chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a physician concerning a 7 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient was administered expired FLUMIST QUADRIVALENT on 08-Sep-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Physician concerning a 10 year old, male subject who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUARIVALENT (intranasal) started on an unknown date. The patient reported administered expired FLUMIST QUADRIVALENT which started on 08-Sep-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: A consumer report has been received. The report concerns a 4 year old, male patient. The patient relevant history and concurrent disease was not reported. Patient had been receiving FLUMIST (intranasal), started during Sep-2011. The patient experienced tested positive for flu A and flu B which started during Nov-2011. The outcome of the event of tested positive for flu A and flu B was unknown. The reporter considered the event tested positive for flu A and flu B to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza B virus test positive
Clinical narrative: A consumer report has been received. The report concerns a 30 year old, female consumer, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started during Oct-2008. The patient experienced tested positive for Flu B. The outcome of the event of tested positive for Flu B is unknown. The report was considered to be non-serious.
Age: 1.51
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, weight: 30.0 pounds, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The 18 month old patient was administered QUADRIVALENT FLUMIST which started on 02-Sep-2014. The outcome of the event of 18 month old patient was administered QUADRIVALENT FLUMIST is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Malaise, Nasal congestion, Pyrexia
Clinical narrative: A report has been received from a physician concerning a 8 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 02-Sep-2014. The patient experienced fever of 101, headache, stuffy nose and not feeling well which started on 05-Sep-2014. The outcome of the event of fever of 101, headache, stuffy nose and not feeling well is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a female patient, who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) was administered on 14-May-2014. The patient received FLUMIST while being pregnant in the third trimester. At the time of reporting, the result of the pregnancy was not known. The pregnancy due date was reported as 20-Oct-2014. The outcome of the event pregnant was unknown. The report was considered to be non-serious by the reporter. Follow-up insignificant information received by AstraZeneca/MedImmune 25-Jun-2014 from consumer: Pregnancy due date was added.
Sex: F
Vaccine: FLUN4
Symptoms: Stomatitis
Clinical narrative: A report has been received from a physician via medical representative concerning an adult female patient, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started during 2008. The patient experienced severe inflammation of upper soft palate which started during 2008. The patient recovered from the event of inflammation of upper soft palate on an unspecified date. The report was considered to be non-serious by the reporter.
Sex: F
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A report has been received from a health professional concerning a female patient in her forties. Relevant history and concomitant medication were not provided. The patient received FLUMIST QUADRIVALENT (Intranasal). Later in the year, she contracted influenza B. The outcome of the event of influenza B was unknown. The event of influenza B was assessed as non-serious by the reporter.
Sex: U
Vaccine: FLUN4
Symptoms: Wheezing
Clinical narrative: A report has been received from a health professional concerning a patient of unknown gender. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unknown date, the patient started receiving nasal FLUMIST (intranasal). The patient wheezed two days post administration of FLUMIST. Action taken with the suspect vaccine was unknown. The outcome of the event of wheezing is unknown. The report was considered to be non-serious by the reporter.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain, Pyrexia, Rash, Sneezing
Clinical narrative: A consumer report has been received. The report concerns a 5 year old. Female consumer, who had been receiving nasal FLUMIST (intranasal) started on an unknown date. The patient experienced fever, sneezing, abdominal pain, and rash started on 16-MAR-2014. The patient recovered from the event of fever, sneezing, abdominal pain and rash on unspecified date. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Respiratory tract congestion
Clinical narrative: A consumer report has been received. The report concerns a 4 year old, male consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced congestion. The outcome of the event of congestion is unknown. The report was considered to be  non-serious. Corrected report on 26-Sep-2014: Az date was updated.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Epistaxis, Respiratory tract congestion, Vomiting
Clinical narrative: A consumer report has been received, concerning a 2 year old female patient. The patient's concurrent diseases and concomitant medications were not reported. On an unknown date the patient received nasal FLUMIST (intranasal). The patient experienced severe vomiting, nose bleeding, severe congestion which started on 08 OCT 2013. The action taken of FLUMIST was unknown. The outcome of the events was unknown. Due to lack of customer follow-up this adverse event could not investigated by the lot information. However, trend analysis reported does not show a trend for this   complaint type. The events of vomiting and nose bleeding were considered to be non-serious by company physician. The event of congestion have been identified by the company physician from the source document and added as non-serious adverse events. Corrected report 24-SEP-2014: The reporter type of Product Complaints corrected from other to reference. Narrative was edited. Associated case ID added. PQC box was un ticked.
