chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Nuclear magnetic resonance imaging spinal cord abnormal, Rash, Swelling, Urticaria
Clinical narrative: This case is part of a cluster of 5 patients who experienced similar adverse events following vaccination with ADACEL. The original report (mother case) had been received on 17 May 2011 from a health care professional and contained the following information: A group of 5 unidentified patients received on unknown dates an intramuscular injection (sites not reported) of ADACEL, sanofi pasteur Ltd. lot number C3823 corresponding to sanofi pasteur Inc. lot number U3874CA. The patients developed 5-7 days after vaccination, red, raised welt about the size of a half dollar at the injection site which was warm and tender to touch, painful and itchy. The patients also had rashes, hives and swelling. The vaccinations were given over the last two weeks. The patients required a doctor's visit. The outcomes were reported as unknown. Follow-up information was received on 26 May 2011 from the healthcare professional. Additional information was also received on 01 June 2011. Identifying information was provided for 4 of the 5 previously noted patients. This case pertains to 1 of the 4 identified patients. The patient was a 46-year-old female who received the ADACEL injection in the left deltoid. Medical history included shoulder and back pain. At the time of vaccination, the patient had a cat bite. The reporter also noted that the ADACEL prefilled syringe had a clear appearance with white particulant matter. Follow-up information was received from the health care professional on 14 July 2011. Based upon receipt of new information, it was determined that the event meets seriousness criteria. The patient received ADACEL on 09 May 2011; no other vaccines had been administered within 4 weeks of vaccination. The patient reported that she experienced a "twisted arm/left shoulder" 1 hours after the catbite on 09 May 2011. On 11 May 2011, she was treated with BENADRYL, AMOXIL 500mg three times daily, ADVIL as needed, and PERCOCET 5/325 as needed for pain. On 16 May 2011 she was seen in the emergency room with complaints of severe neck pain. She was diagnosed with a "pinched nerve", and treated with prednisone and FLEXERIL. On 17 May 2011 she underwent an MRI of the c-spine, which showed small disc herniation of the C5-C7, with degenerative changes in C6-C7. No cord compromise was observed. An EMG and nerve conduction study performed 19 May 2011 were normal. The patient was seen by a neurologist on 25 May 2011, and was prescribed gabapentin. An MRI of the brachial plexus on 03 June 2011 was normal. The patient had a repeat EMG on 23 June 2011 which was abnormal, and she was diagnosed with brachial neuralgia at that time. Treatment included physical therapy, shoulder mobilization, and exercise; per the reporter, the patient "is good". Outcome was still unknown. The events for the other 3 patients are captured in cases 2011-02872 (mother case), 2011-03100 and 2011-03101. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Body temperature fluctuation, Cardiac enzymes increased, Chest X-ray normal, Chest pain, Computerised tomogram normal
Clinical narrative: This study case was received from the investigator on 15 July 2011. A 21 year-old male subject with no significant medical history was found to have myocardial infarction, unspecified site and an unspecified disease of the pericardium 12 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 06 January 2011. Relevant laboratory data: an abnormal Troponin I with the highest recorded value of 00.58 and a normal ECG. The subject's echocardiogram result was not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Cough, Dyspnoea, Electrocardiogram normal, Fibrin D dimer, Myocarditis
Clinical narrative: This study case was received from the investigator on 15 July 2011. A 21 year-old male subject with no significant medical history was found to have myocardial infarction, unspecified site and an unspecified disease of the pericardium 12 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 06 January 2011. Relevant laboratory data: an abnormal Troponin I with the highest recorded value of 00.58 and a normal ECG. The subject's echocardiogram result was not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator on 15 July 2011. A 21 year-old male subject with no significant medical history was found to have myocardial infarction, unspecified site and an unspecified disease of the pericardium 12 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 06 January 2011. Relevant laboratory data: an abnormal Troponin I with the highest recorded value of 00.58 and a normal ECG. The subject's echocardiogram result was not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Body temperature fluctuation, Cardiac enzymes increased, Chest X-ray normal, Chest pain, Computerised tomogram thorax normal
Clinical narrative: This study case was received from the investigator on 15 July 2011. A 21 year-old male subject with no significant medical history was found to have myocardial infarction, unspecified site and an unspecified disease of the pericardium 12 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 06 January 2011. Relevant laboratory data: an abnormal Troponin I with the highest recorded value of 00.58 and a normal ECG. The subject's echocardiogram result was not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Cough, Dyspnoea, Electrocardiogram normal, Fibrin D dimer increased, Myocarditis
