chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Lethargy, Mobility decreased
Clinical narrative: Initial unsolicited report received from consumer on 10-Oct-2016. This case is linked to case 2016SA027253, 2016SA027286. This case involves a 69-year-old female patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (FLUZONE HD) (batch number, expiry date site of administration were not reported) intramuscularly in left deltoid on 16-Oct-2015. Medical history and concomitant medications were not reported. On 17-Oct-2015, four hours following the vaccination patient experienced lethargic and could not move, could not ambulate, and weakness. Laboratory investigation was not reported. Corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a physician concerning a subject of unknown gender, who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, Unknown. FLUMIST (intranasal) started on an unknown date. It was reported that there was a vaccine cold chain failure. The outcome of the event of VACCINE COLD CHAIN FAILURE is unknown. The report was considered to be non-serious.
Age: 0.8
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 9 month old, female subject who had been receiving Nasal FLUMIST (intranasal), 0.2 ml ONCE for INFLUENZA VACCINATION. FLUMIST (intranasal) started on 05-Nov-2015 for INFLUENZA VACCINATION. The patient experienced INADVERTENTLY ADMINISTERED TO A PATIENT 10 MONTHS OLD. FLUMIST (intranasal) was discontinued on 05-Nov-2015. The outcome of the event of INADVERTENTLY ADMINISTERED TO A PATIENT 10 MONTHS OLD is unknown. The reporter's description of the event (s) was as follows: None. The report was considered to be non-serious. The reporter and company physician considered that there was no causal relationship between INADVERTENTLY ADMINISTERED TO A PATIENT 10 MONTHS OLD and FLUMIST.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Physician concerning a patient of unknown gender, who received Nasal FLUMIST (intranasal), 0.2 Millilitres, Unknown for INFLUENZA. FLUMIST (intranasal) started on an unknown date for INFLUENZA. HCP reported that several patients received FLUMIST vaccine that underwent cold chain temperature excursions over the period of 2 months. FLUMIST (intranasal) was continued. The outcome of the event of RECEIPT of FLUMIST VACCINE THAT HAD COLD CHAIN TEMPERATURE EXCURSION was unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Lymphadenopathy, Rhinorrhoea
Clinical narrative: A report has been received from a Medical Rep concerning an about 11 or 12 years old Male patient, who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, Once/Single administration. FLUMIST (intranasal) started on 10-Oct-2015. The patient experienced SWOLLEN LYMPH GLANDS which started on 11-Oct-2015 and RUNNY NOSE which started during Oct-2015. At the time of reporting, the event of SWOLLEN LYMPH GLANDS was ongoing and the patient recovered from the event of RUNNY NOSE on an unspecified date. The report was considered to be non-serious by the company physician.
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A spontaneous report had been received from a Health Professional concerning an adult female patient. The patient had received nasal FLUMIST (intranasal), 0.2 millilitres, unknown for influenza on 19-Oct-2015. Nurse reported that FLUMIST was inadvertently given on 19-Oct-2015 as one full dose up one nostril to an adult female. The outcome of the event of full dose up one nostril was unknown. The company physician assessed the reported event to be non-serious.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Activities of daily living impaired, Aggression, Eczema, Gastrointestinal disorder, Measles antibody positive
Clinical narrative: Within a week he stopped progressing in speech and motor skills, became aggressive, poor modulation, unable to participate in activities, excessive eczema, GI problems.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Mumps antibody test positive, Psychomotor skills impaired, Rubella antibody positive, Speech disorder developmental
Clinical narrative: Within a week he stopped progressing in speech and motor skills, became aggressive, poor modulation, unable to participate in activities, excessive eczema, GI problems.
Sex: U
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: The report had been received from a physician. The report concerns a patient of unknown age and gender. Concomitant product, concurrent disease and medical history were not reported. The patient received nasal FLUMIST (intranasal) 0.2 millilitres, unknown for influenza. The patient experienced urticarial started several days after FLUMIST administration. The outcome of the event of urticarial was unknown. The event was considered to be non-serious by the company physician.
Age: 48.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: We are filing this report since state specific policies show that PNEUMOVAX 23 should be administered due to the age of the patient. The patient does not present any adverse event.
Sex: F
Vaccine: FLUN4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A spontaneous report  has been received from a Health Professional concerning a female patient. The patient's medical history, concurrent diseases and concomitant medications were not provided. The patient was receiving nasal FLUMIST (intranasal) started on an unknown date for influenza vaccine. It was reported that the patient received 2 doses of FLUMIST 4 days apart. Doctor explained she thought the first dose was expired, then later found out it was not expired-after administering the second dose. Action taken on FLUMIST was unknown. The outcome of the event of overdose was unknown. The reporter assessed the event of overdose to be non-serious.
