chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling, Lipoma, Skin nodule, Tenderness
Clinical narrative: LIPOMAS-After the anthrax vaccine received on 3/24/03, patient noted a new onset mass on his right inner thigh. He later noted a second mass on his right flank. He then noted a mass over his mid-sternum which tripled in size over a couple of weeks. This mass was biopsied and patient recalls a large amount of drainage as the mass was removed. The final diagnosis of the biopsy was reported as a lipoma. Patient is not aware of any cultures or lab studies that were performed on the drainage from the site. Since then, the patient has noted other masses appearing on his abdomen, around his knees and along his lower ribs. The most recent mass appeared about 30 days ago and is on his left flank area (40 x 20 mm). These masses persist and fluctuate in size. They are tender to deep palpitation and the tenderness seems to decrease after the area is massaged. Patient had no history of lipomas or masses prior to March 2003. He had a biopsy of a cyst near salivary gland around his left ear which was benign prior to receipt of his anthrax vaccines. Patient reports receiving an initial series of anthrax vaccine when he was a Marine in the first Gulf War, but has no documentation of any vaccinations between 1987 and 1992. (He is not sure how many anthrax vaccines he received at that time). He was then given 4 doses of a second dose of the anthrax vaccines on 3/7/03, 3/24/2003, 4/9/2003 and 1/29/2004. Patient reports burning type pain with each anthrax vaccine injection which resolved within minutes of the injections. He experienced minimal redness and swelling at his vaccines sites. He experienced persistent subcutaneous nodules at vaccine sites with associated tenderness to palpitation. The nodules varied in size from the diameter of golf ball to the diameter of a lime. The subcutaneous nodule at the site of the anthrax vaccine received on 3/24/2003 is still present (30 x 25 mm) and tender to deep palpitation. Patient denies persistent headaches, myalgias, arthralgias, fatigue or fever or chills following receipt of any of his anthrax vaccines.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site induration
Clinical narrative: Left shoulder - 2-3cm induration at site of injection. Erythema reported earlier by pt. - now visible on exam.
Age: 20.0
Sex: M
Vaccine: TYP
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Symptoms: Urticaria on torso, upper extremities, neck and face 58 hours after ingesting 1st of 4 capsules  and 10 hours after ingesting 2nd of 4 capsules of Vivotif Typhoid Vaccine Live Oral Ty21A. Treatment: Stop vaccine course. Administer Benydryl to ameliorate allergic reaction.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 7 month old female who was vaccinated with third 2 ml oral dose of Rotateq. Concomitant vaccinations given at the same time included DTaP, Hib and IPV. Subsequently, the patient experienced intussusception and was hospitalized (length of stay unspecified). A physical examination was performed results not provided. Intussusception was considered to be immediately life-threatening and an other important medical event which required surgery. Additional information has been requested. 8/20/07-records received from facility for DOS 7/1-7/2/07- DX: Intussusception. Incisional Reduction of intussusception lysis of fiber strands, appendectomy. C/O 4 days vomiting and diarrhea with some blood yesterday,
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a nurse practitioner concerning a 7-month-old male who on 01-MAY-2007 was vaccinated PO with a third 2mL dose of Rotateq. Concomitant therapy that day included a dose of PedvaxHIB, a dose of Pediarix, and a dose of Prevnar. On 28-MAY-2007 the patient developed intussusception and was hospitalized. It was noted that the patient underwent surgery. The reporter indicated that the patient is doing well, and has recovered. No additional information is available. Intussusception was considered to be immediately life-threatening and an other important medical event by the reporter. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Explorative laparotomy, Intussusception, Pyrexia, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 7-month-old male who on 01-MAY-2007 was vaccinated PO with a third 2mL dose of Rotateq. Concomitant therapy that day included a dose of PedvaxHIB, a dose of Pediarix, and a dose of Prevnar. On 28-MAY-2007 the patient developed intussusception and was hospitalized. It was noted that the patient underwent surgery. The reporter indicated that the patient is doing well, and has recovered. No additional information is available. Intussusception was considered to be immediately life-threatening and an other important medical event by the reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Blood culture negative, Injection site cellulitis, Injection site reaction, Skin lesion
