chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Hepatic enzyme increased, Irritability, Speech disorder, White blood cell count decreased
Clinical narrative: Pronounced and strained speech tic/stutter causing difficulty finishing sentences that previously were communicated with no impediment. The patient, our son, would get stuck between words for an extended period of time in these tics, and sometimes be unable to finish sentences that he had been able to say easily prior to vaccination. The onset of the speech tics was three days after the administration of the vaccines, peaking at its worst one week after the administration for 2-3 days, and slowly subsiding in the following two weeks (three weeks after vaccination). Also, he has had an eczema-like rash on much of his body, behind his knees, in and around his armpits, on his lower back and belly, which showed up after vaccination and has still not completely gone away. We noticed marked irritability after vaccination as well, which persisted for about two weeks.
Age: 3.0
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 1 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's concurrent disease(s) included Down syndrome and chronic lung disease. Concomitant medications included Salbutamol and Budesonide for asthma and paraffin, liquid, petrolatum, wool fat. FLUMIST QUADRIVALENT started on 14-Oct-2013. The FLUMIST QUADRIVALENT administered to a patient with asthma and Down syndrome on 14-Oct-2013. The outcome of the event of FLUMIST QUADRIVALENT administered to a patient with asthma and Down syndrome is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Epistaxis, Underdose
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST started on 22-Oct-2013. The patient experienced BLOODY NOSE ON LEFT SIDE and WEREN'T ABLE TO FINISH THE DOSE which started on 22-Oct-2013. The patient recovered from the event of BLOODY NOSE ON LEFT SIDE on an unspecified date and the outcome of the event of WEREN'T ABLE TO FINISH THE DOSE is unknown. The report was considered to be non-serious. Summary of follow up information received by AstraZeneca/MedImmune on 24-Oct-2013 from Health Professional: Form completed date added. Outcome of the event bloody nose on left side changed from unknown to recovered. Corrected report 16-Nov-2013: Dosing regimen updated.
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 FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The reporter reported that they inadvertently gave expired FLUMIST which started on 16-Sep-2013. The outcome of the event of inadvertent gave expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 57.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 57 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 27-Nov-2013. The patient was inadvertently administered FLUMIST QUADRIVALENT who was 57 years old which started on 27-Nov-2013. The outcome of the event of inadvertently administered/we inadvertently administered FLUMIST QUADRIVALENT to a patient who is 57 years old is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Asthma, Condition aggravated, Influenza like illness, Wheezing
Clinical narrative: A report had been received from a health professional via medical representative concerning a male patient, 12-15 years old. The patient had moderate to severe asthma but wanted FLUMIST Quadrivalent. This child had wheezing and severe asthma attack post FLUMIST Quadrivalent. The patient also had flu-like symptoms within 24-48 hours. Action taken with FLUMIST Quadrivalent and outcome of all the event was unknown. The report was considered to be non-serious by the reporter.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 12 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. Registered nurse reported that a patient received FLUMIST on 02-Oct-2013 and again on 22-Oct-2013. The patient indicated he had not received a flu vaccination but they realized after looking at his chart that he had Patient has not reported any symptoms. The outcome of the event of patient received FLUMIST on 02-OCT-2013 and on 22-OCT-2013 is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The nurse reported that FLUMIST was inadvertently given to a patient with asthma which started on 24-Oct-2013. The outcome of the event of FLUMIST inadvertently given to a patient with asthma 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 FLUMIST, (intranasal). FLUMIST started on an unknown date. The reporter stated that inadvertently administered FLUMIST to a 50 year old patient which started on 29-Oct-2013. The outcome of the event of inadvertently administered FLUMIST to a 50 year old patient is unknown. The report was considered to be non-serious by the reporter.
Age: 43.0
Sex: M
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: A report has been received from a Health Professional concerning a 43 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. A patient who has asthma received FLUMIST QUADRIVALENT which started on 29-Oct-2013. The outcome of the event of a patient who has asthma received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Age: 42.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Pharmacist concerning a 42 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated that while administering FLUMIST QUADRIVALENT the clip was removed first and the entire dose of FLUMIST QUADRIVALENT was administered into one nostril which started on 31-Oct-2013. The outcome of the event of while administering FLUMIST QUADRIVALENT the clip was removed first and the entire dose of FLUMIST QUADRIVALENT was administered into one nostril is unknown. The report was considered to be non-serious by the reporter.
