chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: Case number PHEH2012US023559 is an initial spontaneous report received from a consumer on 28 Nov 2012: This report refers to a female patient of unknown age group. She was vaccinated with FLUVIRIN (batch number: 1200501 and expiry date: Jun 2013) intramuscularly into the left arm at a dose of 0.5 ml on 01 Oct 2012. On 02 Oct 2012, she experienced a locked arm with crippling pain that had limited movement of her left arm for 30 days. She presented with inability to sleep for one month because the pain was bothersome, she was unable to put on sleeves when dressing, she had to use her right arm/hand to move her left arm and she was unable to lift and hold items with her left arm. One month after the pain started, she went to a clinic where the physician suggested that she had experienced a rotary cuff injury; however she denied the claim. She had reported this incident to the Vaccine Adverse Event Reporting System (VAERS). Although the intensity of the pain had subsided significantly there was residual pain and discomfort with the movement of her left arm that still persisted. No further information was available.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Blood culture, CSF culture, Electroencephalogram, Lumbar puncture, Myoclonus
Clinical narrative: Fever preceded by Myoclonic jerks (possible seizure).
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever preceded by Myoclonic jerks (possible seizure).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Right upper arm area immediately became painful turning to pink color on third day. Visited Dr. who diagnosed full-blown Cellulitis. Took Cephalexin 500 3 times a day for 10 days. Recovered.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Cardiac function test normal
Clinical narrative: Patient received flu vaccine on 11/15/12. Few hours later developed mid back pain requiring trip to Emergency Room where she was admitted to the hospital, cardiac work up (-). Pain resolved the following day.
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Influenza like illness, Spinal pain
Clinical narrative: Case number PHEH2012US023403 is an initial spontaneous report received from a consumer on 27 Nov 2012. This report refers to a male patient whose medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date. On an unknown date he experienced flu like symptoms. The second day after injection, he experienced a sharp pain along his spine and was unable to walk and get around by himself for 3 weeks. It was reported that he still complains of some pain when walking and was unable to go to physician. The outcome of the event was not reported. No further information was provided.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Oropharyngeal discomfort, Throat irritation
Clinical narrative: 430 Coughing and tickly throat after FLUMIST. No hives, swelling lips/tongue, BENADRYL 25mg po at 440. Resp rate 18, no hives, swelling lips or tongue. 450 - Resp rate 18. No hives, swelling lips, diff breathing. Child states "felt medicine dripping in throat". 500 - Resp 18 "throat OK, not tickly".
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Visual field defect, Visual impairment
Clinical narrative: 3:45pm - black spot in center vision 1 min after vaccine given. States felt coming on when putting medication (vaccine) in arm. Laid pt down on examining table vitals taken, cool cloth over eyes. Vitals normal, patient declined 911, called 911, after taking her into hallway, pt. black spot gone but right eye loss of peripheral vision, right side, right fingers tingling. Smile normal equal, hand grasps equal, ambulance came took patient to hospital. Pt. able to walk to cart. Called 11/29/12 vision return to normal did stay at ER - went home.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Developed redness, swelling injection site, diarrhea, nausea, fatigue within 12 hrs of injection. Tx with BENADRYL & ZOFRAN.
Age: 18.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: 14cm x 16.5cm erythematous, indurated oval on left arm at injection site, fever 103 for 3 days, pounding headache lasting six days.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Catheterisation cardiac, Chest X-ray, Chest discomfort, Chills, Echocardiogram
Clinical narrative: Severe chest pressure, headache, fever, chills, fatigue, body aches.  Treated at medical facility and diagnosed with pericarditis after EKG and heart cath, due to symptoms of heart attack.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram, Fatigue, Headache, Laboratory test, Myocardial infarction
Clinical narrative: Severe chest pressure, headache, fever, chills, fatigue, body aches.  Treated at medical facility and diagnosed with pericarditis after EKG and heart cath, due to symptoms of heart attack.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Pain, Pericarditis, Pyrexia
Clinical narrative: Severe chest pressure, headache, fever, chills, fatigue, body aches.  Treated at medical facility and diagnosed with pericarditis after EKG and heart cath, due to symptoms of heart attack.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Patient stated he felt dizzy. Laid patient down on exam table. Patient stated felt better. BP 113/68. Patient sat up BP 100/67 and stated felt fine. Patient stood up BP 98/69 and patient stated felt fine. Walked patient to car and notified him to lay down if he feels dizzy again. Also if he does not feel better by laying down go to ER.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Maternal exposure during pregnancy, Pyrexia
Clinical narrative: Pt c/o swelling at injection site with fever x 1 day.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Extensive swelling of vaccinated limb, Screaming
Clinical narrative: 2-3 hours of inconsolable screaming/crying. HUGE leg swelling.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Fatigue, Feeling abnormal, Headache, Injection site pruritus
