chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza A virus test positive, Influenza like illness, Myalgia, Respiratory tract congestion
Clinical narrative: A report has been received from a Health Professional concerning a 12 year old, female patient. No concomitant medication or relevant medical history has been reported. The patient had been receiving nasal FLUMIST started on 20-Sep-2012. On 25-Sep-2012, five days after receiving FLUMIST vaccine, the patient came to doctors office with symptoms of congestion and muscle aches. He was subjected to swab test and turned to be positive for Influenza vaccine A and diagnosed with flu-like symptoms. The patient was retested on 02-Oct-2012 and the result came to be Negative for Influenza. The patient recovered from the event of positive for influenza A on 02-Oct-2012 and the outcome of the event of flu-like symptoms was unknown. The report was considered to be non-serious by the reporter.
Age: 48.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthma, Chest discomfort, Condition aggravated, Cough, Nasal congestion
Clinical narrative: A report has been received from a Health Professional concerning a 48 year old, Female patient. The patient's concurrent diseases included asthma triggered by infection, smoke, pollen and changes in the weather. She had symptoms when she run. The patient was a former smoker. She had respiratory issues two consecutive years. Family history included sinusitis. Concomitant medications included MENOCET, ascorbic acid, biotin, minerals nos, nicotinic acid, retinol, tocopherol, vitamin b nos, vitamin d nos and calcium. A nurse reported that another employee in the office from a previous season had asthma and got FLUMIST and made her have as asthmatic episode both in 2010 and 2011. They lasted for 2-3 days. The symptoms were fever, wheezing, coughing, and nasal and chest congestion, chest tightness and sputum production. The patient experienced these symptoms for about one week after receiving FLUMIST. The patient stated that she was treated at the office with XOPENEX inhaler and used it for a week. She was out of work both episodes for 2-3 days. At the time of the reporting the patient recovered from the events of asthmatic episode, wheezing, fever, chest congestion, coughing, chest tightness, sputum production and nasal congestion. The report was considered to be non-serious by company physician. Summary of follow-up information received by AstraZeneca/MedImmune on 07-Nov-2012 from health professional: new events of wheezing, fever, chest congestion, coughing, chest tightness, sputum production and nasal congestion added, event outcome updated, patient medical history added, concomitant medications added, patient details updated, reporter information updated, narrative updated.
Age: 48.0
Sex: F
Vaccine: FLUN3
Symptoms: Productive cough, Pulmonary congestion, Pyrexia, Wheezing
Clinical narrative: A report has been received from a Health Professional concerning a 48 year old, Female patient. The patient's concurrent diseases included asthma triggered by infection, smoke, pollen and changes in the weather. She had symptoms when she run. The patient was a former smoker. She had respiratory issues two consecutive years. Family history included sinusitis. Concomitant medications included MENOCET, ascorbic acid, biotin, minerals nos, nicotinic acid, retinol, tocopherol, vitamin b nos, vitamin d nos and calcium. A nurse reported that another employee in the office from a previous season had asthma and got FLUMIST and made her have as asthmatic episode both in 2010 and 2011. They lasted for 2-3 days. The symptoms were fever, wheezing, coughing, and nasal and chest congestion, chest tightness and sputum production. The patient experienced these symptoms for about one week after receiving FLUMIST. The patient stated that she was treated at the office with XOPENEX inhaler and used it for a week. She was out of work both episodes for 2-3 days. At the time of the reporting the patient recovered from the events of asthmatic episode, wheezing, fever, chest congestion, coughing, chest tightness, sputum production and nasal congestion. The report was considered to be non-serious by company physician. Summary of follow-up information received by AstraZeneca/MedImmune on 07-Nov-2012 from health professional: new events of wheezing, fever, chest congestion, coughing, chest tightness, sputum production and nasal congestion added, event outcome updated, patient medical history added, concomitant medications added, patient details updated, reporter information updated, narrative updated.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A report has been received from a health professional concerning a 11 year-old male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. During Sep-2012, the patient received a treatment with nasal FLUMIST. The dosage, frequency and indication for use of this medication were not provided. On 24-Sep-2012, the patient developed influenza A. The event of influenza A was ongoing. The report was considered to be non-serious by the reporter.
