chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Antibody test negative, Antibody test positive, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody positive, Arthralgia
Clinical narrative: AVA #1 within a couple of days noted "flu-like" reactions described as chest congestion.  Arm slightly sore, slightly raised and extended a couple of inches.  No redness at the site.  He stated he felt fine by the time he received his second shot.  AVA #2 continued to battle recurrent flu-like symptoms with cough and yellow sputum production within a couple of days.  Arm swelling as #1 and lasted one wk.  His episode of congestion persisted and did not clear until 2 yrs later.  With AVA #3 on 13 Apr 1999, he reported the same symptoms but with worsening of his congestion.  Local reaction remained the same as his previous two shots.  At end of June, he began to notice that he was more fatigued than usual.  He stated that the fatigue persists and with any current activity, he feels like he has been hit with a stun gun.  He stated he feels better after a rest but that the fatigue may last wks.  In Aug 1999 he began to snore.  No prior history.  He was diagnosed in 05 with sleep apnea.  He stated that even though he used his C-pap machine he noted no improvement in his fatigue.  He stated he had ENT surgery this past Aug 07, and he no longer requires his C-pap but he continues to note fatigue.  He stated that he also noted headaches at this time that would start in the back of his head and at times, associated with "floaters".  He received his 4th AVA while he was sick and developed his fibromyalgia symptoms that did not improve.  He stated that he has autoimmune reactive arthritis and that is why he had contracture problems so soon after his knee surgery and that in spite of his surgery his knees still bother him.  Currently he stated that the congestion lasted 2 yrs before it cleared.  He continues to suffer from extreme fatigue, in spite of correction of his OSA.  He reports that he has tremors in times of the extreme fatigue and has them about one time per week and it would last the full day.  He stated that the headaches continue especially when he is fatigued.  Symptom: Fatigue, malaise >60 days.  Start: 06/01/1999.  Comment: 780.79.  Symptom: Bradypnea.  Start: 08/1999.  Comment: 786.09 snoring.  Symptom: Cough, chronic.  Start: 03/1999.  End: 2001.  Comment: 786.2.  Symptom: Joint pain, multiple joints.  Start: 2003.  Comment: 719.49 bil knees.  Symptom: Headache, general.  Start: 08/1999.  Comment: 784.0.  Symptom: Tremors.  Comment: 781.0.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Arthritis reactive, Autoimmune disorder, Blood thyroid stimulating hormone decreased, Bradypnoea, C-reactive protein normal
Clinical narrative: AVA #1 within a couple of days noted "flu-like" reactions described as chest congestion.  Arm slightly sore, slightly raised and extended a couple of inches.  No redness at the site.  He stated he felt fine by the time he received his second shot.  AVA #2 continued to battle recurrent flu-like symptoms with cough and yellow sputum production within a couple of days.  Arm swelling as #1 and lasted one wk.  His episode of congestion persisted and did not clear until 2 yrs later.  With AVA #3 on 13 Apr 1999, he reported the same symptoms but with worsening of his congestion.  Local reaction remained the same as his previous two shots.  At end of June, he began to notice that he was more fatigued than usual.  He stated that the fatigue persists and with any current activity, he feels like he has been hit with a stun gun.  He stated he feels better after a rest but that the fatigue may last wks.  In Aug 1999 he began to snore.  No prior history.  He was diagnosed in 05 with sleep apnea.  He stated that even though he used his C-pap machine he noted no improvement in his fatigue.  He stated he had ENT surgery this past Aug 07, and he no longer requires his C-pap but he continues to note fatigue.  He stated that he also noted headaches at this time that would start in the back of his head and at times, associated with "floaters".  He received his 4th AVA while he was sick and developed his fibromyalgia symptoms that did not improve.  He stated that he has autoimmune reactive arthritis and that is why he had contracture problems so soon after his knee surgery and that in spite of his surgery his knees still bother him.  Currently he stated that the congestion lasted 2 yrs before it cleared.  He continues to suffer from extreme fatigue, in spite of correction of his OSA.  He reports that he has tremors in times of the extreme fatigue and has them about one time per week and it would last the full day.  He stated that the headaches continue especially when he is fatigued.  Symptom: Fatigue, malaise >60 days.  Start: 06/01/1999.  Comment: 780.79.  Symptom: Bradypnea.  Start: 08/1999.  Comment: 786.09 snoring.  Symptom: Cough, chronic.  Start: 03/1999.  End: 2001.  Comment: 786.2.  Symptom: Joint pain, multiple joints.  Start: 2003.  Comment: 719.49 bil knees.  Symptom: Headache, general.  Start: 08/1999.  Comment: 784.0.  Symptom: Tremors.  Comment: 781.0.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Cardiolipin antibody negative, Complement factor C3 increased, Complement factor C4, Condition aggravated, Cough
