chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Ear infection, Eye infection, Influenza like illness
Clinical narrative: R - ear infection, L - eye infection, gave stomas as the flu. L - arm swollen. Medicine prescribed Polymycin B Sulfate (6) Pack of antibiotic, BENADRYL, REFRESH Classic Eye Drop.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had 4y old vaccine, the next day she started with redness and swelling to the area where the vaccines where given. Physical exam 2 days later: Vaccine area is warm, mild tenderness. No systemic symptoms. Clindamycin.
Age: 70.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient felt injection site and it was warm, then noticed the redness and swelling. Patient also had pain around injection site and up the arm toward armpit.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Decreased appetite, Injection site rash, Malaise
Clinical narrative: Rash at injection site, arthralgia of multiple joints, anorexia, malaise.
Age: 21.0
Sex: F
Vaccine: HPV9, PPV, TDAP
Symptoms: Headache, Injection site erythema, Pyrexia
Clinical narrative: Fever developed in the evening after vaccine given, persisted throughout the following 3 days. During that time, she developed headache and increased/spreading redness around the site of vaccine administration.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Started with red area at the site getting large each day with increase itching and soreness at the site. 08/24/2016 came into office red area 5 x 7cm oval shape at injection site. Physician ordered Zyrtec, Benadryl, and cold compresses to return to office if symptoms worsens.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Flushing, Skin discolouration, Urticaria
Clinical narrative: PATIENT BEGAN WITH A SCALDED LOOK FROM THE NECK AREA UP. HE HAD A BURNED TO LOOK THAT BEGAN AROUND HIS NOSE AND ON HIS EARS AND FACE. HE THEN BEGAN WITH WHELPS ALONG HIS EXTREMITIES. TODAY AFTER EXAMINING IN OFFICE BY DOCTOR HIS EYELIDS ARE PURPLISH AND CHEEKS ARE FLUSHED. NO TROUBLE BREATHING AT ANY TIME.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Red swelling 5 inches below injection site.
Age: 26.0
Sex: M
Vaccine: PPV, TYP, YF
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Erythema of Rt anterior arm w/ swelling and tenderness that goes into Rt shoulder. Taking Tylenol and motrin currently.
Age: 26.0
Sex: M
Vaccine: PPV, TYP, YF
Symptoms: Tenderness
Clinical narrative: Erythema of Rt anterior arm w/ swelling and tenderness that goes into Rt shoulder. Taking Tylenol and motrin currently.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash around injection site about the size of a half dollar.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hyperaesthesia, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient came into pharmacy 8/24/16 the day after the Fluzone Quad and Pneumovax 23 injections complaining of soreness in deltoid muscle of left arm where the two injections were located.  I explained that it was normal to feel sore.  On 8/25/16 patient returned to the pharmacy with a swelling in the left arm where the injections where given.  The skin was sensitive to touch and felt warm.  She described how she was unable to lift her arm without pain and her arm felt like a rock.  An ice pack was provided to her and recommendation to take Tylenol or Ibuprofen once she got home.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain
Clinical narrative: Patient came into pharmacy 8/24/16 the day after the Fluzone Quad and Pneumovax 23 injections complaining of soreness in deltoid muscle of left arm where the two injections were located.  I explained that it was normal to feel sore.  On 8/25/16 patient returned to the pharmacy with a swelling in the left arm where the injections where given.  The skin was sensitive to touch and felt warm.  She described how she was unable to lift her arm without pain and her arm felt like a rock.  An ice pack was provided to her and recommendation to take Tylenol or Ibuprofen once she got home.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, PNC13
Symptoms: Crying
Clinical narrative: Mom says that she cried for 2 days inconsolable crying after 2 months vaccines.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, PNC13
Symptoms: Crying, Immediate post-injection reaction
Clinical narrative: Mom says that she cried for 2 days inconsolable crying after 2 months vaccines.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Complained of left upper extremity pain, redness and swelling.  Limited range of motion.  Sought medical care with her PCM and received Medrol Pak 4 mg, advised to use warm compression and rest.  Returned to provider with slow relief from symptoms and was given another Medrol pac to.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Atrophy, Electromyogram, Fine motor skill dysfunction, Grip strength decreased, Immunoglobulin therapy
Clinical narrative: Right upper extremity weakness and atrophy. Difficulty with hand (R) fine and gross motor skills. Loss of grip in right hand. Intravenous immunoglobulin (IVIg) treatment starting 7/21/2016.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Nerve conduction studies