Age: 58.0
Sex: F
Vaccine: FLUN4
Symptoms: Intentional product misuse, Product used for unknown indication
Clinical narrative: A report has been received from a Health Professional concerning a 58 year old, Female subject, who had been received Nasal FLUMIST (intranasal), 0.2 Millilitres, Unknown for INFLUENZA. FLUMIST (intranasal) started on 28-Sep-2015 for INFLUENZA. The patient who was 49 years of age was administered FLUMIST on 28-Sep-2015. FLUMIST (intranasal) was discontinued on 28-Sep-2015. The outcome of the event over OVER 49 YEARS OF AGE and MISUSE/FLUMIST WAS ADMINISTERED OVER THE AGE OF 49 YEARS is unknown.
Sex: U
Vaccine: FLUN4
Symptoms: Laceration, Syringe issue
Clinical narrative: A report has been received from consumer concerning a patient of unknown gender and age, who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, Unknown for FLU. FLUMIST (intranasal) started on an unknown date for FLU. The patient reported that four nurse received cuts on index and middle fingers when attempting to administer FLUMIST. Ears of syringe broke off when pressing syringe up. FLUMIST (intranasal) was continued. At the time of reporting, the event of CUT FINGERS was improving and the outcome of the event of EARS OF SYRINGE BROKEN OFF WHEN PRESSING SYRINGE UP was unknown. The report was considered to be non-serious.
Age: 61.0
Sex: F
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: A report has been received from a Health Professional concerning a 61 year old, Female subject, who had been received Nasal FLUMIST (intranasal), 0.2 Millilitres, unknown for INFLUENZA. The patient who was 49 years of age was administered FLUMIST on 28-Sep-2015. FLUMIST (intranasal) was discontinued on 28-Sep-2015. The outcome of the event of OVER 49 YEARS OF AGE and FLUMIST WAS ADMINISTERED OVER THE AGE OF 49 YEARS is unknown. The report was considered to be non-serious.
Age: 44.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been receiving from a Study Investigator concerning a 44 year old, female subject, Height: 5.2 inches; Weight: 133.0 Pounds, enrolled in study MA-VA-MEDI3250-1115; A Postmarketing Safety Study of Q/LAV in Subjects 2 Through 49 years of age. FLUMIST (intranasal) started on 01-Oct-2013. The patient experienced PREGNANCY which started on 28-Sep-2013. The patient recovered from the event of PREGNANCY on 06-Jun-2014. The outcome of the pregnancy was reported to be a Healthy baby both on 08-Jun-2014. The report was considered to be non-serious. The investigator considered that there was no causal relationship between PREGNANCY and FLUMIST.
Age: 62.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Acupuncture, Mobility decreased, Muscular weakness, Pain in extremity, X-ray limb
Clinical narrative: Severe upper arm pain, felt like hit funny bone after reaching around and hugging another individual. Severe pain upper arm with decreased ability to move freely, pain, weakness left arm.
Age: 62.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Acupuncture, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Severe upper arm pain, felt like hit funny bone after reaching around and hugging another individual. Severe pain upper arm with decreased ability to move freely, pain, weakness left arm.
Age: 62.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, Pain in extremity, X-ray limb
Clinical narrative: Severe upper arm pain, felt like hit funny bone after reaching around and hugging another individual. Severe pain upper arm with decreased ability to move freely, pain, weakness left arm.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling hot, Rash, Urticaria
Clinical narrative: Rash, hives, and warmth.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme; conservative treatment with diphenhydramine and topical hydrocortisone.
Age: 19.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult formulation of Hep B vaccine given in error. Pt. should have gotten the adolescent formulation.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV9
Symptoms: Asthma, Condition aggravated, Cough
Clinical narrative: Day after receiving Flumist and HPV patient developed cough which lead into asthma exacerbation 2-3 days later.
Age: 1.38
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash macular
Clinical narrative: The patient had a red, splotchy rash on legs that mother noticed around 4:30 PM on date vaccine was given.  She stated no difficulty breathing or distress.  She stated rash did not progress to other parts of body that day (2/23/2016). Mother took child to daycare the next day (2/24/2016).  Daycare called around lunch and said rash was back and had progressed down legs to feet and some on arms.  No other apparent distress was noted.  Mother was at ED with child waiting to be seen.
