chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: MMRV, PNC
Symptoms: Upper respiratory tract infection
Clinical narrative: Information has been received from an investigator concerning a 12 month old male who was teething who on 10/4/06 the pt was vaccinated in the right arm with a 0.5 ml SC first dose of MMR II/Varicella. Suspect vaccination administered that day in the right thigh included in IM Third dose of Prevnar. it was noted that the pt was enrolled in a study. The subject received three doses of study vaccines (HCP 015 IPV and ActHib), the last doses prior to the event were administered on 4/17/06. Concomitant vaccination administered on 4/17/06 included a third IM dose in the right thigh of Hep B vaccine (manufacturer unk). The subject developed a fever with an axillary temp of 100 degs F and the same day had a febrile seizure 171 days post immunization with the study vaccines. According to the subjects mother, he felt hot to touch upon waking up. No antipyretics were administered before the seizure episode, which started 22 hours post vaccination with MMR II/Varicella and Prevnar. Lowering the body temp was attempted with a cool shower and reportedly the seizure stopped. Following the seizure, the subject had a runny nose and cough that were symptoms of an upper respiratory infection. The subject recovered and continued in the clinical trial. He had another episode of febrile seizure 20 days earlier. The subject was not to received any further MMR II/Varicella vaccine. The subject received no treatment for the event of febrile seizure and was not scheduled for any further evaluation. The event of febrile seizure was not reported by the investigator as unrelated to the study vaccine, and related to the MMR II/Varicella and Prevnar vaccine. The pts febrile seizure was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Apnoea, Aspiration
Clinical narrative: Information has been received from a physician concerning a 2-month-old patient who was vaccinated PO with a 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Concomitant vaccinations included "all other required 2 month vaccines".  Other concomitant therapy included acetaminophen (TYLENOL) which was administered before the office visit.  The physician reported that the patient was taken to the hospital (unknown if admitted) in an ambulance.  At some point, it was noted that the patient was not breathing.  It was believed that the patient aspirated some of the vaccine into his lungs.  The patient subsequently recovered.  Upon internal review, not breathing was determined to be an important medical event.  Additional information has been requested. (OMIC)
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Pain, Sleep disorder
Clinical narrative: Information has been received from a medical assistant and an 89 year old female consumer with arthritis, increased cholesterol levels, coronary artery disease and shingles. since 9/28/1992 and a history of a mass in the right hand with surgery, gout, skin cancer on her face in 1984, cellulitis, cholelithiasis in 1978 and a heart attack in 1988 and 1989, she had angiogram in 1990 and a 30% double vessel occlusion. On 9/6/06 was vaccinated SC in the right arm with a dose of Varicella zoster virus vaccine live. There was no concomitant vaccinations. Concomitant therapy included Carbatrol, Allopurinol, Synthroid, Simvastatin, Spironolactone, aspirin and Tylenol. The pt thought that one shot of the vaccine would cure her shingles. It was noted that the pt was not experiencing pain from the injection site. the medical assistant also stated that the pt had pain from a previous shingles experience, however, the pain is reportedly worse since receiving the vaccine. The pt was worse later in the day and has interrupted the pts ability to sleep at night. It was reported that the pt did not experienced a rash. The pt had reported that she was previously seen by a neurologist, had acupuncture but nothing works for her shingles. About 3 weeks ago, on approx 10/16/06, the pt was experiencing severe pain in her back area after receiving varicella zoster virus vaccine live. At the time of this report, the pt had not recovered. It was reported that the pts experienced were disabling. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Dizziness, Hypokinesia, Influenza like illness, Injection site erythema
Clinical narrative: Information has been received from a licensed practical nurse concerning one pt out of a total of four (previously reported as three) who was vaccinated with Pneumococcal 23v polysaccharide vaccine. Subsequently, the pt experienced an injection site reaction with swollen arm, fever, heat and difficulty using the arm. This pt also experienced nausea, vomiting, pain radiation down the arm and is in bed. Follow up information from the practical nurse indicated that on the second day after vaccination, the pt has arm pain, was just not feeling well, and had flu like symptoms. The pt was instructed to ice the arm and use Tylenol for discomfort. On day 3 after vaccination, the pts daughter (who is a dentist) called the physicians office and stated that her mother had a fever of 103, was nauseous, dizzy and could not get out of bed. the daughter described the pts arm as red, painful and swollen to elbow, looking like cellulitis. The pt visited the physicians office and required an IM injection of Celestone in the opposite arm to prevent serious complications. On day 4 after vaccination, the pt phone the physicians office stating that she was feeling better. The licensed practical nurse stated that the pt was not hospitalized, the events were not disabling or life threatening. Arm pain, just not feeling well, flu like symptoms, fever of 103, nauseous, dizzy, could not get out of bed, arm red, and swollen to elbow, looking like cellulitis were considered other important medical events (OMIC). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Malaise, Nausea
