chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Patient received injection 12/14/04 SQ LA. 12/15/04, came to office having questionable reaction: fever, bad pain left arm, redness, swelling, flushed, headache. Patient called and admitted to hospital on 12/15/04 - 12/16/04. Diagnosed with cellulitis. Went to ER; got worse. Still in hospital.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Constipation, Coordination abnormal, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Patient admitted to hospital with ascending polyneuropathy consistent with Guillain Barre Syndrome. Symptoms worsened, given IVIG and he was transferred to tertiary care center for plasmapheresis. Symptoms began one hour after vaccine. He had URI 2 weeks prior to symptoms.   1/3/2005  Hospital d/c summary of 12/8-12/9/2004 states GBS, urinary retention & weakness.  Neuro consult done.  Pt had recent URI.  Admitted to ICU & tx w/IVIG initially.  Transferred to higher level of care.  2/02/2005 Hospital d/c summary of 12/9-12/15/2004 FINAL DX: GBS, Miller Fisher variant Records states pt experienced numbness of hands & feet within 2 hrs of vaccination on 12/7, weakness, difficulty walking, urinary retention, ataxia & constipation. Neuro consult & LP done.  Exam revealed marked ataxia.  Transferred to inptient rehab.  Follow up 03/01/05: The patient has not recovered from the events, has presistant ataxia and gait instability and neuropathic pain. As per annual follow up 01/04/2006 Some improvement, peripheral neuropathy of hands and feet. Trouble with gait and urinary retention. Some neuropathic pain.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Neuropathy, Pain, Polyneuropathy, Urinary retention
Clinical narrative: Patient admitted to hospital with ascending polyneuropathy consistent with Guillain Barre Syndrome. Symptoms worsened, given IVIG and he was transferred to tertiary care center for plasmapheresis. Symptoms began one hour after vaccine. He had URI 2 weeks prior to symptoms.   1/3/2005  Hospital d/c summary of 12/8-12/9/2004 states GBS, urinary retention & weakness.  Neuro consult done.  Pt had recent URI.  Admitted to ICU & tx w/IVIG initially.  Transferred to higher level of care.  2/02/2005 Hospital d/c summary of 12/9-12/15/2004 FINAL DX: GBS, Miller Fisher variant Records states pt experienced numbness of hands & feet within 2 hrs of vaccination on 12/7, weakness, difficulty walking, urinary retention, ataxia & constipation. Neuro consult & LP done.  Exam revealed marked ataxia.  Transferred to inptient rehab.  Follow up 03/01/05: The patient has not recovered from the events, has presistant ataxia and gait instability and neuropathic pain. As per annual follow up 01/04/2006 Some improvement, peripheral neuropathy of hands and feet. Trouble with gait and urinary retention. Some neuropathic pain.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Anaemia, Cough, Dehydration, Diarrhoea, Fatigue
Clinical narrative: Patient has a history of metastatic uterine leiomyosarcoma treated with chemotherapy (most recently thalidomide), radiation, hepatic chemoembolization and recent back surgery. One day after receiving a flu vaccine, patient developed fevers to 103 degrees F, nausea/vomiting, fatigue and pain and weakness in the proximal legs. Renal function also deteriorated and hemoglobin dropped (see lab results below) requiring a three day hospital admission for blood transfusion and treatment of dehydration and leg pain. Medical Record received on 1/12/2005 states mouth ulcers, wheezes, diarrhea, and cough.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Mouth ulceration, Muscular weakness, Nausea, Pain
Clinical narrative: Patient has a history of metastatic uterine leiomyosarcoma treated with chemotherapy (most recently thalidomide), radiation, hepatic chemoembolization and recent back surgery. One day after receiving a flu vaccine, patient developed fevers to 103 degrees F, nausea/vomiting, fatigue and pain and weakness in the proximal legs. Renal function also deteriorated and hemoglobin dropped (see lab results below) requiring a three day hospital admission for blood transfusion and treatment of dehydration and leg pain. Medical Record received on 1/12/2005 states mouth ulcers, wheezes, diarrhea, and cough.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Renal impairment, Vomiting, Wheezing
Clinical narrative: Patient has a history of metastatic uterine leiomyosarcoma treated with chemotherapy (most recently thalidomide), radiation, hepatic chemoembolization and recent back surgery. One day after receiving a flu vaccine, patient developed fevers to 103 degrees F, nausea/vomiting, fatigue and pain and weakness in the proximal legs. Renal function also deteriorated and hemoglobin dropped (see lab results below) requiring a three day hospital admission for blood transfusion and treatment of dehydration and leg pain. Medical Record received on 1/12/2005 states mouth ulcers, wheezes, diarrhea, and cough.
Age: 3.0
Sex: F
Vaccine: HIBV, PNC
Symptoms: Cellulitis, Erythema, Laboratory test abnormal, Oedema peripheral
Clinical narrative: Patient received PedvaxHIB, lot 0915N, via airgun in her right thigh 12/22/04. Subsequently developed cellulitis requiring IV antibiotics. Follow up 01/20/05: 2 days after receiving immunizations had swelling and redness that got severly worse and required Iv antibiotics for resolution (Cellulitis).
