chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia, Rash generalised, Red blood cell sedimentation rate abnormal, Urinary system X-ray, Urinary system x-ray normal
Clinical narrative: A report has been received from VAERS concerning a 5 year old male patient. No information regarding relevant history, concomitant disease, and concomitant medications was provided. Patient received H1N1 nasal mist vaccine on 26-Oct-2009. On 05-Nov-2009, patient was hospitalized for 1 week history of fever, abdominal pain, diarrhea, and vomiting. Appendicitis was ruled out. Patient was discharged 07-Nov-2009. The same day 11-Nov-2009, patient developed purpuric rash with bloody stool, readmitted to hospital with presumed diagnosis of HSP (vasculitis). Discharged home 10-Nov-2009. Patient presented initially with abdominal pain, diarrhea, vomiting. Appendicitis ruled out by surgery and discharged home with presumptive diagnosis of HSP. Later developed purpuric rash on buttocks, thighs, ears, neck and feet bilaterally and grossly bloody stools. Readmitted, treated with prednisone which helped abdominal pain. Stools became negative for blood. KUB -unremarkable; CT of abdomen/ pelvic showed no signs of intussusception; Labs: LFT's (abnormal), CRP (abnormal), ESR, (abnormal), CBC with diff (Abnormal; Urinalysis (abnormal). The patient recovered from the event of the Henoch Schonlein purpura and liver function test abnormal on unspecified date. The reporter considered the events to be serious due to hospitalization.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Urine analysis abnormal, Vasculitis, Vomiting
Clinical narrative: A report has been received from VAERS concerning a 5 year old male patient. No information regarding relevant history, concomitant disease, and concomitant medications was provided. Patient received H1N1 nasal mist vaccine on 26-Oct-2009. On 05-Nov-2009, patient was hospitalized for 1 week history of fever, abdominal pain, diarrhea, and vomiting. Appendicitis was ruled out. Patient was discharged 07-Nov-2009. The same day 11-Nov-2009, patient developed purpuric rash with bloody stool, readmitted to hospital with presumed diagnosis of HSP (vasculitis). Discharged home 10-Nov-2009. Patient presented initially with abdominal pain, diarrhea, vomiting. Appendicitis ruled out by surgery and discharged home with presumptive diagnosis of HSP. Later developed purpuric rash on buttocks, thighs, ears, neck and feet bilaterally and grossly bloody stools. Readmitted, treated with prednisone which helped abdominal pain. Stools became negative for blood. KUB -unremarkable; CT of abdomen/ pelvic showed no signs of intussusception; Labs: LFT's (abnormal), CRP (abnormal), ESR, (abnormal), CBC with diff (Abnormal; Urinalysis (abnormal). The patient recovered from the event of the Henoch Schonlein purpura and liver function test abnormal on unspecified date. The reporter considered the events to be serious due to hospitalization.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Paraesthesia
Clinical narrative: Per phone call of 2/17/14 pt reported tingling and deep soreness after injection. Tingling lasted 24 hours. Soreness remains and increased, causing limited mobility. To treat with physical therapy and ibuprofen.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Pt. went and purchased medication at pharm. and brought over here for administration. Pt came, V/S taken 98 degrees 73 20 116/64 98% at approx 11:50A vaccine given in (L) arm SQ approx 12N pt c/o starting to itch. Dr. notified V-O BENADRYL 25mg IM. Pt itching on (L) arm and numerous places on body. BENADRYL given in (R) buttock.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, redness, swelling and heat at site.
