chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dizziness, Dyspnoea, Face oedema, Feeling hot
Clinical narrative: Initial report received on Nov 01 2005 from a health care professional. A female patient with no reported age and denies allergy to eggs felt hot and itchy in the right side, had nausea, dizziness, shortness of breath, media sternal chest pressure, right arm numbness, hypertension at 152/105, swelling of face and tongue at an unspecified time, the day she received the influenza vaccine (Fluzone SV 2005-2006) lot # U1754AA in the right deltoid on Oct 20 2005. She had received Ativan, Magnesium sulfate, Lopressor, H1 and H2 blockers, Benadryl and epinephrine during unspecified time frame. She was admitted and discharged from an ER at an unspecified time. The outcome was not reported at the time of the report. Of note that the reporter was not sure whether the patient received the influenza vaccine but she was receiving yearly vaccinations for the past five years. According to the reporter the above mentioned symptoms of the adverse events were not consistent with influenza vaccine specially the hypertension. Additional information received from a health care provider on Nov 7 2005. Per the reporter, the vaccine administrator confirmed that Fluzone was administered, and the facility was able to provide the lot number. Per the reporter, the patient had recovered.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Hypoaesthesia, Nausea, Pruritus, Tongue oedema
Clinical narrative: Initial report received on Nov 01 2005 from a health care professional. A female patient with no reported age and denies allergy to eggs felt hot and itchy in the right side, had nausea, dizziness, shortness of breath, media sternal chest pressure, right arm numbness, hypertension at 152/105, swelling of face and tongue at an unspecified time, the day she received the influenza vaccine (Fluzone SV 2005-2006) lot # U1754AA in the right deltoid on Oct 20 2005. She had received Ativan, Magnesium sulfate, Lopressor, H1 and H2 blockers, Benadryl and epinephrine during unspecified time frame. She was admitted and discharged from an ER at an unspecified time. The outcome was not reported at the time of the report. Of note that the reporter was not sure whether the patient received the influenza vaccine but she was receiving yearly vaccinations for the past five years. According to the reporter the above mentioned symptoms of the adverse events were not consistent with influenza vaccine specially the hypertension. Additional information received from a health care provider on Nov 7 2005. Per the reporter, the vaccine administrator confirmed that Fluzone was administered, and the facility was able to provide the lot number. Per the reporter, the patient had recovered.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Neuritis, Neuropathy, Pain, Paralysis
Clinical narrative: Initial report received on Nov 1 2005 from a health care professional. A 17 year old female patient with a medical history of chronic pain, reflex sympathetic dystrophy and seasonal allergies developed paralysis in right arm Sept 22 2005, I.E. the day after the intramuscular influenza vaccine (Fluzone SV 2005-2006) lot # U1772AA, administration. The patient had the ongoing reflex sympathetic dystrophy at the time of the vaccination. On Oct 4 2005, had an MRI for the persistent paralysis. On Oct 21 2005, the consulting neurologist diagnosed the Parsonage turner syndrome. It was reported that, on Oct 27 2005, she was hospitalized due to total body paralysis from the neck to downwards but had some movements. The patient was not recovered at the time of this report.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Radiculitis brachial
Clinical narrative: Initial report received on Nov 1 2005 from a health care professional. A 17 year old female patient with a medical history of chronic pain, reflex sympathetic dystrophy and seasonal allergies developed paralysis in right arm Sept 22 2005, I.E. the day after the intramuscular influenza vaccine (Fluzone SV 2005-2006) lot # U1772AA, administration. The patient had the ongoing reflex sympathetic dystrophy at the time of the vaccination. On Oct 4 2005, had an MRI for the persistent paralysis. On Oct 21 2005, the consulting neurologist diagnosed the Parsonage turner syndrome. It was reported that, on Oct 27 2005, she was hospitalized due to total body paralysis from the neck to downwards but had some movements. The patient was not recovered at the time of this report.
Sex: U
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report received from another company on 11/2/2005. It was initially reported by a physician that a health care professional (no individual patient identification provided) received a dose of influenza vaccine in the deltoid on an unspecified date. The lot numbers was not reported, but the manufacturer was reported. An unspecified amount of time later, the patient experienced an anaphylactic reaction. No other information was provided. The reporter of this case is the same as for non serious case 200502307.
Sex: F
Vaccine: FLU3
Symptoms: Blister, Dermatitis bullous, Rash maculo-papular
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on Nov 3 2005 from a health care professional. A female geriatric patient had received an (route and site not reported) administration of Fluzone SV 2005-2006 usp, lot number and date of vaccination not reported. At an unspecified time later, the patient developed a whole body chicken pox like rash that was macular papular in appearance with some clear fluid filled vesicles. She was admitted to the hospital (date not reported) from an emergency care facility and was treated by an infectious disease physician. Biopsy of the vesicles were completed and the results were pending at the time of this report.
