chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Activities of daily living impaired, Axillary pain, Breast pain, Breast swelling, Erythema
Clinical narrative: had to be picked up at ball practice because did not feel well. Began running a fever of 101 and had local reaction of redness, swelling and pain on left deltoid site which spread to axillary and breast tissue.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Malaise
Clinical narrative: had to be picked up at ball practice because did not feel well. Began running a fever of 101 and had local reaction of redness, swelling and pain on left deltoid site which spread to axillary and breast tissue.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: had to be picked up at ball practice because did not feel well. Began running a fever of 101 and had local reaction of redness, swelling and pain on left deltoid site which spread to axillary and breast tissue.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Delirium, Dizziness, Injection site pain, Injection site paraesthesia, Laboratory test normal
Clinical narrative: Pt complained of "shooting, tingling" pain in left arm from site of administration to fingertips. Pt briefly lost consciousness but quickly returned to awareness with minimal intervention. Throughout remainder of day the pt continued to display periods of lightheadedness and pain in affected arm.  At approximately 1420 the pt had a prolonged period of delirium but was able to respond appropriately to verbal commands. Vital signs at this time were within normal limits, PERRLA 4mm bilat, moving all extremities with equal strength. Pt was transported to a local ER via EMS for further evaluation.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt complained of "shooting, tingling" pain in left arm from site of administration to fingertips. Pt briefly lost consciousness but quickly returned to awareness with minimal intervention. Throughout remainder of day the pt continued to display periods of lightheadedness and pain in affected arm.  At approximately 1420 the pt had a prolonged period of delirium but was able to respond appropriately to verbal commands. Vital signs at this time were within normal limits, PERRLA 4mm bilat, moving all extremities with equal strength. Pt was transported to a local ER via EMS for further evaluation.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Hypoaesthesia
Clinical narrative: Numbness to right leg. trouble with balance. Pt seen by neurologist and was told not to take flu shot again. recieved anti-inflammatory medication
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, RVX
Symptoms: Abnormal faeces, Constipation, Diet refusal, Faeces discoloured, Fatigue
Clinical narrative: My daughter was extremely tired, and fussy.  She is not a fussy baby and screamed inconsolably for 2 and half hours straight that night.  She also was constipated for almost 24 hours.  She went from having at least 6 poops a day to nothing for almost 24 hours and when she did start pooping again it was very runny and green.  She had a fever and was not wanting to eat.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, RVX
Symptoms: Irritability, Pyrexia, Screaming
Clinical narrative: My daughter was extremely tired, and fussy.  She is not a fussy baby and screamed inconsolably for 2 and half hours straight that night.  She also was constipated for almost 24 hours.  She went from having at least 6 poops a day to nothing for almost 24 hours and when she did start pooping again it was very runny and green.  She had a fever and was not wanting to eat.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Myalgia, Pyrexia, Swelling
Clinical narrative: Swelling, myelgia, erythema, fever and chills
Age: 0.34
Sex: M
Vaccine: DTAP
Symptoms: Cough, Crepitations, Dyspnoea, Pyrexia, Respiratory syncytial virus infection
Clinical narrative: This case was reported by a consumer and described the occurrence of respiratory syncytial virus in a 4-month-old male subject who was vaccinated with Diphtheria tetanus acellular pertussis (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma and milk allergy. On 1 March 2010 at 15:15 and 5 May 2010 at 11:30 the subject received 2nd dose and 3rd dose of Diphtheria tetanus acellular pertussis (unknown, unknown thigh) respectively. On 5 March 2010, 4 days after 2nd dose vaccination with Diphtheria tetanus acellular pertussis, the subject experienced funny cough, wheezing, crackle, tight breathing, and fever of 102. The subject was taken to the physician's office where he was diagnosed with possible respiratory syncytial virus or possible pneumonia. The subject was prescribed an Antibiotic, PULMICORT and Albuterol. The fever resolved on 05 March 2010; wheezing, crackles, tightness in breathing, cough, possible respiratory syncytial virus or possible pneumonia resolved on an unspecified date in April 2010. On 10 May 2010, 5 days after 3rd dose vaccination with Diphtheria tetanus acellular pertussis, the subject experienced wheezing, crackles, tightness in breathing and cough. The patient was placed on asthma related medications. On 18 June 2010 the subject developed a fever of 100 so he was taken to the physician's office where he was diagnosed and treated for possible bronchitis. The wheezing, crackles, tightness in breathing, cough and possible bronchitis resolved by the end of June 2010. This case was assessed as medically serious by GSK.