Clinical narrative: Information has been received from a licensed practical nurse concerning one pt out of a total of four (previously reported as three) who was vaccinated with Pneumococcal 23v polysaccharide vaccine. Subsequently, the pt experienced an injection site reaction with swollen arm, fever, heat and difficulty using the arm. This pt also experienced nausea, vomiting, pain radiation down the arm and is in bed. Follow up information from the practical nurse indicated that on the second day after vaccination, the pt has arm pain, was just not feeling well, and had flu like symptoms. The pt was instructed to ice the arm and use Tylenol for discomfort. On day 3 after vaccination, the pts daughter (who is a dentist) called the physicians office and stated that her mother had a fever of 103, was nauseous, dizzy and could not get out of bed. the daughter described the pts arm as red, painful and swollen to elbow, looking like cellulitis. The pt visited the physicians office and required an IM injection of Celestone in the opposite arm to prevent serious complications. On day 4 after vaccination, the pt phone the physicians office stating that she was feeling better. The licensed practical nurse stated that the pt was not hospitalized, the events were not disabling or life threatening. Arm pain, just not feeling well, flu like symptoms, fever of 103, nauseous, dizzy, could not get out of bed, arm red, and swollen to elbow, looking like cellulitis were considered other important medical events (OMIC). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning one pt out of a total of four (previously reported as three) who was vaccinated with Pneumococcal 23v polysaccharide vaccine. Subsequently, the pt experienced an injection site reaction with swollen arm, fever, heat and difficulty using the arm. This pt also experienced nausea, vomiting, pain radiation down the arm and is in bed. Follow up information from the practical nurse indicated that on the second day after vaccination, the pt has arm pain, was just not feeling well, and had flu like symptoms. The pt was instructed to ice the arm and use Tylenol for discomfort. On day 3 after vaccination, the pts daughter (who is a dentist) called the physicians office and stated that her mother had a fever of 103, was nauseous, dizzy and could not get out of bed. the daughter described the pts arm as red, painful and swollen to elbow, looking like cellulitis. The pt visited the physicians office and required an IM injection of Celestone in the opposite arm to prevent serious complications. On day 4 after vaccination, the pt phone the physicians office stating that she was feeling better. The licensed practical nurse stated that the pt was not hospitalized, the events were not disabling or life threatening. Arm pain, just not feeling well, flu like symptoms, fever of 103, nauseous, dizzy, could not get out of bed, arm red, and swollen to elbow, looking like cellulitis were considered other important medical events (OMIC). Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Chills, Erythema, Erythema, Injection site cellulitis
Clinical narrative: Chills, fever 104, swelling in arm, pain, pt called back to report pneumonia shot was given at 10:00am and symptoms started at 4:00pm. Pt went to ER and was admitted. Diagnosis unk. 01/09/07-records received and reviewed for DOS 10/28-10/28/06. DC DX: cellulitis left upper extremity. Developed fever and redness spreading down her arm almost to wrist area. In ER treated with Vancomycin IV, but developed "red man syndrome". Changed to IV Levaquin.  PMH: Hypertension, Cerebrovascular accident, congestive heart failure and osteoporosis.  PE: Erythema remaining in her left upper extremity extends through the antecubital area and down towards wrist, she does not have any erythema in the actual injection site.  Follow-up: Spoke with pt on 11/1/06 and patient was home from hospital and on antibiotics. She stated that her arm still appeared red and told her to call the doctors office. Spoke with pt on 11/8/06 and she stated that she did not call the doctor back on 11/1/06, however she finished her antibiotics and has had no problems since. The arm has no discoloration of any kind and she feels fine.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Lymphocyte count increased, Monocyte count normal, Neutrophil count increased, Oedema peripheral, Pain in extremity
Clinical narrative: Chills, fever 104, swelling in arm, pain, pt called back to report pneumonia shot was given at 10:00am and symptoms started at 4:00pm. Pt went to ER and was admitted. Diagnosis unk. 01/09/07-records received and reviewed for DOS 10/28-10/28/06. DC DX: cellulitis left upper extremity. Developed fever and redness spreading down her arm almost to wrist area. In ER treated with Vancomycin IV, but developed "red man syndrome". Changed to IV Levaquin.  PMH: Hypertension, Cerebrovascular accident, congestive heart failure and osteoporosis.  PE: Erythema remaining in her left upper extremity extends through the antecubital area and down towards wrist, she does not have any erythema in the actual injection site.  Follow-up: Spoke with pt on 11/1/06 and patient was home from hospital and on antibiotics. She stated that her arm still appeared red and told her to call the doctors office. Spoke with pt on 11/8/06 and she stated that she did not call the doctor back on 11/1/06, however she finished her antibiotics and has had no problems since. The arm has no discoloration of any kind and she feels fine.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Ultrasound Doppler normal, White blood cell count increased, White blood cell disorder
