chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Body temperature increased, Erythema, Nausea, Oedema peripheral, Vomiting
Clinical narrative: Swelling and redness of arm. Swelling approximately 5 cm, erythema > 26cm also nausea, vomiting, increase temp. This is in follow-up report (s) previously submitted on 4/6/2007. Information has been received from a 24 year old female and her physician. On 06-MAR-2007, the patient was vaccinated intramuscularly with a 0.5 ml third dose of GARDASIL. The physician reported that this was the patient's first dose of GARDASIL. The patient had no relevant medical history or illness at the time of vaccination. Concomitant therapy included YASMIN. The patient mentioned that she did not have any problems with dose 1 or 2 and that these doses were given in the outer part of her arm. She reported that the third dose was given less in the outer area and towards the inner arm but still in the muscle. On 06-MAR-2007, the patient experienced red, sore lump at the injection site. The physician reported that on 07-MAR-2007, the patient developed swelling and redness of the arm with swelling of approximatley 5 cm and erythema greater than 26 cm. On 07-MAR-2007, the patient experienced nausea, started to throw up, and she developed a fever. On 09-MAR-2007, the patient went tot he emergency room due to continued vomiting and dizziness. She was treated with intravenous fluid and was released at approximatley 04:00 pm. As of 12-MAR-2007, the patient continued to experience dizziness and nausea. At the time of this report, the outcome was unknown as per the physician. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Fluid replacement, Nausea, Pyrexia, Vomiting
Clinical narrative: Swelling and redness of arm. Swelling approximately 5 cm, erythema > 26cm also nausea, vomiting, increase temp. This is in follow-up report (s) previously submitted on 4/6/2007. Information has been received from a 24 year old female and her physician. On 06-MAR-2007, the patient was vaccinated intramuscularly with a 0.5 ml third dose of GARDASIL. The physician reported that this was the patient's first dose of GARDASIL. The patient had no relevant medical history or illness at the time of vaccination. Concomitant therapy included YASMIN. The patient mentioned that she did not have any problems with dose 1 or 2 and that these doses were given in the outer part of her arm. She reported that the third dose was given less in the outer area and towards the inner arm but still in the muscle. On 06-MAR-2007, the patient experienced red, sore lump at the injection site. The physician reported that on 07-MAR-2007, the patient developed swelling and redness of the arm with swelling of approximatley 5 cm and erythema greater than 26 cm. On 07-MAR-2007, the patient experienced nausea, started to throw up, and she developed a fever. On 09-MAR-2007, the patient went tot he emergency room due to continued vomiting and dizziness. She was treated with intravenous fluid and was released at approximatley 04:00 pm. As of 12-MAR-2007, the patient continued to experience dizziness and nausea. At the time of this report, the outcome was unknown as per the physician. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Lacrimation increased, Oedema
Clinical narrative: Edema, erythema, watery right eye.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Urticaria
Clinical narrative: C/O Welts around injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: 2 X 2 in red warm area.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Pt stated she had slight fever after 1st shot.
Age: 1.5
Sex: M
Vaccine: IPV, MMRV, PNC
Symptoms: Erythema, Rash papular
Clinical narrative: Red papules scatter over trunk anterior trunk greatest density no vesicles.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Allergy to vaccine, Erythema, Swelling
Clinical narrative: Swelling and redness right shoulder for 1 1/2 day. Had vaccines 3/12/07.
Age: 2.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: 03/08/2007 Received call that child's leg was red approx 2 1/2" in diameter, area was hard and warm to touch. Mother used cool cloth and acetaminophen for comfort. 03/09/07 talked to mother, stated area was still red but not as hard lump.  .25 size. No redness notes.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Blood glucose, Head injury, Loss of consciousness, Mouth haemorrhage, Pallor
Clinical narrative: Pt while standing at Counter with mother and sister for discharge paper, fainted and hurt his mouth and head with edge of the door frame. LOC (few second). According to mother pt had twisting of hands no eye rolling, no drooling. Pt was pale, blood in mouth.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Pt while standing at Counter with mother and sister for discharge paper, fainted and hurt his mouth and head with edge of the door frame. LOC (few second). According to mother pt had twisting of hands no eye rolling, no drooling. Pt was pale, blood in mouth.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Rt arm biceps and tricep-deltoid area. Red, swollen, warm to touch. Advil-Ice, Clarinex 5 mg QD.
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Body temperature increased, Drug ineffective, Rash, Varicella
Clinical narrative: Pt given Hep A #1 and Varivax #1 on 3-2-07. Pt seen in our office 3-6-07 for temp 101.3 and rash at 1:30 pm. Dx post vaccine chicken pox rash. 3-6-07 temp 103.9R and rash allover. Mom took pt to hosp ER. Dx ear infection and viral rash.
