chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Gaze palsy, Laboratory test normal, Loss of consciousness, Opisthotonus
Clinical narrative: Information has been received from a physician concerning a 12 month old male with a "history of seizure" who on 25-MAR-2010 was vaccinated with a dose of VAQTA (dose, route and lot number unspecified). Suspect vaccines included a dose of: MMR II and VARIVAX received on the same day (25-MAR-2010) (doses, routes and lot numbers unspecified). Concomitant vaccine included PREVNAR (date, dose, route and lot number unspecified). The nurse reported that on 25-MAR-2010, the patient experienced seizure in the afternoon after receiving a dose of VARIVAX (Merck), MMR II and VAQTA (inactive). The patient was taken in the emergency room. It was reported that the patient had no fever but he had sores in the mouth which was diagnosed as herpes. A "CT scan" was performed (date and results not reported). At the time of the report the outcome of the patient was unknown. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, VARCEL
Symptoms: Syncope, Viral infection
Clinical narrative: Information has been received from a physician concerning a 12 month old male with a "history of seizure" who on 25-MAR-2010 was vaccinated with a dose of VAQTA (dose, route and lot number unspecified). Suspect vaccines included a dose of: MMR II and VARIVAX received on the same day (25-MAR-2010) (doses, routes and lot numbers unspecified). Concomitant vaccine included PREVNAR (date, dose, route and lot number unspecified). The nurse reported that on 25-MAR-2010, the patient experienced seizure in the afternoon after receiving a dose of VARIVAX (Merck), MMR II and VAQTA (inactive). The patient was taken in the emergency room. It was reported that the patient had no fever but he had sores in the mouth which was diagnosed as herpes. A "CT scan" was performed (date and results not reported). At the time of the report the outcome of the patient was unknown. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, VARCEL
Symptoms: Computerised tomogram, Condition aggravated, Convulsion, Herpes virus infection, Stomatitis
Clinical narrative: Information has been received from a physician concerning a 12 month old male with a "history of seizure" who on 25-MAR-2010 was vaccinated with a dose of VAQTA (dose, route and lot number unspecified). Suspect vaccines included a dose of: MMR II and VARIVAX received on the same day (25-MAR-2010) (doses, routes and lot numbers unspecified). Concomitant vaccine included PREVNAR (date, dose, route and lot number unspecified). The nurse reported that on 25-MAR-2010, the patient experienced seizure in the afternoon after receiving a dose of VARIVAX (Merck), MMR II and VAQTA (inactive). The patient was taken in the emergency room. It was reported that the patient had no fever but he had sores in the mouth which was diagnosed as herpes. A "CT scan" was performed (date and results not reported). At the time of the report the outcome of the patient was unknown. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Nausea, Pyrexia, Vomiting
Clinical narrative: Stomach ache, fever, N/V.  Patient said this happened twice (2009 and 2010)
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient said she had some minor swelling and redness of whole left arm.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: She reports waking up with a very sore left deltoid on 3/30/10. The redness grew that day and is still really bad on 3/31/10. Her arm is warm, red and very painful. She feels her hand strength is more weak.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Haematoma
Clinical narrative: MILD HEMATOMA AND 7CM X 6CM CIRCULAR ERYTHEMA
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Haematoma
Clinical narrative: MILD HEMATOMA 7CM X 6CM CIRCULAR ERYTHEMA
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis continues to spread to elbow
Age: 1.44
Sex: M
Vaccine: HEPA
Symptoms: Lymphadenopathy, No reaction on previous exposure to drug
Clinical narrative: Gland is in large on the left side. 3-30-10 received second dose.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Feeling abnormal, Headache, Paraesthesia, Pruritus, Tinnitus
Clinical narrative: C/o symptoms starting 1 1/2 hrs after receiving imm. shots. Weird H.A.-felt like a band across the eyes. 3/31 now feeling like a little bit of pressure. Tinnitus, tingling on face, shoulders, upper part of body. Some itching with tingling muscles of face feel slack. Feels blah and spacey.