Clinical narrative: Chills, fever 104, swelling in arm, pain, pt called back to report pneumonia shot was given at 10:00am and symptoms started at 4:00pm. Pt went to ER and was admitted. Diagnosis unk. 01/09/07-records received and reviewed for DOS 10/28-10/28/06. DC DX: cellulitis left upper extremity. Developed fever and redness spreading down her arm almost to wrist area. In ER treated with Vancomycin IV, but developed "red man syndrome". Changed to IV Levaquin.  PMH: Hypertension, Cerebrovascular accident, congestive heart failure and osteoporosis.  PE: Erythema remaining in her left upper extremity extends through the antecubital area and down towards wrist, she does not have any erythema in the actual injection site.  Follow-up: Spoke with pt on 11/1/06 and patient was home from hospital and on antibiotics. She stated that her arm still appeared red and told her to call the doctors office. Spoke with pt on 11/8/06 and she stated that she did not call the doctor back on 11/1/06, however she finished her antibiotics and has had no problems since. The arm has no discoloration of any kind and she feels fine.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Client developed chest tightness 30 minutes after receiving vaccine but did not report it to nurse in health unit. Came to health unit 11/8/06 complain of redness, swelling, pain and itching at site of injection (left deltoid). Doctor checked site-not infected. Area cleansed with alcohol, hydrocortisone cream and cold pack applied. Client did not divulge that chest tightness was still present. She apparently took Benadryl at home 11/8 and it went away. re-checked 11/9, local reaction diminished. No more chest symptoms.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site warmth, Skin ulcer
Clinical narrative: Local 16 x 9 cm erythematous lesion around the injection site, warm to touch, no fissures or discharge noted.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Lymphadenopathy, Muscular weakness
Clinical narrative: 22 June 2004-Client received his fourth anthrax vaccination. He thinks he received it subcutaneously in his left arm, with no other vaccines received that day. He recalls a mild local reaction (Burning sensation while vaccination injected, some tenderness, swelling and redness surrounding vaccine site and a subcutaneous nodule). None of these local symptoms lasted for more than 1 week. He recalls similar reactions following his first 3 anthrax vaccines. Client denies any unusual systemic symptoms until approximately 5-6 months later. Around December 2004, service member recalls going to the clinic for evaluation of sinus problems. He had swollen glands, sinus pressure and nasal and sinus congestation. After his initial evaluation, he was started on decongestants which helps relieve his symptoms 'somewhat'. When his symptoms lingered into the following spring (around March 2005), he thought they might be related to allergies and sought evaluation by an Allergist. His allergy testing revealed a mild reaction to seasonal molds. He had a normal CT scan of his sinuses. He was treated with Allerest, which did a good job drying up his drainage. Also, around March/April 2005, client experienced tingling and weakness of all his extremities. The sensation started in his fingers and toes and later progressed to his forearms and up to his knees. He did not experience a loss in strength, as he could still lift, run and had a strong hand grasp. He continued to have intermittent tingling. He was evaluated by Neurology during July through December 2005. These evaluations revealed a normal EMG/NCS, an MRI of the brain with increased T2 signal in the deep and subcortical white matter of both cerebral hemispheres, and slightly increased protein levels in his CSF. Currently, client reports that he is asymptomatic except for occasional feeling of extremity paresthesia, but no loss of strength. There has been some suggestion that the tingling in his hands and arms may be related to carpal tunnel syndrome (Demonstrates a + Tinel's and Phalen's) and C4-5, C5-6 stenosis per MRI. He has tried use of night splints, ergonomic adjustments in work setting and physical therapy. Physical therapy provided relief from paresthesia. Symptom: Paresthesia and weakness of all extremities, nasal and sinus congestion, sinus pressure, nasal discharge.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Nasal congestion, Paraesthesia, Sinus congestion
Clinical narrative: 22 June 2004-Client received his fourth anthrax vaccination. He thinks he received it subcutaneously in his left arm, with no other vaccines received that day. He recalls a mild local reaction (Burning sensation while vaccination injected, some tenderness, swelling and redness surrounding vaccine site and a subcutaneous nodule). None of these local symptoms lasted for more than 1 week. He recalls similar reactions following his first 3 anthrax vaccines. Client denies any unusual systemic symptoms until approximately 5-6 months later. Around December 2004, service member recalls going to the clinic for evaluation of sinus problems. He had swollen glands, sinus pressure and nasal and sinus congestation. After his initial evaluation, he was started on decongestants which helps relieve his symptoms 'somewhat'. When his symptoms lingered into the following spring (around March 2005), he thought they might be related to allergies and sought evaluation by an Allergist. His allergy testing revealed a mild reaction to seasonal molds. He had a normal CT scan of his sinuses. He was treated with Allerest, which did a good job drying up his drainage. Also, around March/April 2005, client experienced tingling and weakness of all his extremities. The sensation started in his fingers and toes and later progressed to his forearms and up to his knees. He did not experience a loss in strength, as he could still lift, run and had a strong hand grasp. He continued to have intermittent tingling. He was evaluated by Neurology during July through December 2005. These evaluations revealed a normal EMG/NCS, an MRI of the brain with increased T2 signal in the deep and subcortical white matter of both cerebral hemispheres, and slightly increased protein levels in his CSF. Currently, client reports that he is asymptomatic except for occasional feeling of extremity paresthesia, but no loss of strength. There has been some suggestion that the tingling in his hands and arms may be related to carpal tunnel syndrome (Demonstrates a + Tinel's and Phalen's) and C4-5, C5-6 stenosis per MRI. He has tried use of night splints, ergonomic adjustments in work setting and physical therapy. Physical therapy provided relief from paresthesia. Symptom: Paresthesia and weakness of all extremities, nasal and sinus congestion, sinus pressure, nasal discharge.
