chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm, Swelling face
Clinical narrative: Received vaccine and a few hours later, he started feeling fatigue, feverish, myalgias, and complained of L arm soreness and warmth to touch. He also noticed facial erythema and swelling that day as well.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Muscular weakness, Myalgia
Clinical narrative: Joint aches leading to joint and muscle pain, muscle weakness. Symptoms worsened then dissipated over past 9 days.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Cardiac enzymes normal, Chest pain, Computerised tomogram, Electrocardiogram, Fibrin D dimer increased
Clinical narrative: Chest pain with increased heart rate to approx. 130 beats/min. 3 liters of NS, Benadryl, Zofran, Toradol, and Dilaudid given. Labs drawn with elevated D-Dimer, normal cardiac enzymes. CT Scan, series of EKGs.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased
Clinical narrative: Chest pain with increased heart rate to approx. 130 beats/min. 3 liters of NS, Benadryl, Zofran, Toradol, and Dilaudid given. Labs drawn with elevated D-Dimer, normal cardiac enzymes. CT Scan, series of EKGs.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt returns to clinic to report redness and slight swelling at site of flu shot. Because of history of shoulder replacements (years ago), pt was prescribed an antibiotic and referred to orthopedic surgeon for follow up.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PPV
Symptoms: Eczema
Clinical narrative: intense and debilitating excema
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: 6 X 8 CM erythema L thigh
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Severe vomit/runs/chills/fever of 99.5 increasing to 100.2 at 8:00 PM. Cannot hold fluids down. Husband spoke to primary doctor on phone/ MD said give clear soup and gatorade / aspirin to lower fever.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: RED, HOT TO TOUCH SITE COVERING 4 INCHES IN DIAMETER AROUND INJECTION SITE.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Feeling cold, Headache, Injection site pain
Clinical narrative: At about 5:30 pm Monday night of the shot, I notices muscle soreness in left shoulder and tenderness in left upper shoulder at injection site.  By ten was feeling overall body muscle aches, took two Tylenol and went to bed still unconcerned, assumed I'd be fine int he morning.  Was feeling unusually cold at bedtime.  At 2am woke up freezing, shivering hard enough to make the bed vibrate, and was very nauseous and with a bad HA.  Started vomiting at 3am and this repeated about 8 times until 6 or 7 am.  The next day I continued to have a a very bad HA in the front of my head and also at the back of my skull.  On a saltine diet all day.  By Wednesday morning I was basically better and able to return to work and eating.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: At about 5:30 pm Monday night of the shot, I notices muscle soreness in left shoulder and tenderness in left upper shoulder at injection site.  By ten was feeling overall body muscle aches, took two Tylenol and went to bed still unconcerned, assumed I'd be fine int he morning.  Was feeling unusually cold at bedtime.  At 2am woke up freezing, shivering hard enough to make the bed vibrate, and was very nauseous and with a bad HA.  Started vomiting at 3am and this repeated about 8 times until 6 or 7 am.  The next day I continued to have a a very bad HA in the front of my head and also at the back of my skull.  On a saltine diet all day.  By Wednesday morning I was basically better and able to return to work and eating.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Rash, Urticaria
Clinical narrative: Broke out in mild rash and hives.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Hypertension, Pyrexia, Wheezing
Clinical narrative: Fever, difficulty breathing, wheezing, rapid heart beat, high blood pressure.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Cough, Dizziness, Dysphagia
Clinical narrative: Tightening of throat, making swallowing and mouth breathing very difficult; throat pain starting at 7 pm and continuing through the night, with a post-nasal drip type of cough (especially when reclining). Severe headache starting around 9:30 PM and increasing during the night. Hallucinations accompanying high fever, chills, and headache between 11 PM and 5 AM. Weakness, lightheadedness, and blood pressure of 83/65 around 8:30 AM on 10/21. Slight throat soreness continuing during the day 10/21/10. Eyes oozing, crusting, and puffy during the night 10/20-21/10.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye discharge, Eyelid margin crusting, Eyelid oedema, Hallucination
Clinical narrative: Tightening of throat, making swallowing and mouth breathing very difficult; throat pain starting at 7 pm and continuing through the night, with a post-nasal drip type of cough (especially when reclining). Severe headache starting around 9:30 PM and increasing during the night. Hallucinations accompanying high fever, chills, and headache between 11 PM and 5 AM. Weakness, lightheadedness, and blood pressure of 83/65 around 8:30 AM on 10/21. Slight throat soreness continuing during the day 10/21/10. Eyes oozing, crusting, and puffy during the night 10/20-21/10.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Oropharyngeal pain, Pyrexia, Throat tightness
Clinical narrative: Tightening of throat, making swallowing and mouth breathing very difficult; throat pain starting at 7 pm and continuing through the night, with a post-nasal drip type of cough (especially when reclining). Severe headache starting around 9:30 PM and increasing during the night. Hallucinations accompanying high fever, chills, and headache between 11 PM and 5 AM. Weakness, lightheadedness, and blood pressure of 83/65 around 8:30 AM on 10/21. Slight throat soreness continuing during the day 10/21/10. Eyes oozing, crusting, and puffy during the night 10/20-21/10.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Blood test, Cardiac stress test, Chest pain, Echocardiogram
Clinical narrative: Back pain and severe chest pain. ER treatment aspirin, oxygen, nitroglycerin and morphine.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram
Clinical narrative: Back pain and severe chest pain. ER treatment aspirin, oxygen, nitroglycerin and morphine.
