chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Thyroxine free
Clinical narrative: Within first week after vaccination patient started having symptoms of increased moodiness, anger outburst, irritability, bloating, tearfullness.  Started menses 5/30/08 (day of vaccination) Patient states she has continued to have these symptoms periodically over the last 2 months.  She also feels her periods have become irregular since getting the shot.  Menarche, however was 2/2008 and pt reported irregular cycle the month prior.  Patient also has had many stressors recently, with maternal grandmother recently passing.  Patient in counselling and counselor is the one who states that she has had several clients with increased anger outburst and mood swings since receiving gardasil.  Currently patient states she is not having any anger or mood issues, still complains of bloating.  LMP 7/9/08
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal distension, Amenorrhoea, Anger, Irritability, Mood altered
Clinical narrative: Within first week after vaccination patient started having symptoms of increased moodiness, anger outburst, irritability, bloating, tearfullness.  Started menses 5/30/08 (day of vaccination) Patient states she has continued to have these symptoms periodically over the last 2 months.  She also feels her periods have become irregular since getting the shot.  Menarche, however was 2/2008 and pt reported irregular cycle the month prior.  Patient also has had many stressors recently, with maternal grandmother recently passing.  Patient in counselling and counselor is the one who states that she has had several clients with increased anger outburst and mood swings since receiving gardasil.  Currently patient states she is not having any anger or mood issues, still complains of bloating.  LMP 7/9/08
Age: 1.17
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Activated partial thromboplastin time, Haematoma, Neutropenia, Petechiae, Platelet count normal
Clinical narrative: Rash on legs and buttocks beginning two days after vaccination, petecchial in appearance, also vesicular rash on hands and feet, hematoma on neck
Age: 1.17
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Prothrombin time, Rash vesicular
Clinical narrative: Rash on legs and buttocks beginning two days after vaccination, petecchial in appearance, also vesicular rash on hands and feet, hematoma on neck
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Headache, Malaise, Somnolence, Upper respiratory tract infection
Clinical narrative: Pt describes symptoms as occurring after 3rd Gardasil injection.  Also received meningococcal vaccine on same day. Symptoms include headache, dizziness, URI symptoms, goggy feeling, malaise for 7 days.  Improved for 3 days then symptoms reoccurred.  Vaccines administered on July 2, 2008.  Outpatient clinic visit on 15 July.
Age: 1.92
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Eyelid oedema, Pyrexia
Clinical narrative: Low grade fever and R eyelid swelling. No respiratory distress, no other rashes present.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Had swelling, redness, warmth to right arm after varicella injection
Age: 11.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Back pain, Neck pain, Urticaria
Clinical narrative: hives both arms, pain in neck and upper back
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Full blood count, Intussusception, Irritability, Lethargy, Rectal haemorrhage
Clinical narrative: Blood per his rectum, fussy, lethargic. 7/17/08-records received with report for DOS 5/24-5/26/08-DC DX: Intussusception. Presented to Ed with history of bloood per rectum. Fussy. Appetitie decreased. Constipated. One hard stool day before and vomtiting once.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Blood per his rectum, fussy, lethargic. 7/17/08-records received with report for DOS 5/24-5/26/08-DC DX: Intussusception. Presented to Ed with history of bloood per rectum. Fussy. Appetitie decreased. Constipated. One hard stool day before and vomtiting once.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Heart rate increased, Throat tightness
Clinical narrative: 0954 patient c\o throat tightness and coughing. C\O racing pulse. B\P 117/73, pulse 63, resp. - 20. O2 sat % 98%. Kenalog 20mg given IM per provider orders. 1032 vs - 118/77, 56 and 18. Pt discharged at 1100 alert and no distress.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Disorientation, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Sweating/perspiration, discoloration (pallor), dizziness, disorientation. BP 100/62 patient laid down ammonia capsule administered.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Skin discolouration
