chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Flu shot, fever/chills, myalgia, nauseated, headache and flushes.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Hypokinesia, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Patient's left deltoid, axillae and left chest wall, swollen, red and inflamed. Painful and impedes use of left arm. Symptoms developed 3 days after receiving pneumococcal vaccine in left deltoid. Seen by MD and dx'd with infection and started on antibiotics.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Swelling
Clinical narrative: Patient's left deltoid, axillae and left chest wall, swollen, red and inflamed. Painful and impedes use of left arm. Symptoms developed 3 days after receiving pneumococcal vaccine in left deltoid. Seen by MD and dx'd with infection and started on antibiotics.
Age: 39.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Injection site erythema, Injection site pain, Pain, Urticaria
Clinical narrative: Friday 9:30am given flu and pneumonia in right and left aut thighs at pt request. At 5:30pm while in a meeting, experienced sharp pain in left leg (given pneumo in LAT), left the mtg and went home and took pain meds. Slept through the night, slight pain in the morning. At about 2:30pm on Saturday while doing work outside, pt noticed a rash like hives on her upper body and back. Still red on Monday.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypokinesia
Clinical narrative: Shoulder joint pain and restricted range of motion.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site pain, Sensation of heaviness
Clinical narrative: Light headedness, dizziness, heavy feeling and throbbing in affected arm. Treated with Benadryl 50 mg PO.
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Light headedness, dizziness followed by syncope lasting approximately 2 minutes treated with Benadryl 50 mg PO.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bursitis, Hypokinesia, Myalgia
Clinical narrative: Muscular and shoulder joint pain with restricted range of motion. 11/07/01 Patient diagnosed with bursitis in shoulder of arm vaccinated.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Rash at injection site and upper left arm. Treatment with Benadryl cream.
Sex: F
Vaccine: FLU3
Symptoms: Face oedema
Clinical narrative: Swollen face and eyes. Treatment with 25mg Benadryl and referred to MD.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Hypersensitivity, Injection site oedema, Vasodilation procedure
Clinical narrative: Left upper arm from elbow to half way up shoulder, pink warm, and swollen and tender to touch. Family MD thought it was an allergic reaction and pt allergies. Talked with pt 10/25/2001 and she states it is almost better.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm from elbow to half way up shoulder, pink warm, and swollen and tender to touch. Family MD thought it was an allergic reaction and pt allergies. Talked with pt 10/25/2001 and she states it is almost better.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site oedema, Injection site pain
Clinical narrative: Painful, can't raise right arm above shoulder level. Swollen around site of injection. Given 60mg Toradol FM, Naprosyn 500mg and Vicodin.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Pruritus, Rash
Clinical narrative: SOB, itching, coughing, red rash on chest, arm and face. Treated with Akid, Singulair, Prednisone and Allegra.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Area of injection became reddened and it change on 10/14/2001. On 10/15/2001 and 10/16/2001 with redness and itching. Improved by 10/17/2001.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Fever 102 degree, malaise, body aches and treatment.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: 5 cm X 3 cm warm erythematous area at vaccination sites. Therapy with reflex 500 mg twice daily.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Malaise, Nausea, Pain
Clinical narrative: Aching, woke up in middle of night feeling like I was going to pass out. Feeling really flush feeling. Nauseated, Ill feeling passed in about 24 hours.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes simplex
Clinical narrative: Right nasal herpes simplex outbreak. Pt previously unexposed/symptom free. Therapy - Famvir.
Age: 38.0
Sex: M
Vaccine: FLU3, YF
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Rash papular
Clinical narrative: On the afternoon of 10/19/01, the arm that the yellow fever was taken in, there was itching, swelling and a large red circle with about a 4" papular rash. No fever.
Age: 32.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Malaise, Pain, Vitreous disorder
Clinical narrative: Medical history and concurrent conditions were not provided. The pt had no known drug allergies. Concurrent medications included Zyrtec 10 mg daily and doxycycline 100 mg twice daily for unspecified indications. The pt received his first injection of Lymerix on 01-OCT-1999. The physician reported that he had not seen or spoken to the ptsince that time. In October 2001, the physician was notified as part of litigation proceedings that the pt experienced "persistent worsening of aches and pains" in the ankles and feet, "floaters' (NOS0, fatigue and malaise. The pt reportedly claimed that these events were caused by the administration of Lymerix. As of 14-OCT-2001, the pain in the ankles and feet was "persistent". The outcome of the "floaters", fatigue and malaise were not provided. Comment: The reporter indicated that the pt received Lymerix lot LY13099; however, this is not a valid lot number. The adverse event "worsening pain in ankles" does not meet ICH serious criteria but is being submitted as an expedited report be special FDA request per the June 28, 200 letter.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Rash erythematous
Clinical narrative: The patient had a red, raised rash starting at his trunk and spreading out toward his limbs for two days. The rash did not bother the patient and there was no treatment.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying
Clinical narrative: Mom states baby got shots on 08/08/2001 at around 12 noon. At 9pm, baby began crying a lot and mom could not calm him down, no matter what she did to console him, it didn't help. Crying at least 3 hours, probably more. Mom brought baby to ER that night. Baby was checked and found to be healthy, no noted fever.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Rash
Clinical narrative: Rash started on 10/19/2001. Vaccines administered on 10/18/2001.