Clinical narrative: 11-26-12 PM itchiness at the vaccination site in afternoon / evening with little or no pain at the site. 11-27-12 in AM presented with cold symptoms and mild pain at the vaccination site muscular area of left arm. 11-27-12 in PM cold symptoms increased with some congestion and mild pain spreading from vaccination site through arm. Late PM muscular area pain increase and patient self medicated with 2 Advil. 11-28-12 AM called in sick to work, entire left arm and hand now has moderate muscular and nerve type pain, headache and tiredness present. 11-28-12 PM moderate muscular and nerve type pain on left arm increase and muscular pain started to spread across left side pectoral and into trapezius muscles with continued tiredness and headache. Planned to seek urgent care if pain did not subside, however, self medicated with 4 Advil and slept for 2 hours. Felt better when awakening. 11-29-12 AM returned to work but still felt bad with slight headache, tiredness and moderate muscular and nerve type pain on left arm. 11-30-12 felt better.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Nasopharyngitis, Neuralgia, Pain in extremity, Respiratory tract congestion
Clinical narrative: 11-26-12 PM itchiness at the vaccination site in afternoon / evening with little or no pain at the site. 11-27-12 in AM presented with cold symptoms and mild pain at the vaccination site muscular area of left arm. 11-27-12 in PM cold symptoms increased with some congestion and mild pain spreading from vaccination site through arm. Late PM muscular area pain increase and patient self medicated with 2 Advil. 11-28-12 AM called in sick to work, entire left arm and hand now has moderate muscular and nerve type pain, headache and tiredness present. 11-28-12 PM moderate muscular and nerve type pain on left arm increase and muscular pain started to spread across left side pectoral and into trapezius muscles with continued tiredness and headache. Planned to seek urgent care if pain did not subside, however, self medicated with 4 Advil and slept for 2 hours. Felt better when awakening. 11-29-12 AM returned to work but still felt bad with slight headache, tiredness and moderate muscular and nerve type pain on left arm. 11-30-12 felt better.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Vaccination site pain
Clinical narrative: 11-26-12 PM itchiness at the vaccination site in afternoon / evening with little or no pain at the site. 11-27-12 in AM presented with cold symptoms and mild pain at the vaccination site muscular area of left arm. 11-27-12 in PM cold symptoms increased with some congestion and mild pain spreading from vaccination site through arm. Late PM muscular area pain increase and patient self medicated with 2 Advil. 11-28-12 AM called in sick to work, entire left arm and hand now has moderate muscular and nerve type pain, headache and tiredness present. 11-28-12 PM moderate muscular and nerve type pain on left arm increase and muscular pain started to spread across left side pectoral and into trapezius muscles with continued tiredness and headache. Planned to seek urgent care if pain did not subside, however, self medicated with 4 Advil and slept for 2 hours. Felt better when awakening. 11-29-12 AM returned to work but still felt bad with slight headache, tiredness and moderate muscular and nerve type pain on left arm. 11-30-12 felt better.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash, Swelling face
Clinical narrative: Pt rcd flu vaccine on 11/26, went to ER on 11/27 with facial swelling and rash bilat upper arms and neck. All sx resolved with IV abx. Pt instructed to never get flu shot again.
Age: 51.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Flu mist administered out of directed age range of 2-49.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pain in left arm (where injection was given) radiating down to elbow. Becomes severe when moving arm up or over to the right side. Severe at night. Became worse the next day and continues with no relief. No relief from anti-inflammatories (ibuprofen, Mobic).
Sex: F
Vaccine: FLU3, HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event, not treatment.
Age: 1.27
Sex: M
Vaccine: DTAP, FLU3, HIBV
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Cough, Dyspnoea, Full blood count, Laboratory test
Clinical narrative: Coughing, wheezing, shortness of breath, tachycardia, @0530, treatment included Bi-pap, iv steroids, breathing treatments, chest xray, blood work, antibiotics, po steroids, inhalers.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia, Wheezing
Clinical narrative: Coughing, wheezing, shortness of breath, tachycardia, @0530, treatment included Bi-pap, iv steroids, breathing treatments, chest xray, blood work, antibiotics, po steroids, inhalers.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Itchy red rash on area where injection was administered.  Other arm also had slight rash, but left deltoid rash was much more prominent.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Soreness of upper arm, progressively worsening since vaccination, especially w/movement, state pain, 6-7/10.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: Can barely lift arm without pain. Can't cross arms over head to pull off a shirt and it aches all the time.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Neck pain, Pain in extremity, Sleep disorder
Clinical narrative: About a day and 1/2 after shot had intense pain radiating up the neck and down the arm. Has difficulty raising arm. Can't sleep because of pain. Took Aleve and will see a doctor if not better.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site red & swollen about 2 inches wide 6 inches long at ZOSTAVAX site -  still getting worse on 11/20/12 FLUZONE site red, swollen & sore to touch about the size of a dime.