Clinical narrative: Sweating/perspiration, discoloration (pallor), dizziness, disorientation. BP 100/62 patient laid down ammonia capsule administered.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood test normal, Computerised tomogram normal, Electroencephalogram, Grand mal convulsion
Clinical narrative: 7th grade PE at 1100, health, given ADACEL and MENACTRA. At about 2000 - generalized T.C. seizure (2 min). No fever.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Basophil percentage, Haemoglobin increased, Headache, Lymphocyte percentage decreased, Monocyte percentage
Clinical narrative: 7/6 1:30AM fever to 103 degrees - all day - nausea, headache.  F/u clinic visit -  after blood draw.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nausea, Neutrophil percentage increased, Pyrexia, White blood cell count normal
Clinical narrative: 7/6 1:30AM fever to 103 degrees - all day - nausea, headache.  F/u clinic visit -  after blood draw.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Tenderness
Clinical narrative: Localized tenderness, redness, erythema.  Responded rapidly, well to cold packs overnight.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Fatigue, Feeling of body temperature change, Headache, Hot flush, Hyperhidrosis
Clinical narrative: Headaches severe, hot-cold flashes, muscle weakness, sweats, fatigue, pains in leg. Was given 4th shot by mistake.  7/31/2008 MR received for 2 OV's 6/27/08 and 7/9/08 with DX: Fatigue. Pt reports hot flashes, sweats, migraines, leg cramps and fatigue which began after receipt of 4th HPV4 vax (given in error). PE WNL. MD reports no obvious relation between vaccine and fatigue.  Seen again 7/9/08 with same c/o. MD reports no physical abnormalities found.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration, Muscular weakness, Pain in extremity
Clinical narrative: Headaches severe, hot-cold flashes, muscle weakness, sweats, fatigue, pains in leg. Was given 4th shot by mistake.  7/31/2008 MR received for 2 OV's 6/27/08 and 7/9/08 with DX: Fatigue. Pt reports hot flashes, sweats, migraines, leg cramps and fatigue which began after receipt of 4th HPV4 vax (given in error). PE WNL. MD reports no obvious relation between vaccine and fatigue.  Seen again 7/9/08 with same c/o. MD reports no physical abnormalities found.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Feeling of body temperature change, Headache, Inappropriate schedule of drug administration, Sensation of heaviness
Clinical narrative: Headaches severe, hot-cold flashes, muscle weakness, sweats, fatigue, pains in leg. Was given 4th shot by mistake.  7/31/2008 MR received for 2 OV's 6/27/08 and 7/9/08 with DX: Fatigue. Pt reports hot flashes, sweats, migraines, leg cramps and fatigue which began after receipt of 4th HPV4 vax (given in error). PE WNL. MD reports no obvious relation between vaccine and fatigue.  Seen again 7/9/08 with same c/o. MD reports no physical abnormalities found.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Decreased appetite, Feeling of body temperature change, Headache, Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: Headaches severe, hot-cold flashes, muscle weakness, sweats, fatigue, pains in leg. Was given 4th shot by mistake.  7/31/2008 MR received for 2 OV's 6/27/08 and 7/9/08 with DX: Fatigue. Pt reports hot flashes, sweats, migraines, leg cramps and fatigue which began after receipt of 4th HPV4 vax (given in error). PE WNL. MD reports no obvious relation between vaccine and fatigue.  Seen again 7/9/08 with same c/o. MD reports no physical abnormalities found.
Sex: M
Vaccine: FLUN3
Symptoms: Conjunctivitis, Cough, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: A non-serious spontaneous report or INFLUENZA LIKE ILLNESS, FEVER, CONJUNCTIVITIS, DRY COUGH and MUSCLE ACHE has been received from a  physician concerning a male child subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither past medical history nor concomitant medications have been reported. The patient received FluMist vaccine intranasally on an unknown date. Three to four days later, the patient developed an influenza-like illness with fever "up to 105", conjunctivitis, dry cough and muscle aches. The reported events lasted for about five days.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Medication error
Clinical narrative: None.  Pt had chicken pox as infant, was given varicella vaccine today.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Pain in extremity, Physical examination
Clinical narrative: Chronic leg pain.  ? First complain my have preceded (9/7/05) but increased over past 4 checks.