Age: 28.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Fatigue, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Extreme physical exhaustion. Also redness, rash, and swelling at injection site.
Age: 28.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Exposure during pregnancy, Fatigue, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Extreme physical exhaustion. Also redness, rash, and swelling at injection site.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Injection site pain, Malaise, Mobility decreased, Pain
Clinical narrative: General malaise, achiness, and tired.  Extremely sore injection site, inability to move arm.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient complains of soreness and redness at site of injection. No shortness of breath, or difficulty breathing. No rash.  Patient to place icepack at site of injection and to seek medical attention if symptoms persist or worsen.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: After Administration of Zostavax, patient began seeing redness around the injection site.  On day 2 after injection, the redness has spread to about 6 inches in diameter around the injection site.  Patient claims that the area is slightly itchy with some tenderness in the middle.  Area is not warm and is not raised.  Patient instructed to take Benadryl orally or to use hydrocortisone cream topically as needed.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Abdominal pain upper, Pallor, Vomiting
Clinical narrative: A few minutes after vaccines administered, client started to say that her "stomach hurts" when walking out to the lobby to head home. Client started to look pale and wanted to sit down. Assisted client onto chair out in lobby. Mom beside client at the time. Staff member from health department brought in wheelchair over for client. Client started to puke up a little bit of clear liquid. Mom states that client had breakfast and was nervous during shots. Wheeled client into immunization room with ice pack applied to back and forehead, water, and snacks. Client laid in bed for few minutes.
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Seizure, Specialist consultation
Clinical narrative: Seizure.
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cardiac function test normal, Neurological examination normal, Seizure, Unresponsive to stimuli
Clinical narrative: Seizure.
Age: 1.24
Sex: F
Vaccine: HEP, HIBV, MMR, PNC13, VARCEL
Symptoms: Apparent life threatening event, Blood culture, Culture urine, Febrile convulsion, Full blood count
Clinical narrative: 15mo presents for follow up after inpatient stay for complex febrile seizure. Presented to facility febrile after short episode at home witnessed by babysitter (cold hands, perioral cyanosis, staring, drooling x20sec) and was subsequently admitted for ALTE vs febrile seizure. During admission she had a 5-10 minute tonic-clonic febrile seizure on pediatric ward (witnessed by resident) at facility, and then was transferred to PICU. She had no further fevers or seizures after she was transferred. She was discharged from the PICU later that afternoon (<12hrs later). Tmax since discharge was 100.1 measured 2 nights ago. PO intake has been normal. She has not had any cough/runny nose/diarrhea/vomiting/signs of illness. She does have a rash on her body that started the day of her first seizure and really began to get darker pink/red colored the day she was in the PICU, and is now fading. Mom insists that it is different appearing than her normal eczema breakouts. She was discharged from the PICU with Diastat, and a consult was placed for outpatient peds neurology consult. The febrile seizure occurred 10 days after her first MMR vaccine was given.
Age: 1.24
Sex: F
Vaccine: HEP, HIBV, MMR, PNC13, VARCEL
Symptoms: Generalised tonic-clonic seizure, Influenza virus test negative, Intensive care, Laboratory test, Rash generalised
Clinical narrative: 15mo presents for follow up after inpatient stay for complex febrile seizure. Presented to facility febrile after short episode at home witnessed by babysitter (cold hands, perioral cyanosis, staring, drooling x20sec) and was subsequently admitted for ALTE vs febrile seizure. During admission she had a 5-10 minute tonic-clonic febrile seizure on pediatric ward (witnessed by resident) at facility, and then was transferred to PICU. She had no further fevers or seizures after she was transferred. She was discharged from the PICU later that afternoon (<12hrs later). Tmax since discharge was 100.1 measured 2 nights ago. PO intake has been normal. She has not had any cough/runny nose/diarrhea/vomiting/signs of illness. She does have a rash on her body that started the day of her first seizure and really began to get darker pink/red colored the day she was in the PICU, and is now fading. Mom insists that it is different appearing than her normal eczema breakouts. She was discharged from the PICU with Diastat, and a consult was placed for outpatient peds neurology consult. The febrile seizure occurred 10 days after her first MMR vaccine was given.
