chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Disorientation, Dizziness, Headache, Kidney infection
Clinical narrative: Initial report received on 12 October 2009 from an investigator in the above mentioned trial. A 80 year old male subject developed transient ischemic attack on 7 October 2009 i.e. 14 days after receiving an intramuscular injection of FLUZONE SV 2009-2010 in left arm on 23 September 2009 (batch number- UD12321). The subject had medical history of hypertension diagnosed in 2005, hypercholesterolemia diagnosed in 2005. Glaucoma diagnosed in 2008, bladder cancer diagnosed in 2005 and benign prostatic hyperplasia diagnosed in 2008 and also had a transient ischemic attack 6 months ago in the past. The subject was on following concomitant medications: PLAVIX, ASPIRIN, SIMVASTATIN, METOPROLOL, TRAVATAN and DOXAZOSIN. On 07 October 2009, the subject developed muscle weakness, headache, dizziness and disorientation, leading to hospitalization on 07 October 2009. He was admitted to the regional hospital and was under observation for 25 hours and was diagnosed of having transient ischemic attack and kidney infection. FLUCONAZOLE 100mg 1 tablet for 3 days was started as corrective treatment. No laboratory data was provided. The symptoms of headache, dizziness and disorientation resolved on 8 October 2009 and the subject was discharged on the same day. The event of Transient ischemic attack resolved 2 days later on 10 October 2009. According to the investigator, the event was related to the study vaccine. The serious adverse event did not lead to the termination of the subject from the study. List of the documents held by sender: None.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Transient ischaemic attack
Clinical narrative: Initial report received on 12 October 2009 from an investigator in the above mentioned trial. A 80 year old male subject developed transient ischemic attack on 7 October 2009 i.e. 14 days after receiving an intramuscular injection of FLUZONE SV 2009-2010 in left arm on 23 September 2009 (batch number- UD12321). The subject had medical history of hypertension diagnosed in 2005, hypercholesterolemia diagnosed in 2005. Glaucoma diagnosed in 2008, bladder cancer diagnosed in 2005 and benign prostatic hyperplasia diagnosed in 2008 and also had a transient ischemic attack 6 months ago in the past. The subject was on following concomitant medications: PLAVIX, ASPIRIN, SIMVASTATIN, METOPROLOL, TRAVATAN and DOXAZOSIN. On 07 October 2009, the subject developed muscle weakness, headache, dizziness and disorientation, leading to hospitalization on 07 October 2009. He was admitted to the regional hospital and was under observation for 25 hours and was diagnosed of having transient ischemic attack and kidney infection. FLUCONAZOLE 100mg 1 tablet for 3 days was started as corrective treatment. No laboratory data was provided. The symptoms of headache, dizziness and disorientation resolved on 8 October 2009 and the subject was discharged on the same day. The event of Transient ischemic attack resolved 2 days later on 10 October 2009. According to the investigator, the event was related to the study vaccine. The serious adverse event did not lead to the termination of the subject from the study. List of the documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Body temperature increased, Headache, Rash
Clinical narrative: Headache, increased temp, rash on face.
Age: 52.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: On 10/7/09 pt came to the clinic to receive a H1N1 nasal spray. I administered this vaccine to the patient. The H1N1 spray is only recommended for patients between the age of 2 years up to 50 years, so this patient was too old to receive this vaccine.
Age: 45.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia
Clinical narrative: Fever x 24 hours. Treated with antipyretics.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Seizure-DIASTAT given. # didn't take all of AM DEPAKOTE per dad.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Initial case received from a consumer, who is also the patient's parent, on 13 October 2009. A six-year-old male patient experienced blurry vision, dizziness, a rash, hives, and itching after receiving intramuscular deltoid injection of FLUZONE (lot number not reported) on 07 October 2009. The patient had no relevant medical history, and no known allergies. Approximately 48 hours post-vaccination, the patient developed a red rash on his upper body, hives, itching, blurry vision, and dizziness. He was taken to the emergency department that day, and was treated with prednisone. On 12 October 2009, he was seen by an allergist, and additional treatment included BENADRYL, ZYRTEC, and PEPCID. At the time of the report, the itching and redness was ongoing. Additional information was received on 19 October 2009 from a health care professional. According to the reporter, the patient developed generalized hives, rash and itching two days after he had received FLUZONE No Preservative (previously reported as FLUZONE SV); the lot number was reported as unknown. The patient went to the emergency room and received steroids, BENADRYL and ZYRTEC with some relief. At the time of the report, the patient had been seeing an allergist. It was further noted that the patient had developed hives after receiving Hepatitis vaccine when he was five years of age. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Initial case received from a consumer, who is also the patient's parent, on 13 October 2009. A six-year-old male patient experienced blurry vision, dizziness, a rash, hives, and itching after receiving intramuscular deltoid injection of FLUZONE (lot number not reported) on 07 October 2009. The patient had no relevant medical history, and no known allergies. Approximately 48 hours post-vaccination, the patient developed a red rash on his upper body, hives, itching, blurry vision, and dizziness. He was taken to the emergency department that day, and was treated with prednisone. On 12 October 2009, he was seen by an allergist, and additional treatment included BENADRYL, ZYRTEC, and PEPCID. At the time of the report, the itching and redness was ongoing. Additional information was received on 19 October 2009 from a health care professional. According to the reporter, the patient developed generalized hives, rash and itching two days after he had received FLUZONE No Preservative (previously reported as FLUZONE SV); the lot number was reported as unknown. The patient went to the emergency room and received steroids, BENADRYL and ZYRTEC with some relief. At the time of the report, the patient had been seeing an allergist. It was further noted that the patient had developed hives after receiving Hepatitis vaccine when he was five years of age. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Axillary pain, Discomfort, Pain, Pain in extremity
Clinical narrative: Received H1N1 on 10-14-09 at apporx. 4:00pm. Started getting sore the next day. Continues to be sore to this day, 10-19-09, Has pain if raises arm or if arm is down at her side. Pain is in shoulder joint and in arm pit. Takes TYLENOL for discomfort. Patient states arm pain and discomfort lasted about one week and is okay now. 11-25-2009
Age: 25.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Myalgia, Pain
Clinical narrative: Woke up 10/20/09 with severe dizziness, body aches, muscle aches. Referred to physician regarding dizziness.