Age: 28.0
Sex: F
Vaccine: FLUN4
Symptoms: No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 28 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal). Vaccine given on same day included oseltamvir. FLUMIST QUADRIVALENT (Intranasal) started on 02-Sep-2014. The patient experienced No AE reported which started on 03-Sep-2014. The outcome of the event of no AE reported is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Exposure via direct contact, Eye irrigation
Clinical narrative: A spontaneous report has been received from a Health Professional concerning an 11 year old, male patient. Patient relevant, history concurrent disease and concomitant drugs were not reported. The reporter stated that child pulled back and right eye was sprayed with FLUMIST QUADRIVALENT (intranasal). The nurse stated they flushed the eye out. At the time of reporting, the event of right eye sprayed with FLUMIST QUADRIVALENT was improving. The reporter assessed the event of right eye sprayed with FLUMIST QUADRIVALENT to be non serious.
Age: 60.0
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 60 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on 30-Aug-2014. It was reported that inadvertently administered FLUMIST QUADRIVALENT to a person over 49 year old which started on 08-Sep-2014. The outcome of the event of inadvertently administered FLUMIST QUADRIVALENT to a person over 49 year old is unknown. The report was considered to be non-serious.
Age: 36.0
Sex: F
Vaccine: FLUR3
Symptoms: Exposure during pregnancy
Clinical narrative: his is an initial report of a pregnancy, received on 21 OCT 2014. Subject number: 2014-031068/KE, a 36-year-old female received FLUBLOK, intramuscularly on 20 OCT 2014. On day 2 of receiving FLUBLOK, 21 OCT 2014 (FLUBLOK was administered on OCT 2014) (lot # 441253F) the pharmacist contacted the call center to inform that the above reference subject was pregnant. No information on previous pregnancy history, medical history or concomitant medication provided. Causality information was not provided. Since it is a one time dose, action taken, outcome, de challenge and re challenge has been reported as not applicable.    Company assessment: based on the initial information received 21 OCT 2014, that the FLUBLOK was administered  to the subject who was pregnant, the company assessment of causality between the event and FLUBLOK is not related.
Age: 33.0
Sex: F
Vaccine: FLUR3
Symptoms: Exposure during pregnancy
Clinical narrative: This is an initial report of a Pregnancy, received on 06Nov2014, for FLUBLOK; a 33-year-old female who received FLUBLOK Intramuscular on 06Nov2014. On Day 0 (06Nov2014), the same day as received FLUBLOK (Lot #: unknown), the subject contacted the call center stating that she received FLUBLOK while pregnant. The subject reported that she discussed getting FLUBLOK with both her obstetrician and her allergist and all stated it was acceptable to received FLUBLOK. The subject noted that she is due in approximately 03Jul2015. Medical history included asthma. No information on previous pregnancy history was provided. Concomitant medications included PULMICORT for asthma, levothyroxine for thyroid, and multivitamin for an unknown indication. Causality information was not provided. Since FLUBLOK was a single dose (unable to confirm), action taken, outcome, De Challenge and ReChallenge have ben reported as Not Applicable.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a physician concerning a 3 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient reported administered expired FLUMIST QUADRIVALENT which started on 08-Sep-2014. The outcome of the event of ADMINISTERED EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old, male subject, who had been received FLUMIST QUDRIVALENT (intranasal). FLUMIST QUDRIVALENT (intranasal) started on 08-Sep-2014. Expired FLUMIST QUADRIVALENT was administered to the patient on 08-Sep-2014.The outcome of the event of administered expired FLUMIST QUADRAVALENT is unknown. The report was considered to be non-serious by the reporter.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a physician concerning a 3 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient reported administered expired FLUMIST QUADRIVALENT which started on 08-Sep-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 52.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 52 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 12-Sep-2014. The patient experienced administered FLUMIST QUADRIVALENT to a doctor who is over 49 which started on 12-Sep-2014. The outcome of the event of administered FLUMIST QUADRVIALENT to a doctor who is over 49 is unknown. The report was considered to be non-serious by the reporter.