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 patient. Medical history of the patient was not reported. There was no information on her concomitant medication. On 30-Oct-2013 she received nasal FLUMIST QUADRIVALENT, was outside of approved age indication. Action taken with FLUMIST and outcome was unknown. The report was considered to be non-serious.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug dispensing error
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 for WHEEZING. A PATIENT WHO CAME IN FOR BREATHING TREATMENT DUE TO ACTIVELY WHEEZING RECEIVED FLUMIST QUADRIVALENT BY MISTAKE. FLUMIST WAS INTENDED FOR ANOTHER PATIENT. FLUMIST QUADRIVALENT started on 02-Nov-2013 for WHEEZING. The patient experienced RECEIVED FLUMIST QUADRIVALENT BY MISTAKE which started on 02-Nov-2013. The outcome of the event of RECEIVED FLUMIST QUADRIVALENT BY MISTAKE is unknown. The report was considered to be non-serious by the reporter.
Age: 59.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 59 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The pharmacist reported that they inadvertently administered FLUMIST QUADRIVALENT to a 59 years old patient which started on 04-Nov-2013. The outcome of the event of inadvertently administered to a patient who was 59 years old is unknown. The report was considered to be non-serious by the reporter.
Age: 53.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 53 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The health professional reported, that they inadvertently gave FLUMIST to a 49 years old patient which started on 02-Nov-2013. The outcome of the event of administration to individual over the age of 49 is unknown. The report was considered to be non-serious by the reporter.
Age: 62.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 62 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 01-Nov-2013. The reporter stated that ADMINISTRATION TO 62 YEAR OLD MALE which started on 01-Nov-2013. The outcome of the event of ADMINISTRATION TO 62 YEAR OLD MALE is unknown. The report was considered to be non-serious by the reporter.
Age: 53.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 53 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 02-Nov-2013. The reporter stated that there was FLUMIST QUADRIVALENT administration to individual over the age of 49 which started on 02-Nov-2013. The outcome of the event of administration to individual over the age of 49 is unknown. The report was considered to be non-serious by the reporter.
Age: 64.0
Sex: F
Vaccine: FLUN4
Symptoms: Asthenia, Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 64 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST(Intranasal) started on 15-Oct-2013. The patient experienced weakness and inadvertently administered to a patient 64 years of age which started on 15-0ct-2013. The outcome of the event of weakness and inadvertently administered to a patient of 64 years of age is unknown. The report was considered to be non-serious by the reporter.
Age: 1.04
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Physician concerning a 1 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 04-Nov-2013. It was reported that MedImmune representative inadvertently administered FLUMIST QUADRIVALENT to 13 month old male patient which started on 04-Nov-2013. The outcome of the event of ADMINISTRATION TO 13 MONTH OLD is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Exposure via direct contact, Underdose
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 started on an unknown date. It was reported that patient received half of a dose of FLUMIST in one nostril and other half squired into his face and maybe in his eye which started on 02-Nov-2013. The outcome of the event of received half of a dose of FLUMIST in one nostril and other half squirted into his face and maybe eye is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Granuloma annulare
Clinical narrative: A report has been received from a Physician concerning a patient, Male subject, who has been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced Granuloma annulare of dorsal hands and elbows. The outcome of the event of Granuloma annulare of dorsal hands and elbows is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Pruritus, Urticaria
Clinical narrative: A report has been received from a health professional concerning a 10 years old, female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient was administered FLUMIST, (intranasal) on 20-Oct-2013, and experienced hives that day on her lower body. Her upper body was itchy and she had no lesions. The patient's mother treated her with BENADRYL that night. On 21-Oct-2013, the patient was seen by the nurse. She treated the patient with BENADRYL. The event had resolved. The reporter considered the event to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: A consumer report has been received. The report concerns, female consumer, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. It was reported that a child who was vaccinated with IIV and two weeks later against her mother's wishes was vaccinated wit FLUIMST in a school-located vaccination program. The child developed a fever post FMQ administration. The outcome of the event of fever and vaccinated with IIV and two weeks later against her mother's wished was vaccinated with FLUMIST and child received FLUMIST vaccine twice by mistake is unknown. The report was considered to be non-serious.