Age: 1.24
Sex: F
Vaccine: HEP, HIBV, MMR, PNC13, VARCEL
Symptoms: Respiratory syncytial virus test negative, Urine analysis, Viral test
Clinical narrative: 15mo presents for follow up after inpatient stay for complex febrile seizure. Presented to facility febrile after short episode at home witnessed by babysitter (cold hands, perioral cyanosis, staring, drooling x20sec) and was subsequently admitted for ALTE vs febrile seizure. During admission she had a 5-10 minute tonic-clonic febrile seizure on pediatric ward (witnessed by resident) at facility, and then was transferred to PICU. She had no further fevers or seizures after she was transferred. She was discharged from the PICU later that afternoon (<12hrs later). Tmax since discharge was 100.1 measured 2 nights ago. PO intake has been normal. She has not had any cough/runny nose/diarrhea/vomiting/signs of illness. She does have a rash on her body that started the day of her first seizure and really began to get darker pink/red colored the day she was in the PICU, and is now fading. Mom insists that it is different appearing than her normal eczema breakouts. She was discharged from the PICU with Diastat, and a consult was placed for outpatient peds neurology consult. The febrile seizure occurred 10 days after her first MMR vaccine was given.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Heart rate increased, Infectious mononucleosis, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Large swollen glands, fatigue, sore throat, rapid heart rate.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Sinus tachycardia
Clinical narrative: Large swollen glands, fatigue, sore throat, rapid heart rate.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza B virus test positive, Pyrexia
Clinical narrative: Cough during night fever, treatment in hospital emergency room of cruise ship. Treated with IV, drugs.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Redness, induration, itching.
Age: 1.66
Sex: M
Vaccine: HIBV, PNC13, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No reports of allergic reactions today.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Erythema, Skin warm
Clinical narrative: Slightly red and warm.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Rash on upper arm expanding past injection site. Upper arm is swollen, itchy, and painful.
Age: 0.34
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: NONE YET.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Bone pain, Fatigue, Injection site reaction, Muscle spasms, Pyrexia
Clinical narrative: Bone pain at injection site 12 pm; tiredness/low fever 100.6; leg and upper body spasm; hives 11pm lasted for 2 weeks; went to ER they gave Benadryl.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Bone pain at injection site 12 pm; tiredness/low fever 100.6; leg and upper body spasm; hives 11pm lasted for 2 weeks; went to ER they gave Benadryl.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: The flu shot was very painful. The pain on the shot area was so bad that I couldn't raise my arm and lasted a few days. It got a little better, but still felt pain when I raised my arm. It lasted for 2-months and still hadn't got better. Not it got worse. It's been 4-months and I can't even move my arm to left side to close my button of my pants. It's very painful to raise my arm. I can't move my arm around without suffering a lot of pain.
Age: 21.0
Sex: M
Vaccine: TD, TYP, YF
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient developed left posterior pain and swelling (4x5 cm) erythematous induration 48 hours or less at the injection site. Low grade fever 99.6 F.
Sex: F
Vaccine: FLUN4
Symptoms: Caesarean section, Exposure during pregnancy
Clinical narrative: A report has been received from a Study Investigator concerning a female subject, Height 68.0 inches, Weight: 135.0 Pounds. A post marketing Safety Study of Q/LAIV in Subjects 2 through 49 years of age. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on an unknown date. The date of last menstrual period was 24-SEP-2013. The patient experienced pregnancy which was started on 24-SEP-2013. The estimated date of delivery was 23-JUN-2014. The outcome of the pregnancy was reported to be a healthy baby born on 16-JUN-2014. The number of weeks of outcome of pregnancy was 39. The delivery was done by caesarean. The report was considered to be non-serious. The study considered that there was no casual relationship between pregnancy and study therapy.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: A report has been received from a Health Professional via medical representative concerning a 4 year old female patient, who received Nasal FLUMIST Quadrivalent. Once/Single administration. FLUMIST Quadrivalent was started on 09-NOV-2015. The patient experienced vomiting, fever and congestion which started on 10-NOV-2015. The outcome of the events of vomiting, fever and congestion were unknown. The report was considered to be non-serious.
Age: 38.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Study Investigator concerning a 38 year old, female subject, Weight: 215.0 Pounds. A post marketing Safety study of Q/LAIV in Subjects 2 through 49 years of age. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on an unknown date. The date of last menstrual period was 05-MAY-2013. The patient experienced pregnancy which started on 05-MAY-2013. The estimated date of delivery was 08-FEB-2014. The outcome of the pregnancy was reported to be a healthy baby female weighed 3.99 kg born on 30-JAN-2014. The number of weeks at outcome of pregnancy was 38.4. The report was considered to be non-serious. The study investigator considered that there was no casual relationship between pregnancy and study therapy.