Age: 32.0
Sex: M
Vaccine: TTOX
Symptoms: Depressed level of consciousness, Hyperhidrosis, Pallor
Clinical narrative: Gave donor injection turned around to dispose of needle and when I turned back to donor he was pale, sweaty - asked if he was ok? Donor stated he does not do well with injections. Donor wanted to lay on bed and stood to his feet and I stood up to guide donor to the floor. No complaints of SOB, hives, rash, CP. Was alert within 15 sec. Form was not initially filled out because did not feel it was related to vaccine but after taking med- ops form nd to be completed.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Alcohol use
Clinical narrative: Patient went drinking and got a prostitute and had sex. He hadn't had been in 24 years of marriage.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Loss of consciousness, Walking aid user, Wheelchair user
Clinical narrative: Found unconscious/ hospital MD/ hospital MA/ 7 months physical therapy/ from dioplast/ wheel chair/ never got balance back/ walk with walker/ lives in semi-care facility.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Feeling cold, Gaze palsy, Screaming
Clinical narrative: Aprox. 2-3 hrs after injection. Pt was at home after nursing he screamed, eyes rolled back in his head and then he had his head on mom's shoulder. Per mom he was cool to touch but did respond to verbal stimuli by visually tracking her; but no further cry. She took pt to ED, he was evaluated and sent home.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: Large red swollen area, warm to the touch and extremely sore.  3-29-10 area measures 45mm X 50mm.  Also firm to touch.  RN.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site warmth
Clinical narrative: Left arm - deltoid area with 4.0 x 3.0 cm area erythema. Induration warmth 1.0 cm area ecchymosis over injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: Left deltoid with circular 6.5 cm x 7 cm area of erythema around Dtap site.
Age: 2.0
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Rash papular
Clinical narrative: Mom noticed red raised rash to arms and legs about 5 hours after vaccine. Spread to face today. Rash - 3/17/10 spread to face 3/18/10
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Syncope
Clinical narrative: Child received GARDASIL - that night developed abdominal pain, dizziness, diarrhea, and fainted - Seen next day - better - No Temperature - No sore arm.
Age: 0.8
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Urticarial rash 1 day after vaccine.
Age: 59.0
Sex: F
Vaccine: TTOX
Symptoms: Alopecia, Skin exfoliation
Clinical narrative: Hair came out and still coming out. Face peel front of body back. By the hand food hair falling out.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Electroencephalogram, Gaze palsy, Hypotension, Hypotonia, Injection site pain
Clinical narrative: I gave GARDASIL in right deltoid she said it was a little pain then. I gave Hepatitis A in left deltoid. About 1 minute later child's eyes rolled up, she was limp and nonresponsive, but within seconds she stiffened legs and arms with arms in rhythmic movements too 10 seconds then stiffened again. Pale white, I pulled chin down to get her to breathe. O2 nasal applied. BP 80/52. Became responsive with the O2 and said "what happened?" 911 arrived and child was on way to ER by 9:51AM.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Musculoskeletal stiffness, Pallor, Unresponsive to stimuli
Clinical narrative: I gave GARDASIL in right deltoid she said it was a little pain then. I gave Hepatitis A in left deltoid. About 1 minute later child's eyes rolled up, she was limp and nonresponsive, but within seconds she stiffened legs and arms with arms in rhythmic movements too 10 seconds then stiffened again. Pale white, I pulled chin down to get her to breathe. O2 nasal applied. BP 80/52. Became responsive with the O2 and said "what happened?" 911 arrived and child was on way to ER by 9:51AM.
Age: 58.0
Sex: F
Vaccine: TTOX
Symptoms: Asthenia, Dizziness, Fatigue, Heart rate increased, Hyperhidrosis
Clinical narrative: Pain on arm for about 6 days/tiredness, nausea, weakness, dizziness, sweating, fast heart beat, noise like pin head moving. Resulting on missed wages for 4 days.
Age: 58.0
Sex: F
Vaccine: TTOX
Symptoms: Impaired work ability, Nausea, Pain in extremity, Tinnitus
Clinical narrative: Pain on arm for about 6 days/tiredness, nausea, weakness, dizziness, sweating, fast heart beat, noise like pin head moving. Resulting on missed wages for 4 days.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site discomfort, Injection site erythema
Clinical narrative: Erythematous oval ring on left thigh (same side as injection) measuring 12 cm in length & 7 cm in width. Plus discomfort.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, soreness, redness and itching at the injection site noticed 3 days after injection. Recommended cold compress, Acetaminophen for the pain and Diphenhydramine for itching.
