chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: MMR, TYP, DTAP, MMR, DTAP, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Skin disorder
Clinical narrative: Subsequent to receiving vax, the pt developed an injection site reaction on left deltoid, characterized by tautness, redness, swelling and warmth. Parent was advised to seek medical attention.
Age: 4.0
Sex: F
Vaccine: MMR, TYP, DTAP, MMR, DTAP, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Subsequent to receiving vax, the pt developed an injection site reaction on left deltoid, characterized by tautness, redness, swelling and warmth. Parent was advised to seek medical attention.
Age: 4.0
Sex: F
Vaccine: MMR, TYP, DTAP, MMR, DTAP, MMR
Symptoms: Erythema, Feeling hot, Infection, Injection site erythema, Injection site pain
Clinical narrative: Subsequent to receiving vax, the pt developed an injection site reaction on left deltoid, characterized by tautness, redness, swelling and warmth. Parent was advised to seek medical attention.
Age: 4.0
Sex: F
Vaccine: MMR, TYP, DTAP, MMR, DTAP, MMR
Symptoms: Injection site swelling, Joint swelling
Clinical narrative: Subsequent to receiving vax, the pt developed an injection site reaction on left deltoid, characterized by tautness, redness, swelling and warmth. Parent was advised to seek medical attention.
Age: 0.75
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Injection site erythema, Injection site warmth, Otitis media, Pyrexia
Clinical narrative: 15 minutes post vax, the pt developed redness at the right vastus lateralis immunization site and slight redness at the left vastus lateralis immunization site. The pt was observed for 30 minutes. No distress was noted, the pt was happy. Ice pack was applied bilaterally and pts mother was instructed to treat with Benadryl. On 01/17/2001 parent reported that the pt was doing well. On 01/18/2001 the parent reported that the pts legs were still red. Advised to bring in to the office. Pt presented to office with no redness or swelling to the left leg. Noted right leg redness and warmth. Advised to continue Benadryl and visit ER if problems breathing or any change in status noted. On 01/22/2001 parent states pt not laughing and temperature of 103 degrees was noted. Advised to take to ER. On 01/23/2001 parent states pt was seen by physician on 01/22/2001 and was treated for ear infection.
Age: 0.75
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Ear disorder, Infection, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: 15 minutes post vax, the pt developed redness at the right vastus lateralis immunization site and slight redness at the left vastus lateralis immunization site. The pt was observed for 30 minutes. No distress was noted, the pt was happy. Ice pack was applied bilaterally and pts mother was instructed to treat with Benadryl. On 01/17/2001 parent reported that the pt was doing well. On 01/18/2001 the parent reported that the pts legs were still red. Advised to bring in to the office. Pt presented to office with no redness or swelling to the left leg. Noted right leg redness and warmth. Advised to continue Benadryl and visit ER if problems breathing or any change in status noted. On 01/22/2001 parent states pt not laughing and temperature of 103 degrees was noted. Advised to take to ER. On 01/23/2001 parent states pt was seen by physician on 01/22/2001 and was treated for ear infection.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia, Upper respiratory tract infection
Clinical narrative: Within 24 hours post vax, the pts entire arm from shoulder to elbow became red/purple, swollen, warm but not tender. Fever developed on day 2. Resolved within 5 days.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site inflammation, Injection site oedema, Injection site reaction, Pyrexia
Clinical narrative: Within 24 hours post vax, the pts entire arm from shoulder to elbow became red/purple, swollen, warm but not tender. Fever developed on day 2. Resolved within 5 days.
Age: 1.5
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Subsequent to receiving vax, the pts entire arm from shoulder to elbow swelled, became red but not tender, no fever. The pt recovered from this experience.