Age: 35.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Study Investigator concerning a 35 year old, female subject, Weight: 124.0 pounds, enrolled in study MA-VA-MEDI3250-1115; A Postmarketing Safety Study of Q/LAV in Subjects 2 Through 49 Years of Age. The patient's medical and concurrent history was not provided at the time of reporting. FLUMSIT (intranasal) started on 22-Oct-2013 for influenza. The patient experienced pregnancy. Action taken with FLUMIST was unknown at the time of reporting. The outcome of pregnancy was abnormal outcome. The investigator assessed the event of pregnancy to be non-serious.
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Abortion induced, Exposure during pregnancy
Clinical narrative: A report has been received from a Study Investigator concerning a 17 year old, female subject, Height: 4.1 inches; Weight: 94.0 Pounds, enrolled in a study. The patient's medical and concurrent history was not provided at the time of reporting. FLUMIST (intranasal) started on 28-Sep-2013 for influenza. The patient experienced undesired pregnancy which started on 06-Sep-2013. The outcome of the event of undesired pregnancy is unknown. Action taken with FLUMIST was unknown at the time of reporting. The outcome of the pregnancy was reported to be an elective abortion on 24-Oct-2013. The investigator assessed the event of pregnancy to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a patient of unknown gender, who had been receiving FLUMIST Quadrivalent, 0.2 milliliters, Unknown. FLUMIST Quadrivalent started on an unknown date. It was reported that the patient administered FLUMIST that is stored under 35F to consumers-medication error, which started on 20-OCT-2015. The outcome of the event of administered FLUMIST Quadrivalent that is stored under 45F to consumers - medication error was unknown. The report was considered to be non-serious.
Age: 15.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Study Investigator concerning a 15 year old, Female subject, Height: 65.0 inches; Weight: 173.0 Pounds, enrolled in study MA-VA-MEDI3250-1115; A Post Marketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on an unknown date for influenza. The date of last menstrual period was 27-May-2013. The patient experienced undesired pregnancy which was started on 27-May-2013. The estimated date of delivery was unknown. The outcome of the pregnancy was reported to be elective abortion which occurred on 23-Oct-2013. The number of weeks at outcome of pregnancy was 21. The report was considered to be non-serious. The study investigator considered that there was no causal relationship between pregnancy and study therapy.
Age: 30.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Study Investigator concerning a 30 year old, female subject, Height 5.8 inches, Weight: 171.0 Pounds. A post marketing Safety study of Q/LAIV in Subjects 2 through 49 years of age.  The patient did not receive any concomitant medications. No relevant history was reported. The study therapy was started on an unknown date. The date of last menstrual period was 09-OCT-2013. The patient experienced pregnancy which started on 09-OCT-2013. The estimated date of delivery was 08-FEB-2014. The outcome of the pregnancy was reported to be a healthy baby born on 10-JUL-2014.  The baby was male and weighed 3.08Kg. The report was considered to be non-serious. The investigator considered that there was no casual relationship between pregnancy and study therapy.
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive, Ultrasound antenatal screen normal
Clinical narrative: A report has been received from a Study Investigator concerning a 17 year old, female subject, Height: 68.0 inches; Weight: 137.0 pounds, enrolled in study MA-VA-MEDI3250-1115; A post marketing Safety Study of Q/LAIV in subjects 2 through 49 years of age. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on 10-Oct-2013 for influenza. The date of last menstrual period was 20-Sep-2013. The first test was done with urine on an unknown date which was positive. The second test was done on 26-Nov-2013 with ultrasound and was found positive. The patient experienced pregnancy which was started on unknown date. The estimated conception date was 04-Oct-2013. The estimated date of delivery was 27-Jun-2014. The outcome of the pregnancy was reported to be a healthy baby. The baby was male, weighed 3.735 kg, height 52.1 cm. The number of weeks at outcome of pregnancy was 40. There were no complications during delivery or pregnancy and the delivery was normal (vaginal type). The report was considered to be non-serious. The study investigator considered that there was no causal relationship between pregnancy and study therapy.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Study Investigator concerning a 31 year old, female subject. A post marketing Safety study of Q/LAIV in Subjects 2 through 49 years of age. Patient medical history and concomitant medications were not provided. FLUMIST Quadrivalent started on 19-SEP-2013. The patient experienced pregnancy which started on 25-AUG-2013. At the time of reporting, action taken with the study therapy was unknown. The outcome of the pregnancy was reported to be a healthy baby of 2.93 kg weight and 51 cm height. There were not abnormalities. The report was considered to be non-serious. The investigator considered that there was no causal relationship between pregnancy and FLUMIST Quadrivalent.