Age: 17.0
Sex: M
Vaccine: FLU3, IPV, MNQ
Symptoms: Urticaria, Vomiting
Clinical narrative: PERSISTENT VOMITING.  HIVES BEGAN 8-10 HOURS LATER.  WAS ALSO ON AN ANTIBIOTIC WHICH WAS ALSO STOPPED.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives covering the entire body, itching, treated with Kenalog steroid 40 mg and hydrozine HCl for itching. Rash still active 24 hrs later but reduced in mass area.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Influenza like illness
Clinical narrative: This case was reported by a healthcare professional via a distributor and described the occurrence of cellulitis in a 48-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (0.5 ml, details unknown). The lot number and expiration were unknown. At an unspecified time after vaccination with FLULAVAL, the subject experienced cellulitis and flu-like symptoms. This case was assessed as medically serious by GSK. The subject was treated with antibiotics. At the time of reporting the outcome of the events was unspecified. At the time of reporting, the healthcare professional reported five other adult female subjects who experienced side effects from FLULAVAL injections at her practice (see case id's A0887616A, A0887617A, A0887618A, A0887619A, and A0887620A for specific details on these other subjects). It was unknown if all six subject's FLULAVAL was administered from the same vial.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Dizziness, Feeling hot, Syncope
Clinical narrative: After about 1 to 2 minutes of receiving vaccine, patient complained of feeling hot & dizzy and collapsed on her way to sit. Had a seizure that lasted about 1 minute and was taken to the ER.
Age: 1.26
Sex: F
Vaccine: DTAPIPVHIB, FLU3, MMR
Symptoms: Convulsion, Dyskinesia, Postictal state
Clinical narrative: Seizure activity 10/15/10 jerking upper extremities. Postictal for 1 hour.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Injection site pain, Nasal congestion, Oropharyngeal pain, Throat irritation
Clinical narrative: Puffy eyes, sore throat - scratchy, stuffed nose, pain at injection site.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Paraesthesia
Clinical narrative: Reported Lt arm tingly w/o fingertips, chest feels heavy BP 150/90 A&O VS clear 1130 unable to reach Dr ambulance then call to ER Dr order epi 0.3 wait 5 min then 0.3 wait 5 min - 0.3 given at 1147 ambulance arrives 1152.
Age: 9.0
Sex: M
Vaccine: FLU3, PNC13, VARCEL
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Skin tightness
Clinical narrative: Pt received PCV13 (L) thigh and FLUZONE (L) thigh on 10-15-10. Mom stated in distant past developed cellulitis to a vaccine, she now believes was PCV7. Pt c/o pain (L) thigh, some firmness to (L) thigh, no redness, min. warmth.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site paraesthesia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Pt had flu shot (L) deltoid at about 6 AM at 6:30 AM pt had paresthesias down entire arm.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Given TDAP 10-10-10. Developed red, warm, swelling & pain at injection site. Returned for re-check, diagnosed with cellulitis s/p injection. Given Rx for KEFLEX 500mg 1 TID X 10 days.
Age: 25.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling, tenderness at the place of injection.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Hot flush, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Client reports had "bad fever", like hot flashes x 2days, some flu like symptoms that lasted 15 days. After shot on 8-30-10 also c/o arm aching ((L) arm) up to 2 days ago.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Patient awoke 10/12/10 with redness, swelling to deltoid described as half dollar size round, tenderness, achy arm. Advised ice, gentle massage and Ibuprofen.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: According to patient 2 days after the shot he experienced rash. It begin one spot then after 2 weeks 10/19/10. He visited the pharmacy for OTC medication because the rash is all over the body. RPH suggestion BENADRYL/CLARITIN (po) and Hydrocortisone cream and visit MD if it get worse.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Anterior (L) thigh - around the injection site large area of redness, induration, warmth (approximately 12 cm diameter) 48 hrs after injection, getting larger since time of injection.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site coldness, Injection site pain, Nausea, Slow response to stimuli
Clinical narrative: Patient experienced coldness at the injection site upon administration. Then quickly felt a burning sensation in same area. Started to complain of dizziness, nausea, and lightheadedness. About 15 minutes later complained of increased dizziness, blurred vision and slow response. Ambulance took to emergency room at this point. After a couple of hours was released & instructed to take BENADRYL & an NSAID.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Patient experienced coldness at the injection site upon administration. Then quickly felt a burning sensation in same area. Started to complain of dizziness, nausea, and lightheadedness. About 15 minutes later complained of increased dizziness, blurred vision and slow response. Ambulance took to emergency room at this point. After a couple of hours was released & instructed to take BENADRYL & an NSAID.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: Itching, rash at injection site neck and torso.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea
Clinical narrative: Patient received vaccine at 11:15 AM and called pharmacy at around 5 PM complaining of diarrhea and shortness of breath. Patient was advised to call physician or go to emergency room.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Palpitations
Clinical narrative: Hoarse heart palpitations cough.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Oedema peripheral, Pyrexia