Age: 12.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain lower, Full blood count normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Developed severe RLQ pain within 48hrs of H1N1 mist. Admitted to hospital ER overnight for observation. ABD MRI was normal.
Sex: U
Vaccine: FLU3
Symptoms: Chest pain
Clinical narrative: Initial report was received from a health care professional on 15 October 2009 which involved a cluster of seven patients, male and female, who were 26 years of age and older. This case represents one patient who experienced an event of a chest pain. A patient (age and gender not reported) with no known allergies and no concurrent illness had received a 0.5  mL intramuscular deltoid injection of FLUZONE, lot number U3216AA on 16 September 2009 and one hour later, developed chest pain. The patient took BENADRYL and the event resolved in one hour. No additional information was provided. The remaining six patients have been captured in case numbers 2009-04358 (one patient), 2009-04359 (four patients) and 2009-04361 (one patient). Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Rash, Urticaria
Clinical narrative: Hive-like rash appx 5 hours after admin. of vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Electrocardiogram normal, Syncope
Clinical narrative: Initial report was received from a health care professional on 15 October 2009 which involved a cluster of seven patients, male and female, who were 26 years of age and older. This case represents one patient who experienced an event of fainting. A patient (age and gender not reported) with no known allergies and no concurrent illness had received a 0.5  mL intramuscular deltoid injection of FLUZONE, lot number U3216AA on 16 September 2009 and 30 minutes later, the patient fainted. The patient was taken to the emergency room and received corrective treatment with fluids. An EKG performed was within normal limits. The patient was released; however their recovery status was reported as unknown. No additional information was provided at the time of the report. The remaining six patients have been captured in case numbers 2009-04358 (one patient), 2009-04359 (four patients) and 2009-04360 (one patient). Documents held by sender: None.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Injection site dermatitis, Injection site papule, Injection site pruritus
Clinical narrative: Popular, pruvitic dermatitis at sit of injection.
Sex: F
Vaccine: FLU3
Symptoms: Muscle atrophy
Clinical narrative: Initial report received on 15 October 2009 from a health care professional. A female patient (age not provided) with no reported medical history was diagnosed with muscular degeneration after receiving FLUZONE (lot number U3207AA) on 30 September 2009 (route and site were not reported). The patient did not recover. No further information was provided. List of Documents held by Sender: none.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pain in extremity
Clinical narrative: This case was received from a health care professional on 06-August 2009. A 30-year-old female patient, with no reported medical history, received a left deltoid intramuscular injection of ADACEL (lot number C2994BA) on 03 August 2009. It was not known by the reporter the date on which the patient had received her last tetanus injection. On 04 August 2009, approximately 24 hours after vaccination, the patient developed injection site pain and induration, described as a two-inch hard, red lump. The patient also complained of pain in the entire arm extending to the axillary area. She was seen by a physician for her symptoms, which had not yet resolved at the time of the report. Follow-up information was received 19 October 2009 from a health care professional. Based upon this new information received, it was determined that the event meets seriousness criteria and has been upgraded from non serious to serious. The patient had no concurrent illness at the time of vaccination. The patient had questionable cellulitis at the site and KEFLEX was ordered. According to the reporter, the patient recovered. No additional information was provided. Documents held by sender: None.
Age: 49.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: No whelps, hives, itching, red + neck, arms + face.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU(H1N1)
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Had cellulitis @ site of injection with redness, and site is warm to the touch. Site is 2"x3". Site is L deltoid. Mom instructed on comfort measures - cold cloth and TYLENOL. No fever.