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 5-year-old female, with no pertinent medical history and allergies, who on 14-JUN-2007 was vaccinated in the right thigh with a 0.5 milliliter dose of PROQUAD (lot# 657300/0545U). Concomitant therapy included IPV (unspecified), DTaP (unspecified) and VAQTA in different injection sites. On 15-JUN-2007 the patient experienced a 2 centimeter x 4 centimeter lesion on the right thigh at the injection site. She was treated with AUGMENTIN ES. The following day on 16-Jun-2007 she was worse and was hospitalized with cellulitis at the injection site. She was treated with intravenous antibiotics, nafcilin sodium and ceftoaxime sodium. Laboratory studies included a negative blood culture on 16-Jun-2007. The patient was discharged from the hospital on 19-Jun-2007. It was reported that on 13-Dec-2002 the patient initially received a dose of MMR II and on 25-Mar-2003 received a dose of VARIVAX and had no adverse reactions. No product quality complaint was involved. The reporter considered the patient's cellulitis to be an other important medical event. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLUX, HEPA, MMR
Symptoms: Agitation, Breath sounds abnormal, Cough, Hypersensitivity, Rash erythematous
Clinical narrative: Information has been received from a physician assistant concerning a 27 month old male with hypersensitivity to gelatin and a history of reactive airway disease and he had his skull suture lines released at birth, who on 17-DEC-2003 was vaccinated in the thigh with a dose of MMR II. Secondary suspect vaccinations given the same day included an in the other thigh a dose of VAQTA and a dose of influenza virus vaccine (unspecified). On 17-DEC-2003 the patient developed a systemic reaction after receiving his vaccinations. It was reported that within 30 minutes of being vaccinated he developed increased secretions, coughing and noisy breathing. Then he vomited and started to scratch his throat. About 45 minutes after receiving his vaccinations he developed a red confluent rash on his cheeks, right and left thighs and his arms. He was sleepy and later became fussy. The child was taken to the emergency room where he received an injection of BENADRL. He was sent home on oral BENADRYL. The child was then seen by an allergist who diagnosed him with an allergy to gelatin. On 18-DEC-2003 the patient recovered. no product quality complaint was involved. The patient's adverse events were considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLUX, HEPA, MMR
Symptoms: Salivary hypersecretion, Scratch, Somnolence, Vomiting
Clinical narrative: Information has been received from a physician assistant concerning a 27 month old male with hypersensitivity to gelatin and a history of reactive airway disease and he had his skull suture lines released at birth, who on 17-DEC-2003 was vaccinated in the thigh with a dose of MMR II. Secondary suspect vaccinations given the same day included an in the other thigh a dose of VAQTA and a dose of influenza virus vaccine (unspecified). On 17-DEC-2003 the patient developed a systemic reaction after receiving his vaccinations. It was reported that within 30 minutes of being vaccinated he developed increased secretions, coughing and noisy breathing. Then he vomited and started to scratch his throat. About 45 minutes after receiving his vaccinations he developed a red confluent rash on his cheeks, right and left thighs and his arms. He was sleepy and later became fussy. The child was taken to the emergency room where he received an injection of BENADRL. He was sent home on oral BENADRYL. The child was then seen by an allergist who diagnosed him with an allergy to gelatin. On 18-DEC-2003 the patient recovered. no product quality complaint was involved. The patient's adverse events were considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Pyrexia, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female patient who on 10-JUL-2007, was vaccinated with a first dose of Gardasil. There was no concomitant medication. On 12-JUL-2007 (more than 48 hours after her first vaccination), the patient became shaky, feverish and had heart palpitations and her heart was racing. It was reported that she called the paramedics but did not go to the hospital. Subsequently, the patient recovered. No product quality complaint was involved. The registered nurse considered the had heart palpitations, heart racing and being shaky to be considered other important medical events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who was vaccinated with a dose of Gardasil. Subsequently, four days after the vaccination the patient experienced tingling in her legs and was admitted to the hospital. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Full blood count, Joint range of motion decreased, Joint swelling, Mobility decreased