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Unevaluable event
Clinical narrative: Actual physical exam as not done. Patient presents to urgent care for COs adverse reaction. FOLLOW UP: 12/19/04 RN at facility of vaccination reported that reaction was bright red inflammed area on left thigh. Apparently not related to flu vaccine since DTaP was given at that site. Reaction was on left thigh (DTaP) site. Follow up 01/19/05: Unkown time and date of adversevent, mother of child did not follow up with reporter.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain
Clinical narrative: Arm pain since vaccination was administered intermittent joint pain with in 1 day hands, knees, fingers. No arm pain after injection until approximately 4 days later.
Age: 47.0
Sex: M
Vaccine: FLUN3
Symptoms: Difficulty in walking, Dizziness
Clinical narrative: Dizziness, Difficulty walking secondary to above
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Pruritus, Rash
Clinical narrative: Generalized rash over arms and legs "itching" and slight edema around mouth. Sent to ED MD and given epinephrine and prednisone pack. Released. On date of report to employee health, denied any symptoms.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Swelling, Urticaria
Clinical narrative: Large local allergic reaction (hives and swelling) adjacent to site. No history of allergy to eggs or antibiotics. Given prednisone and Benadryl.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Headache, Hypercholesterolaemia, Visual disturbance
Clinical narrative: Disorientation while at post office, sudden headache and some difficulty seeing. He stated he was seeing spots with more difficulty from right eye. Medical Record received on 1/06/2005 states hypercholesteremia.
Age: 0.51
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Dyskinesia, Tremor
Clinical narrative: Phone call received at 3:45 from mom stated son's head was shaking back and forth and hands twitching and jerking upon getting him out of car seat. She had given him Tylenol at 2PM. DTaP is only immunization. She read about that could have this side effect. Advised to go to ER and call pediatrician. Drs office closed today. Went to ER immediately after . Was observed x 15-20 min and sent home. Appointment with pediatrician 12/11/04. Mom refused lab work. Reaction thought to be possible seizure from temperature spiking.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Infection
Clinical narrative: Doctor's office 12/14/04 : states infected. Advil: warm compresses, red, hot arm. No temperature.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Hemiparesis, Hyperhidrosis, Hypoaesthesia, Paralysis
Clinical narrative: Weakness on the right side of his body. Touch makes right side of body sweat. Numbness in belly area. Loss of use of right hand. Pt is right handed.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Client called on 11/22/2004 requesting to know the type of vaccine administered to her on 11/19/04. Client reports that she developed a rash covering her entire body following administration of vaccine. Instructed client to see family physician client reports that she is going to contact family physician. 11/29/04 TC: pt reports that she is taking prednisone, saw physician and rash is resolving.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Hypersensitivity, Oedema, Pruritus, Urticaria
Clinical narrative: Reports developing area of swelling of her forehead which progressed to generalized swelling on various areas of her body with urticaria and pruritus within 2-4 hrs of receiving her anthrax immunization. She reports no problems with 3 prior anthrax vaccines.
Age: 58.0
Sex: M
Vaccine: ANTH, HEP, HEPA
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site swelling, Skin burning sensation
Clinical narrative: Received AVA (4), Hep A (2), and Hep B (3) on 9/28/04. Noted burning sensation for a minute or two during injection and right after receipt of the anthrax vaccine in his right arm. (He had not experienced that sensation with previous anthrax vaccines). He also noted a local reaction around his anthrax injection site-redness, tenderness, and swelling about the diameter of a golf ball and raised about 1/2.
Age: 58.0
Sex: M
Vaccine: ANTH, HEP, HEPA
Symptoms: Tenderness
Clinical narrative: Received AVA (4), Hep A (2), and Hep B (3) on 9/28/04. Noted burning sensation for a minute or two during injection and right after receipt of the anthrax vaccine in his right arm. (He had not experienced that sensation with previous anthrax vaccines). He also noted a local reaction around his anthrax injection site-redness, tenderness, and swelling about the diameter of a golf ball and raised about 1/2.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Skin ulcer
Clinical narrative: Received smallpox vaccination, 03Dec04. Over last few days has developed diffuse eruption of pustular lesions on arms, face, abdomen and back. Large lesion at site of innoculation. 25mm with multiple satellite lesions. No specific treatment. Shaving profile to minimize spread on face. F/U in 5 days or prn sooner if worse.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Erythema, Oedema, Tenderness
Clinical narrative: Left thigh redness/swelling/tenderness 10cm/12cm no streaking, no fever.
Age: 31.0
Sex: M
Vaccine: TYP
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: About 1 1/2 hrs after taking the 1st oral typhoid he developed hives and itching then became dyspneic. Given epinephrine by EMS and taken to ER. By the time he got to the ER he was back to normal.