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: 08/16/2001 at 2:30 am, pt had temp 101 with "jerking" seizure activity. CHA prescribed Tylenol/Motrin. Case reported on RMT later that morning. Infabt was fine that morning about 9:30 am. Was sent to pediatrician on 08/17/2001. Older sibling with seizure disorder. Infant had a febrile seizure last month with pneumonia.
Age: 0.75
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Apnoea, Cyanosis, Somnolence
Clinical narrative: Immediately post vax, the patient let out a sob, "had no breath left", seemed to turn blue for 5-6 seconds and then started breathing again. The patient was very drowsy afterward and slept about 15 minutes in the clinic and then 1 1/2 hours at home.
Age: 0.75
Sex: M
Vaccine: HIBV, PNC
Symptoms: Abnormal behaviour, Agitation, Balance disorder, Coma, Cough
Clinical narrative: The patient spit up his formula shortly after arriving home from the clinic. He spit up another unusual amount before going to sleep around 8:30 that same night. This was an extremely early time for the patient to go to sleep. The patient awoke about 9:00 am and did not call out as he usually does. The patient did not reach out or have his usually bubbly personality. He lay in the bed after awaking and made whining sounds. That PM it was noted that the patient's left cheek bone area was swollen. On 10/18/2001 the patient remained unresponsive and the swollen cheek now had a red line it it, which seemed to be inside the skin. The patient does not interact with others and will often sit and stare. When in his high chair he will lean over and lay his head to the side. The patient also coughs a lot now. The patient is now no longer active in his bath or when he is having his diaper changed. As of 10/23/2001, the patient has not regained his previous disposition. The patient is mopey, whines alot, leans or falls over slowly while being held as if he is going to sleep, but he is wide awake. He has spurts of joviality then returns to a lethargic state. He no longer wakes up playing.
Age: 0.75
Sex: M
Vaccine: HIBV, PNC
Symptoms: Erythema, Face oedema, Fatigue, Mood altered, Somnolence
Clinical narrative: The patient spit up his formula shortly after arriving home from the clinic. He spit up another unusual amount before going to sleep around 8:30 that same night. This was an extremely early time for the patient to go to sleep. The patient awoke about 9:00 am and did not call out as he usually does. The patient did not reach out or have his usually bubbly personality. He lay in the bed after awaking and made whining sounds. That PM it was noted that the patient's left cheek bone area was swollen. On 10/18/2001 the patient remained unresponsive and the swollen cheek now had a red line it it, which seemed to be inside the skin. The patient does not interact with others and will often sit and stare. When in his high chair he will lean over and lay his head to the side. The patient also coughs a lot now. The patient is now no longer active in his bath or when he is having his diaper changed. As of 10/23/2001, the patient has not regained his previous disposition. The patient is mopey, whines alot, leans or falls over slowly while being held as if he is going to sleep, but he is wide awake. He has spurts of joviality then returns to a lethargic state. He no longer wakes up playing.
Age: 0.75
Sex: M
Vaccine: HIBV, PNC
Symptoms: Staring, Vomiting
Clinical narrative: The patient spit up his formula shortly after arriving home from the clinic. He spit up another unusual amount before going to sleep around 8:30 that same night. This was an extremely early time for the patient to go to sleep. The patient awoke about 9:00 am and did not call out as he usually does. The patient did not reach out or have his usually bubbly personality. He lay in the bed after awaking and made whining sounds. That PM it was noted that the patient's left cheek bone area was swollen. On 10/18/2001 the patient remained unresponsive and the swollen cheek now had a red line it it, which seemed to be inside the skin. The patient does not interact with others and will often sit and stare. When in his high chair he will lean over and lay his head to the side. The patient also coughs a lot now. The patient is now no longer active in his bath or when he is having his diaper changed. As of 10/23/2001, the patient has not regained his previous disposition. The patient is mopey, whines alot, leans or falls over slowly while being held as if he is going to sleep, but he is wide awake. He has spurts of joviality then returns to a lethargic state. He no longer wakes up playing.
Age: 0.1
Sex: M
Vaccine: HEP
Symptoms: Rash papular
Clinical narrative: Two days after the vaccination, the patient developed a papular rash on his forearms.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Pain
Clinical narrative: Painful to lift left arm. Painful to drive car. Painful to push down on an object MD visit on 09/16/2001 indicated 1. No loss of function in left arm. 2. No neurologic deficit.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Pt had fever 103-104 for 7 days followed by a diffuse mobilization rash. No other complication.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Post vax the patient developed a measles like rash.