Clinical narrative: Information has been received from a physician, concerning a 21 year old female patient, who on 15-MAY-2007 was vaccinated IM, with the second dose, 0.5ml, of Gardasil (Lot # not provided). There was no concomitant medication. On 01-JUN-2007, the patient began to experience prolonged swelling and tenderness of all her joints, as well as, a decreased mobility of her joints. Diagnostic labs included a complete blood count (CBC) with differential, sedimentation rate, rheumatoid factor C3 and C4, and an autoimmune workup (results were not provided). Treatment included meloxicam (MOBIC), and the patient was referred to a rheumatologist for further evaluation. At the time of this report, the patient had not recovered from the events. The reporting physician considered one or more of the events to be serious, as disabling/incapacitating. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Information has been received from a physician, concerning a 21 year old female patient, who on 15-MAY-2007 was vaccinated IM, with the second dose, 0.5ml, of Gardasil (Lot # not provided). There was no concomitant medication. On 01-JUN-2007, the patient began to experience prolonged swelling and tenderness of all her joints, as well as, a decreased mobility of her joints. Diagnostic labs included a complete blood count (CBC) with differential, sedimentation rate, rheumatoid factor C3 and C4, and an autoimmune workup (results were not provided). Treatment included meloxicam (MOBIC), and the patient was referred to a rheumatologist for further evaluation. At the time of this report, the patient had not recovered from the events. The reporting physician considered one or more of the events to be serious, as disabling/incapacitating. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Confusional state, Psychiatric symptom, Speech disorder, Thinking abnormal
Clinical narrative: Within one day of dose, pt developed psychiatric symptoms (disorganized thoughts, speech, etc.) and ended up admitted 5 days after dose to psychiatric inpatient facility for 12 days. 8/23/07-records received for DOS 7/3-7/16/07- DC DX: Axis IBipolar affective disorder, manic; alcohol abuse; alcohol induced mood disorder.Axis II and III none. Axis IV:alcohol abuse, genetic predisposition to a mood disorder; social and family issues. Axis V 60 to 65. Admitted with bizarre behavior. She had gone away a week for a program. When she came back she appeared to be responding to internal stimuli. She was reporting she talks to a person which apparently the family was not aware of. She was found in a closet talking to herself and laughing. Not sleeping well at night and very disorganized. Very labile, from agitated to crying to being very hyper. Reports auditory hallucinations Patient using significant amount of alcohol. Drinks to point that she loses her memory. Denied suicidal or homicidal ideation. Insight and judgement grossly impaired Follow-up: It is still felt that the psychiatric symptoms represented a psychotic break, temporarily related but causally unrelated to the vaccine.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Abnormal behaviour, Psychotic disorder
Clinical narrative: Within one day of dose, pt developed psychiatric symptoms (disorganized thoughts, speech, etc.) and ended up admitted 5 days after dose to psychiatric inpatient facility for 12 days. 8/23/07-records received for DOS 7/3-7/16/07- DC DX: Axis IBipolar affective disorder, manic; alcohol abuse; alcohol induced mood disorder.Axis II and III none. Axis IV:alcohol abuse, genetic predisposition to a mood disorder; social and family issues. Axis V 60 to 65. Admitted with bizarre behavior. She had gone away a week for a program. When she came back she appeared to be responding to internal stimuli. She was reporting she talks to a person which apparently the family was not aware of. She was found in a closet talking to herself and laughing. Not sleeping well at night and very disorganized. Very labile, from agitated to crying to being very hyper. Reports auditory hallucinations Patient using significant amount of alcohol. Drinks to point that she loses her memory. Denied suicidal or homicidal ideation. Insight and judgement grossly impaired Follow-up: It is still felt that the psychiatric symptoms represented a psychotic break, temporarily related but causally unrelated to the vaccine.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Arthralgia, Bone pain, Convulsion, Headache
