine (medication error). The outcome of the event of patient received expired vaccine (medication error) is unknown. The report was considered to be non-serious by the company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Physician concerning a, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Unknown. FLUMIST QUADRIVALENT started on an unknown date. It was reported that patient had been have receiving expired FLUMIST two weeks past the expiration date. The outcome of the event of expired FULMIST is unknown. The reporter's description of the event was as follows: none reported. The report was considered to be non-serious.
Age: 7.0
Sex: U
Vaccine: FLUN4
Symptoms: Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: A consumer report has been received. The report concerns a 7 year old, patient of unknown gender, who had been receiving unknown FLUMIST QUADRILAVENT, 0.2 Millilitres, Unknown. The patient experienced high fever, fatigue and runny nose. The patient recovered from the event of high fever, fatigue and runny nose on an unspecified date. The reporter's descriptions of the event was as follows: Unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Pyrexia, Vomiting
Clinical narrative: A consumer report has been received. The report concerns a patient of unknown gender, who received Nasal FLUMIST QUADRILAVENT, 0.2 Millilitres, Unknown. FLUMIST QUADRIVALENT started on 26-Dec-2015. The patient experienced high fever and vomiting. The outcome of the event of high fever and vomiting was unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: A consumer report has been received. The report concerns a, consumer of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Unknown. FLUMIST QUADRIVALENT started on 26-Dec-2015. The patient experienced fever which started on 26-Dec-2015. The patient recovered from the event of fever on 27-Dec-2015. The reporter's description of the event was as follows: Unknown. The report was considered to be non-serious.
Age: 1.6
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, Off label use
Clinical narrative: A report had been received from a Health Professional concerning a patient, female patient, who had been receiving FLUMIST Quadrivalent (Intranasal), 0.2 Milliliters. FLUMIST Quadrivalent (Intranasal) started on and unknown date. It was reported that a 19 month old patient had accidentally received FLUMIST which is considered as an off label use. The outcome of the even of Off Label use in a 19 month old received FLUMIST is unknown. The reporter's description of the event(s) was as follows: no medical history, no medications listed. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Cough, Pain
Clinical narrative: A consumer report has been received. The report concerns a, consumer of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Milliliters, unknown. The patient experienced cough hurting after receiving FLUMIST which started on 05-Jan-2016. The outcome of cough hurting after receiving FLUMIST is unknown. The reporter's description of the event(s) was as follows: Unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A spontaneous report has been received from a Health Professional concerning a patient of unknown gender, who had been receiving FLUMIST, 0. 1 millilitres, unknown. FLUMIST started during Nov-2015. It was reported that FLUMIST with temperature excursion administered to five patients and FLUMIST temperature excursion maximum 47 fahrenheit degrees for approximately 24h and also stated that FLUMIST 0.1 ml dose given to five patients. The outcome of the event of FLUMIST with temperature excursion administered to five patients FLUMIST excursion maximum 47 Fahrenheit degrees for approximately 24 H and FLUMIST 0.1 ml dose given to 5 patients is unknown. The report was considered to be non-serious.
Age: 36.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 36 year old, Female subject, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres. FLUMIST Quadrivalent (Intranasal) started on 29-Jan-2016. The patient administered expired FLUMIST on 29-Jan-2016. FLUMIST Quadrivalent (Intranasal) was continued. The outcome of the event of expired FLUMIST administered to a patient is unknown. The report was considered to be non-serious.
Age: 48.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A spontaneous report has been received from a Health Professional concerning a 48 year old, male patient, who had been administered FLUMIST, 0.2 millilitres, unknown. FLUMIST started on an unknown date. Nurse reported that FLUMIST that expired on Jan 12, 2016 was administered on Jan 29, 2016. The outcome of the event of expired dose was unknown. The report was considered to be non-serious by company physician.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 5 years 8 months old, male subject, who had been receiving FLUMIST, 0.2 millilitres, once/single administration. FLUMIST started on an unknown date. HCP gave FLUMIST 0.2 mL February 3, 2016 then realized 20 minutes later that it had expired on January 4, 2016. FLUMIST was continued. The outcome of the event of took expired med is unknown. The report was considered to be non-serious.