Sex: U
Vaccine: VARCEL
Symptoms: Amniocentesis, Drug exposure during pregnancy, Foetal disorder, Ultrasound scan
Clinical narrative: Information has been received from a pregnancy registry via a a medical assistant concerning an unborn baby of a 18 year old female with family history free from abnormalities who in September 2006, was vaccinated with a dose of VARIVAX (lot # not reported). Secondary suspect vaccination was given in August 2006 included an intramuscular injection with a dose of GARDASIL (lot # not reported). At the time of reporting, the patient was 4 months pregnant (estimated last menstrual period 03-NOV-2006 and estimated date of delivery 10-AUG-2007). On an unspecified date, the mother had ultrasounds and an amniocentesis performed. The medical assistant reported that the unborn child had fetal abnormalities which were detected shortly after mother's vaccination with VARIVAX and GARDASIL. At the time of the report the patient's outcome was unknown. The infant's fetal abnormality was considered a congenital anomaly. The mother's experience has been captured in WAES 0702USA01359. The infant's fetal abnormality was previously reported in WAES 0702USA01359. Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: VARCEL
Symptoms: Convulsion, Diarrhoea, Hepatitis C positive, Pyrexia
Clinical narrative: Information has been received from a physician's assistant concerning a 17 month old patient with no pertinent medical history who on 19-MAR-2010 was vaccinated with a dose of VARIVAX (Merck) (lot# not reported). There was no concomitant medication. On 21-MAR-2010 the patient developed fever, diarrhea, seizure and a positive Hepatitis C antibody and was sent to emergency room and admitted to hospital. At the time of this report, the patient was still in hospital with possible discharge that day. It was reported that the patient was one of a twin. The other twin received the VARIVAX (Merck) and was fine. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Barium double contrast, Crying, Intussusception, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 12 week old patient who "last month", on approximately 23-FEB-2010, was vaccinated with a first dose of ROTATEQ (oral route, lot # unknown). Concomitant therapy included PENTACEL and PREVNAR (lot # not reported) also administered "last month". The physician reported that "a week after getting the vaccines", on approximately 02-MAR-2010, the patient was crying and was taken to the hospital, the patient was diagnosed with intussusception, was admitted and treated with Air contrast enema and the intussusception resolved. Lab diagnostic studies performed were unspecified. The patient was seen last month for a follow-up visit and the patient had recovered. Additional information has been requested.
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Congenital anomaly, Foetal disorder, Foetal growth retardation, Foetal heart rate abnormal, Gastroschisis
Clinical narrative: Information has been received from medical record concerning a female baby whose 25 year old mother smokes and has no pre-existing allergies, birth defects or medical conditions, no illness at time of vaccination and no history of previous pregnancies was vaccinated on 16-FEB-2009 was vaccinated IM in her right deltoid with the first dose of GARDASIL vaccine. Concomitant vaccination received the same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot # A014). The physician indicated that her mother was pregnant at time of vaccination but it was too early to detect it. Her LMP was 26-JAN-2009, her EDD was 09-NOV-2009. From 17-FEB-2009 to 03-MAR-2009, the patient's mother took on CHANTIX to quit smoking. On 04-MAR-2009, the patient's mother had a positive urine pregnancy test. Subsequently on 18-MAR-2009 and on 20-APR-2009, two ultrasounds were done respectively to verify dates and pregnancy viability, and confirmed that vaccination occurred around conception, her estimated conception date was 16-FEB-2009 (+)/- 1 week). On 21-OCT-2009 at 5:45 am the infant's mother experienced spontaneous rupture of membranes. Her labor was induced and the infant experienced intrauterine growth restriction, baseline fetal tachycardia, loss of fetal heart rate variability and fetal gastroschisis during labor and delivery which have been captured in WAES # 0904USA01203. Fetal gastroschitis is considered a congenital anomaly. Additional information has been requested.
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Premature baby, Tachycardia foetal, Ultrasound scan
Clinical narrative: Information has been received from medical record concerning a female baby whose 25 year old mother smokes and has no pre-existing allergies, birth defects or medical conditions, no illness at time of vaccination and no history of previous pregnancies was vaccinated on 16-FEB-2009 was vaccinated IM in her right deltoid with the first dose of GARDASIL vaccine. Concomitant vaccination received the same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot # A014). The physician indicated that her mother was pregnant at time of vaccination but it was too early to detect it. Her LMP was 26-JAN-2009, her EDD was 09-NOV-2009. From 17-FEB-2009 to 03-MAR-2009, the patient's mother took on CHANTIX to quit smoking. On 04-MAR-2009, the patient's mother had a positive urine pregnancy test. Subsequently on 18-MAR-2009 and on 20-APR-2009, two ultrasounds were done respectively to verify dates and pregnancy viability, and confirmed that vaccination occurred around conception, her estimated conception date was 16-FEB-2009 (+)/- 1 week). On 21-OCT-2009 at 5:45 am the infant's mother experienced spontaneous rupture of membranes. Her labor was induced and the infant experienced intrauterine growth restriction, baseline fetal tachycardia, loss of fetal heart rate variability and fetal gastroschisis during labor and delivery which have been captured in WAES # 0904USA01203. Fetal gastroschitis is considered a congenital anomaly. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received from a licensed practical nurse, for GARDASL, a Pregnancy Registry product, concerning a 17 year old female patient who in February 2009, was vaccinated with the first dose of GARDASIL (lot# not reported). The patient subsequently became pregnant. Date of LMP not reported. On 18-MAR-2009 the patient had an elective abortion. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. Upon internal review, elective abortion was considered to be an important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with a history of seizures who on an unknown date was vaccinated with her first dose of GARDASIL (lot# not reported). The next day after vaccination the patient experienced a seizure. It was reported that two to three days later the patient went to see a pediatrician, who told the patient to go back to the Ob-Gyn physician and let him know about the seizure. It was noted that the patient did have a history of seizures but had not had any seizures for a while until the day after vaccination with GARDASIL. No further seizures were noted since the seizure the day after receiving GARDASIL. At the time of the report, the outcome of the patient was unknown. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 6" x 5" bright red painful itchy area upper left arm.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: "Achy bone feeling, fever up to 100.6, chills and shakes, soreness and redness at site of injection. Placed on Keflex 500mg every six hours. Ice to area as needed. Ibuprofen 200mg every six hours with food.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Tremor
Clinical narrative: "Achy bone feeling, fever up to 100.6, chills and shakes, soreness and redness at site of injection. Placed on Keflex 500mg every six hours. Ice to area as needed. Ibuprofen 200mg every six hours with food.
