chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood creatine phosphokinase increased, Chest pain, Hyperhidrosis, Laboratory test abnormal, Myocarditis
Clinical narrative: This 34 year old received his primay Smallpox vaccine 02 June 2006.  Approximately 12 days later (14 June 2006) he reported onset of flu-like symptoms of fatigue, body aches, fevers with temperatures of 101 degree F by day 13. His symptoms resolved over the next 24 hours.  By day 15 (17 Jun 2006) he awoke about 0600 with severe substernal left chest pain with radiating pain to both shoulders and left arm with minimal diaphoresis to extremities (hands). He described his pain as a constant pressure, sharp and stabbing while lying flat 9/10, that eased to a 7.5/10 standing or leaning forward. He also c/o difficulty breathing stating it "hurt to breathe". He denied any recent exertion, trauma or illness, nausea, vomiting, back or jaw pain, or any syncope with positional changes. After 20 minutes without resolving, his wife took him to the base emergency room.   Diagnostic studies identified "myocarditis with dilated aortic root" (records pending). Prior to diagnosis he was given Dilaudid IV with resolution of pain but he continued to feel pressure at a 3-4/10 scale that was tolerable.  He was admitted for 3-4 days with resolution of all pain within 12-18 hours post admission (by Sat evening). He reported a normal cardiac catherization that Monday prior to discharge with a resulting groin hematoma one week later that required overnight admission; otherwise no reoccurrence of chest pain/pressure. He continued with limited profile for 2 weeks followed by light duties for 1 week. He currently performs all activities of daily living normally, completes assisgned physical activities noticing some shortness of breath with long distance running >1-2 miles not previously felt prior to illness.   His 6-12 week follow up with the doctor is scheduled in 3 weeks due to unit deployment for maneuvers this week (8/21/06). He again denies any reoccurrance of chest pain/pressure and is on no NSAIDs at this time. Small pox vaccination induced myocarditis resolving.  Assessment: myopericarditis in temporal association to the smallpox vaccine.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Cerebral haematoma, Chest pain, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: This 34 year old received his primay Smallpox vaccine 02 June 2006.  Approximately 12 days later (14 June 2006) he reported onset of flu-like symptoms of fatigue, body aches, fevers with temperatures of 101 degree F by day 13. His symptoms resolved over the next 24 hours.  By day 15 (17 Jun 2006) he awoke about 0600 with severe substernal left chest pain with radiating pain to both shoulders and left arm with minimal diaphoresis to extremities (hands). He described his pain as a constant pressure, sharp and stabbing while lying flat 9/10, that eased to a 7.5/10 standing or leaning forward. He also c/o difficulty breathing stating it "hurt to breathe". He denied any recent exertion, trauma or illness, nausea, vomiting, back or jaw pain, or any syncope with positional changes. After 20 minutes without resolving, his wife took him to the base emergency room.   Diagnostic studies identified "myocarditis with dilated aortic root" (records pending). Prior to diagnosis he was given Dilaudid IV with resolution of pain but he continued to feel pressure at a 3-4/10 scale that was tolerable.  He was admitted for 3-4 days with resolution of all pain within 12-18 hours post admission (by Sat evening). He reported a normal cardiac catherization that Monday prior to discharge with a resulting groin hematoma one week later that required overnight admission; otherwise no reoccurrence of chest pain/pressure. He continued with limited profile for 2 weeks followed by light duties for 1 week. He currently performs all activities of daily living normally, completes assisgned physical activities noticing some shortness of breath with long distance running >1-2 miles not previously felt prior to illness.   His 6-12 week follow up with the doctor is scheduled in 3 weeks due to unit deployment for maneuvers this week (8/21/06). He again denies any reoccurrance of chest pain/pressure and is on no NSAIDs at this time. Small pox vaccination induced myocarditis resolving.  Assessment: myopericarditis in temporal association to the smallpox vaccine.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Influenza like illness, Laboratory test abnormal, Myocarditis, Pain
Clinical narrative: This 34 year old received his primay Smallpox vaccine 02 June 2006.  Approximately 12 days later (14 June 2006) he reported onset of flu-like symptoms of fatigue, body aches, fevers with temperatures of 101 degree F by day 13. His symptoms resolved over the next 24 hours.  By day 15 (17 Jun 2006) he awoke about 0600 with severe substernal left chest pain with radiating pain to both shoulders and left arm with minimal diaphoresis to extremities (hands). He described his pain as a constant pressure, sharp and stabbing while lying flat 9/10, that eased to a 7.5/10 standing or leaning forward. He also c/o difficulty breathing stating it "hurt to breathe". He denied any recent exertion, trauma or illness, nausea, vomiting, back or jaw pain, or any syncope with positional changes. After 20 minutes without resolving, his wife took him to the base emergency room.   Diagnostic studies identified "myocarditis with dilated aortic root" (records pending). Prior to diagnosis he was given Dilaudid IV with resolution of pain but he continued to feel pressure at a 3-4/10 scale that was tolerable.  He was admitted for 3-4 days with resolution of all pain within 12-18 hours post admission (by Sat evening). He reported a normal cardiac catherization that Monday prior to discharge with a resulting groin hematoma one week later that required overnight admission; otherwise no reoccurrence of chest pain/pressure. He continued with limited profile for 2 weeks followed by light duties for 1 week. He currently performs all activities of daily living normally, completes assisgned physical activities noticing some shortness of breath with long distance running >1-2 miles not previously felt prior to illness.   His 6-12 week follow up with the doctor is scheduled in 3 weeks due to unit deployment for maneuvers this week (8/21/06). He again denies any reoccurrance of chest pain/pressure and is on no NSAIDs at this time. Small pox vaccination induced myocarditis resolving.  Assessment: myopericarditis in temporal association to the smallpox vaccine.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Anaphylactic reaction, Urticaria, Vomiting