Age: 9.0
Sex: U
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Health Professional concerning a 9 year old, subject of unknown gender, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient received only one half of a dose in one nostril. The outcome of the event of patient received only one half of a dose in one nostril is unknown. The report was considered to be non-serious by the company physician.
Age: 23.0
Sex: F
Vaccine: FLUN4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: A consumer report has been received. The report concerns a 23 year old, Female consumer, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres. The patient experienced fever, body ache and chills which started during 2007. The patient recovered from fever, body ache and chills on an unspecified date. The reporter's description of the event(s) was as follows: Unknown. The report was considered to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 years male patient Height 40.0 inches; Weight 34.0 Pounds, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal),  0.2 Milliliters, unknown for flu vaccine. It was reported that patient had been taken expired medication FLUMIST Quadrivalent (Intranasal) was discontinued on 04-FEB-2016. The report was considered to be non-serious. 24-Mar-2016: Corrected report 24-Mar-2016: Reporter details were corrected and auto narrative has been done.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning, subject of unknown of gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres (frequency not reported). FLUMIST QUADRIVALENT started on 09-Mar-2016. The patient received expired dose of FLUMIST. The outcome of the event of received expired dose of FLUMIST is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a patient of 2 years 39 weeks 4 days, Female subject, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal). FLUMIST Quadrivalent (Intranasal) started on 11-Mar-2016. Nurse reports that expired FLUMIST was administered today to 3 patients. FLUMIST expired on March 9, 2016. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between expired FLUMIST and FLUMIST Quadrivalent. Based on the information in this report and awaiting the reporter's assessment, the company physician considered the event expired FLUMIST and drug FLUMIST Quadrivalent to be unrelated.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza, Influenza virus test positive, Malaise
Clinical narrative: Spontaneous report has been received from a Health professional concerning a 13 years 18 weeks 4 days old male patient. Patient relevant history, concurrent diseases and concomitant drugs were not reported. On an unspecified date, patient received FLUMIST, 0.2 millilitres, once/single administration. Reporter stated that after receiving FLUMIST vaccine, flu confirmed via nasal swab and rapid test to a patient. Patient became ill on 09-Mar-2016. The outcome of after receiving FLUMIST vaccine, flu confirmed via nasal swab and rapid test and became ill was unknown. Company physician considered after receiving FLUMIST vaccine, flu confirmed via nasal swab and rapid test and became ill to be non serious.
Sex: F
Vaccine: FLUN4
Symptoms: Respiratory tract infection, Sinusitis
Clinical narrative: A solicited consumer report has been received from a market researcher. The report concerns a female patient. The patient's relevant medical history, concurrent diseases and concomitant medications were unknown. The patient received FLUMIST quadrivalent (intranasal) 0.2 milliliters a few years ago. The patient experienced sever sinus infection and respiratory infection which lasted several weeks. The outcome of the events of sinus infection and respiratory infection were unknown. The report was considered to be non-serious by the company physician. Based on the information in this report and awaiting the reporter's assessment, the company physician considered the events to be unrelated to FLUMIST quadrivalent.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a patient of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres (frequency not reported). FLUMIST QUADRIVALENT started on 10-Mar-2016. It was reported that patient had been received expired dose. The outcome of the event of pt received expired dose is unknown. The report was considered to be non-serious.
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: Spontaneous report received from a Health Professional concerning a 15 years 16 weeks 7 days old male patient with Height: 71.0 inches and Weight: 160.0 pounds. Patient relevant history, concomitant diseases and concomitant medications were not reported. Patient had received FLUMIST, 0.2 millilitres, on 08-Mar-2016. The patient experienced flu which started on 06-Mar-2016. Reporter reported that wife had worst symptoms. The outcome of flu was unknown. The company physician assessed flu to be non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza, Influenza B virus test positive
Clinical narrative: A spontaneous report had been received from physician via medical representative concerning a 13 years, 13 weeks, 6 days old male patient, height 67.0 in; weight 110.00 lb. No information was provided regarding medical history and concomitant medications and concurrent disease of the patient. Patient received the Nasal FLUMIST (Intranasal) vaccine sometime in November or December of 2015.Patient went to the doctor on 10-Mar-2016 and was diagnosed with the B strain of the Flu. FLUMIST Quadrivalent was continued. The outcome of diagnosed with B strain of flu was unknown. The company physician assessed the diagnosed with the B strain of flu to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a pharmacist concerning a Male patient, who had been receiving Nasal FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. Expired FLUMIST Quadrivalent was administered in a pharmacy setting, by a pharmacist on 08-Mar-2016. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Sex: F
Vaccine: FLUN3
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Pharmacist. The report, concerning a Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced administration of expired FLUMIST which started on 08-Mar-2016. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious by the company physician.
