chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Cough, Dyspnoea, Malaise, Wheezing
Clinical narrative: Short of breath & wheezing with general malaise within 24 hrs after receiving Tdap & TWINRIX on 11/10/11 cough started 11/13/11 (prone to pneumonia) persistent SOB & cough still today.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Generalised erythema, Papule
Clinical narrative: Generalized erythematous, papules scattered through - out face, neck, trunk & bil upper & lower extremities. Resolved with conservative Tx x 48 hr.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Pain in extremity, Somnolence
Clinical narrative: Severe drowsiness x 2 days. Severe dizziness x 2 days. Pain in arm x 2 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Red, swollen (Rt) arm 1 D after PNEUMOVAX shot given. Went to U.C. & they gave her a steroid shot & its better.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site movement impairment, Injection site pain
Clinical narrative: Right deltoid: red, tender to touch, unable to lift arm up. No wheezing or SOB, hives or dizziness.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: 0200 Eyes swollen, lips, tongue swollen. "Whole face puffy." Patient took albuterol, SINGULAIR, BENADRYL, & put PANTHENOL eye drops in both eyes." 0600 repeated above.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling on injection site.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient reported pain after admin of flu shot.
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Cellulitis
Clinical narrative: 5x5 cms (L) arm cellulitis 2 vaccine (1) Influenza and SQ chickenpox varicella. Placed on warm compress & PO AUGMENTIN will do a follow up in 5 days.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Head discomfort, Pain, Pyrexia
Clinical narrative: Fever of 99.9, slight body aches, "head felt strange" - she took 3 baby ASA - completely resolved in 48 hrs.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Rash generalised
Clinical narrative: 4 hours post inj had sm red area on RD. later in the day became a rash all over the body. SOLU-MEDROL 40 mg inj. given. BENADRYL, Prednisone, Promethazine for N/V.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Dizziness, diaphoresis, nausea. Lasted most of morning and early afternoon. No treatment sought.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Computerised tomogram, Dizziness, Fall, Head injury, Headache
Clinical narrative: Syncopal episode with loss of consciousness in the parking lot.  Mother states child fell from car & hit head on asphalt.  Complained of head pain, dizziness, numbness/tingling in both arms & knees.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Hypoaesthesia, Loss of consciousness, Paraesthesia, Syncope, X-ray
Clinical narrative: Syncopal episode with loss of consciousness in the parking lot.  Mother states child fell from car & hit head on asphalt.  Complained of head pain, dizziness, numbness/tingling in both arms & knees.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Erythema, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: Severe pain in arm, hard to move, large hive and very hot to the touch, that night. Next morning pain and stiffness in arm continued and hive got larger and redder and bruising started to set in very tired and felt sick like flu onset. Today is 11/17/2011 and hive is gone, but bruising is still very visible. Patient has gotten flu shots every year for the last 6 years and have never had any issues ever. This shot was very different. The pain when it was administered was so excruciating, very different shot and outcome.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Mobility decreased, Musculoskeletal stiffness, Pain in extremity, Skin warm
Clinical narrative: Severe pain in arm, hard to move, large hive and very hot to the touch, that night. Next morning pain and stiffness in arm continued and hive got larger and redder and bruising started to set in very tired and felt sick like flu onset. Today is 11/17/2011 and hive is gone, but bruising is still very visible. Patient has gotten flu shots every year for the last 6 years and have never had any issues ever. This shot was very different. The pain when it was administered was so excruciating, very different shot and outcome.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Severe pain in arm, hard to move, large hive and very hot to the touch, that night. Next morning pain and stiffness in arm continued and hive got larger and redder and bruising started to set in very tired and felt sick like flu onset. Today is 11/17/2011 and hive is gone, but bruising is still very visible. Patient has gotten flu shots every year for the last 6 years and have never had any issues ever. This shot was very different. The pain when it was administered was so excruciating, very different shot and outcome.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Computerised tomogram, Confusional state, Dizziness, Fatigue
Clinical narrative: Felt queasy and dizzy about 15min after vaccination. Symptoms progressed to extreme fatigue, falling asleep, muscle aches, severe headache, confusion, nausea, pallor, severe vomiting by the early afternoon. Patient was treated at the Emergency Room at about 3pm that afternoon. Received medicine, IV, blood work, CAT scan. Sent home later that evening and rested for the next several days.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Myalgia, Nausea, Pallor, Somnolence