Age: 3.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Maculopathy
Clinical narrative: 10/10/2001 pt presented for DTap and Varicella Vaccination. On history parents reported Toby "had a cold". Day 13 (10/23/2001) 1 maculopapular lesion on buttock, Day 16 about is maculopapular lesion. (Us cab bed (2) with fluid.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Chills, Dizziness, Dry mouth, Dysphagia
Clinical narrative: On 09/03/2001 the patient found it hard to swallow and breath, had extreme hot and cold spells, generalized weakness, dry mouth and shortness of breath. On 09/06/2001 the previous symptoms worsened and the patient also had a headache, sore throat and dizziness.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Headache, Pharyngolaryngeal pain
Clinical narrative: On 09/03/2001 the patient found it hard to swallow and breath, had extreme hot and cold spells, generalized weakness, dry mouth and shortness of breath. On 09/06/2001 the previous symptoms worsened and the patient also had a headache, sore throat and dizziness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient's mother reported the patient developed warmness and redness to the left upper arm on 10/19/2001, which became more red, hot and very hard by 10/20/2001. Reports redness and warmth continues today, 10/22/2001, but not as severe and hardness resolved.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Injection site swelling, Injection site vesicles, Pyrexia, Rash erythematous
Clinical narrative: The patient developed diffuse, erythematous, granular rash on his arm in a 4cm wide pattern radiating from injection site, consisting of very tiny vesicles, closedly packed and grainy to feel. These symptoms began 2 days post vax and lasted 4 days with a low grade fever and fatigue.
Age: 12.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Erythema, Headache
Clinical narrative: The pt developed a red discoloration of skin from shoulder to wrist on his right arm which was warm to touch. He complained of a headache within 1 hours, post vax. His mother is to take pt to the doctor today for evaluation.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Abdominal pain, Fatigue, Feeling hot, Pain, Vomiting
Clinical narrative: On 10/17/2001, at 8:00 am the patient complained of body aches and abdominal pain. The patient felt warm to the touch, but her temperature was not taken. The patient vomited 6 times today, has had no food or liquid all day, and has been fatigued. On 10/18/2001 the patient ate soup and had no more vomiting.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Urticaria
Clinical narrative: Mom reports that pt complained of tenderness at site on Friday. Sat. night 2 areas, hive-like, were at the site about 1 inch by 2 inches; these merged to a hot, red, raised area, on Sunday. ER was called but no visit made. child was given Benadryl on Sunday night. On Monday the area was palm-sized, but not as red or hot. Benadryl given again X 1.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, MMR, TD
Symptoms: Hypoaesthesia, Hypokinesia, Injection site pain
Clinical narrative: Received 4 shots at 4 PM on 9/24. Complained of numbness in left upper arm on 9/25. Saw Dr on 9/25. Treated with Advil. Continued to be difficult to move and sore for several days.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Severe cellulitis at site of injection.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Dermatitis bullous, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling and pain of right bicep after vaccination. CL Mid biceps circumference = 22 cm, R = 26 cm. Small bullas surrounding vesicles at site of injection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: The pt woke up on 10/16/01 and had redness and a hard knot to thigh. Mom called school nurse to look at it and the school nurse said there was a large red, hot area on thigh and painful to touch. The school nurse referred him to MD. Mom couldn't get child to MD so went to ER. He was dx'd with allergic reaction and given Benadryl and Augmentin. He never had a temperature. By 10/18/01, almost all of the redness and hardness was gone. On 10/23/01, mom states "no redness noted".
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site swollen and red.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles
Clinical narrative: Site swollen, red, hard and blister bump on left upper thigh.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site warmth, Pruritus
Clinical narrative: Redness, warmth, and itching persisting for 10 days.
Age: 5.0
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: classic shingle (Zoster of dermatone) of left T 8-9 dermatone.
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Chills, Injection site induration, Injection site inflammation, Myalgia
Clinical narrative: Mylagia, fever, chills, status post Td booster on 10/06/01 for injury to index finger. PE showed 12 cm area . Inflamation and induration of right deltoid site. On 10/9/01 dx of cellulitis made and treated with Keflex. By 10/16/01 clinically improving.  Follow up 12/14/2001: "Contact hospital medical records department."
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Mylagia, fever, chills, status post Td booster on 10/06/01 for injury to index finger. PE showed 12 cm area . Inflamation and induration of right deltoid site. On 10/9/01 dx of cellulitis made and treated with Keflex. By 10/16/01 clinically improving.  Follow up 12/14/2001: "Contact hospital medical records department."