Clinical narrative: It was reported to the other manufacturer that a two month old male pt received primary doses of ActHib, lot number UE878AA ( another manufacturers lot number Z0434-2), administered in the right leg, Daptacel, lot number C2406AA, administered in the left leg, Ipol, lot number Y1068, administered in the left leg, Prevnar, lot number B08658C, administered in the right leg, and Rotateq lot number 653915-0389F, administered per OS on 7/20/06 at 2:30 PM. The pt has a history of atopic dermatitis, but did not have any illness at the time of vaccination. on Approx 7/20/06 exact latency not reported, the pt developed hives and vomited once at home. The events lasted for approx one hour. At the time of this report, the pt was reported to be recovered. The reporter considered the events of hives and vomiting to be immediately life threatening.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Urticaria, Vomiting
Clinical narrative: It was reported to the other manufacturer that a two month old male pt received primary doses of ActHib, lot number UE878AA ( another manufacturers lot number Z0434-2), administered in the right leg, Daptacel, lot number C2406AA, administered in the left leg, Ipol, lot number Y1068, administered in the left leg, Prevnar, lot number B08658C, administered in the right leg, and Rotateq lot number 653915-0389F, administered per OS on 7/20/06 at 2:30 PM. The pt has a history of atopic dermatitis, but did not have any illness at the time of vaccination. on Approx 7/20/06 exact latency not reported, the pt developed hives and vomited once at home. The events lasted for approx one hour. At the time of this report, the pt was reported to be recovered. The reporter considered the events of hives and vomiting to be immediately life threatening.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Abasia, Anorexia, Aphasia, Hypotonia, Irritability
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in 2 month old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine Dtpa, manufacturer unspecified, inactivated poliomyelitis virus vaccine IPV, manufacturer unspecified and combination Haemophilus influenzae type B conjugate, hepatitis B vaccine Comvax. A physician or other health care professional has not verified this report. The subjects medical history, concurrent conditions, and concurrent medications were not reported. On 11/12/04, the subject received an unspecified dose of Dtpa lot number C1698AA, unspecified dose of IPV lot number X1119-1), and an unspecified dose of Comvax 00439. For the first 48 hours after vaccination with Comvax, Dtpa and IPV, the subject experienced fever. He had the fever off and on for the next two weeks and then he stopped eating. The subject could not move his muscles. He went to the hospital and a spinal tap was done and results came back negative. it was reported that results of the tests do not suggest there should be any kind of developmental delay. On 7/19/06, at the time of reporting, the subject could not talk, walk, or sit up, which is not normal for his age. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unresolved.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Mental retardation severity unspecified, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in 2 month old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine Dtpa, manufacturer unspecified, inactivated poliomyelitis virus vaccine IPV, manufacturer unspecified and combination Haemophilus influenzae type B conjugate, hepatitis B vaccine Comvax. A physician or other health care professional has not verified this report. The subjects medical history, concurrent conditions, and concurrent medications were not reported. On 11/12/04, the subject received an unspecified dose of Dtpa lot number C1698AA, unspecified dose of IPV lot number X1119-1), and an unspecified dose of Comvax 00439. For the first 48 hours after vaccination with Comvax, Dtpa and IPV, the subject experienced fever. He had the fever off and on for the next two weeks and then he stopped eating. The subject could not move his muscles. He went to the hospital and a spinal tap was done and results came back negative. it was reported that results of the tests do not suggest there should be any kind of developmental delay. On 7/19/06, at the time of reporting, the subject could not talk, walk, or sit up, which is not normal for his age. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unresolved.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Abasia, Agitation, Anorexia, Crying, Hypotonia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in 2 month old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine Dtpa, manufacturer unspecified, inactivated poliomyelitis virus vaccine IPV, manufacturer unspecified and combination Haemophilus influenzae type B conjugate, hepatitis B vaccine Comvax. A physician or other health care professional has not verified this report. The subjects medical history, concurrent conditions, and concurrent medications were not reported. On 11/12/04, the subject received an unspecified dose of Dtpa lot number C1698AA, unspecified dose of IPV lot number X1119-1), and an unspecified dose of Comvax 00439. For the first 48 hours after vaccination with Comvax, Dtpa and IPV, the subject experienced fever. He had the fever off and on for the next two weeks and then he stopped eating. The subject could not move his muscles. He went to the hospital and a spinal tap was done and results came back negative. it was reported that results of the tests do not suggest there should be any kind of developmental delay. On 7/19/06, at the time of reporting, the subject could not talk, walk, or sit up, which is not normal for his age. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unresolved.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Irritability, Mental retardation severity unspecified, Pyrexia, Screaming, Speech disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in 2 month old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine Dtpa, manufacturer unspecified, inactivated poliomyelitis virus vaccine IPV, manufacturer unspecified and combination Haemophilus influenzae type B conjugate, hepatitis B vaccine Comvax. A physician or other health care professional has not verified this report. The subjects medical history, concurrent conditions, and concurrent medications were not reported. On 11/12/04, the subject received an unspecified dose of Dtpa lot number C1698AA, unspecified dose of IPV lot number X1119-1), and an unspecified dose of Comvax 00439. For the first 48 hours after vaccination with Comvax, Dtpa and IPV, the subject experienced fever. He had the fever off and on for the next two weeks and then he stopped eating. The subject could not move his muscles. He went to the hospital and a spinal tap was done and results came back negative. it was reported that results of the tests do not suggest there should be any kind of developmental delay. On 7/19/06, at the time of reporting, the subject could not talk, walk, or sit up, which is not normal for his age. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unresolved.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Viral infection
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in 2 month old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine Dtpa, manufacturer unspecified, inactivated poliomyelitis virus vaccine IPV, manufacturer unspecified and combination Haemophilus influenzae type B conjugate, hepatitis B vaccine Comvax. A physician or other health care professional has not verified this report. The subjects medical history, concurrent conditions, and concurrent medications were not reported. On 11/12/04, the subject received an unspecified dose of Dtpa lot number C1698AA, unspecified dose of IPV lot number X1119-1), and an unspecified dose of Comvax 00439. For the first 48 hours after vaccination with Comvax, Dtpa and IPV, the subject experienced fever. He had the fever off and on for the next two weeks and then he stopped eating. The subject could not move his muscles. He went to the hospital and a spinal tap was done and results came back negative. it was reported that results of the tests do not suggest there should be any kind of developmental delay. On 7/19/06, at the time of reporting, the subject could not talk, walk, or sit up, which is not normal for his age. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unresolved.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Anorexia, Difficulty in walking, Hypokinesia, Muscle disorder, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in 2 month old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine Dtpa, manufacturer unspecified, inactivated poliomyelitis virus vaccine IPV, manufacturer unspecified and combination Haemophilus influenzae type B conjugate, hepatitis B vaccine Comvax. A physician or other health care professional has not verified this report. The subjects medical history, concurrent conditions, and concurrent medications were not reported. On 11/12/04, the subject received an unspecified dose of Dtpa lot number C1698AA, unspecified dose of IPV lot number X1119-1), and an unspecified dose of Comvax 00439. For the first 48 hours after vaccination with Comvax, Dtpa and IPV, the subject experienced fever. He had the fever off and on for the next two weeks and then he stopped eating. The subject could not move his muscles. He went to the hospital and a spinal tap was done and results came back negative. it was reported that results of the tests do not suggest there should be any kind of developmental delay. On 7/19/06, at the time of reporting, the subject could not talk, walk, or sit up, which is not normal for his age. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unresolved.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Speech disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in 2 month old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine Dtpa, manufacturer unspecified, inactivated poliomyelitis virus vaccine IPV, manufacturer unspecified and combination Haemophilus influenzae type B conjugate, hepatitis B vaccine Comvax. A physician or other health care professional has not verified this report. The subjects medical history, concurrent conditions, and concurrent medications were not reported. On 11/12/04, the subject received an unspecified dose of Dtpa lot number C1698AA, unspecified dose of IPV lot number X1119-1), and an unspecified dose of Comvax 00439. For the first 48 hours after vaccination with Comvax, Dtpa and IPV, the subject experienced fever. He had the fever off and on for the next two weeks and then he stopped eating. The subject could not move his muscles. He went to the hospital and a spinal tap was done and results came back negative. it was reported that results of the tests do not suggest there should be any kind of developmental delay. On 7/19/06, at the time of reporting, the subject could not talk, walk, or sit up, which is not normal for his age. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unresolved.