Sex: U
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Urticaria
Clinical narrative: Facial urticaria.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1), HEPA
Symptoms: Pain in extremity, Rash papular, Stomatitis
Clinical narrative: Tender papules on palms + sores in mouth, 2 days after vaccination.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye swelling, Flushing, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Initial report received on 19 October 2009 from a health care professional. A 35 year old female patient with seasonal allergies reported that her eyes became swollen, she developed a sore throat which felt swollen, began coughing, and her face was flushed within 2 hours of receiving an initial dose of FLUZONE (lot number U3200AA) intramuscularly in the right deltoid on 16 October 2009 at 2:00 PM. The patient took an oral dose of BENADRYL. The patient's spouse took the patient to an urgent care clinic. The patient was treated with BENADRYL, epinephrine, and SOLUMEDROL. Following the appointment, the patient returned to work. The patient recovered. This reporter is the same as case number 2009-04395. 12/1/09 Medical records received for date 10/14/09. DX: systemic reaction to influenza vaccine. Pt presented w/ c/o receiving flu vax and within 1/2hr experienced itching bilat eyes, lump in throat, heart racing, wheezing, eye drainage. Currently at clinic pt states sx worse, diff. swallowing, throat swelling. Assessment: prolonged expiratory phase, sclera are markedly injected, eye drainage noted. Pt tx for vax reaction, pt. became stable before leaving clinic.
Age: 42.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dysphonia, Lip swelling, Oropharyngeal pain, Urticaria
Clinical narrative: Hives on torso (hips, underneath breasts, stomach) and elbows. Swollen bottom lip. Sore throat & hoarseness.
Age: 58.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 24 hours later had trouble breathing. I have asthma. Had to use nebulizer every 4 hours - 1 vial of 2.5 mg/ml Albuterol Solution. Will continue to take, (site of inj. reaction expanded - red, size of baseball) feels hot.
Age: 1.48
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, Injection site rash, Oedema peripheral, Pyrexia, Rash erythematous
Clinical narrative: Initial report received on 22 September 2009 from a Healthcare Professional. An 17 month old female patient, with no known allergies and no medical history, received an intramuscular injection of FLUZONE (lot number not reported) in the left thigh on 18 September 2009. The patient had received a 0.5 ml dose instead of 0.25 ml. She had no illness at the time of vaccination and had received TYLENOL before vaccination. Prior vaccinations included influenza vaccination the previous year and an intramuscular right thigh injection of PENTACEL (lot number C3376AA) on 07 August 2009. On 19 September 2009, the patient developed vomiting and a rash was noted at the injection site. On 21 September 2009, the rash generalized throughout the body including on the ears, forehead, trunk, etc. The patient's hands and feet were also swollen. She was taken to the emergency room where BENADRYL was suggested. At the time of the report, the patient had not recovered. Follow up information received on 16 October 2009 from a health care professional who reported that the patient received a second dose of FLUZONE (lot number U3186AA) on 18 September 2009. The day after vaccination, the patient vomited four times. Two days post vaccination, the patient's mother noticed raised, red spots on the patient's body including right thigh, left arm, and the belly. The patient also had a low grade fever. Three days post vaccination, the patient's mother noted swelling in the patient's feet and hands and the red spots had spread all over. The patient's mother decided to take the patient to the emergency room. The patient was diagnosed with STEVEN JOHNSON Syndrome and was treated with BENADRYL. Per the progress notes, the patient experienced a runny nose in addition to the other symptoms, however an onset date was not clear. The patient's mother stated that the patient was doing well. The patient was reported as recovering at the time of the report. Based upon new information received, this case has been upgraded to serious. List of Documents held by Sender: none.
Age: 1.48
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rhinorrhoea, Stevens-Johnson syndrome, Vomiting
Clinical narrative: Initial report received on 22 September 2009 from a Healthcare Professional. An 17 month old female patient, with no known allergies and no medical history, received an intramuscular injection of FLUZONE (lot number not reported) in the left thigh on 18 September 2009. The patient had received a 0.5 ml dose instead of 0.25 ml. She had no illness at the time of vaccination and had received TYLENOL before vaccination. Prior vaccinations included influenza vaccination the previous year and an intramuscular right thigh injection of PENTACEL (lot number C3376AA) on 07 August 2009. On 19 September 2009, the patient developed vomiting and a rash was noted at the injection site. On 21 September 2009, the rash generalized throughout the body including on the ears, forehead, trunk, etc. The patient's hands and feet were also swollen. She was taken to the emergency room where BENADRYL was suggested. At the time of the report, the patient had not recovered. Follow up information received on 16 October 2009 from a health care professional who reported that the patient received a second dose of FLUZONE (lot number U3186AA) on 18 September 2009. The day after vaccination, the patient vomited four times. Two days post vaccination, the patient's mother noticed raised, red spots on the patient's body including right thigh, left arm, and the belly. The patient also had a low grade fever. Three days post vaccination, the patient's mother noted swelling in the patient's feet and hands and the red spots had spread all over. The patient's mother decided to take the patient to the emergency room. The patient was diagnosed with STEVEN JOHNSON Syndrome and was treated with BENADRYL. Per the progress notes, the patient experienced a runny nose in addition to the other symptoms, however an onset date was not clear. The patient's mother stated that the patient was doing well. The patient was reported as recovering at the time of the report. Based upon new information received, this case has been upgraded to serious. List of Documents held by Sender: none.