Age: 5.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Pt has a local reaction reddened/ warm to touch area 4 1/2 x 4 1/2  inches in Rt thigh she received a DTaP/IPV. Treatment is Benedryl and cool compresses. No complaints of pain.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: 24 hour after vaccine, pt developed redness 4-5cm around Dtap site. No fever, no pain, no change in ROM of left shoulder, vaccine given to left deltoid.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Left deltoid redness, swollen, warm to touch
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Hypersensitivity
Clinical narrative: Left deltoid hypersensitivity reaction (Arthus reaction) Treatment observation, antihistamine
Age: 1.65
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Cellulitis, Feeling hot
Clinical narrative: Cellulitis 7cm diam total 11cm diam vesicles, warmth right thigh. ABT Keflex 250mg PO tid x 7 days.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain, Insomnia, Shoulder pain
Clinical narrative: Injection site sore for a few weeks.  Muscle pain around injection site persists a year later, particularly when lifting arm above shoulder or reaching.  Pain constantly radiated down arm into hand for 6 months then became intermittent.  Had difficulty sleeping for several months on left side as arm and shoulder hurt.  Didn't seek treatment as I assumed a nerve was hit and damaged.
Age: 21.0
Sex: M
Vaccine: HEP, SMALL
Symptoms: Erythema, Pruritus, Skin ulcer, Vaccination complication
Clinical narrative: Pt noted itching in R inguinal area approx 12/17/04.  Vaccinated with smallpox 12/08/04.  Erythematous and lesion consistent with autoinoculation.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthma, Atelectasis, Constipation, Cough, Dyspnoea
Clinical narrative: A report was received from a healthcare professional in the USA on 12/8/04 concerning a 30 year old female vaccinee. The vaccinees past medical history includes severe allergies to food, including eggs, wheat and corn. However on the patient's consent for influenza vaccine administration, it is documented that the vaccinee does not have allergies to eggs, chicken feathers, chicken dander, mercury or thimerosal. In addition, the vaccinee does not have severe latex sensitivity and did not have an acute illness with fever at the time of vaccination. The vaccinee did not receive an influenza vaccine during the previous season and she did not have a fever within 24 hours prior to vaccination. The vaccinees concomitant medication at the time of vaccination includes Albuterol, Aerobid, Biaxin, Zithromax, and antibiotics (unspecified). On approximately 12/18/03, the vaccinee received a single dose of Fluvirin (batch 765796) in the right deltoid. On approximately 12/24/03, the vaccinee developed severe congestion, shortness of breath, difficulty breathing (which were all thought to be due to a chest cold on 12/26/03), constipation and chronic fatigue. The vaccinee attended the emergency room on multiple occasions, but was never admitted to hospital. The vaccinee was treated with unspecified IV antioxidant treatments. The vaccinee underwent a thorough evaluation including an electrocardiogram and a chest x-ray which showed bibasilar atelectasis and infiltrates. Blood work included D. dimmer and arterial blood gases, but no results were provided. The vaccinee was seen by a pulmonary consultant and it was felt that she has a respiratory infection, as well as a history of asthma. The vaccinee was last seen by the pulmonologist on 3/1/04, when she was felt to have bronchial asthma, cough and allergic rhino-sinusitis. Chest x-ray demonstrated congestion, but was better than the last one and CT scan of the chest on 3/15/04 was normal. PA chest x-ray on 3/4/04 demonstrated atelectasis and a C-spine x-ray on an unspecified date demonstrated soft tissue swelling. It was not reported whether the vaccinee has recovered from these events. No information was provided regarding the reporter's assessment of causality between the events reported and the vaccination with Fluvirin. No further information is expected.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Rhinitis allergic, Upper respiratory tract infection
Clinical narrative: A report was received from a healthcare professional in the USA on 12/8/04 concerning a 30 year old female vaccinee. The vaccinees past medical history includes severe allergies to food, including eggs, wheat and corn. However on the patient's consent for influenza vaccine administration, it is documented that the vaccinee does not have allergies to eggs, chicken feathers, chicken dander, mercury or thimerosal. In addition, the vaccinee does not have severe latex sensitivity and did not have an acute illness with fever at the time of vaccination. The vaccinee did not receive an influenza vaccine during the previous season and she did not have a fever within 24 hours prior to vaccination. The vaccinees concomitant medication at the time of vaccination includes Albuterol, Aerobid, Biaxin, Zithromax, and antibiotics (unspecified). On approximately 12/18/03, the vaccinee received a single dose of Fluvirin (batch 765796) in the right deltoid. On approximately 12/24/03, the vaccinee developed severe congestion, shortness of breath, difficulty breathing (which were all thought to be due to a chest cold on 12/26/03), constipation and chronic fatigue. The vaccinee attended the emergency room on multiple occasions, but was never admitted to hospital. The vaccinee was treated with unspecified IV antioxidant treatments. The vaccinee underwent a thorough evaluation including an electrocardiogram and a chest x-ray which showed bibasilar atelectasis and infiltrates. Blood work included D. dimmer and arterial blood gases, but no results were provided. The vaccinee was seen by a pulmonary consultant and it was felt that she has a respiratory infection, as well as a history of asthma. The vaccinee was last seen by the pulmonologist on 3/1/04, when she was felt to have bronchial asthma, cough and allergic rhino-sinusitis. Chest x-ray demonstrated congestion, but was better than the last one and CT scan of the chest on 3/15/04 was normal. PA chest x-ray on 3/4/04 demonstrated atelectasis and a C-spine x-ray on an unspecified date demonstrated soft tissue swelling. It was not reported whether the vaccinee has recovered from these events. No information was provided regarding the reporter's assessment of causality between the events reported and the vaccination with Fluvirin. No further information is expected.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Atelectasis, Condition aggravated, Constipation, Cough, Dyspnoea