Clinical narrative: This study case was received from the investigator on 15 July 2011. A 21 year-old male subject with no significant medical history was found to have myocardial infarction, unspecified site and an unspecified disease of the pericardium 12 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 06 January 2011. Relevant laboratory data: an abnormal Troponin I with the highest recorded value of 00.58 and a normal ECG. The subject's echocardiogram result was not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Painful respiration, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator on 15 July 2011. A 21 year-old male subject with no significant medical history was found to have myocardial infarction, unspecified site and an unspecified disease of the pericardium 12 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 06 January 2011. Relevant laboratory data: an abnormal Troponin I with the highest recorded value of 00.58 and a normal ECG. The subject's echocardiogram result was not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Acute myocardial infarction, Echocardiogram, Electrocardiogram normal, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator on 15 July 2011. A 21 year-old male subject with no significant medical history was found to have myocardial infarction, unspecified site and an unspecified disease of the pericardium 12 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 06 January 2011. Relevant laboratory data: an abnormal Troponin I with the highest recorded value of 00.58 and a normal ECG. The subject's echocardiogram result was not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Angioedema, Arthralgia, Chest pain, Urticaria
Clinical narrative: Initial report was received from a health care professional on 13 July 2011. A 35 year-old male patient who had a previous pre-exposure series of rabies vaccines, "? 10 yrs ago" and was found to have a low titer, had received a booster dose of IMOVAX RABIES, lot number E0393-1 (route and site of administration not reported) on 29 June 2011 and 10 days later on 09 July 2011, experienced a generalized rash from head to toe and tachycardia. On 12 July 2011, the patient was found to have fluid of the right side of the lung. The patient was hospitalized. Treatments were not reported. The patient had no other vaccines within four weeks prior to suspect vaccine and no illness at the time of vaccination. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Pulmonary oedema, Rash generalised, Tachycardia
Clinical narrative: Initial report was received from a health care professional on 13 July 2011. A 35 year-old male patient who had a previous pre-exposure series of rabies vaccines, "? 10 yrs ago" and was found to have a low titer, had received a booster dose of IMOVAX RABIES, lot number E0393-1 (route and site of administration not reported) on 29 June 2011 and 10 days later on 09 July 2011, experienced a generalized rash from head to toe and tachycardia. On 12 July 2011, the patient was found to have fluid of the right side of the lung. The patient was hospitalized. Treatments were not reported. The patient had no other vaccines within four weeks prior to suspect vaccine and no illness at the time of vaccination. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 1.05
Sex: F
Vaccine: DTAP
Symptoms: Mobility decreased, Pyrexia, Rash, Weight bearing difficulty, X-ray limb
Clinical narrative: Favoring and not wanting touse her right leg.  Still favoring and not putting weight on it 7/25/2011.  Also on 7/21/11 fever 7/22/11 to 7/24/11 Rash on torso.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood test, Computerised tomogram, Convulsion, Decreased appetite
Clinical narrative: Small staring seizures, severe headaches, severe fatigue, severe muscle pain and weakness, numbness of the legs, loss of appetite, tremors, sleeping 15 to 20 hours a day.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram, Fatigue, Headache, Hypersomnia, Hypoaesthesia
Clinical narrative: Small staring seizures, severe headaches, severe fatigue, severe muscle pain and weakness, numbness of the legs, loss of appetite, tremors, sleeping 15 to 20 hours a day.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Staring, Tremor
Clinical narrative: Small staring seizures, severe headaches, severe fatigue, severe muscle pain and weakness, numbness of the legs, loss of appetite, tremors, sleeping 15 to 20 hours a day.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: red, swollen, pain and fever
Age: 40.0
Sex: F
Vaccine: DTIPV
Symptoms: Dizziness, Hypoaesthesia, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Pain at site, the first day of injection. On day 2 developed  redness at site which has increased daily to a 6cm all around. HOT to the touch, now there is a firm mass at injection site. Increased pain at site. Since 7/23, increased lethargy, nausea, dizziness. Throbbing at site, and slight numbing of rt hand felt last night for the first time.  Warm compresses to the site were applied, with mild relief.  Ibuprofen for pain and to decrease swelling, with minor relief. Called MD this am to request antibiotic therapy for a possible cellulitis.
Age: 40.0
Sex: F
Vaccine: DTIPV
Symptoms: Injection site pain, Injection site warmth, Lethargy, Nausea, Pain
Clinical narrative: Pain at site, the first day of injection. On day 2 developed  redness at site which has increased daily to a 6cm all around. HOT to the touch, now there is a firm mass at injection site. Increased pain at site. Since 7/23, increased lethargy, nausea, dizziness. Throbbing at site, and slight numbing of rt hand felt last night for the first time.  Warm compresses to the site were applied, with mild relief.  Ibuprofen for pain and to decrease swelling, with minor relief. Called MD this am to request antibiotic therapy for a possible cellulitis.