Clinical narrative: Developed swelling (L) arm - felt feverish, chills say swelling was "size of softball". Seen at medical center 10/13, ER 10/14 advised Ibuprofen/rest/ice.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Laboratory test, Muscle spasms, Nuclear magnetic resonance imaging brain
Clinical narrative: 5 hrs following influenza vaccination. Pt developed acute paracervical muscle spasm and suboccipital headache which has persisted for ten (10) days.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Wheezing
Clinical narrative: 10/18/10 patient called in to say she felt lightheaded, a little short of breath and some wheezing. Dr ordered patient to take BENADRYL 50 mg po. Call back in one hour. Go to ER if she becomes worse.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 15cm(L)x15cm(w) (L) Deltoid 13cm(L)x13(w) (R) Deltoid - areas with induration, erythema & warmth. Currently being Tx for cellulitis. ROCEPHIN IM.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient presented to the pharmacy 3 days after receiving the vaccine with a red, swollen arm from the injection site down to the elbow. The arm was also hot to the touch. She went to the doctor the following day and received an antibiotic.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Bacterial test negative, Blindness transient, Blood immunoglobulin M, CSF culture negative, CSF glucose decreased
Clinical narrative: The patient had an influenza vaccination on 09/27/10. Two days later on 09/29/10 the patient claims experiencing a severe right sided headache, 10/10, with brief bilateral loss of vision, then stated feeling numbness, tingling, and pain on left lower face and left shoulder area. The patient was hospitalized at an outside local hospital where she was examined and discharged on pain medications. On 10/03/10 the patient started experiencing bilateral lower extremity weakness starting from her feet and gradually ascending to bilateral thigh resulting in inability to move bilateral lower extremities. On 10/05/10 the patient went to primary care doctor where she was told she had Guillain-Barre syndrome and was sent to ER. On 10/05/10 the patient presented to the ER with bilateral lower extremity weakness for two to three days. Differential diagnosis post admission was Guillain-Barre syndrome versus transverse myelitis. Per neurology consult on 10/05/10, the patient has intact reflexes which makes the Guillain-Barre syndrome highly unlikely. The patient's weakness improved from 0/5 to 3/5 bilaterally. The patient underwent lumbar puncture on 10/08/10 and there was absence of pleocytosis. The patient was then discharged on 10/11/10 on stable condition being able to ambulate on a walker with follow up plan to attend neuromuscular clinic visit in one week. On 10/12/10, the result of HSV PCR in CSF that was sent on 10/08/10 came back positive. Therefore the patient was readmitted to hospital for further work up. Active HSV related radiculitis/transverse myelitis was considered. On 10/14/10 her bilateral lower extremity weakness was significantly improved from the day of admission and patient was oriented x4. Given the positive HSV PCR in CSF, Anti-HSV treatment was started and the patient was discharged on 10/14 and was instructed to follow up with neuromuscular clinic.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: CSF protein normal, CSF virus identified, CSF white blood cell count negative, Cryptococcus test, Facial pain
Clinical narrative: The patient had an influenza vaccination on 09/27/10. Two days later on 09/29/10 the patient claims experiencing a severe right sided headache, 10/10, with brief bilateral loss of vision, then stated feeling numbness, tingling, and pain on left lower face and left shoulder area. The patient was hospitalized at an outside local hospital where she was examined and discharged on pain medications. On 10/03/10 the patient started experiencing bilateral lower extremity weakness starting from her feet and gradually ascending to bilateral thigh resulting in inability to move bilateral lower extremities. On 10/05/10 the patient went to primary care doctor where she was told she had Guillain-Barre syndrome and was sent to ER. On 10/05/10 the patient presented to the ER with bilateral lower extremity weakness for two to three days. Differential diagnosis post admission was Guillain-Barre syndrome versus transverse myelitis. Per neurology consult on 10/05/10, the patient has intact reflexes which makes the Guillain-Barre syndrome highly unlikely. The patient's weakness improved from 0/5 to 3/5 bilaterally. The patient underwent lumbar puncture on 10/08/10 and there was absence of pleocytosis. The patient was then discharged on 10/11/10 on stable condition being able to ambulate on a walker with follow up plan to attend neuromuscular clinic visit in one week. On 10/12/10, the result of HSV PCR in CSF that was sent on 10/08/10 came back positive. Therefore the patient was readmitted to hospital for further work up. Active HSV related radiculitis/transverse myelitis was considered. On 10/14/10 her bilateral lower extremity weakness was significantly improved from the day of admission and patient was oriented x4. Given the positive HSV PCR in CSF, Anti-HSV treatment was started and the patient was discharged on 10/14 and was instructed to follow up with neuromuscular clinic.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Fungal test negative, Headache, Herpes simplex, Herpes simplex serology positive, Hypoaesthesia