Clinical narrative: AVA #1 within a couple of days noted "flu-like" reactions described as chest congestion.  Arm slightly sore, slightly raised and extended a couple of inches.  No redness at the site.  He stated he felt fine by the time he received his second shot.  AVA #2 continued to battle recurrent flu-like symptoms with cough and yellow sputum production within a couple of days.  Arm swelling as #1 and lasted one wk.  His episode of congestion persisted and did not clear until 2 yrs later.  With AVA #3 on 13 Apr 1999, he reported the same symptoms but with worsening of his congestion.  Local reaction remained the same as his previous two shots.  At end of June, he began to notice that he was more fatigued than usual.  He stated that the fatigue persists and with any current activity, he feels like he has been hit with a stun gun.  He stated he feels better after a rest but that the fatigue may last wks.  In Aug 1999 he began to snore.  No prior history.  He was diagnosed in 05 with sleep apnea.  He stated that even though he used his C-pap machine he noted no improvement in his fatigue.  He stated he had ENT surgery this past Aug 07, and he no longer requires his C-pap but he continues to note fatigue.  He stated that he also noted headaches at this time that would start in the back of his head and at times, associated with "floaters".  He received his 4th AVA while he was sick and developed his fibromyalgia symptoms that did not improve.  He stated that he has autoimmune reactive arthritis and that is why he had contracture problems so soon after his knee surgery and that in spite of his surgery his knees still bother him.  Currently he stated that the congestion lasted 2 yrs before it cleared.  He continues to suffer from extreme fatigue, in spite of correction of his OSA.  He reports that he has tremors in times of the extreme fatigue and has them about one time per week and it would last the full day.  He stated that the headaches continue especially when he is fatigued.  Symptom: Fatigue, malaise >60 days.  Start: 06/01/1999.  Comment: 780.79.  Symptom: Bradypnea.  Start: 08/1999.  Comment: 786.09 snoring.  Symptom: Cough, chronic.  Start: 03/1999.  End: 2001.  Comment: 786.2.  Symptom: Joint pain, multiple joints.  Start: 2003.  Comment: 719.49 bil knees.  Symptom: Headache, general.  Start: 08/1999.  Comment: 784.0.  Symptom: Tremors.  Comment: 781.0.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Fibromyalgia, HLA marker study, Headache, Influenza
Clinical narrative: AVA #1 within a couple of days noted "flu-like" reactions described as chest congestion.  Arm slightly sore, slightly raised and extended a couple of inches.  No redness at the site.  He stated he felt fine by the time he received his second shot.  AVA #2 continued to battle recurrent flu-like symptoms with cough and yellow sputum production within a couple of days.  Arm swelling as #1 and lasted one wk.  His episode of congestion persisted and did not clear until 2 yrs later.  With AVA #3 on 13 Apr 1999, he reported the same symptoms but with worsening of his congestion.  Local reaction remained the same as his previous two shots.  At end of June, he began to notice that he was more fatigued than usual.  He stated that the fatigue persists and with any current activity, he feels like he has been hit with a stun gun.  He stated he feels better after a rest but that the fatigue may last wks.  In Aug 1999 he began to snore.  No prior history.  He was diagnosed in 05 with sleep apnea.  He stated that even though he used his C-pap machine he noted no improvement in his fatigue.  He stated he had ENT surgery this past Aug 07, and he no longer requires his C-pap but he continues to note fatigue.  He stated that he also noted headaches at this time that would start in the back of his head and at times, associated with "floaters".  He received his 4th AVA while he was sick and developed his fibromyalgia symptoms that did not improve.  He stated that he has autoimmune reactive arthritis and that is why he had contracture problems so soon after his knee surgery and that in spite of his surgery his knees still bother him.  Currently he stated that the congestion lasted 2 yrs before it cleared.  He continues to suffer from extreme fatigue, in spite of correction of his OSA.  He reports that he has tremors in times of the extreme fatigue and has them about one time per week and it would last the full day.  He stated that the headaches continue especially when he is fatigued.  Symptom: Fatigue, malaise >60 days.  Start: 06/01/1999.  Comment: 780.79.  Symptom: Bradypnea.  Start: 08/1999.  Comment: 786.09 snoring.  Symptom: Cough, chronic.  Start: 03/1999.  End: 2001.  Comment: 786.2.  Symptom: Joint pain, multiple joints.  Start: 2003.  Comment: 719.49 bil knees.  Symptom: Headache, general.  Start: 08/1999.  Comment: 784.0.  Symptom: Tremors.  Comment: 781.0.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Laboratory test, Local reaction, Malaise, Muscle contracture, Oedema peripheral
Clinical narrative: AVA #1 within a couple of days noted "flu-like" reactions described as chest congestion.  Arm slightly sore, slightly raised and extended a couple of inches.  No redness at the site.  He stated he felt fine by the time he received his second shot.  AVA #2 continued to battle recurrent flu-like symptoms with cough and yellow sputum production within a couple of days.  Arm swelling as #1 and lasted one wk.  His episode of congestion persisted and did not clear until 2 yrs later.  With AVA #3 on 13 Apr 1999, he reported the same symptoms but with worsening of his congestion.  Local reaction remained the same as his previous two shots.  At end of June, he began to notice that he was more fatigued than usual.  He stated that the fatigue persists and with any current activity, he feels like he has been hit with a stun gun.  He stated he feels better after a rest but that the fatigue may last wks.  