Age: 29.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A spontaneous-unsolicited report has been received from a pharmacist concerning a 29 year old, female patient. The patient's medical history and concomitant medications were not reported. Since 12-Sep-2014, the patient had been receiving FLUMIST QUADRIVALENT (intranasal). The pharmacist reported that full dose of FLUMIST QUADRIVALENT was administered into one nostril which started on 12-Sep-2014. The outcome of the event of full dose of FLUMIST QUADRIVALENT was administered into one nostril was unknown. The reporter assessed the report 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 female patient, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient was administered expired FLUMIST QUADRIVALENT. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Epistaxis
Clinical narrative: A report has been received from a health professional concerning a 5 year old, male patient. No medical history, concomitant diseases and concomitant medications were reported for consumer. Patient was administered FLUMIST QUADRIVALENT (intranasal) unknown date for unknown indication. It was reported that after administration of FLUMIST in the left nostril, the patient had developed a nose bleed. The mother declined the second spray in the right nostril. The outcome of the event of nose bleed was unknown. The report was considered to be non-serious by reporter.
Age: 0.5
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 6 month old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that inadvertently administered FLUMIST QUADRIVALENT to a 6 month old patient. The outcome of the event of inadvertently administered FLUMIST QUADRIVALENT to a 6 month old patient is unknown. The report was considered to be non-serious.
Age: 42.0
Sex: F
Vaccine: FLUN4
Symptoms: Nonspecific reaction
Clinical narrative: A report has been received from a pharmacist concerning a 42 year old, female subject, who had been receiving FLUMIST QUADRIVALWNT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 12-Sep-2014. Pharmacist reported patient believed she received more of the FLUMIST in one nostril that the other which started on 12-Sep-2014. The outcome of the event of patient said she got more of the FLUMIST in one nostril than the other is unknown. The report was considered to be non-serious by the reporter.
Age: 18.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Pyrexia
Clinical narrative: A spontaneous report from a health professional via VAERS concerns an 18 years old male. Concomitant medications and concomitant diseases were not reported. On an unknown date the patient received FLUMIST QUADRIVALENT (intranasal). The patient experienced fever and cough. The outcome of the fever and cough was unknown. The reporter assessed the fever and cough as serious due to medical importance. In the absence of reporter's causality the company physician considered the fever and cough to be related to the suspect drug FLUMIST QUADRIVALENT. Corrected report 17-Oct-2014: company causality changed from no to yes, narrative amended.
Sex: U
Vaccine: FLUN4
Symptoms: Neonatal disorder, Pulmonary hypertension
Clinical narrative: A spontaneous report from a Regulatory Authority (VAERS) concerns a neonate of unknown gender. Concomitant medications and concomitant diseases were not reported. On an unknown date the patient's mother received FLUMIST QUADRIVALENT (intranasal). The patient experienced pulmonary hypertension as a neonate. The outcome of the pulmonary hypertension was unknown. The reporter considered the pulmonary hypertension serious as an important medical event. In the absence of reporter's causality the company physician considered the pulmonary hypertension to be related to the suspect drug FLUMIST QUADRIVALENT. Corrected report 17-Oct-2014: company causality changed from no to yes, route changed from nasal to transplacental, parental route (nasal) added, pregnancy page filled in.
