chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Syncope
Clinical narrative: Transient Syncope; pt laid down, BP stable wnl at all times.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Generalised erythema
Clinical narrative: Patient was given his 2 month vaccines today.  He was given the Rotavirus vaccine first and then his 3 shots.  Pentacel, Prevnar 13 and Hep B.  The child started crying like kids normally do after receiving their shots but patient's whole body turned red.  His head was the most noticeable.  It was like the color of a cherry tomato.  He was not crying that hard at the time and did stop crying shortly after.  His body remained that red for several minutes.  He did not have any sort of rash or hives or breathing issues, just the change in color.  His color gradually went back to normal over the next 2-3 minutes.  The child was monitored for any signs of further reaction.  He was kept in the clinic for 30 minutes.  The incident was reported to Dr.  Dr. did re-evaluate the child and everything was back to normal.   Patients mom instantly got concerned.  Patient has never turned that color even when he is crying really hard.  She is also a nurse and right away assumed it was a reaction to his vaccines.   We are unsure if this is related to his vaccines but are reporting this just in case.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Headache, Nasal congestion, Pyrexia, Vomiting
Clinical narrative: Headache started first, mid afternoon, then a couple of hours later, spiked a fever of 103 and vomited. Fever went down to 101 without medications within an hour, but headache persisted. Fever went back up within 24 hours and was 103-104 for 36 hours. Administered acetaminophen initially until fever could be tolerated and then it was sustained at 102 for 12 hours before starting to go down. A stuffy nose and low energy followed the next day.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Headache, Injection site pain, Injection site swelling, Pain
Clinical narrative: Headache, Body Aches, Moderate pain and swelling where shot given.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Computerised tomogram, Culture wound, Mumps antibody test, Parotitis, Polymerase chain reaction
Clinical narrative: Right side parotitis started on 1/25/2015 PM, went to ED, diagnosed with sialadenitis. Patient came to see me the next morning, with increasing swelling. No testing done at that office visit, but swelling increased in size over the next 24 hours, she visited my office again on 1/27/2015, at which time I took a saliva sample for mumps PCR. At that same office visit, I admitted her to the hospital for concern of possible abscess/cellulitis in the submandibular region, which was subsequently drained and found to contain staph aureus. Since discharge from the hospital, swelling has significantly subsided (last office visit with me was on 2/5/2015).
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Sialoadenitis, Staphylococcal infection, Staphylococcus test positive, Swelling, Wound drainage
Clinical narrative: Right side parotitis started on 1/25/2015 PM, went to ED, diagnosed with sialadenitis. Patient came to see me the next morning, with increasing swelling. No testing done at that office visit, but swelling increased in size over the next 24 hours, she visited my office again on 1/27/2015, at which time I took a saliva sample for mumps PCR. At that same office visit, I admitted her to the hospital for concern of possible abscess/cellulitis in the submandibular region, which was subsequently drained and found to contain staph aureus. Since discharge from the hospital, swelling has significantly subsided (last office visit with me was on 2/5/2015).
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: Patient awoke around 6-7 am with a blotchy, red, rash on her face. Non- itchy. Received Rabies immune globulin and vaccine about 15 hour prior. No local or systemic reactions.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Erythema, Feeling hot, Injection site discolouration, Injection site reaction, Injection site streaking
Clinical narrative: Red, Streaky Rash on thigh where DTaP vaccine was injected.  It is about 4 inches by 4 inches.  Hot, red, swollen, and stiff.  The injection site is light purple.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Musculoskeletal stiffness, Rash erythematous, Swelling
Clinical narrative: Red, Streaky Rash on thigh where DTaP vaccine was injected.  It is about 4 inches by 4 inches.  Hot, red, swollen, and stiff.  The injection site is light purple.
Age: 1.42
Sex: M
Vaccine: DTAP, HEP, VARCEL
Symptoms: Angioedema, Decreased eye contact, Screaming
Clinical narrative: Giant hives all over child's trunk. Waking from sleep with uncontrollable screaming/unable to make eye contact.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema and pain at site of inoculation.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Respiratory tract infection
Clinical narrative: Very painful, large redness spreading from injection site, doctor prescribed Doxycycline; redness spread further that night; redness seemed to lessen starting on 02/15/2015; patient developed respiratory infection 02/15/2015 but is unknown whether it is related to vaccine.