Age: 1.5
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Subsequent to receiving vax, the pts entire arm from shoulder to elbow swelled, became red but not tender, no fever. The pt recovered from this experience.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Crying, Cyanosis, Hyperhidrosis, Hypotonia, Pallor
Clinical narrative: On 2/15/01, the day of vax, the pt experienced an unspecified respiratory disorder for which he required oxygen and had to be transported to an ER facility for observation. The pt recovered. The event was considered to be "medically important". From follow-up mailed correspondence received on 7/18/01, it was reported that the pt received his 1st dose of Tripedia, not the 4th as previously reported. The pt was seen in the ER. No further information is anticipated for this report. This case is closed. F/U received on 9/26/01, states it was reported that the pt "turned blue around the mouth and under eyes, face was white". Pt was taken to ER at 10:55. Pt was alert and awake, his temperature was 98.9F, pulse-156, RR-60. At 11:00, 98% Oxygen saturation. At 13:00, 100% oxygen saturation, lungs sound clear bilaterally. Pt was discharged to go home. Discharge dx: respiratory distress, cyanosis, Valvar PS-mild, breath holding spell.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Hypoxia
Clinical narrative: On 2/15/01, the day of vax, the pt experienced an unspecified respiratory disorder for which he required oxygen and had to be transported to an ER facility for observation. The pt recovered. The event was considered to be "medically important". From follow-up mailed correspondence received on 7/18/01, it was reported that the pt received his 1st dose of Tripedia, not the 4th as previously reported. The pt was seen in the ER. No further information is anticipated for this report. This case is closed. F/U received on 9/26/01, states it was reported that the pt "turned blue around the mouth and under eyes, face was white". Pt was taken to ER at 10:55. Pt was alert and awake, his temperature was 98.9F, pulse-156, RR-60. At 11:00, 98% Oxygen saturation. At 13:00, 100% oxygen saturation, lungs sound clear bilaterally. Pt was discharged to go home. Discharge dx: respiratory distress, cyanosis, Valvar PS-mild, breath holding spell.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Cyanosis, Electrocardiogram abnormal, Hypoxia, Lung disorder, Pallor
Clinical narrative: On 2/15/01, the day of vax, the pt experienced an unspecified respiratory disorder for which he required oxygen and had to be transported to an ER facility for observation. The pt recovered. The event was considered to be "medically important". From follow-up mailed correspondence received on 7/18/01, it was reported that the pt received his 1st dose of Tripedia, not the 4th as previously reported. The pt was seen in the ER. No further information is anticipated for this report. This case is closed. F/U received on 9/26/01, states it was reported that the pt "turned blue around the mouth and under eyes, face was white". Pt was taken to ER at 10:55. Pt was alert and awake, his temperature was 98.9F, pulse-156, RR-60. At 11:00, 98% Oxygen saturation. At 13:00, 100% oxygen saturation, lungs sound clear bilaterally. Pt was discharged to go home. Discharge dx: respiratory distress, cyanosis, Valvar PS-mild, breath holding spell.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Pulmonary valve stenosis, Respiratory distress, Respiratory rate increased
Clinical narrative: On 2/15/01, the day of vax, the pt experienced an unspecified respiratory disorder for which he required oxygen and had to be transported to an ER facility for observation. The pt recovered. The event was considered to be "medically important". From follow-up mailed correspondence received on 7/18/01, it was reported that the pt received his 1st dose of Tripedia, not the 4th as previously reported. The pt was seen in the ER. No further information is anticipated for this report. This case is closed. F/U received on 9/26/01, states it was reported that the pt "turned blue around the mouth and under eyes, face was white". Pt was taken to ER at 10:55. Pt was alert and awake, his temperature was 98.9F, pulse-156, RR-60. At 11:00, 98% Oxygen saturation. At 13:00, 100% oxygen saturation, lungs sound clear bilaterally. Pt was discharged to go home. Discharge dx: respiratory distress, cyanosis, Valvar PS-mild, breath holding spell.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Crying, Eye disorder, Hyperhidrosis, Hypertonia, Hypotonia
Clinical narrative: "A nurse reported that a 2 month old male received injections of Prevnar, Hib-Titer, Tripedia and IPV on 3/19/01. The pt was born at 35 weeks gestation. He was not receiving any other medications concomitantly. On 3/19/01, the day of vaccination, the pt became hypotonic and stopped crying (following Prevnar vaccination). He 'turned blue in circumoral area and his brows' and his eyes rolled to the upper right for 30 seconds. About 30 seconds later, 'painful stimuli' was applied to his jaw and his color was noted to be 'better'. Then, Tripedia vaccine was administered, and the pt turned pale. He regained his color after nursing. The pt recovered. The events were considered to be "Medically Important"." From follow-up, mailed correspondence received on 7/18/01, the time of the vaccination and the time of adverse event onset was provided. It was also reported that following the Prevnar vaccination, the pt instantly began to scream, turned pale and became diaphoretic, then hypotonic and hyporesponsive.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Pallor, Skin discolouration, Stupor
Clinical narrative: "A nurse reported that a 2 month old male received injections of Prevnar, Hib-Titer, Tripedia and IPV on 3/19/01. The pt was born at 35 weeks gestation. He was not receiving any other medications concomitantly. On 3/19/01, the day of vaccination, the pt became hypotonic and stopped crying (following Prevnar vaccination). He 'turned blue in circumoral area and his brows' and his eyes rolled to the upper right for 30 seconds. About 30 seconds later, 'painful stimuli' was applied to his jaw and his color was noted to be 'better'. Then, Tripedia vaccine was administered, and the pt turned pale. He regained his color after nursing. The pt recovered. The events were considered to be "Medically Important"." From follow-up, mailed correspondence received on 7/18/01, the time of the vaccination and the time of adverse event onset was provided. It was also reported that following the Prevnar vaccination, the pt instantly began to scream, turned pale and became diaphoretic, then hypotonic and hyporesponsive.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Cyanosis, Eye movement disorder, Hyperhidrosis, Hypotonia, Pallor
