chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Feeling abnormal, Gastric disorder, Headache, Influenza like illness
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain and swelling in his joints, flu-like symptoms, fatigue, headaches, short term memory loss, cognitive problems, back pain, neck pain, shoulder pain, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 10 December 2008 via an interview between the subject and attorney(s). The subject had a history of fatigue and depression. The subject was vaccinated with LYMERIX on 07 April 1999, 04 May 1999, and 02 June 1999. In the summer of 1999 the subject developed achy joints (upper back, shoulders, ankles, knees). In the winter of 2000 he developed depression and cognitive problems. Cognitive problems were described as "forgetfulness, brain fog, slow processing speed, memory problems, word searching, and disorganization". In 2000 or 2001 he experienced sleep disturbance and testing reportedly confirmed sleep apnea. In 2001 he developed fatigue and severe headaches. Diagnostic tests reportedly showed a "small aneurysm" in the brain, and the subject was advised that the aneurysm was "nothing to worry about". In 2002 he developed stomach problems which "caused weight gain, weight loss, and diarrhea". In 2004 he experienced temper/anger issues and noted that he had quit his previous three jobs after he "blew up at work". In November 2008 he developed hand pain (unable to grip or shake hands without pain). Treatment including a breathing machine, NEXIUM, ROCEPHIN (to treat Lyme disease), unspecified stimulants, and other unspecified medications. With the exception of stomach issues, the events were unresolved at the time of this report. Based upon follow up information, this case was assessed by GSK to be medically significant.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Intracranial aneurysm, Joint swelling, Musculoskeletal pain, Neck pain, Nervous system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain and swelling in his joints, flu-like symptoms, fatigue, headaches, short term memory loss, cognitive problems, back pain, neck pain, shoulder pain, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 10 December 2008 via an interview between the subject and attorney(s). The subject had a history of fatigue and depression. The subject was vaccinated with LYMERIX on 07 April 1999, 04 May 1999, and 02 June 1999. In the summer of 1999 the subject developed achy joints (upper back, shoulders, ankles, knees). In the winter of 2000 he developed depression and cognitive problems. Cognitive problems were described as "forgetfulness, brain fog, slow processing speed, memory problems, word searching, and disorganization". In 2000 or 2001 he experienced sleep disturbance and testing reportedly confirmed sleep apnea. In 2001 he developed fatigue and severe headaches. Diagnostic tests reportedly showed a "small aneurysm" in the brain, and the subject was advised that the aneurysm was "nothing to worry about". In 2002 he developed stomach problems which "caused weight gain, weight loss, and diarrhea". In 2004 he experienced temper/anger issues and noted that he had quit his previous three jobs after he "blew up at work". In November 2008 he developed hand pain (unable to grip or shake hands without pain). Treatment including a breathing machine, NEXIUM, ROCEPHIN (to treat Lyme disease), unspecified stimulants, and other unspecified medications. With the exception of stomach issues, the events were unresolved at the time of this report. Based upon follow up information, this case was assessed by GSK to be medically significant.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Neurological symptom, Pain in extremity, Sleep apnoea syndrome, Sleep disorder, Weight decreased
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain and swelling in his joints, flu-like symptoms, fatigue, headaches, short term memory loss, cognitive problems, back pain, neck pain, shoulder pain, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 10 December 2008 via an interview between the subject and attorney(s). The subject had a history of fatigue and depression. The subject was vaccinated with LYMERIX on 07 April 1999, 04 May 1999, and 02 June 1999. In the summer of 1999 the subject developed achy joints (upper back, shoulders, ankles, knees). In the winter of 2000 he developed depression and cognitive problems. Cognitive problems were described as "forgetfulness, brain fog, slow processing speed, memory problems, word searching, and disorganization". In 2000 or 2001 he experienced sleep disturbance and testing reportedly confirmed sleep apnea. In 2001 he developed fatigue and severe headaches. Diagnostic tests reportedly showed a "small aneurysm" in the brain, and the subject was advised that the aneurysm was "nothing to worry about". In 2002 he developed stomach problems which "caused weight gain, weight loss, and diarrhea". In 2004 he experienced temper/anger issues and noted that he had quit his previous three jobs after he "blew up at work". In November 2008 he developed hand pain (unable to grip or shake hands without pain). Treatment including a breathing machine, NEXIUM, ROCEPHIN (to treat Lyme disease), unspecified stimulants, and other unspecified medications. With the exception of stomach issues, the events were unresolved at the time of this report. Based upon follow up information, this case was assessed by GSK to be medically significant.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Weight increased