Age: 1.6
Sex: M
Vaccine: HEPA, HIBV, MMR
Symptoms: Blood culture, Culture urine, Febrile convulsion, Full blood count, Pyrexia
Clinical narrative: Approximately 7 days after receiving vaccine he developed very high fevers >103 which lasted for 8 days. He also had a febrile seizure on 2/23/07 which caused a visit to local ER full workup. Over the course of the 8 days of febrile illness he saw his doctor twice developed thrombocytopenia, weight less of >10% of his body weight and is still trying to recover. No more vaccines/poisons for him.
Age: 1.6
Sex: M
Vaccine: HEPA, HIBV, MMR
Symptoms: Thrombocytopenia, Viral infection, Weight decreased
Clinical narrative: Approximately 7 days after receiving vaccine he developed very high fevers >103 which lasted for 8 days. He also had a febrile seizure on 2/23/07 which caused a visit to local ER full workup. Over the course of the 8 days of febrile illness he saw his doctor twice developed thrombocytopenia, weight less of >10% of his body weight and is still trying to recover. No more vaccines/poisons for him.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash began 3/2/07 evaluated in office by doctor. Erythema multiform rash-arms/legs extensor surfaces and face-mild trunk involvement, no palms or soles, no oral lesions.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Aggression, Eye irritation, Skin discolouration
Clinical narrative: Around three minutes after, pt had a tantrum and started rubbing his eyes and spots appeared on pt's forehead.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Reddened area 2 inch by 2 inch, slightly warm to touch in the area where Varicella was given.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Tenderness
Clinical narrative: Patient called clinic AM on 2/28/07 to report that arm was reddened and tender. Declined office visit on 2/28/07. Was on her way out of town and would apply intermittent ice pack and take Tylenol prn. Will come to clinic 3/1/07 if no better or has questions when she return to town. Will seek treatment out of town 2/28/07, if worse.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Oedema, Skin lesion, Skin warm
Clinical narrative: Pt received Dtap R anterior thigh 3/5/07 he was seen in office 3/7/07 with warm erythematous, mildly elevated lesion R anterior thigh, + area of erythema/edema, patella.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Crying, Headache, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: 3/6/07 1:30am headache, crying, low grade fever, 3/6/07 10:15 am headache, crying temp 99.1, 3/6/07 3:45 pm headache, crying temp 101.1, 3/8/07 9:00 am headache, sore throat, to Dr office temp 99.4.
Age: 18.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Asthenia, Nausea, Night sweats, Pain
Clinical narrative: Took 1st dose Vivotif. After 24 hrs felt achy, nauseated and faint within 36 hours he developed night sweats which continued 2/1 night. 48 hours post dose he feels very weak. After discussion he decided to take 2nd dose at 70 hrs. 18 hrs post dose he says he has slight abd cramping but no other Sx.
Age: 18.0
Sex: M
Vaccine: TYP
Symptoms: Syncope
Clinical narrative: Took 1st dose Vivotif. After 24 hrs felt achy, nauseated and faint within 36 hours he developed night sweats which continued 2/1 night. 48 hours post dose he feels very weak. After discussion he decided to take 2nd dose at 70 hrs. 18 hrs post dose he says he has slight abd cramping but no other Sx.
Age: 1.3
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Swelling and erythema at injection site Prevnar. Vomiting started after 4 hours, lasted 6 hours, 2 diarrhea stools. Asymptomatic in 36 hours.
Age: 1.61
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt received Dtap on 2/27/07. Lt dorsum of thigh, indurated erythematous local reaction.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Pain, Paraesthesia, Pruritus
Clinical narrative: C/O itching and pain with movement. Feels tingling sensation in skin of L arm. Erythematous skin of L upper arm from injection site to elbow. Initially there was swelling but currently there is none. Symptoms are resolving.
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Dysphagia, Eyelid oedema, Pharyngeal oedema, Pharyngolaryngeal pain
Clinical narrative: Extremely swollen throat, excruciatingly sore, could not swallow own saliva, very puffy eyelids, localized rash, first noted at 4am 3/6/07 woke me up,  took 4 capsule 3/5 at 8am mild reaction 3/04/07 at 4am. Swelling reduced over day 3/6/07 throat still sore.
Age: 27.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt L arm reddened, swollen, warm approximately 1 1/2 - 2" around injection site (full diameter 1 1/2 - 2").
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Hypokinesia, Inflammation, Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: Developed pain at site of injection after receiving injection in L deltoid. Progressed to continual L shoulder pain with decreased range of motion.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Nuclear magnetic resonance imaging abnormal
Clinical narrative: Developed pain at site of injection after receiving injection in L deltoid. Progressed to continual L shoulder pain with decreased range of motion.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, hot to the touch, redness.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Angiogram, Headache, Nuclear magnetic resonance imaging, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Initial report received from a physician (who is the patient's grandparent) on 04 December 2006. A 15 year old, female patient (with a medical history of hypothyroidism, positive thyroid antibiotics) developed a headache, 1 week after she received an injection of Menactra (lot number was unknown, route and site of administration not reported) on 09 October 2006. The reporter stated the headaches was no chronic and varied in intensity. The patient also has left sided arm and leg pain. She did not have any illness at the time of vaccination. She was seen by a neurologist and had an MRI, MRH and Sed Rate. At the time of the report, the patient was not recovered.