Clinical narrative: Right upper extremity weakness and atrophy. Difficulty with hand (R) fine and gross motor skills. Loss of grip in right hand. Intravenous immunoglobulin (IVIg) treatment starting 7/21/2016.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Amylase, Asthenia, Blood thyroid stimulating hormone, Clostridium test
Clinical narrative: Bad acid reflux, abdominal pain, nausea, dizziness, weak, fatigued, vomiting, diarrhea, lost 40 lbs within a month, depression. This went on from July of 2014 to May of 2015. Was prescribed Zofran, and Cymbalta.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Colonoscopy, Computerised tomogram abdomen, Computerised tomogram pelvis, Depression, Diarrhoea
Clinical narrative: Bad acid reflux, abdominal pain, nausea, dizziness, weak, fatigued, vomiting, diarrhea, lost 40 lbs within a month, depression. This went on from July of 2014 to May of 2015. Was prescribed Zofran, and Cymbalta.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Endoscopy, Escherichia test, Fatigue, Full blood count
Clinical narrative: Bad acid reflux, abdominal pain, nausea, dizziness, weak, fatigued, vomiting, diarrhea, lost 40 lbs within a month, depression. This went on from July of 2014 to May of 2015. Was prescribed Zofran, and Cymbalta.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Gastrooesophageal reflux disease, Laboratory test, Lipase, Liver function test, Metabolic function test
Clinical narrative: Bad acid reflux, abdominal pain, nausea, dizziness, weak, fatigued, vomiting, diarrhea, lost 40 lbs within a month, depression. This went on from July of 2014 to May of 2015. Was prescribed Zofran, and Cymbalta.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Mononucleosis heterophile test, Nausea, Pregnancy test, Red blood cell sedimentation rate, Ultrasound biliary tract
Clinical narrative: Bad acid reflux, abdominal pain, nausea, dizziness, weak, fatigued, vomiting, diarrhea, lost 40 lbs within a month, depression. This went on from July of 2014 to May of 2015. Was prescribed Zofran, and Cymbalta.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound liver, Ultrasound scan, Vomiting, Weight decreased
Clinical narrative: Bad acid reflux, abdominal pain, nausea, dizziness, weak, fatigued, vomiting, diarrhea, lost 40 lbs within a month, depression. This went on from July of 2014 to May of 2015. Was prescribed Zofran, and Cymbalta.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Pain and swelling at injection site; arm ache; muscle aches, headache, fatigue, lethargy; felt feverish.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Pain and swelling at injection site; arm ache; muscle aches, headache, fatigue, lethargy; felt feverish.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Nausea, Thirst
Clinical narrative: Patient stated she felt nauseated and wanted a drink of water, patient was standing by the sink sipping water and started to feel faint, patient was sat on a chair, patient said she felt dizzy, patient knew her name, age, date of birth and where she was, patient lost consciousness and help was called. Dr assisted with patient and took vital signs, patient aroused awake and was moved to exam table where further vitals continued, fluids by mouth and snacks were consumed by patient.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Dry skin, Rash erythematous, Rash pruritic
Clinical narrative: This is a new problem. The current episode started 1 to 4 weeks ago. The problem has been gradually improving since onset. The affected locations include the left arm, right arm, left upper leg and right upper leg. The rash is characterized by redness, itchiness and dryness. He was exposed to a new medication (PREVNAR immunization). Pertinent negatives include no cough, facial edema, fatigue, fever, nail changes, rhinorrhea or shortness of breath. Past treatments include topical steroids and antihistamine. The treatment provided moderate relief.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left VL red, hot to touch, with darker red circle in the core.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Lethargy, Muscular weakness
Clinical narrative: Immediate syncope. Dizziness. Headache. Lethargy. Drowsiness. Complaining of leg weakness and pain afterward and still currently to date.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain in extremity, Somnolence, Syncope
Clinical narrative: Immediate syncope. Dizziness. Headache. Lethargy. Drowsiness. Complaining of leg weakness and pain afterward and still currently to date.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Malaise
Clinical narrative: Patient called complaining of general malaise and shivering/chill episodes. Denied Fever. Said it resolved by that afternoon.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: Lump the size of a quarter.  Red mark about 5"x3".  Warm to the touch. Sore to the touch.  Still have it today 8/25/2016. Not getting better.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, hot and red at injection site.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain upper, Dizziness, Nausea, Pyrexia