Age: 21.0
Sex: M
Vaccine: FLUN4
Symptoms: Anaphylactic reaction
Clinical narrative: A solicited report had been received from health professional via Post-Licensure Surveillance of FLUMIST QUADRIVALENT from regulatory authority concerning a 21 year old male patient. Concomitant medications included yellow fever vaccine and hepatitis B vaccine. No information regarding relevant history and concurrent disease of the patient was provided. The patient had been receiving FLUMIST QUADRIVALENT (intranasal) unknown frequency, started on an unknown date for an unknown indication. The patient presented symptoms that met Brighton level 2 criteria, anaphylaxis. Action taken with FLUMIST QUADRIVALENT was unknown. The patient recovered from the event of anaphylaxis on an unspecified date. The company physician upgraded reported non-serious event of anaphylaxis to serious with serious criteria of important medical event. Based on the information in this report, and awaiting the assessment of the reporter, the company physician considered the event of anaphylaxis to be related to the vaccine FLUMIST QUADRIVALENT.
Age: 39.0
Sex: M
Vaccine: FLUN4
Symptoms: Asthma, Condition aggravated
Clinical narrative: A report from a healthcare professional via VAERS concerns a 39 year old male patient. His medical history, concurrent diseases, and concomitant medications were not reported. On an unknown date, the patient received FLUMIST QUADRIVALENT (intranasal). On an unspecified date, the patient developed asthma exacerbation. At the time of reporting the outcome of the event of asthma exacerbation was unknown. According to the reporter the adverse event of asthma exacerbation was considered to be serious as an important medical event and according to company physician, the adverse event was at least possibly causally related to the suspect drug.
Age: 33.0
Sex: M
Vaccine: FLUN4
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: A report from VAERS concerns a 33 year old male. Medical history and concomitant medications were not reported. The patient received FLUMIST QUADRIVALENT (intranasal) and experienced ADEM. At the time of reporting, the outcome of the event was unknown. The reporter assessed the event to be serious as an important medical event. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event to be at least possibly related to FLUMIST QUADRIVALENT. Corrected Report 12-Sep-2014: implied yes causality captured, solicited reporter deleted.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Febrile convulsion
Clinical narrative: A report has been received from regulatory authority via post-licensure surveillance of FLUMIST QUADRIVALENT concerning a 5 year old, female subject, enrolled in a non-interventional/post-marketing study. No information regarding the relevant history, concomitant disease and concomitant drug was provided. The patient received FLUMIST QUADRIVALENT (intranasal) on an unknown date. The patient experienced febrile seizures. Action taken with FLUMIST QUADRIVALENT was not applicable. The outcome of the event of febrile seizures was recovered. The report was considered to be non-serious by Company physician. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of febrile seizures to be not related to FLUMIST QUADRIVALENT.
Age: 46.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning a 46 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST (intranasal) started on 06-Sep-2014. Physician assistant reported patient possibly only received partial dose of FLUMIST QUADRIVALENT. When administered. The outcome of the event of partial dose of FLUMIST QUADRIVALENT administered is 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 physician concerning a 3 year old, male subject who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 08-Sep-2014. Patient inadvertently administered expired FLUMIST QUADRIVALENT which started on 08-Sep-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 1.0
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 1 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The patient administered FLUMIST quadrivalent to a 21 month old which started on 18-Sep-2014. The outcome of the event of administered FLUMIST quadrivalent to a 21 month old is unknown. The report was considered to be non-serious.
Age: 0.43
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a health professional concerning a 5 months old, female patient. The patient's concomitant medications, medical history and concurrent diseases were not reported. Patient had been receiving FLUMIST QUADRIVALENT (intranasal) started on 15-Sep-2014. On 15-Sep-2014, patient experienced administered FLUMIST QUADRIVALENT to a nursing mother. Action taken with FLUMIST QUADRIVALENT was unknown. The outcome of the event of administered FLUMIST QUADRIVALENT to a nursing mother was unknown. The reporter considered the event of administered FLUMIST QUADRIVALENT to a nursing mother to be non serious.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: A consumer report has been received. The report concerns a 2 year old Male consumer, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. At the time of reporting, the event of fever was ongoing. The report was considered to be non-serious by the reporter.