Clinical narrative: Felt queasy and dizzy about 15min after vaccination. Symptoms progressed to extreme fatigue, falling asleep, muscle aches, severe headache, confusion, nausea, pallor, severe vomiting by the early afternoon. Patient was treated at the Emergency Room at about 3pm that afternoon. Received medicine, IV, blood work, CAT scan. Sent home later that evening and rested for the next several days.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Felt queasy and dizzy about 15min after vaccination. Symptoms progressed to extreme fatigue, falling asleep, muscle aches, severe headache, confusion, nausea, pallor, severe vomiting by the early afternoon. Patient was treated at the Emergency Room at about 3pm that afternoon. Received medicine, IV, blood work, CAT scan. Sent home later that evening and rested for the next several days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Had her Shingles Vaccine on Tuesday November 8th, 2011, she said yesterday the injection site Under her left arm was a little bit swollen, she noticed it because it was hot and itching, patient felt chest tightness and took her albuterol and some antihistamine (Claritin) this was last night, she measure the spot and she said it is 3.5 inches long and 2 inches across, no fever, no chest tightness and no SOB today, no numbness, and no new tingling in her arms and feet. She knows the achiness is normal but would like advise. I also told her if she develops chest tightness and becomes SOB she should go to the ER.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: At approx 8:05 pm, He began vomiting, no other symptoms of illness had been present. Vomiting continued every 30-90 minutes through the night until approx. 7:30 AM, 11/17/2011.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Headache, Malaise
Clinical narrative: General malaise, fatigue, achy joints, headache, symptoms increasing through day. Not serious but enough to cause the patient to go to bed and sleep. Though mild reactions, the symptoms seemed worth mentioning. This patient generally has a reaction to flu vaccine each year.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Nausea, Vomiting, Headache.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: At 5:00Am after influenza injection at 1:45AM employees complained of arm itching. Upon examination it was on the lower arm, elbow to wrist red and itching. At the injection site there was no redness or swelling.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Grip strength decreased, Limb discomfort, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to touch, red streaking, hard to make fist, uncomfortable feeling in whole side of left arm.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Febrile convulsion, Postictal state, Pyrexia
Clinical narrative: Fever >102 degrees. Febrile Seizure. Duration uncertain. Post-ictal upon evaluation in office.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased, Hypertension, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediate red lump at site of injection which grew in minutes to the size of a quarter.  Heart racing, throat itched, very dizzy.  Blood pressure and heart rate were high.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Palpitations, Throat irritation
Clinical narrative: Immediate red lump at site of injection which grew in minutes to the size of a quarter.  Heart racing, throat itched, very dizzy.  Blood pressure and heart rate were high.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Headache, Injection site erythema, Injection site haematoma, Injection site swelling
Clinical narrative: Chest pain, lethargy, myalgias, headache, nausea, erythema around injection site, scratchy throat, swelling and bruising at injection site. R arm 3/4", L arm 3/4".
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Lethargy, Myalgia, Nausea, Throat irritation
Clinical narrative: Chest pain, lethargy, myalgias, headache, nausea, erythema around injection site, scratchy throat, swelling and bruising at injection site. R arm 3/4", L arm 3/4".
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient reports that she immediately experienced pain in her left arm. States later that night pain radiated to neck and hand. Saw MD and is being treated for bursitis.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Fatigue, Headache, Hot flush
Clinical narrative: Headache, extreme fatigue. Patient has been having ongoing, continuous severe headaches, and extreme fatigue. Symptoms are debilitation at times patient has to stay home, and hot flashes.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Faeces pale, Fatigue, Flatulence
Clinical narrative: Initial symptoms were chills, low grade fever, nausea and fatigue.  GI symptoms progressed to extensive gas for 10 days and stool that was pale and soft.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Gastrointestinal disorder, Nausea, Pyrexia
Clinical narrative: Initial symptoms were chills, low grade fever, nausea and fatigue.  GI symptoms progressed to extensive gas for 10 days and stool that was pale and soft.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus, Rash pruritic
Clinical narrative: 11/12 Raised, itchy raised rash 11/13 Blisters developed, itchy & worsened 11/14 Red Blistered
Age: 36.0
Sex: M
Vaccine: HEPAB
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Nausea, Vertigo
Clinical narrative: Pt. became dizzy several hrs. After shot became worse and had nausea & vomiting for a few days after shot. CT scan negative, blood work Neg. Dr. gave him med for vertigo & changed his BP med.
Age: 36.0
Sex: M
Vaccine: HEPAB
Symptoms: Vomiting
Clinical narrative: Pt. became dizzy several hrs. After shot became worse and had nausea & vomiting for a few days after shot. CT scan negative, blood work Neg. Dr. gave him med for vertigo & changed his BP med.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Arthralgia, Fatigue, Malaise, Myalgia
Clinical narrative: Severe joint and muscle pain, fatigue/malaise, nausea, abdominal cramping worsening on 11/15-11/16.  Relieved by Benadryl.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea
Clinical narrative: Severe joint and muscle pain, fatigue/malaise, nausea, abdominal cramping worsening on 11/15-11/16.  Relieved by Benadryl.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Pain, Tremor
Clinical narrative: Approximately 5 days after the shot had general body aches, severe pain to lower back that has not stopped, and legs are very shaky when walking down stairs.  Legs feel like they are having tremors when weight bearing descending stairs and has not resolved. Pain to lower back continues, but not as severe as within the first two weeks following the injection.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever 101.2 Malaise for 24 hours.