Age: 43.0
Sex: M
Vaccine: FLUX(H1N1), HEPAB, TD, TYP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: By the time I took the 3rd pill, I was experiencing 1 episode of vomiting and when I took the 4th pill, I had moderate diarrhea for several hours.
Age: 27.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abortion spontaneous
Clinical narrative: Miscarriage
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Lip swelling, Pharyngeal oedema, Swelling face
Clinical narrative: Client reported adverse event to us on 03-31-10 in the pm via the State Health Center answering machine.  In follow up on 4-1-10: The Client received her GARDASIL (HPV) vaccine @ approximately 1 pm on 3-25-10.  Client states she felt "fine the rest of the day and evening." and went to spend the night at a friend's house (on 03/25/1020).  She reports waking up at 1 AM on 3-26-10 with the following symptoms: right-sided swollen lip, cheek and eye, and a swollen throat.  At approximately 4 a.m. she states she took x4 "over-the-counter" Benadryl tablets and by approximately 6 to 7 AM on 3-26-10 the swelling "started going down".  At 11 A.M. on 4-1-10 client states "I feel perfectly fine now."
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Took ZOSTAVAX 3/4/08 Lot #1836U Expos/14/09 Developed shingles 5/23/09 4 other patients see #13 have also had shingles > 1 year after ZOSTAVAX (different lots I think). Someone keeping track of efficacy? At $225/vaccine, it should work.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Head injury, Syncope
Clinical narrative: Patient had episode syncope in waiting room. Hit head against chair. Recovered easily. Improved with rest in swinging position. BP HR stable.
Age: 18.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: 03-27-10 Quarter size redness to back of left arm.  03-29-10 Redness to back of arm & warm & tender.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Rash pruritic
Clinical narrative: Small area of redness at bedtime (Tues) (left deltoid area). 10cm x 10cm hive-like pruritc, no pain very mild Edema center of deltoid on Thurs.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Chest pain, Confusional state, Dizziness, Fatigue
Clinical narrative: 3/16/10 Patient called day after GARDASIL injection 3 hrs. after injection, shopping for groceries and felt dizzy, confused. Home that night developed pain, neck, stomach, legs, chest. Gone by 3/17/10. Patient felt tired 3/16/10. At work now 3/17/10.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pain in extremity
Clinical narrative: 3/16/10 Patient called day after GARDASIL injection 3 hrs. after injection, shopping for groceries and felt dizzy, confused. Home that night developed pain, neck, stomach, legs, chest. Gone by 3/17/10. Patient felt tired 3/16/10. At work now 3/17/10.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Dysphonia, Fatigue, Nausea, Palpitations
Clinical narrative: Really tired 24 hrs later or less on & off through today.  Noted palpitations, tightness in chest about 5 hrs after vaccination intermittent til now.  Welts on back & shoulders 3/20, 6 AM until MN.  Has had light intermittent wheezing, ongoing.  Hoarseness noted til now.  Also notes nausea.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria, Wheezing
Clinical narrative: Really tired 24 hrs later or less on & off through today.  Noted palpitations, tightness in chest about 5 hrs after vaccination intermittent til now.  Welts on back & shoulders 3/20, 6 AM until MN.  Has had light intermittent wheezing, ongoing.  Hoarseness noted til now.  Also notes nausea.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: At 24 hrs after vaccination, seen in office with left deltoid region has a small area of warmth, mild swelling and erythema. Afeb.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, swelling, redness
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Mild swelling were the VARICELLA vaccine was administered. (R) thigh.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site lymphadenopathy, Injection site pain, Rash
Clinical narrative: Injection given on arm's underside. 24 hr. later rash had developed & spread down to the elbow. Lump could be felt under the skin at injection site. That area of arm very painful, rash lasted for one week. Today (3-20) there is still a "blotch" at injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Clinical narrative: VESICULAR RASH OVER R T2 DERMATOME
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Blood culture positive, Body temperature increased, Computerised tomogram abnormal, Drooling, Dysphonia