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever and vomiting, multiple times.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Respiratory distress, Throat tightness, Urticaria
Clinical narrative: Ten minutes following administration of vaccine, pt c/o warmth over her body, then hives, then immediate respiratory distress and throat closing. 911 called, and she was given stat Epi pen 0.3 mg subq with relief. She was transported to the ER and observed until stable.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Erythema, swelling, tenderness on 2/3 of arm below injection.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Flu shot given on 11/4/05 went to ER on 11/5/05 had broke out in hives on trunk and legs over night; no distress- hives fading due to any intervention.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Flushing, Nasal congestion, Urticaria
Clinical narrative: Patient noted to have cough within 10 minutes of immunization, then became stuffy and very flushed. Patient had a normal exam except, diffuse flushing as told  ; few hives on trunk and arms. Significant nasal congestion.
Age: 81.0
Sex: M
Vaccine: BCG
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Experienced runny nose and coughing day after the shot and still continues to have the same problem. Shot was administered on 10/31/05.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dehydration, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Felt weak, thirsty, must have been running fever. Drank a lot of liquids and crawled in bed; too weak to take temperature. Also had breathing problems, heart racing, headache. Did not take any medication. Was OK by next day.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Felt weak, thirsty, must have been running fever. Drank a lot of liquids and crawled in bed; too weak to take temperature. Also had breathing problems, heart racing, headache. Did not take any medication. Was OK by next day.
Age: 0.65
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV
Symptoms: Pyrexia, Rash
Clinical narrative: Mother noticed flat rash on trunk of body salmon in color, non papular, non-macular. Temperature of 101 degrees today.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Erythema, Feeling hot, Pain, Shoulder pain
Clinical narrative: On 11/8/2005 I received the Pneumovax vaccine in my right deltoid. Hours later I had intense right arm pain which kept me from sleeping.  The following day I noticed a large area of redness, warmth and swelling extending from the right shoulder to the elbow, especially on the inner aspect of the right arm. This swelling/redness persists today.  I also have had peristent aching of my shoulder and lower back since the vaccine.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Sleep disorder, Swelling
Clinical narrative: On 11/8/2005 I received the Pneumovax vaccine in my right deltoid. Hours later I had intense right arm pain which kept me from sleeping.  The following day I noticed a large area of redness, warmth and swelling extending from the right shoulder to the elbow, especially on the inner aspect of the right arm. This swelling/redness persists today.  I also have had peristent aching of my shoulder and lower back since the vaccine.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Fatigue, Injection site warmth, Pain, Urticaria
Clinical narrative: SORENESS IN ARM WITHIN 3 HOURS. HIVES AND HOT TO TOUCH BETWEEN ELBOW AND SHOULDER. HURT TO LIFT ARM ABOVE SHOULDER OR LAY ON ARM. FELT TIRED ALL OVER.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Influenza vaccine administered in right deltoid at 13:30. Patient stated that he felt as though the room was closing in and then everything went black. Patient fell to the floor and blacked out for a split second.  Patient's color had drained out of him and he was diaphoretic. Patient was awake, alert and talking. Given a piece of candy. Color returned to normal. Patient given a lollipop and water and layed on the floor for 15-20 minutes. Then sat in chair for 5 minutes. Made complete recovery.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Diarrhoea, Eye pain, Headache, Injection site pain, Pyrexia
Clinical narrative: Headache, pain behind the eyes, slight fever, local pain at site of injection, mild diarrhea next morning.  Better by next morning but still not 100%  Treatment:  2 Advil
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Anorexia, Arthralgia, Diarrhoea, Myalgia, Nausea
Clinical narrative: High temperature (39 oC, 102F) for 2 days after 1 day from the flu shot. Muscle and joint ache at whole body for 2 days after 1 day from the flu shot. Nausea and diarrhea for 3 days after 1 day from the flu shot. No appetite for 3 days after 1 day from the flu shot. I had slept for two days and cured.  I just want to report my case. These symptoms were so severe. I couldn't move and therefore couldn't go to a hospital.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: High temperature (39 oC, 102F) for 2 days after 1 day from the flu shot. Muscle and joint ache at whole body for 2 days after 1 day from the flu shot. Nausea and diarrhea for 3 days after 1 day from the flu shot. No appetite for 3 days after 1 day from the flu shot. I had slept for two days and cured.  I just want to report my case. These symptoms were so severe. I couldn't move and therefore couldn't go to a hospital.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Pharyngolaryngeal pain, Rash pustular
Clinical narrative: Sore throat X 1 day. Red pustules X many over upper torso and scalp. Ulcerated pustules X 3 on back.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dysphonia, Hypoaesthesia, Paraesthesia, Speech disorder
Clinical narrative: TEN MINUTES AFTER RECEIVING VACCINE PATIENT COMPLAINED OF A TINGLING AND NUMB TONGUE. STATED IT WAS HARD TO FORM WORDS. HE ALSO STATED HIS THROAT WAS GETTING "HOARSE" AND BEGIN CLEARING HIS THROAT ALL THE TIME. ALSO   COMPLAINED OF SLIGHT TIGHTNESS OF THE CHEST AND THAT IT WAS HARD TO GET A FULL BREATH.  PATIENT STATED THAT  THE SYMPTOMS HE WAS  EXPERIENCING WERE THE SAME AS THOSE HE EXPIRENCED IN A PAST ANAPHYLACTIC REACTION.   PATIENT WAS PROMPTLY ADMINISTERED 0.3MG OF EPINEPHRINE VIA EPIPEN. FIRE/ RESCUE ARRIVED 5 MINUTES LATER. PATIENT REFUSED TRANSPORT TO HOSPITAL BUT INSTEAD WENT TO URGENT  CARE WITH WIFE. PER PATIENT HE  WAS GIVEN A STEROID INJECTION AND A SCRIPT FOR METHYLPREDNISOLONE  AT URGENT CARE. SPOKE TO PATIENT VIA PHONE 7 HOURS LATER AND STATED HE WAS DOING FINE.