Age: 11.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to 11 year old patient (gender unspecified). On 20-FEB-2014, nurse inadvertently administered ZOSTAVAX, subcutaneous (dose unspecified) to an 11 year old patient for vaccination. It was reported this would have been dose two of the patient's VARIVAX (Merck). Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Pruritus generalised, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: A report has been received from a Pharmacist concerning a 9 year old male. Medical history and concomitant medications were not reported. The patient received nasal FLUMIST, one dose, on Monday, 04-Nov-2013. On Tuesday he developed a rash which was red and itchy (no hives). The rash was all over his body (all over his arms and legs). His mother gave him BENADRYL (25mg each dose), and the rash improved. Once the BENADRYL wears off the rash returns; once administered the BENADRYL again the rash improved. The oral BENADRYL was not controlling his reaction as rash began to get worse, entire body. Patient visited hospital and was given injectable BENADRYL and advised to take REACTINE and BENADRYL orally. The patient recovered from the events of itchy all over the body, rash which is red and itchy all over the body/ rash and rash after another 24 hours. The reporter assessed the events of itchy all over the body, rash which is red and itchy all over the body/ rash and rash which is red to be serious as important medical events. The reporter assessed the events of itchy all over the body, rash which is red and itchy all over the body/ rash and rash which is red to be causally related with the suspect drug of FLUMIST. Follow-up information received by AstraZeneca/MedImmune 18-Nov-2013 from pharmacist upgraded this case to Expeditable as seriousness updated for events of itchy all over the body and itchy all over the body/ rash and rash, event of rash which is red separated. Reporter causality added. Outcome updated.
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: A consumer report has been received concerning a foetus of unknown gender. No information regarding relevant history, concurrent disease and concomitant medications was provided. The consumer reported that he and his wife had received nasal FLUMIST from their doctor on 24-Oct-2013 and his wife was pregnant for seven months. The foetus was exposed to vaccine via mother and at the time of reporting experienced no adverse event. Consumer asked if there was any risk to his wife and the foetus. The outcome of the event of no adverse event was unknown. The company physician assessed the event of no adverse event to be serious due to the criterion of important medical event.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Arthropathy, Femur fracture, Weight bearing difficulty
Clinical narrative: Subject is enrolled on a clinical trial that is evaluating the quadrivalent HPV vaccine in cancer survivors. Subject received dose #2/3 of GARDASIL vaccine on 2/5/14. When she was contacted for her 2-week post-vaccine telephone follow-up on 2/20/14, she reported that she had sustained a fracture of her (R) distal femoral condyle on 2/16/14. This reportedly occurred without associated trauma; subject stated that she was walking, her (R) knee "went out" and she could not bear weight on it. She was seen in her local ER where X-rays were taken and the fracture was diagnosed.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose 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. FLUMIST QUADRIVALENT started on 23-Oct-2013. It was reported that patient received FLUMIST QUADRIVALENT twice which started on 05-Nov-2013. The outcome of the event of received FLUMIST QUADRIVALENT twice is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Pneumonia
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's medical history included lung disease. The patient's concurrent disease(s) included bronchospasm and asthma. Family history included asthma and sinusitis. FLUMIST QUADRIVALENT started on 21-Oct-2013. The patient experienced pneumonia. FLUMIST QUADRIVALENT was discontinued on 21-Oct-2013. The outcome of the event of pneumonia is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza like illness
Clinical narrative: A spontaneous report has been received from 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 nasal FLUMIST quadrivalent started on an unknown date. The reporter stated that a patient was showing influenza like symptoms and the provider would like to test them for the flu. They received the FLUMIST and would like to know how long after receiving that vaccine they were able to complete a nasal swab for influenza testing without the FLUMIST altering the results. The outcome of the event of influenza like symptoms was unknown. The reporter considered the event of influenza like symptoms to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 05-Nov-2013. It was reported that FLUMIST was given to few patients who were over 50 years old which started on 05-Nov-2013. The outcome of the event of gave FLUMIST to a few patients who were over 50 years old is unknown. The report was considered to be non-serious.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Chest discomfort, Cough, Fatigue, Wheezing