Age: 82.0
Sex: F
Vaccine: UNK
Symptoms: Cellulitis, Erythema, Injection site inflammation, Pain, Swelling
Clinical narrative: Office visit at clinic following vaccination on 11/10/2006. Right upper arm cellulitis red/inflammed secondary to Pneumovax vaccine. Swelling, pain. Augmentin 500mg BID for 10 days.
Age: 9.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 8 x 7 cm red, warm, edematous at deltoid (left) which was injection site. Antibiotic treated. Recheck 2 days and resolved.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches, fever 103.0.
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema, Eye swelling, Hot flush, Lymphadenopathy
Clinical narrative: First started on 10/26/06-red right ear lobe and neck-swollen lymph node-flush-painful-minor emergency same evening. EPP shot and prescribed Allerga/Claritin. Next day worse prescribed Methyprednisone over phone. Sunday was covering face, eyes swollen, doctor's office directed to emergency room, was given EPP shot and Benadryl shot, took out flush hot, lobster color. Prescribed Zantac, Prednisone and Benadryl.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Anorexia, Fatigue, Irritability, Pyrexia
Clinical narrative: He had fever the same day in the afternoon until Friday 12. High fever over 105 degrees F. We went to the pediatric (doctor), but he don't pay attention to child. So we went on Tuesday at medical center because the child don't eat, drink juice or water. And he was vomiting. He have high fever, fussiness, tiredness and don't eat nothing.
Age: 17.0
Sex: M
Vaccine: OPV, SMALL, TTOX, TYP, YF
Symptoms: Hepatic fibrosis, Hepatic necrosis, Hepatic steatosis, Hepatitis C virus
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received from a consumer on 6/22/06. A 58 year old male pt reported that he received the yellow fever vaccine. lot number 5792 in the right arm on 3/27/1965 while in the military. The pt reported he also received tetanus, smallpox, typhus and polio vaccination on 3/17/65. Trade name, manufacturer and lot numbers were not reported. Per reporter, who is the pt, in April 2002 he had blood tests and tested positive for Hep C. In 2003 he had a liver biopsy. Recovery status reported as not recovered. Follow up information received on 10/30/06. Per the reporter, the pt has chronic Hep C and a liver biopsy on 4/3/03 showed liver fibrosis, necrosis and steatosis. Other diagnostic and treatments were not provided. Per this new information, and due to medical evaluation of the case, this case was upgraded to serious.
Age: 74.0
Sex: U
Vaccine: FLU3
Symptoms: Liver function test abnormal, Lymphadenopathy
Clinical narrative: Initial report received on 07 November 2006 from a health care professional.  A 74-year-old patient (gender not provided), with a past medical history of hypothyroidism, had received an intra-muscular injection os FLUZONE SV '2006-'2007 USP, lot number U2242AA, on 23 October 2006. The route of administration was not reported.  The patient was taking Lipitor, Coumadin and Synthyroid at the time of vaccination.  Two days post-immunization, on 25 October 2006, the patient developed symptoms (symptoms were not reported).  At an unspecified amount of time later, the patient was evaluated by a physician and diagnosed with mesenteric adenitis.  The patient required hospitalization (dates were not reported).  Diagnostic tests revealed an increased liver function test, and an increased INR level.  At the time of this report, the patient had not recovered.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Urticaria
Clinical narrative: Red wheals appeared on client's upper arm's and back approximately 10-15 minutes after receiving influenza vaccine in left deltoid. No complain of itching.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Joint range of motion decreased
Clinical narrative: 11/15/06 Patient presented today with complains of unable to lift right arm at times. Has moved to left arm also. Complain of pain left arm also. No redness, hardness noted upon examination. I lifted arm without complains of voided by patient. Right arm warm and dry. No numbness can feel stimulation.
Age: 0.41
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Erythema, Faecal incontinence, Irritability, Pharyngitis, Pyrexia
Clinical narrative: Low grade fever on 10/04/06 afternoon, fussy, cold symptoms, freq stools, rash 6 prominent red peppery of entire body,palms and soles.
