chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, CSF test abnormal, Guillain-Barre syndrome, Laboratory test abnormal, Red blood cell sedimentation rate increased
Clinical narrative: Guillain Barre syndrome. IVIG for 5 days. Follow up on 05/06/04: "Final diagnosis is still Guillian-Barre Syndrome.  Diagnosis of GBS was made by neurologist.  The pt experienced other illnesses within the 4 weeks before onset of GBS symptoms, this included a stuffy nose.  The pt never had GBS or a related illness.  The pt never previously received influenza vaccination. "  Nurse follow up on 05/18/04 states: weakness lower extremities, urinary incontinence Medical records states rhinitis. msv
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinitis, Urinary incontinence
Clinical narrative: Guillain Barre syndrome. IVIG for 5 days. Follow up on 05/06/04: "Final diagnosis is still Guillian-Barre Syndrome.  Diagnosis of GBS was made by neurologist.  The pt experienced other illnesses within the 4 weeks before onset of GBS symptoms, this included a stuffy nose.  The pt never had GBS or a related illness.  The pt never previously received influenza vaccination. "  Nurse follow up on 05/18/04 states: weakness lower extremities, urinary incontinence Medical records states rhinitis. msv
Age: 42.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Significant swelling and redness of the right arm, beginning at the armpit and extending down to mid forearm, anterior aspect. Dull pain +6.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nasal congestion
Clinical narrative: C/O dizziness at 3am. Awoke in bed turned to side. Noticed dizziness. Mild dizziness continued states she feels well as of 1p 12/2/03-less dizziness, stuffy nose. Pt returned to work, feels improved.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: 11/13th at 11pm she received a flu shot then at 2pm she noticed that her arm was really sore, and swollen from the scapula area to below her elbow on left extremity. She states her arm was a dark red. MD stated to put cold packs on arm.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Felt dizzy after the vaccine but is now (at 5:25pm) feeling better.
Age: 3.7
Sex: M
Vaccine: FLU3
Symptoms: Cough, Rash, Wheezing
Clinical narrative: Received Fluzone on 10/28/03. Seen on 11/3/03 for cough, wheeze. Tx with 2-max. 11/4/03 mother report rash on trunk. Unclear if reaction was due to Abx or latex stopper of Fluzone.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Headache, Pyrexia, Somnolence
Clinical narrative: Extreme sleepiness, vision blurry, sensitive to noise, fever, joint pain, headache lasting 4-5 days. Light-headed, unable to drive for 2 days. Moving objects (such as cars) seemed to be in "slow motion." Doctor visit on 10/31/03.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Extreme sleepiness, vision blurry, sensitive to noise, fever, joint pain, headache lasting 4-5 days. Light-headed, unable to drive for 2 days. Moving objects (such as cars) seemed to be in "slow motion." Doctor visit on 10/31/03.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Laboratory test abnormal, Muscle spasms, Myelitis transverse
Clinical narrative: Patient had flu vaccine on 10/14/03. On 10/26/03, she developed numbness and tingling in feet which gradually moved up legs to waist. On 11/5/03, developed progressive weakness in legs and back spasms. On 11/3/03, she was unable to walk and had urinary retention, and was admitted. She could still move feet on admission. She was started on IV Solumedrol. Was completely paraplegic on 10/10/03. Now plasma exchange for transverse myelitis. The medical record received on 3/23/04 states burning pain. She is still paraplegic and has no movement or sensation in her legs. It is uncertain if the myelitis is due to the flu vaccine. Per annual report she remains completely paraplegic with no movement or sensation in her legs. Her last MRI 06/21/2004 showed very significant atrophy of the lower thoracic spinal cord.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia, Paraplegia, Urinary retention
Clinical narrative: Patient had flu vaccine on 10/14/03. On 10/26/03, she developed numbness and tingling in feet which gradually moved up legs to waist. On 11/5/03, developed progressive weakness in legs and back spasms. On 11/3/03, she was unable to walk and had urinary retention, and was admitted. She could still move feet on admission. She was started on IV Solumedrol. Was completely paraplegic on 10/10/03. Now plasma exchange for transverse myelitis. The medical record received on 3/23/04 states burning pain. She is still paraplegic and has no movement or sensation in her legs. It is uncertain if the myelitis is due to the flu vaccine. Per annual report she remains completely paraplegic with no movement or sensation in her legs. Her last MRI 06/21/2004 showed very significant atrophy of the lower thoracic spinal cord.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injection site erythema, Injection site swelling