Clinical narrative: Bad stomach ache, dizziness, nausea. Continued stomach ache and low grade fever until morning of 8/25/2016.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Activities of daily living impaired, Impaired driving ability, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe Left upper arm pain that affects movement of Left arm and prevents normal function to do daily ADRs. The pain even affects driving due to pain when turning steering wheel.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Local swelling, Vaccination site rash
Clinical narrative: Patient likely had a reaction to the influenza vaccine, with localized swelling, rash covering vaccine area and spreading around right arm. Symptoms began evening of 8/23/16 and worsened morning of 8/24/16. No systemic systems associated with the rash. I told the patient to take Benadryl, and I recommended an over-the-counter hydrocortisone 1% cream to use twice daily until the rash resolves. I told her that if the rash starts to spread, or if she has any other symptoms like facial swelling or difficulty breathing, to report to a physician immediately for stronger treatment. Symptoms have already begun to recede following a single Benadryl dose, and patient is expected to make a full recovery.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Developed rash on the site of injection after 48 hours then patient to come in and purchased 1 bottle of Benadryl 25mg.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pharyngeal oedema, Pyrexia, Rash macular
Clinical narrative: Patient reported swollen throat, feeling feverish, blotchy skin, and fatigue. Onset approximately 2 hours after injection.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Heart rate increased, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT RECEIVED FLU SHOT IN RIGHT ARM & PNEUMOVAX IN LEFT ARM.  LEFT ARM HAD REACTION AND HAD ABNORMAL SWELLING, PAIN, INCREASED HEART RATE, & DIZZINESS.  PATIENT WAS HOSPITALIZED AND IT WAS CONCLUDED POSSIBLE DEHYDRATION, CELLULITIS, & REACTION TO IMMUNIZATION.
Age: 4.0
Sex: M
Vaccine: HIBV, MMR
Symptoms: Cellulitis, Erythema, Immunisation reaction, Pain, Pruritus
Clinical narrative: On 8/23/16, mother noticed an area of redness, swelling, warmth pain, and itching. She took pt to ED on 8/23/16 and was given a Rx for Keflex 250mg TID for cellulitis secondary to immunization reaction Per ED notes, area of redness was 6 cm. On 8/24/16, area increased to 10 cm. Pt was given a Rx for Benadryl. Redness decreased on 8/25/16 after taking Benadryl and Keflex.
Age: 4.0
Sex: M
Vaccine: HIBV, MMR
Symptoms: Skin warm, Swelling
Clinical narrative: On 8/23/16, mother noticed an area of redness, swelling, warmth pain, and itching. She took pt to ED on 8/23/16 and was given a Rx for Keflex 250mg TID for cellulitis secondary to immunization reaction Per ED notes, area of redness was 6 cm. On 8/24/16, area increased to 10 cm. Pt was given a Rx for Benadryl. Redness decreased on 8/25/16 after taking Benadryl and Keflex.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, itching around injection site 10cm x 11cm.
Age: 30.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No adverse event was report by the patient. Due to refrigerator temperature excursion occurred on 8/12/16, manufacture determined base on drop on temperature that vaccine is not viable and CDC recommend revacccine.
Age: 24.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Loss of consciousness, Seizure
Clinical narrative: Pt received both Tdap and Afluria. After getting a bandaid placed on the site, he got dizzy, blacked out, and started seizing.  Only lasted 30 seconds and pt refused Epipen.  Pt thinks it might be stress from the shots not an allergy.
Age: 21.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Urticaria
Clinical narrative: Welps, severe pain.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Wheezing
Clinical narrative: Difficulty breathing, chest tightness, wheezing, cough. Patient tried her inhaler and a nebulizer treatment and checked her peak flow.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on backs of arms, front and back of torso, thighs, calves.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Pharmacist concerning a 6 year old, female subject who had been receiving FLUMIST. FLUMIST started on 15-Feb-2016. It was reported that expired FLUMIST was administered to the patient. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between administration of expired FLUMIST and FLUMIST Quadrivalent. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of administration of expired FLUMIST to be unrelated to FLUMIST Quadrivalent.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Pharmacist concerning a 10 year old, Female patient who had been receiving Nasal FLUMIST Quadrivalent (Intranasal). FULMIST Quadrivalent started on an unknown date. On 15-FEB-2016 pharmacist administered expired FLUMIST Quadrivalent. The outcome of the event of administration of expired FLUMIST was unknown. The report was considered to be non-serious. The reporter and company physician considered that event of administration of expired FLUMIST to be unrelated to FLUMIST Quadrivalent.
