chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Cellulitis, Coagulation test normal, Deep vein thrombosis, Dyspnoea, Fibrin D dimer increased
Clinical narrative: Case number PHHY2011IN44349 is an initial literature report received on 24 May 2011. The authors discussed a rare case of calf muscle injury due to dog bite leading to deep vein thrombosis. This report refers to a 32 year old man presented with a history of unprovoked bite by a stray dog causing a penetrating, lacerated wound on his right calf and thigh, and bleeding from the site of wound. He was treated with local antiseptic and was vaccinated with rabies virus vaccine (manufacturer and batch number: unknown). Two days later, the patient experienced a swelling of the right calf which was ignored. Over the next 10 days, the swelling worsened and progressed from the calf to the thigh and was associated with pain in the right leg while walking. He also had acute onset of breathlessness, uneasiness, restlessness, palpitations and intolerable pain in the right leg for which he was hospitalized. On examination, the patient was restless and writhing in pain. His vital parameters were normal except for tachycardia and tachypnoea. No other abnormality was found on chest and cardiovascular examination. Local examination revealed swelling and tenderness over the right calf and thigh. Pratt sign and the Homan's test were positive. A differential diagnosis of deep vein thrombosis (DVT) with pulmonary embolism and cellulitis with septicemia were made. The patient was investigated and a Doppler of the right leg showed total occlusion of the right common femoral vein below the saphno-femoral junction by a thrombus with partial occlusion above the junction. His D-dimer level was 5131 ng/ml which was significantly raised. no evidence of pulmonary embolism was found on further investigations. The patient was treated with low molecular weight heparin and then shifted over to oral warfarin after overlapping the treatment for 4 days. The pain, swelling and dyspnoea improved during hospital stay and he was discharged with a target international normalized ratio (INR) between 2 and 3. On follow up, his symptoms, prothrombin time (PT) and INR were monitored. No contributory thrombophilic factors (cardiolipin antibody, C-reactive protein, lupus anticoagulant, factor V Leiden, anti-thrombin, antinuclear antibody (ANA), protein C and protein S) were found during the 6 months post-injury examinations. The author commented that the patient's only identifiable major thrombotic risk factor was the traumatic injury due to the dog bite.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Homans' sign positive, International normalised ratio, Laboratory test abnormal, Muscle injury, Oedema peripheral
Clinical narrative: Case number PHHY2011IN44349 is an initial literature report received on 24 May 2011. The authors discussed a rare case of calf muscle injury due to dog bite leading to deep vein thrombosis. This report refers to a 32 year old man presented with a history of unprovoked bite by a stray dog causing a penetrating, lacerated wound on his right calf and thigh, and bleeding from the site of wound. He was treated with local antiseptic and was vaccinated with rabies virus vaccine (manufacturer and batch number: unknown). Two days later, the patient experienced a swelling of the right calf which was ignored. Over the next 10 days, the swelling worsened and progressed from the calf to the thigh and was associated with pain in the right leg while walking. He also had acute onset of breathlessness, uneasiness, restlessness, palpitations and intolerable pain in the right leg for which he was hospitalized. On examination, the patient was restless and writhing in pain. His vital parameters were normal except for tachycardia and tachypnoea. No other abnormality was found on chest and cardiovascular examination. Local examination revealed swelling and tenderness over the right calf and thigh. Pratt sign and the Homan's test were positive. A differential diagnosis of deep vein thrombosis (DVT) with pulmonary embolism and cellulitis with septicemia were made. The patient was investigated and a Doppler of the right leg showed total occlusion of the right common femoral vein below the saphno-femoral junction by a thrombus with partial occlusion above the junction. His D-dimer level was 5131 ng/ml which was significantly raised. no evidence of pulmonary embolism was found on further investigations. The patient was treated with low molecular weight heparin and then shifted over to oral warfarin after overlapping the treatment for 4 days. The pain, swelling and dyspnoea improved during hospital stay and he was discharged with a target international normalized ratio (INR) between 2 and 3. On follow up, his symptoms, prothrombin time (PT) and INR were monitored. No contributory thrombophilic factors (cardiolipin antibody, C-reactive protein, lupus anticoagulant, factor V Leiden, anti-thrombin, antinuclear antibody (ANA), protein C and protein S) were found during the 6 months post-injury examinations. The author commented that the patient's only identifiable major thrombotic risk factor was the traumatic injury due to the dog bite.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Pain, Pain in extremity, Palpitations, Protein C, Protein S normal