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Generalised oedema, Hypersensitivity, Pruritus, Rash
Clinical narrative: Pt states she had reaction on 09/08/01 consisting of rash and edema of arms, face, legs, feet. Pt states she was tx with Benadryl. Pt states rash lasted for 2 weeks with itching. C/O still felling itchy.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hive on left wrist, immunization give in left arm. 4mg chlorpheriramune give.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Abdominal pain, Amnesia, Arthralgia, Blepharitis, Diarrhoea
Clinical narrative: Follow up information received on 16Oct01: Follow up information revealed the pt was in excellent health until Feb 1999. The pt noted gradual onset of intermittent nausea, continued minor headaches (since receiving Anthrax vaccine #1) and post prandial cramping pain. She developed episodes of irritability and forgetfulness in Feb 1999 and experienced constipation, weight loss, recurrent ileus, and amenorrhea since April 1999. The first week of May 1999, the pt's GI symptoms worsened and after the third anthrax vaccination on 18May99, the GI symptoms worsened again within one week. Within 1-2 weeks, the pt developed post prandial abdominal cramping pain, fatigue, worsening headaches, diarrhea, and intermittent nausea relieved by emesis. GI symptoms increased in severity over the next few months. She reported no fever, bloody diarrhea and hematemesis. In subsequent months, the pt continued to experience severely disabling abdominal pain as well as diarrhea shortly after eating. The problem was not relieved with diet change or small frequent meals. In Aug 1999, the pt was treated for a Helicobacter pylori infection with bismuth, tetracycline and metronidazole, but her symptoms did not improve. In Sept 1999 pelvic abdominal CT scan demonstrated thickening of the first and second part of her duodenum. An endoscopy on 05Oct99 revealed candida esophagitis and patchy gastritis. Also at that time, the pt was given a 10 day course of Diflucan and another course of treatment for the Helicobacter pylori infection. The pt's esophagitis symptoms resolved, but she continued to suffer with severe post prandial nausea, abdominal pains, and diarrhea. On 06Oct1999, a repeat endoscopy revealed inflammatory esophagitis and gastritis. Her stools were negative for blood and leukocytes, but one culture demonstrated Blastocystis hominis (presumably not a significant pathogen). A cholecystectomy in Oct 1999 was performed, due to findings of a thickened gallbladder wall with significant reduction in ejection fraction on a HIDA scan, but there was no improvement in symptoms after the procedure.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Disturbance in attention, Fatigue, Headache, Nausea, Oesophagitis
Clinical narrative: Follow up information received on 16Oct01: Follow up information revealed the pt was in excellent health until Feb 1999. The pt noted gradual onset of intermittent nausea, continued minor headaches (since receiving Anthrax vaccine #1) and post prandial cramping pain. She developed episodes of irritability and forgetfulness in Feb 1999 and experienced constipation, weight loss, recurrent ileus, and amenorrhea since April 1999. The first week of May 1999, the pt's GI symptoms worsened and after the third anthrax vaccination on 18May99, the GI symptoms worsened again within one week. Within 1-2 weeks, the pt developed post prandial abdominal cramping pain, fatigue, worsening headaches, diarrhea, and intermittent nausea relieved by emesis. GI symptoms increased in severity over the next few months. She reported no fever, bloody diarrhea and hematemesis. In subsequent months, the pt continued to experience severely disabling abdominal pain as well as diarrhea shortly after eating. The problem was not relieved with diet change or small frequent meals. In Aug 1999, the pt was treated for a Helicobacter pylori infection with bismuth, tetracycline and metronidazole, but her symptoms did not improve. In Sept 1999 pelvic abdominal CT scan demonstrated thickening of the first and second part of her duodenum. An endoscopy on 05Oct99 revealed candida esophagitis and patchy gastritis. Also at that time, the pt was given a 10 day course of Diflucan and another course of treatment for the Helicobacter pylori infection. The pt's esophagitis symptoms resolved, but she continued to suffer with severe post prandial nausea, abdominal pains, and diarrhea. On 06Oct1999, a repeat endoscopy revealed inflammatory esophagitis and gastritis. Her stools were negative for blood and leukocytes, but one culture demonstrated Blastocystis hominis (presumably not a significant pathogen). A cholecystectomy in Oct 1999 was performed, due to findings of a thickened gallbladder wall with significant reduction in ejection fraction on a HIDA scan, but there was no improvement in symptoms after the procedure.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Vomiting, Weight decreased