Age: 12.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Fatigue, Muscular weakness, Musculoskeletal pain, Myalgia
Clinical narrative: Left arm and shoulder pain and weakness, decending to torso, hip and left leg.  Muscle aches and fatigue x 3 days.
Age: 12.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Left arm and shoulder pain and weakness, decending to torso, hip and left leg.  Muscle aches and fatigue x 3 days.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Crying, Epistaxis, Immediate post-injection reaction
Clinical narrative: Patient given Flumist.  Immediately after administering in each nostril, child started crying and nose began to bleed.  Pressure applied to nose by mom, bleeding lasted approx 2 min.
Age: 1.03
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Apnoea, Blood test normal, Chest X-ray normal, Febrile convulsion, Pyrexia
Clinical narrative: Patient was feverish, administered Tylenol throughout the day which didn't control the fever, causing a febrile seizure and the patient to stop breathing. Patient had no other symptoms of illness besides a fever of approx 104 when he arrived at the hospital. Was given a double dose of Tylenol and Ibuprofen upon arrival and diagnosis. All tests came back negative except for a few white blood cells in his urine.
Age: 1.03
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: White blood cells urine positive
Clinical narrative: Patient was feverish, administered Tylenol throughout the day which didn't control the fever, causing a febrile seizure and the patient to stop breathing. Patient had no other symptoms of illness besides a fever of approx 104 when he arrived at the hospital. Was given a double dose of Tylenol and Ibuprofen upon arrival and diagnosis. All tests came back negative except for a few white blood cells in his urine.
Age: 1.43
Sex: M
Vaccine: PNC13
Symptoms: Abasia, Paralysis
Clinical narrative: Onset was within 1 hour of vaccination. Child could not walk. It was not numbness of limbs - it was the inability to ambulate - paralysis.
Age: 0.84
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Blood culture negative, CSF culture negative, Convulsion, Culture urine negative, Metabolic function test normal
Clinical narrative: Fever with seizure.  Seizure lasting at least 20 minutes requiring IV medications to stop.
Age: 0.84
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever with seizure.  Seizure lasting at least 20 minutes requiring IV medications to stop.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Accessory nerve disorder, Blood test, Burning sensation, Demyelinating polyneuropathy, Fatigue
Clinical narrative: Neurological Symptoms -SEVERE and EXCRUCIATING muscle pain (myalgia) in legs and arms, worse in legs, numbness, burning, tingling, fatigue, severe cramping in feet and legs some weakness in legs.  Diagnosis Post Vaccination Syndrome, ADPN, neuropathy.  Subsequent nerve testing. Symptoms continue, treatment with medications continue.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Muscle spasms, Muscular weakness, Myalgia, Nerve stimulation test
Clinical narrative: Neurological Symptoms -SEVERE and EXCRUCIATING muscle pain (myalgia) in legs and arms, worse in legs, numbness, burning, tingling, fatigue, severe cramping in feet and legs some weakness in legs.  Diagnosis Post Vaccination Syndrome, ADPN, neuropathy.  Subsequent nerve testing. Symptoms continue, treatment with medications continue.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Neurological symptom, Neuropathy peripheral, Paraesthesia, Post vaccination syndrome
Clinical narrative: Neurological Symptoms -SEVERE and EXCRUCIATING muscle pain (myalgia) in legs and arms, worse in legs, numbness, burning, tingling, fatigue, severe cramping in feet and legs some weakness in legs.  Diagnosis Post Vaccination Syndrome, ADPN, neuropathy.  Subsequent nerve testing. Symptoms continue, treatment with medications continue.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Culture urine positive, Escherichia test positive, Urinary tract infection
Clinical narrative: Patient with onset of UTI symptoms (unclear when), Urine positive, cx positive for E. coli, treated with antibiotics.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Swelling of the arm the vaccine was administered.