Clinical narrative: "A nurse reported that a 2 month old male received injections of Prevnar, Hib-Titer, Tripedia and IPV on 3/19/01. The pt was born at 35 weeks gestation. He was not receiving any other medications concomitantly. On 3/19/01, the day of vaccination, the pt became hypotonic and stopped crying (following Prevnar vaccination). He 'turned blue in circumoral area and his brows' and his eyes rolled to the upper right for 30 seconds. About 30 seconds later, 'painful stimuli' was applied to his jaw and his color was noted to be 'better'. Then, Tripedia vaccine was administered, and the pt turned pale. He regained his color after nursing. The pt recovered. The events were considered to be "Medically Important"." From follow-up, mailed correspondence received on 7/18/01, the time of the vaccination and the time of adverse event onset was provided. It was also reported that following the Prevnar vaccination, the pt instantly began to scream, turned pale and became diaphoretic, then hypotonic and hyporesponsive.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Screaming, Strabismus
Clinical narrative: "A nurse reported that a 2 month old male received injections of Prevnar, Hib-Titer, Tripedia and IPV on 3/19/01. The pt was born at 35 weeks gestation. He was not receiving any other medications concomitantly. On 3/19/01, the day of vaccination, the pt became hypotonic and stopped crying (following Prevnar vaccination). He 'turned blue in circumoral area and his brows' and his eyes rolled to the upper right for 30 seconds. About 30 seconds later, 'painful stimuli' was applied to his jaw and his color was noted to be 'better'. Then, Tripedia vaccine was administered, and the pt turned pale. He regained his color after nursing. The pt recovered. The events were considered to be "Medically Important"." From follow-up, mailed correspondence received on 7/18/01, the time of the vaccination and the time of adverse event onset was provided. It was also reported that following the Prevnar vaccination, the pt instantly began to scream, turned pale and became diaphoretic, then hypotonic and hyporesponsive.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Cyanosis, Eye movement disorder, Hypotonia, Hypoxia, Pallor
Clinical narrative: "A nurse reported that a 2 month old male received injections of Prevnar, Hib-Titer, Tripedia and IPV on 3/19/01. The pt was born at 35 weeks gestation. He was not receiving any other medications concomitantly. On 3/19/01, the day of vaccination, the pt became hypotonic and stopped crying (following Prevnar vaccination). He 'turned blue in circumoral area and his brows' and his eyes rolled to the upper right for 30 seconds. About 30 seconds later, 'painful stimuli' was applied to his jaw and his color was noted to be 'better'. Then, Tripedia vaccine was administered, and the pt turned pale. He regained his color after nursing. The pt recovered. The events were considered to be "Medically Important"." From follow-up, mailed correspondence received on 7/18/01, the time of the vaccination and the time of adverse event onset was provided. It was also reported that following the Prevnar vaccination, the pt instantly began to scream, turned pale and became diaphoretic, then hypotonic and hyporesponsive.
Age: 18.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Dizziness, Hypotension, Loss of consciousness, Pallor
Clinical narrative: Expressed dizziness following shot. Nurse assisted her to lower head. Brief loss of consciousness of 30-45 seconds; awakened and color was pale. BP 90/50-deep breathing done. Remained with head down 3-4 minutes. Felt less dizzy and took water. BP 104/58-ambulated to waiting area. Supervised by parent. Dismissed at 16:05.
Age: 18.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Blood pressure decreased, Dizziness, Loss of consciousness, Pallor
Clinical narrative: Expressed dizziness following shot. Nurse assisted her to lower head. Brief loss of consciousness of 30-45 seconds; awakened and color was pale. BP 90/50-deep breathing done. Remained with head down 3-4 minutes. Felt less dizzy and took water. BP 104/58-ambulated to waiting area. Supervised by parent. Dismissed at 16:05.
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, IPV
Symptoms: Cardiac failure congestive, Congenital megacolon, Oesophagitis, Sudden infant death syndrome
Clinical narrative: It was reported that a 2 month old healthy male infant was vaccinated on 4/17/01 with IPOL, DPT and Hib-Titer. Reportedly, the parents found the baby dead in the morning of 4/18/2001. An autopsy is being performed. Sudden Infant Death reported. Autopsy report findings: Hirschsprung's disease.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion
Clinical narrative: Information has been received from a 32 year old female consumer with no past medical history or known allergies. On 10/16/00 and 12/12/00, the pt was vaccinated with a 1st and 2nd dose of varicella virus vaccine live 0.5ml, respectively. There was no concomitant medication. The consumer reported that she conceived on 1/26/01 and discovered that she was pregnant on 2/28/00. Based on the date of conception, the calculated date of LMP was 1/12/01. It was reported that the pt had no diagnostic tests during pregnancy and there were no infections/illnesses during pregnancy. The pt did not take any prescription drugs during pregnancy. Follow-up from the physician indicated that the pt had a spontaneous abortion, 6 weeks from her LMP. No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Asphyxia, Coma, Cyanosis
Clinical narrative: A patient received DTaP #3, IPV #3, Comvax #1, on 02/21/01 during her well baby visit. The patient was found blue and unresponsive at home midday on 02/26/01. She was transferred to the ER unable to resuscitate. The ER Dr states the patient was secured in infant seat device to maintain upright position. The patient was found in infant seat turned on side , the foster mother had been out of the room approximately 10 minutes. ER doctor states "probable positional asphyxia"). The patient had been well prior to death.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Blood pressure increased, Completed suicide, Disturbance in attention
Clinical narrative: Loss of concentration, dizzy, memory loss, mood swings, night sweats, tinnitus, joint pains, increased BP, low pulse, syncope, staring spells for 5-10 minutes duration, numbness and tingling of left upper and lower extremities, splinter hemorrhages, 75 lb weight loss, rash and swollen glands. Also, had Anthrax vaccines on 10/31/98, 11/9/98, 4/4/99, 11/99 and 6/3/00. Committed suicide. Autopsy report received states pt cause of death as gun shot wound to the head. Death certificate confirms cause of death.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Haemorrhage, Heart rate decreased, Lymphadenopathy, Mood swings