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Carbon dioxide decreased, Collapse of lung, Dyspnoea, Off label use, Respiration abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of collapse (nos) in a 16-year-old male subject who was vaccinated with Flu vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included SOLODYN. On 15 October 2009 at 07:30 the subject received unspecified dose of Flu vaccine (unknown, right arm) and experienced drug use for unapproved indication. On 16 October 2009, at an unspecified time after vaccination with Flu vaccine, the subject experienced shortness of breath and collapse (nos). On an unknown date, at an unspecified time after vaccination with Flu vaccine, the subject experienced possible collapsed lung, and erratic breathing. This case was assessed as medically serious by agency. Relevant test results included blood gases of CO2 at 12. At the time of reporting the outcome of the events was unspecified. On 20 October 2009, the mother reported that the subject received FLUARIX or FLULAVAL on 15 October 2009. She could not make out the lot number completely and believed it was AFLUAA257CA, however, she could not tell if there was an L or a U in the lot number for certain. The subject played football and was hit in the chest on the evening of 16 October 2009. He experienced shortness of breath, possible collapsed lung and was taken to the emergency room. He collapsed while walking in the parking lot. He did not have to be admitted overnight. He resumed physical activity a few days later and again his breathing was erratic.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Sports injury, Syncope
Clinical narrative: This case was reported by a consumer and described the occurrence of collapse (nos) in a 16-year-old male subject who was vaccinated with Flu vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included SOLODYN. On 15 October 2009 at 07:30 the subject received unspecified dose of Flu vaccine (unknown, right arm) and experienced drug use for unapproved indication. On 16 October 2009, at an unspecified time after vaccination with Flu vaccine, the subject experienced shortness of breath and collapse (nos). On an unknown date, at an unspecified time after vaccination with Flu vaccine, the subject experienced possible collapsed lung, and erratic breathing. This case was assessed as medically serious by agency. Relevant test results included blood gases of CO2 at 12. At the time of reporting the outcome of the events was unspecified. On 20 October 2009, the mother reported that the subject received FLUARIX or FLULAVAL on 15 October 2009. She could not make out the lot number completely and believed it was AFLUAA257CA, however, she could not tell if there was an L or a U in the lot number for certain. The subject played football and was hit in the chest on the evening of 16 October 2009. He experienced shortness of breath, possible collapsed lung and was taken to the emergency room. He collapsed while walking in the parking lot. He did not have to be admitted overnight. He resumed physical activity a few days later and again his breathing was erratic.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pain
Clinical narrative: Vaccine administered 10-9-09 in afternoon that evening, area began to hurt and throb. The next day elbow to shoulder was in pain and area where vaccinated was red. Monday (10-12) area was 7cm in diameter, hard and red. Today (10-15) redness, swelling is decreasing.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient said her arm still hurts after 3 weeks after injection.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Musculoskeletal stiffness, Pain
Clinical narrative: Client received flu shot 10/7/09 and the following days, he felt soreness, burning sensation on the L scapular area radiates to the back of neck. Also felt stiffness on the back of neck. On the 4th day got better.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Immunisation reaction, Vomiting
Clinical narrative: Pt called our store stating he had severe headache and vomiting. I called pt. he believes he is having a reaction to vaccine. He's at ER 2:00pm.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Gait disturbance, Hypoaesthesia, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Left side of body, head face became numb plus pins & needles. Hard to walk for 1-2 wks, left arm seemed to be at half strength for 9-12 months (dropped mugs, plates). Currently symptoms are mostly isolated to left palm. When stressed 1/2 of left arm becomes numb/tingling. Emergency room ruled out stroke, heart attack, neuropathy, etc. No treatment offered.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Stress
Clinical narrative: Left side of body, head face became numb plus pins & needles. Hard to walk for 1-2 wks, left arm seemed to be at half strength for 9-12 months (dropped mugs, plates). Currently symptoms are mostly isolated to left palm. When stressed 1/2 of left arm becomes numb/tingling. Emergency room ruled out stroke, heart attack, neuropathy, etc. No treatment offered.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Cough, Defaecation urgency, Muscular weakness, Nausea