Age: 1.69
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Full blood count, Full blood count abnormal, Oedema peripheral
Clinical narrative: Extensive swelling of left thigh, started next day (mother noticed), size of an orange and redness from upper thigh to approx 3-4 cm above left knee and laterally.  Patient went to ER and admitted with diagnosis of Cellulitis (suspicion). Admitted 3/4/07-D/C 3/6/07.  03/15/2007 MR received for an ER visit for c/o an erythematous area on the right thigh at the site of the DTaP 2 days prior.    PE: WNL except a 10cm area of moderate swelling on the right thigh.  There is evidence of infection as manifested by moderate erythema, induration, warmth, and mild to moderate tenderness.  Diagnosis:  Leg cellulitis.   Confirmed with vaccine administrator (who verified with mother)  that vaccine was given in the LEFT thigh.
Age: 1.69
Sex: M
Vaccine: DTAP
Symptoms: White blood cell count increased
Clinical narrative: Extensive swelling of left thigh, started next day (mother noticed), size of an orange and redness from upper thigh to approx 3-4 cm above left knee and laterally.  Patient went to ER and admitted with diagnosis of Cellulitis (suspicion). Admitted 3/4/07-D/C 3/6/07.  03/15/2007 MR received for an ER visit for c/o an erythematous area on the right thigh at the site of the DTaP 2 days prior.    PE: WNL except a 10cm area of moderate swelling on the right thigh.  There is evidence of infection as manifested by moderate erythema, induration, warmth, and mild to moderate tenderness.  Diagnosis:  Leg cellulitis.   Confirmed with vaccine administrator (who verified with mother)  that vaccine was given in the LEFT thigh.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Pyrexia
Clinical narrative: Next day after immunization was given. Child woke up with fever of 102.0. Mother gave Tylenol. Few hours later fever elevated and child had a seizure. Mother took child to ER and this time fever was 107.0 had several test done and was sent by helicopter to hospital. Released from hosp 3-2-07. 03/20/07-records received from facility for DOS 02/28/07- Seen in ER at 2:30pm and 8:50pm. Temp ranged from 103.2 (O) to 104.5 (R), DX:pneumonia. Asthmatic bronchitis with cyanotic episodes by history. Dehydration by clinical exam. Shock, hypovolemic. Resp rate 40. Presented to ER with apnea and fever. Duration lasting 50 seconds.  CXR:minimal subsegmental atelectasis. WBC 12. Transferred  03/26/07-records received from receiving facility for DOS 02/28-03/02/07- DC DX: Influenza A viral infection. Febrile seizures. Previously healthy. Temp 104. PE: WNL except for ears mildly erythematous, probably secondary to fever. Maculopapular rash on both cheeks also with candidal rash in groin. During hospitalization one episode of temperature up to 103 associated with abnormal movements lasting a few seconds
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dizziness postural, Electrocardiogram abnormal, Headache
Clinical narrative: Briefly after injection given, pt stood up, said she felt dizzy, chest tightness, headache. 04/17/07-records received from facility for DOS 3/8-3/9/17. DC DX: Neck pressure that was noncardiac.
Age: 1.29
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC, VARCEL
Symptoms: Incorrect dose administered, No adverse effect, Wrong drug administered
Clinical narrative: Pt was given an MMRV in right arm along with a Varicella vaccine in left arm, resulting in 2 Varicella doses during 1 office visit. Both vaccines were administered by two medical assistants. The vial were retrieved from refrigeration by a third medical assistant. All events transpired on 3/14/07. No symptoms have been noted thus far.
Age: 60.0
Sex: F
Vaccine: TYP, VARZOS
Symptoms: Dizziness, Fatigue, Hyperaesthesia, Skin irritation
Clinical narrative: Nerve sensation and irritation in left thigh 7 or 8 inches in diameter, lasting 3 days, starting 3/18 approximately at 6: am. Fatigue and dizziness through the weekend.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody, Full blood count, Headache, Pain, Pain in extremity
Clinical narrative: C/O pain in extremities and headaches since administration of Gardasil (HPV Vaccine), constant pain, rated 6-7/10 on pain scale. Does not interfere with daily activity.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Viral test
Clinical narrative: C/O pain in extremities and headaches since administration of Gardasil (HPV Vaccine), constant pain, rated 6-7/10 on pain scale. Does not interfere with daily activity.