Age: 4.0
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a, subject of unknown gender, who had been receiving FLUMIST. FLUMIST started on 05-Feb-2016. It was reported that preschool aged (4 years old) child was inadvertently received expired FLUMIST. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Decreased appetite, Fatigue, Headache, Ocular hyperaemia
Clinical narrative: A consumer report has been received. The report concerns a 7 year old Female consumer, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced stomach ache, appetite decrease, red eyes, fatigue, headache, and looking tired. The outcome of the event of stomach ache, appetite decrease, red eyes, fatigue, headache and looking tired is unknown. The report was considered to be non-serious by the reporter.
Sex: U
Vaccine: FLUN4
Symptoms: Intentional product misuse, Underdose
Clinical narrative: A report has been received from a Physician concerning a patient of unknown gender, who received Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. Physician had been administering FLUMIST QUADRIVALENT without removing the plastic stopper (thus administering only 0.1 ml of the 0.2 ml dose). The outcome of the event of been administering FMQ without removing the plastic stopper and administering only 0.1 ml of the 0.2 ml dose was unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between been administering FMQ without removing the plastic stopper and administering only 0.1 ml of the 0.2 ml dose and FLUMIST QUADRIVALENT. The company physician agreed with the reporter causality assessment of the events been administering FMQ without removing the plastic stopper and administering only 0.1 ml of the 0.2 ml dose with the FLUMIST QUADRIVALENT to be unrelated.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional via Medical Representative concerning, patients with unknown number and gender, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Milliliters, Unknown. FLUMIST Quadrivalent (Intranasal) started on an unknown date. The nurse reported that the Doctor was not taking the clip off the FLUMIST when administering to patients. The outcome of the event of Doctor not taking clip off FLUMIST (Half-Dose) is unknown. The report was considered to be non-serious by the company physician.
Sex: F
Vaccine: FLUN4
Symptoms: Pharyngitis streptococcal
Clinical narrative: A report has been received from a consumer concerning a, female patient, who had been receiving FLUMIST, 0.2 Millilitres, Once/Single administration. FLUMIST started during 2015. The patient experienced strep throat. FLUMIST was discontinued during 2015. The outcome of the event strep throat is unknown. The report was considered to be non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 13 years 24 weeks 1 day old, male patient who had been received Nasal FLUMIST Quadrivalent (Intranasal) 0.2 Mililitres, started on an unknown date. It was reported that a dose of FLUMIST that expired on 04-JAN-2016 was administered to a patient on 25-JAN-2016. The outcome of the event of Expired Dose was unknown. The report was considered to be non-serious.
Sex: F
Vaccine: HPV4
Symptoms: Systemic lupus erythematosus
Clinical narrative: Information has been received from a consumer referring to her neighbor's daughter of unknown age. Information about medical history, concurrent condition and concomitant medication was unspecified. On an unknown date, the patient was vaccinated with GARDASIL (lot number, dose and route were unknown). On an unknown date the patient experienced lupus. The outcome and causality of the event were unknown. Upon internal review, the event lupus was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Arthralgia, Joint effusion, Joint fluid drainage, Musculoskeletal stiffness, Neck pain
Clinical narrative: Information has been received from a consumer referring her 12 year old healthy daughter. The patient had no drug reactions or allergies. There was no concomitant medication. On 22-MAY-2015, the patient was vaccinated with first dose of unidentified Merck HPV vaccine (it was unspecified if it was GARDASIL or GARDASIL 9, lot number, dose and route were unknown). On an unknown date in 2015 (reported as "a few days later), the patient complained of waking with a very stiff neck and it was painful off and on. Then "for the next 3 or so weeks", the patient was experiencing different pain in her knees and feet. She was diagnosed with rheumatoid arthritis. The symptoms was so bad that the doctor had to drain her knees because there was a lot of fluid there. But the pain was still continued and the patient was referred to arthritis clinic nearby where she continued aggressive treatment for the arthritis. In approximately June 2016 (reported as "about 2 months ago"), the patient was feeling relief of the arthritis and she could be "an active teenager again". At the time of report, the patient had received all 3 dose of unidentified Merck HPV vaccine. The outcome of rheumatoid arthritis was recovering. The causality between the events and suspect therapy was unknown. Upon internal review, the event rheumatoid arthritis was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Pain in extremity, Rheumatoid arthritis