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain and swelling in his joints, flu-like symptoms, fatigue, headaches, short term memory loss, cognitive problems, back pain, neck pain, shoulder pain, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 10 December 2008 via an interview between the subject and attorney(s). The subject had a history of fatigue and depression. The subject was vaccinated with LYMERIX on 07 April 1999, 04 May 1999, and 02 June 1999. In the summer of 1999 the subject developed achy joints (upper back, shoulders, ankles, knees). In the winter of 2000 he developed depression and cognitive problems. Cognitive problems were described as "forgetfulness, brain fog, slow processing speed, memory problems, word searching, and disorganization". In 2000 or 2001 he experienced sleep disturbance and testing reportedly confirmed sleep apnea. In 2001 he developed fatigue and severe headaches. Diagnostic tests reportedly showed a "small aneurysm" in the brain, and the subject was advised that the aneurysm was "nothing to worry about". In 2002 he developed stomach problems which "caused weight gain, weight loss, and diarrhea". In 2004 he experienced temper/anger issues and noted that he had quit his previous three jobs after he "blew up at work". In November 2008 he developed hand pain (unable to grip or shake hands without pain). Treatment including a breathing machine, NEXIUM, ROCEPHIN (to treat Lyme disease), unspecified stimulants, and other unspecified medications. With the exception of stomach issues, the events were unresolved at the time of this report. Based upon follow up information, this case was assessed by GSK to be medically significant.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Child seen in clinic 12-4-08 - well child visit with vaccines given. Child put to bed 12-6-08 on stomach. Unresponsive two hours later by parents at home.2/20/09-autopsy report received-Sudden unexplained infant death, prone sleeping position. Minute foci of pneumonia.
Age: 66.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Arthralgia, Atrial fibrillation, Condition aggravated, Cough, Decreased appetite
Clinical narrative: Hypertension, unstable heart rhythm, atrial fibrilation, shortness of breath, cough, jaw pain, joint pain, skin rash, insomnia, loss of muscle mass, malaise, insomnia, treated w/SOTALOL, inhalants, steroids, nsaids, TEVETEN, symptoms still persist.  12/19/2008 MR received for DOS 10/16-17/2008 with D/C DX:  COPD/asthma exacerbation.  A-fib, converted to NSR.  HTN.  Psoriasis.  GERD. Pt presented with c/o R sided chest pain following several week hx of cough/SOB and low grade fever. Found to be in A-fib and wheezing on admission. Converted to NSR with Betapace. Tx with nebs, anti-inflammatories and steroids with improvement. Cardiac consult with dx:  URI.  Pleuritic chest pain.   12/26/08 Office note from PCP recd for DOS 10/1/08. Pt c/o joint pain, malaise decreased appetite, insomnia and blotches. Asessment:  Immune response vs drug reaction./  02/01/2010 Follow-up: Following the Innoculations symptoms continued. In August of 2009 I was diagnosed with Lyme disease. There is some doubt about which symptoms result from Lyme and/or innoculation.
Age: 66.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Dyspnoea, Heart rate irregular, Insomnia, Lyme disease, Malaise
Clinical narrative: Hypertension, unstable heart rhythm, atrial fibrilation, shortness of breath, cough, jaw pain, joint pain, skin rash, insomnia, loss of muscle mass, malaise, insomnia, treated w/SOTALOL, inhalants, steroids, nsaids, TEVETEN, symptoms still persist.  12/19/2008 MR received for DOS 10/16-17/2008 with D/C DX:  COPD/asthma exacerbation.  A-fib, converted to NSR.  HTN.  Psoriasis.  GERD. Pt presented with c/o R sided chest pain following several week hx of cough/SOB and low grade fever. Found to be in A-fib and wheezing on admission. Converted to NSR with Betapace. Tx with nebs, anti-inflammatories and steroids with improvement. Cardiac consult with dx:  URI.  Pleuritic chest pain.   12/26/08 Office note from PCP recd for DOS 10/1/08. Pt c/o joint pain, malaise decreased appetite, insomnia and blotches. Asessment:  Immune response vs drug reaction./  02/01/2010 Follow-up: Following the Innoculations symptoms continued. In August of 2009 I was diagnosed with Lyme disease. There is some doubt about which symptoms result from Lyme and/or innoculation.