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Rash, Rash generalised, Rash pruritic
Clinical narrative: Reaction was to the MMRV. My daughter woke up with a SEVERE rash from head to toe 12 days after MMRV vaccination. The rash hurt and was itchy. It lasted 4 days.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: After receiving shot had a hard, red lump about the size of half dollar and turned itchy.  Lasted for a few weeks.  Now has flare ups of itchy skin and rash at site of injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling and itching. Pt took Benadryl told pt to see MD.
Age: 2.0
Sex: M
Vaccine: DTAPH, VARCEL
Symptoms: Injection site cellulitis, Varicella post vaccine
Clinical narrative: Severe Cellulitis at injection site followed by onset of Varicella virus.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Anger, Autism, Condition aggravated, Disturbance in attention
Clinical narrative: Significantly increased Autism symptoms and reemergence of symptoms that had not been seen in over a year: pacing, arm flapping, fits of anger, poor mood, inappropriate hand gestures, decreased attention. These symptoms began the day after the vaccination and have continued and increased in severity over the past 6 days. They have yet to resolve.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Mood altered
Clinical narrative: Significantly increased Autism symptoms and reemergence of symptoms that had not been seen in over a year: pacing, arm flapping, fits of anger, poor mood, inappropriate hand gestures, decreased attention. These symptoms began the day after the vaccination and have continued and increased in severity over the past 6 days. They have yet to resolve.
Age: 32.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mouth swelling, Oral mucosal erythema, Pruritus generalised
Clinical narrative: Patient received both Afluria and Prevnar. Patient remained in pharmacy area for 5 minutes, but 20 minutes after leaving the pharmacy she experienced itching over her entire body and her mouth was red and swollen. Patient was advised by the pharmacist to call 911. In the ambulance, patient was given a dose of an Epipen.  At the hospital, patient also received Zofran and Ativan
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Chills, Dyspnoea, Lung infiltration, Pyrexia
Clinical narrative: Chills, fever, shaking, shortness of breath.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Tremor, White blood cell count increased
Clinical narrative: Chills, fever, shaking, shortness of breath.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown ages and genders. Since October 2014 the patients were vaccinated with doses of improperly stored ROTATEQ (oral, lot#, dose and frequency were unknown). No adverse effects were noted. It was unspecified if the patients sought medical attention. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. On unknown dates, the patients received ROTATEQ (lot#, expiration date and dose not reported), orally, after being improperly stored for one month. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Injection site pain, Injection site swelling, Mixed connective tissue disease, Systemic lupus erythematosus
Clinical narrative: We became aware recently (2/4/15) of arm pain and swelling at site of HPV vaccine. Please see enclosed records for subsequent symptoms, with most recent evaluation by rheumatology consistent with SLE or mixed connective tissue disease.
Age: 15.0
Sex: M
Vaccine: HPVX
Symptoms: Drug screen, Electrocardiogram, Generalised tonic-clonic seizure, Laboratory test, Memory impairment
Clinical narrative: This spontaneous report as received from a nurse, via company representative, refers to her 15 year old son with hay fever. The patient's medical history included neonatal seizures after birth which stopped after unspecified time. On 05-FEB-2015, he was vaccinated with the third dose of HPV vaccine (manufacturer unknown) (dose, route and lot number were not reported) (dates of the first and the second dose were not provided). Concomitant therapies included AUGMENTIN for sinus infections. On 09-FEB-2015, the patient experienced grand mal seizure which lasted approximately 5-6 minutes. After the seizure, on the same day, he experienced forgetfulness. The patient had magnetic resonance imaging (MRI), electrocardiography (ECG), urine analysis, drug analysis and other unspecified laboratory work done, results were not provided. He sought medical attention at the emergency room (ER). The outcome of grand mal seizure was unknown. The outcome of forgetfulness was reported as not recovered ("was still persisting"). Relatedness between the therapy and the events was not provided. Upon internal review, grand mal seizure was considered to be medically significant. Additional information is not expected because the reporter did not wish to be contacted.