In Aug 1999 he began to snore.  No prior history.  He was diagnosed in 05 with sleep apnea.  He stated that even though he used his C-pap machine he noted no improvement in his fatigue.  He stated he had ENT surgery this past Aug 07, and he no longer requires his C-pap but he continues to note fatigue.  He stated that he also noted headaches at this time that would start in the back of his head and at times, associated with "floaters".  He received his 4th AVA while he was sick and developed his fibromyalgia symptoms that did not improve.  He stated that he has autoimmune reactive arthritis and that is why he had contracture problems so soon after his knee surgery and that in spite of his surgery his knees still bother him.  Currently he stated that the congestion lasted 2 yrs before it cleared.  He continues to suffer from extreme fatigue, in spite of correction of his OSA.  He reports that he has tremors in times of the extreme fatigue and has them about one time per week and it would last the full day.  He stated that the headaches continue especially when he is fatigued.  Symptom: Fatigue, malaise >60 days.  Start: 06/01/1999.  Comment: 780.79.  Symptom: Bradypnea.  Start: 08/1999.  Comment: 786.09 snoring.  Symptom: Cough, chronic.  Start: 03/1999.  End: 2001.  Comment: 786.2.  Symptom: Joint pain, multiple joints.  Start: 2003.  Comment: 719.49 bil knees.  Symptom: Headache, general.  Start: 08/1999.  Comment: 784.0.  Symptom: Tremors.  Comment: 781.0.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity, Respiratory tract congestion, Rheumatoid factor negative, Sleep apnoea syndrome, Snoring
Clinical narrative: AVA #1 within a couple of days noted "flu-like" reactions described as chest congestion.  Arm slightly sore, slightly raised and extended a couple of inches.  No redness at the site.  He stated he felt fine by the time he received his second shot.  AVA #2 continued to battle recurrent flu-like symptoms with cough and yellow sputum production within a couple of days.  Arm swelling as #1 and lasted one wk.  His episode of congestion persisted and did not clear until 2 yrs later.  With AVA #3 on 13 Apr 1999, he reported the same symptoms but with worsening of his congestion.  Local reaction remained the same as his previous two shots.  At end of June, he began to notice that he was more fatigued than usual.  He stated that the fatigue persists and with any current activity, he feels like he has been hit with a stun gun.  He stated he feels better after a rest but that the fatigue may last wks.  In Aug 1999 he began to snore.  No prior history.  He was diagnosed in 05 with sleep apnea.  He stated that even though he used his C-pap machine he noted no improvement in his fatigue.  He stated he had ENT surgery this past Aug 07, and he no longer requires his C-pap but he continues to note fatigue.  He stated that he also noted headaches at this time that would start in the back of his head and at times, associated with "floaters".  He received his 4th AVA while he was sick and developed his fibromyalgia symptoms that did not improve.  He stated that he has autoimmune reactive arthritis and that is why he had contracture problems so soon after his knee surgery and that in spite of his surgery his knees still bother him.  Currently he stated that the congestion lasted 2 yrs before it cleared.  He continues to suffer from extreme fatigue, in spite of correction of his OSA.  He reports that he has tremors in times of the extreme fatigue and has them about one time per week and it would last the full day.  He stated that the headaches continue especially when he is fatigued.  Symptom: Fatigue, malaise >60 days.  Start: 06/01/1999.  Comment: 780.79.  Symptom: Bradypnea.  Start: 08/1999.  Comment: 786.09 snoring.  Symptom: Cough, chronic.  Start: 03/1999.  End: 2001.  Comment: 786.2.  Symptom: Joint pain, multiple joints.  Start: 2003.  Comment: 719.49 bil knees.  Symptom: Headache, general.  Start: 08/1999.  Comment: 784.0.  Symptom: Tremors.  Comment: 781.0.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Sputum discoloured, Streptococcal identification test, Surgery, Thyroxine, Tremor
Clinical narrative: AVA #1 within a couple of days noted "flu-like" reactions described as chest congestion.  Arm slightly sore, slightly raised and extended a couple of inches.  No redness at the site.  He stated he felt fine by the time he received his second shot.  AVA #2 continued to battle recurrent flu-like symptoms with cough and yellow sputum production within a couple of days.  Arm swelling as #1 and lasted one wk.  His episode of congestion persisted and did not clear until 2 yrs later.  With AVA #3 on 13 Apr 1999, he reported the same symptoms but with worsening of his congestion.  Local reaction remained the same as his previous two shots.  At end of June, he began to notice that he was more fatigued than usual.  He stated that the fatigue persists and with any current activity, he feels like he has been hit with a stun gun.  He stated he feels better after a rest but that the fatigue may last wks.  In Aug 1999 he began to snore.  No prior history.  He was diagnosed in 05 with sleep apnea.  He stated that even though he used his C-pap machine he noted no improvement in his fatigue.  He stated he had ENT surgery this past Aug 07, and he no longer requires his C-pap but he continues to note fatigue.  He stated that he also noted headaches at this time that would start in the back of his head and at times, associated with "floaters".  He received his 4th AVA while he was sick and developed his fibromyalgia symptoms that did not improve.  