Age: 69.0
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 69 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient inadvertently administered FLUMIST QUADRIVALENT to a 69 year old patient which started on 16-Sep-2014. The outcome of the event of inadvertently administered FLUMIST QUADRIVALENT to a 69 year old patient is unknown. the report was considered to be non-serious.
Age: 52.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 52 year old, female subject. who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 23-Sep-2014. The patient experienced 52 year old female has been administered FLUMIST QUADRIVALENT which started on 23-Sep-2014. The outcome of event of 52 year old female has been administered FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 67.0
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 patient, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 20-Sep-2014. It was reported that Nurse practitioner reports they administered FLUMIST to 2 patients over 49. The outcome of the event of administered FLUMIST to two patients over 49 is unknown. The report was considered to be non-serious.
Age: 68.0
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 68 year old, male patient. On unknown date, the patient received FLUMIST QUADRIVALENT (intranasal). The patient was above the appropriate age for receiving the vaccine on 21-Sep-2014. The outcome of the event of administered FLUMIST to two patients over 49 was unknown. The report was considered to be non-serious by reporter.
Age: 1.03
Sex: F
Vaccine: FLU3, HEPA, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever x 3 days. Low grade-High (103F).
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: (L) arm upper swelling and redness 12 x 10 cm light red, mild induration was initially very red according to parent.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain that still has not resolved. Doing physical therapy and it improves but still hurt when he lifts weights.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Synovitis
Clinical narrative: A report has been received from a consumer concerning a 6 year old, male patient. No medical history, concurrent diseases and concomitant medications were reported. On 23-Sep-2014, the patient received FLUMIST QUADRIVALENT (intranasal). The patient experienced Toxic Synovitis which started on 23-Sep-2014. The outcome of the event of Toxic Synovitis was unknown. The report was considered to be non-serious by the reporter.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Muscle tightness, Pyrexia
Clinical narrative: Itchy and redness under inj site. Tightness in (L) jaw slight fever. Itchin started day after injection.
Age: 56.0
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 56 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that FLUMIST QUADRIVALENT inadvertently administered a person who was 56 on 20-Sep-2014. The outcome of the event of administered FLUMIST QUADRIVALENT to a 56 YO is unknown. The report was considered to be non-serious.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The reporter stated patient has been administered FLUMIST QUADRIVALENT twice this season which started on 22-Sep-2014. The outcome of the event of patient received FLUMIST QUADRIVALENT twice this season is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
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 an unknown date. It was reported that the patient was administered with expired FLUMIST. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 0.63
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Irritability, Rash, Urticaria
Clinical narrative: Rash on back AM following 2nd flu vaccine given. Spread to involve chest and inner arms. Described as hives. Afebrile. Seems fussy, uncomfortable. Hives confirmed at Dr. visit 2/19/15 at 1710.
Age: 1.9
Sex: F
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, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported by physician that a patient under 2 years given FLUMIST QUADRIVALNET which started on 24-Sep2014. The outcome of the event of Patient under 2 years given FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 48.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A spontaneous report has been received from a consumer concerning a 48 year old, female patient. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The reporter stated she and her friend both received a full syringe of FLUMIST QUADRIVALENT in each nostril. Nurse giving vaccine stated beforehand this was the first time she was administering FLUMIST QUADRIVALENT. The outcome of the event of full syringe of FLUMIST QUADRIVALENT administered on both nostrils was unknown. The reporter considered the events full syringe of FLUMIST QUADRIVALENT administered on both nostrils as non-serious.