Clinical narrative: A report was received from a healthcare professional in the USA on 12/8/04 concerning a 30 year old female vaccinee. The vaccinees past medical history includes severe allergies to food, including eggs, wheat and corn. However on the patient's consent for influenza vaccine administration, it is documented that the vaccinee does not have allergies to eggs, chicken feathers, chicken dander, mercury or thimerosal. In addition, the vaccinee does not have severe latex sensitivity and did not have an acute illness with fever at the time of vaccination. The vaccinee did not receive an influenza vaccine during the previous season and she did not have a fever within 24 hours prior to vaccination. The vaccinees concomitant medication at the time of vaccination includes Albuterol, Aerobid, Biaxin, Zithromax, and antibiotics (unspecified). On approximately 12/18/03, the vaccinee received a single dose of Fluvirin (batch 765796) in the right deltoid. On approximately 12/24/03, the vaccinee developed severe congestion, shortness of breath, difficulty breathing (which were all thought to be due to a chest cold on 12/26/03), constipation and chronic fatigue. The vaccinee attended the emergency room on multiple occasions, but was never admitted to hospital. The vaccinee was treated with unspecified IV antioxidant treatments. The vaccinee underwent a thorough evaluation including an electrocardiogram and a chest x-ray which showed bibasilar atelectasis and infiltrates. Blood work included D. dimmer and arterial blood gases, but no results were provided. The vaccinee was seen by a pulmonary consultant and it was felt that she has a respiratory infection, as well as a history of asthma. The vaccinee was last seen by the pulmonologist on 3/1/04, when she was felt to have bronchial asthma, cough and allergic rhino-sinusitis. Chest x-ray demonstrated congestion, but was better than the last one and CT scan of the chest on 3/15/04 was normal. PA chest x-ray on 3/4/04 demonstrated atelectasis and a C-spine x-ray on an unspecified date demonstrated soft tissue swelling. It was not reported whether the vaccinee has recovered from these events. No information was provided regarding the reporter's assessment of causality between the events reported and the vaccination with Fluvirin. No further information is expected.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Lung disorder, Nasal congestion, Oedema, Respiratory tract infection
Clinical narrative: A report was received from a healthcare professional in the USA on 12/8/04 concerning a 30 year old female vaccinee. The vaccinees past medical history includes severe allergies to food, including eggs, wheat and corn. However on the patient's consent for influenza vaccine administration, it is documented that the vaccinee does not have allergies to eggs, chicken feathers, chicken dander, mercury or thimerosal. In addition, the vaccinee does not have severe latex sensitivity and did not have an acute illness with fever at the time of vaccination. The vaccinee did not receive an influenza vaccine during the previous season and she did not have a fever within 24 hours prior to vaccination. The vaccinees concomitant medication at the time of vaccination includes Albuterol, Aerobid, Biaxin, Zithromax, and antibiotics (unspecified). On approximately 12/18/03, the vaccinee received a single dose of Fluvirin (batch 765796) in the right deltoid. On approximately 12/24/03, the vaccinee developed severe congestion, shortness of breath, difficulty breathing (which were all thought to be due to a chest cold on 12/26/03), constipation and chronic fatigue. The vaccinee attended the emergency room on multiple occasions, but was never admitted to hospital. The vaccinee was treated with unspecified IV antioxidant treatments. The vaccinee underwent a thorough evaluation including an electrocardiogram and a chest x-ray which showed bibasilar atelectasis and infiltrates. Blood work included D. dimmer and arterial blood gases, but no results were provided. The vaccinee was seen by a pulmonary consultant and it was felt that she has a respiratory infection, as well as a history of asthma. The vaccinee was last seen by the pulmonologist on 3/1/04, when she was felt to have bronchial asthma, cough and allergic rhino-sinusitis. Chest x-ray demonstrated congestion, but was better than the last one and CT scan of the chest on 3/15/04 was normal. PA chest x-ray on 3/4/04 demonstrated atelectasis and a C-spine x-ray on an unspecified date demonstrated soft tissue swelling. It was not reported whether the vaccinee has recovered from these events. No information was provided regarding the reporter's assessment of causality between the events reported and the vaccination with Fluvirin. No further information is expected.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Sinusitis
Clinical narrative: A report was received from a healthcare professional in the USA on 12/8/04 concerning a 30 year old female vaccinee. The vaccinees past medical history includes severe allergies to food, including eggs, wheat and corn. However on the patient's consent for influenza vaccine administration, it is documented that the vaccinee does not have allergies to eggs, chicken feathers, chicken dander, mercury or thimerosal. In addition, the vaccinee does not have severe latex sensitivity and did not have an acute illness with fever at the time of vaccination. The vaccinee did not receive an influenza vaccine during the previous season and she did not have a fever within 24 hours prior to vaccination. The vaccinees concomitant medication at the time of vaccination includes Albuterol, Aerobid, Biaxin, Zithromax, and antibiotics (unspecified). On approximately 12/18/03, the vaccinee received a single dose of Fluvirin (batch 765796) in the right deltoid. On approximately 12/24/03, the vaccinee developed severe congestion, shortness of breath, difficulty breathing (which were all thought to be due to a chest cold on 12/26/03), constipation and chronic fatigue. The vaccinee attended the emergency room on multiple occasions, but was never admitted to hospital. The vaccinee was treated with unspecified IV antioxidant treatments. The vaccinee underwent a thorough evaluation including an electrocardiogram and a chest x-ray which showed bibasilar atelectasis and infiltrates. Blood work included D. dimmer and arterial blood gases, but no results were provided. The vaccinee was seen by a pulmonary consultant and it was felt that she has a respiratory infection, as well as a history of asthma. The vaccinee was last seen by the pulmonologist on 3/1/04, when she was felt to have bronchial asthma, cough and allergic rhino-sinusitis. Chest x-ray demonstrated congestion, but was better than the last one and CT scan of the chest on 3/15/04 was normal. PA chest x-ray on 3/4/04 demonstrated atelectasis and a C-spine x-ray on an unspecified date demonstrated soft tissue swelling. It was not reported whether the vaccinee has recovered from these events. No information was provided regarding the reporter's assessment of causality between the events reported and the vaccination with Fluvirin. No further information is expected.