Clinical narrative: Case number PHHY2011IN44349 is an initial literature report received on 24 May 2011. The authors discussed a rare case of calf muscle injury due to dog bite leading to deep vein thrombosis. This report refers to a 32 year old man presented with a history of unprovoked bite by a stray dog causing a penetrating, lacerated wound on his right calf and thigh, and bleeding from the site of wound. He was treated with local antiseptic and was vaccinated with rabies virus vaccine (manufacturer and batch number: unknown). Two days later, the patient experienced a swelling of the right calf which was ignored. Over the next 10 days, the swelling worsened and progressed from the calf to the thigh and was associated with pain in the right leg while walking. He also had acute onset of breathlessness, uneasiness, restlessness, palpitations and intolerable pain in the right leg for which he was hospitalized. On examination, the patient was restless and writhing in pain. His vital parameters were normal except for tachycardia and tachypnoea. No other abnormality was found on chest and cardiovascular examination. Local examination revealed swelling and tenderness over the right calf and thigh. Pratt sign and the Homan's test were positive. A differential diagnosis of deep vein thrombosis (DVT) with pulmonary embolism and cellulitis with septicemia were made. The patient was investigated and a Doppler of the right leg showed total occlusion of the right common femoral vein below the saphno-femoral junction by a thrombus with partial occlusion above the junction. His D-dimer level was 5131 ng/ml which was significantly raised. no evidence of pulmonary embolism was found on further investigations. The patient was treated with low molecular weight heparin and then shifted over to oral warfarin after overlapping the treatment for 4 days. The pain, swelling and dyspnoea improved during hospital stay and he was discharged with a target international normalized ratio (INR) between 2 and 3. On follow up, his symptoms, prothrombin time (PT) and INR were monitored. No contributory thrombophilic factors (cardiolipin antibody, C-reactive protein, lupus anticoagulant, factor V Leiden, anti-thrombin, antinuclear antibody (ANA), protein C and protein S) were found during the 6 months post-injury examinations. The author commented that the patient's only identifiable major thrombotic risk factor was the traumatic injury due to the dog bite.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Prothrombin time, Pulmonary embolism, Restlessness, Sepsis, Tachycardia
Clinical narrative: Case number PHHY2011IN44349 is an initial literature report received on 24 May 2011. The authors discussed a rare case of calf muscle injury due to dog bite leading to deep vein thrombosis. This report refers to a 32 year old man presented with a history of unprovoked bite by a stray dog causing a penetrating, lacerated wound on his right calf and thigh, and bleeding from the site of wound. He was treated with local antiseptic and was vaccinated with rabies virus vaccine (manufacturer and batch number: unknown). Two days later, the patient experienced a swelling of the right calf which was ignored. Over the next 10 days, the swelling worsened and progressed from the calf to the thigh and was associated with pain in the right leg while walking. He also had acute onset of breathlessness, uneasiness, restlessness, palpitations and intolerable pain in the right leg for which he was hospitalized. On examination, the patient was restless and writhing in pain. His vital parameters were normal except for tachycardia and tachypnoea. No other abnormality was found on chest and cardiovascular examination. Local examination revealed swelling and tenderness over the right calf and thigh. Pratt sign and the Homan's test were positive. A differential diagnosis of deep vein thrombosis (DVT) with pulmonary embolism and cellulitis with septicemia were made. The patient was investigated and a Doppler of the right leg showed total occlusion of the right common femoral vein below the saphno-femoral junction by a thrombus with partial occlusion above the junction. His D-dimer level was 5131 ng/ml which was significantly raised. no evidence of pulmonary embolism was found on further investigations. The patient was treated with low molecular weight heparin and then shifted over to oral warfarin after overlapping the treatment for 4 days. The pain, swelling and dyspnoea improved during hospital stay and he was discharged with a target international normalized ratio (INR) between 2 and 3. On follow up, his symptoms, prothrombin time (PT) and INR were monitored. No contributory thrombophilic factors (cardiolipin antibody, C-reactive protein, lupus anticoagulant, factor V Leiden, anti-thrombin, antinuclear antibody (ANA), protein C and protein S) were found during the 6 months post-injury examinations. The author commented that the patient's only identifiable major thrombotic risk factor was the traumatic injury due to the dog bite.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Tachypnoea, Tenderness, Ultrasound Doppler abnormal, Venous occlusion