Age: 0.41
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Rash, Rhinitis
Clinical narrative: Low grade fever on 10/04/06 afternoon, fussy, cold symptoms, freq stools, rash 6 prominent red peppery of entire body,palms and soles.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Headache, Lethargy, Myalgia
Clinical narrative: On 8 Nov 2006, at ~10:00 AM I received a free dose (I.M.) of infuenza vaccine administered by our Health Services department.  At ~8:30PM, the same day, I gean ito experience chills which manifested into uncontrollable shaking of my entire body.  This lasted for approximalety 2 hours.  I had no fever at that time.  The shaking subsided and I was able to go to sleep.  The next morning I awoke with a sever headache, 101.5 fever, muscles aches, and extreme lethargy. I said home and slpet most of the day.  pain killers did not help my feveror headache.  I couldn't eat any food.  The next day, Friday, 10 November 2006, I had the same symptoms.  i went to my docutor who agrred that it appreaded that I had vaccine-induced flu.  I also began to get diarrhea on this day. I started alternating my pain meds and that helped my headache and my fever started to come down.  By Sunday, 12 November 2006, I was able to begin taking solid foods.  I returned to work on 13 November 2006 but in a very lethargic state.  I still have some of the effects of this event.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Oral intake reduced, Pyrexia, Tremor
Clinical narrative: On 8 Nov 2006, at ~10:00 AM I received a free dose (I.M.) of infuenza vaccine administered by our Health Services department.  At ~8:30PM, the same day, I gean ito experience chills which manifested into uncontrollable shaking of my entire body.  This lasted for approximalety 2 hours.  I had no fever at that time.  The shaking subsided and I was able to go to sleep.  The next morning I awoke with a sever headache, 101.5 fever, muscles aches, and extreme lethargy. I said home and slpet most of the day.  pain killers did not help my feveror headache.  I couldn't eat any food.  The next day, Friday, 10 November 2006, I had the same symptoms.  i went to my docutor who agrred that it appreaded that I had vaccine-induced flu.  I also began to get diarrhea on this day. I started alternating my pain meds and that helped my headache and my fever started to come down.  By Sunday, 12 November 2006, I was able to begin taking solid foods.  I returned to work on 13 November 2006 but in a very lethargic state.  I still have some of the effects of this event.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Hypokinesia, Joint range of motion decreased, Pain, Sleep disorder
Clinical narrative: 2 wk history of shoulder s/p receiving Tdap vaccine.  Pain is worse with ROM and deep palplation.  Unable to sleep on shoulder at night.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Large erythematous area surrounded by larger, hard, circumscribed area Tender to touch + pain
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: First noted signs at 6:00 AM, when she got out of bed. Felt arthritic. Aches in feet, ankles, all joints of hands and wrist. Swelling at injection site. site was puffy for about 1 inch in diameter. Red in center. No treatment. Still feels symptoms in feet and hands today. Particularly in proximal thumb joint. When standing whole foot hurts.
Age: 1.19
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Erythema, Rash papular
Clinical narrative: Presented to the office on 11/14/06 with multiple erythematous papules all over his body. Approximately 25 lesions. Rash had been present for several days. No fever or any other symptoms.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Laryngitis, Postnasal drip, Pyrexia, Upper respiratory tract infection
Clinical narrative: Extreme fatigue 1 hour after the shot; followed by laryngitis, fever and upper respiratory infection which lasted 7 days so far at this writing.  At this writing my head is still stuffy and I have post-nasal drip.
Age: 41.0
Sex: M
Vaccine: HEPAB, IPV, MMR, TYP
Symptoms: Diarrhoea, Headache, Pyrexia
Clinical narrative: 11/10/06 - Patient reported fever 102.3  11/11/06 - Patient reported fever 102.4.  Treated with Advil 11/12/06 - Patient reported headache/diarrhea, fever.  Treated with Advil.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Anorexia, Chills, Cough, Fatigue, Headache
Clinical narrative: Within 12 hours flue-like symptons of muscle ache, headache, chills, fatigue, cough, loss of appetite. In general, myalgia. Persisted with gradual improvement over 7 days. Shot given about 2PM on Nov. 4, 2006.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Within 12 hours flue-like symptons of muscle ache, headache, chills, fatigue, cough, loss of appetite. In general, myalgia. Persisted with gradual improvement over 7 days. Shot given about 2PM on Nov. 4, 2006.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Aout 7 hours after receiving vaccine I was itching and noticed red bumps on my abdomen and back. I still have them (2.5 days later) only from my neck down to hips, occasionally itchy. I took benadryl one night but didn't seem to have any effect.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Throat tightness, Tongue oedema
Clinical narrative: Rec'd flu immunization for first time.  Screened at employee flu clinic prior to immunization, which did not contraindicate giving flu vaccine.  Approx 2 hours later at home, c/o swelling tongue, increased dyspnea, "throat closing up"  After taking Albuterol inhaler without relief, took Benedryl, 911 called, transported to local ER.  Rec'd followup care for anaphylaxis.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cyanosis, Dyspnoea, Injection site hypersensitivity, Pruritus
Clinical narrative: Special note:  Patient is a nurse in the immunization clinic.   Within 5 minutes after injection patient had itching at right arm injection site, chest tightness, and throat itching, shortness of breath.  Patient took two (2) puffs of Albuteral inhaler at 4:45 pm.  Experienced loud pulmonary wheezing at 5:30 pm.  Patient took Xophrenox per nebulizer x2 treatments consecutively.  Within the hour patient took 3rd Xophrenox treatment with decrease in wheezing and shortness of breath.  No problems at injection site other than itching which did not increase later in the day.  Patient also experienced cyanosis around mouth with wheezing episode.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Special note:  Patient is a nurse in the immunization clinic.   Within 5 minutes after injection patient had itching at right arm injection site, chest tightness, and throat itching, shortness of breath.  Patient took two (2) puffs of Albuteral inhaler at 4:45 pm.  Experienced loud pulmonary wheezing at 5:30 pm.  Patient took Xophrenox per nebulizer x2 treatments consecutively.  Within the hour patient took 3rd Xophrenox treatment with decrease in wheezing and shortness of breath.  No problems at injection site other than itching which did not increase later in the day.  Patient also experienced cyanosis around mouth with wheezing episode.