He stated that he has autoimmune reactive arthritis and that is why he had contracture problems so soon after his knee surgery and that in spite of his surgery his knees still bother him.  Currently he stated that the congestion lasted 2 yrs before it cleared.  He continues to suffer from extreme fatigue, in spite of correction of his OSA.  He reports that he has tremors in times of the extreme fatigue and has them about one time per week and it would last the full day.  He stated that the headaches continue especially when he is fatigued.  Symptom: Fatigue, malaise >60 days.  Start: 06/01/1999.  Comment: 780.79.  Symptom: Bradypnea.  Start: 08/1999.  Comment: 786.09 snoring.  Symptom: Cough, chronic.  Start: 03/1999.  End: 2001.  Comment: 786.2.  Symptom: Joint pain, multiple joints.  Start: 2003.  Comment: 719.49 bil knees.  Symptom: Headache, general.  Start: 08/1999.  Comment: 784.0.  Symptom: Tremors.  Comment: 781.0.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Vitreous floaters
Clinical narrative: AVA #1 within a couple of days noted "flu-like" reactions described as chest congestion.  Arm slightly sore, slightly raised and extended a couple of inches.  No redness at the site.  He stated he felt fine by the time he received his second shot.  AVA #2 continued to battle recurrent flu-like symptoms with cough and yellow sputum production within a couple of days.  Arm swelling as #1 and lasted one wk.  His episode of congestion persisted and did not clear until 2 yrs later.  With AVA #3 on 13 Apr 1999, he reported the same symptoms but with worsening of his congestion.  Local reaction remained the same as his previous two shots.  At end of June, he began to notice that he was more fatigued than usual.  He stated that the fatigue persists and with any current activity, he feels like he has been hit with a stun gun.  He stated he feels better after a rest but that the fatigue may last wks.  In Aug 1999 he began to snore.  No prior history.  He was diagnosed in 05 with sleep apnea.  He stated that even though he used his C-pap machine he noted no improvement in his fatigue.  He stated he had ENT surgery this past Aug 07, and he no longer requires his C-pap but he continues to note fatigue.  He stated that he also noted headaches at this time that would start in the back of his head and at times, associated with "floaters".  He received his 4th AVA while he was sick and developed his fibromyalgia symptoms that did not improve.  He stated that he has autoimmune reactive arthritis and that is why he had contracture problems so soon after his knee surgery and that in spite of his surgery his knees still bother him.  Currently he stated that the congestion lasted 2 yrs before it cleared.  He continues to suffer from extreme fatigue, in spite of correction of his OSA.  He reports that he has tremors in times of the extreme fatigue and has them about one time per week and it would last the full day.  He stated that the headaches continue especially when he is fatigued.  Symptom: Fatigue, malaise >60 days.  Start: 06/01/1999.  Comment: 780.79.  Symptom: Bradypnea.  Start: 08/1999.  Comment: 786.09 snoring.  Symptom: Cough, chronic.  Start: 03/1999.  End: 2001.  Comment: 786.2.  Symptom: Joint pain, multiple joints.  Start: 2003.  Comment: 719.49 bil knees.  Symptom: Headache, general.  Start: 08/1999.  Comment: 784.0.  Symptom: Tremors.  Comment: 781.0.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Convulsion, Fall, Head injury, Orthostatic hypotension, Syncope
Clinical narrative: Initial report received on 22 March 2007 and follow-up on 07 June 2007 from another manufacturer, reference number WAES 0703USA00641, this manufacturer had received the original report from a pharmacist. Verbatim from report: "Information has been received from a pharmacist concerning an 18 year old female patient who on 28-FEB-2007 was vaccinated with a first dose of Gardasil, lot # 635735-0888F. Concomitant therapy included Menomune. The patient fainted 10 minutes after Gardasil injection. The patient fell and hit her head when she wake and was orthostatic (time line was unspecified). The patient also vomited twice (no time line). The patient recovered later in the day. The reporter considered the events to be disabling. "Upon internal review, seizure was considered to be another important medical event." Additional information has been requested." "Additional information was obtained on request by the company from the government under the Freedom of Information Act. There is no additional information."
Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Vomiting
Clinical narrative: Initial report received on 22 March 2007 and follow-up on 07 June 2007 from another manufacturer, reference number WAES 0703USA00641, this manufacturer had received the original report from a pharmacist. Verbatim from report: "Information has been received from a pharmacist concerning an 18 year old female patient who on 28-FEB-2007 was vaccinated with a first dose of Gardasil, lot # 635735-0888F. Concomitant therapy included Menomune. The patient fainted 10 minutes after Gardasil injection. The patient fell and hit her head when she wake and was orthostatic (time line was unspecified). The patient also vomited twice (no time line). The patient recovered later in the day. The reporter considered the events to be disabling. "Upon internal review, seizure was considered to be another important medical event." Additional information has been requested." "Additional information was obtained on request by the company from the government under the Freedom of Information Act. There is no additional information."