Age: 15.0
Sex: M
Vaccine: HPVX
Symptoms: Nuclear magnetic resonance imaging, Urine analysis
Clinical narrative: This spontaneous report as received from a nurse, via company representative, refers to her 15 year old son with hay fever. The patient's medical history included neonatal seizures after birth which stopped after unspecified time. On 05-FEB-2015, he was vaccinated with the third dose of HPV vaccine (manufacturer unknown) (dose, route and lot number were not reported) (dates of the first and the second dose were not provided). Concomitant therapies included AUGMENTIN for sinus infections. On 09-FEB-2015, the patient experienced grand mal seizure which lasted approximately 5-6 minutes. After the seizure, on the same day, he experienced forgetfulness. The patient had magnetic resonance imaging (MRI), electrocardiography (ECG), urine analysis, drug analysis and other unspecified laboratory work done, results were not provided. He sought medical attention at the emergency room (ER). The outcome of grand mal seizure was unknown. The outcome of forgetfulness was reported as not recovered ("was still persisting"). Relatedness between the therapy and the events was not provided. Upon internal review, grand mal seizure was considered to be medically significant. Additional information is not expected because the reporter did not wish to be contacted.
Age: 30.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a health professional concerning a 30 year old, female patient. The patient's concomitant medications, medical history and concurrent disease 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: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Influenza, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old female patient who received Influenza vaccine Quadrivalent. In September 2014, the patient received Influenza vaccine Quadrivalent. In September 2014, an unknown time after receiving Influenza vaccine Quadrivalent, the patient experienced fatigue and fever. In November 2014, the patient experienced swine influenza and unwell. In September 2014, the outcome of the fatigue and fever were recovered/resolved. On an unknown date, the outcome of the swine influenza and unwell were recovered/resolved. Additional information received: Consumer reported having the 4 dose in September, and felt fatigued and feverish for ten days. Then, got the swine flu in November and was desperately ill for over one month. Consumer had 73 y/o and wondered if this illness would be her last.
Sex: F
Vaccine: FLUN4
Symptoms: Headache
Clinical narrative: A report has been received from a Health Professional concerning an adult, female patient. On 12-Sep-2013, the patient had received FLUMIST QUADRIVALENT (intranasal). The patient experienced massive headache which started on 12-Sep-2013. The outcome of the event of massive headache was unknown. The report was considered to be non-serious by reporter.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Bad pain unrelieved with MOTRIN/TYLENOL for over 2 weeks. Patient had to see a doctor for "pain treatment".
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local reaction, Nausea, Pain, Swelling
Clinical narrative: Local reaction : pain, redness or swelling, nausea.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced 1/2 dose FLUMIST administered for dose which started on 10-Oct-2014. The outcome of the event of 1/2 dose FLUMIST administered for dose is unknown. The report was considered to be non-serious.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cold sweat, Fall, Head injury, Loss of consciousness, Pallor
Clinical narrative: Patient came out from her room and standing at nurses's station for her 2nd and 3rd GARDASIL appointment. Suddenly she fell on ground and hit her head. Remain unconscious for less than min turn pale and clammy.
Age: 1.2
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 1 year old, subject of unknown gender, who had been receiving NASAL FLUMIST QUADRIVALENT started on an unknown date. It was reported that the patient had received FLUMIST QUADRIVALENT under the age of 2. The outcome of the event of PATIENT UNDER THE AGE OF 2 RECEIVED FLUMIST QUADRIVALNET is unknown. The report was considered to be non-serious.
Age: 0.24
Sex: M
Vaccine: HEP, RV1
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting, diarrhea 3 days after vaccine and continued through 2/24/15.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Patient fainted from a seated position to the floor about 3 minutes after receiving the vaccines. The pt reports vision going black and awakening on the floor. The pt was arousable. Pulse and BP were taken between 9:32-9:46 am until stable. No localized reaction noted.