Age: 0.34
Sex: M
Vaccine: DTAP
Symptoms: Wheezing
Clinical narrative: This case was reported by a consumer and described the occurrence of respiratory syncytial virus in a 4-month-old male subject who was vaccinated with Diphtheria tetanus acellular pertussis (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma and milk allergy. On 1 March 2010 at 15:15 and 5 May 2010 at 11:30 the subject received 2nd dose and 3rd dose of Diphtheria tetanus acellular pertussis (unknown, unknown thigh) respectively. On 5 March 2010, 4 days after 2nd dose vaccination with Diphtheria tetanus acellular pertussis, the subject experienced funny cough, wheezing, crackle, tight breathing, and fever of 102. The subject was taken to the physician's office where he was diagnosed with possible respiratory syncytial virus or possible pneumonia. The subject was prescribed an Antibiotic, PULMICORT and Albuterol. The fever resolved on 05 March 2010; wheezing, crackles, tightness in breathing, cough, possible respiratory syncytial virus or possible pneumonia resolved on an unspecified date in April 2010. On 10 May 2010, 5 days after 3rd dose vaccination with Diphtheria tetanus acellular pertussis, the subject experienced wheezing, crackles, tightness in breathing and cough. The patient was placed on asthma related medications. On 18 June 2010 the subject developed a fever of 100 so he was taken to the physician's office where he was diagnosed and treated for possible bronchitis. The wheezing, crackles, tightness in breathing, cough and possible bronchitis resolved by the end of June 2010. This case was assessed as medically serious by GSK.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site joint pain, Injection site pain, Injection site reaction, Myalgia
Clinical narrative: This case was reported by a healthcare professional (a nurse, also the subject) and described the occurrence of injection site pain in a 57-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included FOSAMAX. Medical history was significant for sulfa allergy, prevention of bone density disease and also in 2003 had a diagnosis of frozen shoulder. On the afternoon of 21 October 2010 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. At an unspecified time following administration of FLULAVAL the subject experienced consistent injection site pain, pain in left shoulder joint, back pain and muscle pain in left shoulder. The pain was described as achy and sometimes sharp in nature. It was noted that the pain gets worse at night. The healthcare professional considered the events were disabling. The subject had an appointment to see her physician. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Chest discomfort, Throat tightness
Clinical narrative: This case was reported by a healthcare professional (a nurse, also the subject) and described the occurrence of anaphylactic reaction in a 51-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included latex allergy. There were no concurrent medications. In October 2010 the subject received unspecified dose of FLUARIX at 0.5 cc in the left arm. Quickly following administration of FLUARIX, the subject went into an anaphylactic reaction (thought to be latex allergy related). She developed tightening in her throat and chest. The subject had not known that there was latex involved with the 2010 flu vaccine. The subject was treated at her office with epinephrine and transported to the emergency room (ER) via ambulance. Oxygen was administered in the ambulance and the ER. The subject was discharged from the ER with the reaction resolving. It was noted that the anaphylactic reaction ended 2 to 3 days later. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). It was noted that the reporter felt that the anaphylactic reaction was probably related to treatment with FLUARIX, but attribution for throat tightness and chest tightness was not specifically mentioned.
Age: 0.4
Sex: U
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Dry skin, Exfoliative rash
Clinical narrative: This is a spontaneous report from a contactable nurse. A 4-month old patient received PREVNAR 13 on an unknown date along with suspect vaccine PENTACEL, which was given in the opposite arm. Relevant medical history and concomitant medications were not provided. On an unspecified date, the patient developed a dry scaly rash on both arms after receiving "both doses of PREVNAR 13." Outcome was unknown at time of report. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female with no pre-existing allergies, birth defects or medical conditionswho in approximately 2008, "about 2 years ago" was vaccinated elsewhere with GARDASIL IM three doses (therapy doses and site unknown). On 24-MAY-2010 the pap smear showed LGSIL (Low Grade Squamous Intraepitheliel Lesion) and high risk HPV (human papilloma virus). At the time of this report, the patient's outcome was unknown. The reporting physician considered these adverse events to be other important medical events. This is one of several reports received from the same source. No further information is available.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Convulsion, Dizziness, Echocardiogram