Age: 24.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Study Investigator concerning a 24 year old, female subject, Height: 64.0 inches,  Weight: 195.0 Pounds. A post marketing Safety study of Q/LAIV in Subjects 2 through 49 years of age. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on an unknown date. The date of last menstrual period was 21-SEP-2013. The patient experienced pregnancy which started on 21-SEP-2013. The estimated date of delivery was 28-JUN-2014. The outcome of the pregnancy was reported to be a healthy baby  born on 26-JUN-2014. The number of weeks at outcome of pregnancy was 39.5. The report was considered to be non-serious. The study investigator considered that there was no casual relationship between pregnancy and study therapy.
Age: 43.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Study Investigator concerning a 43 year old, female subject, Height: 68.0 inches, Weight: 155.0 Pounds. A post marketing Safety study of Q/LAIV in Subjects 2 through 49 years of age. No relevant history was reported. The patient did not receive any concomitant medications.  The date of last menstrual period was 13-JUN-2013. The estimated date of conception was on 27-JUN-2013. The patient received a single dose of FLUMIST Quadrivalent on 03-OCT-2013.   The patient experienced pregnancy which started on 03-OCT-2013. The patient recovered from the event on the same day. The estimated date of delivery was 20-MAR-2014. The outcome of the pregnancy was reported to be a healthy baby born on 03-MAR-2014. The number of weeks at outcome of pregnancy at outcome was 37.3. They delivery type was vaginal. There were no problems or complications during delivery. The gender of the baby was female, the weight was 3.525 kg, the length was 49.5 cm. The Apgar Score at 1 minute was 8, at 5 minutes was 9. There were no abnormalities. The report was considered to be non-serious. The study investigator considered that there was no casual relationship between pregnancy and study therapy.
Age: 37.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Study Investigator concerning a 37 year old, female subject, height: 5.7 inches; weight: 106.0 pounds, enrolled in a study. FLUMIST QUADRIVALENT (intranasal) started on 08-Oct-2013. The patient experienced pregnancy which started on 31-Jul-2013. The patient recovered from the event of pregnancy. The outcome of the pregnancy was reported to be a healthy baby born. The report was considered to be non-serious. The investigator considered that there was no causal relationship between pregnancy and FLUMIST QUADRIVALENT.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a health professional concerning a, subject of unknown gender, who received FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres. FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The nurse reported FLUMIST temp excursions over the course of several months (9 excursions in Sept 2015, 11 excursions in Oct 2015; both to 1 degree C. Admitted that FLUMIST had been administered to several patients during this time. The outcome of the event of FLUMIST stored below pi recc temp and administered to several patients was unknown. The report was considered to be non-serious by company physician.
Age: 32.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a study investigator concerning a 32 year old, female subject, height: 60.0 inches; weight: 127.0 pounds, enrolled in study. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on an unknown date for influenza. The date of last menstrual period was 03-Aug-2013. The patient experienced pregnancy which was started on 03-Aug-2013. The outcome of the pregnancy was reported to be a healthy baby. The number of weeks at outcome of pregnancy was 38.6. The report was considered to be non-serious. The study investigator considered that there was no causal relationship between pregnancy and study therapy.
Age: 39.0
Sex: F
Vaccine: FLUN4
Symptoms: Caesarean section, Exposure during pregnancy
Clinical narrative: A report has been received from a study investigator concerning a 39 year old, female subject, weight: 115.0 pounds, enrolled in study. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on an unknown date for influenza. The date of last menstrual period was 06-Oct-2013. The patient experienced pregnancy which was started on 24-Sep-2013. The estimated date of delivery was 13-Jul-2014. The outcome of pregnancy was reported to be a healthy baby. The number of weeks at outcome of pregnancy was 38. The delivery was done by caesarean. The report was considered to be non-serious. The study investigator considered that there was no causal relationship between pregnancy and study therapy.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a health professional concerning a, subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres. FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that FLUMIST that was in a fridge that went down to temps as low as 0.8 degrees Celsius nightly from 15-Oct-2015 to 05-Nov-2015 and that there were greater than 3 freezing episodes and the fact that it may not be stable any more which started on 15-Oct-2015. FLUMIST QUADRIVALENT (intranasal) was continued. The outcome of the event of FLUMIST that was in a fridge that went down to temps as low as 0.8 degrees Celsius is unknown. The report was considered to be non-serious.