Age: 11.0
Sex: F
Vaccine: FLUN3, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Syncopal episode 11/28/12, 2 days after immunizations - recovered & none since.
Age: 26.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Eye movement disorder, Syncope, Tremor
Clinical narrative: Client fainted following injections positioned onto floor feet elevated - eyes rolled back - several tremors extremities awake - did not know what happened & where she was - then oriented self to place & event maintained BP - P - because B.P. decreased once medics decided to transport - to be checked out B.P. 134/86 80 - 20 - 120/60 - 80 BP 100/70 90 standing 120/88 P 88.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Injection site erythema, Pharyngeal oedema
Clinical narrative: Redness at site, throat swelling, chest pain.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain
Clinical narrative: 1st night after, looked bruised, then proceeded to red & has remained painful to this date (grapefruit size area of upper left arm).
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Hypoaesthesia oral, Lip swelling
Clinical narrative: 2 hrs after swelling in lips, numbness tongue, express care, allergic rxn in mucous glands according to express care doctor.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus
Clinical narrative: Itching at injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis bullous, Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: Began swelling at injection site right arm 24 hr post injection red approximately 12 x 12 cm subsequent vesiculobullous eruption consistent with local herpes type reaction (foster).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema, Injection site pruritus, Injection site warmth, Throat irritation
Clinical narrative: Large, warm, red area at site of injection (above elbow) itchy. Large hard area below elbow on same arm possibly related. Scratchy throat.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Headache, Influenza virus test positive, Pain
Clinical narrative: Pt spouse called reports, pt has 103 degree temp after Flu shot 11-29-12 c/o HA body ache.
Age: 36.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling, Urticaria
Clinical narrative: Raised red welt, pain, swelling, hot to touch on (R) arm.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Inflammation, Oedema peripheral, Skin warm
Clinical narrative: Left arm started swelling up on 10/22. Arm was warm and continued to swell up. Went to Dr on 10/24 & they ordered a MEDROL dose pak for the inflammation. Provider said due to ADACEL & Pneumo together.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Pain in extremity
Clinical narrative: Patient reports metallic taste the day after receiving vaccination, and also moderate leg pain x2 weeks. I told her a physician visit might be in order.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Swollen tongue, Tremor
Clinical narrative: Patient reported having a fever of 103, shaking, swollen tongue for 2 days after receiving the vaccine. She reported symptoms lasted for one week. (Said it took her a week to feel good again.)
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Pruritus
Clinical narrative: Shortness of breath, itching, tightness in chest.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Neuralgia
Clinical narrative: Nerve pain from neck to arm MD feels this is unrelated, pt feels it is related (has had a fusion in the discs of the neck).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pruritus generalised, Rash, Scab
Clinical narrative: Headache, rash on torso, itching at various spots, spots which then got scabs on them showed up on 1 DEC 12 to  3 DEC 12 on left leg.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient has had soreness in the arm since administration. Pain is decreasing over time.
Age: 1.1
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt developed hives after flu shot. She had no resp. distress.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Grip strength decreased, Injected limb mobility decreased, Injection site pain
Clinical narrative: Taken vaccine shot in right arm, time shot given could feel sting pain. 3 hrs later my right arm could not lift arm, could not hold keys or anything in right hand.