Sex: U
Vaccine: FLUN3
Symptoms: Incorrect storage of drug
Clinical narrative: A consumer report has been received. The report concerns about 2 patients of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter stated they had a power outage on 25Sep12. Their power outage lasted for one hour and six minutes, their storage unit reached 50 degrees F. The customer had administered one dose on 26-Sep-12 and one dose on 28-Sep-12. The outcome eof the event of COLD CHAIN BREAK is unknown. The report was considered to be non-serious.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Barium swallow normal, Catatonia, Eating disorder, Electroencephalogram normal, Gastrointestinal tube insertion
Clinical narrative: Within 6 hrs patient's muscles became really tight. At 12 hrs. her eyes started to become unfocused. At 24 hrs. she was almost catatonic. 48 hrs. she was admitted to the ER by a neurologist. At that point patient stopped eating and was given an NG tube. She received an EEG, MRI and 2 different swallow studies with all of them coming back normal.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Muscle tightness, Nuclear magnetic resonance imaging normal, Vision blurred
Clinical narrative: Within 6 hrs patient's muscles became really tight. At 12 hrs. her eyes started to become unfocused. At 24 hrs. she was almost catatonic. 48 hrs. she was admitted to the ER by a neurologist. At that point patient stopped eating and was given an NG tube. She received an EEG, MRI and 2 different swallow studies with all of them coming back normal.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Electroencephalogram normal, Febrile convulsion, Pyrexia
Clinical narrative: 15 mo old with MMR given 2/5/13, on 2/14/13 had a febrile sz at daycare (T 39.3) seen in ED. Sent back to ED 3 hours later with another sz / fever (38.1). Admitted overnight for observation, EEG nl - has. OM persists.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood test, Electromyogram, Hypoaesthesia, Lumbar puncture, Myelitis transverse
Clinical narrative: Patient reports that week of January 14, 2013 her feet began to feel numb bilaterally. Over the next few weeks progressed to calf and thigh area. Numbness progressed to buttock area. Pt hospitalized 2-11-13 thru 2-16-13 and diagnosed with Transverse Myelitis.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Patient reports that week of January 14, 2013 her feet began to feel numb bilaterally. Over the next few weeks progressed to calf and thigh area. Numbness progressed to buttock area. Pt hospitalized 2-11-13 thru 2-16-13 and diagnosed with Transverse Myelitis.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash, Swelling face
Clinical narrative: A report has been received from a health professional concerning a 4 year old male patient. No concomitant medication or relevant history was provided. The patient received nasal FLUMIST, during Sep-2012. In Sep-2012, the patient experienced that nose totally swelled up, face exploded and rash all over the front of his chest. Patient was observed for one and a half hour and was given BENADRYL and seemed to finally calm him down. The outcome of the events of nose totally swelled up, face exploded and rash all over the front of his chest was unknown. The event of face exploded was considered to be non-serious by the reporting health professional and the company physician assessed the events of nose totally swelled up and rash all over the front of his chest to be not serious.
Age: 29.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A report has been received from Nurse Practitioner concerning herself a 29 year old, Female patient, who had been receiving Nasal FLUMIST. FLUMIST started on 11-Oct-2012. The patient experienced positive flu test 3 days after receiving FLUMIST and not feeling well which started on 11-Oct-2012. The outcome of the event of positive flu test 3 days after receiving FLUMIST and not feeling well is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 24-Oct-2012: the event of not feeling well was deleted because the patient reported that she was "feeling under the weather" prior to giving herself FLUMIST.
Sex: U
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on 27-Sep-2012. The patient experienced fever. FLUMIST was discontinued on 27-Sep-2012. The outcome of the event of fever is unknown. The report was considered to be non-serious.
Age: 0.24
Sex: F
Vaccine: HIBV, PPV
Symptoms: Crying, Dyskinesia, Glassy eyes, Injection site erythema, Injection site swelling
Clinical narrative: Uncontrollable rapid head jerking! Non stop crying and screaming for 1 1/2 to 2 hours and redness and swelling at injection site. Glassy eyes.
Age: 0.24
Sex: F
Vaccine: HIBV, PPV
Symptoms: Screaming
Clinical narrative: Uncontrollable rapid head jerking! Non stop crying and screaming for 1 1/2 to 2 hours and redness and swelling at injection site. Glassy eyes.
Age: 18.0
Sex: M
Vaccine: YF
Symptoms: Dyspnoea, Rash, Urticaria
Clinical narrative: Rash (hives) and mild dyspnea.
Age: 0.39
Sex: M
Vaccine: DTAP, HIBV, RVX
Symptoms: Urticaria
Clinical narrative: Hives on face, chest, and back. He is strictly breastfed and my (mother's) diet had not changed so I feel confident that it is one of the vaccines he received at his four month check up.