Age: 37.0
Sex: F
Vaccine: FLUN4
Symptoms: Amniocentesis normal, Exposure during pregnancy, Ultrasound scan
Clinical narrative: A report has been received from a study investigator concerning a 37 year old, female subject, weight: 173.0 pounds, enrolled in study. The patient had amniocentesis and amino level was normal on 11-Feb-2014. The patient did not receive any concomitant medications. The study therapy was started on 31-Oct-2013 for influenza. The date of last menstrual period was 23-Oct-2013. The first test was done on 11-Dec-2013 by using ultrasound which was positive. The second test was done on 20-Dec-2013 using ultrasound and was found positive. The patient experienced pregnancy which was started on unknown date. The estimated conception date was 06-Nov-2013. The estimated date of delivery was 30-Jul-2014. The outcome of the pregnancy was reported to be a healthy baby. The baby was male, weighed 3.35 kg, height 51.5 cm. The number of weeks at outcome of pregnancy was 38. There were no complications during delivery or pregnancy and the delivery was normal (vaginal type). The report was considered to be non-serious. The study investigator considered that there was no causal relationship between pregnancy and study therapy.
Age: 29.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Study Investigator concerning drug exposure during pregnancy in a 29 year old, female subject. The patient's medical and concomitant history was not provided at the time of reporting. The patient received FLUMIST quadrivalent (intranasal) on 28-Sep-2013. The patient experienced drug exposure during pregnancy on an unknown date. The outcome of the pregnancy was reported to be a healthy baby. The investigator assessed the event of drug exposure during pregnancy to be non-serious.
Age: 37.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a study investigator concerning a 37 year old, female subject, height: 172.0 centimeters; weight: 59.0 kilograms, enrolled in study. FLUMIST QUADRIVALENT (intranasal) started on 28-Oct-2013. The patient became pregnant on 15-Jul-2013. The date of last menstrual period was 01-Jul-2013. FLUMIST QUADRIVALENT (intranasal) was discontinued on 28-Oct-2013. The patient gave birth. The outcome was reported to be a healthy baby. The report was considered to be non-serious. The investigator considered that there was no causal relationship between pregnancy and FLUMIST QUADRIVALENT.
Sex: F
Vaccine: FLUN4
Symptoms: Rash
Clinical narrative: A consumer report has been received. The report concerns a female consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, unknown for influenza. FLUMIST QUADRIVALENT Intranasal) started on an unknown date for influenza. The patient experienced rash. FLUMIST QUADRIVALENT (intranasal) was continued. The outcome of the event of rash is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: U
Vaccine: FLUN4
Symptoms: Influenza B virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old, subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 15-Dec-2014. The reporter stated that the patient experienced patient administered FLUMIST QUADRIVALENT on 15dec2014 and tested positive for flu b on 09mar15 which started on 09-Mar-2015. The outcome of the event of patient administered FLUMIST QUADRIVALENT on 15DEC2014 and tested positive for flu B on 09Mar2015 is unknown. The report was considered to be non-serious. Corrected report 20-Oct-2015: Key ingredient updated. Initial unit updated.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product 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 30-Jan-2015. It was reported that patient was administered expired FLUMIST QUADRIVALENT on 30-Jan-2015. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious. Corrected report 21-Pct-2015: Key ingredient updated.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 20-Jan-2015. Reporter stated that the three patients received expired FLUMIST quadrivalent which started on 20-Jan-2015. The outcome of the event of three patients received expired FLUMIST quadrivalent is unknown. The report was considered to be non-serious. Corrected report 20-Oct-2015: Key ingredient corrected.
Age: 0.6
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered at inappropriate site
Clinical narrative: A report has been received from a health professional concerning a female subject, height: 67.0 cm; weight: 7.99 kg, who received FLUMIST Quadrivalent (intranasal). FLUMIST Quadrivalent started on 11-Nov-2015. The nurse working in the family health team administered FLUMIST to a 7 month old child. The outcome of FLUMIST given to a child under 2 is unknown. The reporter's description of the event(s) was as follows: healthy child. The report was considered to be non-serious. The reporter considered that there was no causal relationship between FLUMIST given to a child under 2 and FLUMIST Quadrivalent.
Age: 0.6
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 7 month old, Female subject, who received FLUMIST quadrivalent (intranasal), 0.2 Millilitres. FLUMIST quadrivalent (intranasal) started on an unknown date. The Pharmacist reports that FLUMIST was administered to a 7 month old girl 2 days ago. The outcome of administration to 7 mo old is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a pharmacist concerning a 3 year old, male patient, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. The patient stated inadvertent administration of full dose in one nostril which started on 12-Nov-2015. The outcome of the event of inadvertent administration of full dose in one nostril was unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no causal relationship between inadvertent administration of full dose in one nostril and FLUMIST Quadrivalent.