Clinical narrative: Information has been received from a consumer referring her 12 year old healthy daughter. The patient had no drug reactions or allergies. There was no concomitant medication. On 22-MAY-2015, the patient was vaccinated with first dose of unidentified Merck HPV vaccine (it was unspecified if it was GARDASIL or GARDASIL 9, lot number, dose and route were unknown). On an unknown date in 2015 (reported as "a few days later), the patient complained of waking with a very stiff neck and it was painful off and on. Then "for the next 3 or so weeks", the patient was experiencing different pain in her knees and feet. She was diagnosed with rheumatoid arthritis. The symptoms was so bad that the doctor had to drain her knees because there was a lot of fluid there. But the pain was still continued and the patient was referred to arthritis clinic nearby where she continued aggressive treatment for the arthritis. In approximately June 2016 (reported as "about 2 months ago"), the patient was feeling relief of the arthritis and she could be "an active teenager again". At the time of report, the patient had received all 3 dose of unidentified Merck HPV vaccine. The outcome of rheumatoid arthritis was recovering. The causality between the events and suspect therapy was unknown. Upon internal review, the event rheumatoid arthritis was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLUN4
Symptoms: Wheezing
Clinical narrative: A report has been received from a registered nurse via sales representative concerning a patient of unknown gender and ethnicity. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unknown date the patient received FLUMIST, 0.2 millilitres. Representative stated that she was told by a nurse in a doctor's office that one of the doctors patients experienced a wheezing attack a couple of weeks after received the FLUMIST vaccine. Action taken with FLUMIST was unknown. The outcome of the event of wheezing attack was unknown. The report was considered to be non-serious by the company physician.
Sex: M
Vaccine: FLUN3
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 22-Apr-2010, Male subject, who had been receiving Nasal FLUMIST, 0.1mL, in each nostril intranasally. FLUMIST started on an unknown date. The outcome of the event of given expired medication is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a male patient, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.1mL, in each nostril. FLUMIST QUADRIVALENT was started on an unknown date. It was reported that twins received expired FLUMIST on 27-Jan-2016 that expired on 20-Jan-2016. The outcome of the event of given expired medication was unknown. The reporter's description of the event(s) was as follows: No pertinent medical history reported. The report was considered to be non-serious.
Age: 58.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 58 year old, female subject, Height: 63.0 inches; Weight: 135.0 pounds. It was reported that the patient was administered by expired FLUMIST, 0.2 millilitres, once/single administration for vaccine on 26-Jan-2016. The FLUMIST was expired on 21-Jan-2016. Patient was older than 49 years of age and this information was also considered as off label use. The outcome of the events of received an expired vaccine, FLUMIST was given to the patient older than 49 years old-off label use and off label use is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a, Female subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal), 0.2 Millilitres, unknown. FLUMIST QUADRIVALENT (intranasal) started on 21-Jan-2016. It was reported that patient was administered expired FLUMIST QUADRIVALENT. The outcome of the event of administered expired FLUMIST QUADRIVALENT was unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Physician concerning a, patient of unknown gender, who had been receiving FLUMIST, 0.2 Millilitres, Unknown. FLUMIST started on an unknown date. It was reported that pediatric patient after administering and expired dose of FLUMIST. FLUMIST expired on 13-Jan-2016. The outcome of the event of administered expired FLUMIST - misuse was unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Pharmacist and from a Health professional concerning a patient of unknown gender, who had been receiving Nasal FLUMIST (Intranasal), 0.2 millilitres, once/single administration for antiviral FLUMIST (Intranasal) started on an unknown date for antiviral EXPIRED DOSE OF FLUMIST was administered-Off label use. The action taken of FLUMIST was unknown. The outcome of the event of EXPIRED DOSE OF FLUMIST was administered-OFF LABEL USE and ADMINISTRATION OF AN EXPIRED DOSE is unknown.