Age: 50.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 50 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced a male patient of 50 years old received FLUMIST QUADRIVALENT. The outcome of the event of a male patient of 50 years old received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
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 FLUMIST (intranasal). It was reported that consumer was administered expired dose which started on 27-Nov-2013. The outcome of the event of administration of expired dose 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 FLUMIST, (intranasal). FLUMIST started on 01-Oct-2013. It was reported that a 50 years old woman was vaccinated with FLUMIST on 01-Oct-2013. The outcome of the event of 50 year old woman vaccinated with FLUMIST is unknown. The report was considered to be non-serious.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Headache, Influenza like illness, Oropharyngeal pain
Clinical narrative: A report has been received from a consumer concerning a 14 years old female patient. No concomitant medication or medical history was reported. The patient received nasal FLUMIST QUADRIVALENT on 14-Oct-2013 and one week later started to experienced flu like symptoms, cough and throat hurt. She also had a mild headache, but reported that she received a mild concussion over the weekend while playing soccer. The reporter who was the mother of the patient reported that the patient developed flu-like symptoms after receiving FLUMIST QUADRIVALENT. Over the weekend prior to seeing her doctor, the patient experienced a mild concussion. On 21-Oct-2013 (Monday) she went to see her physician for the concussion at which time she was ok. While she was at the doctor's office, she was given FLUMIST QUADRIVALENT. Later that day, the patient began to have symptoms but she did not have fever. The patient did not see her doctor for the symptoms. The mother said she was well now. The patient was treated with ibuprofen/ TYLENOL and DAYQUIL. The outcome of the events of patient experienced flu like symptoms after one week of receiving FLUMIST QUADRIVALENT, cough, throat hurts, concussion and headache were unknown. The events of patient experienced flu like symptoms after one week of receiving FLUMIST QUADRIVALENT, cough, throat hurts and headache considered to be non-serious by the reporter and the event of concussion have been identified by the company physician from the source documents and added as non-serious adverse event. Summary of follow up information received by MedImmune 30-Oct-2013 from consumer: Form completed date updated. Dosing regimen updated.
Age: 63.0
Sex: F
Vaccine: FLUN4
Symptoms: Accidental exposure to product, Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: A report has been received from a Health Professional concerning a 63 year old, female subject, who had been receiving FLUMIST (Intranasal). Concomitant medications included ADDERALL and cycidrine. FLUMIST (Intranasal) started on an unknown date. It was reported that the patient had fever and headaches which started on 21-oct-2013, no appetite, generalized aching, tired and accidental exposure while administering drug was considered as an event. The outcome of the event of fever, no appetite, headaches, generalized aching and tired is unknown and the patient recovered from the event of accidental exposure while administering drug/patient was not administered FLUMIST-This would be secondary contact on 27-Oct-2013. The report was considered to be non-serious. The event of generalized aching, tired and no appetite has been identified by the company physician from the source documents and added as adverse event and considered it as non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 28-Oct-2013 from Health Professional:New events of generalized aching, tired and no appetite were added. The outcome of the event accidental exposure while administering drug/patient was not administered FLUMIST-this would be secondary contact was changed to recovered and stop date added. Corrected report 17-Nov-2013: Reporter's added. Action taken with FLUMIST was changed to not applicants.
Age: 63.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a 63 year old, female subject, who had been receiving FLUMIST (Intranasal). Concomitant medications included ADDERALL and cycidrine. FLUMIST (Intranasal) started on an unknown date. It was reported that the patient had fever and headaches which started on 21-oct-2013, no appetite, generalized aching, tired and accidental exposure while administering drug was considered as an event. The outcome of the event of fever, no appetite, headaches, generalized aching and tired is unknown and the patient recovered from the event of accidental exposure while administering drug/patient was not administered FLUMIST-This would be secondary contact on 27-Oct-2013. The report was considered to be non-serious. The event of generalized aching, tired and no appetite has been identified by the company physician from the source documents and added as adverse event and considered it as non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 28-Oct-2013 from Health Professional:New events of generalized aching, tired and no appetite were added. The outcome of the event accidental exposure while administering drug/patient was not administered FLUMIST-this would be secondary contact was changed to recovered and stop date added. Corrected report 17-Nov-2013: Reporter's added. Action taken with FLUMIST was changed to not applicants.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Underdose
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 11-Oct-2013. It was reported that the patient received only half dose of FLUMIST which started on 11-Oct-2013. FLUMIST was discontinued on 11-Oct-2013. The outcome of the event of patient received only half dose of FLUMIST is unknown. The report was considered to be non-serious.
Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Health Professional concerning a 33 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 11-Oct-2013. The patient received only half dose of FLUMIST QUADRIVALENT which started on 11-Oct-2013. The outcome of the event of patient received only half dose of FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 14.0
Sex: M
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Health Professional concerning a 14 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 11-Oct-2013. The patient received only half dose of FLUMIST QUADRIVALENT on 11-Oct-2013. The outcome of the event of patient received only half dose of FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Exposure via direct contact
Clinical narrative: A report has been received from a Health Professional concerning an 11 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient was administered into eye on 22-Oct-2013. The outcome of the event of ADMINISTRATION INTO EYE is unknown. The report was considered to be non-serious.
Age: 0.7
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning an 8 month old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The fifty-one year old woman received FLUMIST QUADRIVALENT on 10-Oct-2013. The outcome of the event of fifty-one year old woman received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A consumer report has been received. The report concerns a 3 year old, Female consumer, who had been receiving FLUMIST, (intranasal) started on an unknown date. It was reported that patient received two doses of FLUMIST on the same day. The outcome of the event of patient received two doses of FLUMIST on the same day is unknown. The report was considered to be non-serious.
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Influenza virus test positive, Nasal congestion, Pain, Pyrexia
Clinical narrative: A report has been received from a physician concerning a 15 year old, male patient. The patient's medical history and concomitant medications were not reported. On 08-Oct-2013, the patient started receiving treatment with nasal FLUMIST (Intranasal). Patient began to have nasal congestion, cough, fever, body aches, two days ago (20-OCT-2013). Patient tested positive for flu on 22-OCT-2013. Action taken with FLUMIST was unknown. The outcome of the event of tested positive for flu, cough, fever, nasal congestion and body aches was unknown. Patient was on TAMIFLU as he was tested positive for flu. MD sent specimen of viral culture from his nose to see what kind of virus was the patient having. The report was considered to be non-serious by reporter.
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Viral test
Clinical narrative: A report has been received from a physician concerning a 15 year old, male patient. The patient's medical history and concomitant medications were not reported. On 08-Oct-2013, the patient started receiving treatment with nasal FLUMIST (Intranasal). Patient began to have nasal congestion, cough, fever, body aches, two days ago (20-OCT-2013). Patient tested positive for flu on 22-OCT-2013. Action taken with FLUMIST was unknown. The outcome of the event of tested positive for flu, cough, fever, nasal congestion and body aches was unknown. Patient was on TAMIFLU as he was tested positive for flu. MD sent specimen of viral culture from his nose to see what kind of virus was the patient having. The report was considered to be non-serious by reporter.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 4 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter reported that patient received one half dose of FLUMIST which started on 15-Oct-2013. The outcome of the event of patient received one half dose of FLUMIST is unknown. The report was considered to be non-serious.
Age: 58.0
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 patient, male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 16-Oct-2013. It was reported that patient received FLUMIST quadrivalent over age 49 on 16-Oct-2013. The outcome of the event received FLUMIST quadrivalent over age 49 is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by Astrazeneca/MedImmune 25-Oct-2013 from health professional: Last name and reporters address of reporter administered by were added.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Influenza like illness, Wheezing
Clinical narrative: A report had been received from a health professional that concerned a 04 year old male patient. Concomitant medication included salbutamol sulfate. The patient did not have a history of asthma. The patient did not have history of allergies and lung disease. The medical history and the concomitant medications were not reported. The patient received nasal FLUMIST QUADRIVALENT (Intranasal) on an 03-Oct-2012 and then on 05-Oct-2013 for unknown indication. The patient who received FLUMIST QUADRIVALENT had not wheezed in the past two years, but wheezed after FLUMIST QUADRIVALENT on 18-Oct-2013 and almost had to go to the emergency room. The patient also became very sick with flu like symptoms within 24 hours. He has received FLUMIST in the past without any adverse events. The lot number: BH2186 Exp date: 09-Dec-2013. On unspecified date, the patient experienced coughing. The outcome of the events of wheezing, flu-like symptoms and coughing was unknown. The reporter considered the events of wheezing, coughing and flu-like symptoms to be non-serious. Summary of follow up information received by MedImmune on 23-Oct-2013 and 06-Nov-2013 from Responsible Physician: New non serious event coughing added. Concomitant drug added. Dosing regimen of suspect drug added. The start date of the event wheezing added. Patient details added. Corrected report 12-Nov-2013: The reporter type of other changed of responsible physician and the earlier reporter type as responsible physician deleted. Vaccinated at and vaccine purchased with added.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Rash generalised
Clinical narrative: A report has been received from a Health Professional concerning a 13 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 28-Sep-2013. The patient experienced RASH ALL OVER BODY which started on 02-Oct-2013. The outcome of the event of RASH ALL OVER BODY is unknown. The report was considered to be non-serious.
Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error, Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 33 year old, female patient. On 17-Oct-2013 the patient received her nasal FLUMIST QUADRIVALENT vaccination. On 17-Oct-2013 the nurse who administered the vaccine did not remove the clip and the employee only received a half of a dose. Not reporting any symptoms currently. The outcome of the event of patient received half dose of FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST started on an unknown date. A patient over 49 years old received FLUMIST. The outcome of the event of patient over 49 years old received FLUMIST is unknown. The report was considered to be non-serious by the company physician.
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Pharmacist concerning a patient, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The patient stated that patient received the entire dose in one nostril. The outcome of the event of patient received the entire dose in one nostril is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The patient reported that FLUMIST administered in one nostril which started on 16-Oct-2013. The outcome of the event of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 37.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Pharmacist concerning a 37 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 16-Oct-2013. When pharmacist administered the FLUMIST quadrivalent to a patient today, the patient reported that she thought all of the dose went into the first nostril and none in the second on 16-Oct-2013. The outcome of the event of patient reported that she got all of the dose into the first nostril 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 FLUMIST, (intranasal). FLUMIST started on 02-Oct-2013. The patient received FLUMIST which started on 02-Oct-2013. The outcome of the event of received FLUMIST over age 49 is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by Astrazeneca/MedImmune 25-Oct-2013 from Health professional: reporters tab updated.
Age: 55.0
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 55 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on 16-Oct-2013. The reporter stated that the patient had received FLUMIST over age 49 which started on 16-Oct-2013. The outcome of the event of received FLUMIST over age 49 is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by Astrazeneca/MedImmune 25-Oct-2013 from Health professional: reporters tab updated.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Pharmacist concerning a 7 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on 15-Oct-2013. The reporter stated that FLUMIST had been inadvertently administered entire dose into one nostril of the patient which started on 15-Oct-2013. The outcome of the event of inadvertently administered entire dose into one nostril is unknown. The report was considered to be non-serious.
Age: 66.0
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 66 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 21-Oct-2013. The reporter reported that they inadvertently administered FLUMIST to 66 year old woman on 21-Oct-2013. The outcome of the event of inadvertently administered FLUMIST to 66 year old woman is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect dose 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 started on 16-Aug-2013. The reporter stated that the patient had received flu shot and FLUMIST by mistake/child received flu shot on Oct 8th and FLUMIST on Oct 16th by mistake is unknown. The report was considered to be non-serious.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Pharmacist concerning an 8 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The reporter stated that the patient had received entire dose in one nostril which started on 16-Oct-2013. The outcome of the event of received entire dose in one nostril is unknown. The report was considered to be non-serious.
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error, Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 17 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST (intranasal) started on 15-Oct-2013. It was reported that during administration product did not go into the first nostril when the clip was removed the FLUMIST streamed into the second nostril and ran down her face onto lips which started on 15-Oct-2013. The outcome of the event of during administration product did not go into the first nostril when the clip was removed the FLUMIST streamed into the second nostril and ran down her face onto lips is unknown. The report was considered to be non-serious.
Age: 53.0
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 53 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The medical assistant reported that a 53 year old female came with daughter and stated both wanted FLUMIST so they accidentally gave FLUMIST to her. She had not experienced any adverse symptoms. The outcome of the event of administered FLUMIST to a 53 year old is unknown. The report was considered to be non-serious.