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A spontaneous report has been received from pharmacist concerning a female patient. No information regarding medical history, concomitant disease and concomitant medication was provied. Patient had received nasal FLUMIST (intranasal) for unknown indication, started on an unknown date. Pharmacist reported that we administered FLUMIST and the entire dose went in one nostril on 5-Oct-2014. The outcome of the event of entire syringe of FLUMIST administered in one nostril was unknown. Reporter considered the events of entire syringe of FLUMIST administered in one nostril to be non serious.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site papule, Injection site rash, Injection site urticaria, Pruritus
Clinical narrative: 1 day after vaccines developed rash on bilateral thighs. (+) pruritus. On exam erythema of (B) anterior thighs with pinpoint papules, some more urticarial. Placed on BENADRYL. Told to trial Band-Aids once well to see if was more of a contact dermatitis.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Administration site cellulitis, Erythema, Headache, Pain, Pruritus
Clinical narrative: Pt developed cellulitis on administration site (L) arm. She went to her MD and prescribed her AUGMENTIN 875mg and TYLENOL 500mg. She had fever, pain, headache, itching, redness, swelling; is under treatment.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: Pt developed cellulitis on administration site (L) arm. She went to her MD and prescribed her AUGMENTIN 875mg and TYLENOL 500mg. She had fever, pain, headache, itching, redness, swelling; is under treatment.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Accidental exposure to product, Skin irritation
Clinical narrative: A report has been received from a Health Professional concerning a 31 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The patient got FLUMIST on parent hands and parent's hand became irritated which started on 29-Oct-2014. The outcome of the event of HAND IRRITATION and FLUMIST GOT ON PARENT HANDS 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 pharmacist a 52 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on 04-Nov-2014. 52 year old received FLUMIST QUADRIVALENT which started on 04-Nov-2014. The outcome of the event of 52 year old received 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 received Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. It was reported that the patient experienced 21 month old female received FLUMIST which started on 24-Oct-2014. The outcome of the event of 21 MONTH OLD FEMALE RECEIVED FLUMIST is unknown. The reporter was considered to be non-serious.
Age: 70.0
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 70 year old, subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL). 70 years patient was inadvertently administered by FLUMIST, which started on 10-Oct-2014. The outcome of the event of INADVERTENTLY ADMINISTERED FLUMIST TO A 70 Y/O PATIENT is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Pruritus
Clinical narrative: A report has been received   from a Pharmacist concerning a female subject who had  been receiving FLUMIST Quadrivalent. started on an unknown date. The patient experienced itching which started on 13-OCT-2014. The outcome of the event of itching is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Circumstance or information capable of leading to medication error, Drug administration error, Exposure via direct contact
Clinical narrative: A report has been received from a pharmacist concerning a patient of unknown gender. No medical history, concomitant diseases and concomitant medications were reported for consumer. The patient received FLUMIST QUADRIVALENT (intranasal) on unknown date. It was reported that when administering FLUMIST QUADRIVALENT (intranasal) the patient flinched and only one nostril received, also the dose went into the patient's eye. Did not have information on patient or lot number at time of call. Action taken for FLUMIST was not applicable. Outcome of both events were unknown. The report was considered to be non-serious by reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two Licensed Practical Nurse referring to unspecified number of patients (age and gender were unknown). Information regarding concurrent conditions and medical history was not provided. On 09-JUL-2014, ROTATEQ was improperly exposed to 10.9C for 17 hours. On unspecified dates after this, unspecified number of patients were vaccinated with doses of the improperly stored ROTATEQ, orally (strength, dose, dose number and lot # were not reported). Concomitant therapy was not reported. No known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: FLUN4
Symptoms: Exposure via direct contact
Clinical narrative: A report has been received from a health professional concerning a patient born on 25-JAN-2006, male subject, who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The patient experienced part of the FLUMIST Quadrivalent leaked into the eye of the patient. The outcome of the event of part of the FLUMIST Quadrivalent leaked into the eye of the patient is unknown. The report was considered to be non-serious.