Clinical narrative: Case number PHHY2011IN44349 is an initial literature report received on 24 May 2011. The authors discussed a rare case of calf muscle injury due to dog bite leading to deep vein thrombosis. This report refers to a 32 year old man presented with a history of unprovoked bite by a stray dog causing a penetrating, lacerated wound on his right calf and thigh, and bleeding from the site of wound. He was treated with local antiseptic and was vaccinated with rabies virus vaccine (manufacturer and batch number: unknown). Two days later, the patient experienced a swelling of the right calf which was ignored. Over the next 10 days, the swelling worsened and progressed from the calf to the thigh and was associated with pain in the right leg while walking. He also had acute onset of breathlessness, uneasiness, restlessness, palpitations and intolerable pain in the right leg for which he was hospitalized. On examination, the patient was restless and writhing in pain. His vital parameters were normal except for tachycardia and tachypnoea. No other abnormality was found on chest and cardiovascular examination. Local examination revealed swelling and tenderness over the right calf and thigh. Pratt sign and the Homan's test were positive. A differential diagnosis of deep vein thrombosis (DVT) with pulmonary embolism and cellulitis with septicemia were made. The patient was investigated and a Doppler of the right leg showed total occlusion of the right common femoral vein below the saphno-femoral junction by a thrombus with partial occlusion above the junction. His D-dimer level was 5131 ng/ml which was significantly raised. no evidence of pulmonary embolism was found on further investigations. The patient was treated with low molecular weight heparin and then shifted over to oral warfarin after overlapping the treatment for 4 days. The pain, swelling and dyspnoea improved during hospital stay and he was discharged with a target international normalized ratio (INR) between 2 and 3. On follow up, his symptoms, prothrombin time (PT) and INR were monitored. No contributory thrombophilic factors (cardiolipin antibody, C-reactive protein, lupus anticoagulant, factor V Leiden, anti-thrombin, antinuclear antibody (ANA), protein C and protein S) were found during the 6 months post-injury examinations. The author commented that the patient's only identifiable major thrombotic risk factor was the traumatic injury due to the dog bite.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Anxiety, Headache
Clinical narrative: STOMACH ACHE HEADACHE ANXIETY ISSUES DUE TO STEP SISTERS EPISODE (FAINTED). RECIEVED VACCINES AT SAME TIME. BP 142/180 HR 78.  FOLLOW UP PHONE CALL 6:50 PM, MOM STATES DOING WELL.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Abdominal pain upper, Dizziness, Flushing, Headache, Visual impairment
Clinical narrative: FACE FLUSHED DIZZY, SPOTS BEFORE EYES, HEADACHE, STOMACH ACHE. LAID CLIENT DOWN TO MONITOR BLOOD PRESSURE.  BP 124/86 142/88 112/74. HR 105 INITIALLY AND THEN RETURNED TO 78 AFTER 15 MINUTES. FOLLOW UP PHONE CALL TO MOM 6:58 PM 5/12/11 DOING WELL.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incoherent, Pallor
Clinical narrative: COMPLETELY PALE NOT COHERENT BUT CONSCIOUS. LAID TO FLOOR. BENADRYL 50 MG ADM LT ARM 12:35 PM. MONITORED BP CALLED 911 EVALUATED BY EMS AND DR. RELEASED TO HOME BY EMS AND DR ON SITE DURING EVENT. BP 127/81 140/78 HR 67. FOLLOW UP CALL TO MOM DONE AT 6:45 PM 15-12-11 CLIENT DOING WELL.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Anxiety, Headache, Nausea, Visual impairment
Clinical narrative: HEADACHE STOMACH ACHE, NAUSEA, SPOTS BEFORE EYES, EXTREMELY ANXIOUS. RELEASED TO HOME AND DAD WHO IS DOCTOR. FOLLOW UP PHONE CALL MADE AT 6:11 PM DOING WELL, NO PROBLEMS
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Patient LOC, code white, transfer to UC for observation.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Pt received HPV & MCV4 on 6-01-11, started with vomiting & diarrhea symptoms on 6-02-11. Seen for office visit on 6-03-11.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Pain
Clinical narrative: Received injection pain started few days later from March now also when in bed take TYLENOL for pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 101 degrees, vomiting.
Age: 22.0
Sex: F
Vaccine: FLU3, HEPA, MNQ
Symptoms: Asthenia, Condition aggravated, Pyrexia, Syncope
Clinical narrative: Patient reports fainting at 0600 on 5/25/11; reports weakness and fever of 99-101. Reports no treatment given so far. Informed her to see primary care provider for follow-up.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: 4 x 3 inch warm and reddened area on right arm.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash maculo-papular, Urticaria
Clinical narrative: Maculopapular rash, intermittent hives on day following immunizations.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Local reaction, Pyrexia
Clinical narrative: Local reaction, redness, fever of 100. Same reaction as one other patient given same day same lot # for DTAP.
Age: 47.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Dizziness, Nausea
Clinical narrative: Wife reports client stated he had light headed and needed to lie down.  He also complained of some nausea and mild diarrhea.  Started taking his oral typhoid vaccine 6-5-11.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Headache, Injection site pain, Nausea, Pruritus
Clinical narrative: Nausea, vomiting, diarrhea, itching throughout body but no hives, slight headache, tenderness to the injection site.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, itching throughout body but no hives, slight headache, tenderness to the injection site.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: RASH OVER BOTH ARMS, INTENSE ITCHING. SCHOOL ADMINISTERED BENADRYL 25 MG PO. RECD PERMISSION FROM MOTHER. NO DIZZINESS, NO PROBLEMS BREATHING. FOLLOW UP CALL 6:00 PM, DOING WELL.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Asthma, Headache, Hypersensitivity, Respiration abnormal, Swelling face