Age: 0.77
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on face and low fever, lasted several hours (was gone the next morning), treated with dose of Benadryl per Dr.'s orders. Rash/fever returned every day at the same time for 6 days. Treated with Benadryl each time successfully.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Burning sensation, Henoch-Schonlein purpura, Pain, Rash macular, Scab
Clinical narrative: Red blotchy area on both lower legs. On 12/07/2012 complained of burning on legs and red blotchy areas spread to groin and buttocks. Never totally cleared but became better with prednisone and Benadryl. On 01/04 2013 red raised area now on waist areas and continued on legs. Rash is now painful to touch and some scabbed areas. Dr. diagnosed it as Henoch-Schonlein Purpura
Age: 0.78
Sex: F
Vaccine: PER
Symptoms: Crying, Irritability, Pyrexia, Vomiting
Clinical narrative: 103 fever, crying, irritable, gave Tylenol. 9:00 PM vomit.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Bronchitis, Cough, Ear infection, Ear pain, Headache
Clinical narrative: A report has been received from a Health Professional concerning a 40 year old, Female subject, Height: 64.0 Inches; Weight: 160.0 Pounds, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included thyroid disorder. Concomitant medications included levothyroxine sodium. FLUMIST started on 12-Oct-2012. The patient experienced bronchitis, double ear infections, ear pain, sinus infection, slight sore throat and muscle aches which started on 12-Oct-2012. Cough, severe congestion, slight fever and headaches. The outcome of the event of bronchitis, cough, double ear infections, ear pain, severe congestion, sinus infection, slight fever, slight sore throat, headaches and muscle aches is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 16-Nov-2012 from reporter: new nonserious events of sinus infection & bronchitis & double ear infections added, patient details updated, new reporters patient, administered by & responsible physician added, relevant medical history updated.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Sinusitis
Clinical narrative: A report has been received from a Health Professional concerning a 40 year old, Female subject, Height: 64.0 Inches; Weight: 160.0 Pounds, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included thyroid disorder. Concomitant medications included levothyroxine sodium. FLUMIST started on 12-Oct-2012. The patient experienced bronchitis, double ear infections, ear pain, sinus infection, slight sore throat and muscle aches which started on 12-Oct-2012. Cough, severe congestion, slight fever and headaches. The outcome of the event of bronchitis, cough, double ear infections, ear pain, severe congestion, sinus infection, slight fever, slight sore throat, headaches and muscle aches is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 16-Nov-2012 from reporter: new nonserious events of sinus infection & bronchitis & double ear infections added, patient details updated, new reporters patient, administered by & responsible physician added, relevant medical history updated.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Per Dad, fever started at 4am.  It was 102.8 rectally.  Gave Acetaminophen 2ml.  Fever responded, dropping to 99.9.  Fever continued to spike to 103 everytime the acetaminophen wore off throughout the day. Phoned after hours triage nurse at 7:54 pm and was instructed to continue with acetaminophen every 4 hrs as needed.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Hypoaesthesia, Injected limb mobility decreased, Pain
Clinical narrative: Shoulder is numb, weakness, hard to lift left arm dull pain after flu shot.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, CSF test, Electromyogram abnormal, Endotracheal intubation, Fatigue
Clinical narrative: Admitted for pneumonia on 1-14-13 and receive PPSV23. Discharged on 1-18-13. Represented to ER on 1-21-13 with c/o worsening weakness/fatigue.  Diagnosed with Guillain-Barre.  Rec'd IgG. Intubated on 1-24-13, trach, PEG, vent for progressive ascending weakness.  Still hospitalized at this time.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Gastrostomy tube insertion, Guillain-Barre syndrome, Immunoglobulin therapy, Mechanical ventilation, Tracheostomy
Clinical narrative: Admitted for pneumonia on 1-14-13 and receive PPSV23. Discharged on 1-18-13. Represented to ER on 1-21-13 with c/o worsening weakness/fatigue.  Diagnosed with Guillain-Barre.  Rec'd IgG. Intubated on 1-24-13, trach, PEG, vent for progressive ascending weakness.  Still hospitalized at this time.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Loss of feeling in feet ascending to waist.  Diagnosed as Guillain Barre Syndrome GBS.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Ocular hyperaemia, Orbital oedema, Pyrexia, Wheezing
Clinical narrative: Developed wheezing, ocular hyperemia and orbital edema.  She denies dyspnea or dysphagia. At 11:55 pm developed fever of 101.3 F and myalgias.  Wheezing subsided at 11:55 pm.
Age: 1.86
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Death, Influenza A virus test positive, Laboratory test, Respiratory arrest, Resuscitation
Clinical narrative: Per hospital and family reports, child was talking to grandfather when she collapsed and stopped breathing. Grandfather performed CPR until EMS arrived and child was transported via AirMed to Medical Center. Child expired on 01/30/2013.
Age: 1.86
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Syncope
Clinical narrative: Per hospital and family reports, child was talking to grandfather when she collapsed and stopped breathing. Grandfather performed CPR until EMS arrived and child was transported via AirMed to Medical Center. Child expired on 01/30/2013.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Erythema with warmth at injection site consistent with cellulitic reaction.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site was red, slightly swollen and warm to the touch where Varicella was given. Benadryl given. MD advised to continue use of heat pack and will follow up in the AM to check whether symptoms have improved.
Age: 21.0
Sex: F
Vaccine: IPV
Symptoms: Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Started with left shoulder stiffness, then left wrist and finally left hip.