Age: 38.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A spontaneous report has been received from a pharmacist concerning a 38 year old, female patient. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving Nasal FLUMIST (Intranasal) started on 10-Oct-2014. The reporter administered almost the full dose of FLUMIST into one nostril of the patient which started on 10-Oct-2014. The outcome of the event of patient received FLUMIST full dose in one nostril was unknown. The reporter considered the event patient received FLUMIST full dose in one nostril as non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Urticaria
Clinical narrative: A report has been received from a health professional concerning a 6 year old female patient. No concomitant drugs or relevant history was provided. The patient had been receiving FLUMIST Quadrivalent on 20-OCT-2014. The patient experienced hives on face, neck, back and stomach after receiving FLUMIST Quadrivalent and stomach ache which started on 20-OCT-2014. Patient was treated with oral BENADRYL 25mg. Patient pulse was 92. Action taken with FLUMIST was unknown. The patient recovered from the event of hives on face, neck, back and stomach after receiving FLUMIST Quadrivalent and stomach ache on 20-OCT-2014. The report was considered to be non-serious by the reporter. Summary of follow-up information received on 07-NOV-2014 from health professional: Events outcome changed to recovered and events stop date added. Narrative updated. Lab data added.
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 (INTRANASAL). FLUMIST (INTRANASAL) started on 07-Oct-2014. Office manager reported that patient was inadvertently administered by FLUMIST. The outcome of the event of INADVERTENTLY ADMINISTERED FLUMIST TO A 53 YEAR OLD PATIENT is unknown. The report was considered to be non-serious.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Epistaxis
Clinical narrative: A report has been received from a Health Professional concerning a 13 years old, female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient received FLUMIST Quadrivalent during Oct-2014. The patient experienced nose bleed one day after receiving FLUMIST Quadrivalent which started on 09-OCT-2014. The patient recovered from the event of nose bleed one day after receiving FLUMIST Quadrivalent on 09-OCT-2014. The reporter considered the event to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Ocular hyperaemia
Clinical narrative: A consumer report has been received. The report concerns an adult, male consumer who had been receiving FLUMIST Quadrivalent started on an unknown date. The patients one eye turned pink 2 hrs after FLUMIST administration which started on 18-OCT-2014. At the time of reporting, the event of one eye turned pink 2 hrs after FLUMIST administration was ongoing. The report was considered to be non-serious.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Nasal congestion
Clinical narrative: A consumer report has been received. The report concerns an 11 year old female consumer, who had been receiving FLUMIST Quadrivalent started on an unknown date. The patient experience my daughter received FLUMIST Quadrivalent yesterday and has a stuffy nose today which started on 16-OCT-2014. The patient recovered from the even of my daughter received FLUMIST yesterday and has a stuffy nose today. The report was considered to be non-serious.  Summary of follow-up information received on 18-NOV-2014 from a consumer via spontaneous source: Updated event outcome to recovered and updated the narrative.
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 a 7 month old, female patient, who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that the FLUMIST Quadrivalent was given to a 7 month old patient, which was started on 17 OCT-2014. The outcome of the event of administration to 7 month old is unknown. The report was considered to be non-serious.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a health professional concerning a 12 year old, male subject, who had been receiving FLUMIST Quadrivalent.  FLUMIST Quadrivalent started on 10-OCT-2014. The patient wads given 1/2 dose FLUMIST administered for dose which started on 10-OCT-2014. The outcome of the event 1/2 dose of FLUMIST administered for dose is unknown. The report was considered to be non-serious.