Age: 40.0
Sex: F
Vaccine: DTIPV
Symptoms: Swelling
Clinical narrative: Pain at site, the first day of injection. On day 2 developed  redness at site which has increased daily to a 6cm all around. HOT to the touch, now there is a firm mass at injection site. Increased pain at site. Since 7/23, increased lethargy, nausea, dizziness. Throbbing at site, and slight numbing of rt hand felt last night for the first time.  Warm compresses to the site were applied, with mild relief.  Ibuprofen for pain and to decrease swelling, with minor relief. Called MD this am to request antibiotic therapy for a possible cellulitis.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Local reaction, Pruritus
Clinical narrative: Initially localized reaction with redness at injection site: sore, inflamed, tender. Subsequent days the reaction spread towards 2 inches below left elbow. Complained of tenderness and pruritis.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: Tenderness
Clinical narrative: Initially localized reaction with redness at injection site: sore, inflamed, tender. Subsequent days the reaction spread towards 2 inches below left elbow. Complained of tenderness and pruritis.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture, Chest X-ray, Culture urine, Full blood count, Lumbar puncture
Clinical narrative: Fever 103.5 AX within 24 hours of receiving vaccines - child was taken to ER.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Fever 103.5 AX within 24 hours of receiving vaccines - child was taken to ER.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blister, Skin warm
Clinical narrative: (R) arm rx to GARDASIL, arm hot, swollen blister? Imm given 7/8/11 reaction on 7/9-10? - No tx given.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Vomiting
Clinical narrative: Persistent Vomiting and Lethargy.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Persistent Vomiting and Lethargy.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal mass, Caecum operation, Ileectomy, Intussusception
Clinical narrative: Persistent Vomiting and Lethargy.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Surgery, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Persistent Vomiting and Lethargy.
Age: 2.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Welts on face then spreading to stomach.  Child was itching profusely.  Gave child Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Rash generalised, Rash papular, Skin lesion
Clinical narrative: Rash 2-3days. started on stomach and spread all over. vaccines 4 days ago. no new food/meds. not otherwise ill. had tick bite a week ago, improving. no target rash noted. many diffuse small isolated papulovesicular red lesions over entire body. few on palms/soles. none in mouth/scalp. 1cm drying papule on center of chest at site of tick bite. no annular rash.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test negative, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with asthma and sulfonamide allergy who on 02-APR-2009, was vaccinated with the first dose of 0.5ml of GARDASIL (Lot#: 662229/1497X). On 02-DEC-2009, the patient was vaccinated with the second dose 0.5ml of GARDASIL (Lot#: 662229/1497X). On 29-APR-2010 was vaccinated with the third dose 0.5ml of GARDASIL (Lot#: 662529/1317Y). Concomitant therapy included albuterol as needed. The physician reported that the patient received the third dose on 29-APR-2010, and a pregnancy test at that visit was negative. She was seen in the office on 28-APR-2010, and a urine for pregnancy was positive. Last Menstrual Period (LMP) was on 01-APR-2010, Estimated Date of Delivery (EDD) is on 06-JAN-2011. Follow up information has been received from a physician. The physician stated that the patient electively terminated her pregnancy on 06-JUL-2010 due to personal reasons. The physician did not have any other information. Upon internal review, electively terminated her pregnancy was determined to be an other important medical event. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MEN, TDAP, VARCEL
Symptoms: Asthenia, Diarrhoea, Dizziness, Myalgia, Nausea
Clinical narrative: MUSCLE PAIN DIZZINESS NAUSEA DIARRHEA WEAKNESS
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site of MMR.
Age: 1.26
Sex: M
Vaccine: DTAPH, PPV
Symptoms: Dizziness, Fear, Irritability, Mobility decreased, Pain
Clinical narrative: Fever, clingy, whiny, apparent dizzy symptoms when lying flat (when in crib, holding onto the bars, lying, not moving, eyes closed, screaming in pain and fear).  Dizzy signs started around 130pm during nap.  Treating with snuggles, Tylenol, increased fluids, and just relaxing. Holding for sleep for his comfort.  Called dr Office to inform them and get criteria for him to be taken in.