Clinical narrative: Loss of concentration, dizzy, memory loss, mood swings, night sweats, tinnitus, joint pains, increased BP, low pulse, syncope, staring spells for 5-10 minutes duration, numbness and tingling of left upper and lower extremities, splinter hemorrhages, 75 lb weight loss, rash and swollen glands. Also, had Anthrax vaccines on 10/31/98, 11/9/98, 4/4/99, 11/99 and 6/3/00. Committed suicide. Autopsy report received states pt cause of death as gun shot wound to the head. Death certificate confirms cause of death.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Night sweats, Paraesthesia, Rash, Staring, Syncope
Clinical narrative: Loss of concentration, dizzy, memory loss, mood swings, night sweats, tinnitus, joint pains, increased BP, low pulse, syncope, staring spells for 5-10 minutes duration, numbness and tingling of left upper and lower extremities, splinter hemorrhages, 75 lb weight loss, rash and swollen glands. Also, had Anthrax vaccines on 10/31/98, 11/9/98, 4/4/99, 11/99 and 6/3/00. Committed suicide. Autopsy report received states pt cause of death as gun shot wound to the head. Death certificate confirms cause of death.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Tinnitus, Weight decreased
Clinical narrative: Loss of concentration, dizzy, memory loss, mood swings, night sweats, tinnitus, joint pains, increased BP, low pulse, syncope, staring spells for 5-10 minutes duration, numbness and tingling of left upper and lower extremities, splinter hemorrhages, 75 lb weight loss, rash and swollen glands. Also, had Anthrax vaccines on 10/31/98, 11/9/98, 4/4/99, 11/99 and 6/3/00. Committed suicide. Autopsy report received states pt cause of death as gun shot wound to the head. Death certificate confirms cause of death.
Age: 3.0
Sex: F
Vaccine: DTP, MMR
Symptoms: Autism
Clinical narrative: Information has been received from a pharmacist concerning his approx. 42 month old daughter who was vaccinated with MMRII and DTP. Subsequently, the child developed autism and the father "feels that the autism may be due to the vaccines that his child received." The child received unspecified medical attention. Upon internal review, the pt's autism was considered to be "Other Medical Event". Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Abasia, Cough, Dizziness, Eructation, Headache
Clinical narrative: Information has been received from a pt's husband concerning a 39 year old female with penicillin allergy who on 4/4/01 was vaccinated with Hep-B recombinant (yeast). Concomitant therapy included quetiapine fumarate (Seroquel) and "other medications" that the husband was unable to recall. On 4/5/01, the pt began to experience "flu-like symptoms". She had a fever, headache, upset stomach, vomiting, belching, cough, dizziness, nasal and chest congestion. The husband reported the pt could not stand by herself. The husband stated that the pt was "very sick". At the time of the report, the pt's condition had not improved. The husband did report the flu virus had been "going around" his wife's place of employment. The pt saw her physician who administered an unspecified injection in her back on 4/11/01 to help her with nausea and vomiting. Upon internal review, the pt not being able to stand by herself was determined to be an "Other Medical Event". Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Nasal congestion, Nausea, Pulmonary congestion, Pyrexia
Clinical narrative: Information has been received from a pt's husband concerning a 39 year old female with penicillin allergy who on 4/4/01 was vaccinated with Hep-B recombinant (yeast). Concomitant therapy included quetiapine fumarate (Seroquel) and "other medications" that the husband was unable to recall. On 4/5/01, the pt began to experience "flu-like symptoms". She had a fever, headache, upset stomach, vomiting, belching, cough, dizziness, nasal and chest congestion. The husband reported the pt could not stand by herself. The husband stated that the pt was "very sick". At the time of the report, the pt's condition had not improved. The husband did report the flu virus had been "going around" his wife's place of employment. The pt saw her physician who administered an unspecified injection in her back on 4/11/01 to help her with nausea and vomiting. Upon internal review, the pt not being able to stand by herself was determined to be an "Other Medical Event". Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Stomach discomfort, Vomiting
Clinical narrative: Information has been received from a pt's husband concerning a 39 year old female with penicillin allergy who on 4/4/01 was vaccinated with Hep-B recombinant (yeast). Concomitant therapy included quetiapine fumarate (Seroquel) and "other medications" that the husband was unable to recall. On 4/5/01, the pt began to experience "flu-like symptoms". She had a fever, headache, upset stomach, vomiting, belching, cough, dizziness, nasal and chest congestion. The husband reported the pt could not stand by herself. The husband stated that the pt was "very sick". At the time of the report, the pt's condition had not improved. The husband did report the flu virus had been "going around" his wife's place of employment. The pt saw her physician who administered an unspecified injection in her back on 4/11/01 to help her with nausea and vomiting. Upon internal review, the pt not being able to stand by herself was determined to be an "Other Medical Event". Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Dysgeusia, Facial palsy, Hypoaesthesia, Optic atrophy, Pain
Clinical narrative: It was reported that a 44 year old female pt was bitten by a dog in 1998. The pt began the Imovax Rabies series on 2/4/98 with dose #1; #2, 3 and 4 were given on 2/6/98, 2/11/98 and 2/18/98. Five days, after dose 3 (2/16/98), the pt developed "paralysis" of the face and was hospitalized. Pt still has damage to optical cortex of left eye, "stroke-like" effects of left side of face (drooping), her sense of smell and taste have been affected. Dx'd by neurologist as Bell's Palsy. The pt did not receive dose #5. From follow-up received on 08/22/2001 it was reported, "On 02/19/1998, the physician advised to take dose #4. After this is when the symptoms worsened and the pt ended up in the hospital. Pt became sensitive to light and noise, experience dhorendous pain and sinuses collapsed on left side of face. Also experienced numbness in extremities and later loss of feeling when intimate. The day pt came home of hospital would be in for her shot. This in itself, was 4.5 hours after the designated time for shot-March 1998-two weeks after 02/19/2001. We are in litigation."