Age: 36.0
Sex: M
Vaccine: MNQ
Symptoms: Axillary pain, Dyspnoea, Eye irritation, Injection site pain, Sluggishness
Clinical narrative: SLUGGISH, INJECTION SITE WAS SORE AND TENDER TO TOUCH, ARMPIT WAS SORE, SHORTNESS OF BREATH, FEELS LIKE EYES BURN
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Angioedema, Endotracheal intubation, Intensive care, Mechanical ventilation, Respiratory failure
Clinical narrative: Angioedema, Respiratory Failure.  Intubated and placed onto ventilator.  Admitted to ICU.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Angioedema, Dyspnoea, Mechanical ventilation, Respiratory failure
Clinical narrative: Angioedema, Respiratory Failure.  Intubated and placed onto ventilator.  Admitted to ICU.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Arthralgia, Chills, Lethargy, Nausea, Pyrexia
Clinical narrative: Fever, lethargy, chills, elbow pain, N/V; no ill contacts, so suspect vaccine reaction.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Vomiting
Clinical narrative: Fever, lethargy, chills, elbow pain, N/V; no ill contacts, so suspect vaccine reaction.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: SORE ARM.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Mobility decreased, Musculoskeletal pain
Clinical narrative: Extremely sore shoulder. Affects ability to perform daily tasks even now after one week after the vaccination. Administrator indicated the needle was hard to get through "thick skin." Can barely lift arm, cross it over body, dress self, use restroom, etc. Not recovered to date.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Blood glucose normal, Dizziness, Loss of consciousness
Clinical narrative: Pt complained of feeling lightheaded.  Within 5 minutes, pt lost consciousness.  She went in and out of consciousness over the next few minutes, with total LOC approx 1 minute or less.  Vitals 4:45:  84/30, pulse 51, resp 16, 100% O2 sat.  4:50:  57/29, pulse 62, 99% O2 sat.   FSBG 77 mg/dL.  EMS called and pt taken to ER.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Patient had flu shot on 10/23/2011. After the shot that evening patient's left arm became weak, she states 50% of arm strength gone. Feeling numbness ever since flu shot administered.
Age: 1.77
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Skin warm, Swelling, Urticaria
Clinical narrative: Dad brings child to clinic 11/7/11 , one month after immunizations were given. Describes whelps ? redness, warmth, swelling on child trunk and extremities after 10/6/11 immunizations were given. Treated child with OTC TYLENOL, was much improved the next morning.
Age: 1.34
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Localized inflammatory response, redness, heat, (L) arm.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot
Clinical narrative: About 45 minutes after the vaccine was given, the patient became dizzy and felt faint. She was given a chair to sit in, and her blood pressure was checked (87/54 mmHg). She said she was hot, so she was given water, Ginger Ale & crackers. She sat for about 1 hour before being picked up and taken home.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site rash, Papule
Clinical narrative: Yesterday (11/16/11) began with rash to (L) thigh. Today has pink/red macular rash to (L) thigh, lower abdomen, (B) axilla with scattered pink/red papules to abdomen, upper thighs & arms.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient has c/o injection site pain and pain radiating down (L) arm since vaccine administration.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Sensory loss
Clinical narrative: Patient has c/o progressive weakness and loss of sensation since Flu vaccine administered in LUE 10-19-11.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site swelling
Clinical narrative: Lower extremity swelling.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Amnesia, Chills, Influenza like illness
Clinical narrative: After injection pt suffered, chills, fever none. Pt. felt like, he had the flu. Also one episode of memory loss - for a few moments. This reported to the office on 11-17-11. Pt states started 11-15-11 evening.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Headache, Malaise, Pain
Clinical narrative: Patient's symptoms started with cough & headache on Friday. Later in the evening, she developed diarrhea, vomiting, and body aches which persisted through Saturday. She did not feel well until Monday.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient's symptoms started with cough & headache on Friday. Later in the evening, she developed diarrhea, vomiting, and body aches which persisted through Saturday. She did not feel well until Monday.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: 11-17 pt called c/o pain in arm of shot - (Flu) - throbbing pain, can not lift arm w/o pain. Waken pt up at night. Pain on day 1 of shot & continues today. Been taking Ibuprofen at onset but pain continues advised pt to see PCP re: further Tx. Site not red or warm.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Eye swelling, Lip swelling, Urticaria
Clinical narrative: Hives, increased blood pressure, swollen eyes & lips. Pt went to emergency room.
Age: 52.0
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain
Clinical narrative: Report mild sore throat on 11/10/11 and resolved 11/11/11. Acquire info by contact client.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Oedema peripheral
Clinical narrative: Pain at injection site radiates up to neck behind (L) ear & down to fingers. Edema (L) arm & wrist sl. edema in (L) hand. Started 11-16-11. No fever no numbness. Some pain behind ear approximately 10 mins. after injection woke up at 2:00AM with other symptoms.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site reaction, Muscle twitching, Tremor
Clinical narrative: Pt reported tremor of the left arm (where vaccine received) that occurred after vaccination. Also some poking pain in her wrist. After a few wks this moved up the arm to the elbow. She saw has twisted of biceps muscle and poking feeling above the elbow when at rest.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness, Conjunctival oedema, Dizziness, Dyspnoea, Rales
Clinical narrative: Loss of vision, conjunctival chemosis, lightheadedness, shortness of breath and rales both lungs within 180 mins of influenza vaccination. Transferred to hospital, after epinephrine, BENADRYL, discharged after SOLU-MEDROL & PEPCID. Referred to ophthalmologist.