Clinical narrative: A report has been received from a Physician concerning a 5 year old male patient. The patient's medical history included asthma, bronchitis, frequent ear infections and eczema. Concomitant medications included salbutamol sulfate and salbutamol. The patient received FLUMIST quadrivalent on 20-Sep-2011 without any side effect. Further patient received another dose of vaccine with lot number BK2062 and expiry date 20-Jan-2014. The patient experienced tightness in the chest, wheezing, his stomach was hurting, and fatigue which started in the evening after administration of FLUMIST on 04-Nov-2013 and coughing. Patient's pulse oxygen on room air was 97%. The prescribed treatment included: albuterol for 2 days and ORAPRED for 5 days. He had received FLUMIST in the past and no issues were documented after receiving the 2011 dose. Action taken with FLUMIST was not applicable. At the time of reporting, the event of tightness in the chest, wheezing, stomach hurts and fatigue were ongoing and the outcome of the event of coughing was unknown. The reporter considered the events of tightness in the chest, wheezing, stomach hurts and fatigue to be non-serious and company physician identified the event of coughing and assessed it as non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Pneumonia
Clinical narrative: A report has been received from a Health Professional concerning an adolescent, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's concurrent disease(s) included asthma and bronchospasm. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced pneumonia. The outcome of the event of pneumonia is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Pneumonia
Clinical narrative: A report has been received from a Health Professional concerning a child, subject of unknown gender, who had been receiving FLUMIST. The patient's concurrent disease(s) included Asthma and Bronchospasm. FLUMIST started on an unknown date. The patient experienced Pneumonia. The outcome of the event of Pneumonia is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Pneumonia
Clinical narrative: A report has been received from a Health Professional concerning, subject of unknown gender, who had been receiving FLUMIST. The patients concurrent disease(s) included Asthma and Bronchospasm. FLUMIST started on an unknown date. THe patient experienced Pnemonia. The outcome of the event of Pneumonia is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: A consumer report has been received. The report concerns a 4 year old, Female consumer, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced fever which started on 05-Nov-2013. The patient recovered from the event of fever on 06-Nov-2013. The report was considered to be non-serious.
Age: 50.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 26-Nov-1962, Female subject, who had been receiving FLUMIST started on an unknown date. The reporter stated that the we inadvertently administered FLUMIST to a 51 y/o patient. The outcome of the event of inadvertently administered FLUMIST to a 51 y/o patient is unknown. The report was considered to be non-serious.
Age: 61.0
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 61 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 01-Oct-2013. The reporter stated they administered FLUMIST QUADRIVALENT to a 61 yo on 01-Oct-2013. The outcome of the event of administered FLUMIST QUADRIVALENT to a 61 yo is unknown. The report was considered to non-serious.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Lacrimation increased, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced mild runny nose, mild sore throat which started on 06-Nov-2013. The outcome of the event of runny nose, sore throat, and watery eyes is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia, Vomiting
Clinical narrative: A consumer report has been received. The report concerns a 6 year old. Male consumer, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 05-Nov-2013. The patient experienced fever and vomiting which started on 06-Nov-2013. FLUMIST (Intranasal) was discontinued on 05-Nov-2013. At the time of reporting, the event of fever and vomiting was ongoing. The report was considered to be non-serious.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning an 8 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 07-Nov-2013. It was reported that a patient inadvertently received FLUMIST two days in a row, one at the doctor office and the other at school/administration of extra dose which started on 07-Nov-2013. The outcome of the event of administration of extra dose is unknown. The report was considered to be non-serious.
Age: 1.29
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 05-Oct-2013. It was reported that nurse had inadvertently given FLUMIST to a 15 months old child which started on 05-Oct-2013. The patient recovered from the event of inadvertently gave FLUMIST to a 15 month old child on an unspecified date. The report was considered to be non-serious.
Age: 52.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 52 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The nurse reported that they inadvertently gave FLUMIST to a 52 year old which started on 28-Oct-2013. The patient has not had any issues or symptoms since FLUMIST. The outcome of the event of inadvertently gave FLUMIST to a 52 year old is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 09-Oct-2008, male subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced administration of FLUMIST to patient with asthma. The outcome of the event of administration of FLUMIST to patient with asthma is unknown. The report was considered to be non-serious.
Age: 5.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Unevaluable event
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 09-Oct-2008, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (intranasal). The patient's concurrent(s) included Asthma. FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The physician's assistant reported that they administered FLUMIST QUADRIVALENT to a patient who had asthma on 01-Nov-2013. The outcome of the event of administration of FLUMIST QUADRIVALENT to patient with asthma is unknown. The report was considered to be non-serious by the reporter.