Age: 11.0
Sex: M
Vaccine: FLUN3, MNQ
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Cellulitis down left deltoid approx. 13cm width x 14cm length; red, warm to touch; tx: cold compress to site watch for spreading, BENADRYL as needed. Call office with concerns.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Cough, Oropharyngeal pain, Pruritus
Clinical narrative: 11/21/12 24 hrs after: itching, swelling, blistering of both arms, hands- worse on Rt side (inj on left) even up behind Rt ear. Itching was intolerable. Blisters started1/4", then stretched 4"-5" long, lasted 40 hours. Coughing & sore throat.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Urticaria
Clinical narrative: 10/16/12 Tuesday pt given ZOSTAVAX inj. SQ (L) upper arm. 4" diam. whelp is evident with heat and redness. Rec: ibuprofen & BENADRYL x 3-4 days.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included four full-term previous pregnancies; history of the births was not known. On 10 October 2012 the subject received unspecified dose of FLUARIX (unknown). Her last menstrual period was on an unspecified date and estimated date of delivery in February 2013. The subject was exposed to FLUARIX during unknown trimester. On 10 October 2012, at the time of vaccination with FLUARIX, the subject experienced vaccine exposure during pregnancy. The outcome of the pregnancy was unknown. Follow up information was received on 26 November 2012 via healthcare professional. The subject's last menstrual period was on 27 July 2012 and estimated date of delivery was 16 April 2013. The pregnancy was by normal conception and consisted of one fetus. The subject was exposed to FLUARIX at 10 weeks gestation during the first trimester. The reporting healthcare professional considered the event of vaccine exposure during pregnancy to be serious [clinically significant] due to the potential risk of congenital anomaly. At the time of the report, the congenital anomaly was not confirmed by diagnostic/ prenatal testing or relevant medical history; no details were provided. The outcome of the pregnancy was ongoing.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Mobility decreased, Pain, Weight bearing difficulty
Clinical narrative: Day of vaccination client complained of burning sensation & unable to lift anything heavy took ADVIL with little relief. Saw MD 10/20/12 who advised warm compresses and ice. Client still has pain & unable to lift arm above head.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: Local reaction, cellulitis on site.
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Lupus-like syndrome, Platelet count decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of drop in platelet level in a teenager female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). In approximately 2002, the subject received unspecified dose of Hepatitis B vaccine (unknown). In 2002, two weeks after vaccination with Hepatitis B vaccine, the subject experienced drop in platelet level, hair loss, lupus-like reaction, possible lupus and vaccine reaction. The reporting healthcare professional stated that a subject previously received a hepatitis B vaccine 10 years ago (was unsure of the brand), two weeks after receiving the vaccine the subject experienced hair loss and platelets dropped. It was reported that "back then physicians were unsure if the subject had lupus type reaction or if this was due to the vaccine". The "hair loss may have been lupus or some delayed reaction to vaccination". The healthcare professional was inquiring about what the difference was between ENGERIX B and HAVRIX since the subject was to received a hepatitis A vaccine, the subject was instructed not to received another hepatitis B vaccine; the subject is currently 26-years old. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the drop in platelet level, hair loss, lupus-like reaction, possible lupus and vaccine reaction was unspecified. The vaccination course with Hepatitis B vaccine was discontinued.
Age: 86.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth, Vaccination complication
Clinical narrative: 10-3-12 rec'd injection. 10-9-12 developed warm itchy, red, rash on left deltoid. Saw uc provider 10-10-12. Pt treated with azithromycin just in case. 10-12-12 dr who saw pt at uc stated this was a probable vaccine reaction. No fever temp 97.8 & 98 degrees F,
Sex: F
Vaccine: TDAP
Symptoms: Coeliac disease, Vaccination complication
Clinical narrative: This case was reported by a pharmacist via Merck and described the occurrence of pertussis vaccination reaction in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced pertussis vaccination reaction and possible gluten reaction. The pharmacist reported a subject had a "reaction to the gluten that's in the pertussis vaccine. The subject has recovered". At the time of the report no other information was provided. At the time of reporting the events were resolved.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash over entire arm.
Age: 0.9
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events at this time 11/30/12.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Culture negative, Dizziness, Fatigue, Headache
Clinical narrative: 11/13 AM - not feeling well. By afternoon, had headache, nausea, dizzy, fever of 101.4 degrees and weak. Went to ER, they said "classic flu signs" but cultured neg. Gave anti-emetic & fluids. Noticed 3" x 3" red spot at injection site. 11/15 - went to primary doctor because rash spreading on entire upper arm. Started on CIPRO 500mg twice daily. 11/15 - no longer nauseous, feeling a little better, but still very tired. Treating with ice, TYLENOL, ALEVE and lots of water.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza, Injection site erythema, Injection site rash, Malaise, Nausea