Age: 4.0
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, patient of unknown gender, who had been receiving nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres, once/single administration. FLUMIST Quadrivalent (Intranasal) started on 09-Mar-2016. It was reported that the patient received an expired dose of FLUMIST on 09-Mar-2016 that expired on 03-Mar-2016. The outcome of the event of expired FLUMIST administered to patient is unknown. The reporter's description of the event(s) was as follows: None reported. The report was considered to be non-serious.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: Feeling abnormal, Influenza A virus test positive
Clinical narrative: A spontaneous consumer report has been received. The report concerns a 41 year old female patient, height 64.0 inches, Weight: 145.0 Pounds. The patient relevant history and concurrent diseases were not reported. PSS reporting an AE for herself. She received the Nasal FLUMIST (Intranasal) vaccine 0.2 ml on Sep-2015. On Tuesday 08-MAR-2016, patient states she tested positive for Influenza A. Patient also mentioned that she does not feel good. FLUMIST Quadrivalent was continued. The outcome of the events of tested positive for influenza A and does not feel good was unknown. The report was considered to be non-serious by company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A spontaneous report had been received from pharmacist concerning a child, patient of unknown gender. No information was provided regarding medical history and concomitant medications and concurrent disease of the patient. The patient had received FLUMIST. The FLUMIST expired on 24-Feb-2016. Child received the vaccine on 07-Mar-2016. The outcome of use of expired product was unknown. The reporter assessed the use of expired product to be non serious.
Age: 42.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A report has been received from consumer concerning a 42 years 6 weeks 5 days old, female patient, height 63.0 inches; weight: 131.0 pounds. Patient relevant history and concurrent diseases were not provided. Concomitant medications included acetaminophen for flu symptoms. Patient recent nasal FLUMIST (Intranasal), 0.2 milligrams, once/single administration during 2015. She was diagnosed with the flu via nasal swab on 06-Mar-2016. She was then on TAMIFLU 2 pills daily for 5 days. FLUMIST Quadrivalent was continued. At the time of reporting, flu was ongoing. The company physician assessed flu to be non serious.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza, Influenza virus test positive, Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning patients of unknown gender. Two employees and one child with 6-7 days of flu symptoms, tested positive for the flu with high fevers after receiving FLUMIST. The action taken with FLUMIST was unknown. The outcome of the flu and high fevers was unknown. The report was considered to be non-serious by company physician.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: A report has been received from a Physician concerning a, female subject, who had been receiving FLUMIST, 0.2 millilitres, unknown. FLUMIST started on an unknown date. The patient experienced fever of 103-104 temperature. FLUMIST was continued. The outcome of the event of fever of 103-104 temperature was unknown. The report was considered to be non-serious.
Age: 0.2
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 2 month old, female patient. The patient received Nasal FLUMIST QAUDRIVALENT (Intranasal), 0.2 Millilitres, Once/Single administration. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. Product use issue was reported as FLUMIST was administered to a 2 month old by error. No adverse event was observed. The outcome of the event of FLUMIST administered to a 2 month old by error is unknown. The report was considered to be non-serious by company physician.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 9 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Yearly. FLUMIST QUADRIVALENT started on an unknown date. It was reported an expired dose of FLUMIST was given to a patient on 3/2/2016 that expired in February. No adverse events reported. The patient experienced took expired dose which started on 02-Mar-2016. The outcome of the event of took expired dose is unknown. The reporter's description of the events was as follows: Nurse stated checklist stated: no asthma, heart, lung, kidney or live problems. No fever. No allergies. Received flu shot last year. The report was considered to be non-serious by the company physician.