Age: 46.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A consumer report has been received concerning a 46 year old female patient. Medical history and concomitant medications of the patient were not reported. The patient had been received FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient received a full syringe of FLUMIST QUADRIVALENT in each nostril. Nurse giving vaccine stated beforehand this was the first time she was administering FLUMIST QUADRIVALENT. Action taken with FLUMIST QUADRIVALENT was unknown. The outcome of the event of full syringe of FLUMIST QUADRIVALENT administered on both nostrils was unknown. The reporter considered the event full syringe of FLUMIST QUADRIVALENT administered on both nostrils to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Nasopharyngitis
Clinical narrative: A consumer report has been received. The report concerns a consumer of unknown gender, who had been received FLUMIST (Intranasal). FLUMIST (intranasal) started on an unknown date. The patient experienced cold like symptoms. The outcome of the event of cold like symptoms is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between cold like symptoms and FLUIMST. Reporter and company physician considered the event cold like symptoms was related with suspect drug FLUMIST.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Physician concerning a 2 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 08-Sep-2014. The patient administered expired FLUMIST QUADRIVALENT which started on 08-Sep-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Complication of pregnancy, Exposure during pregnancy
Clinical narrative: A report had been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning an adult, female subject, enrolled in a post-marketing study. FLUMIST was administered on an unknown date. There was one report of unspecified complication of pregnancy after receiving QLAIV3 during pregnancy. The outcome of the event of pregnant patient received LAIV3 and unspecified complication of pregnancy was unknown. The report was considered to be non-serious. The company physician considered the causality between suspect FLUMIST with the events of pregnant patient received LAIV3 and unspecified complication of pregnancy to be No.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a physician  concerning a 3 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent.  FLUMIST Quadrivalent was  started on an unknown date. The patient was administered expired FLUMIST which    started on 08-SEP-2014. The outcome of the event of administered expired FLUMIST Quadrivalent is unknown. The  repo was considered to be non-serious.
Age: 39.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza, Pneumonia viral
Clinical narrative: A report from a health professional via VAERS concerns a 39 year old male. The patient's relevant medical history and concomitant medications were not reported. On an unknown date the patient received FLUMIST QUADRIVALENT (intranasal). The patient [subsequently] experienced influenza and viral pneumonia. The outcome of the events was unknown. The company physician assessed influenza and viral pneumonia to be serious due to medical importance. The company causality was implied yes for both events.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Guillain-Barre syndrome
Clinical narrative: A solicited report has been received from health professional via Regulatory Authority concerning a 2 year old, male patient, enrolled in study. Concomitant medications of the patient were not reported. Patient had no recent history of respiratory or gastrointestinal infection. The patient received FLUMIST QUADRIVALENT (intranasal), on an unknown date. The patient experienced Guillain-Barre syndrome. Action taken with FLUMIST was unknown. The outcome of the event of Guillain-Barre syndrome was unknown. The company physician considered the event of Guillain-Barre syndrome as serious due to criteria of Important Medical Event. Based on the information in the report, and awaiting the reporter's assessment, the company physician considered the events of Guillain-Barre Syndrome to be related to FLUMIST.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure to vaccinated person, Headache, Nasal congestion, Pyrexia
Clinical narrative: A report has been received from a Physician concerning a 3 year old, Female subject. FLUMIST quadrivalent (intranasal) was administrated to the sister of the patient. The patient had exposure to vaccinated person and experienced fever, headache, stuffy nose. The outcome of the event of fever, headache, stuffy nose and exposure to vaccinated person is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Exposure during pregnancy, Respiratory disorder
Clinical narrative: A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning an adult, female subject who had been receiving FLUSMIT. FLUMIST started on an unknown date. The patient received FLUMIST while she was pregnant . The patient experienced respiratory condition . The outcome of the event of pregnant patient received FLUMIST and respiratory condition  is unknown. The outcome of the pregnancy was unknown. The reporter's description of the event(s) was as follows: There were four reports of non-serious respiratory conditions after receiving FLUMIST during pregnancy. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of respiratory condition to be not related to the suspect drug FLUMIST. The company causality was implied to be no for the event of pregnant patient received FLUMIST.