Age: 5.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Unevaluable event
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's concurrent disease(s) included asthma. FLUMIST QUADRIVALENT started on an unknown date. The physician's assistant reported they administered FLUMIST QUADRIVALENT to a patient with asthma which started on 01-Nov-2013. The outcome of the event of administration of FLUMIST QUADRIVALENT to patient with asthma is unknown. The report was considered to be non-serious by the reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dysphonia, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Within 24 hours - redness and swelling at site after 48 hours - dizziness, hoarseness, fatigue.
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning, pregnant female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter reported that patient received FLUMIST QUADRIVALENT and later found out she was pregnant which was also considered as drug exposure during pregnancy. The outcome of the event of patient received FLUMIST QUADRIVALENT and later found out she was pregnant and drug exposure during pregnancy is unknown. The report was considered to be non-serious. Outcome of the pregnancy was unknown.
Age: 60.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 60 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 22-Oct-2013. It was reported that consumer was administered FLUMIST QUADRIVALENT to a person over 49 years who was 60 years old which started on 22-Oct-2013. The outcome of the event of administered FLUMIST QUADRIVALENT to a person over 49 years/60 YO is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Rec'd MMRV and KINRIX on 2/21 at 4 y.o. WCC. Seen 2/23 for (L) outer arm swollen at MMRV site. Dx with cellulitis on cephalexin, afebrile no other c/o.
Age: 61.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Diarrhoea, Drug administered to patient of inappropriate age, Fatigue, Headache
Clinical narrative: Drug administered to patient of inappropriate age. A consumer report had been received. The report concerns a 61 year old, female consumer, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 17-Oct-2013. The patient experienced very tired, headaches, muscle aches, cough, and diarrhea which started on 19-Oct-2013 and 61 year old patient was administered FLUMIST which started on 17-Oct-2013. The outcome of the event of 61 year old patient was administered FLUMIST very tired, headaches, muscle aches, cough and diarrhea is unknown. The report was considered to be non-serious.
Age: 61.0
Sex: F
Vaccine: FLUN4
Symptoms: Myalgia
Clinical narrative: Drug administered to patient of inappropriate age. A consumer report had been received. The report concerns a 61 year old, female consumer, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 17-Oct-2013. The patient experienced very tired, headaches, muscle aches, cough, and diarrhea which started on 19-Oct-2013 and 61 year old patient was administered FLUMIST which started on 17-Oct-2013. The outcome of the event of 61 year old patient was administered FLUMIST very tired, headaches, muscle aches, cough and diarrhea is unknown. The report was considered to be non-serious.
Age: 46.0
Sex: F
Vaccine: FLUN4
Symptoms: Chest pain, Musculoskeletal chest pain
Clinical narrative: A report has been received from a Health Professional concerning a 46 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 25-Oct-2013. The patient experienced body aches in chest and ribs which started on 26-Oct-2013. At this time of reporting, the event of body aches in chest and ribs was ongoing. The report was considered to be non-serious by the reporter.
Sex: U
Vaccine: FLUN4
Symptoms: Pneumonia
Clinical narrative: A report has been received from a Health Professional concerning, subject of unknown gender, who had been receiving FLUMIST. The patient's concurrent disease(s) included Asthma and Bronchospasm. FLUMIST started on an unknown date. The patient experienced Pneumonia. The outcome of the event of Pneumonia is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TD
Symptoms: Wrong drug administered
Clinical narrative: Gave Zostavax instead of varicella.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Gastrointestinal disorder, Lymphadenopathy, Mental status changes, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Vomiting, change in mental status, thickened terminal ileum and lymph nodes.