Age: 66.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Muscle atrophy, Pain in jaw, Rash, Rash macular
Clinical narrative: Hypertension, unstable heart rhythm, atrial fibrilation, shortness of breath, cough, jaw pain, joint pain, skin rash, insomnia, loss of muscle mass, malaise, insomnia, treated w/SOTALOL, inhalants, steroids, nsaids, TEVETEN, symptoms still persist.  12/19/2008 MR received for DOS 10/16-17/2008 with D/C DX:  COPD/asthma exacerbation.  A-fib, converted to NSR.  HTN.  Psoriasis.  GERD. Pt presented with c/o R sided chest pain following several week hx of cough/SOB and low grade fever. Found to be in A-fib and wheezing on admission. Converted to NSR with Betapace. Tx with nebs, anti-inflammatories and steroids with improvement. Cardiac consult with dx:  URI.  Pleuritic chest pain.   12/26/08 Office note from PCP recd for DOS 10/1/08. Pt c/o joint pain, malaise decreased appetite, insomnia and blotches. Asessment:  Immune response vs drug reaction./  02/01/2010 Follow-up: Following the Innoculations symptoms continued. In August of 2009 I was diagnosed with Lyme disease. There is some doubt about which symptoms result from Lyme and/or innoculation.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Iron deficiency, Nuclear magnetic resonance imaging abnormal, Pain, Paraesthesia
Clinical narrative: Within 2 hrs. after I had the shot, I had tingling on my left side.  I thought it would go away.  I went to the hospital the next morning & the MRI showed I had a stroke.  12/26/2008 MR received for DOS 11/15-16/2008 with D/C DX: Partially reversible ischemic neurologic deficit.  Esophageal reflux.  Iron deficiency anemia.  Hyperlipidemia. Pt presented to ER with c/o numbness and tingling on the L side of body which began several hours after receiving flu shot.  Neuro exam (+) for L sided paresthesia of arm, leg, face. Started on Plavix and ASA to be f/u as outpt.  02/01/2010 Follow-up: I have neuropathy (numbness) in the left hand and foot. Also some weakness in left arm and sometimes a fuzzy slight numbness in left chest area. The neuropathy causes me pain. Also I have loud ringing in my ears constantly.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Within 2 hrs. after I had the shot, I had tingling on my left side.  I thought it would go away.  I went to the hospital the next morning & the MRI showed I had a stroke.  12/26/2008 MR received for DOS 11/15-16/2008 with D/C DX: Partially reversible ischemic neurologic deficit.  Esophageal reflux.  Iron deficiency anemia.  Hyperlipidemia. Pt presented to ER with c/o numbness and tingling on the L side of body which began several hours after receiving flu shot.  Neuro exam (+) for L sided paresthesia of arm, leg, face. Started on Plavix and ASA to be f/u as outpt.  02/01/2010 Follow-up: I have neuropathy (numbness) in the left hand and foot. Also some weakness in left arm and sometimes a fuzzy slight numbness in left chest area. The neuropathy causes me pain. Also I have loud ringing in my ears constantly.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood test normal, Body temperature increased, Chest X-ray normal, Chest pain, Cough
Clinical narrative: The day following vaccination, I experienced very sore throat and worst cough I can recall in past 30 years. Three days later I called the vaccine provider and was told that my symptoms could not have come from vaccines and must be coincidental cold. Sore throat subsided, but cough continued and even got worse. No serious fever -- maximum 100-101 deg F. After suffering for 10 days, I finally saw a doctor (11/17/08) who said I did not have either pneumonia or pleurisy and gave Rx for Azithromycin. He said pain in chest muscles was due to strain of coughing so hard. Cough cleared after 5 days, but pain in chest continued and became more severe. On 12/3/08, I saw same doctor again. Pain has gradually diminished during past 10 days, and 12/10 was first day I felt I could resume most of my normal activities. Still have twinges of pain in rib cage and shoulder blades with any quick motion. I have had mild chronic bronchitis for many years, but have never experience anything like the past 5 weeks. It may have been just coincidence, but I will never risk having another pneumonia or flu vaccination.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Electrocardiogram normal, Oropharyngeal pain
Clinical narrative: The day following vaccination, I experienced very sore throat and worst cough I can recall in past 30 years. Three days later I called the vaccine provider and was told that my symptoms could not have come from vaccines and must be coincidental cold. Sore throat subsided, but cough continued and even got worse. No serious fever -- maximum 100-101 deg F. After suffering for 10 days, I finally saw a doctor (11/17/08) who said I did not have either pneumonia or pleurisy and gave Rx for Azithromycin. He said pain in chest muscles was due to strain of coughing so hard. Cough cleared after 5 days, but pain in chest continued and became more severe. On 12/3/08, I saw same doctor again. Pain has gradually diminished during past 10 days, and 12/10 was first day I felt I could resume most of my normal activities. Still have twinges of pain in rib cage and shoulder blades with any quick motion. I have had mild chronic bronchitis for many years, but have never experience anything like the past 5 weeks. It may have been just coincidence, but I will never risk having another pneumonia or flu vaccination.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration
Clinical narrative: After 48 hrs after vaccination, pt developed redness and a "knot" at the injection site. A brownish color developed between 48 and 72 hours after injection, similar to bruised appearance. Advised BENADRYL and TYLENOL/ADVIL for possible allergic reaction/inflammation.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Drug hypersensitivity, Injection site pain
Clinical narrative: Patient complained that injection site still very sore after 6 weeks.