Age: 1.38
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 student who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 07-OCT-2014. Sixteen month hold patient accidentally received FLUMIST Quadrivalent. The outcome of the event of inadvertent administration of FLUMIST Quadrivalent to a 16 month old patient is unknown. The report was consider4ed to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza like illness, Myalgia, Pyrexia
Clinical narrative: A spontaneous report has been received from a health professional concerning a patient of unknown gender. No information regarding relevant medical history concomitant disease or concomitant medication was provided. The patient was receiving FLUMIST Quadrivalent started on 14 OCT 2014. RN reports we had three patients who received FLUMIST Quadrivalent 2-3 days ago and they had came back to clinic with flu-like symptoms. The reporter stated patients had muscle aches and low grade fever. The outcome of the events of three patients who received FLUMIST Quadrivalent 2-3 days ago have come back with flu-like symptoms and muscle aches was unknown. The reporter considered the three patients who received FLUMIST QUADRIVALENT 2-3 days ago have come back with flu-like symptoms and muscle aches as non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza like illness, Myalgia, Pyrexia
Clinical narrative: A spontaneous report has been received from a Health Professional concerning a patient of unknown gender. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving FLUMIST QUADRIVALENT (intranasal) started on 14-Oct-2014. RN reports we had three patients who received FLUMIST QUADRIVALENT 2-3 days ago and they had came back to clinic with flu-like symptoms. The reporter stated patients had muscle aches and low grade fever. The outcome of the events of three patients who received FLUMIST QUADRIVALENT 2-3 days ago have come back with flu-like symptoms and muscle aches was unknown. The reporter considered the three patients who received FLUMIST QUADRIVALENT 2-3 days ago have come back with flu-like symptoms and muscle aches as non-serious.
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure via direct contact
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 QUADRIVALENT (intranasal) started on an unknown date. Pharmacist inadvertently sprayed FLUMIST into the eye which started on 13-Oct-2014. The outcome of the event of inadvertent administration into eye is unknown. The report was considered to be non-serious.
Age: 14.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Rhinorrhoea, Urticaria
Clinical narrative: A consumer report has been received concerning a 14 year old male patient. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. Patient had received FLUMIST QUADRIVALENT (intranasal) during 07-Oct-2014. It was reported that patient experienced cough, runny nose and hives all over body during 07-Oct-2014. Action taken with FLUMIST QUADRIVALENT was unknown. The outcome of the event of cough, runny nose and hives all over his body was unknown. The report was considered to be non-serious by reporter.
Age: 30.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A spontaneous report has been received from a pharmacist concerning a 30 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 administered almost the full dose of FLUMIST into one nostril of the patient which started on 16-Oct-2014. The outcome of the event of accidentally administered almost the full dose of FLUMIST into one nostril was unknown. The reporter considered the event accidentally administered almost the full dose of FLUMIST into one nostril as non-serious.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. It was reported that the patient was administered with the expired FLUMIST. The outcome of the event of ADMINISTERED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 26.0
Sex: M
Vaccine: FLUN4
Symptoms: Accidental exposure to product
Clinical narrative: A report has been received from a Health Professional concerning a 26 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Health Professional reported that we accidentally administered FLUMIST to an employee who is HIV positive on 10-Oct-2014. The outcome of the event of accidentally administered FLUMIST to an employee who is HIV positive is unknown. The report was considered to be non-serious.
Age: 0.91
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 11 month old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. It was reported that the patient an 11 month old received FLUMIST QUADRIVALENT which started on 10-Oct-2014. The outcome of the event of 11 month old received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Diet refusal, Lethargy, Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Male subject, who had been received FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 03-Oct-2014. The patient experienced fever of 102, would not eat or drink and lethargic which started on 05-Oct-2014. The patient recovered from the event of fever of 102, would not eat or drink and lethargic on an unspecified date. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Condition aggravated, Epistaxis
Clinical narrative: A report had been received from Health Professional via medical representative concerning a male child patient. The patient's medical history included epistaxis. Concurrent disease and concurrent medication were not reported. It was reported that a patient had bad nosebleed approximately one hour after being given FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, unknown frequency. Action taken with FLUMIST QUADRIVALENT was unknown. The outcome of the event of bloody nose was unknown. The reporter considered the event of bloody nose to be non serious.