Age: 0.36
Sex: F
Vaccine: IPV, RV5
Symptoms: Otitis media
Clinical narrative: Received Rotateq vaccine on 1-23-07 and 3 D later had developed enough sxs that mom brought her into the clinic. She was diagnosed with bilateral otitis media. Mom read in manufacturer site that this was a possible side effect.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Crying, Skin discolouration
Clinical narrative: Child cried non stop 3 hours after immunization and continued for about 5-6 hours. Urinated 2 times, and legs were slightly purplish after 3 hours for a few minutes.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness mild swelling, mild tenderness at site if injection, spreading to involve most of Right upper extremity.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, C-reactive protein increased, Full blood count, Pyrexia, Rash
Clinical narrative: 9 days after Varicella MMR admin. mom report onset of 101 deg temp. Next day fever subsided but rash started on legs and progressed to all extremities and few on face. Trunk clear. Playful.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Pain, Pruritus, Skin tightness
Clinical narrative: erythema, pruritis, edema of palms, soles, fingertips,  Pain with flexion of fingers, skin taut & shiny.  symptoms started 2/27/07 continued though 3/1/07.  Treated with ibuprofen 200 mg two tabs every 4-6 hours and diphenhyrdamine 25 mg at bedtime.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Oedema peripheral, Rash, Urticaria
Clinical narrative: localized hives and swelling of bilateral lower extremities occurring 5 minutes after vaccination.  Benadryl given at 5 minutes.  However rash resolved completely after 15 minutes. No systemic anaphylactic symptoms.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Pityriasis rosea
Clinical narrative: Developed pityriasis rosea one week after small pox vaccination. Diagnosis made by dermatology.
Age: 53.0
Sex: F
Vaccine: HEP, HEPA, IPV, TYP, YF
Symptoms: Pyrexia, Respiratory disorder
Clinical narrative: 6 days after administration of vaccine, patient had upper respiratory symptoms and low grade fever.  The fever subsequently increased over the next 24 hours to 102.4F.
Age: 34.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Angioneurotic oedema, Chest discomfort, Fatigue, Muscle spasms, Muscle twitching
Clinical narrative: Patient called on day following receiving Tdap and MMR stating that she had onset of tightness in throat & chest beginning approx. 2 hrs. after injections. Also experienced muscle spasms and twitching all over her body and a fine red rash on both lower extremities. No fever or other sx. Pt. self-treated with her child's albuterol inhaler and benadryl.                          Pt. has hx. of celiac disease. No prior hx. of childhood vaccines because "brother was paralyzed after vaccines" and pediatrician withheld vaccines from pt. because of this. No vaccines as adult until now when going to college. No known allergies to medications.                      Pt. was seen in ER on 3/13/07, diagnosed with "angioedema", & treated with albuterol inhaler & benadryl p.o. Advised to return to family physician in 1 wk. for followup. On 3/14/07 pt. continues to have slight tightness in chest, extreme fatigue, and low grade fever. No further muscle cramps.
Age: 34.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Rash, Throat tightness
Clinical narrative: Patient called on day following receiving Tdap and MMR stating that she had onset of tightness in throat & chest beginning approx. 2 hrs. after injections. Also experienced muscle spasms and twitching all over her body and a fine red rash on both lower extremities. No fever or other sx. Pt. self-treated with her child's albuterol inhaler and benadryl.                          Pt. has hx. of celiac disease. No prior hx. of childhood vaccines because "brother was paralyzed after vaccines" and pediatrician withheld vaccines from pt. because of this. No vaccines as adult until now when going to college. No known allergies to medications.                      Pt. was seen in ER on 3/13/07, diagnosed with "angioedema", & treated with albuterol inhaler & benadryl p.o. Advised to return to family physician in 1 wk. for followup. On 3/14/07 pt. continues to have slight tightness in chest, extreme fatigue, and low grade fever. No further muscle cramps.
Age: 0.2
Sex: M
Vaccine: PNC
Symptoms: Hypotonia, Intubation, Respiratory arrest
Clinical narrative: I am a pediatrician and was paged to ER to help with a 2month old coding.  Mom said pt had received his vaccines then on the way home had stopped breathing so mom stopped the car then saw and ambulance.  Paramedics found pt limp and brought him to Kaiser ER.  When I saw pt., he was already intubated and had received epinephrine, bolus.  Pt was coded for about 40-45 minutes and pulse never returned. I don't know where pt was vaccinated and I don't have any information on the vaccines given.  5/18/07 Received autopsy report which reveals COD as congenital heart disease (tetralogy of Fallot).  Findings at autopsy include: I. Congenital cardiac malformation (tetralogy of Fallot)    A. globular appearance to heart    B. malposition of great vessels w/an "overriding aorta"    C. mild subpulmonic valve stenosis    D. High membranous VSD    E. Right ventricular hypertrophy        1. pulmonary HTN        2. diffuse pulmonary congestion    F.  Large atrial septal defect    G. left superior vena cava that emties into coronary sinus    H. Juxtaposition of atrial appendages w/both atrial appendages lying on left side of great vessels.    I. Right sided aortic arch    J. Bilateral pleural serosanguineous effusions    K. Peritoneal serosanguineous II. Horseshoe kidney III. Postmortem blood toxicology    A. Acetaminophen 4.2 mg/L. IV. Postmortem metabolic profile unremarkable.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Barium double contrast, Diverticulitis Meckel's, Fatigue, Gastrointestinal necrosis, Haematochezia