Age: 28.0
Sex: F
Vaccine: FLU3, JEV
Symptoms: Nausea
Clinical narrative: Pt. received Japanese Encephalitis vaccine and developed acute nausea within 1/2 an hour. No other anaphylactic symptoms.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain, Tenderness
Clinical narrative: Patient was given vaccine in 11-5-08. She had soreness of upper extremities before ZOSTAVAX was given. Over the last 6 weeks, she has complained of her left shoulder being numb. She was using Diclofenac Gel on shoulder for pains. Saw Dr. 12/16/08, confirmed Shingles.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Local reaction, Myalgia
Clinical narrative: Local reaction Myalgias, Fatigue, headache
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Client left clinic Tuesday early morning and later in the evening around 11pm client reports fever 100-103 degree and vomiting through night fever continues through today @ 12 noon.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction on right arm where shot was administered.  Redness, swelling & heat.  Pt. denied pain, itching.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Pruritus
Clinical narrative: Dizziness 2 days, headaches 3 days, itiching 3 days, weakness 4 days; took TYLENOL.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Low grade temp, swelling @ injection site within 2 hours.  Temp & swelling resolved but, persistent pain & tenderness @ site of infection with decreased ROM.
Age: 12.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever, 100.4, started 12-1-08 lasting 36 hrs.  "Injection site reddened and raised, half dollar size" per mother.  Painful to move arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 11-22-08 Client states left upper arm wasosore & painful about 48 hrs after injection.  Afebrile.  Client applied ice initially.  Took TT TYLENOL.  10-23-08 client reports arm improved.  10-26-08 client feels fine.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: 11/14/08 family called to say site of chickenpox vaccine was red and swollen.  End to call back if symptoms worsened or did not start to improve.  No call back to date.  On day of vaccine (11/11/08) cal from family concerned about right arm numbness after being punched at school in right arm just after vaccine given earlier in day.  At end of conversation numbness was already resolving.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Consumer reports injections site started with redness and rash approx. 4-6 hours after injection. Not reported to anyone until 11-14-08. RN visited and reported to doctor - 9 cm x 9 cm red rash surrounding injection site and site tender to touch. Doctor ordered BENADRYL and TYLENOL.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Dyspnoea, Erythema, Fatigue, Nausea
Clinical narrative: Patient became tired within 1-2 hours of vaccine. itching started approximately 4-5 hours later under chin and got worse through out evening resulting in red patch. Next day patch larger and spreading to neck (front and back), scalp, chest, shoulders and forehead. Accompanied by nausea and trouble breathing +fever +chills by day 3 went to urgent care day 3 for steroid shot (unknown name) MEDROL dose pack, steroid cream (unknown) names and BENADRYL 25mg. Meds relieved reaction but took about 9-10 days to do so. Patient now fully relieved as of 12/3/08.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Pruritus, Pyrexia
Clinical narrative: Patient became tired within 1-2 hours of vaccine. itching started approximately 4-5 hours later under chin and got worse through out evening resulting in red patch. Next day patch larger and spreading to neck (front and back), scalp, chest, shoulders and forehead. Accompanied by nausea and trouble breathing +fever +chills by day 3 went to urgent care day 3 for steroid shot (unknown name) MEDROL dose pack, steroid cream (unknown) names and BENADRYL 25mg. Meds relieved reaction but took about 9-10 days to do so. Patient now fully relieved as of 12/3/08.
Age: 20.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site scab, Injection site warmth
Clinical narrative: Received shot 12-5-08.  Patient reports she noticed pain on eve of 12-05-08.  She called nurse line 12-6-08- applied cold with relief.  Called nurse line 12-7-08 - applied heat with relief.  Called doctors office 12-10-08 and we made appt to see her same day.  Site 12-10-08 @ 17:30 is warm, sis cm X 4 cm induration, erythemia central puncture lesion scabbed over.  Temp = 36.8 degrees C.  Tx= cold compress tib + prn for comfort.  Call for increased swelling & pain.