Age: 1.01
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Sudden infant death syndrome
Clinical narrative: Found by family in morning in crib deceased. Received ER medical records which revealed patient arrived in ER lifeless.  COD thought to be cardiac arrest likely caused by SIDS.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Apnoea, Arteriosclerosis, Bradycardia, Coma, Pulse absent
Clinical narrative: Resident with toileting. Observed by staff to become nonresponsive, slumped off toilet two times. Body lift and then to bed. Respirations shallow and significant decreased with decreased ausultated lungs followed by pulse drop to 30-40 BPM. Then no BP. Then no pulse and no respiration. Resident deceased. Attempted CPR and oxygen. Death Certificate received on 12/29/2004 states COD is ASHD.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory rate decreased
Clinical narrative: Resident with toileting. Observed by staff to become nonresponsive, slumped off toilet two times. Body lift and then to bed. Respirations shallow and significant decreased with decreased ausultated lungs followed by pulse drop to 30-40 BPM. Then no BP. Then no pulse and no respiration. Resident deceased. Attempted CPR and oxygen. Death Certificate received on 12/29/2004 states COD is ASHD.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Apnoea, Cardiac arrest, Coma, Sudden infant death syndrome
Clinical narrative: Patient was found unresponsive in her crib at 6:45 AM when her motion sensitive baby monitor sounded on alarm. CRP was performed; EMT arrived. Patient was transported to hospital where she was DOA. Autopsy Report received on 12/22/2004 states SIDS. Discharge Summary received on 1/7/2005 states apnea and asystole.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye irritation, Rhinorrhoea, Sneezing
Clinical narrative: This is not a serious spontaneous case from a nurse in the USA of itching eyes. The reporter causality is not provided to FluMist. This case is submitted according to the VAERS reporting agreement for FluMist. This case is a spontaneous case report sent by a nurse that refers to a female aged 45 years. The patient's past medical history included allergies to grass and cats. She received FluMist on 11/29/04 at 8:20 in the morning. The patient's concomitant medication included Brompheniramine/Pseudoephedrine and Levothyroxine. By the afternoon of 11/29/04, the patient had a runny nose and some sneezing. The events continued through the night and the next morning. On the afternoon of 11/30/04, the events became worse. The patient was constantly sneezing and her nose was running like a faucet. By 6:00 that evening the patient was totally incapacitated. The runny nose and sneezing did not stop until 11:00 that evening. The reporter stated the patient's eyes had some itching and irritation, but mostly the patient's nose was itchy and irritated. The events continued into the following day, but to a lesser degree. The patient was mostly tired for the reaction from the previous 2 days. The reporter stated the patient felt perfect by the fourth day.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Myalgia, Sleep disorder, Uterine disorder
Clinical narrative: Persistent proximal muscle ache. Sleep disturbance, fatigue, pervasive uterine temporarily, Ibuprofen, Tylenol, Destinez Lt3
Age: 0.33
Sex: M
Vaccine: DTP, OPV
Symptoms: Crying, Deafness, Hearing impaired, Pyrexia
Clinical narrative: Approximately 6 hours after vaccination, patient ran temperature of less than 103 in spite of Tylenol every four hours. Crying hysterically, falling asleep for 10-15 minutes then crying again.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cough, Dehydration, Diarrhoea, Pyrexia
Clinical narrative: Fever, dehydration, diarrhea. Follow up : Previoiusly reported symptoms have abated. Ne onset of cought 3-4 days ago. Seen today in office 12/21/2004.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Blood electrolytes normal, Convulsion, Dehydration, Dyskinesia
Clinical narrative: 1 hour after shot, became apneic, eyes rolled up. Went to ER and had another episode there; jerking and stiffening, eyes rolled up. Attempted intubation. Gave phenobarbital and Ativan. No fever. Medical Records received on 1/20/2005 states dehydration and gastroenteritis. Follow-up information received from Product Quality indicated that the lot number, 197440F, was not a valid lot number for PREVNAR. Information regarding PREVNAR was received from a pediatrician via a company representative regarding a 4-month-old male patient who experienced a non-febrile seizure. At 4 months of age, the patient received a dose on 14-Dec-2004. The patient also received a dose of PEDIARIX (GSK) and a dose of PEDVAX-HIB (Merck) on 14-Dec-2004. On 14-Dec-2004, the patient experienced a non-febrile seizure. He was given "two rescue breaths" at home and was taken to an emergency room. The patient was then admitted to a hospital. The patient was then admitted to a hospital. An electroencephalogram and "electrolytes" were normal. Further treatment details were not provided. The patient recovered on an unspecified date. The reporting physician considered the event to be life threatening. The reporter indicated that, "no such reaction occurred at 2 month immunizations." Information regarding this event has been forwarded to Merck and GSK, manufacturers of the concomitantly administered vaccines. Information received from Product Quality indicated that the initially reported lot number, A7440F, was not a valid lot for PREVNAR. The physician's office was contacted on 18-Feb-2005, and another lot number was provided, 197440P (which was the only other number the office had recorded in the patient's chart). This lot number was also reported to be invalid by Product Quality.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Electroencephalogram, Eye rolling, Full blood count, Gastroenteritis, Musculoskeletal stiffness