Clinical narrative: This case was reported in a literature article and described the occurrence of epiglottitis in a 3-year-old male subject who was vaccinated with Haemophilius influenzae type b vaccine (Hib vaccine, manufacturer unspecified). The subject was fully immunized and otherwise healthy. At an unspecified time after vaccination with Hib vaccine, the subject presented to an outside facility with a sore throat and fever of about 39.44 deg C (abruptly 4 h prior to arrival). He had mild symptoms of clear rhinorrhea and nasal congestion for two days prior to presentation. The patient had no cough, stridor, trismus, neck stiffness, nausea, vomiting, diarrhea, or rash. Physical examination initially demonstrated mild trismus and pharyngeal erythema. After 2 h at the outside facility, he developed drooling and a muffled voice. A complete blood count showed a white blood cell count of 12.4 with 74 percent segmented neutrophils, and a blood culture was sent. A nasopharyngeal swab was positive for respiratory syncytial virus (RSV) but negative for influenza A and B. Monospot, rapid strep, and throat culture were all negative. He was initially in no respiratory distress, so a soft tissue neck film and a Computerized tomography of neck without contrast were obtained. The soft tissue neck film showed mild thickening of the epiglottis and aryepiglottic folds (this was confirmed on CT). During the next 3 h, the patient developed worsening odynophagia, inspiratory stridor, and wheezing. He was treated with SOLUMEDROL, salbutamol sulphate (nebulized Albuterol), RACEMIC EPINEPHRINE, and Ceftriaxone, with minimal improvement in his stridor. The patient was airlifted to the hospital presenting mild respiratory distress with inspiratory stridor and was in a modified sniffing position. He was taken immediately to the operating room. During induction of general anesthesia, he had moderate airway obstruction. Direct laryngoscopy revealed a beefy, red epiglottis. He was subsequently intubated without difficulty, and a swab culture was obtained from the epiglottis. The patient remained intubated for the next 40 h, while receiving Ampicillin/ Sulbactam and Vancomycin. On hospital day 2, he received intravenous Dexamethasone. On hospital day 3 he developed an air leak around his endotracheal tube and was successfully extubated. Blood cultures grew nontypeable H. influenza biotype I. The culture from the epiglottis grew normal flora. Antibiotic coverage was narrowed to only ampicillin/sulbactam. The subject's clinical status rapidly improved and he was discharged on hospital day 6. Evidence suggests that children may still be susceptible to H influenzae epiglottitis, despite receiving the recommended vaccination (1,3,4).
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Endotracheal intubation, Epiglottitis, Influenza serology positive, Laryngoscopy abnormal, Nasal congestion
Clinical narrative: This case was reported in a literature article and described the occurrence of epiglottitis in a 3-year-old male subject who was vaccinated with Haemophilius influenzae type b vaccine (Hib vaccine, manufacturer unspecified). The subject was fully immunized and otherwise healthy. At an unspecified time after vaccination with Hib vaccine, the subject presented to an outside facility with a sore throat and fever of about 39.44 deg C (abruptly 4 h prior to arrival). He had mild symptoms of clear rhinorrhea and nasal congestion for two days prior to presentation. The patient had no cough, stridor, trismus, neck stiffness, nausea, vomiting, diarrhea, or rash. Physical examination initially demonstrated mild trismus and pharyngeal erythema. After 2 h at the outside facility, he developed drooling and a muffled voice. A complete blood count showed a white blood cell count of 12.4 with 74 percent segmented neutrophils, and a blood culture was sent. A nasopharyngeal swab was positive for respiratory syncytial virus (RSV) but negative for influenza A and B. Monospot, rapid strep, and throat culture were all negative. He was initially in no respiratory distress, so a soft tissue neck film and a Computerized tomography of neck without contrast were obtained. The soft tissue neck film showed mild thickening of the epiglottis and aryepiglottic folds (this was confirmed on CT). During the next 3 h, the patient developed worsening odynophagia, inspiratory stridor, and wheezing. He was treated with SOLUMEDROL, salbutamol sulphate (nebulized Albuterol), RACEMIC EPINEPHRINE, and Ceftriaxone, with minimal improvement in his stridor. The patient was airlifted to the hospital presenting mild respiratory distress with inspiratory stridor and was in a modified sniffing position. He was taken immediately to the operating room. During induction of general anesthesia, he had moderate airway obstruction. Direct laryngoscopy revealed a beefy, red epiglottis. He was subsequently intubated without difficulty, and a swab culture was obtained from the epiglottis. The patient remained intubated for the next 40 h, while receiving Ampicillin/ Sulbactam and Vancomycin. On hospital day 2, he received intravenous Dexamethasone. On hospital day 3 he developed an air leak around his endotracheal tube and was successfully extubated. Blood cultures grew nontypeable H. influenza biotype I. The culture from the epiglottis grew normal flora. Antibiotic coverage was narrowed to only ampicillin/sulbactam. The subject's clinical status rapidly improved and he was discharged on hospital day 6. Evidence suggests that children may still be susceptible to H influenzae epiglottitis, despite receiving the recommended vaccination (1,3,4).