Clinical narrative: Information has been received from a registered nurse concerning a 44 year old male patient, with no drug reactions or allergies and no pertinent medical history, who on 08-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667912/0933Z, expire date 25-FEB-2012), 0.5 ml, intramuscularly. Concomitant therapy included CELEX, NORCO, SEROQUEL, vitamin D (unspecified), ADDERALL tablets, metformin, atenolol, WELLBUTRIN, amlodipine, TRUVADA, LEXIVA and RESTORIL. On 08-NOV-2010, after receiving PNEUMOVAX 23, the patient experienced a painful cellulitis like reaction. The patient developed fever, chills, convulsion, dizziness, vomiting, shaking and sweats. The patient went to an emergency room and was treated with levofloxin and discharged. On an unspecified date, a "ECHO cardiogram" was performed but the result was not provided. At the time of the report the patient had recovered. Upon internal review, convulsion was considered to be other important medical event. The nurse requested a lot check for this lot, due to adverse experiences. A lot check has been initiated. Additional information has been requested. This is one of two reports from the same source.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Pain, Pyrexia, Tremor, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 44 year old male patient, with no drug reactions or allergies and no pertinent medical history, who on 08-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667912/0933Z, expire date 25-FEB-2012), 0.5 ml, intramuscularly. Concomitant therapy included CELEX, NORCO, SEROQUEL, vitamin D (unspecified), ADDERALL tablets, metformin, atenolol, WELLBUTRIN, amlodipine, TRUVADA, LEXIVA and RESTORIL. On 08-NOV-2010, after receiving PNEUMOVAX 23, the patient experienced a painful cellulitis like reaction. The patient developed fever, chills, convulsion, dizziness, vomiting, shaking and sweats. The patient went to an emergency room and was treated with levofloxin and discharged. On an unspecified date, a "ECHO cardiogram" was performed but the result was not provided. At the time of the report the patient had recovered. Upon internal review, convulsion was considered to be other important medical event. The nurse requested a lot check for this lot, due to adverse experiences. A lot check has been initiated. Additional information has been requested. This is one of two reports from the same source.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a patient who in 2009 was vaccinated with PNEUMOVAX 23 (lot number not provided). Subsequently the patient had a severe pneumonia with a very high white blood cell count. The patient sought unspecified medical attention. At time of the report, the patient's outcome was unknown. Severe pneumonia with a very high white blood cell count was considered to be disabling. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives covering trunk and extremities
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Fever spiked to 101; arm is very red and painful
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Laboratory test, VIIth nerve paralysis
Clinical narrative: Had headache evening of flu immunization (10-01-2010) which continued for 3 days-states headaches responded to Advil and finally went away.  On November 5th, 2010 she woke up and noticed right facial drooping of Right eye and mouth.  Went to emergency room and was diagnosed with Bells Palsy. Treated with course of Prednisone.  She followed up with her Primary Care MD and was referred to a neurologist who began her on a second treatment of prednisone week of December 6th. Symptoms slowly resolving
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Back pain, Burning sensation, Demyelination, Dysarthria
Clinical narrative: Initially developed low back pain in lumbar region, then over next 2-3 days, severe burning and electrical sensation into legs. Over next 24 hours, unable to walk. Also with bilateral facial weakness and slurred speech. Admitted initially to outside facility, then transferred here on 12/07/2010. Evaluation showed normal MRI, EMG consistent with moderate grade demyelinating peripheral neuropathy. Presentation thought consistent with Guillain-Barre. Five days of IVIG 24 GM (~0.5 g/kg IBW) administered.  Patient discharged after 7 days here to SNF with improvement, still with some motor deficits, facial weakness.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Facial paresis, Guillain-Barre syndrome, Hypokinesia, Immunoglobulin therapy
Clinical narrative: Initially developed low back pain in lumbar region, then over next 2-3 days, severe burning and electrical sensation into legs. Over next 24 hours, unable to walk. Also with bilateral facial weakness and slurred speech. Admitted initially to outside facility, then transferred here on 12/07/2010. Evaluation showed normal MRI, EMG consistent with moderate grade demyelinating peripheral neuropathy. Presentation thought consistent with Guillain-Barre. Five days of IVIG 24 GM (~0.5 g/kg IBW) administered.  Patient discharged after 7 days here to SNF with improvement, still with some motor deficits, facial weakness.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Initially developed low back pain in lumbar region, then over next 2-3 days, severe burning and electrical sensation into legs. Over next 24 hours, unable to walk. Also with bilateral facial weakness and slurred speech. Admitted initially to outside facility, then transferred here on 12/07/2010. Evaluation showed normal MRI, EMG consistent with moderate grade demyelinating peripheral neuropathy. Presentation thought consistent with Guillain-Barre. Five days of IVIG 24 GM (~0.5 g/kg IBW) administered.  Patient discharged after 7 days here to SNF with improvement, still with some motor deficits, facial weakness.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient received the wrong vaccine
Age: 0.43
Sex: F
Vaccine: FLU3, PNC13, FLU3, FLU3
Symptoms: Death, Decreased appetite, Diarrhoea, Insomnia, Malaise
Clinical narrative: Patient started getting sick around 9 hours after receiving the vaccine. Patient had never been sick before, not even a cold. Her symptoms included fever, diarrhea, loss of appetite & not sleeping very well.
Age: 0.43
Sex: F
Vaccine: FLU3, PNC13, FLU3, FLU3
Symptoms: Pyrexia
Clinical narrative: Patient started getting sick around 9 hours after receiving the vaccine. Patient had never been sick before, not even a cold. Her symptoms included fever, diarrhea, loss of appetite & not sleeping very well.
Age: 0.43
Sex: F
Vaccine: FLU3, PNC13, FLU3, FLU3
Symptoms: Death, Diarrhoea, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Patient started getting sick around 9 hours after receiving the vaccine. Patient had never been sick before, not even a cold. Her symptoms included fever, diarrhea, loss of appetite & not sleeping very well.