Age: 6.0
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered, Off label use
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old, subject of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres. FLUMIST Quadrivalent (Intranasal) started on 03-Mar-2016. It was reported that FLUMIST which expired on 02-MAR-2016 was given to the patient on 03-Mar-2016 it was administered by the patient and which was considered as an off label use. The outcome of the event of given expired dose - off label use and administration of expired dose is unknown. The report was considered to be non-serious.
Age: 32.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
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), 0.2 milliliters unknown for influenza prevention. FLUMIST Quadrivalent (Intranasal) started on an unknown date for Influenza Prevention. It was reported that the patient FLUMIST inadvertently administered to pregnant patient in her first trimester. FLUMIST Quadrivalent (Intranasal) was continued. The outcome of the event of administered FLUMIST to pregnant patient was unknown. The report was considered to be non-serious.
Age: 1.5
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional (registered nurse) concerning a 1 year old male, who had been receiving FLUMIST QUADRIVALENT (intranasal). On 23-Dec-2015 FLUMIST QUADRIVALENT (intranasal) was administered inadvertently to a 18 months old child. The outcome of the event of inadvertent administration to 18 month old was unknown. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 18-Feb-2016 from health professional: patient demographics newly added, event onset date added, narrative updated.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Intentional product misuse
Clinical narrative: A spontaneous report had been received from a physician concerned a 5 year old, female patient. The patient's concurrent diseases included cerebral atrophy and epilepsy. The patient was prescribed nasal Fluenz tetra started on 15-Dec-2015. It was reported that misuse which started on 24-Feb-2016. The outcome of misuse was unknown. The company physician assessed misuse to be non serious.
Age: 18.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning an 18 year old, Male subject who had been receiving Nasal FLUMIST Quadrivalent (Intranasal). FLUMIST Quadrivalent (Intranasal) started on an unknown date. It was reported that the patient received FLUMIST that expired on 17-FEB-2016 which started on 23-Feb-2016. The outcome of the event of received FLUMIST that expired on 2/17/16 is unknown. The reporter's description of the event(s) was as follows: none reported. The report was considered to be non-serious. The reporter considered that there was no causal relationship between received FLUMIST that expired on 2/17/16 and FLUMIST Quadrivalent.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Extra dose administered, Medication error
Clinical narrative: A report has been received from a Health Professional, mother of the patient concerning a 5 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Unknown. FLUMIST QUADRIVALENT started on 29-Dec-2015. It was reported that FLUMIST was administered to patient in first week of Oct and then again on 29-Dec-2015. MD's office reported not having documentation of first administration of FLUMIST in Oct. This information was considered as FLUMIST administered twice. FLUMIST QUADRIVALENT was continued. The outcome of the event of FLUMIST administered twice is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning an 11 year old, Female subject, who had been receiving nasal FLUMIST Quadrivalent (intranasal), 0.2 Milliliters, Unknown for influenza. FLUMIST Quadrivalent (intranasal) started on 22-Feb-2016 for influenza. It was reported that expired FLUMIST was administered to patient on 22-Feb-2016. The outcome of the event of expired FLUMIST administered to patient is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A spontaneous report has been received from a health professional concerning a, patient of unknown gender, who had been receiving FLUMIST, 0.2 millilitres, unknown. FLUMIST started on 25-Mar-2016. It was reported the patient received FLUMIST that expired on 25-Mar-2016. The outcome of the event of received expired FLUMIST was unknown. The reporter's description of the event was as follows: None Reported. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A spontaneous report has been received from a Health Professional concerning a, patient of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 millilitres. FLUMIST Quadrivalent (Intranasal) started on 25-Mar-2016. It was reported the patient received FLUMIST that expired on 25-Mar-2016 on 26-Mar-2016. The outcome of the event of received expired FLUMIST was unknown. The reporter's description of the event(s) was as follows: None reported. The report was considered to be non-serious.