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 quadrivalent (intranasal). The patient's concurrent disease(s) included immunocompromised, multiple myeloma and chemotherapy. Concomitant medications included acetylsalicylic acid. FLUMIST quadrivalent (intranasal) started on an unknown date. A 52 years old patient received FLUMIST quadrivalent which started on 20-Nov-2013. The outcome of the event received FLUMIST quadrivalent who was immunocompromised (52 years of age) is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A report was received from a health professional via medical representative concerning a 4 year old male patient. Medical history and concomitant medications were not reported. On 08-Oct-2013, patient received FLUMIST, (intranasal). On 18-Nov-2013, patient got the flu. On 20-Nov-2013, patient received TAMIFLU. At the time of reporting, the event was improving. The reporting health professional assessed the event to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 25-Nov-2013 from health professional: patient's DOB, initials, start date, lot number for FLUMIST, event onset date and outcome were added.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure via direct contact
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The reporter reported that a child moved during the second half dose of FLUMIST quadrivalent and it went into his eye on 20-Nov-2013. The outcome of the event FLUMIST went into eye is unknown. The report was considered to be non-serious.
Age: 74.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Physician concerning a 74 year old, Male subject, who has been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). The patient's medical history included Reaction to flu shot. The patient's concurrent disease(s) included DM II, HTN, Hypothyroidism, GERD, Depression, DJD and HLD. Concomitant medications included Tramadol, Gabapentin, Hydrochlorothiazide, Acetylsalicylic acid, Levothyroxine, Lansoprazole, Ergocalciferol and Escitalopram oxalate. FLUMIST QUADRIVALENT (Intranasal) started on 18-Oct-2013. It was reported that a 74 year old patient received FLUMIST on 18-Oct-2013. The outcome of the event of 74 yo patient received FLUMIST is unknown. The report was considered to be non-serious. Summary of follow-up information received by MedImmune on 02-Dec-2013 from Physician: Concomitant disease and relevant history added. Concomitant medications added. Form completed date updated. Corrected Report 12-Dec-2013: Reporter types changed for two reporters changed. Start date of event and product added. Reporter type Responsible Physician deleted.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Alopecia
Clinical narrative: A consumer report has been received. The report concerns a 9 year old, Female consumer, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The patient experienced clumps of hair fell out after receiving FLUMIST. The outcome of the event of clumps of hair fell out after receiving FLUMIST is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Accidental exposure to product
Clinical narrative: A report has been received from a Health Professional concerning a Child, subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started during Oct-2013. It was reported that two children inadvertently got FLUMIST in eyes during Oct-2013. The outcome of the event of two children inadvertently got FLUMIST in eyes is unknown. The report was considered to be non-serious.
Age: 18.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Physician concerning an 18 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 14-Nov-2013. It was reported that consumer was inadvertently given FLUMIST quadrivalent to a pregnant woman which started on 14-Nov-2013. The pregnancy outcome was unknown, last menstruation was in Apr-2013, and the expected delivery date was Jan-2014. The outcome of the event of inadvertently gave FLUMIST quadrivalent to a pregnant woman is unknown. The patient was pregnant and due date was found to be Jan-2014 and pregnancy result was unknown. The report was considered to be non-serious by the reporter. Follow-up of insignificant information received by AstraZeneca/MedImmune 26-Nov-2013 from physician: patient initials changed, last menstruation date added and narrative updated.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A spontaneous report has been received from Health Professional, with follow up from another Health Professional, concerning a 9 years old male patient. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. On 24-Aug-2013, the patient was receiving FLUMIST (Intranasal). The reporter stated that three patients received FLUMIST and then get the flu on 07-Nov-2013. The patient recovered from the event of flu on an unspecified date. The reporter considered the event of flu to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune from Health Professional on 25-Nov-2013: date of birth, two new reporters, patient initials drug start date, onset date, lot number added; outcome changed to recovered.
Sex: U
Vaccine: FLUN4
Symptoms: Accidental exposure to product
Clinical narrative: A report has been received from a Health Professional concerning a Child, subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started during Oct-2013. Inadvertently got FLUMIST in the patient's eyes which started during Oct-2013. The outcome of the event of inadvertently got FLUMIST in eyes is unknown. The report was considered to be non-serious by the reporter.