Clinical narrative: Patient came into office fussy.  Alternating with tired, no source identified, patient was sent out with symptomatic care.  Parents called the next day with bloody stools and sent to ED.  Patient diagnosed with intussuception - Air Enema failed to reduce. Surgery showed 4cm of necrotic bowel. Primary anastomosed, Meckel's found at time of surgery. As given by MD 04/11/07-DC Summary received for DOS 3/11-3/17/07-DX Intussusception. Presented with emesis and bright red blood per rectum. Laparotomy and ileal resection and subclavian placement. Recovered and discharged.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Intussusception, Irritability, Surgery
Clinical narrative: Patient came into office fussy.  Alternating with tired, no source identified, patient was sent out with symptomatic care.  Parents called the next day with bloody stools and sent to ED.  Patient diagnosed with intussuception - Air Enema failed to reduce. Surgery showed 4cm of necrotic bowel. Primary anastomosed, Meckel's found at time of surgery. As given by MD 04/11/07-DC Summary received for DOS 3/11-3/17/07-DX Intussusception. Presented with emesis and bright red blood per rectum. Laparotomy and ileal resection and subclavian placement. Recovered and discharged.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Diverticular hernia, Gastrointestinal necrosis, Intussusception, Surgery
Clinical narrative: Patient came into office fussy.  Alternating with tired, no source identified, patient was sent out with symptomatic care.  Parents called the next day with bloody stools and sent to ED.  Patient diagnosed with intussuception - Air Enema failed to reduce. Surgery showed 4cm of necrotic bowel. Primary anastomosed, Meckel's found at time of surgery. As given by MD 04/11/07-DC Summary received for DOS 3/11-3/17/07-DX Intussusception. Presented with emesis and bright red blood per rectum. Laparotomy and ileal resection and subclavian placement. Recovered and discharged.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Noticed pain, tenderness, and itchiness and swelling of 3 inch diameter on under part of upper arm at injection sight.  Called clinic and was advised to come in for evaluation.  Dr. diagnosed it as an infection and prescribed Keflex antibiotic 500mg, to be taken 4x a day.  He outlined the injection site and said to call the next day if the redness had spread.  It did spread and PCP was contacted via phone on Monday, March 12 about 8AM, and he prescribed Amoxicillin to be taken 2x day. Redness and itchiness began to subside by Wednesday, Mar14, but some symptoms still persist.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, IPV
Symptoms: Agitation, Anorexia, Crying, Dizziness, Encephalitis
Clinical narrative: The day after his shots he had a fever and was very fussy.   He had bouts of vomiting for over two weeks and was so dizzy that he couldn't walk straight.  He cryed an excessive amount for over two weeks.   He had no appetite during this time.  He had fevers off and on as well.  His arm was swollen where he was given two of the shots for over two weeks (and continues to be).  He could possibly have mild encephalitis.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, IPV
Symptoms: Oedema peripheral, Pyrexia, Stool analysis, Vomiting
Clinical narrative: The day after his shots he had a fever and was very fussy.   He had bouts of vomiting for over two weeks and was so dizzy that he couldn't walk straight.  He cryed an excessive amount for over two weeks.   He had no appetite during this time.  He had fevers off and on as well.  His arm was swollen where he was given two of the shots for over two weeks (and continues to be).  He could possibly have mild encephalitis.
Age: 1.1
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMRV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Patient given Rototeq, too old. No adverse events reported.
Age: 1.1
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMRV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient given Rototeq, too old. No adverse events reported.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Rash generalised
Clinical narrative: Rash on body that seemed to start following immunizations. Rash comes and goes, no known egg, seasonal or drug allergies. No wheezing or fever. Was seen in ER - they thought it was possibly a ketchup allergy.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Patient recieved immunizations  3/12/07 at routine well check. On 3/13/07 in evening per mother noted swelling, red, and hot at site of Varicella immunization. On 3/14 Mom called office to report to RN that lump was size of a small egg. No other swelling noted away from site (left upper arm). Child was at school and acting fine.  Advised to give Ibuprophen or Tylenol, alternate ice/heat and to come in if swelling, redness, or pain increases.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Barium enema, Intensive care, Intestinal perforation, Intubation, Intussusception