Clinical narrative: 11/13 AM - not feeling well. By afternoon, had headache, nausea, dizzy, fever of 101.4 degrees and weak. Went to ER, they said "classic flu signs" but cultured neg. Gave anti-emetic & fluids. Noticed 3" x 3" red spot at injection site. 11/15 - went to primary doctor because rash spreading on entire upper arm. Started on CIPRO 500mg twice daily. 11/15 - no longer nauseous, feeling a little better, but still very tired. Treating with ice, TYLENOL, ALEVE and lots of water.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: 11/13 AM - not feeling well. By afternoon, had headache, nausea, dizzy, fever of 101.4 degrees and weak. Went to ER, they said "classic flu signs" but cultured neg. Gave anti-emetic & fluids. Noticed 3" x 3" red spot at injection site. 11/15 - went to primary doctor because rash spreading on entire upper arm. Started on CIPRO 500mg twice daily. 11/15 - no longer nauseous, feeling a little better, but still very tired. Treating with ice, TYLENOL, ALEVE and lots of water.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, chills, body aches, vomiting within 4 hrs of vaccination.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Approximately 24  hours after vaccination experienced lack of movement in right arm from elbow to shoulder. Arm is still sore today (Tuesday) but she is able to move arm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site pain, Contusion, Injection site swelling
Clinical narrative: Patient's arm became swollen and sore at administration site. Then she developed a very large bruise about 4"x6". The bruise resolved within 7-10 days.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Five hours after vaccination, patient said he had a severe dizzy spell that lasted about 20 minutes. He said this was very unusual for him to be dizzy. He reported this to the pharmacy where he received the immunizations.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site (L) arm was swollen, red, warm & painful for a week. Tx w/ ice and ibuprofen.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Pt. states shots were given too high in the arm although nurse states that the injections were given app 2-3 fingers down from shoulder bone.  Flu shot in RA was fine but the pneumonia shot into the LA  became red and swollen and started having trouble moving the arm. Went to the doctor who sent her to ortho doctor and another doctor consulted. Had x-rays done and lots of test done along with blood work. Has been on 3 different prescriptions and shoulder is in a sling.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Laboratory test, X-ray
Clinical narrative: Pt. states shots were given too high in the arm although nurse states that the injections were given app 2-3 fingers down from shoulder bone.  Flu shot in RA was fine but the pneumonia shot into the LA  became red and swollen and started having trouble moving the arm. Went to the doctor who sent her to ortho doctor and another doctor consulted. Had x-rays done and lots of test done along with blood work. Has been on 3 different prescriptions and shoulder is in a sling.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Gait disturbance, Paraesthesia
Clinical narrative: Noticed tingling in feet which then progressed over the next several days to difficulty walking.  She was seen in the ER on 10/31/12 due to difficulty walking and also found to have elevated BP.  Started on Metoprolol.  Went away for the winter and was seen at clinic where Dr. said possible Guillain Barre.  Saw family Dr. yesterday who told her to report as possible reaction to flu vaccine.  Will have EMG and further testing next week.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaemia, Blood culture, Blood test, Candidiasis, Chest X-ray
Clinical narrative: Fevers (102.6 max), sweating, fatigue, malaise, anemia, thrush. Adverse effects lasted until day of death.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram, Culture urine, Death, Echocardiogram, Fatigue
Clinical narrative: Fevers (102.6 max), sweating, fatigue, malaise, anemia, thrush. Adverse effects lasted until day of death.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Full blood count, Hyperhidrosis, Malaise, Pyrexia, Ultrasound scan
Clinical narrative: Fevers (102.6 max), sweating, fatigue, malaise, anemia, thrush. Adverse effects lasted until day of death.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urine analysis
Clinical narrative: Fevers (102.6 max), sweating, fatigue, malaise, anemia, thrush. Adverse effects lasted until day of death.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia
Clinical narrative: Fevers (102.6 max), sweating, fatigue, malaise, anemia, thrush. Adverse effects lasted until day of death.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaemia, Blood culture, Blood test, Candidiasis, Chest X-ray
Clinical narrative: Fever.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram, Culture urine, Death, Echocardiogram, Fatigue
Clinical narrative: Fever.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Full blood count, Hyperhidrosis, Malaise, Pyrexia, Ultrasound scan
Clinical narrative: Fever.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urine analysis
Clinical narrative: Fever.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fundoscopy, Rash, Skin lesion, Slit-lamp examination
Clinical narrative: According to the patient, the rash erupted yesterday morning but thinks that it is spreading. This morning patient noted small lesion in right inner canthus and on eyelid margin. Patient was treated with Valtrex 1g TID x 7 days.