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event
Clinical narrative: None reported when client notified 11/10/11, 11/11/11 & 11/12/11.
Age: 60.0
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event
Clinical narrative: No adverse reaction. Reported after contacting client 11/10/11.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: C/O soreness at site of Influenza 2011-2012 vaccine. Also c/o soreness with any movement of (L) arm. Describes pain as 9 out of 10 with movement. Advised 8-10 days Ibuprofen recheck if persists. Examined by FNP.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Malaise, Pruritus, Throat irritation, Wheezing
Clinical narrative: Per pt - she noticed getting sharp pains in her right chest about 20-30 min after getting flu vaccine. She said she did not report this because she was experienced this at other times. She then got a scratchy throat, itchy chest & wheezing. She obtained some relief with her albuterol inhaler & BENADRYL. Today she is c/o general body malaise. See provider not for additional
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Urinary system X-ray
Clinical narrative: Incessant crying about 2 hrs after vaccines. Rechecked in our office at 2:00 p.m., examined KUB ordered.
Age: 0.75
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Pyrexia, Staring
Clinical narrative: Initial report was received on 05 October 2010 from a health care professional which involved a cluster of four patients who experienced adverse events after receiving FLUZONE, lot number UT3570DA. This report represents one patient, and the other three patients have been captured in case numbers 2010-05757, -05758, and 05760. A nine-month-old female patient had received a first dose intramuscular injection (site not reported) of FLUZONE, lot number UT3570DA on 04 October 2010 and at 7 PM on the evening of vaccination, the patient had fever, chills, decreased appetite and glassy eyes. Outcome was reported as unknown. No additional information was provided at the time of the report. The reporter for this case is the same as for case number 2010-05761.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain, Rash
Clinical narrative: Initial report was received from a health care professional on 24 September 2010. A 78 year-old female patient with no illness at the time of vaccination, had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE, lot number U3600AA on 16 September 2010 and "two hours" later, experienced a cough and sore throat. She reported staying in bed "all day". On 17 September 2010, "the next day" she woke up "covered" with a rash. No treatments were reported. On 22 September 2010 the patient reported the rash was "fading". No further information was provided at the time of the report. The patient's outcome was not reported. Follow-up information was received from health care professional on 22 October 2010. The patient's outcome was reported as recovered. No further information was provided at the time of the report. Documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Palpitations, Vomiting
Clinical narrative: Initial case was received on 30 September 2010 from a healthcare professional. A 66 year old female patient received on 29 September 2010 at 11:00 a.m., a left deltoid intramuscular injection of FLUZONE HIGH-DOSE (lot number U3609AA). The patient had nausea in the a.m. before and at the time of the vaccination. No pre-existing medical conditions were reported and she had no known allergies. She was taking "several" concomitant medication, but the names were not provided. After the vaccination on 29 September 2010, the patient ate lunch, vomited "the lunch then foam." She experienced body aches, then a sore arm and palpitations, which "kept her up until 1 a.m." It was unknown if the patient recovered. Documents held by sender: None.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Activated partial thromboplastin time, Prothrombin time prolonged
Clinical narrative: Initial case was received on 14 October 2010 from a healthcare professional. A 69 year old male patient received on 05 October 2010, a left deltoid intramuscular injection of FLUZONE HIGH-DOSE (lot number U3609AA). The patient's concomitant medications included COUMADIN and a "BP Med." On an unspecified date after vaccination, hit "PT, PTT" level results were "3.9." Prior to the vaccination, "PT, PTT" levels had been "2.2" for several months. The patient had no illness at the time of the vaccination. He had no other vaccinations within 4 weeks. Pre-existing medical conditions included chronic obstructive pulmonary disease (COPD) and hypertension (HTN). No other factors, lifestyle or medication had changed. The outcome was unknown. Documents held by sender: None.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dysphagia, Feeling abnormal, Headache, Injected limb mobility decreased
Clinical narrative: Initial information received on 14 October 2010 from a consumer/patient. An 80-year-old female patient with a past medical history of gastroesophageal reflux disease (GERD) and asthma, received an intramuscular dose of FLUZONE HIGH-DOSE, lot number unknown, in the right arm on 11 October 2010. Four hours later the patient reported that she "felt like there was a bold in her neck sticking out through her neck, with severe pain in her neck". She also had trouble swallowing, which lasted until 10:00 p.m. (exact duration not reported). In addition, she had a headache, could not lift her right arm and had shoulder stiffness and loss of right arm strength. The patient recovered from her symptoms on an unspecified date. Follow-up information was received 03 November 2010 from a health care professional. The FLUZONE HIGH-DOSE lot number was U3633AA and the patient had been immunized at 11:40 AM on 11 October 2010. The patient had no concurrent