Age: 1.26
Sex: M
Vaccine: DTAPH, PPV
Symptoms: Pyrexia, Screaming
Clinical narrative: Fever, clingy, whiny, apparent dizzy symptoms when lying flat (when in crib, holding onto the bars, lying, not moving, eyes closed, screaming in pain and fear).  Dizzy signs started around 130pm during nap.  Treating with snuggles, Tylenol, increased fluids, and just relaxing. Holding for sleep for his comfort.  Called dr Office to inform them and get criteria for him to be taken in.
Age: 1.09
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site pustule
Clinical narrative: Small pustules around injection site.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry Product, concerning a 22 year old female with a none history of previous pregnancies, who on 02-AUG-2010, was vaccinated with the first dose of GARDASIL (Lot No: 662404/0312Y). On 17-SEP-2010, the patient was vaccinated with the second dose of GARDASIL (Lot No: 662404/0312Y). Concomitant therapy included vitamins (unspecified) and iron (unspecified). Subsequently, the patient became pregnant. The patient's last menstrual period was on 09-AUG-2010. Estimated delivery date would be on 06-MAY-2011. Follow up information has been received from a physician who reported that on 25-MAY-2011, the patient delivered a healthy normal male baby via C-section full term. The reason for the C-section was not provided. Additional follow up information received from the physician indicated that she checked the records from her clinic and reported that at the time of delivery, which she performed, the baby was "normal". The physician also stated that she was not able to find records of any exams performed to the baby postnatally. Upon internal review, C-section was determined to be an other important medical event. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Concussion, Convulsion, Fall, Head injury, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning her 15 year old female patient who on an unknown date was vaccinated with a dose of GARDASIL (Lot number not reported) (dose number unspecified). The physician reported that on an unspecified date the patient passed out and had a seizure. It was reported that the patient fell and hit her head and had a concussion. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Injection site swelling, Oedema peripheral, Pyrexia
Clinical narrative: Rabies Dose # 1 7/5/11 then after Dose # 2 on 7/12/11 developed fever 101 degrees after 12 hours with swelling in upper (L) arm with swelling under armpit. Took ALEVE & resolved after 2 days.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture positive, Culture urine positive, Pseudomonas infection, Pseudomonas test positive, Septic shock
Clinical narrative: Presented in septic shock, pseudomonas grew in blood and urine cultures.
Age: 1.27
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Pyrexia, Swelling
Clinical narrative: Pt's mother called and stated that he had some swelling and fever for 1 day.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Convulsion, Muscle twitching, Pallor, Pulse abnormal, Speech disorder
Clinical narrative: Patient walked to car past immunizations wi.  Minutes past shots she sat in car slumped down wtih legs and arms twitching.  Mom's sister has history of seizures.  Mom reported he just had a seizure. Patient pale but able to walk with assistance. Thready pulse @54 beats/minute. Patient speaking slowly. Pt reports thought she fell asleep and dosen't remember what happened in the car. Pulse improved to 68 and strong within 5 minutes. B/P 108/68; Color pink and is now speaking clearly. Ambulatory with assistance. Mom took patient to ER.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Walking aid user
Clinical narrative: Patient walked to car past immunizations wi.  Minutes past shots she sat in car slumped down wtih legs and arms twitching.  Mom's sister has history of seizures.  Mom reported he just had a seizure. Patient pale but able to walk with assistance. Thready pulse @54 beats/minute. Patient speaking slowly. Pt reports thought she fell asleep and dosen't remember what happened in the car. Pulse improved to 68 and strong within 5 minutes. B/P 108/68; Color pink and is now speaking clearly. Ambulatory with assistance. Mom took patient to ER.
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Conjunctival oedema, Eye discharge, Eye pruritus, Rhinorrhoea, Seasonal allergy
Clinical narrative: RUNNING EYES AND NOSE, ITCHING EYES, SWOLLEN CONJUCTIVA AFTER PLAYING OUTSIDE, REDUCED WHEN INDOORS AND ANTIHISTAMINES GIVEN. RESOLVED 3 WEEKS LATER. SEVRE HAY FEVER AFTER POLIO VACCINE.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Tenderness and swelling in armpit of arm where vaccine was administered.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Hot to touch, swelling, redness 7 cm inch diameter area.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives developed evening of 7/25/11, spread overnight, diffuse urticaria 7/26/11, no other symptoms.  Treated 7/26/11 with zyrtec, atarax, triamcinolone topically.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Received 12 mo. immunizations on 7/19/11; per mom, developed hives next day - intermittent x3 days. Seen in office 7/23/11. No rash noted ; positive urticaria on exam. Tx= BENADRYL every 6h x 48h; then prn. Mom requesting VAERS report be filed; concerns hives secondary to vaccine (no local site reaction(s) noted).