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Parosmia, Photophobia
Clinical narrative: It was reported that a 44 year old female pt was bitten by a dog in 1998. The pt began the Imovax Rabies series on 2/4/98 with dose #1; #2, 3 and 4 were given on 2/6/98, 2/11/98 and 2/18/98. Five days, after dose 3 (2/16/98), the pt developed "paralysis" of the face and was hospitalized. Pt still has damage to optical cortex of left eye, "stroke-like" effects of left side of face (drooping), her sense of smell and taste have been affected. Dx'd by neurologist as Bell's Palsy. The pt did not receive dose #5. From follow-up received on 08/22/2001 it was reported, "On 02/19/1998, the physician advised to take dose #4. After this is when the symptoms worsened and the pt ended up in the hospital. Pt became sensitive to light and noise, experience dhorendous pain and sinuses collapsed on left side of face. Also experienced numbness in extremities and later loss of feeling when intimate. The day pt came home of hospital would be in for her shot. This in itself, was 4.5 hours after the designated time for shot-March 1998-two weeks after 02/19/2001. We are in litigation."
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Abscess, Injection site haemorrhage, Injection site mass, Skin discolouration
Clinical narrative: Pt in on 2/2/01 for 4 month well check and received Comvax and Prevnar in right thigh. On 3/23/01, mom called the office and stated "bruising" on right thigh where shots were given along with 2 lumps. No tenderness or redness. Had 2-3cm bluish-purple discoloration on right anterior lateral thigh. Dx'd with resolving hematoma from immunization. In on 4/6/01 for 6 month well check and had worsening discoloration and now 4 lesions. Referred to surgery (letter included). Dx'd with a sterile abscess and had incision and drainage by surgeon on 4/7/01.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Abscess, Contusion, Injection site abscess, Injection site oedema
Clinical narrative: Pt in on 2/2/01 for 4 month well check and received Comvax and Prevnar in right thigh. On 3/23/01, mom called the office and stated "bruising" on right thigh where shots were given along with 2 lumps. No tenderness or redness. Had 2-3cm bluish-purple discoloration on right anterior lateral thigh. Dx'd with resolving hematoma from immunization. In on 4/6/01 for 6 month well check and had worsening discoloration and now 4 lesions. Referred to surgery (letter included). Dx'd with a sterile abscess and had incision and drainage by surgeon on 4/7/01.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, HEP, JEVX, TYP
Symptoms: Atrial fibrillation, Chest pain, Disorientation, Electroencephalogram abnormal, Fatigue
Clinical narrative: Impaired memory/cognition, constant headache since 1/4/00; chest pains; 3 syncopal episodes (totaled car) (lost license), fatigue, personality change, episodes of disorientation with abnormal EEG; episodic atrial fibrillation and pool balance.  Follow up report on 09/07/2001: "As of 08/31/2001, his status is unchanged."
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, HEP, JEVX, TYP
Symptoms: Headache, Histrionic personality disorder, Memory impairment, Syncope
Clinical narrative: Impaired memory/cognition, constant headache since 1/4/00; chest pains; 3 syncopal episodes (totaled car) (lost license), fatigue, personality change, episodes of disorientation with abnormal EEG; episodic atrial fibrillation and pool balance.  Follow up report on 09/07/2001: "As of 08/31/2001, his status is unchanged."
Age: 3.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Pyrexia, Status epilepticus
Clinical narrative: This child had a fever, precipitating status epilepticus. ICU admission , not intubated.
Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Hypokinesia, Myalgia, Neuropathy, Pain
Clinical narrative: This patient had extreme continuous pain in his joints and limbs. She has tried various prescription medications to reduce the pain, but so far nothing seems to be working. The patient no longer had active life is now controlled by pain. For the 60 day follow-up pt states," I still have very bad pain resulting from the 2nd vaccination on 07/10/1999. I have tried many medications but so far nothing helps. It has comletely changed my life in a negatve way. In Doc 213373, annual follow up patient states the following: "I have pain throughought my body and it has increased in intensity. It is constant, residing in the joints and muscles, and so far. No medication seems to help much. Living hell! I am afraid that the pain will keep getting worse. I can barely stand it now. I hope that someone is studying this problem to find out how to reduce the pain and reverse the damage". 7/26/02 Per correspondence from patient, his MRI indicates "severe demyelination of the brain".
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Abdominal pain, Autism, Catatonia, Drug toxicity, Gastrointestinal disorder
Clinical narrative: This patient had DTP, then then had a temp of 104, catatonic, stomach cramps, and vomiting, and excreting mercury in his urine. Each subsequent vaccine (07/28/97, 10/17/97, 10/22/98, 05/12/1997, 04/28/97, 06/25/98) caused a high fever, catatonia, and vomiting. Ultimately, developmental delays and no speech . Diagnosed with autism. Especially MMR vaccine. Gastrointestinal (mercury). The 60 day follw-up states that the pt has a irriable bowel syndrome, heavy metals toxicity (currently under-going chelation with DMSA), autism, and learning delays. Excreting mercury and other toxic in feces. Speech, language developmental delays.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Neurodevelopmental disorder, Pyrexia, Speech disorder, Urine analysis abnormal, Vomiting
Clinical narrative: This patient had DTP, then then had a temp of 104, catatonic, stomach cramps, and vomiting, and excreting mercury in his urine. Each subsequent vaccine (07/28/97, 10/17/97, 10/22/98, 05/12/1997, 04/28/97, 06/25/98) caused a high fever, catatonia, and vomiting. Ultimately, developmental delays and no speech . Diagnosed with autism. Especially MMR vaccine. Gastrointestinal (mercury). The 60 day follw-up states that the pt has a irriable bowel syndrome, heavy metals toxicity (currently under-going chelation with DMSA), autism, and learning delays. Excreting mercury and other toxic in feces. Speech, language developmental delays.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion
Clinical narrative: 16 month old developed focal seizure (left sided) brief X 2, back to back, within a few minutes approx. 1 day, following 12 month vaccinations.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Dyskinesia, Febrile convulsion, Irritability, Status epilepticus
Clinical narrative: Febrile seizure, status epilepticus X about 30 minutes. Seen in ER and received anticonvulsant medication. Negative infectious workup. Patient is a 12 1/2 month old child referred prior to evaluation of an atypical febrile seizure, approximately two weeks priori to evaluation. She had an MMR and Varivax vaccination approximately 10 days prior to the episode. She was irritable throwing herself backwards when mother laid her down, rhythmic jerking was noted of all extremities and then her eyes deviated upwards and she appeared unresponsive. She was taken to hospital where a CT and an LP were normal. It took her approximately one week to get back to normal. During that week, she had vomiting and diarrhea after a fever for two days. Her father had a cold at that time. She does attend a co-op but reportedly no other children were sick. An EEG was to be scheduled but this has not been done yet.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Strabismus, Vomiting
Clinical narrative: Febrile seizure, status epilepticus X about 30 minutes. Seen in ER and received anticonvulsant medication. Negative infectious workup. Patient is a 12 1/2 month old child referred prior to evaluation of an atypical febrile seizure, approximately two weeks priori to evaluation. She had an MMR and Varivax vaccination approximately 10 days prior to the episode. She was irritable throwing herself backwards when mother laid her down, rhythmic jerking was noted of all extremities and then her eyes deviated upwards and she appeared unresponsive. She was taken to hospital where a CT and an LP were normal. It took her approximately one week to get back to normal. During that week, she had vomiting and diarrhea after a fever for two days. Her father had a cold at that time. She does attend a co-op but reportedly no other children were sick. An EEG was to be scheduled but this has not been done yet.