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Neutrophil percentage increased, Obstructive airways disorder, Odynophagia, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: This case was reported in a literature article and described the occurrence of epiglottitis in a 3-year-old male subject who was vaccinated with Haemophilius influenzae type b vaccine (Hib vaccine, manufacturer unspecified). The subject was fully immunized and otherwise healthy. At an unspecified time after vaccination with Hib vaccine, the subject presented to an outside facility with a sore throat and fever of about 39.44 deg C (abruptly 4 h prior to arrival). He had mild symptoms of clear rhinorrhea and nasal congestion for two days prior to presentation. The patient had no cough, stridor, trismus, neck stiffness, nausea, vomiting, diarrhea, or rash. Physical examination initially demonstrated mild trismus and pharyngeal erythema. After 2 h at the outside facility, he developed drooling and a muffled voice. A complete blood count showed a white blood cell count of 12.4 with 74 percent segmented neutrophils, and a blood culture was sent. A nasopharyngeal swab was positive for respiratory syncytial virus (RSV) but negative for influenza A and B. Monospot, rapid strep, and throat culture were all negative. He was initially in no respiratory distress, so a soft tissue neck film and a Computerized tomography of neck without contrast were obtained. The soft tissue neck film showed mild thickening of the epiglottis and aryepiglottic folds (this was confirmed on CT). During the next 3 h, the patient developed worsening odynophagia, inspiratory stridor, and wheezing. He was treated with SOLUMEDROL, salbutamol sulphate (nebulized Albuterol), RACEMIC EPINEPHRINE, and Ceftriaxone, with minimal improvement in his stridor. The patient was airlifted to the hospital presenting mild respiratory distress with inspiratory stridor and was in a modified sniffing position. He was taken immediately to the operating room. During induction of general anesthesia, he had moderate airway obstruction. Direct laryngoscopy revealed a beefy, red epiglottis. He was subsequently intubated without difficulty, and a swab culture was obtained from the epiglottis. The patient remained intubated for the next 40 h, while receiving Ampicillin/ Sulbactam and Vancomycin. On hospital day 2, he received intravenous Dexamethasone. On hospital day 3 he developed an air leak around his endotracheal tube and was successfully extubated. Blood cultures grew nontypeable H. influenza biotype I. The culture from the epiglottis grew normal flora. Antibiotic coverage was narrowed to only ampicillin/sulbactam. The subject's clinical status rapidly improved and he was discharged on hospital day 6. Evidence suggests that children may still be susceptible to H influenzae epiglottitis, despite receiving the recommended vaccination (1,3,4).
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Respiratory distress, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Rhinorrhoea
Clinical narrative: This case was reported in a literature article and described the occurrence of epiglottitis in a 3-year-old male subject who was vaccinated with Haemophilius influenzae type b vaccine (Hib vaccine, manufacturer unspecified). The subject was fully immunized and otherwise healthy. At an unspecified time after vaccination with Hib vaccine, the subject presented to an outside facility with a sore throat and fever of about 39.44 deg C (abruptly 4 h prior to arrival). He had mild symptoms of clear rhinorrhea and nasal congestion for two days prior to presentation. The patient had no cough, stridor, trismus, neck stiffness, nausea, vomiting, diarrhea, or rash. Physical examination initially demonstrated mild trismus and pharyngeal erythema. After 2 h at the outside facility, he developed drooling and a muffled voice. A complete blood count showed a white blood cell count of 12.4 with 74 percent segmented neutrophils, and a blood culture was sent. A nasopharyngeal swab was positive for respiratory syncytial virus (RSV) but negative for influenza A and B. Monospot, rapid strep, and throat culture were all negative. He was initially in no respiratory distress, so a soft tissue neck film and a Computerized tomography of neck without contrast were obtained. The soft tissue neck film showed mild thickening of the epiglottis and aryepiglottic folds (this was confirmed on CT). During the next 3 h, the patient developed worsening odynophagia, inspiratory stridor, and wheezing. He was treated with SOLUMEDROL, salbutamol sulphate (nebulized Albuterol), RACEMIC EPINEPHRINE, and Ceftriaxone, with minimal improvement in his stridor. The patient was airlifted to the hospital presenting mild respiratory distress with inspiratory stridor and was in a modified sniffing position. He was taken immediately to the operating room. During induction of general anesthesia, he had moderate airway obstruction. Direct laryngoscopy revealed a beefy, red epiglottis. He was subsequently intubated without difficulty, and a swab culture was obtained from the epiglottis. The patient remained intubated for the next 40 h, while receiving Ampicillin/ Sulbactam and Vancomycin. On hospital day 2, he received intravenous Dexamethasone. On hospital day 3 he developed an air leak around his endotracheal tube and was successfully extubated. Blood cultures grew nontypeable H. influenza biotype I. The culture from the epiglottis grew normal flora. Antibiotic coverage was narrowed to only ampicillin/sulbactam. The subject's clinical status rapidly improved and he was discharged on hospital day 6. Evidence suggests that children may still be susceptible to H influenzae epiglottitis, despite receiving the recommended vaccination (1,3,4).