Age: 69.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Hot flush, Nausea, Vertigo, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of dizziness in a 69 year old male subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine Twinrix for prophylaxis. The subjects medical history included hypertension. Concurrent medications included Valsartan Diovan. On 8/15/06 the subject received 2nd dose of Twinrix in the let arm Lot AHABB061AA. On 8/16/06, 1 day after vaccination with Twinrix, the subject experienced dizziness, nausea and vomiting. The subject was seen at at physicians office. The healthcare professional reported that the subject, was unable to perform daily task due to dizziness. The subject was treated with meclozine hydrochloride Antivert. The healthcare professional considered the events to be disabling. The vomiting resolved at the time of initial reporting, 8/17/06, but the inability to function, dizziness and nausea were ongoing.
Age: 69.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of dizziness in a 69 year old male subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine Twinrix for prophylaxis. The subjects medical history included hypertension. Concurrent medications included Valsartan Diovan. On 8/15/06 the subject received 2nd dose of Twinrix in the let arm Lot AHABB061AA. On 8/16/06, 1 day after vaccination with Twinrix, the subject experienced dizziness, nausea and vomiting. The subject was seen at at physicians office. The healthcare professional reported that the subject, was unable to perform daily task due to dizziness. The subject was treated with meclozine hydrochloride Antivert. The healthcare professional considered the events to be disabling. The vomiting resolved at the time of initial reporting, 8/17/06, but the inability to function, dizziness and nausea were ongoing.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Blister, Erythema, Injection site warmth, Swelling
Clinical narrative: Patient had right arm redness, swelling, hot to touch, and blisters after receiving DTaP #5 after half of day of placement.  Patient returned 08/11/2006 and was prescribed. Aclovate to apply three times a day and Pre Lore 5mg/teaspoon
Age: 1.09
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Patient seen for rash (bumpy) on upper back trunk, buttocks.  Diagnose: Chicken Pox, 50 plus lesions, no school until lesion crust over.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Skin burning sensation, Swelling
Clinical narrative: Burning, swelling, redness, feels thick
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Syncope
Clinical narrative: After receiving PPD test and Hepatitis A vaccine, client fainted, falling back onto the exam table.  He woke up within 30 seconds asking what happened, color was a little pale.  He rested for a few minutes, was then given MENACTRA vaccine, and walked out to waiting room.  He did faint again about 10 minutes later waking up moments later.  He was sent to emergency room for observation normal recovery.
Sex: U
Vaccine: TDAP
Symptoms: Discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Injection site, left deltoid, warm to the touch, rosy pink, non raised, erythema measuring 55 mm by 60 mm in diameter.  Patient has full range of motion, but complains of discomfort, 48 hours post injection.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Pain
Clinical narrative: Patient with history of Multiple Sclerosis, complains of body aches, lump in throat, fatigue, states causing an "Multiple Sclerosis flare".
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Myalgia, Pain in jaw
Clinical narrative: 07/19/2006 received Tdap, 07/20/2006 developed sore, hot arm for 7 days developed sore, painful, tender jaw approximately 2 weeks following Tdap to present.  Jaw locked shut approximately 3 weeks following Tdap to present.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pain in jaw
Clinical narrative: Sore arm day after vaccine administered (07/19/2006) lasted approximately 1 week.  Painful jaw approximately 2 weeks after vaccine administered (beginning approximately August 1) to present.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain in jaw
Clinical narrative: 07/19/2006 received Tdap noticed sore, painful jaw approximately 2-3 weeks later to present time.  Have also had a mild to moderate headache for 3 weeks.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Rash, Viral infection
Clinical narrative: Varicella type rash, no treatment needed
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Influenza like illness, Neck pain
Clinical narrative: Flu like symptoms left side neck pain, left shoulder and extremities for 1 week following injection
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: 7cm erythema on right deltoid.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red slightly raised area at injection site 4x6cm. Onset 24 hours after vaccine. No pain, no fever.
Age: 69.0
Sex: F
Vaccine: DTOX
Symptoms: Asthenia, Erythema, Pain, Pyrexia, Subcutaneous nodule
Clinical narrative: Redness, soreness, severe pain in the upper arm, swelling, discomfort and fever for a week, also weakness and a severe lump on the neck area the size of a fist that has lasted now more than 4 weeks. I reported it to the doctor 3 days after who prescribed the medication Prednisone for the purpose.
Age: 69.0
Sex: F
Vaccine: DTOX
Symptoms: Swelling, Tenderness
Clinical narrative: Redness, soreness, severe pain in the upper arm, swelling, discomfort and fever for a week, also weakness and a severe lump on the neck area the size of a fist that has lasted now more than 4 weeks. I reported it to the doctor 3 days after who prescribed the medication Prednisone for the purpose.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site induration
Clinical narrative: Hard bump in right leg, cellulitis in leg, red, warm to touch.