Clinical narrative: 10 min following adm of flu vax developed sig. area of erythema, swelling and discomfort around inj site no respiratory prob. Ice pack applied and oral antihistamine advised.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Urticaria
Clinical narrative: Feet sick-couldn't sleep-28 hrs later I broke out in large hives. My Dr gave me large dose of vitamin C to stop the reaction. Two weeks later, I still have redness from the hives.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Injection site pain, Nausea, Palpitations
Clinical narrative: Local pain, rash on arm, progresses to palpitations, N/V, HA, diarrhea later the same day.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Vomiting
Clinical narrative: Local pain, rash on arm, progresses to palpitations, N/V, HA, diarrhea later the same day.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: HIV infection, Skin irritation
Clinical narrative: Hives/irritation in groin and armpit area similar to PCN reaction.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Urticaria
Clinical narrative: 4 hrs after receiving Pneumovax inj pt developed redness swelling and welts on her right arm.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Facial palsy, Muscle twitching
Clinical narrative: Syndrome of facial ticks and altered taste began 11/17 and became recognizable as Bell's Palsy by 11/19.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Oedema peripheral, Pain, Tenderness
Clinical narrative: Received vaccination 11/13. Fri 11/14 late night pain and swelling left axilary. Sat 11/15 extreme tenderness and swelling lymph nodes left axillary. No fever, no rash. Injection site okay. No soreness.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pain, Tenderness
Clinical narrative: Received vaccine 11/13 am. Fri 11/14 afternoon developed left axillary lymphadenopathy. Sat 11/15 extreme tenderness of left axillary area. No problems at shot site. Took anti inflammatory to relieve pain.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, fever 102, aching body.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Heart rate increased, Lymphadenopathy, Nausea, Pain
Clinical narrative: One hour after injections developed focal L frontal headache x 6 hrs. Then experienced nausea, increased HR, flat rash on neck and chest, achiness. Painful swollen lymph nodes R axilla. Rash worse post two days, all over x/sx resolved. No Rx at ER visit.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: One hour after injections developed focal L frontal headache x 6 hrs. Then experienced nausea, increased HR, flat rash on neck and chest, achiness. Painful swollen lymph nodes R axilla. Rash worse post two days, all over x/sx resolved. No Rx at ER visit.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Laboratory test abnormal, Tinnitus
Clinical narrative: Pt c/o tinnitus after last anthrax vaccination on 8/12/03.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Red swollen, hard-warm to touch.
Age: 9.0
Sex: M
Vaccine: UNK
Symptoms: Infection, Rash maculo-papular, Rash vesicular
Clinical narrative: Skin shows multiple macular-papular lesions and a few vesicular lesions. The lesions are now pretty well generalized. Impression: varicella. Pt doesn't appear ill, toxic or in distrexx.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Laboratory test abnormal, Oedema peripheral
Clinical narrative: 11/11/2003 arm started swelling and can't pick up anything that weighs anything causing arm extreme pain. Have no strength in arm.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Screaming
Clinical narrative: Screamed for 3 hrs after receiving Pediarix, Hib and Prevnar on 10/1/03.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Low grade fever and head to toe rash resembling measles.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Pneumovax admin right deltoid.  Had redness and swelling entire upper arm to elbow.  Painful.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Malaise, Pain
Clinical narrative: Arm became very swollen and sore to elbow patient felt sick.
Age: 9.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Patient received Varivax 08/02/2000 (somewhere else, not here) and today is having a large out break of pox over 120 and more appearing.  We don't have the data on who gave shots, lot #, etc.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Upper left arm red, swollen, warm
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Chicken pox 11/20/2003, no treatment required.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Mother reports chicken pox over 100 lesions.
Age: 1.6
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Injection site induration, Injection site inflammation
Clinical narrative: 3cmx4cm inflammation, induration around injection site left thigh, prevnar.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Patient and siblings all received varicella vaccine at different times, recently 11/18, all developed chicken pox. The follow up received on 12/23/03 states varicella not given in our office. Was given 9/26/97 in another office, don't have lot #.