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Stridor, Trismus, Wheezing, White blood cell count increased
Clinical narrative: This case was reported in a literature article and described the occurrence of epiglottitis in a 3-year-old male subject who was vaccinated with Haemophilius influenzae type b vaccine (Hib vaccine, manufacturer unspecified). The subject was fully immunized and otherwise healthy. At an unspecified time after vaccination with Hib vaccine, the subject presented to an outside facility with a sore throat and fever of about 39.44 deg C (abruptly 4 h prior to arrival). He had mild symptoms of clear rhinorrhea and nasal congestion for two days prior to presentation. The patient had no cough, stridor, trismus, neck stiffness, nausea, vomiting, diarrhea, or rash. Physical examination initially demonstrated mild trismus and pharyngeal erythema. After 2 h at the outside facility, he developed drooling and a muffled voice. A complete blood count showed a white blood cell count of 12.4 with 74 percent segmented neutrophils, and a blood culture was sent. A nasopharyngeal swab was positive for respiratory syncytial virus (RSV) but negative for influenza A and B. Monospot, rapid strep, and throat culture were all negative. He was initially in no respiratory distress, so a soft tissue neck film and a Computerized tomography of neck without contrast were obtained. The soft tissue neck film showed mild thickening of the epiglottis and aryepiglottic folds (this was confirmed on CT). During the next 3 h, the patient developed worsening odynophagia, inspiratory stridor, and wheezing. He was treated with SOLUMEDROL, salbutamol sulphate (nebulized Albuterol), RACEMIC EPINEPHRINE, and Ceftriaxone, with minimal improvement in his stridor. The patient was airlifted to the hospital presenting mild respiratory distress with inspiratory stridor and was in a modified sniffing position. He was taken immediately to the operating room. During induction of general anesthesia, he had moderate airway obstruction. Direct laryngoscopy revealed a beefy, red epiglottis. He was subsequently intubated without difficulty, and a swab culture was obtained from the epiglottis. The patient remained intubated for the next 40 h, while receiving Ampicillin/ Sulbactam and Vancomycin. On hospital day 2, he received intravenous Dexamethasone. On hospital day 3 he developed an air leak around his endotracheal tube and was successfully extubated. Blood cultures grew nontypeable H. influenza biotype I. The culture from the epiglottis grew normal flora. Antibiotic coverage was narrowed to only ampicillin/sulbactam. The subject's clinical status rapidly improved and he was discharged on hospital day 6. Evidence suggests that children may still be susceptible to H influenzae epiglottitis, despite receiving the recommended vaccination (1,3,4).
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Rash, Skin warm
Clinical narrative: rash R arm, noted next day after vaccine, warm to touch.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: Trouble with proprioception both arms felt "disconnected." like they wanted to fall off for 3 days. Experienced pain at injection site thru mid-Feb. Then tapered off in late February. Bruise at injection site that lasted a long time.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling, & left arm where vaccine was given warm to touch, pain, warm compresses.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Local erythema and swelling on vaccine site, with some itchiness and pain. Local heat. MOTRIN 100mg/5ml.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Body temperature normal, Injection site erythema, Injection site pruritus
Clinical narrative: Patient given DTAP on left Tzalea developing superflucual erythasmia same day and pruritus, temp 100.2. No evidence of pure cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Mother of child noticed swelling & increased redness of left upper lateral arm. MOC noticed child scratched injection site approximately 4 hrs after receiving MMR. Outer Left arm (lateral aspect) is erythematous, mildly edematous, and increased warmthness with central area of avulsion Acute cellulitis prescribed KEFLEX 250/5-->5ml PO Q 6 hours x 10d. & advised warm soaks.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Scratch
Clinical narrative: Mother of child noticed swelling & increased redness of left upper lateral arm. MOC noticed child scratched injection site approximately 4 hrs after receiving MMR. Outer Left arm (lateral aspect) is erythematous, mildly edematous, and increased warmthness with central area of avulsion Acute cellulitis prescribed KEFLEX 250/5-->5ml PO Q 6 hours x 10d. & advised warm soaks.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Vesicles few scattered on head, extremities; enduration on (R) thigh muscle with  dermal erythema and dermal edema.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Patient seen in emergency department 3/31/2010. Had Tdap given in 3/30/10 in doctors office in left deltoid IM site of injection was warm and sore to touch 3/31/2010. Had fever. Mother states 4/1/10 arm looks better.