Sex: F
Vaccine: FLUN4
Symptoms: Pharyngeal oedema
Clinical narrative: A report received from a Physician concerns a, female patient. No information regarding the relevant history, concomitant disease and concomitant drug was provided. Patient received nasal FLUMIST QUADRIVALENT started on an unknown date. it was reported that patient was the mother of the child, the mother was administered the FLUMIST at the pediatrician's office. After leaving the office she noted throat swelling and went to the emergency room where she received BENADRYL which helped alleviate the reaction. FLUMIST QUADRIVALENT was continued. The outcome of throat swelling was unknown. The report was considered to be non-serious by company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT 0.2 Millilitres, Total. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated patient was administered expired dose which started on 13-Jan-2016. The outcome of the event of expired dose is unknown. The reporter's description of the event(s) was as follows: No pertinent medical history for any of the 3 children. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Rash
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 25-Jul-2013, female subject, who had been receiving FLUMIST, 0.2 Millilitres, unknown. FLUMIST started on an unknown date. The patient experienced rash. The outcome of the event of rash is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 years 6 days old, female patient, who had been receiving Nasal FLUMIST QUADRIVALENT 0.2 Millilitres. FLUMIST QUADRIVALENT started on 19-Jan-2016. Nurse reported that the patient was administered FLUMIST which was expired on 04-Jan-2016. FLUMIST QUADRIVALENT was discontinued on 19-Jan-2016. The outcome of the event of expired dose was unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Physician concerning a, subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (Intranasal), 0.2 milliliters. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The reporter stated that the patient had received expired FLUMIST. The outcome of the event of Received Expired Dose is unknown. The reporter's description of the event(s) was as follows: Unknown at this time. The report was considered to be non-serious.
Age: 48.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 48 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT 0.2 Millilitres. FLUMIST QUADRIVALENT started on 29-Jan-2016. HCP reported consumer received expired FLUMIST 0.2ml nasally 29-Jan-2016. FLUMIST QUADRIVALENT was continued. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 0.2
Sex: U
Vaccine: FLUN4
Symptoms: Medication error, Off label use
Clinical narrative: A report has been received from a Health Professional concerning a, subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 ml 10 pre-filled, single-use sprayers. FLUMIST QUADRIVALENT (intranasal) started on 04-Mar-2016. Health Professional stated that FLUMIST was given in error to a 2 month old child on 04-Mar-2016. The outcome of the event of FLUMIST given in error-medication error and FLUMIST given to a 2 month old child-off label use is unknown. The reporter's description of the event was as follows: No medical history provided. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A spontaneous report had been received from a Pharmacist concerning a patient of unknown age and unknown gender. Lack of relevant history. No concomitant medications reported. The patient had received Nasal FLUMIST QUADRIVALENT on 29-Feb-2016. It was reported that the FLUMIST expired on 24th February. One child received the FLUMIST vaccine on 29-Feb-2016. The outcome of the event of use of expired product was unknown. The reporter assessed the event of use of expired product to be non-serious.
Age: 0.1
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A spontaneous report has been received from a consumer concerning a 1 month old patient of unknown gender, who had been administered Nasal FLUMIST Quadrivalent (Intranasal). FLUMIST Quadrivalent (Intranasal) started on an unknown date. The patient was given FLUMIST Quadrivalent at two months old by accident. FLUMIST Quadrivalent (Intranasal) was continued. The outcome of the event of given FLUMIST Quadrivalent by accident was unknown. The report was considered to be non-serious by company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a patient of unknown gender, who had been receiving nasal FLUMIST QUADRIVALENT 0.2 Millilitres. FLUMIST QUADRIVALENT started on an unknown date. It was reported took expired FLUMIST-medication error which started on 18-Feb-2016. The outcome of the event of given expired FLUMIST-medication error is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Influenza virus test positive
Clinical narrative: A consumer report has been received concerning a, male patient. The patient had received FLUMIST, once/single administration. Reporter stated that a male child received last years FLUMIST vaccine intranasally 2014 to 2015 season. The reporter stated that the patient tested positive for the flu after he received last years FLUMIST vaccine 2014-2015. The reporter stated an adverse event for himself as well submitted under IL207058. No additional information provided. Action taken was continuing. The outcome of the tested positive for the flu was unknown. The company physician considered the tested positive for the flu to be non-serious.