Age: 1.1
Sex: M
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Development vesicular rash to scalp and body and mouth.  15-17 days after varicella vaccine.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Just came down with chicken pox
Age: 6.0
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: Over 20 chicken pox seen.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: A report was received from a consumer on 11/21/2003 concerning a 39 year old male vaccinee who experienced seizures 2 days after receiving Fluvirin on 10/14/2003.  The vaccinee had not been vaccinated for influenza previously and has no known allergies.  Concomitant medications taken included levothyroxine sodium.  On 10/16/2003 the vaccinee experienced a seizure.  A complete work-up was conducted including blood work, magnetic resonance imaging, and electrocardiogram, the results of which were unremarkable.  On 11/16/2003 the vaccinee experienced another seizure.  Following the seizure the vaccinee presented to an ER.  Blood work and an electrocardiogram was obtained, the results of which were unremarkable.  Follow up pending.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Rash macular, Rash pruritic
Clinical narrative: Patient received primary smallpox on 11/15/2003.  On day 3 he developed nocturnal chills (temp. not taken), tender axillary lymph nodes, mild headachex 2-3 days.  On D8. he developed a macular, pruritic rash on the arms, torso and legs following.  He presented to the ER at the hospital.  He was evaluated and released the same day.  Patient is not sure if cultures wre taken.  He was given oral antibiotics for 10 days.  Patient report that the rash has resolved.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Hypersensitivity, Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: 11/4/03: Mother states child c/o slight itching and reddness at sight of injection 11/5/03: Mother called the Health Dept. around 6 p.m. to report that injection site is size of golf ball with reddness and defined borders. Child c/o increased in itching. Told by Health Dept. to take child to ER. Mother states ER MD gave child Benadryl and Ibuprofen and called it allergic reaction.  11/6/03 Mother states child is better and attended school today.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dyspnoea, Heart rate increased, Pallor
Clinical narrative: difficulty breathing, fast heartbeat, paleness, weakness
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Neck pain, Shoulder pain
Clinical narrative: T.C. from client.  States "Igot a flu shot thursday and my neck and shoulder got really sore friday"  Woke up Friday AM with neck being so sore that she was unable to move it denies left arm being sore.  C/O left side to buttocks region being sore.  Taking ibuprofen every 4 hours.  Client intends to call physician.  Denies doing thing unusual thursday.  11-25-03 2:30 pm follow-up with patient - possible adverse reaction to flu vaccine - phone call placed to patient.  She stated she had seen the doctor Monday 11-24-03 and he said it was highly unlikely that the flu shot had anything to do with her sore neck and shoulder and left side of buttocks region.  Doctor ordered cyclobenate (muscle relaxer) and bestra (anti-inflamatory) Patient states she is felling better.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, HEP, MEA, MU, RUB, SMALL, ANTH, HEP, MMR, SMALL, TYP
Symptoms: Accident, Anaemia, Back pain, Blood lactate dehydrogenase increased, Blood pressure decreased
Clinical narrative: Information has been received from a newpaper article concerning a 22 year old female with no history of skin problems or immune system problems, who in March 2003, was vaccinated with a dose of MMR (lot # not reported). Additional suspect therapies included vaccination on the same day with hepatitis B vaccine, smallpox vaccine, anthrax vaccine and typhoid vaccine. Subsequently, she fell sick with aches and fever resembling the cold that other members had. When the symptoms worsened, they resembled lupus. In April 2003, the patient died of a complicated illness, diagnosed as like lupus. It was noted that she eventually died from bleeding in her lungs. It was said two medical panels looked into the case and agreed that the death was probably or possibly an adverse reaction to vaccines, though they did not single out one. No further information is available.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, HEP, MEA, MU, RUB, SMALL, ANTH, HEP, MMR, SMALL, TYP
Symptoms: Chest pain, Collagen disorder, Convulsion, Cough, Dyspnoea
Clinical narrative: Information has been received from a newpaper article concerning a 22 year old female with no history of skin problems or immune system problems, who in March 2003, was vaccinated with a dose of MMR (lot # not reported). Additional suspect therapies included vaccination on the same day with hepatitis B vaccine, smallpox vaccine, anthrax vaccine and typhoid vaccine. Subsequently, she fell sick with aches and fever resembling the cold that other members had. When the symptoms worsened, they resembled lupus. In April 2003, the patient died of a complicated illness, diagnosed as like lupus. It was noted that she eventually died from bleeding in her lungs. It was said two medical panels looked into the case and agreed that the death was probably or possibly an adverse reaction to vaccines, though they did not single out one. No further information is available.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, HEP, MEA, MU, RUB, SMALL, ANTH, HEP, MMR, SMALL, TYP
Symptoms: Electrocardiogram abnormal, Laboratory test abnormal, Mental impairment, Nausea, Pleural effusion
Clinical narrative: Information has been received from a newpaper article concerning a 22 year old female with no history of skin problems or immune system problems, who in March 2003, was vaccinated with a dose of MMR (lot # not reported). Additional suspect therapies included vaccination on the same day with hepatitis B vaccine, smallpox vaccine, anthrax vaccine and typhoid vaccine. Subsequently, she fell sick with aches and fever resembling the cold that other members had. When the symptoms worsened, they resembled lupus. In April 2003, the patient died of a complicated illness, diagnosed as like lupus. It was noted that she eventually died from bleeding in her lungs. It was said two medical panels looked into the case and agreed that the death was probably or possibly an adverse reaction to vaccines, though they did not single out one. No further information is available.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, HEP, MEA, MU, RUB, SMALL, ANTH, HEP, MMR, SMALL, TYP
Symptoms: Pneumonitis, Pyrexia, Sepsis, Supraventricular tachycardia, Vomiting
Clinical narrative: Information has been received from a newpaper article concerning a 22 year old female with no history of skin problems or immune system problems, who in March 2003, was vaccinated with a dose of MMR (lot # not reported). Additional suspect therapies included vaccination on the same day with hepatitis B vaccine, smallpox vaccine, anthrax vaccine and typhoid vaccine. Subsequently, she fell sick with aches and fever resembling the cold that other members had. When the symptoms worsened, they resembled lupus. In April 2003, the patient died of a complicated illness, diagnosed as like lupus. It was noted that she eventually died from bleeding in her lungs. It was said two medical panels looked into the case and agreed that the death was probably or possibly an adverse reaction to vaccines, though they did not single out one. No further information is available.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, HEP, MEA, MU, RUB, SMALL, ANTH, HEP, MMR, SMALL, TYP