Clinical narrative: 1 hour after shot, became apneic, eyes rolled up. Went to ER and had another episode there; jerking and stiffening, eyes rolled up. Attempted intubation. Gave phenobarbital and Ativan. No fever. Medical Records received on 1/20/2005 states dehydration and gastroenteritis. Follow-up information received from Product Quality indicated that the lot number, 197440F, was not a valid lot number for PREVNAR. Information regarding PREVNAR was received from a pediatrician via a company representative regarding a 4-month-old male patient who experienced a non-febrile seizure. At 4 months of age, the patient received a dose on 14-Dec-2004. The patient also received a dose of PEDIARIX (GSK) and a dose of PEDVAX-HIB (Merck) on 14-Dec-2004. On 14-Dec-2004, the patient experienced a non-febrile seizure. He was given "two rescue breaths" at home and was taken to an emergency room. The patient was then admitted to a hospital. The patient was then admitted to a hospital. An electroencephalogram and "electrolytes" were normal. Further treatment details were not provided. The patient recovered on an unspecified date. The reporting physician considered the event to be life threatening. The reporter indicated that, "no such reaction occurred at 2 month immunizations." Information regarding this event has been forwarded to Merck and GSK, manufacturers of the concomitantly administered vaccines. Information received from Product Quality indicated that the initially reported lot number, A7440F, was not a valid lot for PREVNAR. The physician's office was contacted on 18-Feb-2005, and another lot number was provided, 197440P (which was the only other number the office had recorded in the patient's chart). This lot number was also reported to be invalid by Product Quality.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Musculoskeletal stiffness, White blood cell count increased
Clinical narrative: 1 hour after shot, became apneic, eyes rolled up. Went to ER and had another episode there; jerking and stiffening, eyes rolled up. Attempted intubation. Gave phenobarbital and Ativan. No fever. Medical Records received on 1/20/2005 states dehydration and gastroenteritis. Follow-up information received from Product Quality indicated that the lot number, 197440F, was not a valid lot number for PREVNAR. Information regarding PREVNAR was received from a pediatrician via a company representative regarding a 4-month-old male patient who experienced a non-febrile seizure. At 4 months of age, the patient received a dose on 14-Dec-2004. The patient also received a dose of PEDIARIX (GSK) and a dose of PEDVAX-HIB (Merck) on 14-Dec-2004. On 14-Dec-2004, the patient experienced a non-febrile seizure. He was given "two rescue breaths" at home and was taken to an emergency room. The patient was then admitted to a hospital. The patient was then admitted to a hospital. An electroencephalogram and "electrolytes" were normal. Further treatment details were not provided. The patient recovered on an unspecified date. The reporting physician considered the event to be life threatening. The reporter indicated that, "no such reaction occurred at 2 month immunizations." Information regarding this event has been forwarded to Merck and GSK, manufacturers of the concomitantly administered vaccines. Information received from Product Quality indicated that the initially reported lot number, A7440F, was not a valid lot for PREVNAR. The physician's office was contacted on 18-Feb-2005, and another lot number was provided, 197440P (which was the only other number the office had recorded in the patient's chart). This lot number was also reported to be invalid by Product Quality.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Rash pruritic
Clinical narrative: Between 5 and 10 min following injection break out in pruritic red rash. Face, head and few on chest, Benadryl given rash gradually left.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Eyelid oedema, Injection site oedema, Paraesthesia, Tongue oedema
Clinical narrative: Left arm had swelling the size of an orange (at site of subq injection) by evening went to ER when tongue and eyelids felt swollen and tingly. Arm became progressively more swollen over next 2 days despite having received a cortisone shot and tapering Prednisone dose as well as liquid Benadryl. Swelling gradually resolved.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Injection site oedema, Injection site reaction, Malaise, Muscular weakness
Clinical narrative: 1st night arm felt like it was going to burn off. 3x3 red, swollen area formed at site of subq injection (pneumonia). Next day-muscles weak in arm, could hardly pick up cup, no pain but didn't feel well, afebrile. That night woke up in drenching sweat like a fever had broke although I had no temp. Felt fine the next day.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin burning sensation
Clinical narrative: 1st night arm felt like it was going to burn off. 3x3 red, swollen area formed at site of subq injection (pneumonia). Next day-muscles weak in arm, could hardly pick up cup, no pain but didn't feel well, afebrile. That night woke up in drenching sweat like a fever had broke although I had no temp. Felt fine the next day.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Erythema, Injection site mass
Clinical narrative: Developed erythema and induration at vaccine site.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Paraesthesia, Pruritus, Urticaria
Clinical narrative: Received flu shot 10/25/04 in am. 10/26/04 am went to a previously scheduled Dr visit Dr suggested she try Flaxseed-to reduce cholesterol. Tried Flaxseed on 10/26/04 for dinner. 10/27/04 awoke with hives, redness, itching on face and neck. Follow up with private physician 10/27/04 regarding symptoms. Dr put her on Zyrtec daily for 10 days. Began taking Zyrtec immediately. As of 11/1/04 symptoms decreased but continued. 11/3/04 follow up call finds client with continued redness of face and swelling of neck and prickling feeling in throat and neck area. Plans to follow up with own Dr or specialist. 11/29/04 was received by Dr on 11/2/04 recommended f/u TC which was done. Also recommended client f/u with PP re symptoms if continued. See above client plans to do same. Report mailed.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Livedo reticularis, Pyrexia
Clinical narrative: 20 minutes after vaccine, patient became tired, mottled, Temp >102F. Resolved with Motrin and Benadryl. Temp still present after 12 hours. Still with fever after 12 hours.