Age: 0.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Injection site erythema
Clinical narrative: Localized redness as vaccine site then chest pain and shortness of breath.  Patient transported to the emergency department and then discharged home from ED.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness, Demyelination, Encephalitis, Optic neuritis, Strabismus
Clinical narrative: Mother noticed inward deviation of right eye on 11/1/06, immunization given 10/25/06. Patient had progressive vision loss starting 11/12/06. MRI shows multiple demyelinating lesions and bilateral optic neuritis, most likely diagnosis at this time is Acute Demyelinating Encephalomyelitis (ADEM). Further workup pending.  1/2/07 Received medical records from hospital which reveal patient admitted 11/13/06-11/17/06. HPI: 2-3 day hx of acute & worsening visual loss preceded by a 2 week hx of right eye deviation.  Initial s/s began w/preceding viral illness characterized by fatigue & low grade fevers.  Improved & given a flu shot.  Parent noted right eye medial deviation & was referred to ophthal but condition worsened prior to appointment & was admitted to hospital.  Began stumbling, could not feed herself & unable to complete play/puzzle tasks she had done previously.  Opthal exam in ER noted significant bilateral visual loss & inflammation of bilateral optic nerves.  Exam also revealed shotty cervical lymphadenopathy.  Treated w/high dose IV steroids.  Neuro, ophthal & neuro-opthal consults done.  Continued on tapering steroids on d/c to home.  Was to be followed by neuro, opthal clinics.  Although her vision improved in left eye to 20/160, right eye remained unchanged & was responsive only to hand movement with afferent pupillary defect & decreased right abduction.  It was not known if vision would be permanently impaired & family was referred to early intervention specialists.  FINAL DX: Acute Demyelinating encephalomyelitis.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Haemorrhage, Petechiae, Unevaluable event
Clinical narrative: Patient died at home on 8/12/2006. Patient was cosleeping with parents. Breastfed at 3am and found dead next to mother at 6am, according to her mother. Autopsy ruled cause of death as undetermined.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: L arm swollen, red and experiencing pain.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Pallor, Pyrexia
Clinical narrative: The evening after receiving the Influenza Vaccine patient was having SOB, fever, pale, dizzy and went to ER to be evaluated.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Throat tightness
Clinical narrative: Experienced lightheadedness and dizziness and "funny feeling swallowing, like my throat was going to clog up" Felt better after taking Benadryl.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: PT STATED GOT FLU AND PNEUMONIA SHOT; WENT TO ER NIGHT OF INJECTION; WAS TOLD HE HAD CELLULITIS; WENT TO MD THIS AM AND GIVEN ANTIBIOTICS.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dysphagia, Heart rate increased, Pruritus, Rash
Clinical narrative: Received immunization around 9 a.m. 11/1/2006; Patient states she had pulse rate increase;  Chest pains; Trouble Swallowing; Rash all over from head to toe; itching; Tight hissing in Throat afternoon of 11/1/2006; Saw PMD and CNP 11/01/2006 afternoon.
Age: 1.04
Sex: F
Vaccine: FLU3, HBHEPB, PNC
Symptoms: Pyrexia
Clinical narrative: Routine physical 11/6/06.  Received flu vaccine for first time, Comvax#3, Prevnar#4 (fever to 101 after 2 month shots, none since).  Developed fever to 104 later that evening, 102.7 the following morning.  No other symptoms.  Seen 11/7/06.  No fever since follow-up visit 11/7/06.
Age: 58.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Arthralgia, Arthropathy, Myalgia, Myositis, Pain
Clinical narrative: RIGHT ARM PAIN AND ARTHRALGIAS THAT STARTED 1-2 DAYS AFTER THE FIRST HEPATITIS B IMMUNIZATION. PT WENT TO A RHEUMATOLOGIST ON 8/31/2006. TREATMENT HAS BEEN HYDROXYCHLOROQUINE 200MG ONE TWICE DAILY , CELEBREX 200MG TWICE DAILY AND WELLLBUTRIN SR 100MG 4 IN THE AM. DOS 7/28-11/14/06 Complained of excruciating arthritis pain in arm of injection site. Same thing happened last month after 1st immunization. Continued with complaint on 8/16/06- DX myalgia myositis, unspecified, arthropathy unspecified. Anemia labs:
Age: 58.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Arthralgia, Hypokinesia, Injection site inflammation, Insomnia, Muscle contractions involuntary
Clinical narrative: RIGHT ARM PAIN AND ARTHRALGIAS THAT STARTED 1-2 DAYS AFTER THE FIRST HEPATITIS B IMMUNIZATION. PT WENT TO A RHEUMATOLOGIST ON 8/31/2006. TREATMENT HAS BEEN HYDROXYCHLOROQUINE 200MG ONE TWICE DAILY , CELEBREX 200MG TWICE DAILY AND WELLLBUTRIN SR 100MG 4 IN THE AM. DOS 7/28-11/14/06 Complained of excruciating arthritis pain in arm of injection site. Same thing happened last month after 1st immunization. Continued with complaint on 8/16/06- DX myalgia myositis, unspecified, arthropathy unspecified. Anemia labs:
Age: 58.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Musculoskeletal stiffness, Pain, Shoulder pain
Clinical narrative: RIGHT ARM PAIN AND ARTHRALGIAS THAT STARTED 1-2 DAYS AFTER THE FIRST HEPATITIS B IMMUNIZATION. PT WENT TO A RHEUMATOLOGIST ON 8/31/2006. TREATMENT HAS BEEN HYDROXYCHLOROQUINE 200MG ONE TWICE DAILY , CELEBREX 200MG TWICE DAILY AND WELLLBUTRIN SR 100MG 4 IN THE AM. DOS 7/28-11/14/06 Complained of excruciating arthritis pain in arm of injection site. Same thing happened last month after 1st immunization. Continued with complaint on 8/16/06- DX myalgia myositis, unspecified, arthropathy unspecified. Anemia labs:
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Hypokinesia, Pain, Vaccination complication
Clinical narrative: The girl put the shot in too high - up in the shoulder, not in the deltoid muscle.  I am in excruciating pain.  The arm is limited in useage. I felt an excruciating pain in the arm and let her know, as she gave the shot, and she continued to place the drug in my arm. Information received from the annual follow up indicates recipient has not recovered. After I had received the shot-which she put in the wrong place-too high on the arm- into the shoulder joint-I could not use my arm for four months. I had intense pain. Granted the shot was placed wrong, but no one would believe me that it was the flu shot causing an inflammatory reaction in my joint. I cannot seem to get compensation for my injury. The pain has gotten better-it took a full year but my shoulder is weak and atrophied due to non-use. I lost a 1/2 year of work-can I get some compensation. Per 60 day follow up: Chronic bursitis of left shoulder - MRI explains: "Fluid in the subacromial subdeltoid bursa in keeping iwth bursitis." Chronic low grad Left should pain with restricted range of motion and loss of strength-shoulder atrophy. Before the "shot" which she put too high I had no shoulder pain what so ever.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Medication error
Clinical narrative: Boostrix and Menactra given to a newly pregnant female. Given before + pregnancy results obtained.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose decreased, Blood pressure increased, Dizziness, Hyperhidrosis, Tremor
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of tremor in a 51-year-old female subject who was vaccinated with influenza virus vaccine (FluLaval) for prophylaxis. The subject had received influenza virus vaccine in previous years with no subsequent adverse events.  On 09 November 2006 at 8:25 a.m., the subject received a dose of FluLaval.  On 09 November 2006 at 8:50 a.m., 25 minutes after vaccination with FluLaval, the subject experienced tremor, dizziness, and sweating.  The subject returned to the healthcare professional who had administered FluLaval.  The subject's blood pressure was elevated at 170/80 mm Hg and her blood sugar was decreased at 51.  The subject received juice, crackers and diphenhydramine hydrochloride (BENADRYL).  The subject then went to the emergency room and was released the same day. The healthcare professional considered the events were clinically significant (or requiring intervention).  The outcome of the events was not reported.  (OMIC)
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Joint range of motion decreased
Clinical narrative: Right arm sore, itching, swollen, bright red, hot to touch, very painful to touch, restricted motion. lasted approx 1 week.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pruritus
Clinical narrative: Right arm sore, itching, swollen, bright red, hot to touch, very painful to touch, restricted motion. lasted approx 1 week.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Joint range of motion decreased, Myalgia, Pain, Pruritus
Clinical narrative: Right arm sore, itching, swollen, bright red, hot to touch, very painful to touch, restricted motion. lasted approx 1 week.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Swelling
Clinical narrative: Right arm sore, itching, swollen, bright red, hot to touch, very painful to touch, restricted motion. lasted approx 1 week.
Age: 91.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Large red center, indurated surrounding, the injection site, occurred within a few hours of injections (right arm).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Vomiting
Clinical narrative: Vomiting 3-4 hours after vaccine administration and dizzy.
Age: 0.39
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Oral intake reduced, Pyrexia, Screaming
Clinical narrative: Child had fever x 1 night, crying, screaming x 4 days could not be pacified, difficulty nursing.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site oedema, Injection site warmth, Myalgia
Clinical narrative: Redness, swelling down arm to elbow hot to touch, chills, and muscle aches x 3 days. TX Keflex, Motrin.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Tenderness
Clinical narrative: Swelling, redness, tenderness lasted 2 days. TX Benadryl.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Diarrhea x days, body ache, right arm slightly swollen, red and warm x 1 day.