Age: 0.43
Sex: F
Vaccine: FLU3, PNC13, FLU3, FLU3
Symptoms: Death, Decreased appetite, Diarrhoea, Irritability, Lethargy
Clinical narrative: Patient started getting sick around 9 hours after receiving the vaccine. Patient had never been sick before, not even a cold. Her symptoms included fever, diarrhea, loss of appetite & not sleeping very well.
Age: 1.02
Sex: F
Vaccine: MMR, PNC13
Symptoms: Apnoea, Confusional state, Slow response to stimuli, Unresponsive to stimuli
Clinical narrative: 2 minutes apnea, no cyanosis, decreased responsiveness, confusion
Age: 0.82
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: Felt vaccine go into arm. Arm was sore for a few days much like shots he had had in the past. Two weeks following the shot his arm worsened and he could not sleep on his left side and could not raise his arm. He needed help to get dressed it hurt so bad. He rated his pain at its worse a 10. He went to his general doctor and he could not diagnose the problem and sent him to an orthopedic doctor. The orthopedic doctor told him his muscle just needed to work it out. Today he rates his pain a 2 or 3.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Limb immobilisation, Myalgia, Nausea, Pain
Clinical narrative: Intense, excruiting muscle pain, low grade fever (100 - 101), nausea, headache.  Unable to move arm, shoulder.  More intense pain than childbirth and kidney stones.  Very ill x 2 days now.  No relief in sight.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Intense, excruiting muscle pain, low grade fever (100 - 101), nausea, headache.  Unable to move arm, shoulder.  More intense pain than childbirth and kidney stones.  Very ill x 2 days now.  No relief in sight.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: itchy lower back, developed into red rash on lower back
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Axillary pain, Back pain, Breast pain, Cellulitis, Erythema
Clinical narrative: At onset had extreme back and arm pain.  Eventually pain in arm went into breast and armpit.  Pt became flu-like and had a red, hard eduration on arm.  Over next few days, redness and hardness spread down arm.  Pt went to ER 12/12 and was sent home.  Was told to come back if pain/redness spread, which it has.  now it is believed pt may have cellulitis.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Full blood count, Induration, Influenza like illness, Pain in extremity
Clinical narrative: At onset had extreme back and arm pain.  Eventually pain in arm went into breast and armpit.  Pt became flu-like and had a red, hard eduration on arm.  Over next few days, redness and hardness spread down arm.  Pt went to ER 12/12 and was sent home.  Was told to come back if pain/redness spread, which it has.  now it is believed pt may have cellulitis.
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Blister, Erythema, Pruritus, Swelling
Clinical narrative: Swollen, red, hard, itchy, blistered
Age: 49.0
Sex: M
Vaccine: ANTH, DTAP, TYP
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness, swelling, and low-grade fever
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Injection site inflammation, Injection site pain, Malaise
Clinical narrative: malaise,cough
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan abnormal
Clinical narrative: Found out I was pregnant on the 21st.  Went to the doctors on November 30th.  I was suppose to be 7 weeks according to my LMP.  They did an ultrasound and discovered the baby had not developed properly.  I eventually had a miscarriage.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Crying, Dyskinesia, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: After FLUMIST administration pt became, pale nonresponsive, eyes rolled back, followed by body stiffness and seizure like movements, for approximately 45 seconds. Followed by crying and consecutively general weakness. Mother had denied ASE to vaccines in past, but after episode admitted that it had happened twice before once with a Hepatitis vacc & the Kinder Boosters and when pt experiences pain. Mother declined paramedic assistance. Pt had sm amount of urinary incontinence.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Gaze palsy, Musculoskeletal stiffness, Pallor, Similar reaction on previous exposure to drug, Unresponsive to stimuli
Clinical narrative: After FLUMIST administration pt became, pale nonresponsive, eyes rolled back, followed by body stiffness and seizure like movements, for approximately 45 seconds. Followed by crying and consecutively general weakness. Mother had denied ASE to vaccines in past, but after episode admitted that it had happened twice before once with a Hepatitis vacc & the Kinder Boosters and when pt experiences pain. Mother declined paramedic assistance. Pt had sm amount of urinary incontinence.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Urinary incontinence
Clinical narrative: After FLUMIST administration pt became, pale nonresponsive, eyes rolled back, followed by body stiffness and seizure like movements, for approximately 45 seconds. Followed by crying and consecutively general weakness. Mother had denied ASE to vaccines in past, but after episode admitted that it had happened twice before once with a Hepatitis vacc & the Kinder Boosters and when pt experiences pain. Mother declined paramedic assistance. Pt had sm amount of urinary incontinence.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's palsy (half of face was paralyzed).