Age: 27.0
Sex: M
Vaccine: RAB
Symptoms: Burning sensation
Clinical narrative: Burning sensation under tongue and gum.  Comes and hurts then leaves.  Drinking water and brushing teeth do not help.  Symptoms following Rabavert #4 for post-exposure prophylaxis.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Rhinorrhoea
Clinical narrative: Extreme tiredness, runny nose, dizziness.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Biopsy, Biopsy bone marrow, Blood test, Computerised tomogram
Clinical narrative: Started losing all feeling in arms and legs. Unable to walk unassisted.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Sensory loss, X-ray
Clinical narrative: Started losing all feeling in arms and legs. Unable to walk unassisted.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Heart rate increased, Throat irritation
Clinical narrative: She had the vaccination around 11am and sat with us afterward feeling okay. She didn't report any adverse events to us until around 2pm. She had never received the flu vaccine before. Patient had elevated pulse and scratchy throat that worsened as she sat with us but never had trouble breathing. Her voice also became hoarse. She took 25mg of diphenhydramine every 4-6 hours and didn't start to feel better until the next morning.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Adverse reaction, Burning sensation, Erythema, Feeling hot, Swelling
Clinical narrative: Redness, warmth, swelling, measured 4 inches h x 3 1/2 inches w and burning.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient became light headed and briefly lost conciousness following vaccine administration. Regained conciousness shortly after. Patient was provided a coke for sugar.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Chromaturia, Discomfort, Disorientation
Clinical narrative: Cold chills, pain through out entire body. Disoriented. Couldn't sleep. Unable to get comfortable nor warm. Unable to stop pain. For two days. Third day pain subsided, but still had chills. Before waking I sweated untill my bed, blankets, and pillows were saturated. Same thing on the next night. The day following, very weak, and groggy. Urine for all those days very dark yellow, even with plenty of water and other fluids(soups). Am still weak as of today.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Feeling cold, Insomnia, Night sweats, Pain, Somnolence
Clinical narrative: Cold chills, pain through out entire body. Disoriented. Couldn't sleep. Unable to get comfortable nor warm. Unable to stop pain. For two days. Third day pain subsided, but still had chills. Before waking I sweated untill my bed, blankets, and pillows were saturated. Same thing on the next night. The day following, very weak, and groggy. Urine for all those days very dark yellow, even with plenty of water and other fluids(soups). Am still weak as of today.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Febrile convulsion
Clinical narrative: He has had two febrile seizures after the immunization. One in August and one in December.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Lymphadenopathy, Nausea, Neck pain, Vomiting
Clinical narrative: Swollen lymph nodes and pain in neck, nausea and vomiting  12/01/2012 to present (12/04/2012).
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose decreased, Diabetes mellitus inadequate control
Clinical narrative: Low blood sugar, from morning onward, with difficulty to control it.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus
Clinical narrative: Pt. started experiencing itching to hands, soles of feet & knees, day 2 after flu shot. Pain on points. Took BENADRYL starting on Saturday.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site irritation, Injection site pain, Tenderness
Clinical narrative: Turned red (small) then spread, very tender over two days. Pain & irritation right upper shoulder/arm area. 7 inch square area. As of 16th - still red, but not tender.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Influenza like illness, Musculoskeletal stiffness
Clinical narrative: Flu like symptoms w/in 24 hours. Stiff neck. Headache. All symptoms lasted 5 days.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Borrelia test negative, Ear pain, Nuclear magnetic resonance imaging normal, VIIth nerve paralysis
Clinical narrative: Pt states starting on evening of 10/30 he had a sharp pain in ear area. On 10/31 had developed Bell's Palsy. Has been to 3 different physicians & incident has not resolved. Had MRI & Lyme came back negative, started Prednisone, Acyclovir & Doxycycline.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Erythema, Local reaction, Oedema
Clinical narrative: Weakness, chills, fever, emesis day after shots. So went to emergency room. After leaving emergency room, local reaction, edema & erythema left arm.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Weakness, chills, fever, emesis day after shots. So went to emergency room. After leaving emergency room, local reaction, edema & erythema left arm.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Confusional state, Death, Influenza like illness, Malaise
Clinical narrative: Patient died after receiving a HIGH DOSE flu shot on the morning of 11/21/12. The shot was administered at pharmacy. The shot was given to the patient at approximately 11:00 am on November 21, 2012. By late afternoon the patient was experiencing flu-like symptoms; chills, body aches, vertigo, nausea and confusion. The patient spoke with his eldest son late that evening by phone and told his son of his symptoms and the fact that he had been given a flu shot early that day. Patient died after receiving a HIGH DOSE flu shot on the morning of 11/21/12. The shot was administered at pharmacy. The shot was given to the patient at approximately 11:00 am on November 21, 2012. By late afternoon the patient was experiencing flu-like symptoms; chills, body aches, vertigo, nausea and confusion. The patient spoke with his eldest son late that evening by phone and told his son of his symptoms and the fact that he had been giving a flu shot early that day. At approximately 10:30 pm on 11/21/12 the phone conversation ended with the patient stating that he was going to the bathroom because he did not feel well. The next morning the patient did not respond to phone calls or knocking  on the door by relatives. Upon gaining entry to the home, the patient was found dead on the floor between his bedroom and bathroom hallway. The patient was naked and face down on the floor when found. The patient had no history of heart problems and had never experienced a heart attack.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pain, Vertigo
Clinical narrative: Patient died after receiving a HIGH DOSE flu shot on the morning of 11/21/12. The shot was administered at pharmacy. The shot was given to the patient at approximately 11:00 am on November 21, 2012. By late afternoon the patient was experiencing flu-like symptoms; chills, body aches, vertigo, nausea and confusion. The patient spoke with his eldest son late that evening by phone and told his son of his symptoms and the fact that he had been given a flu shot early that day. Patient died after receiving a HIGH DOSE flu shot on the morning of 11/21/12. The shot was administered at pharmacy. The shot was given to the patient at approximately 11:00 am on November 21, 2012. By late afternoon the patient was experiencing flu-like symptoms; chills, body aches, vertigo, nausea and confusion. The patient spoke with his eldest son late that evening by phone and told his son of his symptoms and the fact that he had been giving a flu shot early that day. At approximately 10:30 pm on 11/21/12 the phone conversation ended with the patient stating that he was going to the bathroom because he did not feel well. The next morning the patient did not respond to phone calls or knocking  on the door by relatives. Upon gaining entry to the home, the patient was found dead on the floor between his bedroom and bathroom hallway. The patient was naked and face down on the floor when found. The patient had no history of heart problems and had never experienced a heart attack.