Age: 0.7
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC
Symptoms: Culture urine negative, Pyrexia, Urine analysis normal, White blood cell count increased
Clinical narrative: Fever to 104.6 at the night pt had received vaccines.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: PEDIARIX vaccine given; Hepatitis B vaccine also given (Hep B is component of PEDIARIX) No reaction observed or reported to date.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Injection site pain, Neuralgia, Pain in extremity, Skin warm
Clinical narrative: Rec'd call from patient 12/8/08 who relates that she rec'd flu shot 10/15/08 and shot was given in left deltoid. She experienced typical pain at time shot was given and (3) days later experienced a cramping aching pain. Arm was warm to touch for 2-3 days. She went to her MD on 11/21/08 who prescribed medication for inflammation and nerve pain. Relates arm is still painful and radiates to fingers.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Pruritus
Clinical narrative: Received Flu shot and returned 45 min later - injection site showing white hive on flank R A - complained of itchy palms, client states she gets hives frequently unsure if flu shot was the cause. Unable to take BENEDRYL - Client referred to ER, unable to reach client.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Eye pruritus, Fatigue, Malaise, Nausea
Clinical narrative: Patient complain of dizziness, eye itchy, nauseated, doesn't feel well, fatigue and sleeping more.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Somnolence
Clinical narrative: Patient complain of dizziness, eye itchy, nauseated, doesn't feel well, fatigue and sleeping more.
Age: 1.1
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient given PEDIARIX; not indicated yet at this time. No reaction reported/ observed on this date.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain
Clinical narrative: Patient states that soreness began a few days after vaccination. She states that soreness persists three weeks after vaccination. Patient states that she has difficulty sleeping due to soreness.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, IPV, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: patent given PEDIARIX combination vaccine and also given hepatitis B and polio vaccines. (These are components  of PEDIARIX). no reaction reported/observed.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt received vaccinations at approximately 14:30 on 12/8/08. At 19:30, mom noticed multiple "hives" all on his body. No respiratory distress, fever, nausea, vomiting, diarrhea seen in clinic 12/09/08 AM, had multiple uticiaria lesions all over body. No respiratory distress.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Rash, Swelling face, Urticaria
Clinical narrative: Swelling on face. Shortness of breath. Rash-hives within 20 minutes.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, IPV, PNC, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt. given PEDIARIX combination vaccine and also given Hepatitis B and Polio vaccines.  (These are components of PEDIARIX).  No reaction reported/deserved.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, IPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Site was inflamed, red and hot to the touch, pain. Was put on amoxicillin, prednisone and TYLENOL with codeine.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Lymphadenopathy, Swelling, Tenderness
Clinical narrative: Pt reports her (L) apella is swollen, red and tender. The area around the injection slightly red. She was seen by health services and started on PREDNISONE 12/05/2008 for 6 days with decreasing doses to treat swollen lymph glands related to recent vaccine. 12/08/2008 swelling resolving.
Age: 10.0
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: 11/4/08 School nurse & family called with complaints of red, swollen right arm in area where chickenpox vaccine given.  Site was red, raised & 8 cm in diameter per school nurse.  Family states child had fever the evening of 11/13/08 but no pain at site.  Child's fever resolved the next day.  11/18/08 Site was resolving-pink and 1/2 the size per school nurse.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Vomiting 2 days after shots for 4-6wks has happened after each set of shots. This is the 3rd episode.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, pain, warmth; about 10 cm diameter @ site of inoculation.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Convulsion, Immediate post-injection reaction
Clinical narrative: Patient reported that she had a seizure within 15 minutes of receiving the flu shot.  She has a history of seizures/epilepsy.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Raised red rash weit on upper right thigh near injection site. Four inches in diameter 12/09/2008. grew to about 4 1/4 inches on 12/10/2008
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Tremor
Clinical narrative: While feeding whole body shook for 20 sec on 12/5/08.
Age: 73.0
Sex: U
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Swelling on the site of injection right after the injection.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Convulsion, Immediate post-injection reaction
Clinical narrative: Within 1 minute of administering 3 immunizations listed above, pt began having seizure. o2 was administered and vitals monitored. Seizure was approx. 5-10 secs. She was observed for more than 30 mins until she was able to leave office safely.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: IM vaccine of INFLUENZA administered intra-nasally.
Age: 27.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Cough, Diarrhoea, Fatigue, Headache, Malaise
Clinical narrative: 4 days after vaccination patient developed high fever. Abdominal. Nausea. diarrhea, headache, cough up sputum. Body ache. malaise and fatigue, most symptoms has not resolved since then.
Age: 27.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: 4 days after vaccination patient developed high fever. Abdominal. Nausea. diarrhea, headache, cough up sputum. Body ache. malaise and fatigue, most symptoms has not resolved since then.