Age: 1.42
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 received Nasal FLUMIST QUADRIVALENT (intranasal) 0.2 Millilitres. FLUMIST QUADRIVALENT (intranasal) started on 09-Nov-2015. Reporter stated that 18 month old boy was inadvertently administered FLUMIST. The outcome of the event (s) of inadvertent administration to 18 month old is unknown. The reporter's description of the event(s) was as follows: Boy has some slight asthma but he was given an inhaler a year ago and hasn't really needed it ever since then. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Wrong drug administered
Clinical narrative: A report has been received from a Health Professional concerning a Child patient of unknown gender, who has been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 milliliters, Once/Single administration for Drug use for unknown indication. FLUMIST Quadrivalent (Intranasal) started on an unknown date for Drug use for unknown indication. It was reported that the accidentally wrong vaccine was administered to the child patient. The outcome of the event of Child accidently given wrong vaccine is unknown. The report was considered to be non-serious by the company physician.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, male subject, who had been receiving FLUMIST, 0.2 Millilitres, unknown. Vaccine given within prior 4 weeks included influenza vaccine. FLUMIST started on 23-Dec-2015. It was reported that a 4-year-old child who previously received a flu shot on 08-Dec-2015 was given FLUMIST on 23-Dec-2015. FLUMIST was discontinued on 23-Dec-2015. The outcome of the event of FLUMIST two weeks later after flu shot is unknown. The reporter's description of the event was as follows: none. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, unknown. FLUMIST started on an unknown date. It was reported that the patient received FLUMIST vaccine that had expired by one day. FLUMIST was continued. The outcome of the event of received expired FLUMIST vaccine was unknown. The report was considered to be non-serious.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: Redness, swelling and itching on right deltoid after immunization. Tender to touch. No discharge or blood noted. Took: Clindamycin.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth, Skin tightness
Clinical narrative: Site: Erythematous, edematous, warm tight area that extends around 80% of the upper half of the left arm below the shoulder. Insertion site of vaccine present above redness. Took: Clindamycin.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling, pain and itchiness around local area of injection: 10.5 x 15 cm area on (L) thigh. Improvement with BENARDYL and ice. No fever. Normal mobility.
Age: 91.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient complained of pain at the injection site for multiple days after the vaccine was given.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Seizure, Syncope
Clinical narrative: Patient fainted and had seizure activity lasting approximately 5 seconds (approximately 5 mins after administration). Patient had never had side effects with previous HPV-9 admin. No prev. HX of seizures. Only HPV-9 given at this appointment.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: A physician report was received, concerning a female patient with approximate age of 31 years. No information regarding relevant history, concomitant disease and concomitant medications was provided. It was reported that a 29-week pregnant patient was administered nasal FLUMIST Quadrivalent (Intranasal) on 16-Dec-2015, in her doctor's office. The outcome of the pregnancy was reported to be a Non-healthy baby. The report was considered to be non-serious by reporter. Summary of follow-up information received by Medimmune on 18-Feb-2016 from the physician: The outcome of the pregnancy was reported to be a Non-healthy baby.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: Pt complained of excessive pain, swelling (L) arm (TDAP and MENACTRA) after immunization. Called MD on call - sent to urgent care - diagnosed with cellulitis. Parents concerned wrong needle used (1") as small stature child.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema
Clinical narrative: Reddened area around site. No SOB, no fever. Pt has taken BENADRYL, also no chest pain.
Age: 13.0
Sex: F
Vaccine: FLU4, FLUN4, HPVX
Symptoms: Dizziness, Epistaxis, Haematemesis, Underdose
Clinical narrative: A report has been received from a pharmacist concerning a 13 year old, female patient. Concomitant medications included influenza virus vaccine polyvalent and human papillomavirus vaccine. Patient received FLUMIST QUADRIVALENT (intranasal), 0.2 Millilitres, started on an unknown date. Patient received FLUMIST 1/2 dose (not sure if it was expired) after this they got the FLUZONE and HPV (first dose), 2 days later nosebleed, 4 days later hematemesis and, 12 days later dizziness. The outcome of hematemesis, dizziness, nosebleed and patient received 1/2 dose of FLUMIST was unknown. Company physician assessed hematemesis to be serious with the seriousness criteria of important medical event and rest of the events to be non-serious. AZ physician suggested to capture additional non-serious event patient received 1/2 dose of FLUMIST from the source narrative.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered, Product quality issue
Clinical narrative: A report has been received from a Health Professional concerning an 8 years 45 weeks 1 day old female patient. The patient received expired FLUMIST QUADRIVALENT (Intranasal). 0.2 millitres, once/single administration on 08-Jan-2016. The vaccine had expired on 30-Dec-2015. The patient also had product quality issue. FLUMIST QUADRIVALENT (Intranasal) was discontinued on 08-Jan-2016. The patient recovered from the event of expired FLUMIST on 08-Jan-2016 and the outcome of the event product quality issue is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered, Product quality issue
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old patient of unknown gender, who received Nasal FLUMIST Quadrivalent (Intranasal), 0.2. milliliters, Once/Single administration. FLUMIST Quadrivalent (Intranasal) started on 08-JAN-2016 for Influenza. Two siblings received expired FLUMIST and product quality complain was reported. FLUMIST Quadrivalent (Intranasal) was discontinued on 08-JAN-2016.  The patient recovered from the event Expired FLUMIST on 08-JAN-2016 and the outcome of the event of Product Quality issue was unknown. The reporter's description of the events(s) was as follows: None reported.  The report was considered to be non-serious.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Small bruise (2cm).