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diet refusal, Lethargy, Pallor
Clinical narrative: Received PENTACEL, PREVNAR 13, ROTATEQ on 7/25/11 approx 230pm. Unrelenting vomiting began about 8pm. Refusing to feed and pallor and lethargy prompted ER visit. Was able to rehydrate p.o. there (failed home secondary refusal). Back to baseline by morning.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Joint effusion, Skin warm
Clinical narrative: 1 day after PREVNAR 13 had moderate effusion of knee with erythema, warmth, but nontender and FROM. No objective fever. Ambulatory.
Age: 1.03
Sex: M
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Diffused erythematous rash.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mass
Clinical narrative: Pain, swollen, redness, tenderness in left arm where shot was administered. Patient describes a "lump".
Sex: M
Vaccine: RVX
Symptoms: Rotavirus infection, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional (the subject's mother), via a GSK representative, and described the occurrence of rotavirus in an infant male subject (less than 1 year old) who was vaccinated with Rotavirus vaccine (manufacturer unspecified). The subject's medical history included bell's palsy. On an unspecified date in 2011 the subject received 2nd dose of Rotavirus vaccine (oral). On an unspecified date in 2011, less than one year after vaccination with Rotavirus vaccine, the subject experienced rotavirus and vaccination failure. The subject was hospitalised for 5 days and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. This case was reported as a vaccination failure. However, the time to onset since last dose and confirmatory laboratory results were not provided. Therefore the case does not meet GSK criteria of vaccination failure.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) deltoid area red, swollen arm following the day vaccine given; no SOB, facial, lip or tongue swelling; went to hospital, rx'd with BENADRYL.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Breath holding, Confusional state, Dizziness, Dyskinesia, Fatigue
Clinical narrative: Pt was given ADACEL and HPV while sitting, then was asked if felt nervous. Pt said yes, was noted to be holding her breathe while given the MENACTRA and Hep A vaccines in other arm. Then said she felt dizzy, so was told to lay down. As she lay down, she became pale and then stiffened for several seconds, then had jerky movements of entire body, while eyes were staring straight ahead. Some irregular breathing and paleness but no abnormal HR (ausculated after first few seconds of episode until the end). Jerking movements lasted less than 30 seconds, then patient looked around unsure where she was when asked, but responded to questions. Shortly thereafter she remembered. Was tired but awake. She tried to sit a couple minutes later but felt dizzy again so lay down again. By then EMS had arrived and patient was taken to hospital ER for further testing, I talked with ER doc about episode. Consistent with syncopal episode, probably related to HPV vaccine and nervousness of patient. Pt had been very nervous talking about vaccines earlier in visit. BP ok at onset of visit today and while EMS present. Will notify VAERS.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Musculoskeletal stiffness, Nervousness, Pallor, Respiratory disorder
Clinical narrative: Pt was given ADACEL and HPV while sitting, then was asked if felt nervous. Pt said yes, was noted to be holding her breathe while given the MENACTRA and Hep A vaccines in other arm. Then said she felt dizzy, so was told to lay down. As she lay down, she became pale and then stiffened for several seconds, then had jerky movements of entire body, while eyes were staring straight ahead. Some irregular breathing and paleness but no abnormal HR (ausculated after first few seconds of episode until the end). Jerking movements lasted less than 30 seconds, then patient looked around unsure where she was when asked, but responded to questions. Shortly thereafter she remembered. Was tired but awake. She tried to sit a couple minutes later but felt dizzy again so lay down again. By then EMS had arrived and patient was taken to hospital ER for further testing, I talked with ER doc about episode. Consistent with syncopal episode, probably related to HPV vaccine and nervousness of patient. Pt had been very nervous talking about vaccines earlier in visit. BP ok at onset of visit today and while EMS present. Will notify VAERS.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Staring, Syncope