Clinical narrative: Client returned with spouse, stated "I have this feeling of tachycardia, sl. nausea, and a urge to defecate."States" anxious anxiety." Assisted to lay down flat with feet elevated, called 911. Cold/wet compress to head/neck. Radial pulse 96. Resp even/unlabored, skin dry, color, good. No complaints of itch. States having "bronchitis chronic": heavy thick cough, no note of emesis or phlegm c/o weakness in legs. Asked if diabetic denied. Asked if taking any meds at this time for cardiac - Pt denied. Patient asked when last time ate: states "this morning I had an Activia YoguA and some mashed potatoes". All I ate for dinner last night was mashed potatoes." States not having much of an appetite for the last week, eating only jello. Asked again about bronchitis, pt states "I have had it of/on for the past few days, but felt good yesterday." States taking MUCINEX for congestion. Denies taking antibodies antihistamine. At time of influenza injection, patient was asked how she was feeling, weather she had a flu shot before, patient denied any illness at this time, no mention of having bronchitis. States having flu vaccine in the past with any incidence. Advise patients to stay at vaccine site for 10-15minutes. EMS arrived at the clinic at 1020AM. At this time allowed paramedics to take over. Patient verbal, no s/s of distress noted at this time - 1045 patient transported in ambulance to hospital.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: No reaction on previous exposure to drug, Respiratory tract congestion, Tachycardia
Clinical narrative: Client returned with spouse, stated "I have this feeling of tachycardia, sl. nausea, and a urge to defecate."States" anxious anxiety." Assisted to lay down flat with feet elevated, called 911. Cold/wet compress to head/neck. Radial pulse 96. Resp even/unlabored, skin dry, color, good. No complaints of itch. States having "bronchitis chronic": heavy thick cough, no note of emesis or phlegm c/o weakness in legs. Asked if diabetic denied. Asked if taking any meds at this time for cardiac - Pt denied. Patient asked when last time ate: states "this morning I had an Activia YoguA and some mashed potatoes". All I ate for dinner last night was mashed potatoes." States not having much of an appetite for the last week, eating only jello. Asked again about bronchitis, pt states "I have had it of/on for the past few days, but felt good yesterday." States taking MUCINEX for congestion. Denies taking antibodies antihistamine. At time of influenza injection, patient was asked how she was feeling, weather she had a flu shot before, patient denied any illness at this time, no mention of having bronchitis. States having flu vaccine in the past with any incidence. Advise patients to stay at vaccine site for 10-15minutes. EMS arrived at the clinic at 1020AM. At this time allowed paramedics to take over. Patient verbal, no s/s of distress noted at this time - 1045 patient transported in ambulance to hospital.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site rash, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Achy feeling in limbs, rash around site and fingers hurt when made fist. Next day arm swollen around site (raised 1" in about 4-5" area). Headache, no rash and no achiness today.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Blood product transfusion, Facial paresis, Hypoaesthesia, Influenza like illness, Muscular weakness
Clinical narrative: Flu like symptom, LE weakness, numbness, tingling. Left facial weakness, sensory loss to bilateral lower extremities. IVIG was given. 10/28/09:  Hospital Records received for dates of service 10/1/09 to 10/9/09.  Final Dx:  GBS Assessment:  Had viral prodromal after flu shot.  Woke unable to ambulate. Significant leg weakness and general weakness.  Bilateral foot and leg pain.  Low back pain. Areflexia. Drooping of R eyelid with poor eye closing.  Slightly slurred speech. Trace edema in extremities.  MRI of Head and Spine-Negative.  EMG consistent with GBS.  LP with markedly elevated protein. IVIG.  Abdominal distension; decompressed via NG tube.  Possible ileus or possible Ogilvie Syndrome.  Urinary retention requiring foley catheter. Thrombocytopenia.  Mild protein malnutrition.  Anemic.  Glucose intolerance.  HTN.  Low Vitmin D.   Admitted for rehab. on 10/15/09.    10/29/09:  Neurology consult received for 10/10/09:  Dx:  Guillain Barre Syndrome. Assessment:  Presented with LE weakness, no numbness. Impression-weakness and sensory loss following flu vaccination, pattern of weakness suggests peripheral etiology and abnormalities on the spinal tap are consistent with acute demylenating polyneuropathy.  Need NCS and EMG for formal diagnosis.  Administer additional dose of IVIG.    ICD 9 Codes:  357.0, E858.8, 784.51, 564.00, 401.9, 496  12/3/09 Hospital records received. 10/9/09 to 10/19/09. Additional information abstracted.  Assessment: Ischemic Colitis. Colitis at the right colon from the hepatic flexure to part of the transverse colon.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Sensory loss
Clinical narrative: Flu like symptom, LE weakness, numbness, tingling. Left facial weakness, sensory loss to bilateral lower extremities. IVIG was given. 10/28/09:  Hospital Records received for dates of service 10/1/09 to 10/9/09.  Final Dx:  GBS Assessment:  Had viral prodromal after flu shot.  Woke unable to ambulate. Significant leg weakness and general weakness.  Bilateral foot and leg pain.  Low back pain. Areflexia. Drooping of R eyelid with poor eye closing.  Slightly slurred speech. Trace edema in extremities.  MRI of Head and Spine-Negative.  EMG consistent with GBS.  LP with markedly elevated protein. IVIG.  Abdominal distension; decompressed via NG tube.  Possible ileus or possible Ogilvie Syndrome.  Urinary retention requiring foley catheter. Thrombocytopenia.  Mild protein malnutrition.  Anemic.  Glucose intolerance.  HTN.  Low Vitmin D.   Admitted for rehab. on 10/15/09.    10/29/09:  Neurology consult received for 10/10/09:  Dx:  Guillain Barre Syndrome. Assessment:  Presented with LE weakness, no numbness. Impression-weakness and sensory loss following flu vaccination, pattern of weakness suggests peripheral etiology and abnormalities on the spinal tap are consistent with acute demylenating polyneuropathy.  Need NCS and EMG for formal diagnosis.  Administer additional dose of IVIG.    ICD 9 Codes:  357.0, E858.8, 784.51, 564.00, 401.9, 496  12/3/09 Hospital records received. 10/9/09 to 10/19/09. Additional information abstracted.  Assessment: Ischemic Colitis. Colitis at the right colon from the hepatic flexure to part of the transverse colon.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Erythema, Pruritus, Rash, Rash pustular