Age: 27.0
Sex: F
Vaccine: HEP, HEP
Symptoms: No adverse event
Clinical narrative: 4 days after vaccination patient developed high fever. Abdominal. Nausea. diarrhea, headache, cough up sputum. Body ache. malaise and fatigue, most symptoms has not resolved since then.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Rash papular, Rash pruritic, Urticaria
Clinical narrative: Puritic raised red papular rash also with 3-4 raided red welt-like lesions over right deltoid, shoulder, upper back and chest.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Pt called office stating on 11-14-08 left deltoid area swollen, red, warm to the touch.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Eyelid oedema, Hypersensitivity, Respiratory distress
Clinical narrative: Approximately 30 minutes after receiving the vaccines, child suddenly experienced severe allergic reaction: respiratory distress with swollen, puffy eyelids. Patient seen immediately by MD and improved after she was given an Epi-Pen injection, Nebulizer with XOPENEX 0.63 mg, and IM BENADRYL. She had normal respirations, normal O2 saturation and normal BP. when she left our office; and was transported to hospital via ambulance. The next day mother told MD that child said he had touched a can of paint prior to the allergic episode.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: According to patient, 7:00PM 12/09/08, patient had pain on front and inner parts of left upper arm. 12/10/08 patient states she noticed redness and warmth inner and front part of left arm. Redness and warmth occurred 12/10/08 afternoon. 12/11/08 9:35 AM pt states pain is improving but redness and warmth has worsened.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC
Symptoms: No adverse event
Clinical narrative: Pt given PEDIARIX combination vaccine and also given Hepatitis B and Polio vaccines. These are components of PEDIARIX). No reaction reported/observed.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Lip swelling
Clinical narrative: Hepatitis B administered on 12/9/08. Left side of lip significantly swollen 1 day later. Returned to clinic 12/11/08 and given diphenhydramine 50mg Q6 hrs.
Age: 73.0
Sex: F
Vaccine: JEV
Symptoms: Lip swelling, Musculoskeletal stiffness, Myalgia
Clinical narrative: Swelling of her lower lip within 24 hour. Gradual onset of myalgias-somewhat stiff neck over 48 hour.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, IPV
Symptoms: No adverse event
Clinical narrative: Patient given PEDIARIX combination vaccine and also given Hepatitis B and Polio vaccine's(these are components of PEDIARIX). No reaction reported/observed.
Age: 66.0
Sex: F
Vaccine: DT
Symptoms: Injection site reaction
Clinical narrative: Mild reaction to Td vaccine given to (L) arm, 2 cm x 2 cm, pink  raised arm (L) deltoid area. Ibuprofen prn, BENADRYL prn.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Back pain, Blood pressure, Flushing, Headache, Pain
Clinical narrative: Headache, pain in lower back, fever low grade (99-100), feels flushed. This happened for all 3 doses, feel poorly x1 week by Hx with headaches, body aches.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Headache, pain in lower back, fever low grade (99-100), feels flushed. This happened for all 3 doses, feel poorly x1 week by Hx with headaches, body aches.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Electroencephalogram normal, Febrile convulsion
Clinical narrative: Febrile seizure 05/16/07. Hospital DC 5/17/08 neurology consult EEG-NC. Family Hx epilepsy Co serve hive.
Age: 5.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Hives, swelling and redness around area with itching and warmth to site. Treated with BENADRYL.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Dry skin, Laboratory test normal, Rash macular, Seborrhoeic dermatitis, Skin exfoliation
Clinical narrative: Information has been received from a physician concerning a 42 day old white male who on 09-Jan-2008 was vaccinated with hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (Lot# 656509/0016U). Concomitant therapy included rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot # reported as 1193U). Other concomitant therapy included hepatitis B virus vaccine (unspecified), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine, (PREVNAR) vaccine (CRM197) and Hib conj vaccine (unspecified carrier). On approximately 15-DEC-2007 the patient experienced a rash on his face that had spread over his head. He was not bothered by it, no illness or fevers were reported. The rash was described as a macular rash on his right cheek that went over his right ear and over the top of his head. Both of his cheeks were dry and scaly. The physician's assessment was seborrheic dermatitis on his face. He was treated with (LOTRIMIN) twice a day and another cream to be used daily. It was also reported, that the infant had newborn screening done 2 days after his birth which resulted as normal. At the time of this report, the infant's outcome was unknown. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPIPV, HBHEPB
Symptoms: Antibody test negative, Hepatitis A antibody positive, Hepatitis B antibody negative, Hepatitis C antibody negative
Clinical narrative: Information has been received from a nurse concerning a 10 year old female who on 31-MAR-1998 was vaccinated with one dose of COMVAX (MSD) (lot # 623436/1176E). There was no concomitant medication. On 04-AUG-1998 the patient was vaccinated with COMVAX. Concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, and poliovirus vaccine inactivated (unspecified). Subsequently, the patient was tested for Hepatitis B and Hepatitis C titers. The results came back as non-reactive. No other details were provided. Patient outcome was not reported. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PPV, RV5
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 6 month old female with pertinent medical and adverse drug reaction history unspecified who on 10-OCT-2007 was vaccinated with a dose of COMVAX (lot #657379/0376U). Concomitant therapy diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, pneumococcal conj vaccine (unspecified) and ROTATEQ (MSD). On 10-OCT-2007, after the patient received the COMVAX, she experienced a 102-103 degree fever which lasted 3 days and had pain in both legs. At the time of reporting, the patient was recovering from the event. Unspecified medical attention was sought. No product quality complaint was involved. No further information is available.