Clinical narrative: The patient had an influenza vaccination on 09/27/10. Two days later on 09/29/10 the patient claims experiencing a severe right sided headache, 10/10, with brief bilateral loss of vision, then stated feeling numbness, tingling, and pain on left lower face and left shoulder area. The patient was hospitalized at an outside local hospital where she was examined and discharged on pain medications. On 10/03/10 the patient started experiencing bilateral lower extremity weakness starting from her feet and gradually ascending to bilateral thigh resulting in inability to move bilateral lower extremities. On 10/05/10 the patient went to primary care doctor where she was told she had Guillain-Barre syndrome and was sent to ER. On 10/05/10 the patient presented to the ER with bilateral lower extremity weakness for two to three days. Differential diagnosis post admission was Guillain-Barre syndrome versus transverse myelitis. Per neurology consult on 10/05/10, the patient has intact reflexes which makes the Guillain-Barre syndrome highly unlikely. The patient's weakness improved from 0/5 to 3/5 bilaterally. The patient underwent lumbar puncture on 10/08/10 and there was absence of pleocytosis. The patient was then discharged on 10/11/10 on stable condition being able to ambulate on a walker with follow up plan to attend neuromuscular clinic visit in one week. On 10/12/10, the result of HSV PCR in CSF that was sent on 10/08/10 came back positive. Therefore the patient was readmitted to hospital for further work up. Active HSV related radiculitis/transverse myelitis was considered. On 10/14/10 her bilateral lower extremity weakness was significantly improved from the day of admission and patient was oriented x4. Given the positive HSV PCR in CSF, Anti-HSV treatment was started and the patient was discharged on 10/14 and was instructed to follow up with neuromuscular clinic.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia facial, Lumbar puncture abnormal, Movement disorder, Muscular weakness, Musculoskeletal pain
Clinical narrative: The patient had an influenza vaccination on 09/27/10. Two days later on 09/29/10 the patient claims experiencing a severe right sided headache, 10/10, with brief bilateral loss of vision, then stated feeling numbness, tingling, and pain on left lower face and left shoulder area. The patient was hospitalized at an outside local hospital where she was examined and discharged on pain medications. On 10/03/10 the patient started experiencing bilateral lower extremity weakness starting from her feet and gradually ascending to bilateral thigh resulting in inability to move bilateral lower extremities. On 10/05/10 the patient went to primary care doctor where she was told she had Guillain-Barre syndrome and was sent to ER. On 10/05/10 the patient presented to the ER with bilateral lower extremity weakness for two to three days. Differential diagnosis post admission was Guillain-Barre syndrome versus transverse myelitis. Per neurology consult on 10/05/10, the patient has intact reflexes which makes the Guillain-Barre syndrome highly unlikely. The patient's weakness improved from 0/5 to 3/5 bilaterally. The patient underwent lumbar puncture on 10/08/10 and there was absence of pleocytosis. The patient was then discharged on 10/11/10 on stable condition being able to ambulate on a walker with follow up plan to attend neuromuscular clinic visit in one week. On 10/12/10, the result of HSV PCR in CSF that was sent on 10/08/10 came back positive. Therefore the patient was readmitted to hospital for further work up. Active HSV related radiculitis/transverse myelitis was considered. On 10/14/10 her bilateral lower extremity weakness was significantly improved from the day of admission and patient was oriented x4. Given the positive HSV PCR in CSF, Anti-HSV treatment was started and the patient was discharged on 10/14 and was instructed to follow up with neuromuscular clinic.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Myelitis transverse, Nerve conduction studies normal, Paraesthesia, Polymerase chain reaction, Radiculitis
Clinical narrative: The patient had an influenza vaccination on 09/27/10. Two days later on 09/29/10 the patient claims experiencing a severe right sided headache, 10/10, with brief bilateral loss of vision, then stated feeling numbness, tingling, and pain on left lower face and left shoulder area. The patient was hospitalized at an outside local hospital where she was examined and discharged on pain medications. On 10/03/10 the patient started experiencing bilateral lower extremity weakness starting from her feet and gradually ascending to bilateral thigh resulting in inability to move bilateral lower extremities. On 10/05/10 the patient went to primary care doctor where she was told she had Guillain-Barre syndrome and was sent to ER. On 10/05/10 the patient presented to the ER with bilateral lower extremity weakness for two to three days. Differential diagnosis post admission was Guillain-Barre syndrome versus transverse myelitis. Per neurology consult on 10/05/10, the patient has intact reflexes which makes the Guillain-Barre syndrome highly unlikely. The patient's weakness improved from 0/5 to 3/5 bilaterally. The patient underwent lumbar puncture on 10/08/10 and there was absence of pleocytosis. The patient was then discharged on 10/11/10 on stable condition being able to ambulate on a walker with follow up plan to attend neuromuscular clinic visit in one week. On 10/12/10, the result of HSV PCR in CSF that was sent on 10/08/10 came back positive. Therefore the patient was readmitted to hospital for further work up. Active HSV related radiculitis/transverse myelitis was considered. On 10/14/10 her bilateral lower extremity weakness was significantly improved from the day of admission and patient was oriented x4. Given the positive HSV PCR in CSF, Anti-HSV treatment was started and the patient was discharged on 10/14 and was instructed to follow up with neuromuscular clinic.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Treponema test negative, Walking aid user, West Nile virus test negative