Age: 32.0
Sex: F
Vaccine: HEPA, IPV, MMR, PPV
Symptoms: Flank pain, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: R deltoid is swollen around injection site and skin is blotchy.  No open areas.   Pt notes arm is painful especially when she tries to raise arm.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Asthenia, Chills, Fatigue, Headache, Pain
Clinical narrative: Fever, Chills, Full Body Aches, Weakness / Heavy Fatigue, and Headaches from 08/16/2013 to 08/19/2013.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Fever, Chills, Full Body Aches, Weakness / Heavy Fatigue, and Headaches from 08/16/2013 to 08/19/2013.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, PNC13, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Red patches and dots on face after vaccines, no shortness of breath, no swelling or difficulty swallowing, observed for another 35 minutes post vaccines, client happy and talking, redness and dots diminishing, mom aware to go to ER if symptoms change.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Pt called our office 2/20/14. Stated "there was a 2 inch area of redness to start with. 2/14/14 started with a rash at the site that spread to shoulder to elbow with swelling and itching. States saw his dermatologist who put him on a Z pack and ? ointment. Pt seen in our office 02/20/2014. He prescibed Zyrtec, con't topical steroid and call if worse.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on face and left arm where MMR.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dyspnoea, Erythema, Injection site nodule, Injection site swelling
Clinical narrative: Per patient; itching almost immediately followed by chills, knot at injection site, swelling at injections site, redness, shortness of breath, racing heart.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations, Pruritus
Clinical narrative: Per patient; itching almost immediately followed by chills, knot at injection site, swelling at injections site, redness, shortness of breath, racing heart.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: SORENESS AND PAIN AT SITE OF INJECTION AND ARM.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Erythema, Pain, Swelling
Clinical narrative: Painful, reddened and swollen, causing loss of work day.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: Death.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The reporter stated that the patient had drug in only one nostril was administered which started on 02-oct-2013. The outcome of the event of only one nostril was administered is unknown. The report was considered to be non-serious.
Age: 58.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 58 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 20-Oct-2013. It was reported that FLUMIST QUADRIVALENT was administered to a 58 year old patient which started on 20-Oct-2013. FLUMIST QUADRIVALENT (Intranasal) was discontinued on 20-Oct-2013. The outcome of the event of administered FLUMIST QUADRIVALENT to a 58 year old patient is unknown. The report was considered to be non-serious.
Age: 1.78
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a physician concerning a 1 year old, female subject, who had been receiving FLUMIST (Intranasal). The patient's concurrent disease(s) included bronchitis and migraine. FLUMIST (Intranasal) started on 24-Oct-2013. They inadvertently given FLUMIST to a 21 month old patient on 24-oct-2013. The outcome of the event of inadvertently gave FLUMIST to a 21 month old patient is unknown. The report was considered to be non-serious.
Age: 1.78
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a physician concerning a 1 year old, female subject, who had been receiving FLUMIST (Intranasal). The patient's concurrent disease(s) included bronchitis and migraine. FLUMIST (Intranasal) started on 24-Oct-2013. They inadvertently given FLUMIST to a 21 month old patient on 24-oct-2013. The outcome of the event of inadvertently gave FLUMIST to a 21 month old patient is unknown. The report was considered to be non-serious.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, female subject, who had been receiving FLUMIST (Intranasal) dose and a half. FLUMIST (Intranasal) started on an unknown date. The nurse reported that they inadvertently administered  a dose and a half of FLUMIST to a patient on the same day on 23-Oct-2013. The patient had not experienced any symptoms from the extra FLUMIST. The outcome of the event of patient received dose and a half of FLUMIST is unknown. The report was considered to be non-serious.
Age: 1.02
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 26-Oct-2013. It was reported that they inadvertently administered FLUMIST QUADRIVALENT to a 12 month old on 26-Oct-2013. FLUMIST QUADRIVALENT was discontinued on 26-Oct-2013. The outcome of the event of INADVERTENTLY ADMINISTERED FLUMIST QUADRIVALENT TO A 12 MONTH OLD is unknown. The report was considered to be non-serious.
Age: 28.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a 28 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 24-Oct-2013. It was reported that consumer had received FLUMIST QUADRIVALENT and suspects she might be pregnant which started on 24-Oct-2013. The outcome of the event of patient received FLUMIST QUADRIVALENT and suspects she may be pregnant is unknown. The report was considered to be non-serious. Corrected report 06-Dec-2013: Pregnancy tab was filled. Additional reporter was added as Responsible Physician.