Age: 1.26
Sex: F
Vaccine: HEPA, MMR
Symptoms: Rash
Clinical narrative: Rash-MMR rash vs other viral  Exanthem was described by Children's ER doctor as "measles rash"
Age: 1.29
Sex: F
Vaccine: DTAPH, HEPA, MMR
Symptoms: Body temperature increased, Febrile convulsion, Pyrexia, Rash macular
Clinical narrative: Febrile seizure (20 minutes) Temp 104 30 hours after immunization. ED visit 8/4/06, MD office visit 8/8/06, 8/9/06. Fever 8/4//06 to 8/9/06, macular rash appeared 8/8/06 until 8/11/06.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Body temperature increased, Headache, Skin nodule, Weight decreased
Clinical narrative: Saturday August 5, symptoms "knots behind ears, headache, then on 8/8/06 severe headaches, 8/7/06 increased temperature, weakness, severe headaches. States "I have lost ten pounds". Placed on Prednisone, Claritin and Rhineacort. Saw MD 8/7/06 also treated at ER.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: L arm has hives approximately 3"x1". Donor stated after shot given is allergic to alcohol. No mention of allergies on donor record. Site cleaned with alcohol wipe. Reaction clearing within 30 minutes with ice. No medication given. No distress on donor part.
Age: 0.56
Sex: F
Vaccine: DTAP, HEP, IPV, UNK
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 104, vomiting milk.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Swelling
Clinical narrative: Large local reaction. swelling/induration/erythema 170mmx180mm on left thigh at site of DTaP. Started ~24 hours after shot This was 5th dose in series.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: MMR #2 documented at 3 years 7 months delayed immunization, MMR#3 given at 4 years age.  Noted MMR#2 actually given at  January 2006 so child was 4 years.  No adverse effects, symptoms noted.  No treatment given.  Per grand mother (guardian) child well.  contact agency for contraindications. CRNP aware.  No adverse reaction.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Abdominal pain, Asthenia, Neck pain, Pain
Clinical narrative: MCV4 administered on 8/3/06 at 11:45am.  At 4pm on 8/3/06, pain in neck and down to mid-spine, mild at first.  Then at 4am on 8/4/06, increased pain, weakness, ankles, and arms with abdominal pain.  Described as "felt drained"  MD visit -  ordered Tylenol; little relief for next 12-24 hours.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Headache, Hypersensitivity, Myalgia, Nausea
Clinical narrative: This woman is an employee who is a case worker for the developmentally disabled. She recieved Engerix on August 15th 2006, as a first immunization in a preventative series of three. She developed headache, nausea and upper body muscular skeletal aches and pains and chills. She was seen by a physician on August 17 and it was determined to be an allergic reaction. She has recovered completely but she has been counciled that in the event of an exposure to Hepatitis B she will need to get HBIG initially and again in 4 weeks.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: This woman is an employee who is a case worker for the developmentally disabled. She recieved Engerix on August 15th 2006, as a first immunization in a preventative series of three. She developed headache, nausea and upper body muscular skeletal aches and pains and chills. She was seen by a physician on August 17 and it was determined to be an allergic reaction. She has recovered completely but she has been counciled that in the event of an exposure to Hepatitis B she will need to get HBIG initially and again in 4 weeks.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Alanine aminotransferase increased, Blood pressure increased, Blood urea increased, Fluid retention, Haemoglobin decreased
Clinical narrative: This 23 year old female subject was enrolled in a blinded study. The subject received IM investigational product single dose on 2/18/05, 3/11/05 and 7/27/05, site of injection was the left deltoid. On 2/18/05, 3/11/05 and 7/27/05, the subject received the 1st, 2nd and 3rd IM injection of blinded study vaccine in the left deltoid. The subject had been randomized to received the herpes simplex virus HSV, lot number AHS1020A2. on 2/18/05 and 3/11/05 the subject received a third dose of Hepatitis A vaccine due to an error. From 1/19/03 to 12/14/05 the subject took Orthotricyclen. On 12/13/05 nine months after the 2nd dose of five months after the 3rd dose of blinded vaccine, this 23 year old subject developed minimal change disease. The subject came in with complaints of fluid retention, increased leg edema and weight gain. Relevant test results included weight 89.5kg, blood pressure 160/88, heart rate 78, respiration 18, urinalysis showed 3+ protein, white blood cell 60-75 per high power filed. occasional red blood cells and chemistry panel calcium 7.9 and albumin 2.7. This subject with elevated blood pressure, hypoalbuminenia with nephrotic range proteinuria, asymptomatic pyuria and normal complement factor, was referred to a nephrologist. On 12/14/05 the subject was placed on Frusemide and valsartan for fluid reduction and blood pressure control. A kidney biopsy was performed on 1/4/06 which revealed minimal change disease. The subject was subsequently started on prednisolone, in addition to Frusemide and valsartan. On 1/27/06 she continued to have complaint of fluid retention, elevated blood pressure and lower extremity pitting edema 4+. Medications remained the same (prednisolone, Frusemide and valsartan). The subject continued to be followed closely by a nephrologist. In May 2006 she was followed up by her nephrologist and found to be Prednisolone resistant. She was placed on Cyclophosphamide. On 7/26/06 physically the subject felt much better with decreased fluid retention, decreased edema and better blood pressure control. However, the subject became resistant to the prednisolone and the dose was tapered to 10 mg daily. She was subsequently started on Cyclophosphamide, simvastatin and Gemfibrozil due to new onset hyperlipidemia secondary to the nephrotic syndrome. At time of reporting, the SAE was reported as ongoing. This event has been considered to be medically important (OMIC) secondary to the prednisolone resistant minimal change disease, requiring an immune modulator. The investigator considered that there was a reasonable possibility that the minimal change disease may have been caused by investigational product.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Hyperlipidaemia, Hypoalbuminaemia, Medication error, Nephrotic syndrome, Oedema peripheral