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Excoriation, Head injury, Swelling, Syncope, Wound treatment
Clinical narrative: Pt received 3 vaccines at office visit. While leaving room pt fainted at nurse station, hit head on ledge. Pt awake when hit floor, oriented x 3. Given water and peanut butter crackers. Felt normal 5-10 mins later, small abrasion on (R) elbow, cleaned & dressed. Small <2cm swelling on left occiput, ice applied.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Blood folate normal, Borrelia test negative, CSF test normal
Clinical narrative: Recent prev URI. 12/4 pt presented in ER numbness in hands, headaches, dysphagia diffuse weakness, unable to walk. Pass TIA/CVA, dyspnea, intubated 12/6, R pneumonia = sputum, infused immunoglobulin 32gm x 5 doses, no improvement pt awaiting transfer to hospital.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Cryptococcus test, Dysphagia, Dyspnoea, Endotracheal intubation
Clinical narrative: Recent prev URI. 12/4 pt presented in ER numbness in hands, headaches, dysphagia diffuse weakness, unable to walk. Pass TIA/CVA, dyspnea, intubated 12/6, R pneumonia = sputum, infused immunoglobulin 32gm x 5 doses, no improvement pt awaiting transfer to hospital.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Immunoglobulin therapy, Mycobacterium test, Nuclear magnetic resonance imaging normal
Clinical narrative: Recent prev URI. 12/4 pt presented in ER numbness in hands, headaches, dysphagia diffuse weakness, unable to walk. Pass TIA/CVA, dyspnea, intubated 12/6, R pneumonia = sputum, infused immunoglobulin 32gm x 5 doses, no improvement pt awaiting transfer to hospital.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pneumonia, Productive cough, Red blood cells urine positive, Rheumatoid factor positive, Scan brain
Clinical narrative: Recent prev URI. 12/4 pt presented in ER numbness in hands, headaches, dysphagia diffuse weakness, unable to walk. Pass TIA/CVA, dyspnea, intubated 12/6, R pneumonia = sputum, infused immunoglobulin 32gm x 5 doses, no improvement pt awaiting transfer to hospital.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cells urine positive
Clinical narrative: Recent prev URI. 12/4 pt presented in ER numbness in hands, headaches, dysphagia diffuse weakness, unable to walk. Pass TIA/CVA, dyspnea, intubated 12/6, R pneumonia = sputum, infused immunoglobulin 32gm x 5 doses, no improvement pt awaiting transfer to hospital.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blood cholesterol, Convulsion, Dizziness, Full blood count, Urine analysis
Clinical narrative: After 3 to 4  minutes of vaccinations & blood test. Patient felt dizzy got seizure like convulsions lasted app 2 minutes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration
Clinical narrative: Hard lump site of a quarter near injection site. Symptoms self resolved after 1 week.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Child had large red area on arm where vaccine was administered & it was warm to the touch.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Body temperature increased
Clinical narrative: Temp 103.6.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient presented with bruising on arm below where injection was administered. She stated that she experienced pain > normal post inj then the bruising became evident. (Not taking blood thinners or meds that cause bleeding).
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Red, sore at sites, flu like sx. Seen by doctor.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pt. states (L) arm started hurting immediately following injection. States certain positions are very painful. Hurts to lift (L) arm up. All pain is in (L) shoulder area. No visible external redness or swelling.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pt. states she received injection in (L) arm. Didn't hurt when she got it but had pain in (L) shoulder by the end of the day. States by that time it hurt to lift her arm. States symptoms lasted 1 1/2 days then resolved.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Injection site swelling, Pain, Pain in extremity, Sensation of heaviness
Clinical narrative: Pt. states received injection in (L) arm. States within a few hrs. it felt heavy. States it hurts all the time and claims to have some external swelling in (L) shoulder. States has been in therapy 3xwk for 2wks. States it hurts all the time and hurts to lift her arm.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Pt states (L) arm hurt immediately after receiving injection. States arm is stiff and hurts to lift.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Arthralgia, Autopsy, Death, Fatigue
Clinical narrative: Information has been received from a consumer who was received the information from the internet. The information in the internet was received by a consumer concerning her 17 year old daughter who in July 2007 was vaccinated with the first dose of GARDASIL (Lot not reported). There was no adverse events. In September 2007, the patient was vaccinated with the second dose of GARDASIL (Lot not reported). Following vaccination, the patient experienced joints and muscle pain, fatigue, strong headaches etc. The physician related the symptoms to mental stress and prescribed TYLENOL for the treatment of headaches. The reporter indicated that no one thought that the symptoms were related to therapy with GARDASIL. On 20-FEB-2008, the patient was vaccinated with the third dose of GARDASIL (Lot not reported). On 22-FEB-2010 the reporter found the patient dead on the bathroom floor. An autopsy did not find the cause of death. The reporter felt that the patient had died because of GARDASIL. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Myalgia, Stress
Clinical narrative: Information has been received from a consumer who was received the information from the internet. The information in the internet was received by a consumer concerning her 17 year old daughter who in July 2007 was vaccinated with the first dose of GARDASIL (Lot not reported). There was no adverse events. In September 2007, the patient was vaccinated with the second dose of GARDASIL (Lot not reported). Following vaccination, the patient experienced joints and muscle pain, fatigue, strong headaches etc. The physician related the symptoms to mental stress and prescribed TYLENOL for the treatment of headaches. The reporter indicated that no one thought that the symptoms were related to therapy with GARDASIL. On 20-FEB-2008, the patient was vaccinated with the third dose of GARDASIL (Lot not reported). On 22-FEB-2010 the reporter found the patient dead on the bathroom floor. An autopsy did not find the cause of death. The reporter felt that the patient had died because of GARDASIL. No further information is available.