Clinical narrative: Headaches-migraine headaches bones pains-nervous conditions receiving treatment at hospital 8/15/07-records received DX: Back pain. Adjustment reaction with anxious mood. Derangement of lateral meniscus. Pain in knee. Lumbar Radiculopathy. Pure Hyperglyceridemia.  8/15/07-records received DX: Back pain. Adjustment reaction with anxious mood. Derangement of lateral meniscus. Pain in knee. Lumbar Radiculopathy. Pure Hyperglyceridemia. EMG:abnormal study. Evidence of chronic right L5 radiculopathy with evidence of re-inervation. Bilateral leg pain begin in 9/9/05 after a motor vehicle accident during military service. 1/11/2010 I have seizure headaches. Itching on my skin. Right arm pain and numbness, also E.D. and depression. 02/02/2010 Headaches, a lot of pain in BOHES, nose and right arm hurts.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Migraine, Nervous system disorder, Nervousness, Pruritus
Clinical narrative: Headaches-migraine headaches bones pains-nervous conditions receiving treatment at hospital 8/15/07-records received DX: Back pain. Adjustment reaction with anxious mood. Derangement of lateral meniscus. Pain in knee. Lumbar Radiculopathy. Pure Hyperglyceridemia.  8/15/07-records received DX: Back pain. Adjustment reaction with anxious mood. Derangement of lateral meniscus. Pain in knee. Lumbar Radiculopathy. Pure Hyperglyceridemia. EMG:abnormal study. Evidence of chronic right L5 radiculopathy with evidence of re-inervation. Bilateral leg pain begin in 9/9/05 after a motor vehicle accident during military service. 1/11/2010 I have seizure headaches. Itching on my skin. Right arm pain and numbness, also E.D. and depression. 02/02/2010 Headaches, a lot of pain in BOHES, nose and right arm hurts.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site swelling, Oedema peripheral
Clinical narrative: Swollen arm at injection site and headache.
Age: 1.1
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Varicella
Clinical narrative: Per mom patient developed chickenpox around her mouth and one on her chest 10 days after her ProQuad vaccine.
Age: 44.0
Sex: M
Vaccine: IPV, TYP, YF
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Back pain, Blood creatine phosphokinase, Dehydration
Clinical narrative: 6/3/07 Generalized malaise, hyponatremia, hypokalemia hemo concentrated, dehydration. 6/4/07 Myalgia, elevated hematocrit. 6/5/07 Elevated RBS, bilateral lower extremity swelling. 6/26/07 Myalgia likely due to combination vaccine, back pain, possibly due to muscle weakness.
Age: 44.0
Sex: M
Vaccine: IPV, TYP, YF
Symptoms: Full blood count, Haematocrit increased, Hypokalaemia, Hyponatraemia, Malaise
Clinical narrative: 6/3/07 Generalized malaise, hyponatremia, hypokalemia hemo concentrated, dehydration. 6/4/07 Myalgia, elevated hematocrit. 6/5/07 Elevated RBS, bilateral lower extremity swelling. 6/26/07 Myalgia likely due to combination vaccine, back pain, possibly due to muscle weakness.
Age: 44.0
Sex: M
Vaccine: IPV, TYP, YF
Symptoms: Muscular weakness, Myalgia, Oedema peripheral, Red blood cell count increased
Clinical narrative: 6/3/07 Generalized malaise, hyponatremia, hypokalemia hemo concentrated, dehydration. 6/4/07 Myalgia, elevated hematocrit. 6/5/07 Elevated RBS, bilateral lower extremity swelling. 6/26/07 Myalgia likely due to combination vaccine, back pain, possibly due to muscle weakness.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Convulsion, Dizziness, Fall, Oxygen saturation, Pallor
Clinical narrative: I administered the vaccine Gardasil in (L) arm IM pt was ok at this point within 1 min after vaccine was administered pt. started getting dizzy, turned very pale and fell over to (R) side, her body then started shaking almost like a seizure, Dr enter the room pt was coming to herself we gave her a drink of soda her pulse Ox was 99% and she started feeling better.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Tremor
Clinical narrative: I administered the vaccine Gardasil in (L) arm IM pt was ok at this point within 1 min after vaccine was administered pt. started getting dizzy, turned very pale and fell over to (R) side, her body then started shaking almost like a seizure, Dr enter the room pt was coming to herself we gave her a drink of soda her pulse Ox was 99% and she started feeling better.