Age: 1.6
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Overdose
Clinical narrative: Patient was given two DTaPs, and two Hep A vaccines instead of one DTaP, and one Hep A. Patient is a twin.  No symptoms as yet.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness & slight swelling around injection site, itchy at site only.  BENADRYL q 6-8 hours.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives 1-2 inches on both legs and left side of the abdomen.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Blood testosterone decreased, Depression, Fatigue, Hypogonadism male
Clinical narrative: He received AVA # 1 on 26 Feb 00 and he reported that his arm became sore with slight swelling and he had flu like symptoms for a couple of days. He also reported that he felt fatigued did not fully resolve. He received AVA # 2 on 11 Mar 00 and he does not recall anything out of the ordinary only that his fatigue persisted, and again reported the same with AVA # 3 on 23 Mar 00. He does not recall any immediate worsening of the fatigue. Three to four months after AVA # 3 he began to notice problems with anxiety and depression. He denied any changes in his life at that time and he denied stress. He sought medical attention in Aug 2000 and began treatment. He denied any past problems with anxiety or depression. He began to notice problems with his PT in Sep in that he found it difficult to complete and he felt worse following his PT. He reported he was previously in good shape and now he later that fall he failed his PT. He was on PMPQ status while being treated with antidepressants. He felt that the medication did not work and felt that it made him more anxious. He was beginning to gain weight and was unable to loose wt despite running 1-2 miles 1-2 times weekly. In late 2003 he was diagnosed with hypogonadism. He did have a daughter in June 2002. He started noticing severe fatigue over the last 2-3 yrs and began feeling tired at work. He had spent 9 yrs working the night shift with every Tuesday and Saturday night off. He stated that he always felt tired while working the night shift during the nine years. While he was deployed he worked the day shift. He would go to bed at 11pm, fall and stay asleep until he woke up at 5:30 am. He stated he felt refreshed when he awoken. He stated he could not do his full PT because he could not keep up with the level of intensity due to his decrease testosterone. He did state that he felt tired but stated he was getting enough rest. He stated that his fatigue increased after exercise. He returned from his deployment in Apr 06 and for one week he worked an evening shift from 1830-0130. He noticed he had problems staying awake and felt himself becoming more tired. He had reduce his hours because of the fatigue. He did not work much during the month of May because on ongoing medical exams. He currently goes to sleep at 0400-0500 and awakens at 0900-1000 hrs and never feeling fully rested. He will start this week working form 1430-2300. Overall he states that his major health concerns are hypogonadism with decrease testosterone and fatigue; Symptoms: Anxiety, Erythema, Swelling, Fatigue, Malaise >60 Days.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Impaired work ability, Influenza like illness, Oedema peripheral, Pain in extremity, Physical examination abnormal
Clinical narrative: He received AVA # 1 on 26 Feb 00 and he reported that his arm became sore with slight swelling and he had flu like symptoms for a couple of days. He also reported that he felt fatigued did not fully resolve. He received AVA # 2 on 11 Mar 00 and he does not recall anything out of the ordinary only that his fatigue persisted, and again reported the same with AVA # 3 on 23 Mar 00. He does not recall any immediate worsening of the fatigue. Three to four months after AVA # 3 he began to notice problems with anxiety and depression. He denied any changes in his life at that time and he denied stress. He sought medical attention in Aug 2000 and began treatment. He denied any past problems with anxiety or depression. He began to notice problems with his PT in Sep in that he found it difficult to complete and he felt worse following his PT. He reported he was previously in good shape and now he later that fall he failed his PT. He was on PMPQ status while being treated with antidepressants. He felt that the medication did not work and felt that it made him more anxious. He was beginning to gain weight and was unable to loose wt despite running 1-2 miles 1-2 times weekly. In late 2003 he was diagnosed with hypogonadism. He did have a daughter in June 2002. He started noticing severe fatigue over the last 2-3 yrs and began feeling tired at work. He had spent 9 yrs working the night shift with every Tuesday and Saturday night off. He stated that he always felt tired while working the night shift during the nine years. While he was deployed he worked the day shift. He would go to bed at 11pm, fall and stay asleep until he woke up at 5:30 am. He stated he felt refreshed when he awoken. He stated he could not do his full PT because he could not keep up with the level of intensity due to his decrease testosterone. He did state that he felt tired but stated he was getting enough rest. He stated that his fatigue increased after exercise. He returned from his deployment in Apr 06 and for one week he worked an evening shift from 1830-0130. He noticed he had problems staying awake and felt himself becoming more tired. He had reduce his hours because of the fatigue. He did not work much during the month of May because on ongoing medical exams. He currently goes to sleep at 0400-0500 and awakens at 0900-1000 hrs and never feeling fully rested. He will start this week working form 1430-2300. Overall he states that his major health concerns are hypogonadism with decrease testosterone and fatigue; Symptoms: Anxiety, Erythema, Swelling, Fatigue, Malaise >60 Days.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Pyrexia, Tenderness
Clinical narrative: Infant developed 104 fever the next day.  (was 101.5 late that evening after vaccination).  Erythema, tenderness left thigh.  Temperature 103.3 in office the next day (7/16/08).  Possible left thigh cellulitis.  Treated with Roephn IM and Keflex.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: No known reported averse event.