Sex: U
Vaccine: MEN
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Initial report received on 03 October 2007 from another manufacturer, report number not provided. The initial reporter to this manufacturer had been a health care professional. A patient (age and gender not specified) had received an injection of Menomune, lot number not reported, route and site of administration not reported, on an unspecified date approximately four to five years ago. On an unspecified date post-vaccination, the patient developed a Stevens Johnson reaction. Additional information was not provided.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Hypersomnia, Vomiting
Clinical narrative: Vaccines 10-11-08 rotavirus, Pediarix, pneumococcal.  12-12-08 mom & dad called, cried for 3 hours after vaccines then slept for 12 hours, afebrile, spit up after ate, fine the next day, had 4 month shots.  Had used Tylenol and questioned if that cause.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: This case was reported by a physician and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline), ActHIB, Prevnar and Rotateq. Concurrent medical conditions included diaper rash. On 1 November 2007 the subject received 1st dose of Pediarix (unknown, right leg), 1st dose of ActHIB (unknown), 1st dose of Prevnar (unknown) and 1st dose of Rotateq (unknown). On 8 November 2007 in the morning, 7 days after vaccination with Pediarix, ActHIB, Prevnar and Rotateq, the subject experienced intussusception. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). On 09 November 2007 the event was resolved. The physician considered the event was possibly related to vaccination with Pediarix, ActHIB, Prevnar and Rotateq.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound scan abnormal
Clinical narrative: This case was reported by a physician and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline), ActHIB, Prevnar and Rotateq. Concurrent medical conditions included diaper rash. On 1 November 2007 the subject received 1st dose of Pediarix (unknown, right leg), 1st dose of ActHIB (unknown), 1st dose of Prevnar (unknown) and 1st dose of Rotateq (unknown). On 8 November 2007 in the morning, 7 days after vaccination with Pediarix, ActHIB, Prevnar and Rotateq, the subject experienced intussusception. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). On 09 November 2007 the event was resolved. The physician considered the event was possibly related to vaccination with Pediarix, ActHIB, Prevnar and Rotateq.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: This case was reported by a physician and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline), ActHIB, Prevnar and Rotateq. Concurrent medical conditions included diaper rash. On 1 November 2007 the subject received 1st dose of Pediarix (unknown, right leg), 1st dose of ActHIB (unknown), 1st dose of Prevnar (unknown) and 1st dose of Rotateq (unknown). On 8 November 2007 in the morning, 7 days after vaccination with Pediarix, ActHIB, Prevnar and Rotateq, the subject experienced intussusception. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). On 09 November 2007 the event was resolved. The physician considered the event was possibly related to vaccination with Pediarix, ActHIB, Prevnar and Rotateq.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Blood test normal, Chest X-ray normal, Chest pain, Dyspnoea
Clinical narrative: Chest pain; Back pain; Lightheadedness; Shortness of breath; (+) D diner 623; CT Chest neg for PE; CXR, EKG, labs normal; treated with Percocet
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram, Insomnia, Musculoskeletal pain, Urine analysis
Clinical narrative: Chest pain; Back pain; Lightheadedness; Shortness of breath; (+) D diner 623; CT Chest neg for PE; CXR, EKG, labs normal; treated with Percocet
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Chest X-ray normal, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Chest pain; Back pain; Lightheadedness; Shortness of breath; (+) D diner 623; CT Chest neg for PE; CXR, EKG, labs normal; treated with Percocet
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram normal, Fibrin D dimer increased, Laboratory test normal
Clinical narrative: Chest pain; Back pain; Lightheadedness; Shortness of breath; (+) D diner 623; CT Chest neg for PE; CXR, EKG, labs normal; treated with Percocet
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: Area= +Edema, +Erythema, +Itching  Ht-5", Wd-3"  Treatment= IV Right AC 20G catheter NS  Benadryl IV 50mg, Toradol IV 30mg
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Skin lesion, Varicella
Clinical narrative: Typical varicella exanthem, 750 lesions mostly on trunk, some scattered on extremities & face.
Age: 2.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Amnesia, Loss of consciousness, Syncope vasovagal
Clinical narrative: Vasovagal syncopal reaction - loss of consciousness with amnesia.  No seizure activity, no post ictal period.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient received a Flu vaccination in the R arm -states the immunization was given very high near the "shoulder bone" - immediately she began to experience excruciating pain - didn't report to nurse because she thought it would go away in a few days - She is unable to lift her arm over her head -she went and saw her Dr. because she has a history of MS - the Dr repoted that it was not an exacerbation of the MS but it may be nerve damage and would take 6-8 wks to heal - She called today because it has been over 30 days and there has been no improvement - Her Drs are sending her to the emergency room today because the pain is so excruciating her blood pressure is running 200s/100s and is uncontrollable - She states the Dr. has "maxed" her out on BP medication - She currently takes Vicodin 1 every 6-8 hrs. but it is prescribed for every 4 hrs -She states she doesn't want to become addicted - Patient was encourage to follow through with the Emergency Room instructions per her Dr. and to take the Vicodin as prescribed.