Age: 0.1
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Faeces discoloured, Full blood count, Haematochezia, White blood cell count increased
Clinical narrative: Bloody speckled green loose stool x 1 approx 12 hrs after 1st shots and Rotateq no fever soft abdomen
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Erythema, Skin warm, Urticaria
Clinical narrative: 4x6 in oval red area, warm to touch; soft not tender; increased size over next 24 hr Keflex 500 mg TID given. Then developed urticaria (which he gets chronically at sometimes) ? cellulitis
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Full blood count, Skin warm, Swelling, White blood cell count increased
Clinical narrative: Vaccine DTaP given Lt by 7-12-07 ER visit 7-13-07 red swollen warm Augmentin 400 mg/5 ml 5 ml BID x 10 days
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: IPV give sq Rt leg 7-10-07 red area treated at clinic 7-12-07 with Keflex 250m Q10x 7 days
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Rash macular, Rash papular
Clinical narrative: presented with client on 7/19/07. c/o five rash on both arms, chest lower back. Observed papular rash on arms, chest and lower back. Noted macular rash on both buttocks. Denies fever or itching. No irritation at injection site
Age: 13.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Inadvertent administration of Pediarix (DTaP, IPV, HBV) when not indicated
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mom noticed large red, swollen, hot, painful bump on pt's (R) arm today, same area as immunizations given 7-18-07 > 1/2 dollar. Tylenol PRN discomfort. Warm compresses PRN
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Decreased appetite, Diarrhoea, Haematemesis, Pyrexia, Rash papular
Clinical narrative: Pt received 4 mo imms & Rotateq yesterday. Presented today with fever (100.5 (R) blood streaked vomitus x1, diarrhea x1, decreased appetite, scattered pink papules on abdomen. Treatment: Acetaminophen 0.8 ml po Q4hrs prn fever. Above symptoms/signs likely due to Rotateq. No Rotateq @ 6 mos
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Pt received 4 mo imms & Rotateq yesterday. Presented today with fever (100.5 (R) blood streaked vomitus x1, diarrhea x1, decreased appetite, scattered pink papules on abdomen. Treatment: Acetaminophen 0.8 ml po Q4hrs prn fever. Above symptoms/signs likely due to Rotateq. No Rotateq @ 6 mos
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Chest X-ray, Electroencephalogram, Eye rolling, Full blood count
Clinical narrative: This is a 6 month old male who presents for evaluation after an episode for which he was seen at ER yesterday. He was staying with his Aunt who describes him to be well and happy yesterday morning. He was sitting on the floor playing with toys when he suddenly vomited and became limp and unresponsive. She stated that he lost all tone and his eyes rolled back to the back of his head. He was still breathing during the episode. She stated that the event lasted for approximately 5 minutes. She called 911. When the paramedics arrived 10 minutes later, he was still unresponsive but slowly regained consciousness. He appeared somnolent in the squad and during triage at the ER. Dr. evaluated him about 1 hour after the event at which time he appeared alert, active and playful. His vitals were stable. His laboratory evaluation was within normal limits with the exception of an elevated WBC and platelet count. He was discharged him. He received his 6 month vaccines 6 days prior to this event which included Pediarix, HIB, Prevnar and Rotateq. The parents had reported to me that a similar event occurred 3 days after his 4 month vaccines. This event took place at night while he was sleeping. The dad found him lying in his crib. He was asleep, but had vomited a large amount. The parents were never made aware of this by crying or restless sleep. The emesis was cold by the time they found him. They have expressed concern today regarding possible seizures. There is not family history of a seizure disorder. There is no family history of adverse reaction to vaccine, although the timing of each episode has alerted to this possibility. The parents state that he appears back to himself today.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypotonia, Platelet count increased, Somnolence, Unresponsive to stimuli, Vaccine positive rechallenge