Age: 18.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Cough, Sneezing, Urticaria, Wheezing
Clinical narrative: Information has been received from a physician concerning an 18 year old male with highly allergies to latex who on 10-NOV-2010 was intramuscularly vaccinated with a dose of VARIVAX (Merck) (lot # not reported) into deltoid. On 10-NOV-2010 the patient experienced wheezing and coughing within 6 minutes of getting a VARIVAX (Merck) shot. On an unknown date therapy with VARIVAX was discontinued. After stopping therapy, the patient recovered. It was not sure if there were any previous shots. The patient sought unspecified medical attention. Follow up information was received from a health professional concerning the 18 year old male with cerebral palsy with specificity, seizure disorder, latex allergy, autistic disorder, psychiatric disorder and allergic rhinitis who on 10-NOV-2010 at 15:45 was vaccinated with the 2nd dose of VARIVAX (Merck) (lot # 667917/1108Z) into his left upper arm. At 16:00 (previously reported as within 6 minutes), the patient started sneezing, wheezing as leaving building. His mother brought him back in with hives on chest and wheezing. The patient was treated with BENADRYL. ALBUTEROL treatment was given with positive effects. On 10-NOV-2010 the patient recovered. There was no adverse event following prior vaccine. Upon internal review, sneezing, hives on chest and wheezing were considered to be other important medical events. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug hypersensitivity, Eye irritation, Headache, Latex allergy, Nausea
Clinical narrative: Had severe allergic reaction to FLUVIRIN multidose Vial 2010-115mL on 11-11-10. Started to feel burning of eyes, severe headache. Started to feel nauseated. Vomited for 2 1/2 days. 3rd day after flu shot stomach upset continued was unable to keep down prescribed meds. I am extremely allergic to the drug neomycin in any form, also I am allergic to adhesive or latex tape. By B/P was elevated & body was hot & sweaty. Visited my physician - B/P was 165/110 - temp 102 - weak with muscle aches made chronic disease worse - increased pain. Dr. gave me PHENERGAN HCL 12.5mg q 6hrs for nausea. Ibuprofen for fever. Injection site itchy & swollen with soreness high fever, low pulse B/P elevated sore throat with tightness.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Had severe allergic reaction to FLUVIRIN multidose Vial 2010-115mL on 11-11-10. Started to feel burning of eyes, severe headache. Started to feel nauseated. Vomited for 2 1/2 days. 3rd day after flu shot stomach upset continued was unable to keep down prescribed meds. I am extremely allergic to the drug neomycin in any form, also I am allergic to adhesive or latex tape. By B/P was elevated & body was hot & sweaty. Visited my physician - B/P was 165/110 - temp 102 - weak with muscle aches made chronic disease worse - increased pain. Dr. gave me PHENERGAN HCL 12.5mg q 6hrs for nausea. Ibuprofen for fever. Injection site itchy & swollen with soreness high fever, low pulse B/P elevated sore throat with tightness.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal discomfort, Asthenia, Blood pressure increased, Body temperature increased, Condition aggravated
Clinical narrative: Had severe allergic reaction to FLUVIRIN multidose Vial 2010-115mL on 11-11-10. Started to feel burning of eyes, severe headache. Started to feel nauseated. Vomited for 2 1/2 days. 3rd day after flu shot stomach upset continued was unable to keep down prescribed meds. I am extremely allergic to the drug neomycin in any form, also I am allergic to adhesive or latex tape. By B/P was elevated & body was hot & sweaty. Visited my physician - B/P was 165/110 - temp 102 - weak with muscle aches made chronic disease worse - increased pain. Dr. gave me PHENERGAN HCL 12.5mg q 6hrs for nausea. Ibuprofen for fever. Injection site itchy & swollen with soreness high fever, low pulse B/P elevated sore throat with tightness.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug hypersensitivity, Eye irritation, Feeling hot, Headache, Heart rate decreased