Clinical narrative: Pt was given ADACEL and HPV while sitting, then was asked if felt nervous. Pt said yes, was noted to be holding her breathe while given the MENACTRA and Hep A vaccines in other arm. Then said she felt dizzy, so was told to lay down. As she lay down, she became pale and then stiffened for several seconds, then had jerky movements of entire body, while eyes were staring straight ahead. Some irregular breathing and paleness but no abnormal HR (ausculated after first few seconds of episode until the end). Jerking movements lasted less than 30 seconds, then patient looked around unsure where she was when asked, but responded to questions. Shortly thereafter she remembered. Was tired but awake. She tried to sit a couple minutes later but felt dizzy again so lay down again. By then EMS had arrived and patient was taken to hospital ER for further testing, I talked with ER doc about episode. Consistent with syncopal episode, probably related to HPV vaccine and nervousness of patient. Pt had been very nervous talking about vaccines earlier in visit. BP ok at onset of visit today and while EMS present. Will notify VAERS.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Condition aggravated, Dizziness, Fatigue, Gaze palsy, Headache
Clinical narrative: Patient is a 14 year old female who is here for nurse visit for her GARDASIL vaccine. She complained of feeling tired and dizzy, denies a headache or fever. After she received her GARDASIL. Mom witnessed her eyes roll upwards, patient then became limp and her body was twitching for a minute or 2. I witnessed the second episode. She became pale, diaphoretic, and her eyes rolled up. She then became limp and had some upper extremity twitching for about 10 seconds. She had some drowsiness after this episode. She was oriented and answered questions appropriately. PMH: mononucleosis in 2010, Headaches seen by Dr and a normal brain MRI. ROS: positive for fatigue, chronic headaches, No fever, no pulm or GI Sx, no rashes. FH: neg for seizure disorders. General: WDW, Slightly Drowsy, Responsive; Eyes: nl; Ears: nl TMs; Nose: nasal passages clear Pharynx nl; Neck: supple, no masses, no lymphadenopathy; Resp: clear to auscultation bilaterally; CV: RRR, normal S1/S2, no murmurs; ABD: soft, nontender, no masses, no hepatosplenomegaly; GU: not examined; Extremities: nl; Skin: no rashes or lesions. Assessment: Syncope possible seizure disorder immediately after having a GARDASIL vaccine. Plan: Pulse OX=100, Glucose, O2 At 2 liters, Paramedics called Plan to hospital and admission to choc. Vaers report for GARDASIL vaccine. Follow up as needed.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Hyperhidrosis, Hypotonia, Immediate post-injection reaction, Muscle twitching, Pallor
Clinical narrative: Patient is a 14 year old female who is here for nurse visit for her GARDASIL vaccine. She complained of feeling tired and dizzy, denies a headache or fever. After she received her GARDASIL. Mom witnessed her eyes roll upwards, patient then became limp and her body was twitching for a minute or 2. I witnessed the second episode. She became pale, diaphoretic, and her eyes rolled up. She then became limp and had some upper extremity twitching for about 10 seconds. She had some drowsiness after this episode. She was oriented and answered questions appropriately. PMH: mononucleosis in 2010, Headaches seen by Dr and a normal brain MRI. ROS: positive for fatigue, chronic headaches, No fever, no pulm or GI Sx, no rashes. FH: neg for seizure disorders. General: WDW, Slightly Drowsy, Responsive; Eyes: nl; Ears: nl TMs; Nose: nasal passages clear Pharynx nl; Neck: supple, no masses, no lymphadenopathy; Resp: clear to auscultation bilaterally; CV: RRR, normal S1/S2, no murmurs; ABD: soft, nontender, no masses, no hepatosplenomegaly; GU: not examined; Extremities: nl; Skin: no rashes or lesions. Assessment: Syncope possible seizure disorder immediately after having a GARDASIL vaccine. Plan: Pulse OX=100, Glucose, O2 At 2 liters, Paramedics called Plan to hospital and admission to choc. Vaers report for GARDASIL vaccine. Follow up as needed.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Somnolence, Syncope
Clinical narrative: Patient is a 14 year old female who is here for nurse visit for her GARDASIL vaccine. She complained of feeling tired and dizzy, denies a headache or fever. After she received her GARDASIL. Mom witnessed her eyes roll upwards, patient then became limp and her body was twitching for a minute or 2. I witnessed the second episode. She became pale, diaphoretic, and her eyes rolled up. She then became limp and had some upper extremity twitching for about 10 seconds. She had some drowsiness after this episode. She was oriented and answered questions appropriately. PMH: mononucleosis in 2010, Headaches seen by Dr and a normal brain MRI. ROS: positive for fatigue, chronic headaches, No fever, no pulm or GI Sx, no rashes. FH: neg for seizure disorders. General: WDW, Slightly Drowsy, Responsive; Eyes: nl; Ears: nl TMs; Nose: nasal passages clear Pharynx nl; Neck: supple, no masses, no lymphadenopathy; Resp: clear to auscultation bilaterally; CV: RRR, normal S1/S2, no murmurs; ABD: soft, nontender, no masses, no hepatosplenomegaly; GU: not examined; Extremities: nl; Skin: no rashes or lesions. Assessment: Syncope possible seizure disorder immediately after having a GARDASIL vaccine. Plan: Pulse OX=100, Glucose, O2 At 2 liters, Paramedics called Plan to hospital and admission to choc. Vaers report for GARDASIL vaccine. Follow up as needed.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Slightly red raised rash about trunk, low grade temp 7 days after immunization.