Clinical narrative: Information has been received concerning a male with gastroesophageal reflux who on 03-JAN-2007, at 12:30 pm was vaccinated with a third oral dose Rotateq (lot #655866/1110F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left leg of Pediarix (lot #AC21B079BA) and a third intramuscular dose in the left leg of ActHib (lot # UE992AA). Concomitant therapy included PREVACID. The patient had an upper respiratory tract infection at the time of vaccination. on 03-FEB-2007 the patient developed gastrointestinal symptoms (vomiting). The patient was diagnosed with intussusception on 07-FEB-2007. The patient suffered perforation of the intestine during an attempt to reduce by Barium enema, which required emergency laparotomy and reanastomosis of the small bowel. The patient suffered a second small bowel perforation on 12-FEB-2007. The patient's illness resulted in admission to intensive care unit, with intubation and probable sepsis. The patient's reactions were considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Laparotomy, Sepsis, Small intestinal anastomosis, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Information has been received concerning a male with gastroesophageal reflux who on 03-JAN-2007, at 12:30 pm was vaccinated with a third oral dose Rotateq (lot #655866/1110F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left leg of Pediarix (lot #AC21B079BA) and a third intramuscular dose in the left leg of ActHib (lot # UE992AA). Concomitant therapy included PREVACID. The patient had an upper respiratory tract infection at the time of vaccination. on 03-FEB-2007 the patient developed gastrointestinal symptoms (vomiting). The patient was diagnosed with intussusception on 07-FEB-2007. The patient suffered perforation of the intestine during an attempt to reduce by Barium enema, which required emergency laparotomy and reanastomosis of the small bowel. The patient suffered a second small bowel perforation on 12-FEB-2007. The patient's illness resulted in admission to intensive care unit, with intubation and probable sepsis. The patient's reactions were considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Barium enema, Gastrointestinal disorder, Intestinal perforation, Intubation, Intussusception
Clinical narrative: Information has been received concerning a male with gastroesophageal reflux who on 03-JAN-2007, at 12:30 pm was vaccinated with a third oral dose Rotateq (lot #655866/1110F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left leg of Pediarix (lot #AC21B079BA) and a third intramuscular dose in the left leg of ActHib (lot # UE992AA). Concomitant therapy included PREVACID. The patient had an upper respiratory tract infection at the time of vaccination. on 03-FEB-2007 the patient developed gastrointestinal symptoms (vomiting). The patient was diagnosed with intussusception on 07-FEB-2007. The patient suffered perforation of the intestine during an attempt to reduce by Barium enema, which required emergency laparotomy and reanastomosis of the small bowel. The patient suffered a second small bowel perforation on 12-FEB-2007. The patient's illness resulted in admission to intensive care unit, with intubation and probable sepsis. The patient's reactions were considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Laparotomy, Sepsis, Small intestinal anastomosis, Ultrasound abdomen, Vomiting
Clinical narrative: Information has been received concerning a male with gastroesophageal reflux who on 03-JAN-2007, at 12:30 pm was vaccinated with a third oral dose Rotateq (lot #655866/1110F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left leg of Pediarix (lot #AC21B079BA) and a third intramuscular dose in the left leg of ActHib (lot # UE992AA). Concomitant therapy included PREVACID. The patient had an upper respiratory tract infection at the time of vaccination. on 03-FEB-2007 the patient developed gastrointestinal symptoms (vomiting). The patient was diagnosed with intussusception on 07-FEB-2007. The patient suffered perforation of the intestine during an attempt to reduce by Barium enema, which required emergency laparotomy and reanastomosis of the small bowel. The patient suffered a second small bowel perforation on 12-FEB-2007. The patient's illness resulted in admission to intensive care unit, with intubation and probable sepsis. The patient's reactions were considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Barium enema, Gastrointestinal disorder, Intensive care, Intestinal anastomosis, Intestinal perforation
Clinical narrative: Information has been received concerning a male with gastroesophageal reflux who on 03-JAN-2007, at 12:30 pm was vaccinated with a third oral dose Rotateq (lot #655866/1110F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left leg of Pediarix (lot #AC21B079BA) and a third intramuscular dose in the left leg of ActHib (lot # UE992AA). Concomitant therapy included PREVACID. The patient had an upper respiratory tract infection at the time of vaccination. on 03-FEB-2007 the patient developed gastrointestinal symptoms (vomiting). The patient was diagnosed with intussusception on 07-FEB-2007. The patient suffered perforation of the intestine during an attempt to reduce by Barium enema, which required emergency laparotomy and reanastomosis of the small bowel. The patient suffered a second small bowel perforation on 12-FEB-2007. The patient's illness resulted in admission to intensive care unit, with intubation and probable sepsis. The patient's reactions were considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Intubation, Intussusception, Laparotomy, Sepsis, Ultrasound abdomen abnormal
Clinical narrative: Information has been received concerning a male with gastroesophageal reflux who on 03-JAN-2007, at 12:30 pm was vaccinated with a third oral dose Rotateq (lot #655866/1110F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left leg of Pediarix (lot #AC21B079BA) and a third intramuscular dose in the left leg of ActHib (lot # UE992AA). Concomitant therapy included PREVACID. The patient had an upper respiratory tract infection at the time of vaccination. on 03-FEB-2007 the patient developed gastrointestinal symptoms (vomiting). The patient was diagnosed with intussusception on 07-FEB-2007. The patient suffered perforation of the intestine during an attempt to reduce by Barium enema, which required emergency laparotomy and reanastomosis of the small bowel. The patient suffered a second small bowel perforation on 12-FEB-2007. The patient's illness resulted in admission to intensive care unit, with intubation and probable sepsis. The patient's reactions were considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angiogram, Anxiety, Asthenia, Asthma, Chest X-ray