Age: 0.91
Sex: M
Vaccine: IPV
Symptoms: Blood culture negative, Body temperature increased, Culture urine negative, White blood cell disorder
Clinical narrative: Persistent temperature 104-105F seen in ER seen in MD office twice temp 105. Referred to ER.
Age: 0.57
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Agitation, Crying, Hyperaesthesia, Pain, Pallor
Clinical narrative: Extrement crying, high pitched screaming and agitation for more than 2 hours.   Temperature (taken under arm) of 98.8 taken after calming. Face swollen and pale.    Extremely sensitive to touch and appeared to be in pain for 4-5 hours after onset of screaming.     Attempted to take him to the emergency room at onset of screaming.  Was advised that it was not necessary.  Cared for him at home by nursing, soothing and offering water from bottle.
Age: 0.57
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Screaming, Swelling face
Clinical narrative: Extrement crying, high pitched screaming and agitation for more than 2 hours.   Temperature (taken under arm) of 98.8 taken after calming. Face swollen and pale.    Extremely sensitive to touch and appeared to be in pain for 4-5 hours after onset of screaming.     Attempted to take him to the emergency room at onset of screaming.  Was advised that it was not necessary.  Cared for him at home by nursing, soothing and offering water from bottle.
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: FLUARIX 2007-08 0.5ML ADULT DOSE INADVERTENTLY ADMINISTERED TO NEWBORN BABY.  HEPATITIS B VACCINE IS WHAT NURSE WAS TRYING TO ADMINISTER.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cough, Diarrhoea, Nasal congestion, Pyrexia, Rotavirus test
Clinical narrative: On 12/13/07 Mom brought patient to health department to obtain vaccinations but refused additional rotavirus. Mom reported patient received a dx of rotatvirus after vomiting dose given by a private physician on 09/12/07. Mom reported patient was "very ill" with diarrhea and fever. She also stated he had diarrhea one time in the month and was not allowed to return to daycare due to diarrhea. Dr office states patient was vaccinated at their office on 09/12/07. However, mother did not return until 09/24/07 and on that day complained of nasal cong. and cough. On 10/02/07 mother returned to doctor's office with complaints of diarrhea. Patient was seen on both visits. Dr office did not do any lab work; therefore did not give the patient a dx of rotavirus.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: On 12/13/07 Mom brought patient to health department to obtain vaccinations but refused additional rotavirus. Mom reported patient received a dx of rotatvirus after vomiting dose given by a private physician on 09/12/07. Mom reported patient was "very ill" with diarrhea and fever. She also stated he had diarrhea one time in the month and was not allowed to return to daycare due to diarrhea. Dr office states patient was vaccinated at their office on 09/12/07. However, mother did not return until 09/24/07 and on that day complained of nasal cong. and cough. On 10/02/07 mother returned to doctor's office with complaints of diarrhea. Patient was seen on both visits. Dr office did not do any lab work; therefore did not give the patient a dx of rotavirus.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Death
Clinical narrative: Information regarding Prevenar was received from a Complaint Coordinator from the FDA regarding a 2-month-old male patient who experienced death.  The patient received a dose in Dec-2007.  On the same day, the patient received a dose of Haemophilus influenzae B (manufacturer unknown) and a dose of Pediarix (GlaxoSmithKline) in Dec-2007.  The patient received a dose of Rotarix one day prior to the other vaccines in Dec-2007.  Relevant medical history was not provided.  Concomitant medications were not reported.  Approximately two weeks after receiving Prevnar and three other vaccines the patient died on 26-Dec-2007.  No explanation was given for the death.  No additional information was available at the time of this report.  The cause of death was unexplained and the autopsy cause of death was not reported.  4/15/2008 Per FDA: "The cause of death was SIDS, although we don't have a copy of the death certificate.  I don't think we need anything else for this case." Lengthy investigative report received from FDA.  Infant seen 12/11/07 with hx of cough, runny nose and congestion.  Dx'd with bronchiolitis  and started on nebs. Infant received Rotovirus vaccine 12/11/07. Seen in F/u next day with improved sx and given Pediarix, Hib, and Prevnar 12/12/07. Infant had fed normally in the early morning hours of 12/26/2007 and gone to sleep in parent's bed, and when parent awoke the next morning, the infant was dead. DX: SIDS.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: Information regarding Prevenar was received from a Complaint Coordinator from the FDA regarding a 2-month-old male patient who experienced death.  The patient received a dose in Dec-2007.  On the same day, the patient received a dose of Haemophilus influenzae B (manufacturer unknown) and a dose of Pediarix (GlaxoSmithKline) in Dec-2007.  The patient received a dose of Rotarix one day prior to the other vaccines in Dec-2007.  Relevant medical history was not provided.  Concomitant medications were not reported.  Approximately two weeks after receiving Prevnar and three other vaccines the patient died on 26-Dec-2007.  No explanation was given for the death.  No additional information was available at the time of this report.  The cause of death was unexplained and the autopsy cause of death was not reported.  4/15/2008 Per FDA: "The cause of death was SIDS, although we don't have a copy of the death certificate.  I don't think we need anything else for this case." Lengthy investigative report received from FDA.  Infant seen 12/11/07 with hx of cough, runny nose and congestion.  Dx'd with bronchiolitis  and started on nebs. Infant received Rotovirus vaccine 12/11/07. Seen in F/u next day with improved sx and given Pediarix, Hib, and Prevnar 12/12/07. Infant had fed normally in the early morning hours of 12/26/2007 and gone to sleep in parent's bed, and when parent awoke the next morning, the infant was dead. DX: SIDS.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Eye swelling, Headache
Clinical narrative: Swelling behind and above my eyes.  Headache.  I took 200mg. of Benadryl.