Sex: U
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: Initial report received from a vaccine provider on 21 November 2012. This case is not medically confirmed as the reporter was not identified as a healthcare professional or not. Cluster of 5 children from the same reporter and same lot number UH753AB. Five children (age and gender not provided) had received a dose of FLUZONE (lot number UH753AB, IM) on an unspecified day in October 2012 and tested positive for Influenza A and influenza B via the Binaxnow quick test on an unspecified day in November 2012. Some children tested positive 3-4 days after vaccination, and some 2 weeks post-vaccination. Pre-existing medical histories and illness at time of vaccination were unknown. Outcomes for all five children were not recovered. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Left arm red & swollen, per mother pt was scratching the area.
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site paraesthesia, Joint crepitation, Paraesthesia
Clinical narrative: Initial case was received from a consumer on 21 November 2012. A male patient (age not provided) received a left deltoid intramuscular injection of ADACEL, sanofi pasteur Inc. lot number U4395AA, (corresponding sanofi pasteur Ltd. lot number C4210) on 25 October 2012. On the same day post vaccination, 25 October 2012, the patient complained of sharp pain and redness at left deltoid injection site with tingling down the left arm. He then started to notice a popping and clicking in left shoulder which persists to date, which required a doctor visit. The patient's past medical history was reported as unknown and illness at the time of vaccination was reported as none; however, he did have a bike accident in which he had injured his left arm prior to the injection. No diagnostic testing or treatments were reported. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Initial report was received from a healthcare professional on 26 November 2012. A 59-year-old male patient with no known allergies and a medical history of diabetes had received FLUZONE INTRADERMAL, lot number UH734AB, in the right deltoid on 09 November 2012. The number of previous doses was reported as "7th flu shots (not ID)." The patient had redness the "size of a silver dollar at site right after injection." This subsided after an unspecified time. "Four days ago," the patient started to complain of "neuritis type of pain from site down to forearm." The patient reported that "using the hand and sleeping on it makes it worse." These events required an ER/doctor visit. No further information was available at the time of the report. The patient outcome was not recovered. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Redness, warmth, soreness.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Hypersomnia, Influenza, Musculoskeletal pain
Clinical narrative: The following day I had a very sore shoulder with severe flu symptoms. I slept many hours during the day. Shoulder pain was so severe that I was unable to use the shoulder for about 3 weeks.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom reported on 12-04-12 that on 11-26-12 at 330 pm "(R) leg had redness and swelling from hip to knee." Mom applied cold compresses & adm TYLENOL. By next am swelling had subsided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Induration, Local reaction, Oral herpes
Clinical narrative: Cold sores on inner lip after 24 hrs -> VALTREX. Local reaction w/ erythema, induration after 2-3 hrs. Diarrhea after 48 hrs.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Large erythematous of (L) thigh 6 1/2 in X 4 inch patch. Warm/hot to touch & itching. Treatment- BENADRYL, MOTRIN & ice pack.