Age: 4.0
Sex: F
Vaccine: PNC
Symptoms: Lethargy, Pyrexia
Clinical narrative: This child had a fever of Tues 03/13/01, 2 hours after her shot at about 10 AM to present 03/15/01 at 1:30 PM. Lethargy on Tues at 03/13/01 at 10 AM, continues at this time 3:30 on 03/15/01.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Hot flush
Clinical narrative: Report 2001009942-1 described lump in the throat in a 22 year old female who received Hepatitis B vaccine recombinant (Engerix B) for prophylaxis of Hepatitis B. Reportedly, the vaccinee had no known drug allergies or medical history and received no concomitant medications. No adverse events were reported following the administration of doses 1 and 2 of Engerix B. On 04/17/01, the vaccinee received her 3rd "adult" dose of Engerix B. Ten to fifteen minutes post-immunization, she complained of "severe" chills, headache, dizziness, hot flashes, and a lump in her throat. She had shortness of breath. She was treated with Epinephrine ".3" SC, 1 dose on 4/17/01, oxygen via nasal cannula at 4 liters/minute and Benadryl 50mg IM, 1 dose on 4/17/01. The vaccinee's symptoms resolved the same day, following treatment. The reporter considered the allergic reaction to be severe in intensity and related to Engerix-B. As of 5/3/01, the allergic reaction resolved. This case is considered to be an "Other Important Medical Event". As a result of follow-up info received on 5/3/01, this report has been re-classified as serious expected.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Hypoxia
Clinical narrative: Report 2001009942-1 described lump in the throat in a 22 year old female who received Hepatitis B vaccine recombinant (Engerix B) for prophylaxis of Hepatitis B. Reportedly, the vaccinee had no known drug allergies or medical history and received no concomitant medications. No adverse events were reported following the administration of doses 1 and 2 of Engerix B. On 04/17/01, the vaccinee received her 3rd "adult" dose of Engerix B. Ten to fifteen minutes post-immunization, she complained of "severe" chills, headache, dizziness, hot flashes, and a lump in her throat. She had shortness of breath. She was treated with Epinephrine ".3" SC, 1 dose on 4/17/01, oxygen via nasal cannula at 4 liters/minute and Benadryl 50mg IM, 1 dose on 4/17/01. The vaccinee's symptoms resolved the same day, following treatment. The reporter considered the allergic reaction to be severe in intensity and related to Engerix-B. As of 5/3/01, the allergic reaction resolved. This case is considered to be an "Other Important Medical Event". As a result of follow-up info received on 5/3/01, this report has been re-classified as serious expected.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Aspiration, Choking, Convulsion, Drooling, Gastrooesophageal reflux disease
Clinical narrative: Information has been received from a post marketing surveillance study concerning a 2 month old female. On 04/21/00, the infant received Prevnar, Hib, DTaP, Hepatitis B vaccine, IPV. The same day, upon awakening from a nap, she appeared to be choking on saliva. The infant developed pallor for approximately 5 to 10 minutes. She was seen in the ER and was found to have developed a fever of 101.2 degrees. At this visit the infant was diagnosed with fever with possible seizure vs. possible aspiration vs. reflux episode. Parents refused admission preferring to return to the hospital if necessary. These events were considered to be medically important. Choking and fever are expected; pallor is unexpected. As of 04/06/01, both medical monitor and investigator's assessment of relatedness is unknown. Follow up info received on 11/12/2001 clarified the description of the reported events. On 04/21/2000, while sleeping, the child "turned blue quit breathing, and was shaking, and salivating at the mouth." The child was treated with Tylenol. No personal history of seizure activity was noted. The child has since recovered with no recurrence of similar events following subsequent vaccinations.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pallor, Pyrexia, Respiratory disorder, Tremor
Clinical narrative: Information has been received from a post marketing surveillance study concerning a 2 month old female. On 04/21/00, the infant received Prevnar, Hib, DTaP, Hepatitis B vaccine, IPV. The same day, upon awakening from a nap, she appeared to be choking on saliva. The infant developed pallor for approximately 5 to 10 minutes. She was seen in the ER and was found to have developed a fever of 101.2 degrees. At this visit the infant was diagnosed with fever with possible seizure vs. possible aspiration vs. reflux episode. Parents refused admission preferring to return to the hospital if necessary. These events were considered to be medically important. Choking and fever are expected; pallor is unexpected. As of 04/06/01, both medical monitor and investigator's assessment of relatedness is unknown. Follow up info received on 11/12/2001 clarified the description of the reported events. On 04/21/2000, while sleeping, the child "turned blue quit breathing, and was shaking, and salivating at the mouth." The child was treated with Tylenol. No personal history of seizure activity was noted. The child has since recovered with no recurrence of similar events following subsequent vaccinations.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Aspiration, Choking, Febrile convulsion, Gastrooesophageal reflux disease, Pallor
Clinical narrative: Information has been received from a post marketing surveillance study concerning a 2 month old female. On 04/21/00, the infant received Prevnar, Hib, DTaP, Hepatitis B vaccine, IPV. The same day, upon awakening from a nap, she appeared to be choking on saliva. The infant developed pallor for approximately 5 to 10 minutes. She was seen in the ER and was found to have developed a fever of 101.2 degrees. At this visit the infant was diagnosed with fever with possible seizure vs. possible aspiration vs. reflux episode. Parents refused admission preferring to return to the hospital if necessary. These events were considered to be medically important. Choking and fever are expected; pallor is unexpected. As of 04/06/01, both medical monitor and investigator's assessment of relatedness is unknown. Follow up info received on 11/12/2001 clarified the description of the reported events. On 04/21/2000, while sleeping, the child "turned blue quit breathing, and was shaking, and salivating at the mouth." The child was treated with Tylenol. No personal history of seizure activity was noted. The child has since recovered with no recurrence of similar events following subsequent vaccinations.