Clinical narrative: Had severe allergic reaction to FLUVIRIN multidose Vial 2010-115mL on 11-11-10. Started to feel burning of eyes, severe headache. Started to feel nauseated. Vomited for 2 1/2 days. 3rd day after flu shot stomach upset continued was unable to keep down prescribed meds. I am extremely allergic to the drug neomycin in any form, also I am allergic to adhesive or latex tape. By B/P was elevated & body was hot & sweaty. Visited my physician - B/P was 165/110 - temp 102 - weak with muscle aches made chronic disease worse - increased pain. Dr. gave me PHENERGAN HCL 12.5mg q 6hrs for nausea. Ibuprofen for fever. Injection site itchy & swollen with soreness high fever, low pulse B/P elevated sore throat with tightness.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hyperhidrosis, Hypersensitivity, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Had severe allergic reaction to FLUVIRIN multidose Vial 2010-115mL on 11-11-10. Started to feel burning of eyes, severe headache. Started to feel nauseated. Vomited for 2 1/2 days. 3rd day after flu shot stomach upset continued was unable to keep down prescribed meds. I am extremely allergic to the drug neomycin in any form, also I am allergic to adhesive or latex tape. By B/P was elevated & body was hot & sweaty. Visited my physician - B/P was 165/110 - temp 102 - weak with muscle aches made chronic disease worse - increased pain. Dr. gave me PHENERGAN HCL 12.5mg q 6hrs for nausea. Ibuprofen for fever. Injection site itchy & swollen with soreness high fever, low pulse B/P elevated sore throat with tightness.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Oropharyngeal pain, Pain, Pyrexia, Throat tightness
Clinical narrative: Had severe allergic reaction to FLUVIRIN multidose Vial 2010-115mL on 11-11-10. Started to feel burning of eyes, severe headache. Started to feel nauseated. Vomited for 2 1/2 days. 3rd day after flu shot stomach upset continued was unable to keep down prescribed meds. I am extremely allergic to the drug neomycin in any form, also I am allergic to adhesive or latex tape. By B/P was elevated & body was hot & sweaty. Visited my physician - B/P was 165/110 - temp 102 - weak with muscle aches made chronic disease worse - increased pain. Dr. gave me PHENERGAN HCL 12.5mg q 6hrs for nausea. Ibuprofen for fever. Injection site itchy & swollen with soreness high fever, low pulse B/P elevated sore throat with tightness.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Had severe allergic reaction to FLUVIRIN multidose Vial 2010-115mL on 11-11-10. Started to feel burning of eyes, severe headache. Started to feel nauseated. Vomited for 2 1/2 days. 3rd day after flu shot stomach upset continued was unable to keep down prescribed meds. I am extremely allergic to the drug neomycin in any form, also I am allergic to adhesive or latex tape. By B/P was elevated & body was hot & sweaty. Visited my physician - B/P was 165/110 - temp 102 - weak with muscle aches made chronic disease worse - increased pain. Dr. gave me PHENERGAN HCL 12.5mg q 6hrs for nausea. Ibuprofen for fever. Injection site itchy & swollen with soreness high fever, low pulse B/P elevated sore throat with tightness.
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chest discomfort, Pruritus, Throat irritation
Clinical narrative: Itchy throat, face, lips, & nose; chest tightness; symptoms ongoing at time of report; tx: Benadryl 50mg oral
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Pt called office stated arm where vaccination given is itching, red, & swollen on 12/9/10 (vaccine given 12/8/10). Advised to apply ice and take BENADRYL.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Burning, swelling, redness, itching in baseball size area of injection. Cortisone cream Sunday & Monday - Triamcinolone cream thereafter - did not use.
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Diarrhoea, Dizziness, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Swelling in throat; numbness in mouth-hands-feet; dizzy; diarrhea; joint pain; weakness in muscles, panic feeling.
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Panic reaction, Pharyngeal oedema
Clinical narrative: Swelling in throat; numbness in mouth-hands-feet; dizzy; diarrhea; joint pain; weakness in muscles, panic feeling.
Age: 2.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Facial pain, Musculoskeletal pain
Clinical narrative: One day after receiving FLULAVAL patient complained that she was experiencing pain from her shoulder to her chin. Patient didn't receive treatment as of yesterday.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Respiratory disorder, Vomiting
Clinical narrative: Severe abdominal pain, vomiting and diarrhea for 12 hours. Immediately followed by upper respiratory symptoms. All of this in an extremely healthy person who has not missed work in 20 + years for any medical issues.
Age: 55.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Back pain, Musculoskeletal pain, Myalgia, Oedema peripheral, Pain
Clinical narrative: Onset was soreness in arm muscle. Soreness got progressively worse over the next few days. Noticed swelling in arm. Soreness spread to shoulder and upper left back then down left arm.