Clinical narrative: The patient had an influenza vaccination on 09/27/10. Two days later on 09/29/10 the patient claims experiencing a severe right sided headache, 10/10, with brief bilateral loss of vision, then stated feeling numbness, tingling, and pain on left lower face and left shoulder area. The patient was hospitalized at an outside local hospital where she was examined and discharged on pain medications. On 10/03/10 the patient started experiencing bilateral lower extremity weakness starting from her feet and gradually ascending to bilateral thigh resulting in inability to move bilateral lower extremities. On 10/05/10 the patient went to primary care doctor where she was told she had Guillain-Barre syndrome and was sent to ER. On 10/05/10 the patient presented to the ER with bilateral lower extremity weakness for two to three days. Differential diagnosis post admission was Guillain-Barre syndrome versus transverse myelitis. Per neurology consult on 10/05/10, the patient has intact reflexes which makes the Guillain-Barre syndrome highly unlikely. The patient's weakness improved from 0/5 to 3/5 bilaterally. The patient underwent lumbar puncture on 10/08/10 and there was absence of pleocytosis. The patient was then discharged on 10/11/10 on stable condition being able to ambulate on a walker with follow up plan to attend neuromuscular clinic visit in one week. On 10/12/10, the result of HSV PCR in CSF that was sent on 10/08/10 came back positive. Therefore the patient was readmitted to hospital for further work up. Active HSV related radiculitis/transverse myelitis was considered. On 10/14/10 her bilateral lower extremity weakness was significantly improved from the day of admission and patient was oriented x4. Given the positive HSV PCR in CSF, Anti-HSV treatment was started and the patient was discharged on 10/14 and was instructed to follow up with neuromuscular clinic.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient had pneumonia vaccine (PNEUMOVAX lot 1407Y) given on 10/15/10 and on 10/16/10 went to immediate care center with redness and swelling in Lt upper arm. Treated with IM PCN and given 10 supply of Dicloxacillin x 10 for cellulitis.
Age: 6.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pneumonia
Clinical narrative: A female patient received one dose of H1N1 vaccine (batch and manufacturer unknown) on an unknown date. The patient had a medical history of hypogammaglobulinemia and primary immunodeficiency disease (PID). The patient was on concomitant medication VIVAGLOBIN since ??-NOV-2009. The dose was 13ml (2.08g) weekly in 2 sites over 1-1.5 hours. The patient premedicates with TYLENOL and BENADRYL. Her last infusion was 10-OCT-2010. The patient had previously had a bad cough and was on a nebuliser for 4 weeks with an ongoing mild fever daily for the past 2.5 months. The patient's family had been dealing with a respiratory infection and they all had been on a course of antibiotics recently. On an unknown date, the patient had pneumonia with the H1N1 vaccine. The event outcome was unknown. The reporter did not make a causality assessment. The case was reported as serious due to medical significance. The company considered events unassessable due to lack of information regarding time to onset. This case is related to WAVES case 2010026637 (VIVAGLOBIN adverse event case). Information derived from this AE report does not change the current safety profile of the product.
Age: 52.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abasia, Joint swelling, Laboratory test, Pain, Polyarthritis
Clinical narrative: developed swollen joints, general body pain unable to barely walk generalized polyarthritis
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Cough, Dysphagia, Dyspnoea, Hyperhidrosis
Clinical narrative: Initial report received from a physician via email on 01 Oct 2010: This patient was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date. The patient presented with severe anaphylactic reaction on 01 Oct 2010 for which epinephrine was given two times. Emergency medical service was called and seriousness was considered life threatening. The patient was better but because of anaphylaxis, the patient was taken to emergency room for further monitoring. Following internal review and follow up information received from physician on 15 Oct 2010: This case PHHY2010USA65793 was found to be duplicate of PHHY2010US66559. The information from case PHHY2010US66559 was merged into this case PHHY2010US65793. The case PHHY2010US66559 will be deactivated. The patient had a medical history of asthma which was controlled and the patient was off medications. The patient tolerated the vaccine well in the past. The patient received FLUVIRIN (batch number. 111813P1) 1 ml, intramuscularly on 01 Oct 2010. On the same day evening the patient experienced stiff neck, tingly tongue, cough, shortness of breath (SOB), tongue edema, laryngeal edema, tongue spasm, laryngeal spasm, respiratory distress/failure, dyspnea, chest discomfort, upper airway obstruction, sensation of foreign body, choking, sneezing, erythema, flushing. The patient was also pale, diaphoretic. He was unable to speak, swallow and experienced severe abdominal pain. The patient had persistent asthma symptoms since event. The patient was given one dose of epinephrine and symptoms improved but symptoms recurred again and he was transferred to emergency room. The patient was discharged with prednisone, BENADRYL, H2 blocker. The outcome was reported as recovered with sequelae. The event was submitted to vaccine adverse event reporting system (VAERS reference number. E47059) on 02 Oct 2010.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal stiffness, Pallor, Paraesthesia oral