Symptoms: Systemic lupus erythematosus
Clinical narrative: Information has been received from a newpaper article concerning a 22 year old female with no history of skin problems or immune system problems, who in March 2003, was vaccinated with a dose of MMR (lot # not reported). Additional suspect therapies included vaccination on the same day with hepatitis B vaccine, smallpox vaccine, anthrax vaccine and typhoid vaccine. Subsequently, she fell sick with aches and fever resembling the cold that other members had. When the symptoms worsened, they resembled lupus. In April 2003, the patient died of a complicated illness, diagnosed as like lupus. It was noted that she eventually died from bleeding in her lungs. It was said two medical panels looked into the case and agreed that the death was probably or possibly an adverse reaction to vaccines, though they did not single out one. No further information is available.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, HEP, MEA, MU, RUB, SMALL, ANTH, HEP, MMR, SMALL, TYP
Symptoms: Pain, Pyrexia, Systemic lupus erythematosus
Clinical narrative: Information has been received from a newpaper article concerning a 22 year old female with no history of skin problems or immune system problems, who in March 2003, was vaccinated with a dose of MMR (lot # not reported). Additional suspect therapies included vaccination on the same day with hepatitis B vaccine, smallpox vaccine, anthrax vaccine and typhoid vaccine. Subsequently, she fell sick with aches and fever resembling the cold that other members had. When the symptoms worsened, they resembled lupus. In April 2003, the patient died of a complicated illness, diagnosed as like lupus. It was noted that she eventually died from bleeding in her lungs. It was said two medical panels looked into the case and agreed that the death was probably or possibly an adverse reaction to vaccines, though they did not single out one. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: SIDS.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: SIDS
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Hyperhidrosis, Injection site reaction, Injection site swelling, Pain
Clinical narrative: Information has been received from a health professional concerning a 36 year old male who was vaccinated with a first dose of pneumococcal polysaccharide vaccine (lot # 0364N). Subsequently, the patient experienced hives and possible systemic and local reactions (also reported as injection site reactions). The patient was treated with prednisone. There was no product quality complaint involved. Upon internal review, the patient's hives and possible systemic and local reactions were considered to be other important medical events (OMIC). Additional information has been requested.  Follow up on 12/19/03: "Follow up information on 12/03/03 from the health care professional indicated that she "only knows that the pt was not hospitalized, but was seen in the ER for a fever and swelling at the injection site.  The pt was treated with prednisone and has since recovered.  The reporter indicated that she cannot recall the pt's name and therefore has no other information to report.  Upon internal review, the pt's hives and possible systemic and local reactions, fever and injection site swelling were considered to be other important medical events.  No further information is expected."  "Follow up information from the physician's office indicated that on 27OCT2003 at 18:30, the pt called and reported that he developed sweats, temperature 100.4, chills, headache, rash, swelling at the site and was achy all over. He was seen in the emergency room and was treated with IV fluids, ceftriaxone sodium and methylprednisolone sodium succinate injection. Some shortness of breath and lightheadedness were noted. Unspecified laboratory tests were performed in the emergency room. He received prednisone at a follow up visit on 28OCT2003. The patient received a nebulizeer at his follow up visit on 30OCT2003. It was reported that the patient recovered on 31OCT2003 or 01NOV2003. Upon internal review, the patient's adverse events were considered to be other important medical events. No further informationis expected.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 36 year old male who was vaccinated with a first dose of pneumococcal polysaccharide vaccine (lot # 0364N). Subsequently, the patient experienced hives and possible systemic and local reactions (also reported as injection site reactions). The patient was treated with prednisone. There was no product quality complaint involved. Upon internal review, the patient's hives and possible systemic and local reactions were considered to be other important medical events (OMIC). Additional information has been requested.  Follow up on 12/19/03: "Follow up information on 12/03/03 from the health care professional indicated that she "only knows that the pt was not hospitalized, but was seen in the ER for a fever and swelling at the injection site.  The pt was treated with prednisone and has since recovered.  The reporter indicated that she cannot recall the pt's name and therefore has no other information to report.  Upon internal review, the pt's hives and possible systemic and local reactions, fever and injection site swelling were considered to be other important medical events.  No further information is expected."  "Follow up information from the physician's office indicated that on 27OCT2003 at 18:30, the pt called and reported that he developed sweats, temperature 100.4, chills, headache, rash, swelling at the site and was achy all over. He was seen in the emergency room and was treated with IV fluids, ceftriaxone sodium and methylprednisolone sodium succinate injection. Some shortness of breath and lightheadedness were noted. Unspecified laboratory tests were performed in the emergency room. He received prednisone at a follow up visit on 28OCT2003. The patient received a nebulizeer at his follow up visit on 30OCT2003. It was reported that the patient recovered on 31OCT2003 or 01NOV2003. Upon internal review, the patient's adverse events were considered to be other important medical events. No further informationis expected.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia, Headache, Hypoaesthesia, Swelling, Transient ischaemic attack
Clinical narrative: Right arm swelled to size of egg. On 10/02 experienced numbness in left hand, tongue, and left side of mouth. On 10/4, experienced numbness in left foot and headache. Admitted to hospital on 10/4 for possible stroke. Doctor diagnosed GBS. I am having problems with eyes double vision at close range. Information from Discharge summary states GBS disproved, did show Trancent ischemic attack. msv
Age: 41.0
Sex: M
Vaccine: ANTH, FLU3, HEPA, SMALL
Symptoms: Feeling hot, Nasal congestion, Odynophagia, Pruritus, Pyrexia
Clinical narrative: Received shot 11/25/03 at Okubo Clinic in left shoulder (smallpox vaccine). Not primary vaccine. Also received Typhoid, tetanus booster, and had PPD placed few days prior. First noted itching at local site then feeling warm at site. Couple days later noted bumps in pectoral area on 11/30/03. Then noted back area, started itching. Also felt warm/fevered on 11/30/03. Some odynophagia and congestion on 12/1/03.