Age: 49.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Skin warm
Clinical narrative: Redness to arm associated with warmth, started 24 hours after vaccine.  Advised Tylenol and heat.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Autopsy, Drug screen positive, Malaise
Clinical narrative: Information has been received from a mother concerning her 5 month old underweight daughter who "had been throwing up a lot since around the time she was born and who in August 2007 "was really constipated and had a fever of 103F" who on 24-OCT-2007 was vaccinated with a first dose of PEDVAXHIB. A second dose of PEDVAXHIB was administered on 07-DEC-2007. The mother reported that the patient "was given a lot of other shots" on the same days. The patient was reportedly "really sick" after the second dose of PEDVAXHIB on 07-DEC-2007. The patient was being seen by the health department. Subsequently the patient died on 16-DEC-2007. It was reported that they were awaiting autopsy results but an initial report from the medical examiner that stated "there was cocaine metabolized in her hair." Additional information has been requested.    3/5/08 Autopsy report states COD & manner of death as undetermined.  Circumstances suggested smothering & mechanical asphyxia w/blunt force injuries, acute bronchopneumonia RUL.
Sex: F
Vaccine: ANTH
Symptoms: Arthropathy, Bone disorder, Hip arthroplasty, X-ray abnormal
Clinical narrative: Subject was a marathon runner.  She experienced knee issues after she returned from deployment.  X-ray revealed rapid bone deterioration.  She had R hip replacement 1-2 years ago.  Previous doses of anthrax vaccines received February 14, 2003, February 27, 2003, March 13, 2003, August 10, 2003.
Sex: M
Vaccine: ANTH
Symptoms: Autoimmune disorder, Disability, White blood cell count decreased
Clinical narrative: Low WBC's, down to 1.8. Autoimmune type adverse event. Evaluated by hospital. He has been hospitalized. He is disabled.
Sex: M
Vaccine: ANTH
Symptoms: Autoimmune disorder, Disability, T-lymphocyte count increased
Clinical narrative: High T-Cell count.  Autoimmune type adverse events.  Pt. has been evaluated at clinic.  He has been hospitalized.  He is disabled.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Keratitis
Clinical narrative: Information has been received from a physician concerning an 8-year-old patient with no history of cold sores or exposure and no history of exposure to chicken pox who on 13-AUG-2001 was vaccinated with their first dose of Varivax (Oka/Merck).  On an unspecified date the patient developed right eye subepithelial keratitis "2.5 weeks later".  No cultures or immunology were performed.  The patient was initially seen on the 21-Jul-2005 and again on 26-SEP-2007 and is being treated with push fluids every other day (qod) long-term.  At the time of the report the patient's status was not recovered.  The event of the right eye subepithelial keratitis was considered an other medically important event (OME).  This is one of several reports received from the same source.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: RAB, TDAP
Symptoms: Pallor, Rash erythematous, Rash pruritic
Clinical narrative: Patient received rabies and Tdap vaccines on 1-10-08.  Five days later, on 1-15-08, she developed an itchy rash all over her body.  It was described by an Urgent Care physician as a "circumscribed, raised, and erythematous eruption with central pallor on her trunk and extremities that are blanchable."  She was instructed to use Benadryl but did not do this.  Instead, she used a home accupuncture kit.  Sx were markedly improved at the time of follow up on 1-17-08.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Uterine dilation and curettage
Clinical narrative: Information has been received from a 26 year old female with no pertinent medical history who in approximately July 2007, was vaccinated with her first dose of Gardasil. There was no concomitant medication. The patient called to join the Merck pregnancy registry. It was reported that the patient became pregnant around the same time she received her first vaccination. The patient last menstrual period was approximately 10-JUN-2007 and estimated delivery was 16-MAR-2008. In Jul-2007, the patient experienced no adverse effect. Unspecified medical attention was sought. Information was received on 04-JAN-2008 indicating the patient had a spontaneous abortion on 09-NOV-2007 (approximately 12 weeks from LMP, reported in follow up as 12-AUG-2007). The patient had a D&C on 09-NOV-2007. The pathology result was "consistent with product of conception." The spontaneous abortion was considered to be an other important medical event. No further information available.