Age: 48.0
Sex: F
Vaccine: FLUX, FLU3, FLU3
Symptoms: Cough, Dysphagia, Eye discharge, Headache, Lethargy
Clinical narrative: About 3-4 hrs. after the shot, I had a feeling like my throat was closing up.  I could breathe ok, but felt when I swallowed that there were 2 "boulders" in my throat.  I also started coughing, like there was a tickle in my throat. My throat was not sore. One other symptom was that my eyes were both red and had yellow puss in the corners.  Within the next hour, I went to be examined and treated.  The doctor prescribed Hydroxyzine- 25 mg and also 150 mg zantac.  I took both and within the next hour felt totally better.  The closing of the throat and the cough went away.  And my eyes cleared up. I slept fine.  Today I woke up with a headache which was helped by Tylenol.  All day I felt lethargic and slept but no other symptoms.  Did not need to take any further medication.
Age: 48.0
Sex: F
Vaccine: FLUX, FLU3, FLU3
Symptoms: Ocular hyperaemia, Throat tightness
Clinical narrative: About 3-4 hrs. after the shot, I had a feeling like my throat was closing up.  I could breathe ok, but felt when I swallowed that there were 2 "boulders" in my throat.  I also started coughing, like there was a tickle in my throat. My throat was not sore. One other symptom was that my eyes were both red and had yellow puss in the corners.  Within the next hour, I went to be examined and treated.  The doctor prescribed Hydroxyzine- 25 mg and also 150 mg zantac.  I took both and within the next hour felt totally better.  The closing of the throat and the cough went away.  And my eyes cleared up. I slept fine.  Today I woke up with a headache which was helped by Tylenol.  All day I felt lethargic and slept but no other symptoms.  Did not need to take any further medication.
Age: 48.0
Sex: F
Vaccine: FLUX, FLU3, FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: About 3-4 hrs. after the shot, I had a feeling like my throat was closing up.  I could breathe ok, but felt when I swallowed that there were 2 "boulders" in my throat.  I also started coughing, like there was a tickle in my throat. My throat was not sore. One other symptom was that my eyes were both red and had yellow puss in the corners.  Within the next hour, I went to be examined and treated.  The doctor prescribed Hydroxyzine- 25 mg and also 150 mg zantac.  I took both and within the next hour felt totally better.  The closing of the throat and the cough went away.  And my eyes cleared up. I slept fine.  Today I woke up with a headache which was helped by Tylenol.  All day I felt lethargic and slept but no other symptoms.  Did not need to take any further medication.
Age: 48.0
Sex: F
Vaccine: FLUX, FLU3, FLU3
Symptoms: Eye swelling, Pharyngeal oedema
Clinical narrative: About 3-4 hrs. after the shot, I had a feeling like my throat was closing up.  I could breathe ok, but felt when I swallowed that there were 2 "boulders" in my throat.  I also started coughing, like there was a tickle in my throat. My throat was not sore. One other symptom was that my eyes were both red and had yellow puss in the corners.  Within the next hour, I went to be examined and treated.  The doctor prescribed Hydroxyzine- 25 mg and also 150 mg zantac.  I took both and within the next hour felt totally better.  The closing of the throat and the cough went away.  And my eyes cleared up. I slept fine.  Today I woke up with a headache which was helped by Tylenol.  All day I felt lethargic and slept but no other symptoms.  Did not need to take any further medication.