Age: 41.0
Sex: M
Vaccine: ANTH, FLU3, HEPA, SMALL
Symptoms: Rash
Clinical narrative: Received shot 11/25/03 at Okubo Clinic in left shoulder (smallpox vaccine). Not primary vaccine. Also received Typhoid, tetanus booster, and had PPD placed few days prior. First noted itching at local site then feeling warm at site. Couple days later noted bumps in pectoral area on 11/30/03. Then noted back area, started itching. Also felt warm/fevered on 11/30/03. Some odynophagia and congestion on 12/1/03.
Age: 30.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Less than 24 hrs after immunization Lt upper arm became swollen, erythematous and warm compared to other areas of skin. 72 hrs post immunization swelling expanded to forearm and shoulder. Treated with antihistamines.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Pt developed pain, redness and swelling approx 2 inches posterior to vaccine injection site on left deltoid, within 24 hours of injection. Pt also had persistent bleeding from needle stick.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus, Urticaria
Clinical narrative: Pt received flu vaccine 12/1/03, noticed hive like welts on arm right and right foot later in day. Denies SOB, diaphoresis, etc. did note ringing in ears at bedtime. No other symptoms described/noted.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Aspartate aminotransferase increased, Chills, Convulsion, Depressed level of consciousness, Encephalopathy
Clinical narrative: A report was received from a health care professional on 11/21/2003 concerning a 21 year old female vaccinee who experienced decreased consciousness and fever and was subsequently admitted to hospital with a possible West Nile Virus diagnosis on 11/05/2003 after receiving Fluvirin vaccine on 10/22/2003.  On 11/05/2003, two weeks following Fluvirin vaccination, the vaccinee experienced decreased consciousness and fever and was admitted to hospital with possible West Nile Virus diagnosis.  The vaccine experienced several seizures while in hospital that were resistant to standard doses of IV diazep and lorazepam.  The vaccinee remains hospitalized and her seizures are controlled using propofol drip.  At the time of the report the outcome was not reported.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending. The discharge summary received on 1/15/04 states chills, malaise, tics and drop attacks. Medical records states viral infection, tachycardia, encephalopathy. msv
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Leukocytosis, Malaise, Nausea, Pyrexia
Clinical narrative: A report was received from a health care professional on 11/21/2003 concerning a 21 year old female vaccinee who experienced decreased consciousness and fever and was subsequently admitted to hospital with a possible West Nile Virus diagnosis on 11/05/2003 after receiving Fluvirin vaccine on 10/22/2003.  On 11/05/2003, two weeks following Fluvirin vaccination, the vaccinee experienced decreased consciousness and fever and was admitted to hospital with possible West Nile Virus diagnosis.  The vaccine experienced several seizures while in hospital that were resistant to standard doses of IV diazep and lorazepam.  The vaccinee remains hospitalized and her seizures are controlled using propofol drip.  At the time of the report the outcome was not reported.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending. The discharge summary received on 1/15/04 states chills, malaise, tics and drop attacks. Medical records states viral infection, tachycardia, encephalopathy. msv
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia, Tic, Viral infection
Clinical narrative: A report was received from a health care professional on 11/21/2003 concerning a 21 year old female vaccinee who experienced decreased consciousness and fever and was subsequently admitted to hospital with a possible West Nile Virus diagnosis on 11/05/2003 after receiving Fluvirin vaccine on 10/22/2003.  On 11/05/2003, two weeks following Fluvirin vaccination, the vaccinee experienced decreased consciousness and fever and was admitted to hospital with possible West Nile Virus diagnosis.  The vaccine experienced several seizures while in hospital that were resistant to standard doses of IV diazep and lorazepam.  The vaccinee remains hospitalized and her seizures are controlled using propofol drip.  At the time of the report the outcome was not reported.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending. The discharge summary received on 1/15/04 states chills, malaise, tics and drop attacks. Medical records states viral infection, tachycardia, encephalopathy. msv
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Feeling hot, Hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: Swelling and warmth with fever left arm. C/w cellulitis or severe allergic reaction 24-48 hours after administration, increasing in size - PO Biaxin at 48 hours but continued so gt IV Cipro and PO Cipro at 96 hours in ER.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Pruritus, Rash erythematous, Urticaria