Clinical narrative: Red patches, bumps, blisters, pustules and intense itching-1 TRIANCINOLONE 0.1%-HYDROXYZINE 10mg began within hours of injection-began to ease up after 19 days-still a problem on 10-18-09
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Syncope
Clinical narrative: Pt returned to clinic about 5 hours after Flu vaccination complaining of dizziness, fainting, chest tightness. No itchy throat, rash, hives, throat horsing, or itching. HR = 100, T = 98.3, RR = 20, BP + 100/62. Pt history of asthma.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Oedema peripheral
Clinical narrative: 10 minutes after shot pt began to feel flushed. Face red. 2 BENADRYL given PO 25mg. Monitored pt for 1 hour. Fingers swole slightly. After 7 hours pt fine, no symptoms
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory distress, Urticaria
Clinical narrative: Hives, Resp-distress. Treated with Steroids.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Cough, Heart rate increased, Lacrimation increased, Oedema peripheral
Clinical narrative: 1. Swelling of left arm.  2. Rash on left arm, spreading to chest.  3. Water eyes.  4. Coughing.  5. Increasing blood pressure and pulse 141/91 to 182/103.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: 1. Swelling of left arm.  2. Rash on left arm, spreading to chest.  3. Water eyes.  4. Coughing.  5. Increasing blood pressure and pulse 141/91 to 182/103.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Feeling abnormal, Headache
Clinical narrative: Dizziness, weak, headache, spacey, swollen lymph nodes, soreness on left side.  Fri PM - chills, headache.  Sat AM then got dizzy and passed out.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Lymphadenopathy, Pain
Clinical narrative: Dizziness, weak, headache, spacey, swollen lymph nodes, soreness on left side.  Fri PM - chills, headache.  Sat AM then got dizzy and passed out.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Aldolase increased, Blood creatine phosphokinase increased, Intervertebral disc protrusion, Muscle rupture, Myositis
Clinical narrative: Myositis.  Left vastus medialis rupture.  Left L4 - 5 disc herniation.
Age: 29.0
Sex: M
Vaccine: FLUN3
Symptoms: Face oedema, Hyperhidrosis, Vomiting
Clinical narrative: Diaphoresis, vomiting, facial edema all within 10 minutes of administration. Patient given IV fluids and IV BENADRYL.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Myalgia, Nausea, Pyrexia, Vaccination complication
Clinical narrative: Patient called today she experienced a reaction to the vaccine. On the day after, she had muscle pain and swelling at injection site with some nausea and fever.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Chills, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Skin rash at sight of injection with pain. Chills fever over 101.4, dyspnea, fatigue, HA, loss of appetite, chest pain. Firm erythema about 5x7cm at injection site.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: Skin rash at sight of injection with pain. Chills fever over 101.4, dyspnea, fatigue, HA, loss of appetite, chest pain. Firm erythema about 5x7cm at injection site.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Skin rash at sight of injection with pain. Chills fever over 101.4, dyspnea, fatigue, HA, loss of appetite, chest pain. Firm erythema about 5x7cm at injection site.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Pain 10-14-09 L upper arm woke this am with redness, swelling 5-6" area, fatigue seen 10-15-09. Tx HYDROXYZINE 10-20-09 only slight itch almost completely resolved.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Drug exposure during pregnancy, Headache, Rash macular, Vomiting
Clinical narrative: 10 week obstetric patient - EDC 5-12-10 c/o headache evening of day FLUZONE administered woke up 1-130 AM 1 episode of vomiting, AM of 10-14-09 Patient noted rash on upper abdomen rash worsened over abdomen. Patient seen in office 10-16-09. Physician noted macular rash improved as of this date - 10-19-09 but still with rash. 10/30/09 Medical records received for dates 10/16/09 to 10/23/09. DX: macular erythematous rash on upper abdomen. Possible SE flu vax. Presented with c/o rash on abdomen, itching after getting flu vax on 10/13/09. Pt stated woke up same night vomiting, HA, and then the rash appeared on abdomen. pt. is pregnant. Assessment: erythematous rash on upper abdomen, FHR(+). 10/23/09 Pt called OB stated rash resolved. No further action.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Dizzy, fainting feeling sweating. PO TYLENOL 650mg, BENADRYL 25mg PO and fluids also Hx of Diabetes Sugar fluids given for possible decrease BS.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Feeling abnormal, Limb discomfort, Loss of control of legs, Visual impairment
Clinical narrative: Same day - 2 hr later - began to feel like I had shingles by 10 hrs after my arm ached like full-blown shingles. Next day arm improved but visual problems and legs collapsed from under me. Was away x 3 more days and it happened again (vision/weakness)
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Dizziness 2 hr. after shot continued 2 days no treatment no big deal.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Joint pain, fevers, fatigue, loss of appetite.  2 days, rest, nite time flu capsules (EQUATE).