Age: 35.0
Sex: M
Vaccine: FLUN3, TDAP, TYP, YF
Symptoms: Anaphylactic reaction, Chest discomfort, Chest pain, Dysphagia, Painful respiration
Clinical narrative: This 35 year old reported receipt of Tdap (ac52b094ba SK), YF (uh287aa SP), FLUMIST (AH2193 Medimmune), and Typhoid Vi (g1541 SP) on 9/10/2012 at 10:00 am. Approximately 1 hour later after eating lunch he began to sneeze and had a runny nose. Lunch consisted of 2 slices of pizza bought day before from a family owned pizzeria which had red sauce, ground beef, oil, green peppers, onions and olives. He also advised eating hard boiled eggs with protein shake for breakfast 4 hours before getting vaccinations with no adverse reaction (eats frequently). Approximately 1 hour after eating but 2 hours since vaccinations, he complained of swelling, itching to face, lips, eyes, ears and itching to bilateral arms, difficulty speaking with tingling to mouth, lips and surrounding facial tissue and oral cavity (especially gums, but no tongue swelling), his throat felt tight and full "as if closing off", had difficulty swallowing water and he could only speak in whispers, he had a dull midsternal chest ache-tightness worse with breathing in/out. He denied any use or contact with new detergents, soaps, deodorants, shaving cream, clothing, etc. He took daily Lisinopril, but his was not a new prescription or new bottle. He returned to medical at 1431 hours (4 hours since vaccinated) with chest tightness, wheezing and throat swelling. He was treated for an anaphylactic reaction with IM BENADRYL, Albuterol neb, and EPIPEN with resolution of symptoms about 30 min later. He was released with MEDROL dose pak x 6 day, CLARITIN and ZANTAC with prn BENADRYL. Patient advised he completed all medications (MEDROL/CLARITIN/ZANTAX but no BENADRYL) without difficulty. he reported it took 2 days before he felt "normal" and remains asymptomatic since completion of medication on 9/16/12. He experienced a similar reaction in 2006 after eating falafel - Middle Eastern dish with chickpea's, parsley, tomatoes, and other ingredients: had hives with redness and swelling to hands/feet with some SOB but not as severe as 9/10/2012 event. He advised he routinely eats/uses oil, vinegar, mayo, mustard, ketchup, parsley, basil, regular peas, pita bread, etc with no adverse reaction. He has not eaten chick peas since 2006. He presented to the clinic on 9/19/2012 with no symptoms.
Age: 35.0
Sex: M
Vaccine: FLUN3, TDAP, TYP, YF
Symptoms: Paraesthesia, Paraesthesia oral, Pharyngeal oedema, Pruritus generalised, Radioallergosorbent test negative
Clinical narrative: This 35 year old reported receipt of Tdap (ac52b094ba SK), YF (uh287aa SP), FLUMIST (AH2193 Medimmune), and Typhoid Vi (g1541 SP) on 9/10/2012 at 10:00 am. Approximately 1 hour later after eating lunch he began to sneeze and had a runny nose. Lunch consisted of 2 slices of pizza bought day before from a family owned pizzeria which had red sauce, ground beef, oil, green peppers, onions and olives. He also advised eating hard boiled eggs with protein shake for breakfast 4 hours before getting vaccinations with no adverse reaction (eats frequently). Approximately 1 hour after eating but 2 hours since vaccinations, he complained of swelling, itching to face, lips, eyes, ears and itching to bilateral arms, difficulty speaking with tingling to mouth, lips and surrounding facial tissue and oral cavity (especially gums, but no tongue swelling), his throat felt tight and full "as if closing off", had difficulty swallowing water and he could only speak in whispers, he had a dull midsternal chest ache-tightness worse with breathing in/out. He denied any use or contact with new detergents, soaps, deodorants, shaving cream, clothing, etc. He took daily Lisinopril, but his was not a new prescription or new bottle. He returned to medical at 1431 hours (4 hours since vaccinated) with chest tightness, wheezing and throat swelling. He was treated for an anaphylactic reaction with IM BENADRYL, Albuterol neb, and EPIPEN with resolution of symptoms about 30 min later. He was released with MEDROL dose pak x 6 day, CLARITIN and ZANTAC with prn BENADRYL. Patient advised he completed all medications (MEDROL/CLARITIN/ZANTAX but no BENADRYL) without difficulty. he reported it took 2 days before he felt "normal" and remains asymptomatic since completion of medication on 9/16/12. He experienced a similar reaction in 2006 after eating falafel - Middle Eastern dish with chickpea's, parsley, tomatoes, and other ingredients: had hives with redness and swelling to hands/feet with some SOB but not as severe as 9/10/2012 event. He advised he routinely eats/uses oil, vinegar, mayo, mustard, ketchup, parsley, basil, regular peas, pita bread, etc with no adverse reaction. He has not eaten chick peas since 2006. He presented to the clinic on 9/19/2012 with no symptoms.