Age: 0.12
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Crying, Somnolence
Clinical narrative: crying alot day of shots; sleeping more than usual there after.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER AND SEVERE BODY ACHES
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Myalgia, Pharyngeal oedema, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Temperature of 102 for two consecutive days. Soreness and swelling in throat.  Body aches including muscles and head.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Depressed level of consciousness, Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: She recieved her first Recombivax on 9/16/05 in the right deltoid. 20 minutes later the entire right arm started to tingle and go numb. Examination showed spasm in the posterior deltoid, sensory loss but no motor change. She was treated with celebrex and a pulse dose of medrol. Improved withint 24 hours and then had intermittent symptoms over 1-2 weeks. I thought the problem might have been a result of vaccine location or administration error so I personally gave her a second recombivax in the left deltoid without immediate incident. However, 15 minutes later she developed dysethesias, paresthesias and then numbness in the entire left upper extremity. Again there was no motor weakness. She did not respong to celebrex or an ice pack. Another pulse of medrol was given and symptoms resolved over 16 hours.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient had flu shot 11/08/05. Now has 48mm swelling, erythema, and pain at injection site(left arm).  Left arm has red, firm, slightly raised 10x7 cm area on upper arm. Treated with Levaquin 500mg daily for 5 days.  Zyrtec 10mg daily for 5 days. Predisone 40mg one dose.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Chills, Condition aggravated, Eye discharge, Eye swelling
Clinical narrative: Received flu shot at 3:00PM on 11/11/05 and by 7:00PM started to have asthma symptoms and had to use albuterol spray.  Eyes then became very swollen (nearly shut) and crusty.  Then got chills and very rapid heart beat
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased
Clinical narrative: Received flu shot at 3:00PM on 11/11/05 and by 7:00PM started to have asthma symptoms and had to use albuterol spray.  Eyes then became very swollen (nearly shut) and crusty.  Then got chills and very rapid heart beat
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: Hives around location vaccine given within 24 hour period. Lasted 48 hours.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cough decreased, Injection site erythema, Myalgia, Photophobia, Pyrexia
Clinical narrative: Patient developed fever 103 degrees large red area around injection site axillary lymphadenopathy- malaise, headache
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Headache, Injection site erythema, Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: Patient developed fever 103 degrees large red area around injection site axillary lymphadenopathy- malaise, headache
Age: 9.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Asthenia, Headache, Hyperhidrosis
Clinical narrative: A nurse reported that a 9 year old male experienced diaphoresis, pallor, headache and weakness, 5 minutes after receiving FluMist vaccine on Oct 29 2005. The patient remained oriented during this time. Oxygen was administered and after 15 minutes, the patients color has resumed and was ambulating well. The patient recovered from the adverse events. The reporter assessed the events as possibly related to FluMist. Additional information has been requested. Follow up - A nurse reported that a 9 year old male experinced diaphoresis, pallor, headache and weakness, 5 minutes after receiving FLUMIST vaccine on 29Oct05. The patient was assessed by a nurse practitioner, who consulted with one of their physicians over the phone regarding the event. Blood pressure was 100/60 mmHg and pulse rate was within normal limit. The patient remained oriented during this time. Oxygen was administered at 2.5-3.0 liters and after 15 minutes, the patient's color resumed and was ambulating well. The patient completely recovered from the adverse events. The following day, the patient's mother reported that the patient is doing fine and did not have any complaints. Per the reporter, the patient does not have any past medical history and was not known to be allergic to egg or egg products. The reported assessed the events as possibly related to FLUMIST. 13Nov05 Follow up information obtained and incorporated in the narrative: vital signs, account of O2 administered, confirmed that pt recovered and does not have any past medical history and allergies.
Age: 9.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Asthenia, Headache, Hyperhidrosis, Hypoxia, Pallor
Clinical narrative: A nurse reported that a 9 year old male experienced diaphoresis, pallor, headache and weakness, 5 minutes after receiving FluMist vaccine on Oct 29 2005. The patient remained oriented during this time. Oxygen was administered and after 15 minutes, the patients color has resumed and was ambulating well. The patient recovered from the adverse events. The reporter assessed the events as possibly related to FluMist. Additional information has been requested. Follow up - A nurse reported that a 9 year old male experinced diaphoresis, pallor, headache and weakness, 5 minutes after receiving FLUMIST vaccine on 29Oct05. The patient was assessed by a nurse practitioner, who consulted with one of their physicians over the phone regarding the event. Blood pressure was 100/60 mmHg and pulse rate was within normal limit. The patient remained oriented during this time. Oxygen was administered at 2.5-3.0 liters and after 15 minutes, the patient's color resumed and was ambulating well. The patient completely recovered from the adverse events. The following day, the patient's mother reported that the patient is doing fine and did not have any complaints. Per the reporter, the patient does not have any past medical history and was not known to be allergic to egg or egg products. The reported assessed the events as possibly related to FLUMIST. 13Nov05 Follow up information obtained and incorporated in the narrative: vital signs, account of O2 administered, confirmed that pt recovered and does not have any past medical history and allergies.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Cough, Eye discharge, Eye inflammation, Eye swelling