Age: 42.0
Sex: F
Vaccine: FLUN3, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: It arm swelled to elbow and reddened around injection site sore to touch.  100.1 temp persisted 24 - 48 hours.  Symptom free on 3 days later on 10/13/09.
Age: 32.0
Sex: U
Vaccine: FLU3
Symptoms: Blood pressure normal, Disorientation, Dizziness, Heart rate normal, Hyperhidrosis
Clinical narrative: Patient briefly passed out was dizzy, sweating and unsure of where she was. This occurred about 5 minutes after receiving a flu shot. All was called and patient's HR & BP was checked (rt was normal). EMS stated that patient was fine and had not had a true reaction.
Age: 32.0
Sex: U
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient briefly passed out was dizzy, sweating and unsure of where she was. This occurred about 5 minutes after receiving a flu shot. All was called and patient's HR & BP was checked (rt was normal). EMS stated that patient was fine and had not had a true reaction.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chest discomfort, Nausea
Clinical narrative: C/O nausea & chest discomfort. B/P 96/68.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Local 5x7 cm redness - SL warm to touch. Minimal swelling.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Adnexa uteri pain, Asthenia, Cardiomegaly, Electrocardiogram, Feeling abnormal
Clinical narrative: Got vaccine Oct 7. By Oct 8th I was in pain. I went to the clinic at 8AM could not be seen until 10:00AM. I couldn't sit and/or lay down when the doctor was examining. Had EKG done, x-ray found an enlarged heart. Now I don't know if I have an enlarged heart or not. They had to send me to hospital by ambulance about 3:00PM. I got there about 4:15. When this start in the morning I saw that the left side breast was larger than the right. I never told this to the doctor because by the time I got to the hospital, I could not see the inflammation on my breast. Pain started 6:00AM. I was at the hospital at 4:15 almost 10 hours later. I have been trying to get an appointment with my Dr. since I left the hospital on a antib. Today 10/20/09 I got an appointment for Nov. 5 2009 at 11:15 and I can still tell you I'm not 100% my lungs still hurt. I have pain all around kidney & ovaries it feels like the pain outlines them. I don't know if this is a complication of the vaccine but everything start the next day. I feel out of place. I'm not the person that I used to be.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pneumonia, Renal pain, X-ray abnormal
Clinical narrative: Got vaccine Oct 7. By Oct 8th I was in pain. I went to the clinic at 8AM could not be seen until 10:00AM. I couldn't sit and/or lay down when the doctor was examining. Had EKG done, x-ray found an enlarged heart. Now I don't know if I have an enlarged heart or not. They had to send me to hospital by ambulance about 3:00PM. I got there about 4:15. When this start in the morning I saw that the left side breast was larger than the right. I never told this to the doctor because by the time I got to the hospital, I could not see the inflammation on my breast. Pain started 6:00AM. I was at the hospital at 4:15 almost 10 hours later. I have been trying to get an appointment with my Dr. since I left the hospital on a antib. Today 10/20/09 I got an appointment for Nov. 5 2009 at 11:15 and I can still tell you I'm not 100% my lungs still hurt. I have pain all around kidney & ovaries it feels like the pain outlines them. I don't know if this is a complication of the vaccine but everything start the next day. I feel out of place. I'm not the person that I used to be.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Ear infection, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms, fever, leading to double ear infection
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Got 100.6 degree F fever after vaccination.  No treatment given, resolved on its own.
Age: 2.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythema, edema and pain at the injection site starting 24 hr after receiving injection.  Area of edema, redness measures 7 inches in diameter.
Age: 1.37
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Papule vesicles front and back of trunk down to upper thigh.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Skin warm
Clinical narrative: 7X8 cm sharply demarcated warm red 3X in 11cm tender no induration. Pt given "flu shot" at another facility.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging, Partial seizures
Clinical narrative: New onset partial onset seizures. Onset about 2 weeks s/p administration of KINRIX, MMR, Varicella and Seasonal FLUMIST.  11/9/2009 hospital records for 10/5-10/6/2009. Patient presented with seizure activity with unresponsiveness.  Influenza A+.Tx: Keppra and Tamiflu. DC Dx Seizures
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: About 24 hrs after the vaccine was administered, I felt dizziness which lasted for about 2-3 hours. I went to bed and slept for 3 hrs. The symptoms disappeared and did not reoccur.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, MMR
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, erythema, warmth.