Sex: F
Vaccine: FLUN3
Symptoms: Exposure during pregnancy, Oropharyngeal pain
Clinical narrative: A solicited report was received from Health Professional concerning an adult, female subject enrolled in a study, who ha been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. The patient experienced pregnant patient received LAIV3 and pharyngeal pain. The outcome of the event of pregnant patient received LAIV3 and pharyngeal pain is unknown. The reporter's description of the event(s) was as follows: There was one report of non-serious pharyngeal pain 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 events pregnant patient received LAIV3 and pharyngeal pain with suspect drug FLUMIST to be unrelated.
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Pharmacist concerning a child, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Pharmacist incorrectly administered two doses of FLUMIST to a couple of children, in the past couple of weeks. The outcome of the event of administration of half dose of FLUMIST QUADRIVALENT to two children is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Epistaxis
Clinical narrative: A spontaneous report has been received from a Health Professional concerning a 2 year old, male patient. Patient relevant history, concurrent disease and concomitant drugs were not reported. Patient received FLUMIST QUADRIVALENT (Intranasal) on 10-Oct-2014 and also experienced a bloody nose. Only occurred on left side or left nostril only. The patient recovered from the event of nose bleed on an unspecified date. The reporter assessed the event of nose bleed to be non serious.
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning a 15 year old, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL), HALF DOSE. FLUMIST (FLUMIST) started on an unknown date. The 15 YEAR OLD RECEIVED ONLY A HALF DOSE OF FLUMIST which started on 10-Oct-2014. The outcome of the event of 15 YEAR OLD RECEIVED ONLY A HALF DOSE OF FLUMIST is unknown. The report was considered to be non-serious.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the nurse didn't remove the clip so only half dose was administered. The outcome of the event of 1/2 dose FLUMIST administered for dose is unknown. The report was considered to be non-serious.
Age: 42.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Pharmacist concerning a 42 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 12-Oct-2014. Patient had been administered by expired FLUMIST QUADRIVALENT which started on 12-Oct-2014. The outcome of the event of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Physician concerning an 11 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that patient received last year's FLUMIST QUADRIVALENT. The outcome of the event of patient received last year's 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 report has been received from Health Professional. The report concerns a patient, female consumer, who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on 10-Oct-2014. It was reported that patient was administered with 1/2 dose of FLUMIST. The outcome of the event of 1/2 dose FLUMIST administered for dose is unknown. The report was considered to be non-serious. Corrected report 23-Oct-2014 : Primary reporter was changed from consumer to health professional. Narrative updated. Corrected report 24-Oct-2014 : Periodic clock stop was updated.
Age: 55.0
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 55 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. It was reported that inadvertently administered FLUMIST to 55 year old patient. The outcome of the event of INADVERTENTLY ADMINISTERED FLUMIST TO A 55 YEAR OLD PATIENT is unknown. The report was considered to be non-serious.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure via direct contact, Eye irrigation
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient received FLUMIST QUADRIVALENT (intranasal) on an unknown date. Licensed Practical Nurse reported that patient contacted them and thought that a little bit of the FLUMIST QUADRIVALENT vaccine got into her eye. Licensed Practical Nurse stated the patient received the vaccine at a local pharmacy and the patient stated that the vaccine was administered into both nostrils. Patient had eye flushed out immediately after the event. The outcome of the event of a little bit of FLUMIST QUADRIVALENT got into her eye was unknown. The reporter considered the event to be non-serious.