Age: 27.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Chest X-ray normal, Fatigue, Headache, Influenza like illness, Malaise
Clinical narrative: 27 y/o female, military dependent spouse (no longer AD), calls at 16:24PM on 31 MAR 2010 with concerns re flu-like sx s/p receipt of MGC 30MAR10. "I feel like I have been hit by a truck"- headache, muscles aches, tired, warm. Patient has positive h/o petit mal seizures, rx'd with Tegretol (as child). She has seen civilian neurologist at neurology, who felt that her sx were not related to adult seizure disorder, but to "heart problem" (cardiac arrhythmia). Her PCM did not think anything was wrong with her heart. She has not been referred to Cardiology. PMH is significant for Migraine HA's and n/o positive PPD, with negative chest x-ray changes. NKDA endorsed. Patient has seasonal allergies and is allergic to bee stings. I reassured the patient that flu-like sx-HA, myalgias, malaise, fever-are listed in manufacturer's package insert form MENACTRA as systemic side effects which usually clear up within a few days. Advised patient to go to ED if side effects become severe or in event of seizure-like prodrome or loss of sensation in extremities. Notified patient, per PI that there is a potential for an increased chance of Guillian Barre syndrome following vaccination. Recommended extra strength Tylenol 500 mg po q 6h prn malaise. Patient verbalized understanding and seemed reassured by information provided.
Age: 27.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Migraine, Myalgia, Pyrexia, Skin warm
Clinical narrative: 27 y/o female, military dependent spouse (no longer AD), calls at 16:24PM on 31 MAR 2010 with concerns re flu-like sx s/p receipt of MGC 30MAR10. "I feel like I have been hit by a truck"- headache, muscles aches, tired, warm. Patient has positive h/o petit mal seizures, rx'd with Tegretol (as child). She has seen civilian neurologist at neurology, who felt that her sx were not related to adult seizure disorder, but to "heart problem" (cardiac arrhythmia). Her PCM did not think anything was wrong with her heart. She has not been referred to Cardiology. PMH is significant for Migraine HA's and n/o positive PPD, with negative chest x-ray changes. NKDA endorsed. Patient has seasonal allergies and is allergic to bee stings. I reassured the patient that flu-like sx-HA, myalgias, malaise, fever-are listed in manufacturer's package insert form MENACTRA as systemic side effects which usually clear up within a few days. Advised patient to go to ED if side effects become severe or in event of seizure-like prodrome or loss of sensation in extremities. Notified patient, per PI that there is a potential for an increased chance of Guillian Barre syndrome following vaccination. Recommended extra strength Tylenol 500 mg po q 6h prn malaise. Patient verbalized understanding and seemed reassured by information provided.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Dystonia, Joint sprain, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initial case was received on 19 March 2010 from a physician. A 9 year old male patient received a right arm injection (route not reported) of Influenza A H1N1 2009 Monovalent Vaccine - Preservative (lot number UP022AA) and a left arm injection (route not reported) of FLUZONE No Preservative 2009-2010 (lot number T3252BA) on 22 December 2009. According to the physician, the patient developed right leg sequential dystonia soon after a right ankle sprain which occurred 7-10 days after vaccinations. The dystonia progressed rapidly; no etiology has been found and his brain MRI was normal. The physician was ordering a cervical spine MRI to look for transverse myelitis. The patient's dystonia is severe; he is undergoing physical therapy. The reporter was not sure if the patient had previous doses of the vaccines. No adverse events occurred following prior vaccination. The patient had no illness at the time of the vaccinations, no pre-existing medical conditions, no known allergies and no concomitant medications. The outcome status of the ankle sprain was not reported. As of this report the patient had not recovered from right leg sequential dystonia. Documents held by sender: None.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Dystonia, Joint sprain, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initial case was received on 19 March 2010 from a physician. A 9 year old male patient received a right arm injection (route not reported) of Influenza A H1N1 2009 Monovalent Vaccine - Preservative (lot number UP022AA) and a left arm injection (route not reported) of FLUZONE No Preservative 2009-2010 (lot number T3252BA) on 22 December 2009. According to the physician, the patient developed right leg sequential dystonia soon after a right ankle sprain which occurred 7-10 days after vaccinations. The dystonia progressed rapidly; no etiology has been found and his brain MRI was normal. The physician was ordering a cervical spine MRI to look for transverse myelitis. The patient's dystonia is severe; he is undergoing physical therapy. The reporter was not sure if the patient had previous doses of the vaccines. No adverse events occurred following prior vaccination. The patient had no illness at the time of the vaccinations, no pre-existing medical conditions, no known allergies and no concomitant medications. The outcome status of the ankle sprain was not reported. As of this report the patient had not recovered from right leg sequential dystonia. Documents held by sender: None.