Clinical narrative: Please see mother's detailed history. Attached also ER & allergist note re: event. Pt received his Dtap immunization on Tuesday, May 10, 2011 at approximately 5:00 pm. After the shot was administered the following symptoms and side effects occurred: Wednesday, May 11, 2011 - pt complained of a headache, I gave him acetaminophen for the pain. Thursday, May 12, 2011 - pt woke up early Thursday having an asthma attack. I administered PRO-AIR to support his breathing. Thursday, May 13, 2011 - pt began to get hives of varying sizes, but some hives were approximately the size of oranges on his torso and extremities. I took patient to pediatric office so you could see the hives and check his TB test. After seeing you, patient's condition continued to worsen, so I consulted the allergist, and he suggested I start ZYRTEC qd. You follow-up via phone on Thursday night to see how patient was doing. At this time, I let you know that his condition worsened and that I was very concerned that patient's reaction was from the Dtap vaccination. He has not had a reaction like this since his allergies have been under control, and nothing new was introduced in his daily routine. At this time, you did not want me to think patient's reaction was from the vaccine but some other source. Friday, May 13, 2011 - patient woke up again early Friday morning having an asthma attack. I administered PRO-AIR to support his breathing. Friday morning the hives had subsided but were still present, and by Friday evening, the hives had exhibited themselves again more aggressively. We continued to administer BENADRYL and ZYRTEC. Saturday, May 14, patient woke up again approximately 12:30 am with another asthma attack, more severe than the others, and I administered PRO-AIR to support his breathing. When patient woke up Saturday morning, he was covered, torso, face and limbs, with hives so severe and aggressive that his face was swollen and he was unrecognizable. At this time, I called the pediatric, on call line, and doctor suggested we take patient to the ER. I took patient to the ER and the doctor confirmed that he was having an allergic reaction and prescribed prednisolone bid and a regiment to also include BENADRYL and ZYRTEC. In addition, the doctor told me to follow up with the pediatrician and allergist; therefore, after the ER visit I went directly to the allergist so that the doctor could see the condition and severity of patient's hives and reaction.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Please see mother's detailed history. Attached also ER & allergist note re: event. Pt received his Dtap immunization on Tuesday, May 10, 2011 at approximately 5:00 pm. After the shot was administered the following symptoms and side effects occurred: Wednesday, May 11, 2011 - pt complained of a headache, I gave him acetaminophen for the pain. Thursday, May 12, 2011 - pt woke up early Thursday having an asthma attack. I administered PRO-AIR to support his breathing. Thursday, May 13, 2011 - pt began to get hives of varying sizes, but some hives were approximately the size of oranges on his torso and extremities. I took patient to pediatric office so you could see the hives and check his TB test. After seeing you, patient's condition continued to worsen, so I consulted the allergist, and he suggested I start ZYRTEC qd. You follow-up via phone on Thursday night to see how patient was doing. At this time, I let you know that his condition worsened and that I was very concerned that patient's reaction was from the Dtap vaccination. He has not had a reaction like this since his allergies have been under control, and nothing new was introduced in his daily routine. At this time, you did not want me to think patient's reaction was from the vaccine but some other source. Friday, May 13, 2011 - patient woke up again early Friday morning having an asthma attack. I administered PRO-AIR to support his breathing. Friday morning the hives had subsided but were still present, and by Friday evening, the hives had exhibited themselves again more aggressively. We continued to administer BENADRYL and ZYRTEC. Saturday, May 14, patient woke up again approximately 12:30 am with another asthma attack, more severe than the others, and I administered PRO-AIR to support his breathing. When patient woke up Saturday morning, he was covered, torso, face and limbs, with hives so severe and aggressive that his face was swollen and he was unrecognizable. At this time, I called the pediatric, on call line, and doctor suggested we take patient to the ER. I took patient to the ER and the doctor confirmed that he was having an allergic reaction and prescribed prednisolone bid and a regiment to also include BENADRYL and ZYRTEC. In addition, the doctor told me to follow up with the pediatrician and allergist; therefore, after the ER visit I went directly to the allergist so that the doctor could see the condition and severity of patient's hives and reaction.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Small amount of blood in stool evening of day vaccine was given as reported by parent. Mom also report that same occurred at 4 months.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Anxiety, Fall, Syncope, Urinary incontinence
Clinical narrative: TDAP, MCV4, VARICELLA ADMINISTERED 5-12-11 AT 10:10 AM. ABOUT 10:12 AM CHILD WAS SEATED AND FELL OVER TO LEFT SIDE INTO SOMEONE'S LAP, LOWERED TO FLOOR, LOST BLADDER CONTROL. WOKE UP IMMEDIATELY ANXIOUS. BP 153/98 10:15, 131/89, BP 129/79 10:20, BP 115/76 10:30. CHILD OBSERVED FOR 45 MIN. MOTHER CALLED. CHILD SENT BACK TO CLASS PER MOTHER/CHILD'S CHOICE. AT 1:10 PM RUNNING IN ATHLETICS AND HAD SIT DOWN AND AGAIN SYNCOPAL EPISODE. MOM CALLED SENT HOME WITH GRANDPARENTS. FOLLOW UP CALL 5-12-11 6:50, DOING WELL MOM STATES.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Cardiovascular function test normal, Dizziness, Ear, nose and throat examination normal, Neurological examination normal