Clinical narrative: Initial report received from a physician via email on 01 Oct 2010: This patient was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date. The patient presented with severe anaphylactic reaction on 01 Oct 2010 for which epinephrine was given two times. Emergency medical service was called and seriousness was considered life threatening. The patient was better but because of anaphylaxis, the patient was taken to emergency room for further monitoring. Following internal review and follow up information received from physician on 15 Oct 2010: This case PHHY2010USA65793 was found to be duplicate of PHHY2010US66559. The information from case PHHY2010US66559 was merged into this case PHHY2010US65793. The case PHHY2010US66559 will be deactivated. The patient had a medical history of asthma which was controlled and the patient was off medications. The patient tolerated the vaccine well in the past. The patient received FLUVIRIN (batch number. 111813P1) 1 ml, intramuscularly on 01 Oct 2010. On the same day evening the patient experienced stiff neck, tingly tongue, cough, shortness of breath (SOB), tongue edema, laryngeal edema, tongue spasm, laryngeal spasm, respiratory distress/failure, dyspnea, chest discomfort, upper airway obstruction, sensation of foreign body, choking, sneezing, erythema, flushing. The patient was also pale, diaphoretic. He was unable to speak, swallow and experienced severe abdominal pain. The patient had persistent asthma symptoms since event. The patient was given one dose of epinephrine and symptoms improved but symptoms recurred again and he was transferred to emergency room. The patient was discharged with prednisone, BENADRYL, H2 blocker. The outcome was reported as recovered with sequelae. The event was submitted to vaccine adverse event reporting system (VAERS reference number. E47059) on 02 Oct 2010.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Anaphylactic reaction, Aphasia, Asthma, Chest discomfort
Clinical narrative: Initial report received from a physician via email on 01 Oct 2010: This patient was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date. The patient presented with severe anaphylactic reaction on 01 Oct 2010 for which epinephrine was given two times. Emergency medical service was called and seriousness was considered life threatening. The patient was better but because of anaphylaxis, the patient was taken to emergency room for further monitoring. Following internal review and follow up information received from physician on 15 Oct 2010: This case PHHY2010USA65793 was found to be duplicate of PHHY2010US66559. The information from case PHHY2010US66559 was merged into this case PHHY2010US65793. The case PHHY2010US66559 will be deactivated. The patient had a medical history of asthma which was controlled and the patient was off medications. The patient tolerated the vaccine well in the past. The patient received FLUVIRIN (batch number. 111813P1) 1 ml, intramuscularly on 01 Oct 2010. On the same day evening the patient experienced stiff neck, tingly tongue, cough, shortness of breath (SOB), tongue edema, laryngeal edema, tongue spasm, laryngeal spasm, respiratory distress/failure, dyspnea, chest discomfort, upper airway obstruction, sensation of foreign body, choking, sneezing, erythema, flushing. The patient was also pale, diaphoretic. He was unable to speak, swallow and experienced severe abdominal pain. The patient had persistent asthma symptoms since event. The patient was given one dose of epinephrine and symptoms improved but symptoms recurred again and he was transferred to emergency room. The patient was discharged with prednisone, BENADRYL, H2 blocker. The outcome was reported as recovered with sequelae. The event was submitted to vaccine adverse event reporting system (VAERS reference number. E47059) on 02 Oct 2010.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Choking, Condition aggravated, Cough, Dysphagia, Dyspnoea
Clinical narrative: Initial report received from a physician via email on 01 Oct 2010: This patient was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date. The patient presented with severe anaphylactic reaction on 01 Oct 2010 for which epinephrine was given two times. Emergency medical service was called and seriousness was considered life threatening. The patient was better but because of anaphylaxis, the patient was taken to emergency room for further monitoring. Following internal review and follow up information received from physician on 15 Oct 2010: This case PHHY2010USA65793 was found to be duplicate of PHHY2010US66559. The information from case PHHY2010US66559 was merged into this case PHHY2010US65793. The case PHHY2010US66559 will be deactivated. The patient had a medical history of asthma which was controlled and the patient was off medications. The patient tolerated the vaccine well in the past. The patient received FLUVIRIN (batch number. 111813P1) 1 ml, intramuscularly on 01 Oct 2010. On the same day evening the patient experienced stiff neck, tingly tongue, cough, shortness of breath (SOB), tongue edema, laryngeal edema, tongue spasm, laryngeal spasm, respiratory distress/failure, dyspnea, chest discomfort, upper airway obstruction, sensation of foreign body, choking, sneezing, erythema, flushing. The patient was also pale, diaphoretic. He was unable to speak, swallow and experienced severe abdominal pain. The patient had persistent asthma symptoms since event. The patient was given one dose of epinephrine and symptoms improved but symptoms recurred again and he was transferred to emergency room. The patient was discharged with prednisone, BENADRYL, H2 blocker. The outcome was reported as recovered with sequelae. The event was submitted to vaccine adverse event reporting system (VAERS reference number. E47059) on 02 Oct 2010.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Flushing, Hyperhidrosis, Laryngeal oedema, Laryngospasm