Age: 4.0
Sex: F
Vaccine: HEPA, IPV, MMR, PNC
Symptoms: Agitation, Crying, Erythema, Urticaria
Clinical narrative: Developed hives after crying. No respiratory distress-wheezing noted. Given Benadryl at 3:10 with good response, decreased hives and erythema.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Asthenia, Irritability, Lethargy
Clinical narrative: Weak, lethargic after prolonged about 3 hours irritability.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Atrial flutter, Chest pain, Chronic fatigue syndrome, Complement factor abnormal, Fatigue
Clinical narrative: Myopericarditis and pleural effusion after Hep A. In the past year has developed CFS and is clearly impaired. Meets criteria for Chronic Fatigue Syndrome now. Also has chronic complement activation. Chest pain, sub sternal, pre syncope, tachycardia comment atrial flutter, fatigue, malaise >60 days. Continued with chronic fatigue syndrome & inability to function at a full time job.  This pt developed CFS secondary to the pericarditis that she developed post HEP A vaccine.  Per 60 day follow up: Continues with debilitating fatigue, hyperesthesias, headaches, necessitating retirement from job.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Hyperaesthesia, Impaired work ability, Malaise, Myocarditis
Clinical narrative: Myopericarditis and pleural effusion after Hep A. In the past year has developed CFS and is clearly impaired. Meets criteria for Chronic Fatigue Syndrome now. Also has chronic complement activation. Chest pain, sub sternal, pre syncope, tachycardia comment atrial flutter, fatigue, malaise >60 days. Continued with chronic fatigue syndrome & inability to function at a full time job.  This pt developed CFS secondary to the pericarditis that she developed post HEP A vaccine.  Per 60 day follow up: Continues with debilitating fatigue, hyperesthesias, headaches, necessitating retirement from job.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Pleural effusion, Presyncope, Tachycardia
Clinical narrative: Myopericarditis and pleural effusion after Hep A. In the past year has developed CFS and is clearly impaired. Meets criteria for Chronic Fatigue Syndrome now. Also has chronic complement activation. Chest pain, sub sternal, pre syncope, tachycardia comment atrial flutter, fatigue, malaise >60 days. Continued with chronic fatigue syndrome & inability to function at a full time job.  This pt developed CFS secondary to the pericarditis that she developed post HEP A vaccine.  Per 60 day follow up: Continues with debilitating fatigue, hyperesthesias, headaches, necessitating retirement from job.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid oedema, Injection site erythema, Injection site inflammation
Clinical narrative: Initial report received on 07-OCT-2005 from a health care professional. A 4-year-old male child patient with no reported medical history developed swelling in the left eyelid and injection site inflammation associated with redness, swelling and warmth in the right arm, although the nurse reported that the patient received influenza vaccine (FLUZONE SV 2005-2006, lot U1818AB) in the left deltoid on 04-OCT-2005. All the above mentioned events developed on the day of the vaccination. He had also received a hepatitis-A vaccine on 03-OCT-2005 in the left deltoid. Outcome was unknown at the time of the report. Follow-up information received on 30-JAN-2006 from a healthcare provider. The patient had no diagnostic testing and no treatments. Per the reporter, the patient had recovered.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Medication error
Clinical narrative: Initial report received on 10-OCT-2005 from a health care professional in USA. A 4-year-old female child patient with a medical history of ongoing eczema in the thigh experienced injection site inflammation associated with swelling and redness in the left upper arm on 07-OCT-2005, the day after the influenza vaccine (FLUZONE SV 2005-2006) administration. It was reported that the administration with S/8 needle bunched site resulting in a subcutaneous administration. Her consulting physician prescribed Ibuprofen (MOTRIN) and antitituolic on 10-OCT-2005. The patient's condition was improving at the time of the report. She was taking multivitamins since an unspecified time. Outcome was not reported.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Muscular weakness, Red blood cell sedimentation rate increased
Clinical narrative: Initial report received from the patient on 07-OCT-2005. A 71-year-old female patient with a medical history of rheumatoid arthritis received an injection of Fluzone 5V 2004-2005, lot number not reported, in OCT-2004. The patient had received "many previous doses." The route and site of injection were not reported. Three weeks post-vaccination, the patient started to feel weak and "could not open door handles." She also felt fatigued. The weakness and fatigue level lasted for three months. Per the reporter, she was examined by her rheumatologist and placed on Enbrel. Per the reporter, her sedimentation rates were high during this time. Illness at the time of vaccination and other medications were not reported. At the time of this report, the recovery status was unknown.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dysgeusia, Feeling abnormal
Clinical narrative: Initial report received from a patient who is a health care professional in the USA on 13/Oct/2005. A 37 year old female patient developed a metallic taste in her mouth, her BP was 120/101 and she felt "fuzzy" approximately 10-15 minutes after receiving the injection of Fluzone, lot number U1754AA in the right deltoid on 12/Oct/2005. Patient denied dizziness. Stated BP normalized 10-15 minutes later. Duration of the metallic taste and fuzzy feeling was two hours. No other signs or symptoms were reported. As per reported the patient recovered. Follow-up information received on 21/Feb/2006 from a health care provider. The case was reviewed, and the reported has no additional information.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Initial report received from physician on the 17/Oct/2005. A three and half year old male child developed redness and swelling at the injection site down to the elbow after receiving the injection of Fluzone, lot number U1753AA in the right deltoid on 9/19/05. the pt received in concomitant Havrix, lot number AHABV0711AA in the left deltoid. The pt was seen by a physician on 9/21/05 and was started on Zyrtec and corticosteroids. As per reporter the pt completely recovered within hours. Follow up information received on 12/21/2005 from a health care professional. the route of administration of the Fluzone was IM. To previous dose of flu vaccine were received prior to this vaccination. The adverse events of redness and swelling did extend to the elbow. The pts adverse events were treated with Prelone one teaspoon times two days, then one half teaspoon times two days, then on fourth teaspoon times two days, then stopped. No further information is expected.