Age: 39.0
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 10-Oct-2014. It was reported that the nurse didn't remove the clip so only 1/2 dose was administered. Did not receive the other 1/2 of dose. The outcome of the event of 1/2 dose FLUMIST QUADRIVALENT administered for dose is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: A report has been received from a health professional via Medimmune concerning a 6 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient received FLUMIST QUADRIVALENT twice this season which started on 07-OCT-2014. The outcome of the event of PATIENT RECEIVED FLUMIST QUADRIVALENT TWICE THIS SEASON is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced no adverse event - multiple vaccines received a 15 day period (MMR, Varicella, FLUMIST QUADRIVALENT) which started on 10-Oct-2014. The outcome of the event of no adverse event - multiple vaccines received in a 15 day period (MMR, Varicella, FLUMIST QUADRIVALENT) is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Epistaxis
Clinical narrative: A report has been received from a physician via medical rep. concerning a 10 year old female patient. Follow up received from health professional. No information regarding relevant history, concurrent disease and concomitant medications of the patient was provided. The patient has been receiving FLUMIST QUADRIVALENT (intranasal), unknown frequency, started on 09-Oct-2014 for an unknown indication. It was reported that a 10 year old girl had a nosebleed after insertion of the FLUMIST syringe into the first nostril 09-Oct-2014. Lot Number was CH2063. The nurse said that the patient's nose stopped bleeding right after the FLUMIST was given into the first nostril. They did not administer the second dose into the other nostril. Action taken with FLUMIST QUADRIVALENT was unknown. The patient recovered from the event of nosebleed on an unspecified date. The reporter considered the event of nosebleed to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza like illness, Myalgia, Pyrexia
Clinical narrative: A report has been received from a health professional concerning three patient of unknown gender. Medical history and concomitant medications of the patient were not reported. The patient had been received FLUMIST QUADRIVALENT (intranasal) started on 14-Oct-2014. The reporter stated that three patients who received FLUMIST QUADRIVALENT 2-3 days ago and they had come back into our clinic with flu-like symptoms started on 17-Oct-2014. Reporter stated patients had muscle aches, low grade fever. Reporter did not have any patient information or lot/expiration date info. Action taken with FLUMIST was unknown. The outcome of the event of three patients who received FLUMIST QUADRIVALENT 2-3 days ago have come back with flu-like symptoms, muscle aches and low grade fever was unknown. The reporter considered the events three patients who received FLUMIST QUADRIVALENT 2-3 days ago have come back with flu-like symptoms, muscle aches and low grade fever to be non-serious.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a pharmacist concerning female patient. No information regarding the concomitant disease and concomitant drug was provided. The patient had been receiving FLUMIST QUADRIVALENT (intranasal), unknown dose for unknown indication, started on 05-Oct-2014. It was reported that the patient had administered inadvertently all of the FLUMIST QUADRIVALENT dose in one nostril to two patients. FLUMIST QUADRIVALENT was discontinued on 05-Oct-2014. The outcome of the event of inadvertently administered all the FLUMIST QUADRIVALENT dose in one nostril to two patients is unknown. The report was considered to be non-serious. Corrected report 22-Oct-2014: The source of the case was corrected from Non-interventional/ Post-marketing study to Spontaneous and the company causality was removed from the case.
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a child, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Pharmacist incorrectly administered two doses of FLUMIST to a couple of children, in the past couple of weeks. The outcome of the event of administration of half dose of FLUMIST QUADRIVALENT to two children is unknown. The report was considered to be non-serious.
Age: 65.0
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 an unknown date. It was reported that sixty five year old received FLUMIST. The outcome of the event of 65 year old received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A report has been received from a consumer mother via medical rep concerning her 4 year old, male subject. The concomitant medications of the patient were not provided. Patient had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started during Aug-2012. Patient's mother reported that the patient got flu after receiving FLUMIST QUADRIVALENT which started during Jan-2013. The outcome of the event of children got the flu after receiving FLUMIST was unknown. The report was considered to be non-serious.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Syringe issue
Clinical narrative: A report has been received from a Pharmacist concerning an 8 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal), half dose. FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient administered FLUMIST QUADRIVALENT yesterday and when administering the 2nd nostril the FLUMIST QUADRIVALENT locked up/jammed. No symptoms noted on administration. The outcome of the event of 2nd nostril-FLUMIST QUADRIVALENT locked up/jammed is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A spontaneous report has been received from a Pharmacist concerning a female patient of unknown age. No medical history and concomitant history provided. No concomitant medications were provided. The patient receiving FLUMIST QUADRIVALENT (intranasal), started on an unknown date. A female called to ask a pharmacist what happens if they received FLUMIST QUADRIVALENT in the same nostril on unknown date. The action taken with FLUMIST QUADRIVALENT was not applicable. The outcome of the event was unknown. The report was considered to be non-serious.