Clinical narrative: Pt states received vaccine around 12:45pm 10/27/05 approximately 15 minutes later she reports feeling like her throat was swelling with difficulty breathing. About 3-4 hrs later she reports feeling like she had "water on her lungs" swelling of the face , red and itchy eyes and coughing that sounded like a dog's bark.  That night she states fever 99.9F achiness and chills that continued into the next day. States she took one dose of 500mg acetaminophen 12.5mg diphenhydramine,20mg, ?? the 2nd day.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling cold, Headache, Malaise, Nausea, Pain
Clinical narrative: Pt states received vaccine around 12:45pm 10/27/05 approximately 15 minutes later she reports feeling like her throat was swelling with difficulty breathing. About 3-4 hrs later she reports feeling like she had "water on her lungs" swelling of the face , red and itchy eyes and coughing that sounded like a dog's bark.  That night she states fever 99.9F achiness and chills that continued into the next day. States she took one dose of 500mg acetaminophen 12.5mg diphenhydramine,20mg, ?? the 2nd day.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pharyngeal oedema, Pyrexia, Wheezing
Clinical narrative: Pt states received vaccine around 12:45pm 10/27/05 approximately 15 minutes later she reports feeling like her throat was swelling with difficulty breathing. About 3-4 hrs later she reports feeling like she had "water on her lungs" swelling of the face , red and itchy eyes and coughing that sounded like a dog's bark.  That night she states fever 99.9F achiness and chills that continued into the next day. States she took one dose of 500mg acetaminophen 12.5mg diphenhydramine,20mg, ?? the 2nd day.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Dyspnoea, Face oedema, Ocular hyperaemia, Pain
Clinical narrative: Pt states received vaccine around 12:45pm 10/27/05 approximately 15 minutes later she reports feeling like her throat was swelling with difficulty breathing. About 3-4 hrs later she reports feeling like she had "water on her lungs" swelling of the face , red and itchy eyes and coughing that sounded like a dog's bark.  That night she states fever 99.9F achiness and chills that continued into the next day. States she took one dose of 500mg acetaminophen 12.5mg diphenhydramine,20mg, ?? the 2nd day.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pharyngeal oedema, Pruritus, Pulmonary congestion, Pyrexia
Clinical narrative: Pt states received vaccine around 12:45pm 10/27/05 approximately 15 minutes later she reports feeling like her throat was swelling with difficulty breathing. About 3-4 hrs later she reports feeling like she had "water on her lungs" swelling of the face , red and itchy eyes and coughing that sounded like a dog's bark.  That night she states fever 99.9F achiness and chills that continued into the next day. States she took one dose of 500mg acetaminophen 12.5mg diphenhydramine,20mg, ?? the 2nd day.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye pain, Migraine, Optic neuritis, Vision blurred, Visual field defect
Clinical narrative: Initial report received on 04/Nov/2005 from the patient, a 40-year-old female patient received an intra-muscular injection of Fluzone SV 2005-2006 USP, lot number U1761AA in the left arm on 05/Oct/2005 at 08:15. At 19:00 on 07/Oct/2005 she developed pain near her left eye and vision blurring. She was seen by her primary care physician on 10/Oct/2005 with symptoms of left retro-orbital headache extending to the sinus and left side of the head. She was diagnosed with migraine headache related to stressful family situation and amenorrhea times two months. She was started on Relpax for her migraine headache. She had a Papanicolsou smear and complete blood count that day and the results are pending. On 12/Oct/2005 she was seen by an optometrist who performed a visual field exam and noted a defect in the vision field of the left eye and diagnosed her with left optic neuritis. He ordere3d a computed tomography scan of the head (with an without contrast) to rule out multiple sclerosis and referred her to a neurologist. Th computed tomography scan was completed on 12/Oct/2005 and was unremarkable. On 20/Oct/2005 the patient was seen by a neurologist who diagnosed her with left optic neuritis without other associated symptoms related to multiple sclerosis versus isolated optic neuritis. he wanted to treat the patient with intravenous steroids the following Monday and ordered a magnetic resonance imaging of the brain, orbit and cervical spine. The magnetic resonance imaging was completed on 25/Oct/2005 and was diagnosed with very mild optic neuritis of the left eye versus one of the other conditions that can be associated with visual field loss. These include multiple evanescent white dot syndrome, the Acute Idiopathic enlargement of the blind spot syndrome or more unlikely, one of the atypical retinopathies. She is to follow-up with the retinal specialists.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye pain, Headache, Migraine, Nausea, Optic neuritis