Age: 1.2
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Heart rate increased, Pyrexia, Rash, Tachypnoea
Clinical narrative: Had vaccines on 7/14/08.  At 1015 7/15/08 pt developed fever 101.7 (rectal) and rash across chest + L arm, L thigh + R calf.  HR of 180 and was tachypnic.  Seen in ER and given TYLENOL.  Followed up 7/16/08 at pediatrics for monitoring.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician and an office manager concerning an approximately 18 year old female who on an unspecified date was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot #660391/0063X). After receiving GARDASIL the patient fainted. At the time of the report, it was unknown if the patient had recovered from the event. Unspecified medical attention was sought. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Asthenia, Hypotonia, Musculoskeletal stiffness, Pain, Unresponsive to stimuli
Clinical narrative: Information has been received from a medical assistant concerning a 12 year old female with no medical history, who on 02-JUN-2008 at 11:20 was vaccinated IM in the left arm with a first dose of GARDASIL (Lot# 659962/1740U). Concomitant vaccinations included a first dose of MENACTRA (Lot# U2552AA), administered IM in the left arm, and a first dose of ADACEL (Lot# C2825AA) administered IM in the right arm. There were no illnesses at the time of vaccination. It was reported that the MENACTRA had been administered first, then GARDASIL, and then ADACEL. The child complained about pain after administration of GARDASIL. The medical assistant proceeded to administer the ADACEL and at 11:20 the child fainted upon the needle being withdrawn. The child's eyes were open and glossy, but was unresponsive. The child's arms were tightened and clutched together. The child also voided during this time. The child "came to" after about 20 seconds. No laboratory diagnostics were performed. The patient recovered on 02-JUN-2008. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Incontinence, Muscle contractions involuntary, Pain, Syncope, Unresponsive to stimuli
Clinical narrative: Information has been received from a medical assistant concerning a 12 year old female with no medical history, who on 02-JUN-2008 at 11:20 was vaccinated IM in the left arm with a first dose of GARDASIL (Lot# 659962/1740U). Concomitant vaccinations included a first dose of MENACTRA (Lot# U2552AA), administered IM in the left arm, and a first dose of ADACEL (Lot# C2825AA) administered IM in the right arm. There were no illnesses at the time of vaccination. It was reported that the MENACTRA had been administered first, then GARDASIL, and then ADACEL. The child complained about pain after administration of GARDASIL. The medical assistant proceeded to administer the ADACEL and at 11:20 the child fainted upon the needle being withdrawn. The child's eyes were open and glossy, but was unresponsive. The child's arms were tightened and clutched together. The child also voided during this time. The child "came to" after about 20 seconds. No laboratory diagnostics were performed. The patient recovered on 02-JUN-2008. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, RV5, DTAP, RV5, RV5
Symptoms: Convulsion, Diarrhoea, Pyrexia, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Information has been received from a consumer concerning her child, a 4 month old female with no medical history or allergies, who on 17-MAR-2008 (no adverse effects reported) and 28-May-2008 was vaccinated po with the first and second dose respectively of ROTATEQ (second dose lot # 660291/1829U). Concomitant therapy included amoxicillin. It was reported that on 28-MAY-2008 14 hours after receiving ROTATEQ the patient began vomiting which lasted for 16 hours. On approximately 29-MAY-2008 (20 hours afte receiving ROTATEQ the patient had diarrhea which lasted for four days. It was reported that the patient sought medical attention (unspecified) and an ultrasound was done (date, and results not provided). The consumer reported that the patient recovered and returned to "normal" as of 03-Jun-2008. A product qualty complaint was not involved. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, RV5, DTAP, RV5, RV5
Symptoms: Diarrhoea, Pyrexia, Ultrasound scan, Vomiting
Clinical narrative: Information has been received from a consumer concerning her child, a 4 month old female with no medical history or allergies, who on 17-MAR-2008 (no adverse effects reported) and 28-May-2008 was vaccinated po with the first and second dose respectively of ROTATEQ (second dose lot # 660291/1829U). Concomitant therapy included amoxicillin. It was reported that on 28-MAY-2008 14 hours after receiving ROTATEQ the patient began vomiting which lasted for 16 hours. On approximately 29-MAY-2008 (20 hours afte receiving ROTATEQ the patient had diarrhea which lasted for four days. It was reported that the patient sought medical attention (unspecified) and an ultrasound was done (date, and results not provided). The consumer reported that the patient recovered and returned to "normal" as of 03-Jun-2008. A product qualty complaint was not involved. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, RV5, DTAP, RV5, RV5
Symptoms: Diarrhoea, Ultrasound scan, Vomiting
Clinical narrative: Information has been received from a consumer concerning her child, a 4 month old female with no medical history or allergies, who on 17-MAR-2008 (no adverse effects reported) and 28-May-2008 was vaccinated po with the first and second dose respectively of ROTATEQ (second dose lot # 660291/1829U). Concomitant therapy included amoxicillin. It was reported that on 28-MAY-2008 14 hours after receiving ROTATEQ the patient began vomiting which lasted for 16 hours. On approximately 29-MAY-2008 (20 hours afte receiving ROTATEQ the patient had diarrhea which lasted for four days. It was reported that the patient sought medical attention (unspecified) and an ultrasound was done (date, and results not provided). The consumer reported that the patient recovered and returned to "normal" as of 03-Jun-2008. A product qualty complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: HPV4, HEP
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Umbilical cord around neck
Clinical narrative: Information has been received from medical records concerning an 8 day old female with hyperbilirubinaemia and a history of umbilical cord around neck, transient tachypnoea of the newborn, metabolic acidosis and hypvolaemia who on 20-APR-2008 was vaccinated with the first dose of RECOMBIVAX HB (manufacturer unknown). On 02-May-2008, the patient was seen by the physician for diaper rash, candidal diaper dermatitis. The patient was prescribed LOTRIMIN over the counter along with some hydrocortisone for symptomatic relief of the rash twice a day for 1 week. She was also instructed to use (TRIPLE PASTE with VASELINE) as a barrier protection over the diaper area. The mother was instructed to use a larger diaper to help with aeration. Additional information has been requested.