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 31-Oct-2013. It was reported that FLUMIST quadrivalent was inadvertently administered to a pregnant woman which started on 31-Oct-2013. The outcome of the event of inadvertently administered to pregnant woman is unknown. The patient was pregnant and the pregnancy outcome was unknown. The report was considered to be non-serious. Follow-up of insignificant information received AstraZeneca/MedImmune on 22-Nov-2013 from health professional was provided lot number, and expiration date of FLUMIST quadrivalent.
Sex: F
Vaccine: FLUN4
Symptoms: Influenza B virus test positive
Clinical narrative: A report has been received from a physician concerning, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started during Oct-2013. The patient experienced positive influenza B test which started during 2013. The outcome of the event of positive influenza B test is unknown. The report was considered to be non-serious. Corrected report 25-Nov-2013: Drug and event started dated added. Reporter details and patient details updated.
Age: 57.0
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 57 year old, subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST (intranasal) started on an unknown date. The patient FLUMIST and patient was 57 year old. The outcome of the event of patient received FLUMIST and patient is 57 year old is unknown. The report was considered to be non-serious. Corrected report 22-Nov-2013: the key ingredient of the suspect drug was corrected from FLUMIST to Q/LAIV.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Physician concerning a 7 year old, male subject, Height: 50.0 inches: Weight: 61.4 pounds, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.5 Millilitres, Once/Single administration. The patient's concurrent disease(s) included asthma and ADHD. Concomitant medications included Salbutamol, cetirizine hydrochloride, clonidine and dexmethylphenidate hydrochloride. FLUMIST QUADRIVALENT started on 19-Nov-2013. It was reported that they had inadvertently gave FLUMIST QUADRIVALENT to a patient with very well controlled asthma on 19-Nov-2013. FLUMIST QUADRIVALENT was discontinued on 19-Nov-2013. The outcome of the event of inadvertently gave FLUMIST QUADRIVALENT to a patient with very well controlled asthma is unknown. The report was considered to be non-serious.
Age: 1.95
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 FLUMIST (Intranasal). FLUMIST (Intranasal) started on 21-Oct-2013. The reporter stated that the patient had FLUMIST administered to 23 month old which started on 21-oct-2013. The outcome of the event of FLUMIST administered to 23 month old is unknown. The report was considered to be non-serious.
Age: 55.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a Pharmacist concerning a 55 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's concurrent disease(s) included ALLERGY TO THIMEROSAL. FLUMIST QUADRIVALENT started on 27-Sep-2013. It was reported that pharmacist vaccinated 55 year old female with FLUMIST by mistake which started on 27-Sep-2013, not reported any symptoms. The outcome of the event of ADMINISTERED FLUMIST QUADRIVALENT TO A 55 YO is unknown. The report was considered to be non-serious.
Age: 49.0
Sex: F
Vaccine: FLUN4
Symptoms: Dyspnoea, Feeling jittery, Headache
Clinical narrative: A consumer report has been received. The report concerns a 49 year old, female consumer, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's medical history included jittery all over, shortness of breath and headache. The patient's concurrent disease(s) included Sulfa allergy. FLUMIST QUADRIVALENT started on 01-Oct-2013. The patient experienced jittery all over, shortness of breath and headache which started on 01-Oct-2013. At the time of reporting, the event of jittery all over, shortness of breath and headache was ongoing. The report was considered to be non-serious.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Epistaxis
Clinical narrative: A report has been received from a Health Professional concerning a 13 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST (intranasal) started on 01-Oct-2013. The patient experienced two nose bleeds which started on 01-Oct-2013. The patient recovered from the event of two nose bleeds on an unspecified date. The report was considered to be non-serious.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Accidental exposure to product
Clinical narrative: A report has been received from a Physician concerning a 7 year old, Female subject, Height: 49.0 inches; Weight: 48.0 Kilograms, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 30-Sep-2013. It was reported that when Licensed practical nurse was giving FLUMIST the patient moved and some went in the eyes of patient on 30-Sep-2013. The outcome of the event went in the eye is unknown. The report was considered to be non-serious.
Age: 57.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a pharmacist concerning a 57 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The pharmd reported they accidentally gave FLUMIST to a 56 year old on 24-sep-2013. The outcome of the event of accidentally gave FLUMIST to a 56 year old is unknown. The report was considered to be non-serious.