Clinical narrative: Initial report received on 04/Nov/2005 from the patient, a 40-year-old female patient received an intra-muscular injection of Fluzone SV 2005-2006 USP, lot number U1761AA in the left arm on 05/Oct/2005 at 08:15. At 19:00 on 07/Oct/2005 she developed pain near her left eye and vision blurring. She was seen by her primary care physician on 10/Oct/2005 with symptoms of left retro-orbital headache extending to the sinus and left side of the head. She was diagnosed with migraine headache related to stressful family situation and amenorrhea times two months. She was started on Relpax for her migraine headache. She had a Papanicolsou smear and complete blood count that day and the results are pending. On 12/Oct/2005 she was seen by an optometrist who performed a visual field exam and noted a defect in the vision field of the left eye and diagnosed her with left optic neuritis. He ordere3d a computed tomography scan of the head (with an without contrast) to rule out multiple sclerosis and referred her to a neurologist. Th computed tomography scan was completed on 12/Oct/2005 and was unremarkable. On 20/Oct/2005 the patient was seen by a neurologist who diagnosed her with left optic neuritis without other associated symptoms related to multiple sclerosis versus isolated optic neuritis. he wanted to treat the patient with intravenous steroids the following Monday and ordered a magnetic resonance imaging of the brain, orbit and cervical spine. The magnetic resonance imaging was completed on 25/Oct/2005 and was diagnosed with very mild optic neuritis of the left eye versus one of the other conditions that can be associated with visual field loss. These include multiple evanescent white dot syndrome, the Acute Idiopathic enlargement of the blind spot syndrome or more unlikely, one of the atypical retinopathies. She is to follow-up with the retinal specialists.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vision blurred, Visual field defect
Clinical narrative: Initial report received on 04/Nov/2005 from the patient, a 40-year-old female patient received an intra-muscular injection of Fluzone SV 2005-2006 USP, lot number U1761AA in the left arm on 05/Oct/2005 at 08:15. At 19:00 on 07/Oct/2005 she developed pain near her left eye and vision blurring. She was seen by her primary care physician on 10/Oct/2005 with symptoms of left retro-orbital headache extending to the sinus and left side of the head. She was diagnosed with migraine headache related to stressful family situation and amenorrhea times two months. She was started on Relpax for her migraine headache. She had a Papanicolsou smear and complete blood count that day and the results are pending. On 12/Oct/2005 she was seen by an optometrist who performed a visual field exam and noted a defect in the vision field of the left eye and diagnosed her with left optic neuritis. He ordere3d a computed tomography scan of the head (with an without contrast) to rule out multiple sclerosis and referred her to a neurologist. Th computed tomography scan was completed on 12/Oct/2005 and was unremarkable. On 20/Oct/2005 the patient was seen by a neurologist who diagnosed her with left optic neuritis without other associated symptoms related to multiple sclerosis versus isolated optic neuritis. he wanted to treat the patient with intravenous steroids the following Monday and ordered a magnetic resonance imaging of the brain, orbit and cervical spine. The magnetic resonance imaging was completed on 25/Oct/2005 and was diagnosed with very mild optic neuritis of the left eye versus one of the other conditions that can be associated with visual field loss. These include multiple evanescent white dot syndrome, the Acute Idiopathic enlargement of the blind spot syndrome or more unlikely, one of the atypical retinopathies. She is to follow-up with the retinal specialists.
Age: 12.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Diarrhoea, Erythema, Injection site induration, Injection site reaction
Clinical narrative: Fever 103F, pain of left upper arm, redness, induration 8.5cm x 6.5cm. Treatment with Ancef, Bactrim, Flagyl. The pt developed diarrhea. 2nd day of admission cellulitis started decreasing, decreased WBC, CT scan chronic sinusitis. D/C med: Augmentin, Flagyl, Bactrim, Advair, Flonase. 11/18/05 Per review of d/c summary cellulitis secondary to Pneumovax immunization was confirmed as final diagnosis.
Age: 12.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia, Sinusitis, White blood cell count decreased
Clinical narrative: Fever 103F, pain of left upper arm, redness, induration 8.5cm x 6.5cm. Treatment with Ancef, Bactrim, Flagyl. The pt developed diarrhea. 2nd day of admission cellulitis started decreasing, decreased WBC, CT scan chronic sinusitis. D/C med: Augmentin, Flagyl, Bactrim, Advair, Flonase. 11/18/05 Per review of d/c summary cellulitis secondary to Pneumovax immunization was confirmed as final diagnosis.
Age: 54.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Hypokinesia, Pain
Clinical narrative: Patient claims felt pain in left arm that evening. Pain comes and goes, she cannot lift arm or move side to side. Pain radiates to fingers and to neck. No fever. Saw M.D. 11/10/05 received a shot and Meds (propoxyphene 50mg) claims pain still bothering her.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Fever (low-grade) sore throat, weakness in legs, dizziness. Symptoms beginning within hours of vaccine. Taken to ER and treated fever- dx- unknown sent home. 11/13 feeling better today.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Nausea
Clinical narrative: Patient complaining of light headed, dizziness and flushing within minutes of receiving flu vaccine. No rash noted. Patient blood pressure was normal and pulse was normal. Also had slight nausea, episode lasted 15 minutes.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis at site; patient seen at urgent care center with this reaction not this office.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Patient reports a dark circle approximately 1 inch in diameter at the site of the injection in 7 days.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Tremor
Clinical narrative: Redness in the face Difficulty Breathing Shaky
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid- red- local swelling reaction at site including redness to left elbow.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Time of injection1:05 pm, pt then had lunch (pizza), began with palpitations in chest, feels short of breath 5X began 1:20pm. Patient felt much improved by 2:15
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed fevers of 102 and a large reddened and swelled area on left upper arm at area of injection, TX with Keflex 500mg teaspoons TID X 10 days.