Age: 68.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Asthenia, Burning sensation, Chills, Fatigue, Hypersomnia
Clinical narrative: Woke up with burning sensation under her skin and fingernails-lasted 30 minutes then began with muscle aches and chills lasting until 9am or so. Was extremely exhausted at that point and felt weak and tired and slept a lot for the next two days.  Took 5 days to fully recuperate.
Age: 68.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Myalgia
Clinical narrative: Woke up with burning sensation under her skin and fingernails-lasted 30 minutes then began with muscle aches and chills lasting until 9am or so. Was extremely exhausted at that point and felt weak and tired and slept a lot for the next two days.  Took 5 days to fully recuperate.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient said she started feeling sore in her upper arm about 48 hours after receiving the vaccination.
Age: 65.0
Sex: F
Vaccine: FLUN3
Symptoms: Wheezing
Clinical narrative: A report has been received from a health professional via medical representative, concerning a 65 year old, female patient. The patient's concurrent diseases included reactive airway disease. Concomitant medications included salbutamol, anabolic steroids and other respiratory system products. During Oct-2012, the patient received nasal FLUMIST. It was reported that the patient wheezed for two days after vaccination. The outcome of the event of wheezing was unknown. The report was considered to be non-serious by the reporting health professional. Summary of follow-up information received by AstraZeneca/MedImmune on 28-Nov-2012 from health professional: patient history and concomitant medications added.
Age: 0.1
Sex: M
Vaccine: FLUN3
Symptoms: Body temperature increased, Cough, Influenza virus test positive, Respiratory tract congestion
Clinical narrative: A report has been received from a Physician concerning a 2 month old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 11-Sep-2012. The patient experienced positive flu test, cough, temperature of 103 degrees F and congestion on 19-Oct-2012. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 01-Nov-2012 from Physician via health care professional: Start date added for the events of cough and congestion. Stop date added and outcome updated as recovered for the events of temperature 103 degrees F, cough, congestion and positive flu test. Date of birth updated for the patient.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Oral candidiasis, Oral fungal infection, Oropharyngeal pain
Clinical narrative: A report has been received from a Physician concerning a 5 year old, Female subject, who had been receiving FLUMIST. FLUMIST started on 03-Oct-2012. The patient experienced sore throat which started on 07-Oct-2012 and oral yeast or thrush. The outcome of the event of sore throat and oral yeast or thrush is unknown. The report was considered to be non-serious by a company physician. Corrected Report 25-Oct-2012 typing mistake for primary reporters address corrected, ?Form Completed By? box ticked, relation to patient chosen, Have you reported this adverse event previously box ticked, Vaccinated at and Vaccine purchased with fields filled out, manufacturer added, event onset date or oral yeast or thrush added.
Age: 8.0
Sex: F
Vaccine: FLUN3
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 Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced patient received a full dose of FLUMIST in one nostril which started on 08-Oct-2012. The outcome of the event of patient received a full dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 66.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 66 year old patient (gender unknown). On 12-FEB-2013 the patient was vaccinated with live (Merck) VARIVAX, 0.5 ml, subcutaneous. There was no concomitant medication reported. On 12-FEB-2013 the patient received VARIVAX when he was supposed to receive ZOSTAVAX. There was no adverse event reported. No further information was provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old female patient with no pertinent medical history or drug allergy. On 28-JAN-2012 the patient was vaccinated with live ZOSTAVAX(lot# reported as H0187B; expired date: January 2014). There is no concomitant medications. On 16-FEB-2013, the patient experienced generalized itching all over her body, with no rash present. The outcome of the event was reported as not recovered. No lab tests were performed. The patient had sought medical attention via calling pharmacy and pharmacy visit. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A consumer report has been received, concerning a 23 year old male patient, height: 78.0 inches; weight: 205.0 pounds. No concomitant medication or relevant history was provided. On 27-Sep-2012, the patient received nasal FLUMIST. On 28-Sep-2012, 27 hours after administration of FLUMIST, patient's body was covered in hives, started with minor hives on elbows and stomach rapidly spread over entire body excluding genitalia. The patient was treated with BENADRYL, ZANTAC and prednisone. The action taken with FLUMIST was unknown. At the time of reporting, the event of body covered in hives was improving. The report was considered to be non-serious by a company physician. Summary of follow-up information received by AstraZeneca/MedImmune on 01-Oct-2012 from consumer: country of case changed, reporter information updated, patient's DOB, height and weight, date of vaccination, event onset date provided, outcome added as recovering. Narrative was updated. Corrected report 17-Oct-2012: New reporter added with reporter type Patient, as the consumer was reporting about himself.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash erythematous, Skin warm