Clinical narrative: About 24 hours post injection redness, succinct, itching began at injection site. In another 12 hours hives all over body. 3-4 cm induration, red, raised and itching. Treating with Zyrtec and steroid injection.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Pruritus, Rash erythematous
Clinical narrative: Within 12 hours of vaccination injection site red, swollen itching. In about 2 hours rash, red raised areas to entire extremity, abdomen and back.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: The family noticed redness, swelling, tenderness about 24 hours after the vaccine around the injection site. The area really has not changed. When seen on 12/01/03, area 10 x 14cm indurated, warm, erythematous.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: The family noticed redness, swelling, tenderness about 24 hours after the vaccine around the injection site. The area really has not changed. When seen on 12/01/03, area 10 x 14cm indurated, warm, erythematous.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia
Clinical narrative: No arm pain at time of injection; onset of right arm pain and fever greater than 100.  6 hours after administration, took Motrin 400mg with moderate effect.  Continues to complain of arm pain, radiating to consistant 11/24/2003.  Has not taken any pain medication since; spoke to MD 11/15/2003- MD not concerned; no further MD contact since 11/15/2003; unable to determine present pain level; no fever; pain not tender to touch-deep muscular pain; no fever for last 7 days; patient did not miss any work since med administration.  Does not plan to seek further medical follow-up.  Information received via telephone call to client on 11/24/2003.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Irritability
Clinical narrative: 2 year old child came to Arvada site clinic.  Received DTAP in left deltoid and MMR in right SQ arm.  Mother of child called concerned about redness, swelling and warm to touch in left arm.  Child also fussy.  Child was administered shot on 11/18/2003, went to bed early 11/19/2003 was very fussy and complained of left arm soreness.  Mom treated with Tylenol, cool compresses, swelling resolved 10/21/2003.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site inflammation, Injection site oedema, Pyrexia
Clinical narrative: Inflammation in right anterior thigh.  Increased temperature, swelling.
Age: 0.7
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Abscess, Erythema, Injection site induration
Clinical narrative: Vaccine administered 3 months ago, developed a steril abscess to right thigh - 2x2 cm.  Red and firm center.  Well lowlated.  Non-tender.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Urticaria.  Comfort treatment-Benadryl.
Age: 10.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Rash papular
Clinical narrative: Presented in office 11/24/2003 with scattered red papules arms and chest.  Total of 15 papules including one which later appeared on forehead.  Papules according to mom looked fluid filled, few days later-did not ooze or scab over.  Not itchy-lasted 8-9 days.  No prescription required other than warm baths.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Rash
Clinical narrative: Rash all over.  Benadryl prescribed and Tylenol.
Age: 34.0
Sex: F
Vaccine: TTOX
Symptoms: Face oedema, Flushing, Injection site erythema, Pain
Clinical narrative: From initial info received on 03/20/2003 from a medical assistant regarding an adverse event, it was reported that a 35-year-old female pt received an injection of Tetanus Toxoid, lot #U0737AA, administered in her right deltoid on 03/05/2003. That same day the pt experienced "pain and redness at site of injection, extreme flushing of skin, face and lip swelling". The pt reportedly did recover from these events. A similar event was also reported for another female pt who received an injection of Tetanus toxoid from the same lot (U0737AA) [see case 2003-00469 for details] on 03/04/2003. The reporter of this case is the same reporter of case 2003-00469.
Age: 56.0
Sex: F
Vaccine: TTOX
Symptoms: Face oedema, Flushing, Injection site erythema, Pain
Clinical narrative: From initial info received on 03/20/2003 from a medical assistant regarding an adverse event occurring in the USA, it was reported that a 57-year-old female pt received an injection of Tetanus Toxoid, lot #U0737AA, administered in her right deltoid on 03/04/2003. That same day the pt experienced "pain and redness at injection site, extreme flushing of skin, face and lips swelling". The pt reportedly did recover from these events. A similar event was also reported for another female pt who received an injection of Tetanus Toxoid from the same lot (U0737AA) [see case 2003-00468 for details] on 03/05/2003. The reporter of this case is the same reporter of case 2003-00468.