Sex: F
Vaccine: HPV4, HEP
Symptoms: Candida nappy rash, Dermatitis diaper
Clinical narrative: Information has been received from medical records concerning an 8 day old female with hyperbilirubinaemia and a history of umbilical cord around neck, transient tachypnoea of the newborn, metabolic acidosis and hypvolaemia who on 20-APR-2008 was vaccinated with the first dose of RECOMBIVAX HB (manufacturer unknown). On 02-May-2008, the patient was seen by the physician for diaper rash, candidal diaper dermatitis. The patient was prescribed LOTRIMIN over the counter along with some hydrocortisone for symptomatic relief of the rash twice a day for 1 week. She was also instructed to use (TRIPLE PASTE with VASELINE) as a barrier protection over the diaper area. The mother was instructed to use a larger diaper to help with aeration. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been receive from a certified medical assistant concerning a 9 week old infant with no known allergies or pertinent medical history who on 27-MAY-2008 was vaccinated with ROTATEQ. There was no concomitant medication. Subsequently, on 28-MAY-2008 the patient experienced diarrhea and blue stools from the vaccination. It was reported that the patient's stool was sent for analysis and came back positive for rotavirus. The patient's stool was not checked for blood. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information has been received from a health professional concerning this 8 week old male child with no known allergies or pertinent medical history who on 27-MAY-2008 was vaccinated orally with a first dose of ROTATEQ (lot # 660548/0501X). Concomitant vaccination on the same day included a first dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified (+) tetanus toxoid (lot # C2953AA) (manufacturer unknown) IM in the left leg, a first dose of PREVNAR (lot 3 B70145K) IM in the right lower leg and a first dose of ACTHIB (lot # UF362AA) IM in the Right upper leg. There was no illness at the time of vaccination. Subsequently, on 28-MAY-2008 the patient started with loose stools. Medical attention was sought, the patient had a doctor's had a doctor's visit and a stool specimen was sent to the lab. It was reported that the stool specimen was positive for rotavirus. At the time of the report the patient recovered from the loose stools on an unspecified date. The outcome of the blue stools (feces discoloured) was not reported. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Faeces discoloured, Rotavirus infection, Rotavirus test positive, Stool analysis abnormal
Clinical narrative: Information has been receive from a certified medical assistant concerning a 9 week old infant with no known allergies or pertinent medical history who on 27-MAY-2008 was vaccinated with ROTATEQ. There was no concomitant medication. Subsequently, on 28-MAY-2008 the patient experienced diarrhea and blue stools from the vaccination. It was reported that the patient's stool was sent for analysis and came back positive for rotavirus. The patient's stool was not checked for blood. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information has been received from a health professional concerning this 8 week old male child with no known allergies or pertinent medical history who on 27-MAY-2008 was vaccinated orally with a first dose of ROTATEQ (lot # 660548/0501X). Concomitant vaccination on the same day included a first dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified (+) tetanus toxoid (lot # C2953AA) (manufacturer unknown) IM in the left leg, a first dose of PREVNAR (lot 3 B70145K) IM in the right lower leg and a first dose of ACTHIB (lot # UF362AA) IM in the Right upper leg. There was no illness at the time of vaccination. Subsequently, on 28-MAY-2008 the patient started with loose stools. Medical attention was sought, the patient had a doctor's had a doctor's visit and a stool specimen was sent to the lab. It was reported that the stool specimen was positive for rotavirus. At the time of the report the patient recovered from the loose stools on an unspecified date. The outcome of the blue stools (feces discoloured) was not reported. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: TYP, YF, TYP, YF, TYP, YF
Symptoms: Respiratory distress
Clinical narrative: This 5-year-old male, with a long-standing history of allergic rhinitis, asthma, and eczema, received typhoid and yellow fever vaccinations at the Clinic in preparation for international travel. He had previously received typhoid, but not yellow fever. Approximately 15-20 minutes after the immunization, he developed coughing and wheezing and, after approximately 10 more minutes, developed diffuse retractions and some perioral cyanosis. He was given 2 doses of epinephrine 0.2 mg and 0.5 mg SC in the clinic. En route to the ED, EMS gave him an additional 0.25 mg of epinephrine SC, diphenhydramine 25 mg IM, and an albuterol/ipratropium nebulization. In the ED, he continued to wheeze and was given 2 additional albuterol/ipratropium nebulizations and 1 dose of dexamethasone 12 mg PO. His symptoms resolved about 3 hours after the onset. While in the ED, he developed erythematous wheals surrounding the injection site that the parents reported to be the site of the typhoid immunization. The father reported that the patient had had severe asthma attacks in the past, but had never been hospitalized or intubated. The patient had no recent illnesses or recent sick contacts and no egg allergy. He was admitted and discharged after 1 day in stable condition.