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 50 year old female patient with unspecified leukocytosis and diabetes. The patient's drug reactions/allergies included losartan was associated with dizziness and vancomycin was associated with a rash. On 04-FEB-2013 the patent was vaccinated subcutaneously with live ZOSTAVAX (lot # H012577, expiration date 28-SEP-2013). Concomitant therapies included JANUVIA, metformin, TOPROL, BENICAR, gabapentin, vitamin D and WELCHOL. On 06-FEB-2013 the patient present with a red, warm rash that was five inches in diameter with a small area of blisters. On 02/08/2013, the patient presented with a large red area that was seven-by-five-inches that consisted of a light red area and included a smaller area of 1.5-by-0.5-inches that was very red with multiple blisters and was painful. VALTREX was given for treatment. No laboratory diagnostics studies were performed. The outcome of the events was unknown at reporting time. The patient presented at this nurse practitioner's office for medical attention. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal discomfort, Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 55 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 01-Oct-2012. The patient experienced administration to patient over 49 YO which started on 03-Oct-2012 and upset stomach which started on 02-Oct-2012. The outcome of the event of administration to patient over 49 YO is unknown and the patient recovered from the event of upset stomach on an unspecified date. The report was considered to be non-serious by company physician. Summary of follow-up information received by AstraZeneca/MedImmune on 18-Oct-2012 from pharmacist: new event as upset stomach added, outcome as recovered added, reporter information updated, event start date added.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject, Height: 47.3 Inches; Weight: 58.0 Pounds, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced nosebleed. Reporter stated a couple of seconds after she received the second dose of FLUMIST she had a nosebleed. The patient recovered from the event of nosebleed on an unspecified date. The report was considered to be non-serious. Summary of follow up information received by AstraZeneca/MedImmune from Health Professional on 23-Oct-2012: Patient height, weight, ethnic origin, medical history and siblings added; Reporter occupation, event outcome and Vaccinated at and purchased with updated.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from the patient father refers to a female patient of unknown age. No information regarding the patient's medical history was provided. On 14-AUG-2012 the patient was vaccinated with the first dose of GARDASIL. The second dose was received on 15-OCT-2012 and the third on 07-DEC-2012. No concomitant medication was reported. The healthcare professional involved wanted to give a fourth dose of the vaccine. No adverse reactions were reported. No outcome was reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from a health professional refers to a 66 year old female patient with generalized anxiety disorder, diabetes mellitus without mention of complication, type 2 or unspecified type, uncontrolled, overactive/hypertonicity of bladder, mixed hyperlipidemia, Gastrooesophageal reflux disease (GERD), allergic rhinitis due to pollen, other specified peripheral neuropathy, benign hypertensive heart disease without heart failure, tinea cruris, dermatophytosis of groin and perianal area, other non specified abnormal serum enzyme level-left, localized osteoarthritis not specified whether primary or secondary hand-l thumb, carpal tunnel syndrome bilateral, unspecified vitamin d deficiency, generalized osteoarthritis involving multiple sites, cervical spondylosis with myelopathy and lumbosacral spondylosis without myelopathy. The patient is allergic to AUGMENTIN, BACTRIM DS, CIPRO and Lisinopril (cough). The patient's medical history included palpitations and hives. On an unknown date, the patient was vaccinated with a dose of PCV (manufacturer unknown) (lot number, expiry date, route and dose were not reported). Concomitant therapies included LANTUS and NOVOLOG. On an unknown date, the patient experienced arm swelling. The outcome of arm swelling was unknown. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Swelling
Clinical narrative: This report was received from an agency and was assigned manufacturer report number (5581814), refers to a 84 year old female patient. On unknown date the patient was vaccinated with PNUEMOVAX 23 (lot # H014196, expiration date was 19-MAR-2014). On 04-FEB-2013 the patient came into the office and complained of swelling. The doctor thought it was fine and was a mild local reaction and she was doing okay on 11-FEB-2013. The original reporting source was not provided. This is one of the several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Cough, Fatigue, Influenza like illness, Oropharyngeal pain
Clinical narrative: A report has been received from a health professional. The report concerns a 15 year old female patient. The patient's medical history included acne. Concomitant medications included salbutamol and ibuprofen. The patient received nasal FLUMIST on 28-Sep-2012. The patient started experiencing flu like symptoms on 29-Sep-2012. The patient's symptoms were sore throat, body aches, fatigue, and trouble getting out of bed. It was reported that physicians notes stated cough, acute pharyngitis, possibly strep. It was reported that patient was not given antibiotics, but she was given albuterol nebulizer Q4H and was told to take MUCINEX or MUCINEX D. It was further reported that the patient has sore throat and cough. The reporter also reported that the patient was not allergic to eggs or egg proteins, had no long term aspirin therapy, no previous Guillain-Barre Syndrome, no reactive airways disorder or asthma, not taking TAMIFLU or other related medications, not pregnant or lactating, no heart, kidney or lung disease, no seizure disorder, no cerebral palsy, and would not be in contact with anyone with a weakened immune system. The outcome of the events was unknown. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 01-Nov-2012 from health professional: Non-serious event of cough acute pharyngitis possibly strep was added. Reporter information was added. Suspect Vaccine Information was added. Concomitant medication and medical history was added. Narrative was updated. Summary of follow-up information received by AstraZeneca/MedImmune 02-Nov-2012 from health professional: Events were added as sore throat and cough. Reporter's details were updated.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain, Pharyngitis