Clinical narrative: This is a 6 month old male who presents for evaluation after an episode for which he was seen at ER yesterday. He was staying with his Aunt who describes him to be well and happy yesterday morning. He was sitting on the floor playing with toys when he suddenly vomited and became limp and unresponsive. She stated that he lost all tone and his eyes rolled back to the back of his head. He was still breathing during the episode. She stated that the event lasted for approximately 5 minutes. She called 911. When the paramedics arrived 10 minutes later, he was still unresponsive but slowly regained consciousness. He appeared somnolent in the squad and during triage at the ER. Dr. evaluated him about 1 hour after the event at which time he appeared alert, active and playful. His vitals were stable. His laboratory evaluation was within normal limits with the exception of an elevated WBC and platelet count. He was discharged him. He received his 6 month vaccines 6 days prior to this event which included Pediarix, HIB, Prevnar and Rotateq. The parents had reported to me that a similar event occurred 3 days after his 4 month vaccines. This event took place at night while he was sleeping. The dad found him lying in his crib. He was asleep, but had vomited a large amount. The parents were never made aware of this by crying or restless sleep. The emesis was cold by the time they found him. They have expressed concern today regarding possible seizures. There is not family history of a seizure disorder. There is no family history of adverse reaction to vaccine, although the timing of each episode has alerted to this possibility. The parents state that he appears back to himself today.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: This is a 6 month old male who presents for evaluation after an episode for which he was seen at ER yesterday. He was staying with his Aunt who describes him to be well and happy yesterday morning. He was sitting on the floor playing with toys when he suddenly vomited and became limp and unresponsive. She stated that he lost all tone and his eyes rolled back to the back of his head. He was still breathing during the episode. She stated that the event lasted for approximately 5 minutes. She called 911. When the paramedics arrived 10 minutes later, he was still unresponsive but slowly regained consciousness. He appeared somnolent in the squad and during triage at the ER. Dr. evaluated him about 1 hour after the event at which time he appeared alert, active and playful. His vitals were stable. His laboratory evaluation was within normal limits with the exception of an elevated WBC and platelet count. He was discharged him. He received his 6 month vaccines 6 days prior to this event which included Pediarix, HIB, Prevnar and Rotateq. The parents had reported to me that a similar event occurred 3 days after his 4 month vaccines. This event took place at night while he was sleeping. The dad found him lying in his crib. He was asleep, but had vomited a large amount. The parents were never made aware of this by crying or restless sleep. The emesis was cold by the time they found him. They have expressed concern today regarding possible seizures. There is not family history of a seizure disorder. There is no family history of adverse reaction to vaccine, although the timing of each episode has alerted to this possibility. The parents state that he appears back to himself today.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess, Pain in extremity
Clinical narrative: Upper left arm pain ? abscess, not fluctuant - afebrile, no drainage. Started on Dicloxacillin 500 q6h x 10 days and warm compresses.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Within 15 minutes after vaccine - pt became dizzy, clammy, sweaty, lightheaded, loss of color, fainted in exam room.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Intra-uterine death
Clinical narrative: Patient was pregnant - which she did not inform and then had fetal demise - the cord was wrapped around fetus arm and shoulder 4 times.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Rash papular, Skin hyperpigmentation
Clinical narrative: Rash, flesh colored papules to shoulder with surrounding hyperpigmentation also with flesh colored papules to chest.
Age: 1.1
Sex: F
Vaccine: HEPA, IPV, MMRV
Symptoms: Rash, Rash macular
Clinical narrative: Mother noticed a rash on back 1 hr after immunizations were given. They looked like red blotches on entire back approximately the size of golf balls.
Age: 34.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Cyanosis, Hypoaesthesia, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: This case was reported by a healthcare professional and described the occurence of muscle weakness in a 34-year-old female subject who was vaccinated with Engerix B for prophylaxis. Concurrent medical conditions included allergy to Percocet, allergy to Ultracet and migraine. Previous vaccination included Engerix B given on 26 March 2007 without any adverse events. Concurrent vaccinations included Tetanus vaccine, Allegra, Zomig, Rhinocort, Effexor XR and Topamax. On 26 April 2007 the subject received a 2nd dose of Engerix B at 1.0 ml in the right arm. During the injection the subject experienced a muscle spasm and was referred to a neurologist who prescribed prednisone. After two weeks, the subject reported that her hand turned blue, she developed muscle weakness, cramping, pain and numbness. On exam, the subject did not demonstrate any weakness is grip, swelling, or discoloration. The subject reported worsening symptoms and was hospitalized twice for progressive symptoms. The healthcare professional considered the events were disabling. The hand discoloration resolved.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR
Symptoms: Congenital anomaly, Dysstasia, Electroencephalogram normal, Inappropriate schedule of drug administration, Irritability