Clinical narrative: Vaccines administered 6/1/11. Also treated for otitis externa at same visit. Onset of dizziness 6/2/11, persisting at least 3 days. Normal ENT, CV, neuro exams on 6/4/11 with normal orthostatic vs.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Blood glucose normal, Drug screen negative, Electrocardiogram normal, Erythema, Feeling abnormal
Clinical narrative: About 5 minutes after receiving the vaccines, pt said his throat felt like it was closing. He also appeared somewhat dazed and had redness of his hands and face. He had no respiratory distress and no hives. He was observed carefully in the office while EMS was called to transport him to the hospital. He was given BENADRYL. In the hospital ER he was observed for several hours. An EKG, serum glucose and urine drug screen were done and were normal. He improved and was sent home on BENADRYL. By the following morning all symptoms completely cleared and did not recur.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Throat tightness
Clinical narrative: About 5 minutes after receiving the vaccines, pt said his throat felt like it was closing. He also appeared somewhat dazed and had redness of his hands and face. He had no respiratory distress and no hives. He was observed carefully in the office while EMS was called to transport him to the hospital. He was given BENADRYL. In the hospital ER he was observed for several hours. An EKG, serum glucose and urine drug screen were done and were normal. He improved and was sent home on BENADRYL. By the following morning all symptoms completely cleared and did not recur.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: FELT FAINT, LAID FLAT COOL PACK TO CHEST. STATES AFTER SHOT ALWAYS PASSES OUT. ANXIETY ISSUES PER MOM ALSO PASSED OUT WHEN IV INSERTED IN PAST, ABOUT 1 MTH AGO. FOLLOW UP PHONE CALL 4:45 PM 5-17-11, DOING WELL NO PROBLEMS.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Feeling abnormal, Nervousness
Clinical narrative: SHAKY, JUST FEELS STRANGE. NO DIZZINESS, NO DOUBLE VISION, NO SYNCOPE. COOL PACK TO CHEST. BP 10:41 134/61 HR 55, 10:43 AM 120/75 HR 56, 10:46 AM 126/65 HR 56. WENT HOME 11:05 AM. FOLLOW UP PHONE CALL 4:40 PM, DOING WELL HER MOM, NO PROBLEMS.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: REDNESS SWELLING AND PRURITUS OF INJECTION SITE
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 12.0
Sex: F
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Crying, Tearfulness
Clinical narrative: Received Tdap (IM/RDT), VZV (s/c/RTR) without incident or complaint.  A few seconds later, was given Hep B (IM/LDT and MCV4 (IM/LDT); a few seconds after last IM, client had what appeared to be a small seizure, lasting approximately 5 seconds.  Client was supported in a chair by mother & nurse and remained safe during the seizure. Client began to cry upon opening eyes, and was tearful about 5 min.  BP 140/100, P 100 immediately after and 130/90 after 10 min.  Client given juice and observed about 10 more min., then was encouraged to follow up with primary care provider.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Local swelling, Oedema peripheral
Clinical narrative: Member complains of swelling to her neck left side and left arm and shoulder.  This was also the site where vaccine was adminstered.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Immediate swelling at injection site, approx 20mm diameter and 3mm raised, itching sensation at injection site followed by pain approx 10 minutes after onset.
Age: 17.0
Sex: M
Vaccine: HEPAB
Symptoms: No adverse event
Clinical narrative: No adverse event, gave a combo Hep A and Hep B instead of seperate vaccine Hep A and Hep B Vaccine given was not a VFC vaccine but a adult vaccine.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Hypersensitivity, Rash, Urticaria, Wheezing
Clinical narrative: HIVES AND RASH ON FACE, NECK, CHEST, BEHIND EARS, WHEEZING. GIVEN BENADRYL, SYMPTOMS RESOLVE UNTIL ANTIHISTAMINE WEARS OFF AND THEN HIVES COME BACK. DR DIAGNOSED SEVERE ALLERGIC REACTION.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Hypoaesthesia, Neurological examination normal, Pain in extremity, Tenderness
Clinical narrative: Pt. c/o leg pain/numbness/headaches. As PE WNL except tenderness on calf. Neuro intact. Care discussed with parent by MD 6/7/1011.
Age: 0.22
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RVX
Symptoms: Crying, Emotional distress
Clinical narrative: Vaccine given at doctor's office. Later that day started to cry - crying for > 3hr, not consolable. Mom called Dr at  that they told to give TYLENOL. She wasn't seen by a Dr. after till today with me.
Age: 0.11
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event but patient received a Hepatitis A instead of a Hepatitis B at 1 month old.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal
Clinical narrative: Total of 4 seizures 48 hours after vaccine administration. No fever. Was hospitalized. Normal CT, EEG. Discharged with Diazepam Rx.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Rash, Rash erythematous, Rash macular
Clinical narrative: Blotchy red rash on chest immediately after getting Hepatitis A vaccine. Pt given BENADRYL - rash resolved in 30 minutes.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Death, Premature baby
Clinical narrative: Baby was immunized 4/6/11. Baby was born prematurely. Hep B refused.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Death
Clinical narrative: Baby was immunized 4/6/11. Baby was born prematurely. Hep B refused.
Age: 28.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Full blood count, Injection site abscess, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Soreness in deltoid (L) shoulder and rash and whelps, abscess/swollen area to (L) deltoid & red whelps to (Lt) upper arm.