Age: 6.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Warmth and Erythema and Edema at injection site.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Dizziness, Dyskinesia, Eye movement disorder, Hyperhidrosis
Clinical narrative: Approximately 30 seconds after giving injection- patient became pale and diaphoretic with high response. I encouraged to sit down lower her back slowly breathing. Approximately 10 seconds later she flared her head up and her body started  to jerk hands contracted inwardly to her body and eyes rolled back. I rushed out to call 911 and office staff promptly called. After body ceased convulsing checked pulse- strong at reg 88. She would not respond to voice commands until I applied pressure to upper arm.  Continued to feel dizzy upon standing up.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor
Clinical narrative: Approximately 30 seconds after giving injection- patient became pale and diaphoretic with high response. I encouraged to sit down lower her back slowly breathing. Approximately 10 seconds later she flared her head up and her body started  to jerk hands contracted inwardly to her body and eyes rolled back. I rushed out to call 911 and office staff promptly called. After body ceased convulsing checked pulse- strong at reg 88. She would not respond to voice commands until I applied pressure to upper arm.  Continued to feel dizzy upon standing up.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Facial palsy, Hypoaesthesia, Hypokinesia
Clinical narrative: Friday on 8/19/05- Couldn't move 1/2 of lips unable to blink left eye and couldn't control left nostril. Couldn't feel left side of face. Saturday- Symptoms increased. Went to ER. Started on Prednisone, eye QHS- eye patched.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Localized redness and pain size of palm soon after injection consistent with cellulitis
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cardiac arrest, Respiratory arrest
Clinical narrative: Cardiac Arrest/Respiratory Arrest around 2000 on 25 Sep 05 at home. This was over 72 hours following vaccinations below.  11/28/2005 Via phone call again to ME.  Child was put down to sleep in prone position because of GERD.  She also had a comforter on her.  She was given a bottle at 1 pm, and was found unresponsive at 8 pm.  Father started CPR and child was taken to the ER where she was pronounced.   ME says the preliminary report is SIDS, final awaits the lab results. 4/10/06 Received autopsy report which states COD: Unexplained Infant Death.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Hypoaesthesia, Pyrexia, Rash maculo-papular
Clinical narrative: Information has been received from a healthcare worker concerning a 67 year old female with allergies to erythromycin, aspirini (+) oxycodone hydrochloride (+) oxycodone terephthalate, prochlorperazine maleate, propoxyphene hydrochloride, codeine, cefaclor, dexamethasone, ranitidine hydrochloride, and naproxen sodium who on 10/26/05 was vaccinated in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 650329/0747P). Concomitant therapy included esomeprazole magnesium, levothyroxine Na, estradiol, trazodone HCl, Lactobacillus acidophilus (as drug), PROTAZYME, OSTIVORE, albuterol sulfate (+) ipratropium bromide, salmeterol xinafoate, budesonide, and tramadol HCl. On approximately 10/26/05, the patient experienced numbness in the arm that received vaccination, tightness in chest, fever of 102, and hot red spots on her body. The patient sought medical attention and was hospitalized. The patient's outcome was unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection
Clinical narrative: Information has been received from a Registered Nurse concerning a 28 year old female with "a lot of medical history" (unspecified) and no drug allergies who on 17-Oct-2005 was vaccinated IM in left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot #651318/1006P). On approximately 19-Oct-2005 the patient was hospitalized with a staph infection. She was treated with an IV antibiotic and was recovering at the time of the report. The reporter considered staph infection to be disabling and to be another important medical event (OMIC). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a physician concerning a female patient over the age of 65 who on 18-Oct-2005, was vaccinated in the right arm with a 0.5 ml second dose of pneumococcal 23v polysaccharide vaccine (lot 650302/1039P). Subsequently, the patient presented to the office with complaints of "cellulitis type reaction", local pain, swelling, redness and fever. Onset of symptoms was 2 to 3 days post vaccination. The physician reported that the patient was "the anxious type" and was very concerned about the reaction she experienced. The patient was sent to the emergency room to rule out phlebitis. The patient did not have phlebitis and was not hospitalized. The patient was treated with unspecified oral antibiotics for 10 days and symptoms improved. At the time of this report. the paint was recovering. The physician expressed concern for lot 65032/1039P and requested a lot check to be performed on the lot. The physician felt that cellulitis type reaction, pain, swelling, redness and fever were disabling and were other medical events. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Pyrexia, Swelling
Clinical narrative: Swelling; Cellulitis; Pyrexia, Erythema.  Information has been received from a physician concerning a female patient over the age of 65 who on 10/24/05 was vaccinated with a 0.5ml second dose of pneumococcal 32v polysaccharide vaccine (lot 650302/1039P). Subsequently, the patient presented to the office with complaints of "cellulitis type reaction", swelling, redness and fever. The onset of the symptoms was within 2 to 3 days post vaccination. The patient was treated with acetaminophen (Tylenol), ibuprofen (Advil, or cold packs as needed. The patient also received unspecified oral antibiotics and symptoms improved. At the time of this report, the patient was recovering. The physician expressed concern for lot 650302/1039P and requested a lot check be performed on lot 650302/1039P.  