Age: 34.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Arthralgia, Condition aggravated, Ear pain, Fatigue, Fibromyalgia
Clinical narrative: Onset same day as vaccination within 15 min c/o headache. Local reaction rash around injection site - onset of s/sx same day as injection given pt. states she started having ear pain, fatigue and joint and muscle pain, (R) side of body. Has Hx of fibromyalgia and has been going through a lot of high stress lately. Seen by FNP - here 2/21/14 - pt. 1st called re: reaction - 2/20/14 - in PM offered appt. declined called later in PM and scheduled 2/21/14 appt.
Age: 34.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Headache, Hypersensitivity, Injection site rash, Local reaction, Myalgia
Clinical narrative: Onset same day as vaccination within 15 min c/o headache. Local reaction rash around injection site - onset of s/sx same day as injection given pt. states she started having ear pain, fatigue and joint and muscle pain, (R) side of body. Has Hx of fibromyalgia and has been going through a lot of high stress lately. Seen by FNP - here 2/21/14 - pt. 1st called re: reaction - 2/20/14 - in PM offered appt. declined called later in PM and scheduled 2/21/14 appt.
Age: 34.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Stress
Clinical narrative: Onset same day as vaccination within 15 min c/o headache. Local reaction rash around injection site - onset of s/sx same day as injection given pt. states she started having ear pain, fatigue and joint and muscle pain, (R) side of body. Has Hx of fibromyalgia and has been going through a lot of high stress lately. Seen by FNP - here 2/21/14 - pt. 1st called re: reaction - 2/20/14 - in PM offered appt. declined called later in PM and scheduled 2/21/14 appt.
Age: 66.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 66 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient experienced inadvertently gave FLUMIST to 66 year old woman. The outcome of the event of inadvertently gave FLUMIST to 66 year old woman is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The nurse reported that she had a patient who finished chemotherapy in June and was inadvertently given FLUMIST QUADRIVALENT which started on 24-Oct-2013. The outcome of the event PATIENT FINISHED CHEMOTHERAPY IN JUNE AND WAS INADVERTENTLY GIVEN FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by reporter.
Age: 53.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 53 year old, male subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The nurse practioner reported that a patient over the age of 50 years old received FLUMIST on 16-Oct-2013. Patient had not experienced any symptoms. The outcome of the event of patient over 50 years of age received FLUMIST is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Exposure via direct contact
Clinical narrative: A report has been received from a Health Professional concerning, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. Clinic operations coordinator reported that a FLUMIST Quadrivalent that was given to the child possibly went into the child's eye on 23-Oct-2013. The person reporting was not the nurse administering the FLUMIST. However, she heard about the incident and decided to report it. She did not have patient specifics at the time of the report. She noted that when the patient left the clinic the patient's eye was not red or irritated. The outcome of the event of FLUMIST QUADRIVALENT possibly went into patient's eye is unknown. The report was considered to be non-serious.
Age: 26.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Pharmacist concerning a 26 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The pharmacist reported, when the FLUMIST QUADRIVALENT was administered the clip was off, so more vaccine went in one nostril than the other. The outcome of the event of more vaccine went in one nostril than the other is unknown. The report was considered to be non-serious by the reporter.
Sex: M
Vaccine: FLUN4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: A report has been received from a physician concerning an adult, male patient (son of the physician). The patient drug history was not reproted. He had a well controlled asthma. In the fall of 2013 the patient received FLUMIST. He experienced several days of fever, chills, and aches and was clinically assessed to have flu in March-2013. Action taken with FLUMIST and outcome of flu was unknown. The report was considered to be non-serious.
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Pneumonia
Clinical narrative: A report has been received from a physician a 17 year old, female subject, who had been receiving FLUMIST (Intranasal). The patient's concurrent disease(s) included spinal muscular atrophy four. FLUMIST (Intranasal) started on an unknown date. The patient experienced pneumonia. The outcome of the event of pneumonia is unknown. The report was considered to be non-serious by the reporter.