Age: 5.0
Sex: M
Vaccine: TYP, YF, TYP, YF, TYP, YF
Symptoms: Cough, Cyanosis, Injection site erythema, Injection site urticaria, Respiratory disorder
Clinical narrative: This 5-year-old male, with a long-standing history of allergic rhinitis, asthma, and eczema, received typhoid and yellow fever vaccinations at the Clinic in preparation for international travel. He had previously received typhoid, but not yellow fever. Approximately 15-20 minutes after the immunization, he developed coughing and wheezing and, after approximately 10 more minutes, developed diffuse retractions and some perioral cyanosis. He was given 2 doses of epinephrine 0.2 mg and 0.5 mg SC in the clinic. En route to the ED, EMS gave him an additional 0.25 mg of epinephrine SC, diphenhydramine 25 mg IM, and an albuterol/ipratropium nebulization. In the ED, he continued to wheeze and was given 2 additional albuterol/ipratropium nebulizations and 1 dose of dexamethasone 12 mg PO. His symptoms resolved about 3 hours after the onset. While in the ED, he developed erythematous wheals surrounding the injection site that the parents reported to be the site of the typhoid immunization. The father reported that the patient had had severe asthma attacks in the past, but had never been hospitalized or intubated. The patient had no recent illnesses or recent sick contacts and no egg allergy. He was admitted and discharged after 1 day in stable condition.
Age: 5.0
Sex: M
Vaccine: TYP, YF, TYP, YF, TYP, YF
Symptoms: Wheezing
Clinical narrative: This 5-year-old male, with a long-standing history of allergic rhinitis, asthma, and eczema, received typhoid and yellow fever vaccinations at the Clinic in preparation for international travel. He had previously received typhoid, but not yellow fever. Approximately 15-20 minutes after the immunization, he developed coughing and wheezing and, after approximately 10 more minutes, developed diffuse retractions and some perioral cyanosis. He was given 2 doses of epinephrine 0.2 mg and 0.5 mg SC in the clinic. En route to the ED, EMS gave him an additional 0.25 mg of epinephrine SC, diphenhydramine 25 mg IM, and an albuterol/ipratropium nebulization. In the ED, he continued to wheeze and was given 2 additional albuterol/ipratropium nebulizations and 1 dose of dexamethasone 12 mg PO. His symptoms resolved about 3 hours after the onset. While in the ED, he developed erythematous wheals surrounding the injection site that the parents reported to be the site of the typhoid immunization. The father reported that the patient had had severe asthma attacks in the past, but had never been hospitalized or intubated. The patient had no recent illnesses or recent sick contacts and no egg allergy. He was admitted and discharged after 1 day in stable condition.