The physician felt that cellulitis type reaction, swelling, redness and fever were disabling. Additional informational has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male patient over the age of 65 who on 10/10/05 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 65032/1039P). Subsequently the patient presented to the office with complaints of "cellulitis type reaction", swelling, redness and fever. The onset of the symptoms was within 2 to 3 day post vaccination. The patient was treated with acetaminophen (Tylenol), ibuprofen (Advil) or ice packs as needed. The patient was also treated with unspecified antibiotics, and the symptoms improved. At the time of this report, the patient was recovering. The physician expressed concern for lot 650302/1839P and requested that a lot check be performed on lot 650302/1039P. The physician felt that cellulitis type reaction, swelling, redness and fever  were disabling. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 78 year old male with no drug allergies who on 10/24/2005 was vaccinated intramuscularly in left arm with a dose of pneumococcal 23v polysaccharide vaccine.  On 10/26/2005 the patient presented to office with Cellulitis, redness, swelling at injection site and a lot of pain.  He was treated with amoxicillin clavulanate potassium, 875 twice a day and was recovering at the time of the report.  The reporter considered cellulitis, redness and swelling at injection site and pain to be disabling and to be other important medical events.  Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dehydration, Diarrhoea, Drug ineffective, Infection, Rash
Clinical narrative: Dehydration; Varicella; Diarrhea. Information has been received from a physician concerning 12 month old female with no allergies, and multiple medical conditions, a gastrostomy tube used for high caloric enteral feeding, failur4e to thrive, congential metabolic problems, chronic pulmonary insufficiency and history of otitis media (on "steroid" for 4 days beginning 8/10/05), who on 9/12/05 was vaccinated SC with a 0.5mL first dose of varicella virus vaccine live (Oka/Merck) (647949/0891P). Other vaccine therapy administered on 9/12/05 included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA27/3) (MSD). Concomitant therapy included lansoprazole (Prevacid), montelukast sodium (MDS), fluticasone propionate (Flovent) and a "nebulizer". On 9/30/05 the patient developed symptoms of a rash all over her body and now has chicken pox. The patient has about 100 maculopapular lesions. She was treated with calamine lotion and diphenhydramaine (Benadryl). It was noted that the patient has been on prednisone "off and on" for her chronic lung disease. She was admitted to the hospital on 10/7/05 for diarrhea and dehydration. She was discharged and recovered on 10/12/05. There was no laboratory or diagnostic studies performed. There was no product quality complaint report. No additional information is expected.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: A 51 year old female pt, with no significant pre-existing medical conditions, received an IM injection of Fluzone, lot number U1826AA, in the left deltoid on 02/Nov/2005. Later that evening, she developed numbness in the left side of her face and left top part of her head. No treatment was recommended. (OMIC)
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Medication error
Clinical narrative: Initial report received from a HCP on 03/Nov/2005. A 52 year old female pt with a medical history of hypertension and an allergy to strawberries received an IM left arm injection of 5.0 ml (not the recommended dose) of Fluzone SV 2005-2006, lot number U1761AA, on 03/Nov/2005 at 11:20 AM. One hour and twenty-five minutes later, the pt developed shortness of breath and felt dizzy. The pt was treated with Benadryl 50 mg per os and administered an epinephrine pen. The pt was transported via ambulance to an ER. The pt had received an unspecified number of previous doses of Fluzone, but adverse events following prior vaccinations were not reported. Illness at the time of vaccination was reported as non, and current medications were unknown. At the time of this report, the pt's recovery status was not reported. (OMIC)
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Coronary artery atherosclerosis
Clinical narrative: Expired while sleeping approximately 12 - 18 hours after Flu vaccine administered. Coroner's case. Additonal term added from autopsy report: Atheroscleric CAD/sr
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fatigue extreme, fever, Headache, nausea and vomiting, diarrhea.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Fatigue extreme, fever, Headache, nausea and vomiting, diarrhea.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nasal congestion, Nausea, Pain, Pyrexia
Clinical narrative: Seven hours after the shot, I felt very hungry. That evening, besides the pain in my arm from the shot, I had a headache and body aches. The next morning I had a fever of 100.3, nausea, body aches, and headache. By noon, my fever dropped to 99.6. By the second day after the shot, I began to feel better. Five days after the vaccine I have sinus congestion.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: PNEUMOCOCCAL SHOT WAS GIVEN ON LEFT ARM, SERVERE PAIN DURING THE NIGHT REQUIRING PAIN PILL. INJECTION SITE\AREA SLIGHTLY SWOLLEN AND WARM TO TOUCH. WAS SEEN BY DR. ON 11/09/2005 AND WAS GIVEN ANTIBIOTICS.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Vomiting
Clinical narrative: Patient began having symptoms of severe headache 2 days after receiving flu vaccine.  2 days later vomiting began and she was hopitalized for treatment of symptoms.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Coma, Staring
Clinical narrative: Mom called Nurse line and stated; " My daughter had a flu shot the other day. When she woke up this AM(11/05/2005)at about 9:30 AM, she was not responding. She raises her arm up and is just staring into space."
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bicarbonate decreased, Blood chloride increased, Headache
Clinical narrative: Patient received flu vaccine and then started having severe headaches 1-2 days after receiving the vaccination.  Had vomiting 1 day and was hospitalized for treatment of symptoms. Discharge summary states photophobia. msv Discharge summary states intra cranial hypertension. msv