Age: 28.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Soreness in deltoid (L) shoulder and rash and whelps, abscess/swollen area to (L) deltoid & red whelps to (Lt) upper arm.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5 cm erythema & induration (R) deltoid.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Acute myocardial infarction, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest pain, Chills
Clinical narrative: This case was received by Sanofi Pasteur on 27 Nov 2008 via QScan. Report previously received by Acambis, Inc. on 06 Oct 2008 via a VAERS download and reported in manual dated 31 October 2008. A 21 year old male received ACAM2000 (Sanofi Pasteur Biologics Co., lot number not reported). Eleven days after vaccination, the patient presented with severe midsternal chest pain (rated 10/10) and dyspnea. Forty-eight hours prior to this, he reported having flu-like symptoms of fever, malaise, muscle aches and night sweats. On his initial presentation to medical, he was febrile and hypertensive (blood pressure 150/101). An electrocardiogram revealed diffuse ST-T changes and possible old myocardial infarction. Troponin and CK-MB were positive. An ultrasound revealed preserved left ventricular function and no wall motion changes. The patient was admitted to hospital and treated for hypertension and a possible ischemic event. No low molecular weight heparin was administered as myopericarditis was high on differential. The patient remained stable and was transported to another medical facility where myopericarditis was confirmed. Medical record review of this case on 15 July 2008 reported the final diagnosis as non ST segment myocardial infarction, myopericarditis and hypertension. Electrocardiogram revealed NSR diffuse ST-T elevation- consider injury pericarditis or early repolarization; troponin positive, CK: 281, CK MB: 20, CKMB% 7, (laboratory tests had no units or reference ranges provided); echocardiogram abnormal. The patient's outcome was reported as recovered in the QScan report. No additional information was provided. Follow-up information was received on 27 May 2011 from agency under reference number 315661. The patient received the ACAM2000 in 2008 (exact date not reported) and nine days post vaccination awoke with severe, positional chest pain, dyspnea, fever and rigors. "Treatment" was administered and symptoms resolved rapidly. He had a normal echo, a normal MRI and an elevated Troponin level. Sixty days post vaccination the patient was "doing well" had no new or recurring symptoms, no evidence of CHF (congestive health failure) or myopathy. An ECG showed sinus, PR 69, QRS 0=96, QTC 417 and non-specific T waves. Seventy-one days post vaccination the patient had a normal echo. The patient was diagnosed with Acute Myopericarditis. According to the reporter, the elevated Troponin and the patient's symptoms were consistent with myopericarditis, the proximity to the smallpox vaccine suggests the two are related. List of documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Dyspnoea, Echocardiogram abnormal, Electrocardiogram ST-T change, Electrocardiogram ST-T segment elevation, Hypertension
Clinical narrative: This case was received by Sanofi Pasteur on 27 Nov 2008 via QScan. Report previously received by Acambis, Inc. on 06 Oct 2008 via a VAERS download and reported in manual dated 31 October 2008. A 21 year old male received ACAM2000 (Sanofi Pasteur Biologics Co., lot number not reported). Eleven days after vaccination, the patient presented with severe midsternal chest pain (rated 10/10) and dyspnea. Forty-eight hours prior to this, he reported having flu-like symptoms of fever, malaise, muscle aches and night sweats. On his initial presentation to medical, he was febrile and hypertensive (blood pressure 150/101). An electrocardiogram revealed diffuse ST-T changes and possible old myocardial infarction. Troponin and CK-MB were positive. An ultrasound revealed preserved left ventricular function and no wall motion changes. The patient was admitted to hospital and treated for hypertension and a possible ischemic event. No low molecular weight heparin was administered as myopericarditis was high on differential. The patient remained stable and was transported to another medical facility where myopericarditis was confirmed. Medical record review of this case on 15 July 2008 reported the final diagnosis as non ST segment myocardial infarction, myopericarditis and hypertension. Electrocardiogram revealed NSR diffuse ST-T elevation- consider injury pericarditis or early repolarization; troponin positive, CK: 281, CK MB: 20, CKMB% 7, (laboratory tests had no units or reference ranges provided); echocardiogram abnormal. The patient's outcome was reported as recovered in the QScan report. No additional information was provided. Follow-up information was received on 27 May 2011 from agency under reference number 315661. The patient received the ACAM2000 in 2008 (exact date not reported) and nine days post vaccination awoke with severe, positional chest pain, dyspnea, fever and rigors. "Treatment" was administered and symptoms resolved rapidly. He had a normal echo, a normal MRI and an elevated Troponin level. Sixty days post vaccination the patient was "doing well" had no new or recurring symptoms, no evidence of CHF (congestive health failure) or myopathy. An ECG showed sinus, PR 69, QRS 0=96, QTC 417 and non-specific T waves. Seventy-one days post vaccination the patient had a normal echo. The patient was diagnosed with Acute Myopericarditis. According to the reporter, the elevated Troponin and the patient's symptoms were consistent with myopericarditis, the proximity to the smallpox vaccine suggests the two are related. List of documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Influenza like illness, Malaise, Myalgia, Myopericarditis, Night sweats