Age: 55.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Pain in extremity
Clinical narrative: Onset was soreness in arm muscle. Soreness got progressively worse over the next few days. Noticed swelling in arm. Soreness spread to shoulder and upper left back then down left arm.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Hyperaesthesia, Insomnia, Myalgia, Pyrexia
Clinical narrative: Fever of 100.5' F (oral), Very achy mussels, Sensitive skin, and Restlessness (can't sleep). I feel somewhat week, and run down. Like I was doing hard physical work all day. Witch I did not.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Restlessness
Clinical narrative: Fever of 100.5' F (oral), Very achy mussels, Sensitive skin, and Restlessness (can't sleep). I feel somewhat week, and run down. Like I was doing hard physical work all day. Witch I did not.
Age: 30.0
Sex: M
Vaccine: FLU3, HEP, PPV, TD
Symptoms: Chills, Injection site erythema, Injection site swelling, Nausea, Oropharyngeal pain
Clinical narrative: Described, by patient, as chills, sore throat, nausea and vomiting.  Redness and swelling 30X20 mm at site of injection, right upper arm.
Age: 30.0
Sex: M
Vaccine: FLU3, HEP, PPV, TD
Symptoms: Vomiting
Clinical narrative: Described, by patient, as chills, sore throat, nausea and vomiting.  Redness and swelling 30X20 mm at site of injection, right upper arm.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Hypotonia, Irritability
Clinical narrative: Crying, Cranky, Limp
Age: 76.0
Sex: M
Vaccine: HEPAB, TD, TYP, YF
Symptoms: CSF protein increased, Headache, Mental status changes, Nausea
Clinical narrative: headache/nausea/change in mental status
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, Ultrasound antenatal screen abnormal, Uterine dilation and curettage
Clinical narrative: 9/22 Ultrasound showed no fetal heartbeat.  (On 09/17/2010 there was a confirmed pregnancy, and ultrasound with fetal heartbeat clearly visable.)  D&C was done.
Age: 37.0
Sex: M
Vaccine: ANTH, FLUX, HEPA, IPV, MMR, MU, TD, TYP
Symptoms: Amnesia, Arthralgia, Erectile dysfunction, Fatigue, Pain
Clinical narrative: Short Term Memory Loss, Painful Aches - Joints of whole body, Fatigue and now as of Dec 14,2010 - sexual impotence.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: influenza shot given; client had already had this year's flu shot
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Localized redness and induration at site of injection
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Nausea
Clinical narrative: Intermittent dizziness with occasional nausea. Ongoing to this day.
Sex: F
Vaccine: FLU3
Symptoms: Narcolepsy
Clinical narrative: This case was reported by a consumer (GSK employee reporting on the child of a friend) and described the occurrence of narcolepsy in a child female subject who was vaccinated with influenza virus vaccine (Flu vaccine, GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced narcolepsy symptoms. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 47.0
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Arm is painful, & limited mobility. Decrease range of motion. MD prescribed Diclofenac - TID dosing.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Bed rest, Decreased appetite, Increased upper airway secretion, Productive cough, Pyrexia
Clinical narrative: Fever: 102 degrees F for 2 days, 100 degrees F next 2 days coughing up phlegm from chest & nose - bed rest slept for 3 days, no appetite except chicken broth. After 12 days still coughing but feel better no more fever.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Erythema, Fall, Gait disturbance, Hallucination, visual
Clinical narrative: First I took a flu shot and started itching; when I rub the my skin turned red and swell up, and when I started taking the new pain medicine which was Propoxyphene, I could not hold my water. I got weak and could not walk straight. I kept falling, and when I close my eyes I could see the sky and trees and at night, I lie in bed close my eyes and can see the sky and stars. I still can see the sky through the ceiling.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Skin swelling, Urinary incontinence
Clinical narrative: First I took a flu shot and started itching; when I rub the my skin turned red and swell up, and when I started taking the new pain medicine which was Propoxyphene, I could not hold my water. I got weak and could not walk straight. I kept falling, and when I close my eyes I could see the sky and trees and at night, I lie in bed close my eyes and can see the sky and stars. I still can see the sky through the ceiling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Localized redness and induration at site of injection.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Drug exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: NO ADVERSE EVENT. VACCINE GIVEN, NEXT DAY PREGNANCY TEST WAS GIVEN AND PATIENT WAS POSITIVE
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema, Tenderness
Clinical narrative: Onset within several hours of injection Duration 4-5 days Symptoms- Edema and tenderness localized to deltoid Treatment - None
Age: 26.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Nausea, Swelling, Urticaria
Clinical narrative: welps, swelling, nausea, joint soreness
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Tongue disorder
Clinical narrative: Lower lip numbness within 15 min of injection. Thick feeling of tongue and inside of mouth for the next 24 hours. Benadryl help little with symptoms. No further treatment advised at this time cont to observe Benadryl as needed. Followup if symptoms increase or continue.
Age: 1.04
Sex: M
Vaccine: HEPA, HIBV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large (3-4 inch) red area around injection site.  Area is tender and warm to the touch.  Dr has prescribed an antibiotic.