Age: 5.0
Sex: M
Vaccine: TYP, YF, TYP, YF, TYP, YF
Symptoms: Anaphylactic reaction, Asthma, Respiratory distress, Wheezing
Clinical narrative: This 5-year-old male, with a long-standing history of allergic rhinitis, asthma, and eczema, received typhoid and yellow fever vaccinations at the Clinic in preparation for international travel. He had previously received typhoid, but not yellow fever. Approximately 15-20 minutes after the immunization, he developed coughing and wheezing and, after approximately 10 more minutes, developed diffuse retractions and some perioral cyanosis. He was given 2 doses of epinephrine 0.2 mg and 0.5 mg SC in the clinic. En route to the ED, EMS gave him an additional 0.25 mg of epinephrine SC, diphenhydramine 25 mg IM, and an albuterol/ipratropium nebulization. In the ED, he continued to wheeze and was given 2 additional albuterol/ipratropium nebulizations and 1 dose of dexamethasone 12 mg PO. His symptoms resolved about 3 hours after the onset. While in the ED, he developed erythematous wheals surrounding the injection site that the parents reported to be the site of the typhoid immunization. The father reported that the patient had had severe asthma attacks in the past, but had never been hospitalized or intubated. The patient had no recent illnesses or recent sick contacts and no egg allergy. He was admitted and discharged after 1 day in stable condition.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Laboratory test, Pain in extremity, X-ray
Clinical narrative: Information has been received from a registered nurse concerning a 25 old female who on 16-APR-2008 was vaccinated with a first dose of GARDASIL in the left deltoid. On 18-APR-2008, the patient complained of a sore left arm. On 02-MAY-2008, the sore left arm was treated with heat. On 06-MAY-2008, the arm was still very sore and was treated with ice, heat and ibuprofen. On 12-MAY-2008, the sore left arm was not improving and the patient was referred for an x-ray. The x-ray showed a normal result. On 27-MAY-2008, the patient still complained of a sore left upper arm and was referred to orthopedics for an evaluation of possible unrelated bursitis. It was reported the patient did not go for the evaluation. On approximately 16-JUN-2008, the left arm starting to not be as sore. At the time of the report the outcome of the sore left arm was recovering. The outcome of the possible unrelated bursitis was unknown. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, X-ray normal
Clinical narrative: Information has been received from a registered nurse concerning a 25 old female who on 16-APR-2008 was vaccinated with a first dose of GARDASIL in the left deltoid. On 18-APR-2008, the patient complained of a sore left arm. On 02-MAY-2008, the sore left arm was treated with heat. On 06-MAY-2008, the arm was still very sore and was treated with ice, heat and ibuprofen. On 12-MAY-2008, the sore left arm was not improving and the patient was referred for an x-ray. The x-ray showed a normal result. On 27-MAY-2008, the patient still complained of a sore left upper arm and was referred to orthopedics for an evaluation of possible unrelated bursitis. It was reported the patient did not go for the evaluation. On approximately 16-JUN-2008, the left arm starting to not be as sore. At the time of the report the outcome of the sore left arm was recovering. The outcome of the possible unrelated bursitis was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dysarthria, Memory impairment
Clinical narrative: Information has been received from a nurse concerning a 16 year old female with migraine headaches who on 18-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL vaccine (yeast) (lot# 659439/1267U). Concomitant therapy included aspirin (+) caffeine (+) cinnamedrine (MIDOL) and ibuprofen. On 18-MAR-2008 the patient experienced dizziness, slurred speech and forgetfulness. Subsequently, the patient recovered on an unspecified date from dizziness, slurred speech and forgetfulness. The patient did not seek medical attention, the AE was discovered during follow up. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Dizziness, Eye movement disorder, Feeling cold, Mydriasis, Palpitations
Clinical narrative: Information has been received from a licensed practical nurse concerning a 46 year old (reported as a 38 year old) female with an allergy to codeine and sulfonamide, who on 12-JUN-2008 at 13:15 was vaccinated in the deltoid with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Lot# 655123/1216F).  The patient was not sick at the time of the vaccination.  On 12-JUN-2008 the patient was coaching a ball game and became dizzy to the point that she had to leave the field.  The patient's heart was racing and her friend said that her "eyes were completely dilated, one was not focusing, and the other was aimed way off to the left."  The symptoms lasted about one minute, but the racing heart continued.  The patient felt cold with goosebumps afterwards.  The patient reported that the symptoms did not occur again and that the only thing different that day was that she received the vaccination.  No laboratory diagnostics were performed.  The patient recovered on 12-JUN-2008.  Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Piloerection, Vision blurred
Clinical narrative: Information has been received from a licensed practical nurse concerning a 46 year old (reported as a 38 year old) female with an allergy to codeine and sulfonamide, who on 12-JUN-2008 at 13:15 was vaccinated in the deltoid with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Lot# 655123/1216F).  The patient was not sick at the time of the vaccination.  On 12-JUN-2008 the patient was coaching a ball game and became dizzy to the point that she had to leave the field.  The patient's heart was racing and her friend said that her "eyes were completely dilated, one was not focusing, and the other was aimed way off to the left."  The symptoms lasted about one minute, but the racing heart continued.  The patient felt cold with goosebumps afterwards.  The patient reported that the symptoms did not occur again and that the only thing different that day was that she received the vaccination.  No laboratory diagnostics were performed.  The patient recovered on 12-JUN-2008.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Abdominal pain, Blood test, Diplopia, Fatigue, Hypoaesthesia