Clinical narrative: A report has been received from a health professional. The report concerns a 15 year old female patient. The patient's medical history included acne. Concomitant medications included salbutamol and ibuprofen. The patient received nasal FLUMIST on 28-Sep-2012. The patient started experiencing flu like symptoms on 29-Sep-2012. The patient's symptoms were sore throat, body aches, fatigue, and trouble getting out of bed. It was reported that physicians notes stated cough, acute pharyngitis, possibly strep. It was reported that patient was not given antibiotics, but she was given albuterol nebulizer Q4H and was told to take MUCINEX or MUCINEX D. It was further reported that the patient has sore throat and cough. The reporter also reported that the patient was not allergic to eggs or egg proteins, had no long term aspirin therapy, no previous Guillain-Barre Syndrome, no reactive airways disorder or asthma, not taking TAMIFLU or other related medications, not pregnant or lactating, no heart, kidney or lung disease, no seizure disorder, no cerebral palsy, and would not be in contact with anyone with a weakened immune system. The outcome of the events was unknown. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 01-Nov-2012 from health professional: Non-serious event of cough acute pharyngitis possibly strep was added. Reporter information was added. Suspect Vaccine Information was added. Concomitant medication and medical history was added. Narrative was updated. Summary of follow-up information received by AstraZeneca/MedImmune 02-Nov-2012 from health professional: Events were added as sore throat and cough. Reporter's details were updated.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: This report was received from an agency and was assigned manufacturer report number (5581814), refers to a 64 year old male patient. On 16-JAN-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # H014196, expiration date was 19-MAR-2014). On 18-JAN-2013 the patient experienced local reaction red swelling and local reaction redness and went to the emergency room. While at the emergency room he was administered an antibiotic because they thought it may have been colitis and they also gave him cool compresses to the arm that he received the injection in and TYLENOL. He was discharged from the emergency room the same day and he was doing okay on 11-FEB-2013. The original reporting source was not provided. This is one of the several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect storage of drug
Clinical narrative: A report has been received from a health professional concerning an 11 year old, female patient. The patient's medical history and concomitant medications were not reported. On 28-Sep-2012, received nasal FLUMIST after a power outage on 25-Sep-12 when storage unit reached 50 degrees F. FLUMIST was administered to the patient after six hours after the cut-off time and experienced cold chain break. The patient recovered from the events. The report was considered to be non-serious by reporter. Summary of follow-up information received by AstraZeneca/MedImmune from HCP on 23-Oct-2012: new adverse event, patient's sex, age, reporter's phone number, duration of the events added, outcome changed to recovered.
Age: 7.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Induration
Clinical narrative: 60mm induration no treatment necessary. Normal response to immunization.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect storage of drug, Influenza like illness
Clinical narrative: A consumer report has been received. The report concerns a 2 year old, Male consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 20-Sep-2012. The patient experienced FLU-LIKE SYMPTOMS which started on 21-Sep-2012. There was experienced, that the storage unit reached 50 degrees F. That was outside the temperature stability range. At the time of reporting, the event of FLU-LIKE SYMPTOMS was improving. The report was considered to be non-serious.
Age: 44.0
Sex: F
Vaccine: FLUN3
Symptoms: Anaphylactic reaction, Blood pressure fluctuation, Body temperature decreased, Chills, Decreased appetite
Clinical narrative: A report has been received from a Health Professional concerning a 44 years old female patient. The patient has no significant medical history and no concurrent diseases were reported. Concomitant medications were not reported. On 24-Sep-2012, the patient started receiving a treatment with nasal FLUMIST. Indication, dosing and frequency were not provided. One hour after receiving FLUMIST, she had a headache and 12 hours later she felt the symptoms like dizzy, nauseous, no appetite, malaise, fatigue. Therefore, on 25-Sep-2012, the patient experienced flu like symptoms. Her blood pressure was 119/92, and had a low heart rate of 48. The patient had chills but no fever. Her body temperature was 96.5F. The patient was not tested for influenza. The patient went to her primary physician, who felt that she probably had an anaphylactic reaction because of her change in blood pressure and heart rate. She was treated with TYLENOL for headache, BENADRYL for anaphylaxis and increased her fluid intake. The action taken with the vaccine of FLUMIST was unknown. On 27-Sep-2012, she returned to work and her blood pressure and heart rate were back at normal, the events of anaphylactic reaction and flu like symptoms were considered to be resolved. The event of anaphylactic reaction was considered to be serious by the company physician with the serious criteria of important medical event. The event of flu like symptoms was considered to be non-serious by the reporter. Follow up information received by AstraZeneca/MedImmune on 03-Oct-2012 from a consumer upgraded this case serious with the new event of anaphylactic reaction which was assessed as serious by the company physician with the seriousness criteria of important medical event, the action taken with the events of anaphylactic shock and flu like symptoms was changed to recovered, laboratory values added, narrative updated.