Sex: F
Vaccine: HPV4
Symptoms: Coma, Paralysis
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a dose of Gardasil.  Subsequently, the patient experienced a coma and is now paralyzed.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Upon internal review, coma and paralyzed were determined to be other important medical events.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Alanine aminotransferase normal, Albumin globulin ratio normal, Anorexia, Aspartate aminotransferase normal
Clinical narrative: Information has been received from a physician concerning her 17 year old daughter who on 06-JUL-2007, was vaccinated IM with a first 0.5ml dose of Gardasil. On 12-SEP-2007 and 06-JAN-2008, the patient was vaccinated with a second and third dose of Gardasil (Lot# 657872/0515U), respectively. Concomitant therapy included PROZAC and vitamins (unspecified). On 08-JAN-2008 two days later, the patient experienced nausea. On 09-JAN-2008 the next morning, she vomited. On approximately (09-JAN-2008 )since the last vaccination), she experienced myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping. Unspecified medical attention was sought. Laboratory diagnostic studies included a complete blood cell count which was reported as normal. As of 10-JAN-2008, the patient no longer had a fever or sore throat but she was experiencing an increase in her myalgia. As of 14-JAN-2008, it was reported that the patient started to feel better. It was also reported that the patient had not been able to attend school since 08-JAN-2008. On 15-JAN-2008, the patient returned to school. No product quality complaint was involved. Nausea, vomited, myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping were considered to be disabling by the reporter. Additional information is not expected. This is in follow-up to report(s) previously submitted on 1/18/2008; 1/25/2008. Information has been received from a physician concerning her 17 year old daughter with anxiety who on 06-JAN-2007 at 6:00 pm, was vaccinated IM into her left deltoid with a third dose dose of GARDASIL (Lot# 657872/0515U). On 08-JAN-2008, the patient experienced nausea for 4 days and she vomited three times. She also experienced myalgia, a severe headache for 1 week, a mild sore throat for 3 days, loss of appetite for 1 week, diarrhea for 2 days, prolonged sleeping and fatigue for 1 week. On 12-JAN-2008, the patient experienced a fever of 101.8F with rigors just before spike then she had a fever off and on for another day. Unspecified medical attention was sought. Laboratory diagnostic studies included monospot test, liver function tests and a blood chemistry panel which were all reported as normal. On 15-JAN-2008, the patient returned to school and recovered. It was also reported that on 06-JUL-2007, the patient was vaccinated IM with a 0.5ml dose of GARDASIL and on 12-SEP-2007 she was vaccinated with a second dose of the vaccine (Lot# 657872/0515U). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood albumin decreased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal
Clinical narrative: Information has been received from a physician concerning her 17 year old daughter who on 06-JUL-2007, was vaccinated IM with a first 0.5ml dose of Gardasil. On 12-SEP-2007 and 06-JAN-2008, the patient was vaccinated with a second and third dose of Gardasil (Lot# 657872/0515U), respectively. Concomitant therapy included PROZAC and vitamins (unspecified). On 08-JAN-2008 two days later, the patient experienced nausea. On 09-JAN-2008 the next morning, she vomited. On approximately (09-JAN-2008 )since the last vaccination), she experienced myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping. Unspecified medical attention was sought. Laboratory diagnostic studies included a complete blood cell count which was reported as normal. As of 10-JAN-2008, the patient no longer had a fever or sore throat but she was experiencing an increase in her myalgia. As of 14-JAN-2008, it was reported that the patient started to feel better. It was also reported that the patient had not been able to attend school since 08-JAN-2008. On 15-JAN-2008, the patient returned to school. No product quality complaint was involved. Nausea, vomited, myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping were considered to be disabling by the reporter. Additional information is not expected. This is in follow-up to report(s) previously submitted on 1/18/2008; 1/25/2008. Information has been received from a physician concerning her 17 year old daughter with anxiety who on 06-JAN-2007 at 6:00 pm, was vaccinated IM into her left deltoid with a third dose dose of GARDASIL (Lot# 657872/0515U). On 08-JAN-2008, the patient experienced nausea for 4 days and she vomited three times. She also experienced myalgia, a severe headache for 1 week, a mild sore throat for 3 days, loss of appetite for 1 week, diarrhea for 2 days, prolonged sleeping and fatigue for 1 week. On 12-JAN-2008, the patient experienced a fever of 101.8F with rigors just before spike then she had a fever off and on for another day. Unspecified medical attention was sought. Laboratory diagnostic studies included monospot test, liver function tests and a blood chemistry panel which were all reported as normal. On 15-JAN-2008, the patient returned to school and recovered. It was also reported that on 06-JUL-2007, the patient was vaccinated IM with a 0.5ml dose of GARDASIL and on 12-SEP-2007 she was vaccinated with a second dose of the vaccine (Lot# 657872/0515U). Additional information is not expected.