Sex: F
Vaccine: FLUN3
Symptoms: Exposure during pregnancy, Malaise
Clinical narrative: A report had been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning an adult female subject he had been receiving FLUMIST. FLUMIST started on an unknown date. There was one report of malaise after receiving QLAV3 during pregnancy. The outcome of the event of malaise and pregnant patient received LAIV3 is unknown. The reporter's description of the event(s) was as follows: There was one report of non-serous malaise after receive QLAIV3 during pregnancy. The report was considered to be non-serious. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the causality between the event malaise with the suspect drug of FLUMIST to be related.
Sex: F
Vaccine: FLUN3
Symptoms: Diarrhoea, Exposure during pregnancy, Vomiting
Clinical narrative: A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning a female patient who had been receiving FLUMIST (Intranasal). FLUMIST started on an unknown date. The patient received FLUMIST while she was pregnant, vomiting and diarrhea. The outcome of the event of pregnant patient received LAIV3, vomiting and diarrhea is unknown. The outcome of pregnancy was unknown. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the events of vomiting and diarrhea to be not related to the suspect drug FLUMIST. The company causality was implied to be no for the event of pregnant patient received LAIV3. The reporter's description of the event(s) was as follows: There was one report of nausea and vomiting after receiving QLAIV3 during pregnancy.
Sex: F
Vaccine: FLUN3
Symptoms: Exposure during pregnancy, Sinusitis
Clinical narrative: A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning a female patient. The patient's medical history, concomitant diseases and concomitant medications were not reported. On an unknown date, the patient received FLUMIST (Intranasal) while the patient was pregnant. It was reported that the patient had sinusitis. The outcome of the events was unknown. Also the outcome of pregnancy was unknown. The report was considered to be non-serious. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of sinusitis to be not related to the suspect drug FLUMIST. The company causality was implied to be no for the event of pregnant patient received LAIV3.
Sex: F
Vaccine: FLUN3
Symptoms: Exposure during pregnancy, Headache
Clinical narrative: A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning an adult, female subject, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. The patient received FLUMIST while she was pregnant. The patient experienced headache. The outcome of the event of pregnant patient received LAIV3 and headache is unknown. The outcome of pregnancy was unknown. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of headache to be related to the suspect drug FLUMIST. The company causality was implied to be yes for the event of pregnant patient received LAIV3. The reporter's description of the event(s) was as follows: There was one report of headache after receiving QLAIV3 during pregnancy. The report is considered to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Exposure during pregnancy, Muscle spasms, Vaginal discharge
Clinical narrative: A report had been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning an adult, female subject, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. There was one report of vaginal discharge with cramps after receiving QLAIV3 during pregnancy. The outcome of the event of pregnant patient received LAIV3, vaginal discharge and cramps is unknown. The reporter's description of the event(s) was as follows: There was one report of vaginal discharge with cramps after receiving QLAIV3 during pregnancy. The report was considered to be non-serious. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the causality between the events pregnant patient received LAIV3, vaginal discharge and cramps with the suspect drug of FLUMIST to be unrelated.
Sex: F
Vaccine: FLUN3
Symptoms: Abortion threatened, Exposure during pregnancy
Clinical narrative: A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning a female patient. The patient's medical history, concomitant diseases and concomitant medications were not reported. On an unknown date, the patient received FLUMIST (intranasal) while she was pregnant. The patient was diagnosed with threatened abortion. The outcome of the events were unknown. Also the outcome of pregnancy was unknown. The report was considered to be non-serious. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of threatened abortion to be not related to FLUMIST. The company causality was implied to be no for drug exposure during pregnancy.