Age: 44.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Fatigue, Headache, Heart rate decreased, Influenza like illness
Clinical narrative: A report has been received from a Health Professional concerning a 44 years old female patient. The patient has no significant medical history and no concurrent diseases were reported. Concomitant medications were not reported. On 24-Sep-2012, the patient started receiving a treatment with nasal FLUMIST. Indication, dosing and frequency were not provided. One hour after receiving FLUMIST, she had a headache and 12 hours later she felt the symptoms like dizzy, nauseous, no appetite, malaise, fatigue. Therefore, on 25-Sep-2012, the patient experienced flu like symptoms. Her blood pressure was 119/92, and had a low heart rate of 48. The patient had chills but no fever. Her body temperature was 96.5F. The patient was not tested for influenza. The patient went to her primary physician, who felt that she probably had an anaphylactic reaction because of her change in blood pressure and heart rate. She was treated with TYLENOL for headache, BENADRYL for anaphylaxis and increased her fluid intake. The action taken with the vaccine of FLUMIST was unknown. On 27-Sep-2012, she returned to work and her blood pressure and heart rate were back at normal, the events of anaphylactic reaction and flu like symptoms were considered to be resolved. The event of anaphylactic reaction was considered to be serious by the company physician with the serious criteria of important medical event. The event of flu like symptoms was considered to be non-serious by the reporter. Follow up information received by AstraZeneca/MedImmune on 03-Oct-2012 from a consumer upgraded this case serious with the new event of anaphylactic reaction which was assessed as serious by the company physician with the seriousness criteria of important medical event, the action taken with the events of anaphylactic shock and flu like symptoms was changed to recovered, laboratory values added, narrative updated.
Age: 44.0
Sex: F
Vaccine: FLUN3
Symptoms: Malaise, Nausea
Clinical narrative: A report has been received from a Health Professional concerning a 44 years old female patient. The patient has no significant medical history and no concurrent diseases were reported. Concomitant medications were not reported. On 24-Sep-2012, the patient started receiving a treatment with nasal FLUMIST. Indication, dosing and frequency were not provided. One hour after receiving FLUMIST, she had a headache and 12 hours later she felt the symptoms like dizzy, nauseous, no appetite, malaise, fatigue. Therefore, on 25-Sep-2012, the patient experienced flu like symptoms. Her blood pressure was 119/92, and had a low heart rate of 48. The patient had chills but no fever. Her body temperature was 96.5F. The patient was not tested for influenza. The patient went to her primary physician, who felt that she probably had an anaphylactic reaction because of her change in blood pressure and heart rate. She was treated with TYLENOL for headache, BENADRYL for anaphylaxis and increased her fluid intake. The action taken with the vaccine of FLUMIST was unknown. On 27-Sep-2012, she returned to work and her blood pressure and heart rate were back at normal, the events of anaphylactic reaction and flu like symptoms were considered to be resolved. The event of anaphylactic reaction was considered to be serious by the company physician with the serious criteria of important medical event. The event of flu like symptoms was considered to be non-serious by the reporter. Follow up information received by AstraZeneca/MedImmune on 03-Oct-2012 from a consumer upgraded this case serious with the new event of anaphylactic reaction which was assessed as serious by the company physician with the seriousness criteria of important medical event, the action taken with the events of anaphylactic shock and flu like symptoms was changed to recovered, laboratory values added, narrative updated.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy, Nasopharyngitis
Clinical narrative: A report has been received from a Physician concerning a 34 year old, female subject. No concomitant medication or relevant history was provided. The patient received Nasal FLUMIST on an unknown date. FLUMIST administration to pregnant female on 27-Sep-2012 she had a cold for one and a half week after getting FLUIMST. The action taken with FLUMIST was unknown. The outcome of the event of administration to pregnant female was unknown. The outcome of the event of she had a cold for one and a half week after getting FLUMIST was recovered. The report was considered to be non-serious by the reporter. Corrected report on 04-Oct-2012: reporter as Administered By was added. Summary of follow-up information received by AstraZeneca 18-Oct-2012: New event of cold added. Case is now unsuppressed. Corrected report 20-Nov-2012: The event of administration to pregnant female has become a KUR term, therefore the case has been updated accordingly.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dysphonia, Dyspnoea, Eating disorder, Electromyogram normal
Clinical narrative: Tingling, throat feels like it is closing up - (scratchy, hoarse) shortness of breath, muscles/nerves twitching, jumping, pains in ankles, malaise - cannot eat or drink certain foods. (Still experiencing).