illness at the time of vaccination. The reporter had no additional information at the time of the report. Follow-up information was received 25 January 2011 from a consumer, who is also the patient. The patient was not seen by a physician and the event did not require treatment. According to the patient, by the next morning they were ok. List of documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Initial information received on 14 October 2010 from a consumer/patient. An 80-year-old female patient with a past medical history of gastroesophageal reflux disease (GERD) and asthma, received an intramuscular dose of FLUZONE HIGH-DOSE, lot number unknown, in the right arm on 11 October 2010. Four hours later the patient reported that she "felt like there was a bold in her neck sticking out through her neck, with severe pain in her neck". She also had trouble swallowing, which lasted until 10:00 p.m. (exact duration not reported). In addition, she had a headache, could not lift her right arm and had shoulder stiffness and loss of right arm strength. The patient recovered from her symptoms on an unspecified date. Follow-up information was received 03 November 2010 from a health care professional. The FLUZONE HIGH-DOSE lot number was U3633AA and the patient had been immunized at 11:40 AM on 11 October 2010. The patient had no concurrent illness at the time of vaccination. The reporter had no additional information at the time of the report. Follow-up information was received 25 January 2011 from a consumer, who is also the patient. The patient was not seen by a physician and the event did not require treatment. According to the patient, by the next morning they were ok. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Sensation of foreign body
Clinical narrative: Initial case was received on 14 October 2010 from a healthcare professional. The reporter provided individual patient identifiers for a cluster of three patients (previously reported in case 2010-04957 as a cluster of six patients). This case contains information for the second of the three patients who had received on 09 September 2010 an injection of FLUZONE (lot number UH214AB). The patient was a 32 year old female patient, with no known pre-existing medical conditions and no concomitant medications. On 09 September 2010, she experienced a cough, lump feeling in throat and exhaustion. She had no illness at the time of the vaccination, no other vaccinations within 4 weeks and no adverse event following prior vaccinations. The outcome was recovered. Follow-up information was received 28 December 2010 from a health care professional who reported that the patient had not been seen by a doctor and had not received any corrective treatments. The reporter had no additional information to provide at the time of the report. The reporter for this case (2010-05957) is the same as case number 2010-04957 and 2010-05958. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eyelid oedema, Flushing, Skin warm, Urticaria
Clinical narrative: Initial report received from a patient who is also a health care professional. A 49-year-old female patient with a medical history of allergies to shellfish and rubber accelerator, had received an intramuscular injection of FLUZONE, lot number UH181AA, on 06 October 2010. One day later, on 07 October 2010, the patient's face was red, flushed, and warm to the touch. Her left eye was swollen and she had rare hives on the back of her neck and her left wrist. She was treated with BENADRYL and a MEDROL pack. The patient reported that she reacts similarly to various cleaning agents and that her reaction may possibly have been related to a cleaning agent she had used. The patient's recovery status was not reported. Follow-up information was received on 29 October 2010 from a patient who is also a health care professional. The patient received the FLUZONE injection in the left deltoid muscle. She had been previously tested and she did not have an egg allergy. She was treated with a MEDROL dose pack and all symptoms were resolved within 24 hours (date not reported). List of documents held by sender: none.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to metals, Injection site vesicles, Type IV hypersensitivity reaction
Clinical narrative: Initial report received from a physician on 27 October 2010. A 6-year-old female patient received an injection of FLUZONE (lot number, date, and route of administration not reported), and one day post-vaccination experienced a bullous delayed rash at the injection site with scattered bullous lesions around the immediate site. The patient had no history of allergies. She was treated with antibiotic ointment, and the event resolved within a few days. According to the reporter, the most likely diagnosis was "delayed hypersensitivity reaction secondary to thimerosal", and the physician planned to perform patch testing on the patient to confirm the diagnosis. Follow-up information received from a physician on 13 December 2010. The patient had no known illnesses at the time of the influenza vaccination. Follow-up information was received from a physician on 24 January 2011. The patient had received an intramuscular left deltoid injection FLUZONE, lot number UH180AA. The patient was evaluated by a physician. No further information was available at the time of report. The patient's outcome remained recovered. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Hypoaesthesia oral, Lethargy