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM - Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Leukoencephalomyelitis, Lumbar puncture, Nerve injury, Nuclear magnetic resonance imaging abnormal, Sensation of heaviness
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM - Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Tremor, VIth nerve paralysis
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM - Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Diplopia, Leukoencephalomyelitis, Nuclear magnetic resonance imaging
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM - Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Abdominal pain, Diplopia, Dizziness, Fatigue, Hypoaesthesia
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM - Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Hypoaesthesia, Leukoencephalomyelitis, Lumbar puncture, Multiple sclerosis, Muscular weakness
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM - Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal, Physiotherapy, Sensation of heaviness, Spinal disorder, Tremor
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM - Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: VIth nerve paralysis, Vaginal disorder, Visual impairment
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM - Acute Disseminated Encephalomyelitis.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PPV, RV5, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a consumer concerning his 28 day old son with no known allergies who was born prematurely after a gestation period of 33 weeks and 4 days who on 16-JUN-2008 was vaccinated orally with a "single dose" of ROTATEQ.  Concomitant vaccinations on that same day included PEDVAXHIB (OMPC) (manufacturer unknown), PNEUMOVAX 23 (manufacturer unknown), and DTaP (manufacturer unknown).  Subsequently, on 16-JUN-2008 the patient experienced extreme agitation and crying.  It was reported that the patient appeared to be in pain.  Unspecified medical attention was sought.  There were no lab studies performed.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  Additional information has been requested.  The patient's twin sisters (WAES # 0806USA03071) (WAES # 0807USA01577) also had an adverse event after vaccination with ROTATEQ.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PPV, RV5, RV5
Symptoms: Agitation, Crying, Inappropriate schedule of drug administration, Pain
Clinical narrative: Information has been received from a consumer concerning his 28 day old son with no known allergies who was born prematurely after a gestation period of 33 weeks and 4 days who on 16-JUN-2008 was vaccinated orally with a "single dose" of ROTATEQ.  Concomitant vaccinations on that same day included PEDVAXHIB (OMPC) (manufacturer unknown), PNEUMOVAX 23 (manufacturer unknown), and DTaP (manufacturer unknown).  Subsequently, on 16-JUN-2008 the patient experienced extreme agitation and crying.  It was reported that the patient appeared to be in pain.  Unspecified medical attention was sought.  There were no lab studies performed.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  Additional information has been requested.  The patient's twin sisters (WAES # 0806USA03071) (WAES # 0807USA01577) also had an adverse event after vaccination with ROTATEQ.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PPV, RV5, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant concerning a 28 day old triplet patient who on 16-JUN-2008 was vaccinated po with the first 2.0 ml dose of ROTATEQ (lot # 660596/0211X). No adverse event was reported. It was reported that the patient sought medical attention at the office. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008. Follow-up information was received from a certified medical assistant who reported that the patient was in the clinic on 16-JUN-2008 for check-ups and due to computer error regarding their birthdate (listed as 19-MAR-2008 but actually 19-MAY-2008). It was presumed that the patient was 2 3/4 months and actually they were 28 days old. The patient received the 2 month vaccines by accident. No adverse reactions were reported to date. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PPV, RV5, RV5
Symptoms: Agitation, Crying, Inappropriate schedule of drug administration, Pain
Clinical narrative: Information has been received from a certified medical assistant concerning a 28 day old triplet patient who on 16-JUN-2008 was vaccinated po with the first 2.0 ml dose of ROTATEQ (lot # 660596/0211X). No adverse event was reported. It was reported that the patient sought medical attention at the office. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008. Follow-up information was received from a certified medical assistant who reported that the patient was in the clinic on 16-JUN-2008 for check-ups and due to computer error regarding their birthdate (listed as 19-MAR-2008 but actually 19-MAY-2008). It was presumed that the patient was 2 3/4 months and actually they were 28 days old. The patient received the 2 month vaccines by accident. No adverse reactions were reported to date. Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PPV, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a consumer concerning his 28 day old daughter with  no known allergies who was born prematurely after a gestation period of 33 weeks and 4 days who on 16-JUN-2008 was vaccinated orally with a "single dose" of ROTATEQ. Concomitant vaccinations on the same day included PEDIVAX HIB, PNEUMOVAX 23, and diphtheria toxoid (+) pertussis acellular vaccine
Age: 0.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, DTAPHEPBIP, PPV, RV5, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a consumer concerning his 28 day old daughter with no known allergies who was born prematurely after a gestation period of 33 weeks and 4 days who on 16-JUN-2008 was vaccinated orally with a "single dose" of ROTATEQ. Concomitant vaccinations on the same day included PEDVAX HIB, PNEUMOVAX 23, and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). Subsequently, on 16-JUN-2008 the patient experienced extreme agitation and crying. It was reported that the patient appeared to be in pain. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. The patient's twin sister (WAES # 0806USA03071) and twin brother (WAES # 0807USA01578) also had an adverse event after vaccination with ROTATEQ.