Clinical narrative: This case was received by Sanofi Pasteur on 27 Nov 2008 via QScan. Report previously received by Acambis, Inc. on 06 Oct 2008 via a VAERS download and reported in manual dated 31 October 2008. A 21 year old male received ACAM2000 (Sanofi Pasteur Biologics Co., lot number not reported). Eleven days after vaccination, the patient presented with severe midsternal chest pain (rated 10/10) and dyspnea. Forty-eight hours prior to this, he reported having flu-like symptoms of fever, malaise, muscle aches and night sweats. On his initial presentation to medical, he was febrile and hypertensive (blood pressure 150/101). An electrocardiogram revealed diffuse ST-T changes and possible old myocardial infarction. Troponin and CK-MB were positive. An ultrasound revealed preserved left ventricular function and no wall motion changes. The patient was admitted to hospital and treated for hypertension and a possible ischemic event. No low molecular weight heparin was administered as myopericarditis was high on differential. The patient remained stable and was transported to another medical facility where myopericarditis was confirmed. Medical record review of this case on 15 July 2008 reported the final diagnosis as non ST segment myocardial infarction, myopericarditis and hypertension. Electrocardiogram revealed NSR diffuse ST-T elevation- consider injury pericarditis or early repolarization; troponin positive, CK: 281, CK MB: 20, CKMB% 7, (laboratory tests had no units or reference ranges provided); echocardiogram abnormal. The patient's outcome was reported as recovered in the QScan report. No additional information was provided. Follow-up information was received on 27 May 2011 from agency under reference number 315661. The patient received the ACAM2000 in 2008 (exact date not reported) and nine days post vaccination awoke with severe, positional chest pain, dyspnea, fever and rigors. "Treatment" was administered and symptoms resolved rapidly. He had a normal echo, a normal MRI and an elevated Troponin level. Sixty days post vaccination the patient was "doing well" had no new or recurring symptoms, no evidence of CHF (congestive health failure) or myopathy. An ECG showed sinus, PR 69, QRS 0=96, QTC 417 and non-specific T waves. Seventy-one days post vaccination the patient had a normal echo. The patient was diagnosed with Acute Myopericarditis. According to the reporter, the elevated Troponin and the patient's symptoms were consistent with myopericarditis, the proximity to the smallpox vaccine suggests the two are related. List of documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Nuclear magnetic resonance imaging normal, Pyrexia, Troponin increased, Ultrasound scan normal
Clinical narrative: This case was received by Sanofi Pasteur on 27 Nov 2008 via QScan. Report previously received by Acambis, Inc. on 06 Oct 2008 via a VAERS download and reported in manual dated 31 October 2008. A 21 year old male received ACAM2000 (Sanofi Pasteur Biologics Co., lot number not reported). Eleven days after vaccination, the patient presented with severe midsternal chest pain (rated 10/10) and dyspnea. Forty-eight hours prior to this, he reported having flu-like symptoms of fever, malaise, muscle aches and night sweats. On his initial presentation to medical, he was febrile and hypertensive (blood pressure 150/101). An electrocardiogram revealed diffuse ST-T changes and possible old myocardial infarction. Troponin and CK-MB were positive. An ultrasound revealed preserved left ventricular function and no wall motion changes. The patient was admitted to hospital and treated for hypertension and a possible ischemic event. No low molecular weight heparin was administered as myopericarditis was high on differential. The patient remained stable and was transported to another medical facility where myopericarditis was confirmed. Medical record review of this case on 15 July 2008 reported the final diagnosis as non ST segment myocardial infarction, myopericarditis and hypertension. Electrocardiogram revealed NSR diffuse ST-T elevation- consider injury pericarditis or early repolarization; troponin positive, CK: 281, CK MB: 20, CKMB% 7, (laboratory tests had no units or reference ranges provided); echocardiogram abnormal. The patient's outcome was reported as recovered in the QScan report. No additional information was provided. Follow-up information was received on 27 May 2011 from agency under reference number 315661. The patient received the ACAM2000 in 2008 (exact date not reported) and nine days post vaccination awoke with severe, positional chest pain, dyspnea, fever and rigors. "Treatment" was administered and symptoms resolved rapidly. He had a normal echo, a normal MRI and an elevated Troponin level. Sixty days post vaccination the patient was "doing well" had no new or recurring symptoms, no evidence of CHF (congestive health failure) or myopathy. An ECG showed sinus, PR 69, QRS 0=96, QTC 417 and non-specific T waves. Seventy-one days post vaccination the patient had a normal echo. The patient was diagnosed with Acute Myopericarditis. According to the reporter, the elevated Troponin and the patient's symptoms were consistent with myopericarditis, the proximity to the smallpox vaccine suggests the two are related. List of documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Abortion spontaneous, Blood test, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Initial report received from a health care professional on 06 April 2011. A 15-year-old female patient had received an intramuscular right deltoid injection of MENACTRA (lot number U3508AA), and an intramuscular left deltoid injection of GARDASIL (manufacturer Merck, lot number 14372) on 05 April 2011. The patient was pregnant at the time of vaccination; however the reporter did not know the date of the patient's last menstrual period, or her expected date of delivery. For Current Pregnancy History: comments regarding the mother's health during pregnancy, the reporter had written "none." The patient has not experienced any adverse events since vaccination with MENACTRA and GARDASIL on 05 April 2011. Follow-up information was received 01 June 2011 from a health care professional. From new information received, it was determined this case now meets seriousness criteria and this case has been upgraded from nonserious to serious. MENACTRA and GARDASIL had been first dose injections. The patient had no prior pregnancies and her date of last menstrual period was unknown. At the time of vaccination, the patient had been taking amoxicillin 375 mg bid from 05 April 2011 until 15 April 2011 for a urinary tract infection (UTI). She was noted to have had recurrent UTIs, and had received MACRODANTIN 100 mg bid from 28 February 2011 until 06 March 2011 for a previous UTI. On 18 April 2011, 13 days after vaccination, the patient experienced pregnancy complication consisting of a spontaneous abortion of a single fetus (also reported as miscarriage) prior to 20 weeks gestation. Prenatal testing had not been performed. The event outcome was unknown. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Abortion spontaneous, Complication of pregnancy, Drug exposure during pregnancy