Clinical narrative: Initial case was received on 20 October 2010 from a healthcare professional. A 57 year old female patient received on 19 October 2010 an intramuscular right deltoid injection of FLUZONE (lot number UH223AB). On 19 November 2010 the patient experienced weakness, lethargy and her "arm to lip feels numb, like NOVOCAINE". She was not seen by a healthcare professional, but was going to call physician. No pre-existing medical conditions, allergies or concomitant medications were reported. The patient had not recovered. Follow-up information was received by a health care professional on 06 December 2010. The patient was advised by her physician not to worry unless she has trouble breathing or swelling in the throat. The pharmacist advised the patient to take BENADRYL which helped with the symptoms. The patient felt completely fine the morning of 21 October 2010 when she woke up. The patient had no illness at the time of vaccination and no other vaccinations within 4 weeks of the FLUZONE. The patient had no prior adverse events following prior vaccinations. The outcome was reported as recovered. Documents held by sender: None.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site haematoma, Vaccination site induration, Vaccination site warmth
Clinical narrative: Initial case was received on 04 November 2010 from a healthcare professional. A female patient (age not reported) received on 29 October 2010, a subcutaneous injection "in the flabby part of the arm" of INFLUENZA vaccine (lot not reported). The next day on 30 October 2010, she experienced red, hot, hard spot at the vaccination site. On 01 November 2010, the site was "only bruised." No pre-existing medical conditions and no concomitant medications were reported. It was unknown if the patient recovered completely. Follow-up information was received from the health care professional on 03 January 2011. The patient was 22 years old, and had no illness at the time of vaccination. She received FLUZONE (lot number UH223AC) on 28 October 2010 (previously reported as 29 October 2010). The event recovered in an unspecified date. The reporter had no additional information at this time. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Temporomandibular joint syndrome
Clinical narrative: Initial case was received on 01 November 2010 from a health care professional. A female patient in her forties received on 07 October 2010 an intramuscular injection of influenza vaccine (lot number reported "U3271AA" -not a valid sanofi pasteur lot number). A few days later the patient experienced temporomandibular joint disorder ("TMJ") NOS. The patient "may have seen a dentist" (no report provided). No further information was provided. As of this report the patient had not recovered. Follow-up information received from a nurse on 16 December 2010. The patient had contacted the reporter on 08 November 2010 stating that she did not believe her TMJ symptoms were caused by the flu vaccine that she received on 07 October 2010. The patient's brother told the patient that he misquoted that the flu vaccine can cause lock jaw, he was actually referring to Tdap vaccines. The patient stated she has experienced prior problems with TMJ, however it had not ever been as severe. The patient did not wish to file any further claims for this adverse event following the 07 October 2010 influenza vaccination. The patient sought medical attention from her dentist, who referred her to her primary medical doctor. No treatments was provided and the TMJ eventually resolved on its own approximately 4 weeks after onset. Per the reporter, no further action will be claimed or filed. Follow-up information was received 24 January 2011 from a health care professional. The patient had not been administered a Tdap vaccine; they declined. Per the reporter, the condition was not related to Tdap vaccine. The patient received FLUZONE, lot number U3721AA (previously reported as U3271AA), expiration of 30 June 2011 on 07 October 2010. According to the reporter the reason for TMJ was undetermined. The patient had no illness and she had not been taking any concomitant medications at the time of vaccination. The reporter stated they had no further information to provide. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling
Clinical narrative: Initial case was received on 28 October 2010 from a healthcare professional. A female patient (age not reported) received on 23 October 2010 a right deltoid intramuscular injection of FLUZONE (lot number U3726AA). On 24 October 2010, "48 hours" after vaccination the patient experienced right knee swelling. She had no difficulty walking and no other symptoms were reported. The patient had no vaccinations within four weeks and no illness at the time of the vaccination. Pre-existing medical conditions included arthritis. She had no concomitant medications. At the time of this report she had not recovered. Follow-up information was received 14 February 2011 from a health care professional. The patient was identified as a 65 year old female who developed right knee swelling on 24 October 2010 which changed the event latency from 48 hours to one day post vaccination. The event did not require treatment and the patient recovered (date of recovery not reported). Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Pyrexia, Rash, Respiratory tract infection, Upper respiratory tract infection