Clinical narrative: Information has been received from a physician and registered nurse concerning a 70 year old female who on 13-FEB-2007 was vaccinated SC in the left arm with a 0.65 ml dose of Zostavax (lot #656418/1476F). On 16-FEB-2007 the patient experienced shortness of breath and was taken to the emergency room. She was admitted to the hospital and diagnosed with a pulmonary embolism and was treated with blood thinners. The patient was hospitalized for 3 days. At the time of the report the patient continues to have problems and has not recovered. A lot check has been requested. Pulmonary embolism was considered to be immediately life-threatening. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Condition aggravated, Dyspnoea, Electrocardiogram, Hypokalaemia
Clinical narrative: Information has been received from a physician and registered nurse concerning a 70 year old female who on 13-FEB-2007 was vaccinated SC in the left arm with a 0.65 ml dose of Zostavax (lot #656418/1476F). On 16-FEB-2007 the patient experienced shortness of breath and was taken to the emergency room. She was admitted to the hospital and diagnosed with a pulmonary embolism and was treated with blood thinners. The patient was hospitalized for 3 days. At the time of the report the patient continues to have problems and has not recovered. A lot check has been requested. Pulmonary embolism was considered to be immediately life-threatening. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypomagnesaemia, Pulmonary embolism, Troponin, Ultrasound Doppler
Clinical narrative: Information has been received from a physician and registered nurse concerning a 70 year old female who on 13-FEB-2007 was vaccinated SC in the left arm with a 0.65 ml dose of Zostavax (lot #656418/1476F). On 16-FEB-2007 the patient experienced shortness of breath and was taken to the emergency room. She was admitted to the hospital and diagnosed with a pulmonary embolism and was treated with blood thinners. The patient was hospitalized for 3 days. At the time of the report the patient continues to have problems and has not recovered. A lot check has been requested. Pulmonary embolism was considered to be immediately life-threatening. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Pulmonary embolism
Clinical narrative: Information has been received from a physician and registered nurse concerning a 70 year old female who on 13-FEB-2007 was vaccinated SC in the left arm with a 0.65 ml dose of Zostavax (lot #656418/1476F). On 16-FEB-2007 the patient experienced shortness of breath and was taken to the emergency room. She was admitted to the hospital and diagnosed with a pulmonary embolism and was treated with blood thinners. The patient was hospitalized for 3 days. At the time of the report the patient continues to have problems and has not recovered. A lot check has been requested. Pulmonary embolism was considered to be immediately life-threatening. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: Gardasil given Left upper arm on 2/20/07 experienced pain within 24 hours starting at Left angle of jaw and extending down to mid low back, accompanied by right upper outer arm/deltoid pain with shoulder movement and inability to raise Right arm past 90 degrees home prescribed Ibuprofen seen here 2/26/07 and right arm pain persisted. 1st dose Gardasil 12/14/06 given GYN office, also experienced Left neck/jaw pain down to mid back and Right deltoid pain however 1st dose given in Right arm.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Drug hypersensitivity, Mobility decreased, Pain in extremity, Pain in jaw
Clinical narrative: Gardasil given Left upper arm on 2/20/07 experienced pain within 24 hours starting at Left angle of jaw and extending down to mid low back, accompanied by right upper outer arm/deltoid pain with shoulder movement and inability to raise Right arm past 90 degrees home prescribed Ibuprofen seen here 2/26/07 and right arm pain persisted. 1st dose Gardasil 12/14/06 given GYN office, also experienced Left neck/jaw pain down to mid back and Right deltoid pain however 1st dose given in Right arm.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 83 year old female who "within the last six months," in approximately 2007, was vaccinated with a dose of Zostavax. Subsequently the patient developed shingles. It was also reported that the patient was deceased from causes unrelated to the experience with Zostervax. Additional information has been requested.  3/22/07 Received Death Certificate which reveals COD as sepsis, right lower lobe pneumonia with contributing conditions of COPD & s/p right mastectomy for breast cancer.  6/8/07 Received medical records from PCP which included hospital records from 2/20-2/23/07 hospitalization after patient experienced SOB, nonproductive cough, chest pain, fever & chills, decreased appetitem malaise & weakness w/multiple falls while home.  Family brought to ER & dx w/pneumonia.  Admitted to ICU due to episode of hypotension & started on IV antibiotics.  Respiratory status declined, developed respiratory acidosis & was intubated.  Consult w/pulmonology & cardiology.  Renal function then declined.  Consult w/nephrology.  Continued to decline, developed atrial fibrillation & arrested.  Resuscitation efforts were unsuccessful & patient was pronounced. FINAL DX: Sepsis due to RLL pneumonia; respiratory failure due to sepsis & RLL pneumonia. PCP office visit of 11/15/06 notes that patient had recently received Zosavax & now had faint eruption of shingles.  Tx w/Valtrex at that time.  2/2/07 office visit notes post herpes polyneuropathy tx w/cymbalta & lyrica.