Sex: M
Vaccine: FLUN3
Symptoms: Influenza virus test positive
Clinical narrative: A report has been received from a Health Professional via Sales Representative concerning a child, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced tested positive for the flu twice. The outcome of the event of tested positive for the flu twice is unknown. The report was considered to be non-serious by the reporter.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Lymphadenopathy, Nasal congestion, Respiratory tract infection, Rhinorrhoea, Sinusitis
Clinical narrative: A consumer report has been received. The report concerns a 14 year old, female consumer, who had been receiving FLUMIST, 0.2 milliliters, once/single administration. FLUMIST started on 09-NOV-2012. The patient experienced moderate runny nose and moderate stuffy nose, which started during Nov-2012. Swollen sub mandibular glands, three sinus/3rd sinus infection and respiratory infection. At the time of reporting the event of swollen sub mandibular glands, runny nose, stuffy nose, three sinus/3rd sinus injection and respiratory infection was ongoing. The report was considered to be non-serious.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Malaise
Clinical narrative: A report has been received from a health professional concerning a 35 year old female patient. Medical history and concomitant medications of the patient was not reported. The patient had been receiving FLUMIST (Intranasal) started on an unknown date. The patient could not remember when she received FLUMIST or when the flu began. She said she was sick for about four days. She was treated with TAMIFLU. Action taken with FLUMIST was not reported. The outcome of the event of contracted type a flu and sick was unknown. The reporter considered the event contracted type a flu was considered to be non-serious. The company physician considered the event sick to be non-serious due to sick.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthma, Upper respiratory tract infection
Clinical narrative: A report has been received from a Health Professional concerning via a medical representative concerning a 04 year old female patient. Relevant history of patient included wheezing and coughing. Concurrent diseases of patient included allergies to pets and molds. Concomitant medications of patient included diphtheria toxoid, pertussis vaccine acellular, tetanus toxoid. Patient started receiving Nasal FLUMIST 0.2 ml (frequency not provided) on 14-Jan-2013. It was reported that patient experienced asthma attack on 14-Jan-2013 late in the evening and upper respiratory tract infection on an unspecified date. FLUMIST was continued. At the time of reporting the event of asthma attack was recovered and outcome of the event of upper respiratory tract infection was unknown. The report was considered to be non-serious by reporter.
Sex: U
Vaccine: FLUN3
Symptoms: Influenza, Influenza B virus test positive
Clinical narrative: A report has been received from a physician via medical representative concerning children of unknown age and gender. No information regarding relevant history, concurrent disease and concomitant medications of the patients was provided. The patients received nasal FLUMIST on an unknown date. It was reported that several patients who had FLUMIST last season ending up getting flu last year. No information regarding Lot numbers, expiration dates, number of patients involved was provided. Physician also indicated that the kids who received the flu shots at school did not get the flu, but the kids who received FLUMIST tested positive for the type B strain. She thought it might have been 7 sets of kids, but she was unsure. The outcome of the event of flu was unknown. The report was considered to be non-serious by company physician.
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: No adverse event
Clinical narrative: A report has been received from a Physician via medical representative and the follow-up report from a physician via Health Professional concerning a 40 year old, male subject. The medical representative stated that the physician reported that he had received FLUMIST (intranasal) during 2003 and later had fever and Chills. In the follow-up report the admin checked with the physician if he had reported the adverse event of fever and chills for himself, but he had denied that he reported anything or had any adverse events. The report was considered to be non-serious by the company physician.