Age: 23.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope vasovagal
Clinical narrative: From initial correspondence received on 3/11/03, it was reported that a 23 year old male patient, who is a plasma donor, received a Tetanus Toxoid Absorbed vaccination, administered IM in the deltoid on 1/25/03. Reportedly that same day, exact time not specified, the patient experienced pallor and became lightheaded and diaphoretic after receipt of vaccination. The physician feels it was a vasovagal response. The patient reportedly recovered from this experience.
Age: 16.0
Sex: M
Vaccine: TTOX
Symptoms: Balance disorder, Dysphemia, Muscle twitching, Respiratory rate increased, Speech disorder
Clinical narrative: From initial info received on 04/30/2003 from a physician, regarding an adverse event, it was reported that a 16-year-old male pt received Tet Tox Ads, lot #U0975AA, in the right deltoid at 3:51 PM on 04/28/2003. The expiration date for this product is 11/25/2004. The same day, the pt experienced right arm seizures, speech difficulties, hives on his left clavicle, rapid breathing and balance difficulties. These symptoms began a few hours after vaccination, at 9:58 PM. On 04/29/2003, the pt experienced dizziness and was lightheaded, but did not experienced twitching. The pt was seen by a physician on an unspecified date. The recovery status was not reported. The physician clarified the reported term "arm seizure" as muscular twitching. Per the physician, the pt began to experience muscular twitching in the right antecubital area on the evening of 04/28/2003. The pt did not experience seizure activity. He began stuttering and developed a hive on his left clavicle. He was seen in the ER. His vital signs at that time were reported as stable.
Age: 16.0
Sex: M
Vaccine: TTOX
Symptoms: Urticaria
Clinical narrative: From initial info received on 04/30/2003 from a physician, regarding an adverse event, it was reported that a 16-year-old male pt received Tet Tox Ads, lot #U0975AA, in the right deltoid at 3:51 PM on 04/28/2003. The expiration date for this product is 11/25/2004. The same day, the pt experienced right arm seizures, speech difficulties, hives on his left clavicle, rapid breathing and balance difficulties. These symptoms began a few hours after vaccination, at 9:58 PM. On 04/29/2003, the pt experienced dizziness and was lightheaded, but did not experienced twitching. The pt was seen by a physician on an unspecified date. The recovery status was not reported. The physician clarified the reported term "arm seizure" as muscular twitching. Per the physician, the pt began to experience muscular twitching in the right antecubital area on the evening of 04/28/2003. The pt did not experience seizure activity. He began stuttering and developed a hive on his left clavicle. He was seen in the ER. His vital signs at that time were reported as stable.
Age: 4.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Erythema multiforme, Face oedema, Oedema peripheral, Rash, Urticaria
Clinical narrative: swelling of lips, hands progressing to urticarial lacy rash to trunk buttocks, post. thighs and palms of hand and soles of feet. Erythema Multiforme
Age: 100.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Loss of consciousness, Syncope
Clinical narrative: 10 mins. after pt. received the flu shot she complained of chest pain.  The nurse gave her NTG. & then the pt. c/o of difficulty breathing so the nurse started the pt's O2. After approximately 2 mins. the pt became unconscious and fell to the floor.  The nurse called 911, administered 0.3 ml of adrenalin & performed CPR.  The pt. responded within 30 seconds. The EMT's arrived, took over care of the pt. & transported her to the ED.  She was in the hospital overnight in the telemetry unit & discharged the following day. The hospital discharge summary received on 12/11/03 states syncope.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: pt. phoned to clinic, reporting rt. upper arm red and swollen, fever to touch. and bruising to site, Taking motrin and tylenol
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Rash
Clinical narrative: approximately 5-10" after vaccination red, flat patchy rash appeared on chest area rash lasted about 20" - by 10:55 a.m. rash fading substantially, very faint area present on area around collar bone
Age: 58.0
Sex: M
Vaccine: TD
Symptoms: Hyperplasia, Hypersensitivity, Injection site inflammation, Pruritus, Tenderness
Clinical narrative: On 6/9/3003 seveal days after recieving a deep cat claw puncture wound on finger, got left deltoid injection of TD. About one month later, noticed a small circular (few mms) inflamed area on left deltoid that was sensitive to touch and itched. Did not associate the irritation with the earlier injection. About a month later it was worse and about the size of a dime. Finally, on October 1, 2003 it was size of a quarter, and quite uncomfortable. Went to dermatologist MD. He did not know what it was. I suggested it might be an insect bite reaction. He removed it and sent some material in to be biopsied. I then went home and for the first time, remembered the tetnus injection. Checked my medical records and decided I had probably had a reaction to the vaccine. I called Dr. back and discussed the issue with him. The biopsy report was consistet with a reaction to the tetnus injection. diagonsed a "Persistent Hypersensitiviy Reaction" The biopsy report revealed: "Dense demal lymphoid infiltrate with atypia", and "Cutaneous lymphoid hyperplasia." The surgery has healed. I have no symptoms in that area outher than a quarter sized red area.   where surgical would was. I am following up becuase neither physician is sure whether it would be safe for me to ever again recieve a tetnus booster shot. It seemed appropriate to file this report prior to making more formal inquires. Dr. stated his recommendation would be to not have further tetnus shot injections. But, he stated he was not certain.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Apnoea, Asthenia, Back pain, Coagulation time shortened, Coordination abnormal