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Learning disability
Clinical narrative: Information has been received from a consumer concerning her now 14-year-old daughter who in 2000 was vaccinated with her fourth dose of Recombivax HB, previous doses were received at birth, two months, and one year of age. Subsequently, the patient experienced learning disability (onset date not provided) which was considered to be disabling. No additional information is available. There was no product quality complaint. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: ANTH, FLU3, HEP, HEPA
Symptoms: Amnesia, Arthralgia, Arthritis, Back pain, Balance disorder
Clinical narrative: Allergies, arthritis, balance problems, blood pressure varies, infection fungal, sleep insomnia, sleep problems, memory short terms memory loss, pain leg, pain lower back, arthritic pain in feet like electric shock, pain neck, walking difficulty, urinary frequency.03/27/07-records received from provider  DX:hyperlipidemia health maintenance impaired fasting glucose dental disorder obesity osteoarthrosis involving the knee disorders of bursae and tendons in shoulder region elevated liver function test HX:chronic cervical and lower back pain, recently had a right knee arthroscopy for meniscus tear 11/26/06. feels that epidural block administered during surgery has worsened his low back pain and persists with cervical pain. Sustained knee injury in Iraq.
Age: 50.0
Sex: M
Vaccine: ANTH, FLU3, HEP, HEPA
Symptoms: Blood pressure fluctuation, Fungal infection, Gait disturbance, Hypersensitivity, Insomnia
Clinical narrative: Allergies, arthritis, balance problems, blood pressure varies, infection fungal, sleep insomnia, sleep problems, memory short terms memory loss, pain leg, pain lower back, arthritic pain in feet like electric shock, pain neck, walking difficulty, urinary frequency.03/27/07-records received from provider  DX:hyperlipidemia health maintenance impaired fasting glucose dental disorder obesity osteoarthrosis involving the knee disorders of bursae and tendons in shoulder region elevated liver function test HX:chronic cervical and lower back pain, recently had a right knee arthroscopy for meniscus tear 11/26/06. feels that epidural block administered during surgery has worsened his low back pain and persists with cervical pain. Sustained knee injury in Iraq.
Age: 50.0
Sex: M
Vaccine: ANTH, FLU3, HEP, HEPA
Symptoms: Myalgia, Neck pain, Pain in extremity, Paraesthesia, Pollakiuria
Clinical narrative: Allergies, arthritis, balance problems, blood pressure varies, infection fungal, sleep insomnia, sleep problems, memory short terms memory loss, pain leg, pain lower back, arthritic pain in feet like electric shock, pain neck, walking difficulty, urinary frequency.03/27/07-records received from provider  DX:hyperlipidemia health maintenance impaired fasting glucose dental disorder obesity osteoarthrosis involving the knee disorders of bursae and tendons in shoulder region elevated liver function test HX:chronic cervical and lower back pain, recently had a right knee arthroscopy for meniscus tear 11/26/06. feels that epidural block administered during surgery has worsened his low back pain and persists with cervical pain. Sustained knee injury in Iraq.
Age: 50.0
Sex: M
Vaccine: ANTH, FLU3, HEP, HEPA
Symptoms: Sleep disorder
Clinical narrative: Allergies, arthritis, balance problems, blood pressure varies, infection fungal, sleep insomnia, sleep problems, memory short terms memory loss, pain leg, pain lower back, arthritic pain in feet like electric shock, pain neck, walking difficulty, urinary frequency.03/27/07-records received from provider  DX:hyperlipidemia health maintenance impaired fasting glucose dental disorder obesity osteoarthrosis involving the knee disorders of bursae and tendons in shoulder region elevated liver function test HX:chronic cervical and lower back pain, recently had a right knee arthroscopy for meniscus tear 11/26/06. feels that epidural block administered during surgery has worsened his low back pain and persists with cervical pain. Sustained knee injury in Iraq.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Listless, Vomiting
Clinical narrative: Vomiting and diarrhea and listlessness. Diagnosed with Rotavirus. 4/27/07 Received medical records from hospital which reveal patient experienced diarrhea, vomiting, dehydration, irritability, decreased activity & poor appetite for 1 day prior to admit 2/13/07-2/15/07.  Treated w/IVF, no further vomiting/diarrhea & progressed well w/diet.  D/C to home. FINAL DX: Viral gastroenteritis, rotavirus.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Patient experienced severe vomiting after receiving Rotateq. Advised by provider to discontinue further doses.
Sex: F
Vaccine: HIBV, MMRV
Symptoms: Condition aggravated, Muscle twitching, Respiratory tract infection
Clinical narrative: 1/27/07- Mom called me at home. Patient started with a twitching. Different parts of body. No temp, slight increase respiratory infection - less frequent Sunday and Monday - none on Tuesday 1/30/07. Mom had to have 2nd MMR after sons delivery and did something she said she never told me till after the fact.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash generalised
Clinical narrative: 0953 3/8/07 Mom called into office stating patient had "rash all over body" call back at 1011 appointment given 3/8/07 at 11 am. Seen by doctor reported.