Age: 13.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Blood test, Body temperature fluctuation, Influenza serology negative, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: Pt at 9 pm 7-16-2009 could not stop shaking. I took his temp 95.3. I took him to the ER, his temp was 102.1 when we got there. They gave him a IV and something for fever and nausea. At home he got worse. I took him to the Dr where his temp went up to 105 and he was vomiting and still shaking. They then hospitalized him and ran many tests.
Age: 13.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Pt at 9 pm 7-16-2009 could not stop shaking. I took his temp 95.3. I took him to the ER, his temp was 102.1 when we got there. They gave him a IV and something for fever and nausea. At home he got worse. I took him to the Dr where his temp went up to 105 and he was vomiting and still shaking. They then hospitalized him and ran many tests.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying
Clinical narrative: Pt cried from 9 PM - 5AM after last Imm - no fever.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Biopsy skin abnormal, Blood creatine phosphokinase normal, Connective tissue disorder
Clinical narrative: Dermatomyositis - Dx'd 2/2008.  1st Dx'd by rash on knuckles found during DERM visit for acne on 2/7/08.  Pt & mother stated rash had been present for few months.  Rx'd with PLAQUENIL.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dermatomyositis, Full blood count normal, Liver function test normal, Rash
Clinical narrative: Dermatomyositis - Dx'd 2/2008.  1st Dx'd by rash on knuckles found during DERM visit for acne on 2/7/08.  Pt & mother stated rash had been present for few months.  Rx'd with PLAQUENIL.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Fall, Mouth injury, Pregnancy
Clinical narrative: No symptoms prior-fell face first after stood up from chair and cut lip. Occurred 10 minute after vaccine admin. EMS attended patient. BP 120/80. Transport for lip sutures and evaluation. No other sx noted.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMRV
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure - 1/22/07 lasting < 5 min.  -> ER visit, no labs, observation, education & D/C'd home.  (Had second febrile sz. 6/24/07).
Age: 31.0
Sex: F
Vaccine: FLU(H1N1), FLUN(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: Pt got both H1N1 inj and mist. (Someone at OK health dept adv.)
Age: 15.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Medication error, Rash
Clinical narrative: Patient wasn't sure if allergic to Thimerosal. Patient was given PNEUMOVAX and 2 days later reported a rash to us on her arm. Patient was seen by MD and received Rx's (Prednisone).
Age: 11.0
Sex: M
Vaccine: FLU(H1N1), FLUN(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: H1N1 mist and H1N1 inj given at same time.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing, Paraesthesia, Pruritus, Respiratory rate increased
Clinical narrative: Patient returned to pharmacy counter within 5 min of receiving vaccination complaining of itching/tingling sensation.  Very flushed neck & face with rapid breaths & difficulty breathing.  Condition was not improving after several months, so I called 9-1-1 & administered 1 dose of EPINEPHRINE.  EMS arrived & transport to ER.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory disturbance
Clinical narrative: Patient returned to pharmacy counter within 5 min of receiving vaccination complaining of itching/tingling sensation.  Very flushed neck & face with rapid breaths & difficulty breathing.  Condition was not improving after several months, so I called 9-1-1 & administered 1 dose of EPINEPHRINE.  EMS arrived & transport to ER.
Age: 25.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Immunisation reaction, Lower extremity mass, Myalgia, Pain, Skin mass
Clinical narrative: Muscle soreness, all over body aches. Lumps under skin on legs and back, last about 1 week, saw Dr. on 10/21/09, was told that it was a reaction to H1N1 vaccine, I also have Crohns disease and am treated with REMICADE and IMURAN.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: 10-21-09-4:00 AM awoke with welts on inside of both forearms-subsided throughout the day. 10-22-09 4:00 AM awoke with welts on outside of both forearms, itchy, swollen lower lip-subsided throughout the day.
Age: 49.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Feeling abnormal, Feeling hot, Hyperhidrosis, Palpitations
Clinical narrative: About an hour after shot, heart racing, sweating, hot, heavy pressure down R arm to fingers and through chest, then just felt lousy for about 2 days.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain, Cough, Rhinorrhoea
Clinical narrative: Mild runny nose, cough and abd pain developed 4 days after H1N1 mist - Seen today at the office, Sx improving 10/21/09.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia, Upper respiratory tract congestion
Clinical narrative: Fever, congestion, lasted 2 days.
Age: 4.0
Sex: F
Vaccine: FLU3, FLUN(H1N1)
Symptoms: Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: Fever of 103 degrees. Runny nose.  As of this date 10/19/2009 patient is still not well, fever, runny nose.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Body temperature increased, Chills, Faecal incontinence, Injection site erythema
Clinical narrative: Patient reported she woke up the next day with a fever, chills, and swelling redness at the injection site. Fever reached 103 F and lasted 3 days. Patient also reported that she was incontinent of stools and was very weak. She presented to an emergency department which did not admit her but instructed her to rest and stay hydrated during illness. Patient recovered with 4 days.