Sex: U
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A report has been received from a Health Professional via Medical Representative concerning a patient of unknown gender, who had been receiving FLUMIST (Intranasal) started on an unknown date. The patient experienced fever. The outcome of the event of fever is unknown. The reporter was considered to be non-serious by the reporter.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has ben received from a Health Professional concerning a 4 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The reporter stated that the patient was administration of expired dose which started on 09-sep-2013. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a physician concerning a 31 year old, female subject, who had been receiving FLUMIST (Intranasal), 0.2 Millilitres, once/single administration. FLUMIST (Intranasal) started on 13-Sep-2013. The patient experienced exposure during pregnancy which started on 13-Sep-2013. FLUMIST (Intranasal) was discontinued on 13-Sep-2013. The outcome of the event of exposure during pregnancy is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN3
Symptoms: Headache
Clinical narrative: A report has been received from a Physician concerning an adult, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced headache. The patient recovered from the event of headache on an unspecified date. The report was considered to be non-serious.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Chills, Decreased appetite, Fatigue, Influenza, Influenza A virus test positive
Clinical narrative: A report was received from a health professional concerning a 5 years old female patient. Medical history and concomitant medications were not reported. On 08-Oct-2013, patient received nasal FLUMIST QUADRIVALENT (intranasal). On 22-Oct-2013, the patient suffered from flu symptoms including chills, fever of 102.6 Fahrenheit, decreased appetite, body aches, runny nose, congestion and fatigue. Patient tested positive for influenza A with RIDT in the office. At the time of reporting, the outcome of the events was unknown. The reporter assessed the events to be non-serious.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: A report was received from a health professional concerning a 5 years old female patient. Medical history and concomitant medications were not reported. On 08-Oct-2013, patient received nasal FLUMIST QUADRIVALENT (intranasal). On 22-Oct-2013, the patient suffered from flu symptoms including chills, fever of 102.6 Fahrenheit, decreased appetite, body aches, runny nose, congestion and fatigue. Patient tested positive for influenza A with RIDT in the office. At the time of reporting, the outcome of the events was unknown. The reporter assessed the events to be non-serious.
Age: 60.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 60 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced ADMINISTERED FLUMIST QUADRIVALENT TO A HEALTHY 60 YEAR OLD PATIENT which started on 14-Oct-2013. The outcome of the event of ADMINISTERED FLUMIST QUADRIVALENT TO A HEALTHY 60 YEAR OLD PATIENT is unknown. The report was considered to be non-serious by the reporter.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Neck pain, Photosensitivity reaction, Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a 13 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced fever of 103 F and neck pain which started on 15-Oct-2013 and sensitivity to light. The patient recovered from the event of fever of 103 F, neck pain and sensitivity to light on an unspecified date. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Epistaxis
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient experienced patient experienced a nose bleed after receiving FLUMIST. The patient recovered from the event of patient experienced a nose bleed after receiving FLUMIST on an unspecified date. The report was considered to be non-serious.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 16 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter reported that they inadvertently gave expired FLUMIST (last years vaccine) which started on 16-Sep-2013. The outcome of the event of INADVERTENTLY GAVE EXPIRED FLUMIST (last years vaccine) is unknown. The report was considered to be non-serious.
Age: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST, (intranasal) started on an unknown date. The reporter reported that they inadvertently gave expired FLUMIST (last years vaccine) which started on 16-Sep-2013. The outcome of the event inadvertently gave expired FLUMIST (last years vaccine) is unknown. The report was considered to be non-serious.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Mobility decreased, Musculoskeletal pain, Pain in extremity, Sensation of heaviness
Clinical narrative: Arm felt very heavy and extremely painful, pain got increasingly worse, swelling began and increased, arm became hot and shoulder became painful and hard to move, and red markings showed up on arm at site and around upper arm. At around 36 hours later I finally went back to PCP office.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Arm felt very heavy and extremely painful, pain got increasingly worse, swelling began and increased, arm became hot and shoulder became painful and hard to move, and red markings showed up on arm at site and around upper arm. At around 36 hours later I finally went back to PCP office.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Aphasia, Aspartate aminotransferase increased, Carbon dioxide decreased, Dysphemia, Eczema
Clinical narrative: Pronounced and strained speech tic/stutter causing difficulty finishing sentences that previously were communicated with no impediment. The patient, our son, would get stuck between words for an extended period of time in these tics, and sometimes be unable to finish sentences that he had been able to say easily prior to vaccination. The onset of the speech tics was three days after the administration of the vaccines, peaking at its worst one week after the administration for 2-3 days, and slowly subsiding in the following two weeks (three weeks after vaccination). Also, he has had an eczema-like rash on much of his body, behind his knees, in and around his armpits, on his lower back and belly, which showed up after vaccination and has still not completely gone away. We noticed marked irritability after vaccination as well, which persisted for about two weeks.