Clinical narrative: Follow up information received on 16Oct01: Follow up information revealed the pt was in excellent health until Feb 1999. The pt noted gradual onset of intermittent nausea, continued minor headaches (since receiving Anthrax vaccine #1) and post prandial cramping pain. She developed episodes of irritability and forgetfulness in Feb 1999 and experienced constipation, weight loss, recurrent ileus, and amenorrhea since April 1999. The first week of May 1999, the pt's GI symptoms worsened and after the third anthrax vaccination on 18May99, the GI symptoms worsened again within one week. Within 1-2 weeks, the pt developed post prandial abdominal cramping pain, fatigue, worsening headaches, diarrhea, and intermittent nausea relieved by emesis. GI symptoms increased in severity over the next few months. She reported no fever, bloody diarrhea and hematemesis. In subsequent months, the pt continued to experience severely disabling abdominal pain as well as diarrhea shortly after eating. The problem was not relieved with diet change or small frequent meals. In Aug 1999, the pt was treated for a Helicobacter pylori infection with bismuth, tetracycline and metronidazole, but her symptoms did not improve. In Sept 1999 pelvic abdominal CT scan demonstrated thickening of the first and second part of her duodenum. An endoscopy on 05Oct99 revealed candida esophagitis and patchy gastritis. Also at that time, the pt was given a 10 day course of Diflucan and another course of treatment for the Helicobacter pylori infection. The pt's esophagitis symptoms resolved, but she continued to suffer with severe post prandial nausea, abdominal pains, and diarrhea. On 06Oct1999, a repeat endoscopy revealed inflammatory esophagitis and gastritis. Her stools were negative for blood and leukocytes, but one culture demonstrated Blastocystis hominis (presumably not a significant pathogen). A cholecystectomy in Oct 1999 was performed, due to findings of a thickened gallbladder wall with significant reduction in ejection fraction on a HIDA scan, but there was no improvement in symptoms after the procedure.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Abdominal pain, Amenorrhoea, Bacterial infection, Cholecystitis, Constipation
Clinical narrative: Follow up information received on 16Oct01: Follow up information revealed the pt was in excellent health until Feb 1999. The pt noted gradual onset of intermittent nausea, continued minor headaches (since receiving Anthrax vaccine #1) and post prandial cramping pain. She developed episodes of irritability and forgetfulness in Feb 1999 and experienced constipation, weight loss, recurrent ileus, and amenorrhea since April 1999. The first week of May 1999, the pt's GI symptoms worsened and after the third anthrax vaccination on 18May99, the GI symptoms worsened again within one week. Within 1-2 weeks, the pt developed post prandial abdominal cramping pain, fatigue, worsening headaches, diarrhea, and intermittent nausea relieved by emesis. GI symptoms increased in severity over the next few months. She reported no fever, bloody diarrhea and hematemesis. In subsequent months, the pt continued to experience severely disabling abdominal pain as well as diarrhea shortly after eating. The problem was not relieved with diet change or small frequent meals. In Aug 1999, the pt was treated for a Helicobacter pylori infection with bismuth, tetracycline and metronidazole, but her symptoms did not improve. In Sept 1999 pelvic abdominal CT scan demonstrated thickening of the first and second part of her duodenum. An endoscopy on 05Oct99 revealed candida esophagitis and patchy gastritis. Also at that time, the pt was given a 10 day course of Diflucan and another course of treatment for the Helicobacter pylori infection. The pt's esophagitis symptoms resolved, but she continued to suffer with severe post prandial nausea, abdominal pains, and diarrhea. On 06Oct1999, a repeat endoscopy revealed inflammatory esophagitis and gastritis. Her stools were negative for blood and leukocytes, but one culture demonstrated Blastocystis hominis (presumably not a significant pathogen). A cholecystectomy in Oct 1999 was performed, due to findings of a thickened gallbladder wall with significant reduction in ejection fraction on a HIDA scan, but there was no improvement in symptoms after the procedure.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Diarrhoea, Gastritis, Gastrointestinal disorder, Haematemesis, Haematochezia
Clinical narrative: Follow up information received on 16Oct01: Follow up information revealed the pt was in excellent health until Feb 1999. The pt noted gradual onset of intermittent nausea, continued minor headaches (since receiving Anthrax vaccine #1) and post prandial cramping pain. She developed episodes of irritability and forgetfulness in Feb 1999 and experienced constipation, weight loss, recurrent ileus, and amenorrhea since April 1999. The first week of May 1999, the pt's GI symptoms worsened and after the third anthrax vaccination on 18May99, the GI symptoms worsened again within one week. Within 1-2 weeks, the pt developed post prandial abdominal cramping pain, fatigue, worsening headaches, diarrhea, and intermittent nausea relieved by emesis. GI symptoms increased in severity over the next few months. She reported no fever, bloody diarrhea and hematemesis. In subsequent months, the pt continued to experience severely disabling abdominal pain as well as diarrhea shortly after eating. The problem was not relieved with diet change or small frequent meals. In Aug 1999, the pt was treated for a Helicobacter pylori infection with bismuth, tetracycline and metronidazole, but her symptoms did not improve. In Sept 1999 pelvic abdominal CT scan demonstrated thickening of the first and second part of her duodenum. An endoscopy on 05Oct99 revealed candida esophagitis and patchy gastritis. Also at that time, the pt was given a 10 day course of Diflucan and another course of treatment for the Helicobacter pylori infection. The pt's esophagitis symptoms resolved, but she continued to suffer with severe post prandial nausea, abdominal pains, and diarrhea. On 06Oct1999, a repeat endoscopy revealed inflammatory esophagitis and gastritis. Her stools were negative for blood and leukocytes, but one culture demonstrated Blastocystis hominis (presumably not a significant pathogen). A cholecystectomy in Oct 1999 was performed, due to findings of a thickened gallbladder wall with significant reduction in ejection fraction on a HIDA scan, but there was no improvement in symptoms after the procedure.