Clinical narrative: Initial report received from a health care professional on 28 October 2010. A 66-year-old female patient, with a history of mild asthma, interstitial cystitis, valve surgery post "MVA", received on 18 October 2010 an intramuscular injection of influenza vaccine, lot number not provided. The patient has seasonal allergies and an allergy to penicillin. The patient's concomitant medications included CLARITIN and Aspirin. The patient denied any illness at the time of vaccination and denied any other vaccines within 4 weeks prior to the influenza vaccine. The patient usually becomes "mildly ill" following flu vaccination in the past. The patient, on 18 October 2010 and within 6 hours of the vaccination, developed a fever of 101.4 (units not provided). She then developed a respiratory infection with a diagnosis of asthmatic bronchitis. Approximately, 6-7 days after the patient developed "debilitating vertigo" which required medication. She also developed a rash on her torso which she stated was normal for her anytime her immune system was activated. The outcome was reported as unknown. Follow-up information received from a health care professional on 20 December 2010 reported the patient's concomitant medications also included CRESTOR, ESTRATEST, and PROMETRIUM. The patient's medical history of valve surgery post "MVA" was clarified to valve surgery post mitral valve prolapse (MVP). The patient had mild malaise and arthralgia with distant past flu shot 5 years ago and no recent post vaccine illnesses. The patient received approximately 20 previous flu vaccines. The patient would get 1/2 shot and next 1/2 one week later without sequelae. The patient had no illness at the time of vaccination and no other vaccinations within 4 weeks of the FLUZONE. The patient received on 18 October at 11:00 AM a left deltoid intramuscular injection of FLUZONE, lot number U3700AA. The patient developed at 5:00 PM on 18 October 2010 upper respiratory infection. The vertigo developed on 25 October 2010 and required a doctor's visit on 25 October 2010. The vertigo did not initially respond to Epley maneuvers therefore, she was treated with meclizine and responded rapidly. The vertigo was a gradual resolution with meclizine over 3 days (28 October 2010). The patient returned to work on 27 October 2010. The outcome was reported as recovered. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Initial report received from a health care professional on 28 October 2010. A 66-year-old female patient, with a history of mild asthma, interstitial cystitis, valve surgery post "MVA", received on 18 October 2010 an intramuscular injection of influenza vaccine, lot number not provided. The patient has seasonal allergies and an allergy to penicillin. The patient's concomitant medications included CLARITIN and Aspirin. The patient denied any illness at the time of vaccination and denied any other vaccines within 4 weeks prior to the influenza vaccine. The patient usually becomes "mildly ill" following flu vaccination in the past. The patient, on 18 October 2010 and within 6 hours of the vaccination, developed a fever of 101.4 (units not provided). She then developed a respiratory infection with a diagnosis of asthmatic bronchitis. Approximately, 6-7 days after the patient developed "debilitating vertigo" which required medication. She also developed a rash on her torso which she stated was normal for her anytime her immune system was activated. The outcome was reported as unknown. Follow-up information received from a health care professional on 20 December 2010 reported the patient's concomitant medications also included CRESTOR, ESTRATEST, and PROMETRIUM. The patient's medical history of valve surgery post "MVA" was clarified to valve surgery post mitral valve prolapse (MVP). The patient had mild malaise and arthralgia with distant past flu shot 5 years ago and no recent post vaccine illnesses. The patient received approximately 20 previous flu vaccines. The patient would get 1/2 shot and next 1/2 one week later without sequelae. The patient had no illness at the time of vaccination and no other vaccinations within 4 weeks of the FLUZONE. The patient received on 18 October at 11:00 AM a left deltoid intramuscular injection of FLUZONE, lot number U3700AA. The patient developed at 5:00 PM on 18 October 2010 upper respiratory infection. The vertigo developed on 25 October 2010 and required a doctor's visit on 25 October 2010. The vertigo did not initially respond to Epley maneuvers therefore, she was treated with meclizine and responded rapidly. The vertigo was a gradual resolution with meclizine over 3 days (28 October 2010). The patient returned to work on 27 October 2010. The outcome was reported as recovered. Documents held by sender: None.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Initial case was received on 18 October 2010 from a healthcare provider. An 83 year old male patient received on 27 September 2010 an intramuscular left deltoid injection of FLUZONE (lot number UH182AC). He began having pain throughout the left arm after the vaccine administration. The pain was so intense, the patient had difficulty lifting his arm. No other symptoms were noted. The patient was to have an magnetic resonance imaging (MRI). Pre-existing medical conditions were unknown. Concomitant medications were acetaminophen and Codeine. The patient was "healthy" at the time of the vaccination and had no vaccinations within 4 weeks. At the time of this report the patient had not recovered. Follow-up information was received on 02 November 2010 from a healthcare professional. the results of the MRI (date not reported) showed an inflamed bursa. The patient received an injection of Cortisone and the "symptoms cleared up". The pharmacist stated the "symptoms were not related to the vaccine" the patient received. The outcome status was recovered (date not reported). The reporter for this case (2010-05998) is the same as for case number 2010-05997. Documents held by sender: None.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Mass, Pain
Clinical narrative: Initial report received from a health care professional on 25 April 2011. A male patient, with no medical history reported, received on 23 October 2008 a left deltoid intramuscular injection of FLUZONE, lot number U2802AA. The patient had received doses of influenza vaccine prior to 2008 and doses after 2008. On an unknown date the patient developed a sore lump 3 inches below the injection site from the influenza vaccine that was given in 2008 on his left arm. The outcome was reported as not recovered. Documents held by sender: None.