Clinical narrative: This 23 year old female subject was enrolled in a blinded study. The subject received IM investigational product single dose on 2/18/05, 3/11/05 and 7/27/05, site of injection was the left deltoid. On 2/18/05, 3/11/05 and 7/27/05, the subject received the 1st, 2nd and 3rd IM injection of blinded study vaccine in the left deltoid. The subject had been randomized to received the herpes simplex virus HSV, lot number AHS1020A2. on 2/18/05 and 3/11/05 the subject received a third dose of Hepatitis A vaccine due to an error. From 1/19/03 to 12/14/05 the subject took Orthotricyclen. On 12/13/05 nine months after the 2nd dose of five months after the 3rd dose of blinded vaccine, this 23 year old subject developed minimal change disease. The subject came in with complaints of fluid retention, increased leg edema and weight gain. Relevant test results included weight 89.5kg, blood pressure 160/88, heart rate 78, respiration 18, urinalysis showed 3+ protein, white blood cell 60-75 per high power filed. occasional red blood cells and chemistry panel calcium 7.9 and albumin 2.7. This subject with elevated blood pressure, hypoalbuminenia with nephrotic range proteinuria, asymptomatic pyuria and normal complement factor, was referred to a nephrologist. On 12/14/05 the subject was placed on Frusemide and valsartan for fluid reduction and blood pressure control. A kidney biopsy was performed on 1/4/06 which revealed minimal change disease. The subject was subsequently started on prednisolone, in addition to Frusemide and valsartan. On 1/27/06 she continued to have complaint of fluid retention, elevated blood pressure and lower extremity pitting edema 4+. Medications remained the same (prednisolone, Frusemide and valsartan). The subject continued to be followed closely by a nephrologist. In May 2006 she was followed up by her nephrologist and found to be Prednisolone resistant. She was placed on Cyclophosphamide. On 7/26/06 physically the subject felt much better with decreased fluid retention, decreased edema and better blood pressure control. However, the subject became resistant to the prednisolone and the dose was tapered to 10 mg daily. She was subsequently started on Cyclophosphamide, simvastatin and Gemfibrozil due to new onset hyperlipidemia secondary to the nephrotic syndrome. At time of reporting, the SAE was reported as ongoing. This event has been considered to be medically important (OMIC) secondary to the prednisolone resistant minimal change disease, requiring an immune modulator. The investigator considered that there was a reasonable possibility that the minimal change disease may have been caused by investigational product.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Proteinuria, Pyuria, Renal disorder, Weight increased
Clinical narrative: This 23 year old female subject was enrolled in a blinded study. The subject received IM investigational product single dose on 2/18/05, 3/11/05 and 7/27/05, site of injection was the left deltoid. On 2/18/05, 3/11/05 and 7/27/05, the subject received the 1st, 2nd and 3rd IM injection of blinded study vaccine in the left deltoid. The subject had been randomized to received the herpes simplex virus HSV, lot number AHS1020A2. on 2/18/05 and 3/11/05 the subject received a third dose of Hepatitis A vaccine due to an error. From 1/19/03 to 12/14/05 the subject took Orthotricyclen. On 12/13/05 nine months after the 2nd dose of five months after the 3rd dose of blinded vaccine, this 23 year old subject developed minimal change disease. The subject came in with complaints of fluid retention, increased leg edema and weight gain. Relevant test results included weight 89.5kg, blood pressure 160/88, heart rate 78, respiration 18, urinalysis showed 3+ protein, white blood cell 60-75 per high power filed. occasional red blood cells and chemistry panel calcium 7.9 and albumin 2.7. This subject with elevated blood pressure, hypoalbuminenia with nephrotic range proteinuria, asymptomatic pyuria and normal complement factor, was referred to a nephrologist. On 12/14/05 the subject was placed on Frusemide and valsartan for fluid reduction and blood pressure control. A kidney biopsy was performed on 1/4/06 which revealed minimal change disease. The subject was subsequently started on prednisolone, in addition to Frusemide and valsartan. On 1/27/06 she continued to have complaint of fluid retention, elevated blood pressure and lower extremity pitting edema 4+. Medications remained the same (prednisolone, Frusemide and valsartan). The subject continued to be followed closely by a nephrologist. In May 2006 she was followed up by her nephrologist and found to be Prednisolone resistant. She was placed on Cyclophosphamide. On 7/26/06 physically the subject felt much better with decreased fluid retention, decreased edema and better blood pressure control. However, the subject became resistant to the prednisolone and the dose was tapered to 10 mg daily. She was subsequently started on Cyclophosphamide, simvastatin and Gemfibrozil due to new onset hyperlipidemia secondary to the nephrotic syndrome. At time of reporting, the SAE was reported as ongoing. This event has been considered to be medically important (OMIC) secondary to the prednisolone resistant minimal change disease, requiring an immune modulator. The investigator considered that there was a reasonable possibility that the minimal change disease may have been caused by investigational product.