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Muscle twitching, Nuclear magnetic resonance imaging normal, Paraesthesia, Throat irritation
Clinical narrative: Tingling, throat feels like it is closing up - (scratchy, hoarse) shortness of breath, muscles/nerves twitching, jumping, pains in ankles, malaise - cannot eat or drink certain foods. (Still experiencing).
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Tingling, throat feels like it is closing up - (scratchy, hoarse) shortness of breath, muscles/nerves twitching, jumping, pains in ankles, malaise - cannot eat or drink certain foods. (Still experiencing).
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Antinuclear antibody, C-reactive protein, Full blood count, Metabolic function test, Pain in extremity
Clinical narrative: 3 days 1/18/13 post vaccine - pt awoke with pain & inability to bear weight (L) foot -> joint seen ED - 1/20/13 2 days later (R) foot with pain & difficulty bearing weight. ED visit - lower leg splint.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor, Weight bearing difficulty
Clinical narrative: 3 days 1/18/13 post vaccine - pt awoke with pain & inability to bear weight (L) foot -> joint seen ED - 1/20/13 2 days later (R) foot with pain & difficulty bearing weight. ED visit - lower leg splint.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Discomfort, Erythema, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Rec'd Tdap & felt discomfort like "punched in arm". Continued to feel discomfort throughout week & wkend. Cont'd pain and on 2/13 arm became weaker, decreased strength. Today looked in mirror about 1 inch below injection site & a bit toward the body is a 2 inch circle of redness & swelling. No drainage. Can lift arm with pain. Discomfort from collarbone to fingertips with numbness. (R) arm.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Muscular weakness, Pain in extremity, Swelling
Clinical narrative: Rec'd Tdap & felt discomfort like "punched in arm". Continued to feel discomfort throughout week & wkend. Cont'd pain and on 2/13 arm became weaker, decreased strength. Today looked in mirror about 1 inch below injection site & a bit toward the body is a 2 inch circle of redness & swelling. No drainage. Can lift arm with pain. Discomfort from collarbone to fingertips with numbness. (R) arm.
Age: 17.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, MNQ
Symptoms: Rash generalised, Urticaria
Clinical narrative: 1/11/13 1848 pt received 4 shots developed welts like rash all over body. Goes all the way around her neck like she is being strangled, received vaccine at 1556 that day. Pt advised when called office at 1848 to go to ER immediately. Pt treated in ER on 1/11/13.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Fatigue, Headache, Influenza, Migraine
Clinical narrative: A report has been received from a health professional concerning a 13 year old male patient. Concomitant medications and patient history were not reported. During autumn 2011 the patient received nasal FLUMIST. After that he experienced severe symptoms of flu, chills, migraines, fatigue and headache. The outcome of the events was unknown. The report was considered to be non-serious by company physician.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Hive, 3cm x 2cm erythema with small central flare noted about 5 minutes after MMR vaccine given in (L) thigh. Hive located about 1cm above injection site. No other hives noted. No other.
Sex: F
Vaccine: FLUN3
Symptoms: Nasal discomfort
Clinical narrative: A report has been received from a Health Professional concerning, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced burning in the nose. The outcome of the event of burning in the nose is unknown. The report was considered to be non-serious.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness to right deltoid. Patient states "I've been scratching, it itches"! 5" l x--> Tdap x 3" w. MENACTRA.
Age: 34.0
Sex: F
Vaccine: SMALL
Symptoms: Arthralgia, Headache, Injection site pain, Lymphadenopathy, Nodule
Clinical narrative: About 5 days after vaccine - headache - Day 6 - fever and swelling of lymphnodes, also pain & sensitivity behind (R) knee. Pt. is now experiencing pain in and around the site with a nodule formed around the (L) collarbone.
Age: 34.0
Sex: F
Vaccine: SMALL
Symptoms: Pyrexia, Tenderness
Clinical narrative: About 5 days after vaccine - headache - Day 6 - fever and swelling of lymphnodes, also pain & sensitivity behind (R) knee. Pt. is now experiencing pain in and around the site with a nodule formed around the (L) collarbone.
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Initial report was received from a healthcare professional, who was also the patient, on 11 February 2013. The reporter in this case is the same reporter as case number 2013-02622. A female patient (age and date of birth not reported) received an intramuscular injection of FLUZONE High-Dose, lot number U4492BA, in December 2012 (also reported as "12/12") (site not reported). An unspecified amount of time later, the patient got the flu while traveling overseas. Past medical history was unknown. Outcome was reported as recovered. Documents held by sender: None.