Clinical narrative: Client received an influenza vaccination on 10/21/03. On 11/8/03 he developed an upper respiratoy tract infection. His URTI resolved without treatment. He then developed shooting pains from his lower back down both posterior thighs on 11/14/03. Upon waking on 11/15/03 he experienced numbness and tingling in both of his hands and feet. He experienced progressive symmetric numbness for the next 24 hours, prompting his admission to a Hospital and then his transfer to another hospital. His symptoms continued to progress throughout 11/16/03, requiring his being placed on a mechanical ventilator. Nurse follow up on 05/18/04 states: weakness, leg pain, gait unsteady, arms weak, speech slurred, eyes droopy, difficulty swallowing. Medical records state weakness, ataxia, cough. Other correspondance states apnea.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Demyelination, Dysphagia, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Client received an influenza vaccination on 10/21/03. On 11/8/03 he developed an upper respiratoy tract infection. His URTI resolved without treatment. He then developed shooting pains from his lower back down both posterior thighs on 11/14/03. Upon waking on 11/15/03 he experienced numbness and tingling in both of his hands and feet. He experienced progressive symmetric numbness for the next 24 hours, prompting his admission to a Hospital and then his transfer to another hospital. His symptoms continued to progress throughout 11/16/03, requiring his being placed on a mechanical ventilator. Nurse follow up on 05/18/04 states: weakness, leg pain, gait unsteady, arms weak, speech slurred, eyes droopy, difficulty swallowing. Medical records state weakness, ataxia, cough. Other correspondance states apnea.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Haematuria, Hypoaesthesia, Hypokalaemia, Hypomagnesaemia, Laboratory test abnormal
Clinical narrative: Client received an influenza vaccination on 10/21/03. On 11/8/03 he developed an upper respiratoy tract infection. His URTI resolved without treatment. He then developed shooting pains from his lower back down both posterior thighs on 11/14/03. Upon waking on 11/15/03 he experienced numbness and tingling in both of his hands and feet. He experienced progressive symmetric numbness for the next 24 hours, prompting his admission to a Hospital and then his transfer to another hospital. His symptoms continued to progress throughout 11/16/03, requiring his being placed on a mechanical ventilator. Nurse follow up on 05/18/04 states: weakness, leg pain, gait unsteady, arms weak, speech slurred, eyes droopy, difficulty swallowing. Medical records state weakness, ataxia, cough. Other correspondance states apnea.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Leukocytosis, Pain, Speech disorder, Upper respiratory tract infection, Urine analysis abnormal
Clinical narrative: Client received an influenza vaccination on 10/21/03. On 11/8/03 he developed an upper respiratoy tract infection. His URTI resolved without treatment. He then developed shooting pains from his lower back down both posterior thighs on 11/14/03. Upon waking on 11/15/03 he experienced numbness and tingling in both of his hands and feet. He experienced progressive symmetric numbness for the next 24 hours, prompting his admission to a Hospital and then his transfer to another hospital. His symptoms continued to progress throughout 11/16/03, requiring his being placed on a mechanical ventilator. Nurse follow up on 05/18/04 states: weakness, leg pain, gait unsteady, arms weak, speech slurred, eyes droopy, difficulty swallowing. Medical records state weakness, ataxia, cough. Other correspondance states apnea.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Rash
Clinical narrative: Developed dizziness and red rash to upper chest. Benadryl 50mg IM.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis, Erythema, Rash, Rash macular, Urticaria
Clinical narrative: Received influenza vaccine on Nov 18 2002. Within  30 min developed a rash described as red blotches. No resp distress. Sought medical treatment. Continues to experience episodic outbreaks of rash. Chronic contact dermatitis vs Chronic urticaria
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash maculo-papular, Tenderness
Clinical narrative: RED SPLOTCHES ON INSIDE OF ARM.  NOT AT NEEDLE POINT BUT A FEW INCHES INSIDE ARM.  REDNESS AND TENDERNESS FOR ABOUT A WK.  NOT A PROBLEM - JUST SO YOU KNOW.  NOT SURE ABOUT WHICH FLU SHOT SO ENTERED 1'ST ON LIST.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: Hoarseness and sinus drainage, sore throat, no treatment so far
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chest pain, Feeling cold, Hypoaesthesia
Clinical narrative: Several hours after receiving the vaccine c/o numbness form neck to feet lasting couple of seconds,superficial chest pain lasting few seconds and a feeling of coldness and weakness