Sex: M
Vaccine: FLUN4
Symptoms: Nasopharyngitis, Product quality issue, Rhinorrhoea
Clinical narrative: A report has been received from consumer. The report concerns a male consumer, who had been receiving FLUMIST (intranasal), 0.2 ml unknown. FLUMIST Quadrivalent started on an unknown date. It was reported that the patient experienced cold, felt sick, runny nose and product quality complaint. The outcome of the event of cold, felt sick, runny nose and product quality complaint was unknown. The report was considered to be non-serious. Corrected report 01-Dec-2015: Key ingredient updated for suspect drug FLUMIST. Narrative was updated.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, once/single administration. FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that FLUMIST that had been between 10.2 degrees Celcius and 0.2 degrees Celcius was administered to 21 patients which started on 20-Oct-2015. The outcome of the event of FLUMIST that had been between 10.2 degrees Celcius and 0.2 degrees celcius was administered to 21 patients is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Influenza A virus test positive, Influenza B virus test positive, Pyrexia, Respiratory tract congestion
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old female patient received FLUMIST (intranasal), 0.2 Milliliters, unknown. FLUMIST (intranasal) started on 09-Nov-2015. The patient experienced fever which started on 10-Nov-2015, coughing and congestion which started on 09-Nov-2015 and positive influenza rapid diagnostic A/B test which started during Nov-2015. FLUMIST (intranasal) was continued. At the time of reporting, the event coughing, congestion and fever was ongoing and the outcome of the event of positive influenza rapid diagnostic A/B test was unknown. The report was considered to be non-serious by company physician.
Age: 1.3
Sex: M
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, Male patient, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 Millilitres. FLUMIST quadrivalent (intranasal) started on 22-Oct-2015. It was reported that the FLUMIST was inadvertently administered to a 15 month old infant. The outcome of the event of given to 15 mo old was unknown. The report was considered to be non-serious.
Age: 39.0
Sex: F
Vaccine: FLUN4
Symptoms: Injury associated with device, Laceration, Product quality issue, Syringe issue
Clinical narrative: A report has been received from a health professional concerning a 39 year old, female subject, height: 69.0 inches; weight: 170.0 pounds, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. It was reported that the patient was administering the FLUMIST Quadrivalent and she cut her finger on the applicator of the FLUMIST Quadrivalent. The event occurred approximately two weeks ago, Oct-2015 or Nov-2015. Her index finger and middle finger were bandaged. Patient also reported product quality complaint. The outcome of the event of she cut her finger on the FLUMIST applicator and product quality complaint is unknown. The company physician assessed the event she cut her finger on the FLUMIST applicator to be non-serious. The company physician identified the event product quality complaint from source narrative and assessed them as non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent, (intranasal), 0.2 Millilitres. FLUMIST quadrivalent, (intranasal) started on an unknown date. The patient experienced refrigerator where they stored the vaccine went out of range for 1 hour and 48 minutes with the lowest temperature reading of 33.8 degrees Fahrenheit. FLUMIST quadrivalent, (intranasal) was continued. The outcome of the event of refrigerator where they stored the vaccine went out of range for 1 hour and 46 minutes with the lowest temperature reading of 33.8 degrees Fahrenheit is unknown. The report was considered to be non-serious by the company physician.
Age: 1.0
Sex: U
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional . It was reported that a 1 year old child was potentially inadvertently administered Nasal FLUMIST. FLUMIST started on an unknown date. The outcome of the event of potential inadvertent administration is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A report received from a health professional. The report concerns a female patient of an unknown age and ethnicity. Concomitant medications, concurrent disease and relevant history were not reported. The patient received nasal FLUMIST started on an unknown date. During the administration of FLUMIST, the patient flinched during administration in the second nostril, and some vaccine may have sprayed into the eye. Action taken with FLUMIST was not applicable. At the time of reporting, the outcome of the event inadvertent administration in the eye was unknown. The reporter assessed the event inadvertent administration in the eye as non serious. The reporting health professional considered the causality between the event of inadvertent administration in the eye to be unrelated to the suspect drug of FLUMIST and the company physician agreed with that.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain, Vomiting
Clinical narrative: A report has been received from a Physician concerning a 3 year old, Female subject, who had been receiving nasal FLUMIST Quadrivalent, 0.2 milliliters. Once/Single administration. FLUMIST Quadrivalent started on 28-OCT-2015. The patient experienced abdominal pain and vomiting. The patient recovered from the event of abdominal pain and vomiting on an unspecified date. The report was considered to be non-serious.