Clinical narrative: Initial report received from a physician via email on 01 Oct 2010: This patient was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date. The patient presented with severe anaphylactic reaction on 01 Oct 2010 for which epinephrine was given two times. Emergency medical service was called and seriousness was considered life threatening. The patient was better but because of anaphylaxis, the patient was taken to emergency room for further monitoring. Following internal review and follow up information received from physician on 15 Oct 2010: This case PHHY2010USA65793 was found to be duplicate of PHHY2010US66559. The information from case PHHY2010US66559 was merged into this case PHHY2010US65793. The case PHHY2010US66559 will be deactivated. The patient had a medical history of asthma which was controlled and the patient was off medications. The patient tolerated the vaccine well in the past. The patient received FLUVIRIN (batch number. 111813P1) 1 ml, intramuscularly on 01 Oct 2010. On the same day evening the patient experienced stiff neck, tingly tongue, cough, shortness of breath (SOB), tongue edema, laryngeal edema, tongue spasm, laryngeal spasm, respiratory distress/failure, dyspnea, chest discomfort, upper airway obstruction, sensation of foreign body, choking, sneezing, erythema, flushing. The patient was also pale, diaphoretic. He was unable to speak, swallow and experienced severe abdominal pain. The patient had persistent asthma symptoms since event. The patient was given one dose of epinephrine and symptoms improved but symptoms recurred again and he was transferred to emergency room. The patient was discharged with prednisone, BENADRYL, H2 blocker. The outcome was reported as recovered with sequelae. The event was submitted to vaccine adverse event reporting system (VAERS reference number. E47059) on 02 Oct 2010.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal stiffness, No reaction on previous exposure to drug, Pallor, Paraesthesia oral, Respiratory distress
Clinical narrative: Initial report received from a physician via email on 01 Oct 2010: This patient was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date. The patient presented with severe anaphylactic reaction on 01 Oct 2010 for which epinephrine was given two times. Emergency medical service was called and seriousness was considered life threatening. The patient was better but because of anaphylaxis, the patient was taken to emergency room for further monitoring. Following internal review and follow up information received from physician on 15 Oct 2010: This case PHHY2010USA65793 was found to be duplicate of PHHY2010US66559. The information from case PHHY2010US66559 was merged into this case PHHY2010US65793. The case PHHY2010US66559 will be deactivated. The patient had a medical history of asthma which was controlled and the patient was off medications. The patient tolerated the vaccine well in the past. The patient received FLUVIRIN (batch number. 111813P1) 1 ml, intramuscularly on 01 Oct 2010. On the same day evening the patient experienced stiff neck, tingly tongue, cough, shortness of breath (SOB), tongue edema, laryngeal edema, tongue spasm, laryngeal spasm, respiratory distress/failure, dyspnea, chest discomfort, upper airway obstruction, sensation of foreign body, choking, sneezing, erythema, flushing. The patient was also pale, diaphoretic. He was unable to speak, swallow and experienced severe abdominal pain. The patient had persistent asthma symptoms since event. The patient was given one dose of epinephrine and symptoms improved but symptoms recurred again and he was transferred to emergency room. The patient was discharged with prednisone, BENADRYL, H2 blocker. The outcome was reported as recovered with sequelae. The event was submitted to vaccine adverse event reporting system (VAERS reference number. E47059) on 02 Oct 2010.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Respiratory failure, Sensation of foreign body, Sneezing, Tongue oedema, Tongue spasm
Clinical narrative: Initial report received from a physician via email on 01 Oct 2010: This patient was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date. The patient presented with severe anaphylactic reaction on 01 Oct 2010 for which epinephrine was given two times. Emergency medical service was called and seriousness was considered life threatening. The patient was better but because of anaphylaxis, the patient was taken to emergency room for further monitoring. Following internal review and follow up information received from physician on 15 Oct 2010: This case PHHY2010USA65793 was found to be duplicate of PHHY2010US66559. The information from case PHHY2010US66559 was merged into this case PHHY2010US65793. The case PHHY2010US66559 will be deactivated. The patient had a medical history of asthma which was controlled and the patient was off medications. The patient tolerated the vaccine well in the past. The patient received FLUVIRIN (batch number. 111813P1) 1 ml, intramuscularly on 01 Oct 2010. On the same day evening the patient experienced stiff neck, tingly tongue, cough, shortness of breath (SOB), tongue edema, laryngeal edema, tongue spasm, laryngeal spasm, respiratory distress/failure, dyspnea, chest discomfort, upper airway obstruction, sensation of foreign body, choking, sneezing, erythema, flushing. The patient was also pale, diaphoretic. He was unable to speak, swallow and experienced severe abdominal pain. The patient had persistent asthma symptoms since event. The patient was given one dose of epinephrine and symptoms improved but symptoms recurred again and he was transferred to emergency room. The patient was discharged with prednisone, BENADRYL, H2 blocker. The outcome was reported as recovered with sequelae. The event was submitted to vaccine adverse event reporting system (VAERS reference number. E47059) on 02 Oct 2010.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Upper airway obstruction