Sex: F
Vaccine: FLUN3
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: A report had been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning an adult, female subject, enrolled in a study. FLUMIST (intranasal) was administered on an unknown date. It was reported that after receiving QLAIV3 there was spontaneous abortion. The outcome of the event of drug exposure during pregnancy and spontaneous abortion was unknown. Assessment of the serious criteria for the report was as follows: Important medical event. The company physician considered the causality between suspect drug FLUMIST with the events of drug exposure during pregnancy and spontaneous abortion to be No.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Anaphylactic reaction
Clinical narrative: A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning a 27 year old female patient enrolled in a study. FLUMIST (intranasal) was administered on an unknown date. The patient experienced anaphylaxis. The outcome of the event of anaphylaxis was unknown. The company physician considered the serious criteria for the event of anaphylaxis as: Important medical event. The company physician considered the causality between Suspect FLUMIST with the event of anaphylaxis to be Yes.
Sex: U
Vaccine: FLUN3
Symptoms: VIIth nerve paralysis
Clinical narrative: A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning an adult patient of unknown gender. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unknown date, the patient received FLUMIST (intranasal). The patient experienced Bell's Palsy. The action taken with the suspecting drug FLUMIST was unknown. The outcome of the event was unknown. The reporter assessed the event of Bell's Palsy to be non-serious. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of Bell's Palsy to be not related to FLUMIST.
Age: 18.0
Sex: M
Vaccine: FLUN3, IPV, TYP, YF
Symptoms: Anaphylactic reaction
Clinical narrative: report had been received from a literature source, a regulatory authority concerning a 18 years old male patient, enrolled in a study. The patient presented with anaphylaxis within a few minutes after receiving LAIV3, yellow fever, inactivated poliovirus and typhoid vaccines. Action taken with the suspect drug, FLUMIST was unknown. The outcome of event, anaphylaxis was unknown. Assessment of seriousness criteria of the event was as follows: Important medical event. The company physician assessed the causality for the event, anaphylaxis with the suspect drug of FLUMIST as yes.
Sex: U
Vaccine: FLUN3
Symptoms: VIIth nerve paralysis
Clinical narrative: A report had been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning an adult subject of unknown gender, enrolled in a study. FLUMIST (intranasal) was administered on an unknown date. It was reported that seven patient reports of Bell's Palsy after receiving QLAIV3. The outcome of the event of Bell's Palsy was unknown. Assessment of the serious criteria for the report was as follows: Important medical event. The company physician considered the causality between suspect drug FLUMIST with the event Bell's Palsy to be No.
Age: 5.0
Sex: U
Vaccine: FLUN3
Symptoms: Asthma
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, patient of unknown gender. Patient's relevant history and concomitant disease were not reported. Patient's concomitant medication was not provided. The patient had been receiving FLUMIST (intranasal) started during the year 2013. The patient experienced asthma attack which started during year 2013. Action taken with FLUMIST was unknown. The patient recovered from the event of asthma attack during year 2013. The report was considered to be non-serious by reporter.
Sex: M
Vaccine: FLUN3
Symptoms: Asthma
Clinical narrative: A report has been received from a Health Professional via medical rep. concerning a adult male patient. No information regarding relevant history, concurrent disease and concomitant medications of the patient was provided. The patient had been receiving FLUMIST (intranasal) started during year 2013. The patient experienced asthma attack which started during year 2013. Action taken with FLUMIST (intranasal) was unknown. The patient recovered from the event of asthma attack during year 2013. The report was considered to be non-serious by company physician.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Hypersensitivity, Malaise
Clinical narrative: A report has been received from a Health Professional concerning a 31 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced smell of MSG in FLUMIST causes patient to feel sick due to MSG allergy, she perceives the odor and develops the allergic reaction, feeling sick and severe headache. The outcome of the event of smell of MSG in FLUMIST causes patient to feel sick due to MSG allergy, she perceives the odor and develops the allergic reaction, feeling sick and headache is unknown. The report was considered to be non-serious.