Age: 3.0
Sex: M
Vaccine: HEPA, HIBV, IPV
Symptoms: Asthenia, Eye swelling, Pruritus, Pyrexia, Rash generalised
Clinical narrative: Less energy on 7-16-11; started with itching, swelling (periorbital), fever & rash all over body on 7-17-11 & went to ER 7-18-11 & treated with 2 medicines.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to left SQ inj 25mm x 35mm. BENADRYL given by parent and ice applied to site.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Intussusception.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: Ileus paralytic, Intestinal operation, Intussusception, Procedural complication, Rectal haemorrhage
Clinical narrative: Intussusception.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: Screaming, Vomiting
Clinical narrative: Intussusception.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: Barium enema, Blood culture, Blood test, Gastrointestinal tube insertion, Gastrointestinal tube removal
Clinical narrative: Intussusception.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: Haematochezia, Intensive care, Intestinal operation, Intussusception, Lethargy
Clinical narrative: Intussusception.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: Pain, Post procedural complication, Postoperative adhesion, Vomiting, Vomiting projectile
Clinical narrative: Intussusception.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: X-ray
Clinical narrative: Intussusception.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Hypoaesthesia, Insomnia, Joint stiffness, Joint swelling
Clinical narrative: On July 8, 2011 clients (L) ankle started hurting. She stated she "noticed" the pain, pain was not severe. Then her knees bilaterally started hurting, then (R) hip. Reports morning of July 16 she woke up with both wrists swollen and could not bend them and painful wrist joints. She took Ibuprofen 600mg 3 times a day. July 17 her wrists continued to be like this (swollen and painful) the night of July 19 she experienced numbness in both wrists. The night of July 20 she states she was up every hour on the hour because of pain & numbness. The night of July 21 she states both thumb joints were numb & extremely painful & the tip of her thumb on (L) hand continues to be numb today. She reports trying heat on her thumbs at 4AM this morning but the heat intensified the pain. The only other tx used is ibuprofen at night the past week.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity
Clinical narrative: On July 8, 2011 clients (L) ankle started hurting. She stated she "noticed" the pain, pain was not severe. Then her knees bilaterally started hurting, then (R) hip. Reports morning of July 16 she woke up with both wrists swollen and could not bend them and painful wrist joints. She took Ibuprofen 600mg 3 times a day. July 17 her wrists continued to be like this (swollen and painful) the night of July 19 she experienced numbness in both wrists. The night of July 20 she states she was up every hour on the hour because of pain & numbness. The night of July 21 she states both thumb joints were numb & extremely painful & the tip of her thumb on (L) hand continues to be numb today. She reports trying heat on her thumbs at 4AM this morning but the heat intensified the pain. The only other tx used is ibuprofen at night the past week.
Age: 0.16
Sex: M
Vaccine: RV5, DTAP, HIBV, RV5
Symptoms: Barium enema, Haematochezia, Infantile spitting up, Intussusception, Irritability
Clinical narrative: Patient developed intussusception 7/15/11 and admitted. Reduced by Barium enema required x 3. Sx began 7/14/11 with fussiness and spitting up more and by next day developed frankly bloody stool.
Age: 0.16
Sex: M
Vaccine: RV5, DTAP, HIBV, RV5
Symptoms: Barium enema, Diarrhoea, Diarrhoea haemorrhagic, Enema administration, Gastrointestinal sounds abnormal
Clinical narrative: Patient developed intussusception 7/15/11 and admitted. Reduced by Barium enema required x 3. Sx began 7/14/11 with fussiness and spitting up more and by next day developed frankly bloody stool.
Age: 0.16
Sex: M
Vaccine: RV5, DTAP, HIBV, RV5
Symptoms: Gastrooesophageal reflux disease, Haematochezia, Hypophagia, Infantile spitting up, Intussusception
Clinical narrative: Patient developed intussusception 7/15/11 and admitted. Reduced by Barium enema required x 3. Sx began 7/14/11 with fussiness and spitting up more and by next day developed frankly bloody stool.
Age: 0.16
Sex: M
Vaccine: RV5, DTAP, HIBV, RV5
Symptoms: Irritability, Mean platelet volume decreased, Neutrophil count increased, Platelet count increased, Pyloric stenosis
Clinical narrative: Patient developed intussusception 7/15/11 and admitted. Reduced by Barium enema required x 3. Sx began 7/14/11 with fussiness and spitting up more and by next day developed frankly bloody stool.