Age: 1.3
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a physician and a pharmacist concerning the pharmacist's daughter, a 15 month old female, with no reported medical history or allergies, who on 21-NOV-2007 at 09:45 was vaccinated intramuscularly into the right anterior thigh with a third 0.5 ml dose of COMVAX (Lot# 657380/0377U). Concomitant medication given intramuscularly into the lateral anterior thigh included a fourth dose of PREVNAR (Lot # B540071H). "Within 24-48 hours," her leg became hard at the injection site on the right anterior thigh. She had a "marble like" feeling at the injection site." On 22-NOV-2007 the patient experienced redness and swelling of the thigh at the injection site on the right anterior thigh. No diagnostic laboratory studies were performed. On 28-NOV-2007 the patient recovered. No product quality complaint was involved. No further information is available.
Age: 12.0
Sex: F
Vaccine: HBHEPB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old patient who on 11-JAN-2008 was scheduled to receive a diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTAP) vaccination but was vaccinated IM with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) instead. No symptoms were reported. No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Blood culture negative, Body temperature increased, Crying, Diarrhoea, Eosinophil percentage increased
Clinical narrative: Initial and follow-up information has been received from a physician and medical record concerning a 2 month old white female with gastroesophageal reflux since 2 weeks old, no acute illness at the time of being vaccinated, and no known drug allergies, and a history of hospitalization and born via caesearan section. No family history of asthma, seizures, birth defects, seasonal allergies. On 11-DEC-2007, the patient was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot # 657380/0377U) IM in the right upper thigh at approximately 9:45 AM. Concomitant therapy also given on 11-DEC-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, (PREVNAR) vaccine (CRM197), poliovirus vaccine and ROTATEQ vaccine live (human-bovine) (MSD). Other concomitant therapy included (ZANTAC). On 11-DEC-2007, approximately afternoon, the infant developed crying off and on for 48 hours, loose diarrhea for 48 hours, one episode of vomiting, was very fussy and inconsolable. There was no fever. The infant was examined by the physician. The injection sites looked good without erythema, swelling, nor drainage. Otherwise the exam was normal. The infant was referred to the emergency room because of symptoms concerning possible sepsis as the baby received hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC), vaccine lot that was recalled. The baby was evaluated and discharged home, On 13-DEC-2007, the patient became very fussy. As a precaution the patient was sent to an emergency room for evaluation. It was reported, the lot # administered was one of those in the recent recall. On 13-DEC-2007, the patient was seen in the emergency room. The emergency room record revealed that the infant was feeding well with no vomiting. BM's were normal, she wet her diaper fine, no sick contacts. Development was age appropriate. Vital signs revealed: temperature 98.9, pulse 199, repirations 24 and pulse oximetry 95%. Exam was normal, tanner stage 1. Laboratory evaluation revealed blood culture no growth after 5 days. Cell blood count and differential were performed: hemoglobin 8.7 gm/DL (low), hematocrit 25.3 % (low), red blood cell count 2.59 m/mm3 (low), neutrophild 26% (low), lymphocyte count 54% (high), monocycte count 13% (high), and eosinophil 6% (high). The rest of the CBC was normal. Impression was immunization reaction resolving, pain due to immunization, upper respiratory infection. Patient was sent home to follow-up with primary care physician as needed and to obtain results of lab tests. On 15-DEC-2007, the infant recovered. No additional information is expected'
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Haematocrit decreased, Haemoglobin decreased, Heart rate increased, Irritability, Lymphocyte percentage increased