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Information has been received from a post marketing surveillance study concerning a 2 month old female. On 04/21/00, the infant received Prevnar, Hib, DTaP, Hepatitis B vaccine, IPV. The same day, upon awakening from a nap, she appeared to be choking on saliva. The infant developed pallor for approximately 5 to 10 minutes. She was seen in the ER and was found to have developed a fever of 101.2 degrees. At this visit the infant was diagnosed with fever with possible seizure vs. possible aspiration vs. reflux episode. Parents refused admission preferring to return to the hospital if necessary. These events were considered to be medically important. Choking and fever are expected; pallor is unexpected. As of 04/06/01, both medical monitor and investigator's assessment of relatedness is unknown. Follow up info received on 11/12/2001 clarified the description of the reported events. On 04/21/2000, while sleeping, the child "turned blue quit breathing, and was shaking, and salivating at the mouth." The child was treated with Tylenol. No personal history of seizure activity was noted. The child has since recovered with no recurrence of similar events following subsequent vaccinations.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Aspiration, Choking, Convulsion, Gastrooesophageal reflux disease, Pallor
Clinical narrative: Information has been received from a post marketing surveillance study concerning a 2 month old female. On 04/21/00, the infant received Prevnar, Hib, DTaP, Hepatitis B vaccine, IPV. The same day, upon awakening from a nap, she appeared to be choking on saliva. The infant developed pallor for approximately 5 to 10 minutes. She was seen in the ER and was found to have developed a fever of 101.2 degrees. At this visit the infant was diagnosed with fever with possible seizure vs. possible aspiration vs. reflux episode. Parents refused admission preferring to return to the hospital if necessary. These events were considered to be medically important. Choking and fever are expected; pallor is unexpected. As of 04/06/01, both medical monitor and investigator's assessment of relatedness is unknown. Follow up info received on 11/12/2001 clarified the description of the reported events. On 04/21/2000, while sleeping, the child "turned blue quit breathing, and was shaking, and salivating at the mouth." The child was treated with Tylenol. No personal history of seizure activity was noted. The child has since recovered with no recurrence of similar events following subsequent vaccinations.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pyrexia, Salivary hypersecretion
Clinical narrative: Information has been received from a post marketing surveillance study concerning a 2 month old female. On 04/21/00, the infant received Prevnar, Hib, DTaP, Hepatitis B vaccine, IPV. The same day, upon awakening from a nap, she appeared to be choking on saliva. The infant developed pallor for approximately 5 to 10 minutes. She was seen in the ER and was found to have developed a fever of 101.2 degrees. At this visit the infant was diagnosed with fever with possible seizure vs. possible aspiration vs. reflux episode. Parents refused admission preferring to return to the hospital if necessary. These events were considered to be medically important. Choking and fever are expected; pallor is unexpected. As of 04/06/01, both medical monitor and investigator's assessment of relatedness is unknown. Follow up info received on 11/12/2001 clarified the description of the reported events. On 04/21/2000, while sleeping, the child "turned blue quit breathing, and was shaking, and salivating at the mouth." The child was treated with Tylenol. No personal history of seizure activity was noted. The child has since recovered with no recurrence of similar events following subsequent vaccinations.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Aspiration, Choking, Convulsion, Drooling, Gastrooesophageal reflux disease
Clinical narrative: Information has been received from an investigator regarding a 2 month old female who received Prevnar, Acel-Imune, Hib-Titer, IPV, and Hepatitis B vaccines on 04/21/00 as part of a Prevnar Post-Marketing Surveillance study. She was taken to the ER at 9 Pm that evening; a diagnosis of possible febrile seizure was made. The infant recovered fully. The investigator and medical monitor agree that the febrile seizure is possibly related to Prevnar administration. A copy of this report has been forwarded to Aventis Pasteur, manufacturer if IPV. FOLLOW UP INFORMATION received on 04/06/01 from the study investigator described the reported event. After awaking from a nap on 04/21/00, the child seemed to be choking on saliva with no lapse in breathing, no loss of consciousness, and no seizure-like movements. The child became pale for approximately 5 - 10 minutes. Upon administration to a local ER, the child's body temperature was recorded as 101.2 F. Diagnosis at that time was fever with possible seizure, possible aspiration, or reflux episode. These events were considered medically important. The investigator and medical monitor agree that the reported events were possibly related to Prevnar administration.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pallor, Pyrexia, Respiratory disorder, Tremor
Clinical narrative: Information has been received from an investigator regarding a 2 month old female who received Prevnar, Acel-Imune, Hib-Titer, IPV, and Hepatitis B vaccines on 04/21/00 as part of a Prevnar Post-Marketing Surveillance study. She was taken to the ER at 9 Pm that evening; a diagnosis of possible febrile seizure was made. The infant recovered fully. The investigator and medical monitor agree that the febrile seizure is possibly related to Prevnar administration. A copy of this report has been forwarded to Aventis Pasteur, manufacturer if IPV. FOLLOW UP INFORMATION received on 04/06/01 from the study investigator described the reported event. After awaking from a nap on 04/21/00, the child seemed to be choking on saliva with no lapse in breathing, no loss of consciousness, and no seizure-like movements. The child became pale for approximately 5 - 10 minutes. Upon administration to a local ER, the child's body temperature was recorded as 101.2 F. Diagnosis at that time was fever with possible seizure, possible aspiration, or reflux episode. These events were considered medically important. The investigator and medical monitor agree that the reported events were possibly related to Prevnar administration.