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Headache, Ileus, Irritability, Laboratory test abnormal, Memory impairment
Clinical narrative: Follow up information received on 16Oct01: Follow up information revealed the pt was in excellent health until Feb 1999. The pt noted gradual onset of intermittent nausea, continued minor headaches (since receiving Anthrax vaccine #1) and post prandial cramping pain. She developed episodes of irritability and forgetfulness in Feb 1999 and experienced constipation, weight loss, recurrent ileus, and amenorrhea since April 1999. The first week of May 1999, the pt's GI symptoms worsened and after the third anthrax vaccination on 18May99, the GI symptoms worsened again within one week. Within 1-2 weeks, the pt developed post prandial abdominal cramping pain, fatigue, worsening headaches, diarrhea, and intermittent nausea relieved by emesis. GI symptoms increased in severity over the next few months. She reported no fever, bloody diarrhea and hematemesis. In subsequent months, the pt continued to experience severely disabling abdominal pain as well as diarrhea shortly after eating. The problem was not relieved with diet change or small frequent meals. In Aug 1999, the pt was treated for a Helicobacter pylori infection with bismuth, tetracycline and metronidazole, but her symptoms did not improve. In Sept 1999 pelvic abdominal CT scan demonstrated thickening of the first and second part of her duodenum. An endoscopy on 05Oct99 revealed candida esophagitis and patchy gastritis. Also at that time, the pt was given a 10 day course of Diflucan and another course of treatment for the Helicobacter pylori infection. The pt's esophagitis symptoms resolved, but she continued to suffer with severe post prandial nausea, abdominal pains, and diarrhea. On 06Oct1999, a repeat endoscopy revealed inflammatory esophagitis and gastritis. Her stools were negative for blood and leukocytes, but one culture demonstrated Blastocystis hominis (presumably not a significant pathogen). A cholecystectomy in Oct 1999 was performed, due to findings of a thickened gallbladder wall with significant reduction in ejection fraction on a HIDA scan, but there was no improvement in symptoms after the procedure.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Muscle spasms, Nausea, Oesophagitis, Pyrexia, Sepsis
Clinical narrative: Follow up information received on 16Oct01: Follow up information revealed the pt was in excellent health until Feb 1999. The pt noted gradual onset of intermittent nausea, continued minor headaches (since receiving Anthrax vaccine #1) and post prandial cramping pain. She developed episodes of irritability and forgetfulness in Feb 1999 and experienced constipation, weight loss, recurrent ileus, and amenorrhea since April 1999. The first week of May 1999, the pt's GI symptoms worsened and after the third anthrax vaccination on 18May99, the GI symptoms worsened again within one week. Within 1-2 weeks, the pt developed post prandial abdominal cramping pain, fatigue, worsening headaches, diarrhea, and intermittent nausea relieved by emesis. GI symptoms increased in severity over the next few months. She reported no fever, bloody diarrhea and hematemesis. In subsequent months, the pt continued to experience severely disabling abdominal pain as well as diarrhea shortly after eating. The problem was not relieved with diet change or small frequent meals. In Aug 1999, the pt was treated for a Helicobacter pylori infection with bismuth, tetracycline and metronidazole, but her symptoms did not improve. In Sept 1999 pelvic abdominal CT scan demonstrated thickening of the first and second part of her duodenum. An endoscopy on 05Oct99 revealed candida esophagitis and patchy gastritis. Also at that time, the pt was given a 10 day course of Diflucan and another course of treatment for the Helicobacter pylori infection. The pt's esophagitis symptoms resolved, but she continued to suffer with severe post prandial nausea, abdominal pains, and diarrhea. On 06Oct1999, a repeat endoscopy revealed inflammatory esophagitis and gastritis. Her stools were negative for blood and leukocytes, but one culture demonstrated Blastocystis hominis (presumably not a significant pathogen). A cholecystectomy in Oct 1999 was performed, due to findings of a thickened gallbladder wall with significant reduction in ejection fraction on a HIDA scan, but there was no improvement in symptoms after the procedure.
Age: 0.75
Sex: U
Vaccine: DT, HBHEPB, IPV, PNC, DT, HEP, HIBV, PNC
Symptoms: Hypokinesia, Hypotonia, Infantile spasms
Clinical narrative: Pt had infantile spasms, 3 days, post vax, until the present. Treated with strong anti-convulsants Ex. ACTH Zonigran, etc.