Age: 1.12
Sex: M
Vaccine: DTAP, FLU3, HBHEPB
Symptoms: Convulsion, Dyskinesia, Gaze palsy, Postictal state, Pyrexia
Clinical narrative: At 7:30 PM 7 hrs after shot fever 103.8. Eyes rolled back fully, foaming, 1 min and 5 min post ictal. Went to ER. UA positive, CXR negative. WBC increased 21000, Got Rocephin and Tylenol/ Motrin. At 5am 12/15/04 fever 104.3 jerking and eyes rolling.
Age: 1.12
Sex: M
Vaccine: DTAP, FLU3, HBHEPB
Symptoms: White blood cell count increased
Clinical narrative: At 7:30 PM 7 hrs after shot fever 103.8. Eyes rolled back fully, foaming, 1 min and 5 min post ictal. Went to ER. UA positive, CXR negative. WBC increased 21000, Got Rocephin and Tylenol/ Motrin. At 5am 12/15/04 fever 104.3 jerking and eyes rolling.
Age: 1.26
Sex: M
Vaccine: DTAP, HBHEPB, UNK
Symptoms: Coma, Convulsion, Disorientation
Clinical narrative: Episode of being unresponsive and dazed that lasted several minutes. Thought to be a seizure. Subsequent EEG normal.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blister
Clinical narrative: Blister popped during exertion, spread to other areas 1" away from vaccine site.
Age: 13.0
Sex: F
Vaccine: DT
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Nausea, Pain
Clinical narrative: Presented to clinic an 18x16cm underation on right deltoid area - redness, warmth, Temperature of 98.9, generalized achiness, and nausea.  Given Zyrtec 10mg daily/ice packs
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Presented to clinic an 18x16cm underation on right deltoid area - redness, warmth, Temperature of 98.9, generalized achiness, and nausea.  Given Zyrtec 10mg daily/ice packs
Age: 34.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Pyrexia
Clinical narrative: Pt. states that he developed muscle soreness, joint pain and numbness  - bilateral upper and lower extremeities are involved - on Thursday, Dec. 16. He had fever that night, but none since then.
Age: 0.35
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Hives all over body one day after immunizations
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Nausea, Pyrexia
Clinical narrative: On 12/14/2004: 12cmx15cm of erythema and induration at injection site left deltoid, increased fever. Personal physician treated patient with blood-work to an antibiotic. Joint pain, nausea, 100.8 degree fever. Patient took the antibiotic (Biaxin) and reported blood in urine next AM. Doctor then ordered lab.
Age: 10.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Convulsion
Clinical narrative: Patient had tonic movements of extremities approximately two minutes after immunizations were given. Oxygen saturation was 99-100%, P92-97. 911 called and ambulance transported to ER.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Developed urticaria 10 minutes after vaccines were administered.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Swelling to elbow, redness, warm to touch, painful. Benadryl: warm compresses.
Age: 1.08
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Patient developed chicken pox .Diagnosed 12/15/2004.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Eye swelling, Pruritus, Rash, Urticaria
Clinical narrative: 11/22/04 am mother first notices beginning of rash over body and swelling around both eyes. Child complains that it itches. 11/23/04: She brings him in to clinic. Periorbital swelling with slight redness is noted, eyes bilat. His body, arms and legs are covered in urticarial, irregular shaped wheals of varying sizes. Child appears to be in no distress. Denies trouble breathing now or earlier. No fever. And is not complaining of itch at this time. Mom is instructed to give OTC Benadryl as directed and have him take baking soda baths for itch. 11/24/04: FU by phone. Mom reports; rash almost completely resolved by afternoon of 11/24/04 and was completely gone by the next day.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Cold sweat, Lethargy, Syncope
Clinical narrative: The morning following routine vaccination, the child became lethargic with cold, clammy skin. He fainted. Child became more alert once a cold damp wash cloth appeared to forehead. he was then given breakfast. No other events occurred since the time of fainting.