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 13-Jan-2015, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated FLUMIST administration to child less than 2 years old. The outcome of off-label administration to child less then 2 years old and off label use is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationships between off-label administration to child less then 2 years old and FLUMIST QUADRIVALENT.
Sex: M
Vaccine: FLUN4
Symptoms: Paraesthesia
Clinical narrative: A report has been received from a Health Professional concerning a, Male subject, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal). FLUMIST Quadrivalent (Intranasal) started on an unknown date. The patient experienced peripheral paresthesia. The outcome of the event of peripheral paresthesia is unknown. The report was considered to be non-serious. The reporter and company physician concerned that there was no causal relationship between peripheral paresthesia and FLUMIST Quadrivalent.
Sex: U
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A consumer report has been received concerning a, patient of unknown gender. Patient's relevant history and concomitant disease were not reported. Patient's concomitant medications were not provided. On unknown date patient received nasal FLUMIST, 0.2 millilitres, unknown. It was reported that patient experienced flu symptoms. The cation taken with suspect drug was unknown. The outcome of the event of flu symptoms was unknown. The company physician assessed the events to be non serious.
Sex: M
Vaccine: FLUN4, MMR
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: A consumer report has been received. The report concerns a, male consumer, who had been receiving FLUMIST, 0.2 Millilitres, unknown. Concomitant medications included Measles, Mumps and Rubella vaccine and vaccines. The patient experienced sniffed and threw up. The outcome of sniffed and threw up is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Circumstance or information capable of leading to device use error, Underdose
Clinical narrative: A report has been received from a Physician concerning a, subject of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Milliliters, unknown for Influenza. FLUMIST Quadrivalent (Intranasal) started on an unknown date for Influenza. It was stated that the patient received half dose of FLUMIST and she was unable to follow the correct instructions. The outcome of the event of unable to follow correct instructions and 1/2 dose is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a, subject of unknown gender, who had been receiving FLUMIST, 0.2 Millilitres, once/single administration. FLUMIST started on an unknown date. HCP explained that expired FLUMIST given to patient. FLUMIST expired 3 days before. The outcome of the event of expired FLUMIST given to patient is unknown. The report was considered to be non-serious.
Age: 0.83
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 10 month old, Male subject. It was reported that the patient accidentally received FLUMIST QUADRIVALENT (intranasal), 0.2 Millilitres, (which was usually indicated for 2-40 years) intranasally, on 22-Dec-2015. The outcome of the event of accidentally received medication and underage-medication error is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Pharyngitis streptococcal
Clinical narrative: The report has been received from a physician. The report concerns a 5 years old female patient, height: 55.2 inches, weight: 54 pounds. The patient's medical history and concurrent diseases were not reported. Concomitant medications included cetirizine hydrochloride and fluticasone propionate for allergic rhinitis. On 28-Sep-2015, the patient received FLUMIST, 0.2 milliliters in an unknown frequency. On 14-Dec-2015, the patient developed flu A and strep. Action taken with FLUMIST was unknown. The outcome of the events of flu A and strep was unknown. The events of flu A and strep were identified by the company physician from the source documents and added as non-serious adverse events.
Sex: M
Vaccine: FLUN4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A report has been received from a Health Professional concerning a Male subject who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 milliliters, Once/Single administration. FLUMIST Quadrivalent (Intranasal) started during 2014. HCP reports that patient under 9 only received 1 dose of FLUMIST in 2014 flu season. FLUMIST Quadrivalent (Intranasal) was continued. The patient recovered from the event patient under 9 only received 1 dose of FLUMIST in 2014 flu season during 2014. The report was considered to be non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza like illness
Clinical narrative: A report has been received from a health professional concerning a 6 year old female patient. No relevant history or concomitant medications were provided. The patient received nasal FLUMIST QUADRIVALENT, 0.2 millilitres, once/single administration. The patient experienced flu like symptoms two and half week after vaccination. The outcome of the event of flu symptoms was unknown. The report was considered to be non-serious by company physician.