Age: 0.75
Sex: U
Vaccine: DT, HBHEPB, IPV, PNC, DT, HEP, HIBV, PNC
Symptoms: Infantile spasms
Clinical narrative: Pt had infantile spasms, 3 days, post vax, until the present. Treated with strong anti-convulsants Ex. ACTH Zonigran, etc.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Cardiac arrest, Hypoxia
Clinical narrative: Information has been received from a physician concerning a female pt who was vaccinated with a 2nd dose of Hep-B vaccine recombinant (yeast). Subsequently, the pt experienced an anaphylactic reaction and was hospitalized. No further information was provided. Additional information has been requested. F/U states: Information has been received from a physician concerning a 12 year old female pt with severe asthma and environmental allergies who was vaccinated with a 2nd dose of Hep-B. He indicated that about 1 1/2 hours after receiving the vaccine, she went into cardiac arrest, was resuscitated and transported to the hospital. The pt was intubated and placed on a ventilator for several days. The physician stated that the child is fine now and has had follow-up visits to the clinic. It was noted that the physician "did a skin test to Recombivax in the clinic and the results were positive". Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Condition aggravated, Cystitis haemorrhagic, Haemorrhage intracranial, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 28 year old Haitian male who on 10/9/01 was vaccinated with pneumococcal vaccine 23 polyvalent. On 10/11/01, the pt was hospitalized for the following other unrelated pre-existing conditions: aplastic anemia, prostatic abscess, hematuria, sepsis, colitis and a tuberculosis pleural effusions. On 10/12/01, the pt developed a severe injection site reaction described as severe swelling and induration from the right deltoid to his mid-forearm. On that same date, the pt suffered from hemorrhagic cystitis secondary to Klebsiella infection, bibasal pneumonia and developed an intracranial hemorrhage. As of 10/19/01, the pt was on a ventilator and was doing very poorly.  A chest X-ray on that same date showed a suspicion of infilitration in both lung bases and a  clinical correlation was suggested. The pt was being treated with piperacillin sodium (+) tazobactam (Zosyn), gentamicin and metronidazole (Flagyl). On 10/21/01, the pt died. The cause of death. The cause of death was intracranial hemorrhage. The reporting physician did not feel that the pt's hemorrhagic cystitis and intracranial bleed were related to his pneumococcal vaccine. Additional information is not expected.
Sex: F
Vaccine: HEP, HEPA
Symptoms: Gallbladder disorder, Hepatic enzyme abnormal, Hepatomegaly, Jaundice, Liver disorder
Clinical narrative: Information has been received from a consumer concerning her daughter who on 3/20/01 was vaccinated with a 2nd dose of Hep-B vaccine recombinant (yeast). The mother reported that "within months" of vaccination, her daughter "developed a liver condition". It was noted that the pt experienced "increased liver enzyme levels, jaundice, fever and an enlarged and inflamed liver". Her gall bladder was removed because it "shut down". It was noted that the pt had been hospitalized several times. It was reported that the caller did not know the name of the vaccine and did not know if it was Hep-A or Hep-B. The caller was very difficult, threatened legal action, and refused to provide demographics. She disconnected the call before a legal address was able to be obtained. No further information is available.
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her daughter who on 3/20/01 was vaccinated with a 2nd dose of Hep-B vaccine recombinant (yeast). The mother reported that "within months" of vaccination, her daughter "developed a liver condition". It was noted that the pt experienced "increased liver enzyme levels, jaundice, fever and an enlarged and inflamed liver". Her gall bladder was removed because it "shut down". It was noted that the pt had been hospitalized several times. It was reported that the caller did not know the name of the vaccine and did not know if it was Hep-A or Hep-B. The caller was very difficult, threatened legal action, and refused to provide demographics. She disconnected the call before a legal address was able to be obtained. No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Pityriasis rosea, Pruritus
Clinical narrative: Information has been received from a hospital pharmacist concerning an adult hospital employee who on 9/17/01 was vaccinated with the 1st dose of Hep-B vaccine recombinant (yeast). On 10/2/01, the pt presented to the hospital with an itchy rash on the arms and trunk of the body. The pt was dx'd with pityriasis rosea. In follow up reported that it had been determined by an emergency room physician and an Infection Control Nurse that the pityrissis rosea was not associated with hepatitis  B vaccine recombinant but were associated with a detergent or soap that the patient had used. Further, the patient had made a full recovery and continued with the Hepatitis B vaccine recombiant series. Upon internal review, the pityriasis rosea was considered an other important medical event. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Autism, Neurodevelopmental disorder
Clinical narrative: Information has been received from a healthcare professional concerning a 4 year old male pt who on 6/17/97, 8/4/97 and 4/17/98 was vaccinated with the 1st (lot 621000/1554D), 2nd (lot 620758/1402D) and 3rd (lot 622790/1036E) doses of Hep-B vaccine recombinant (yeast), respectively. It was noted that on 11/18/99, the pt was vaccinated with 1 dose of MMR (lot 628004/1173H). On 6/3/01, the pt was dx'd with autism. It was noted that no current medications have been prescribed by the PCP. The pt's mother indicated that her son was a normal child until he received these 4 shots. Additionally, it was reported that the parents expressed concerns about the thimerosal content in the vaccine because of the mental delays experienced by their son. FOLLOW-UP information has been received from a physician who reports that the patient has autism and the mother is checking into all his vaccines as a possible cause the physician does not feel that there is any connection. Upon internal review, autism was determined to be an "Other Important Medical Event". No further information is availble.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Inflammation