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site mass
Clinical narrative: Palpable <1cm mass in left upper thigh
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Irritability, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: Fever 101.7 , nasal congestion/ rhinorrhea and fussiness. Treatment: Tylenol, symptomatic care.
Age: 0.37
Sex: M
Vaccine: HIBV, PNC
Symptoms: Agitation, Crying, Irritability, Muscle rigidity
Clinical narrative: Prevnar and Hib given 12/13/04 and patient developed periods of irritability , rigidity and inconsolable crying for up to 40 minutes several times a day for 3 days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Inflammation , pain at injection site and surrounding area: prescribed Prednisone 20mg x 2 days  -10 mg x 2days
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Contusion, Injection site discolouration, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Mom calls am 12/16/04 states patient has red knot at shot site getting bigger. Instructed to come in. When patient arrived, red, hot to touch area measures 7cm long and 5cm wide noted to LAT. Blanches white. Dime sized bruised area at injection site.  No reaction symptoms.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Injection site discolouration, Injection site mass, Skin discolouration, Swelling
Clinical narrative: 12/16/04:mom called yesterday afternoon stating patient had red, swollen area that had a small knot. Instructed to use witch hazel and Tylenol. Call in AM to let us know how patient doing. Spoke with mom this am. Knot bigger, will see patient. When patient got to office knot 10 cm in length and 7 cm wide. Purplish red in color and blanches white. Hot to touch.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Fatigue, Headache, Myalgia
Clinical narrative: 8" cellulitis locally, headache, chills, fatigue, arm pain
Age: 23.0
Sex: M
Vaccine: HEP, HEPA, SMALL, TYP
Symptoms: Vaccination complication
Clinical narrative: self-inoculation of smallpox vaccine
Age: 66.0
Sex: F
Vaccine: PPV, TD
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis
Age: 2.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Slight rash 50 mm x 50mm. Advised to give liquid Advil +/or Benadryl and apply cold pack. Given recheck appointment for Monday 12/20/2004. Advised to call doctor over weekend if area gets worse.
Age: 0.65
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child has red, swollen and warm area on left buttock where DTaP was given IM on 12/15/04. Advice to apply cold pack. Give Advil and Benadryl to recheck here with nurse on 12/20. To call doctor if worse.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Malaise, Myalgia, Pyrexia
Clinical narrative: Around one hour after injection, patient experienced fever, pain in arm of injection, malaise, symptoms better around 18 hours, but returned with same and all joints very sore/ achy: per patient symptoms better AM of 12/20/04. Did have MD exam 12/18/04 for follow up. Rest , fluids, NSIDS, RTC prn.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Convulsion, Dizziness, Muscle twitching
Clinical narrative: Already in car leaving clinic when felt dizzy and according to mom blacked out for one minute. Hands were twitching and funny look on face,as if having seizure. Mom called ambulance and BP normal, taken to ER and blood test was normal. Doctor advised to keep an eye on patent for 24 hours.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Rash papular
Clinical narrative: Vesicular papular rash with erythema base at injection site.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Face oedema, Facial palsy
Clinical narrative: (R) facial paralysis w/swelling Dx: (R) Bell's palsy
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash erythematous, Rash maculo-papular
Clinical narrative: Rash started  12-09-04. Office visit stated diffuse maculo-papular erythematous rash on face chest and abdomen.  Benadryl allergy susp 12.5/5ml  3/4 tsp every 6 hours and prn for itching  Aveeno baths
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Eczema, Erythema, High-pitched crying, Pyrexia
Clinical narrative: 48 hours after being administered the dtap vaccination, patient began screaming loudly and high-pitched.  Patient screamed for 5 hours straight and was inconsolable even after being administered tylenol.  A rash and low grade fever also was present.  The patient has had a pink spot of eczema over the injection site for the past 10 months.
Age: 46.0
Sex: M
Vaccine: TD
Symptoms: Abdominal pain, Hypokinesia, Shoulder pain
Clinical narrative: After receiving the vaccine there was a sharp pain running through my shoulder the next day it moved to the middle of my back and i were barely able to stand up,the next day it concentrated in my lower back and stomach cramp. and this stayed with me for over a week. I still feel some pain in the area of my right side where i received the injection.
Age: 0.71
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: Third dose of DAPTACEL injected into left thigh. Next day fever up to 101 rectally. Injection site got red (pink), swollen and indurated. Not tender. Next day, developed shaking in left hand and left leg, especially when reaching for something. Child always acted well in all other respects. Shaking lasted 3 days. Lump lasted 3 weeks. No residual symptoms are noted.
Age: 0.71
Sex: F
Vaccine: DTAP
Symptoms: Tremor
Clinical narrative: Third dose of DAPTACEL injected into left thigh. Next day fever up to 101 rectally. Injection site got red (pink), swollen and indurated. Not tender. Next day, developed shaking in left hand and left leg, especially when reaching for something. Child always acted well in all other respects. Shaking lasted 3 days. Lump lasted 3 weeks. No residual symptoms are noted.
Age: 0.82
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Infection, Irritability, Pyrexia
Clinical narrative: 45 min. post vx baby became irritable and felt warm. Next day in afternoon, fever of 105. Went to E.R. who said symptoms related to an infection, not the flu shot.