Clinical narrative: Initial report received from a physician via email on 01 Oct 2010: This patient was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date. The patient presented with severe anaphylactic reaction on 01 Oct 2010 for which epinephrine was given two times. Emergency medical service was called and seriousness was considered life threatening. The patient was better but because of anaphylaxis, the patient was taken to emergency room for further monitoring. Following internal review and follow up information received from physician on 15 Oct 2010: This case PHHY2010USA65793 was found to be duplicate of PHHY2010US66559. The information from case PHHY2010US66559 was merged into this case PHHY2010US65793. The case PHHY2010US66559 will be deactivated. The patient had a medical history of asthma which was controlled and the patient was off medications. The patient tolerated the vaccine well in the past. The patient received FLUVIRIN (batch number. 111813P1) 1 ml, intramuscularly on 01 Oct 2010. On the same day evening the patient experienced stiff neck, tingly tongue, cough, shortness of breath (SOB), tongue edema, laryngeal edema, tongue spasm, laryngeal spasm, respiratory distress/failure, dyspnea, chest discomfort, upper airway obstruction, sensation of foreign body, choking, sneezing, erythema, flushing. The patient was also pale, diaphoretic. He was unable to speak, swallow and experienced severe abdominal pain. The patient had persistent asthma symptoms since event. The patient was given one dose of epinephrine and symptoms improved but symptoms recurred again and he was transferred to emergency room. The patient was discharged with prednisone, BENADRYL, H2 blocker. The outcome was reported as recovered with sequelae. The event was submitted to vaccine adverse event reporting system (VAERS reference number. E47059) on 02 Oct 2010.
Age: 42.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Urticaria
Clinical narrative: Client received Typhoid & Yellow fever felt flushed w/sensation of ears burning w/i hour of receiving shots. Rec'd BENADRYL from a pharmacy later on that evening. Next morning (Thurs, 10/7/10) client completely covered in hives. Seen by a Dr. at an urgent care facility & prescribed ZANTAC,CLARITIN, continue BENADRYL & she also received a steroid shot.
Age: 42.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Ear discomfort, Flushing, Urticaria
Clinical narrative: Client received Typhoid & Yellow fever felt flushed w/sensation of ears burning w/i hour of receiving shots. Rec'd BENADRYL from a pharmacy later on that evening. Next morning (Thurs, 10/7/10) client completely covered in hives. Seen by a Dr. at an urgent care facility & prescribed ZANTAC,CLARITIN, continue BENADRYL & she also received a steroid shot.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Balance disorder, Cerebrovascular accident, Convulsion, Fall
Clinical narrative: Initial report received from a health care professional on 13 October 2010. A 67-year-old male patient received on 22 September 2010 a left deltoid intramuscular injection of FLUZONE SV 2010-2011, lot number U3652AA. The patient had a medical history of strokes, diabetes mellitus (DM) type II, hypertension (HTN), chronic renal impairment, goiter, vitamin D deficiency, depression, microalbuminuria and rosacea. He had an allergy to penicillin (PCN). The patient's concomitant medications were not provided. He had no illness at the time of vaccination and no other vaccines within 4 weeks. On 22 September 2010 at midnight, the patient had a seizure and was taken to the emergency room. He was diagnosed with a stroke. The patient was sent to a skilled nursing facility for rehabilitation for weakness and ambulation problems. The outcome was reported as not recovered. Documents held by sender: None.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gait disturbance
Clinical narrative: Initial report received from a health care professional on 13 October 2010. A 67-year-old male patient received on 22 September 2010 a left deltoid intramuscular injection of FLUZONE SV 2010-2011, lot number U3652AA. The patient had a medical history of strokes, diabetes mellitus (DM) type II, hypertension (HTN), chronic renal impairment, goiter, vitamin D deficiency, depression, microalbuminuria and rosacea. He had an allergy to penicillin (PCN). The patient's concomitant medications were not provided. He had no illness at the time of vaccination and no other vaccines within 4 weeks. On 22 September 2010 at midnight, the patient had a seizure and was taken to the emergency room. He was diagnosed with a stroke. The patient was sent to a skilled nursing facility for rehabilitation for weakness and ambulation problems. The outcome was reported as not recovered. Documents held by sender: None.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Cerebrovascular accident, Condition aggravated, Convulsion, Gait disturbance
Clinical narrative: Initial report received from a health care professional on 13 October 2010. A 67-year-old male patient received on 22 September 2010 a left deltoid intramuscular injection of FLUZONE SV 2010-2011, lot number U3652AA. The patient had a medical history of strokes, diabetes mellitus (DM) type II, hypertension (HTN), chronic renal impairment, goiter, vitamin D deficiency, depression, microalbuminuria and rosacea. He had an allergy to penicillin (PCN). The patient's concomitant medications were not provided. He had no illness at the time of vaccination and no other vaccines within 4 weeks. On 22 September 2010 at midnight, the patient had a seizure and was taken to the emergency room. He was diagnosed with a stroke. The patient was sent to a skilled nursing facility for rehabilitation for weakness and ambulation problems. The outcome was reported as not recovered. Documents held by sender: None.