Clinical narrative: A pharmacist reported that an 82 year old female vaccinated with Pnu-Imune 23 was subsequently hospitalized with a "shoulder infection". On 10/24/01, the pt received an injection of Pnu-Imune 23 to the left deltoid; on 10/25/01, she developed a swollen arm. On 10/25/01, she saw an orthopedic specialist and was admitted to the hospital with an infection of the left shoulder and underwent surgery. It was noted that the pt received a flu vaccine (Aventis Pasteur) to the same arm on 10/18/01. No further information was provided.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Cold sweat, Convulsion, Irritability, Laboratory test abnormal, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old male with otitis media and no known allergies who on 9/27/01 was vaccinated SC in the right thigh with a first dose of MMR II (lot 637424/0024L). Concomitant vaccinations on 9/27/01 included a first dose SC in the left thigh of varicella virus vaccine (638728/0237L) and a first dose IM in the left thigh of Prevnar (480502). There were no other concomitant medications. On 10/3/01, the pt developed a temperature of 101-102 and became fussy. On 10/4/01, the pt's temperature was 103 and again he was very fussy. On 10/5/01, the pt was fussy; the mother administered Tylenol and laid the pt down. At 8:45 that evening th ept was cool to touch and he experienced a seizure. He was transported to the hospital (transport took approximately 15 mins). He had a temperature of 104 and was admitted to the hospital for 24 hrs observation. Unspecified lab work was drawn and "something was detected in the blood culture" which resulted in the pt being placed on antibiotics. It was noted that the "events continued until the morning of approximately 10/6/01," and the pt recovered. Additional info has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Agitation, Convulsion, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old male with otitis media and no known allergies who on 9/27/01 was vaccinated SC in the right thigh with a first dose of MMR II (lot 637424/0024L). Concomitant vaccinations on 9/27/01 included a first dose SC in the left thigh of varicella virus vaccine (638728/0237L) and a first dose IM in the left thigh of Prevnar (480502). There were no other concomitant medications. On 10/3/01, the pt developed a temperature of 101-102 and became fussy. On 10/4/01, the pt's temperature was 103 and again he was very fussy. On 10/5/01, the pt was fussy; the mother administered Tylenol and laid the pt down. At 8:45 that evening th ept was cool to touch and he experienced a seizure. He was transported to the hospital (transport took approximately 15 mins). He had a temperature of 104 and was admitted to the hospital for 24 hrs observation. Unspecified lab work was drawn and "something was detected in the blood culture" which resulted in the pt being placed on antibiotics. It was noted that the "events continued until the morning of approximately 10/6/01," and the pt recovered. Additional info has been requested.
Age: 1.0
Sex: M
Vaccine: HEP, HIBV, OPV
Symptoms: Autism, Drug level increased, Vaccination complication
Clinical narrative: Mercury poisoning, deterioration began around 12-18 months of age. Mercury chelation started on 5/01. The annual follow up states, "Autism spectrum disorder-mercury poisoning. We have spent over and look now on therapies and biomedical treatments for pt. He is finally able to communicate some, but has a long ways to go. Requires an aide in school and still does five hours of ABA a day outside of school."
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Convulsion, Pyrexia
Clinical narrative: Pt was seen for a well visit at 09:30 and received MMR and HIB at about 12:30 to 13:00. He developed a fever and was given Tylenol and was put down for a nap. At about 17:00, he awoke from his nap with a generalized tonic/clonic seizure which lasted about 8-9 minutes. He was taken to ER by EMS with a fever of 104F on arrival. He was treated with Cefotan. Diagnosed was UTI
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Fontanelle bulging, Irritability, Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: Temperature increased to 104F, was fussy, had bulging fontanel and was vomiting. Treated 2 days with IV Rocephin. Pt's recovery to be determined.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Hypotonia, Pallor, Stupor
Clinical narrative: Pt developed pallor, was hypotonic and hyporesponsive.
Age: 45.0
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Back pain, Disturbance in attention, Fatigue
Clinical narrative: Pt developed pain and swelling in feet, pain in legs, feet, back, shoulders and neck, in joints and muscles. He had difficulty concentrating, memory loss and headaches. He also had excessive fatigue and sleeping. The annual follow up states, "Inability to concentrate, fatigue, memory loss, pain and stiffness in leg muscles, stiffness in neck, pain at toe, knee, hip, shoulder, back and neck joints. Swelling of toes and bottom of feet at toes. Left arm can't be raised at shoulder above about 8 o'clock. neck movement limited to about 60 degrees arc left to right. The limitations seem to be physically constrained and not just limited because of pain. A follow up report received 11/13/2001 adds: Vaccine provider states that pt was a participant in a clinical trial for Lymerix. He received placebo in 1995 and 1996. He was in the Lymerix group for injections on 04/28/1997, 06/03/1997 and 04/29/1998. He was in a Lymerix booster group for injection on 11/01/1999. The pt's complaints have been communicated to trial contact, FDA, manufacturer, etc., per vaccine provider's office. Another follow up report received 11/13/2001 adds: Pt stated that he was evaluated by a rheumatologist who stated that pt's symptoms could not be the result of Lyme disease or Lymerix. He was treated by this doctor with pain medications. The pt was later evaluated by a Lyme specialist who told the pt he had chronic Lyme disease that was present prior to the Lymerix vaccination and was aggravated by the vaccination. Pt is being treated with antibiotics and has improved.