Age: 43.0
Sex: F
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Cardiac arrest, Convulsion
Clinical narrative: Received MMR vaccine and Hepatitis B vaccine at 1:45 PM. Brought in to ER at 10:48 PM in full cardiac arrest. Apparently had witnessed seizure prior to arrest.
Age: 43.0
Sex: F
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Apnoea, Cardiac arrest, Convulsion, Laboratory test abnormal, Pulse absent
Clinical narrative: Received MMR vaccine and Hepatitis B vaccine at 1:45 PM. Brought in to ER at 10:48 PM in full cardiac arrest. Apparently had witnessed seizure prior to arrest.
Age: 43.0
Sex: F
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Syncope
Clinical narrative: Received MMR vaccine and Hepatitis B vaccine at 1:45 PM. Brought in to ER at 10:48 PM in full cardiac arrest. Apparently had witnessed seizure prior to arrest.
Age: 41.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Tachycardia
Clinical narrative: The employee complains of heart like it was racing, the night after vaccines were administered, the next day left upper arm was red about the size of half dollar, no swelling or lump palpated.  Afebrile.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Vaginal haemorrhage
Clinical narrative: Unaware that patient was pregnant.  She was immunized with Menactra vaccine on 07-13-2006, patient began having heavy vaginal bleeding.  Patient denied being pregnant and/or recent sexual activity.  Bleeding continued and was advised to go to emergency room went to urgent care. Positive pregnant test, outcome was miscarriage of pregnancy.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abortion spontaneous, Unintended pregnancy, Vaginal haemorrhage
Clinical narrative: Unaware that patient was pregnant.  She was immunized with Menactra vaccine on 07-13-2006, patient began having heavy vaginal bleeding.  Patient denied being pregnant and/or recent sexual activity.  Bleeding continued and was advised to go to emergency room went to urgent care. Positive pregnant test, outcome was miscarriage of pregnancy.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Had Tdap on 08/15/2006 left deltoid, next day left axilla lymph nodes swollen and sore.  Still sore today (08/17/2006). Lymph nodes still swollen.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Red, swollen right upper arm treated with antibiotics on 08/04/2006 by congential heart disease provider for cellulitis.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen right upper arm treated with antibiotics on 08/04/2006 by congential heart disease provider for cellulitis.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Area of increased erythema 15 centimeter by 13 centimeter left upper extremity.
Age: 68.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient complain of swelling and redness to left arm, injection site.  Treatment given by urgent care medical doctor for 0.1 percent TAC cream, BENADRYL 25 mg, KEFLEX 500 mg.