Clinical narrative: Initial and follow-up information has been received from a physician and medical record concerning a 2 month old white female with gastroesophageal reflux since 2 weeks old, no acute illness at the time of being vaccinated, and no known drug allergies, and a history of hospitalization and born via caesearan section. No family history of asthma, seizures, birth defects, seasonal allergies. On 11-DEC-2007, the patient was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot # 657380/0377U) IM in the right upper thigh at approximately 9:45 AM. Concomitant therapy also given on 11-DEC-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, (PREVNAR) vaccine (CRM197), poliovirus vaccine and ROTATEQ vaccine live (human-bovine) (MSD). Other concomitant therapy included (ZANTAC). On 11-DEC-2007, approximately afternoon, the infant developed crying off and on for 48 hours, loose diarrhea for 48 hours, one episode of vomiting, was very fussy and inconsolable. There was no fever. The infant was examined by the physician. The injection sites looked good without erythema, swelling, nor drainage. Otherwise the exam was normal. The infant was referred to the emergency room because of symptoms concerning possible sepsis as the baby received hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC), vaccine lot that was recalled. The baby was evaluated and discharged home, On 13-DEC-2007, the patient became very fussy. As a precaution the patient was sent to an emergency room for evaluation. It was reported, the lot # administered was one of those in the recent recall. On 13-DEC-2007, the patient was seen in the emergency room. The emergency room record revealed that the infant was feeding well with no vomiting. BM's were normal, she wet her diaper fine, no sick contacts. Development was age appropriate. Vital signs revealed: temperature 98.9, pulse 199, repirations 24 and pulse oximetry 95%. Exam was normal, tanner stage 1. Laboratory evaluation revealed blood culture no growth after 5 days. Cell blood count and differential were performed: hemoglobin 8.7 gm/DL (low), hematocrit 25.3 % (low), red blood cell count 2.59 m/mm3 (low), neutrophild 26% (low), lymphocyte count 54% (high), monocycte count 13% (high), and eosinophil 6% (high). The rest of the CBC was normal. Impression was immunization reaction resolving, pain due to immunization, upper respiratory infection. Patient was sent home to follow-up with primary care physician as needed and to obtain results of lab tests. On 15-DEC-2007, the infant recovered. No additional information is expected'
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Monocyte percentage increased, Neutrophil percentage decreased, Oxygen saturation, Red blood cell count decreased, Respiratory rate increased
Clinical narrative: Initial and follow-up information has been received from a physician and medical record concerning a 2 month old white female with gastroesophageal reflux since 2 weeks old, no acute illness at the time of being vaccinated, and no known drug allergies, and a history of hospitalization and born via caesearan section. No family history of asthma, seizures, birth defects, seasonal allergies. On 11-DEC-2007, the patient was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot # 657380/0377U) IM in the right upper thigh at approximately 9:45 AM. Concomitant therapy also given on 11-DEC-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, (PREVNAR) vaccine (CRM197), poliovirus vaccine and ROTATEQ vaccine live (human-bovine) (MSD). Other concomitant therapy included (ZANTAC). On 11-DEC-2007, approximately afternoon, the infant developed crying off and on for 48 hours, loose diarrhea for 48 hours, one episode of vomiting, was very fussy and inconsolable. There was no fever. The infant was examined by the physician. The injection sites looked good without erythema, swelling, nor drainage. Otherwise the exam was normal. The infant was referred to the emergency room because of symptoms concerning possible sepsis as the baby received hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC), vaccine lot that was recalled. The baby was evaluated and discharged home, On 13-DEC-2007, the patient became very fussy. As a precaution the patient was sent to an emergency room for evaluation. It was reported, the lot # administered was one of those in the recent recall. On 13-DEC-2007, the patient was seen in the emergency room. The emergency room record revealed that the infant was feeding well with no vomiting. BM's were normal, she wet her diaper fine, no sick contacts. Development was age appropriate. Vital signs revealed: temperature 98.9, pulse 199, repirations 24 and pulse oximetry 95%. Exam was normal, tanner stage 1. Laboratory evaluation revealed blood culture no growth after 5 days. Cell blood count and differential were performed: hemoglobin 8.7 gm/DL (low), hematocrit 25.3 % (low), red blood cell count 2.59 m/mm3 (low), neutrophild 26% (low), lymphocyte count 54% (high), monocycte count 13% (high), and eosinophil 6% (high). The rest of the CBC was normal. Impression was immunization reaction resolving, pain due to immunization, upper respiratory infection. Patient was sent home to follow-up with primary care physician as needed and to obtain results of lab tests. On 15-DEC-2007, the infant recovered. No additional information is expected'