Age: 44.0
Sex: M
Vaccine: FLUN4
Symptoms: Rhinorrhoea
Clinical narrative: A report has been received from a consumer, concerning a 44 year old Male consumer, Height: 71.0 Inches; Weight: 165.0 Pounds, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Milliliters, Once/Single administration. Concomitant medications included Finasteride for hair loss and Ergocalciferol for lack of sunlight. FLUMIST Quadrivalent (Intranasal) started during Nov-2015. The patient experienced chronic drippage from nose which started during Nov-2015. FLUMIST Quadrivalent (Intranasal) was continued. The outcome of the event of chronic drippage from nose is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product 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 started on an unknown date. Nurse reported that expired FLUMIST was administered to 3 patients. FLUMIST expired on 09-Mar-2016 and was administered on 11-Mar-2016. The outcome of the event of three patients received expired FLUMIST vaccine/FLUMIST expired on 09-MAR-2016 is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between three patients received expired FLUMIST vaccine/FLUMIST expired on 09-MAR-2016 and FLUMIST QUADRIVALENT.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a male patient who had been receiving Nasal FLUMIST Quadrivalent (Intranasal). FLUMIST Quadrivalent (Intranasal) started on 11-Mar-2016. It was reported that patient was administered with expired FLUMIST. The outcome of the event of administered expired FLUMIST is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between administered expired FLUMIST and FLUMIST Quadrivalent. The company physician considered that there was no causal relationship between administered expired FLUMIST and FLUMIST Quadrivalent.
Sex: M
Vaccine: FLUN4
Symptoms: Cardiac murmur, Foetal exposure during pregnancy, Premature baby, Pulmonary artery stenosis congenital
Clinical narrative: A report has been received from a physician concerning a male premature baby. Medical history and information about concomitant drugs was not provided. On 16-Dec-2015, during the 29th week of the pregnancy the mother received FLUMIST QUADRIVALENT (intranasal) for the safety of the pregnancy. During the 35th week of gestation the baby was born with 5.93 pounds. Delivery was expected on 01-Mar-2016. The mother did not used any hormonal contraception at the time of conception. Heart murmurs and mild pulmonary stenosis were observed after the delivery. The outcome of the events was unknown. The report was considered to be non-serious by the company physician.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product 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) 0.2 Millilitres. FLUMIST Quadrivalent (Intranasal) started on 17-Mar-2016. Nurse reported that FLUMIST which expired on March 9, 2016 was administered today March 17, 2016 to one patient. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Pharmacist concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Milliliters, Once/Single administration. FLUMIST Quadrivalent (Intranasal) started on 11-Feb-2016. The reporter stated patient inadvertent expired product administration which started on 11-Feb-2016. FLUMIST Quadrivalent (Intranasal) was discontinued on 11-Feb-2016. The outcome of inadvertent expired product administration is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional. The report concerning to multiple patients of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres. FLUMIST (Intranasal) started on an unknown date. The patient experienced vaccine exposed to temp excursions. No data on the stability of the product after a temperature excursion on Jan4 to 32F and Jan15 to 32F. The outcome of the event of vaccine exposed to temp excursions is unknown. The report was considered to be non-serious by the company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report received from a Health Professional concerning a patient of unknown gender. The patient received Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Unknown, on 30-Mar-2016 that was expired on 25-Mar-2016. The outcome of the event of expired FLUMIST administered is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional. The report concerning a patient born on 17-Jan-2009, Female subject, Height: 41.0 inches; Weight: 33.0 Pounds, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Milliliters, Once/Single administration. FLUMIST Quadrivalent (Intranasal) started on an unknown date for vaccine. The patient experienced expired FLUMIST. FLUMIST Quadrivalent (Intranasal) was continued. The outcome of the event expired FLUMIST is unknown. The report was considered to be non-serious by the company physician.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product 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 (Intranasal), 0.2 Millilitres. FLUMIST Quadrivalent (Intranasal) started on 11-Mar-2016. It was reported that the patient received FLUMIST on 11-Mar-2016 that expired on 09-Mar-2016. The outcome of the event of expired dose (medication error) is unknown. The reporter's description of the event(s) was as follows: No medical or prescription history. No chronic illness. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a patient of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres. FLUMIST QUADRIVALENT was given to the patient on 06-Apr-2016. The reporter stated that on 06-Apr-2016 expired FLUMIST was given to patient. The report was considered to be non-serious by company physician.