Age: 4.0
Sex: M
Vaccine: HBHEPB, PNC, UNK
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: Redness, some swelling, warm to touch
Age: 1.68
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: DTaP given right leg intramuscular, no reaction after 10 minutes, but next day mother called and said site of immunization was red, hot, and swollen.  Per doctor patient mother notified to us MOTRIN, ice by 10 minutes 2-3 times a day, and to continue antibiotics for ears.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Initial and follow up information has been received from an office administrator and a physician concerning a 16 wk old male pt (weight at birth, 8lb, 4 oz) using an apnea monitor who on 05Jun06 was vaccinated with a first dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine. On 01Aug06 at 10:15AM he was vaccinated IM in right thigh with a 2nd dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (lot 654424/0268F). Concomitant suspect therapy also administered on 01Aug06 at 10:15AM included a 2nd dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (Prevnar) (lotb086838) IM in left thigh, a 2nd dose of poliovirus vaccine (lot Z0001) IM in left thigh, and a 2nd dose of diphtheria toxoid (+) pertussis acellular vaccine (unsp) (+) tetanus toxoid (lotU1857BA) IM in right thigh. The pt had an upper respiratory infection at the time of vaccinations. It was reported that at 10PM on 01Aug06 the infant had an apnea event which required CPR/advanced resuscitation. Approx 12 hrs after the resuscitation, the infant died from complications from a prolonged cardio pulmonary arrest. The physician stated that she had received this information from the pathologist: on the evening the vaccines had been administered the apnea monitor in the child's bedroom went off and the mother found the baby blue. She assumed he had thrown up and was blue due to lack of breathing. The baby was rushed to the ER where after continued resuscitation for 25 mins they got the heart rate back. The baby was transported to ICU but there was already organ damage. 12 hrs later organ failure occurred and the baby died. There had been retinal hemorrhages on autopsy. The physician noted that retinal hemorrhage may be caused by such things as shaken baby syndrome or CPR. An autopsy report was requested however the physician indicated it may take some time to determine etiology. Initial information indicated that the infant died on 02Aug06 and that the cause of death was retinal haemorrhage which occurred when an attempt was made to resuscitate the infant. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Cardio-respiratory arrest, Retinal haemorrhage
Clinical narrative: Initial and follow up information has been received from an office administrator and a physician concerning a 16 wk old male pt (weight at birth, 8lb, 4 oz) using an apnea monitor who on 05Jun06 was vaccinated with a first dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine. On 01Aug06 at 10:15AM he was vaccinated IM in right thigh with a 2nd dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (lot 654424/0268F). Concomitant suspect therapy also administered on 01Aug06 at 10:15AM included a 2nd dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (Prevnar) (lotb086838) IM in left thigh, a 2nd dose of poliovirus vaccine (lot Z0001) IM in left thigh, and a 2nd dose of diphtheria toxoid (+) pertussis acellular vaccine (unsp) (+) tetanus toxoid (lotU1857BA) IM in right thigh. The pt had an upper respiratory infection at the time of vaccinations. It was reported that at 10PM on 01Aug06 the infant had an apnea event which required CPR/advanced resuscitation. Approx 12 hrs after the resuscitation, the infant died from complications from a prolonged cardio pulmonary arrest. The physician stated that she had received this information from the pathologist: on the evening the vaccines had been administered the apnea monitor in the child's bedroom went off and the mother found the baby blue. She assumed he had thrown up and was blue due to lack of breathing. The baby was rushed to the ER where after continued resuscitation for 25 mins they got the heart rate back. The baby was transported to ICU but there was already organ damage. 12 hrs later organ failure occurred and the baby died. There had been retinal hemorrhages on autopsy. The physician noted that retinal hemorrhage may be caused by such things as shaken baby syndrome or CPR. An autopsy report was requested however the physician indicated it may take some time to determine etiology. Initial information indicated that the infant died on 02Aug06 and that the cause of death was retinal haemorrhage which occurred when an attempt was made to resuscitate the infant. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Coma
Clinical narrative: Initial and follow up information has been received from an office administrator and a physician concerning a 16 wk old male pt (weight at birth, 8lb, 4 oz) using an apnea monitor who on 05Jun06 was vaccinated with a first dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine. On 01Aug06 at 10:15AM he was vaccinated IM in right thigh with a 2nd dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (lot 654424/0268F). Concomitant suspect therapy also administered on 01Aug06 at 10:15AM included a 2nd dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (Prevnar) (lotb086838) IM in left thigh, a 2nd dose of poliovirus vaccine (lot Z0001) IM in left thigh, and a 2nd dose of diphtheria toxoid (+) pertussis acellular vaccine (unsp) (+) tetanus toxoid (lotU1857BA) IM in right thigh. The pt had an upper respiratory infection at the time of vaccinations. It was reported that at 10PM on 01Aug06 the infant had an apnea event which required CPR/advanced resuscitation. Approx 12 hrs after the resuscitation, the infant died from complications from a prolonged cardio pulmonary arrest. The physician stated that she had received this information from the pathologist: on the evening the vaccines had been administered the apnea monitor in the child's bedroom went off and the mother found the baby blue. She assumed he had thrown up and was blue due to lack of breathing. The baby was rushed to the ER where after continued resuscitation for 25 mins they got the heart rate back. The baby was transported to ICU but there was already organ damage. 12 hrs later organ failure occurred and the baby died. There had been retinal hemorrhages on autopsy. The physician noted that retinal hemorrhage may be caused by such things as shaken baby syndrome or CPR. An autopsy report was requested however the physician indicated it may take some time to determine etiology. Initial information indicated that the infant died on 02Aug06 and that the cause of death was retinal haemorrhage which occurred when an attempt was made to resuscitate the infant. Additional information has been requested.