Clinical narrative: Initial report received from a health care professional on 06 April 2011. A 15-year-old female patient had received an intramuscular right deltoid injection of MENACTRA (lot number U3508AA), and an intramuscular left deltoid injection of GARDASIL (manufacturer Merck, lot number 14372) on 05 April 2011. The patient was pregnant at the time of vaccination; however the reporter did not know the date of the patient's last menstrual period, or her expected date of delivery. For Current Pregnancy History: comments regarding the mother's health during pregnancy, the reporter had written "none." The patient has not experienced any adverse events since vaccination with MENACTRA and GARDASIL on 05 April 2011. Follow-up information was received 01 June 2011 from a health care professional. From new information received, it was determined this case now meets seriousness criteria and this case has been upgraded from nonserious to serious. MENACTRA and GARDASIL had been first dose injections. The patient had no prior pregnancies and her date of last menstrual period was unknown. At the time of vaccination, the patient had been taking amoxicillin 375 mg bid from 05 April 2011 until 15 April 2011 for a urinary tract infection (UTI). She was noted to have had recurrent UTIs, and had received MACRODANTIN 100 mg bid from 28 February 2011 until 06 March 2011 for a previous UTI. On 18 April 2011, 13 days after vaccination, the patient experienced pregnancy complication consisting of a spontaneous abortion of a single fetus (also reported as miscarriage) prior to 20 weeks gestation. Prenatal testing had not been performed. The event outcome was unknown. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Death, Premature baby
Clinical narrative: None reported to facility.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Death
Clinical narrative: None reported to facility.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness, Eye pain, Impaired driving ability, Nerve injury, Nuclear magnetic resonance imaging
Clinical narrative: Both eyes hurt on 9/20/2010 and 9/21/2010. I tool Benadryl on 9/20/2010 thinking the harvesting was causing allergies. It did not help. I went to the eye doctor on the morning of 9/21/2010 who found nothing wrong with my eyes. I went to my family doctor on the morning of 9/22/2010. The pain in the eyes had diminished but my vision was blurred.  He didn't have an idea of why my eyes hurt and were blurry. The doctor told me to go to the Medical Center as my vision worsened. By noon on 9/22/2010 my vision had worsend significantly. I called my husband who drove me to the hospital mentioned above. We arrived about 3:45 PM. The waiting room was very busy. I waiting and watched my eye sight fade to black, with complete blindness happening around 7:00 PM.  After a night in the Medical Center, I was transferred to another hospital.  Dr. started me on a prednisone IV, did an MRI and other tests.  After 4 or 5 days I was allowed to go home and take medicine orally.  I was completely blind for over 7 weeks. Vision has improved, but I have been told it will never return to normal because the Optic Nerves are both damaged and have atrophied.  I can not drive because I can not see the vehicles or stop signs in front of me.  I do not see colors well so have had to give up art work and photography. I have to have someone drive me to and from work (40 miles one way). I am now off of prednisoe but take Imuran and will for the next year and a half, per Dr.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Optic atrophy, Vision blurred
Clinical narrative: Both eyes hurt on 9/20/2010 and 9/21/2010. I tool Benadryl on 9/20/2010 thinking the harvesting was causing allergies. It did not help. I went to the eye doctor on the morning of 9/21/2010 who found nothing wrong with my eyes. I went to my family doctor on the morning of 9/22/2010. The pain in the eyes had diminished but my vision was blurred.  He didn't have an idea of why my eyes hurt and were blurry. The doctor told me to go to the Medical Center as my vision worsened. By noon on 9/22/2010 my vision had worsend significantly. I called my husband who drove me to the hospital mentioned above. We arrived about 3:45 PM. The waiting room was very busy. I waiting and watched my eye sight fade to black, with complete blindness happening around 7:00 PM.  After a night in the Medical Center, I was transferred to another hospital.  Dr. started me on a prednisone IV, did an MRI and other tests.  After 4 or 5 days I was allowed to go home and take medicine orally.  I was completely blind for over 7 weeks. Vision has improved, but I have been told it will never return to normal because the Optic Nerves are both damaged and have atrophied.  I can not drive because I can not see the vehicles or stop signs in front of me.  I do not see colors well so have had to give up art work and photography. I have to have someone drive me to and from work (40 miles one way). I am now off of prednisoe but take Imuran and will for the next year and a half, per Dr.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Convulsion
Clinical narrative: seizure
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: seizure
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Awoke with redness, warmth and mild tenderness on left upper arm.  That arm had Varicella lot 1000Z administered the day before.  Raised redness 1 1/4 inch in diameter, surrounded by additional redness.  Total reaction diameter 2 1/4 inch.