Age: 0.16
Sex: M
Vaccine: RV5, DTAP, HIBV, RV5
Symptoms: Troponin I increased, Ultrasound abdomen abnormal, Urine output decreased, Vomiting, White blood cell count increased
Clinical narrative: Patient developed intussusception 7/15/11 and admitted. Reduced by Barium enema required x 3. Sx began 7/14/11 with fussiness and spitting up more and by next day developed frankly bloody stool.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Mother noted swelling in L arm. L upper arm was red and hot to the touch. Mother described skin as very tight. Seen at after hours clinic on 7-25. Dx with cellulitis and given Keflex qid. Mother notes significant difference after 1 dose of ATB. Swelling has gone down and redness is almost gone.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Skin tightness
Clinical narrative: Mother noted swelling in L arm. L upper arm was red and hot to the touch. Mother described skin as very tight. Seen at after hours clinic on 7-25. Dx with cellulitis and given Keflex qid. Mother notes significant difference after 1 dose of ATB. Swelling has gone down and redness is almost gone.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Abortion, Drug exposure during pregnancy, Foetal heart rate abnormal, Intra-uterine death, Nausea
Clinical narrative: Initial report was received 30 September 2010 from a health care professional. An adult pregnant female patient (age and date of birth to be confirmed), had received a first dose intramuscular injection of ADACEL, lot number C3476AA on 09 September 2010. The patient's last menstrual period occurred on 06 August 2010 and her expected date of delivery was 13 May 2010. It was unclear at the time of the report if the patient's date of birth was 10 April 1983 or 04 October 1983. The patient had no risk factors, and at the time of the report, she had not experienced any adverse events since receiving ADACEL. Follow-up information was received from a health care professional on 03 June 2011. The patient's last name was corrected as per the reporter. Follow-up information was received from a health care professional on 11 July 2011 reported that the patient had a history of irregular menses and test negative for pregnancy prior to administration of ADACEL. The reporter has no further contact with patient and no further information to provide. The outcome remained unknown. Follow-up information received from a health care professional on 15 July 2011. The patient has history of 2 prior pregnancies that resulted in 2 live births. The patient had no concurrent illnesses, and was diagnosed with irregular menses and dysmenorrhea at time of ADACEL vaccination. She had not received any other vaccinations within 4 weeks of 09 September 2010. The patient had no adverse events following prior vaccinations. The patient had a negative urine pregnancy test on 09 September 2010. Health during pregnancy included nausea and vomiting, and a UTI (urinary tract infection) that was treated with oral CEPHALEXIN from 07-14 October 2010. Obstetrical ultrasound performed on 28 October 2010 revealed a single 7.3 week gestation with negative fetal heart sound determined to be fetal demise. The patient underwent "abortion" (date not provided). Recovery status not reported. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Pregnancy test urine negative, Ultrasound antenatal screen abnormal, Urinary tract infection, Vomiting
Clinical narrative: Initial report was received 30 September 2010 from a health care professional. An adult pregnant female patient (age and date of birth to be confirmed), had received a first dose intramuscular injection of ADACEL, lot number C3476AA on 09 September 2010. The patient's last menstrual period occurred on 06 August 2010 and her expected date of delivery was 13 May 2010. It was unclear at the time of the report if the patient's date of birth was 10 April 1983 or 04 October 1983. The patient had no risk factors, and at the time of the report, she had not experienced any adverse events since receiving ADACEL. Follow-up information was received from a health care professional on 03 June 2011. The patient's last name was corrected as per the reporter. Follow-up information was received from a health care professional on 11 July 2011 reported that the patient had a history of irregular menses and test negative for pregnancy prior to administration of ADACEL. The reporter has no further contact with patient and no further information to provide. The outcome remained unknown. Follow-up information received from a health care professional on 15 July 2011. The patient has history of 2 prior pregnancies that resulted in 2 live births. The patient had no concurrent illnesses, and was diagnosed with irregular menses and dysmenorrhea at time of ADACEL vaccination. She had not received any other vaccinations within 4 weeks of 09 September 2010. The patient had no adverse events following prior vaccinations. The patient had a negative urine pregnancy test on 09 September 2010. Health during pregnancy included nausea and vomiting, and a UTI (urinary tract infection) that was treated with oral CEPHALEXIN from 07-14 October 2010. Obstetrical ultrasound performed on 28 October 2010 revealed a single 7.3 week gestation with negative fetal heart sound determined to be fetal demise. The patient underwent "abortion" (date not provided). Recovery status not reported. Documents held by sender: None.