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of twitch in a 6-month-old male subject who was vaccinated with Pediarix and MMR II for prophylaxis. Concurrent vaccination included PedvaxHib given on 3 May 2006. Previous vaccination included two doses of Pediarix given on 4 January 2006 and 3 March 2006. on 3 may 2006 the subject received 3rd dose of Pediarix at 0.5 ml in the left arm. On 3 May 2006, 5 hours after vaccination with Pediarix, the subject experienced twitching on his left side which the physician described as "drawing up head toward left." The event last for 10 to 15 minutes and then completely and resolved. The subject was seen in the physician's office and was advised to take Benadryl. The healthcare professional considered the events were a congenital anomaly. The following day, 04 May 2007, the physician who did not think this was seizure activity ordered an EEG just to rule out the possibility. The results of the EEG were normal. The healthcare professional considered the events were possibly related to vaccination with Pediarix. The reporter noted that when the subject received his MMR (Merck) vaccine when he was 16 months old, he started twitching, wouldn't stand, became irritable, glassy eyed and extended his head away from his body 30 hours after receiving the vaccine. The symptoms resolved. The subject did not receive any additional vaccines that day, nor has he received any additional DTaP vaccines outside of the 3rd dose as part of the Pediarix.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR
Symptoms: Lacrimation increased, Muscle twitching
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of twitch in a 6-month-old male subject who was vaccinated with Pediarix and MMR II for prophylaxis. Concurrent vaccination included PedvaxHib given on 3 May 2006. Previous vaccination included two doses of Pediarix given on 4 January 2006 and 3 March 2006. on 3 may 2006 the subject received 3rd dose of Pediarix at 0.5 ml in the left arm. On 3 May 2006, 5 hours after vaccination with Pediarix, the subject experienced twitching on his left side which the physician described as "drawing up head toward left." The event last for 10 to 15 minutes and then completely and resolved. The subject was seen in the physician's office and was advised to take Benadryl. The healthcare professional considered the events were a congenital anomaly. The following day, 04 May 2007, the physician who did not think this was seizure activity ordered an EEG just to rule out the possibility. The results of the EEG were normal. The healthcare professional considered the events were possibly related to vaccination with Pediarix. The reporter noted that when the subject received his MMR (Merck) vaccine when he was 16 months old, he started twitching, wouldn't stand, became irritable, glassy eyed and extended his head away from his body 30 hours after receiving the vaccine. The symptoms resolved. The subject did not receive any additional vaccines that day, nor has he received any additional DTaP vaccines outside of the 3rd dose as part of the Pediarix.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PPV, RV5, DTAPHEPBIP, PPV, RV5
Symptoms: Blood glucose, Inappropriate schedule of drug administration, Intussusception, Lethargy, Pallor
Clinical narrative: Seen for lethargy - pallor. Glucose @ 110. Sent to ER for evaluation and was subsequently admitted for intussusception. 8/8/07-records received for DOS 7/5/07-DX: Intussusception. C/O lethargy and became pale. No nausea no vomiting no diarrhea or blood in stool. Successful reduction with air enema.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PPV, RV5, DTAPHEPBIP, PPV, RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Seen for lethargy - pallor. Glucose @ 110. Sent to ER for evaluation and was subsequently admitted for intussusception. 8/8/07-records received for DOS 7/5/07-DX: Intussusception. C/O lethargy and became pale. No nausea no vomiting no diarrhea or blood in stool. Successful reduction with air enema.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PPV, RV5, DTAPHEPBIP, PPV, RV5
Symptoms: Abdominal X-ray, Blood glucose abnormal, Enema administration, Inappropriate schedule of drug administration, Intussusception
Clinical narrative: Seen for lethargy - pallor. Glucose @ 110. Sent to ER for evaluation and was subsequently admitted for intussusception. 8/8/07-records received for DOS 7/5/07-DX: Intussusception. C/O lethargy and became pale. No nausea no vomiting no diarrhea or blood in stool. Successful reduction with air enema.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PPV, RV5, DTAPHEPBIP, PPV, RV5
Symptoms: Lethargy, Pallor, Ultrasound abdomen abnormal
Clinical narrative: Seen for lethargy - pallor. Glucose @ 110. Sent to ER for evaluation and was subsequently admitted for intussusception. 8/8/07-records received for DOS 7/5/07-DX: Intussusception. C/O lethargy and became pale. No nausea no vomiting no diarrhea or blood in stool. Successful reduction with air enema.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt fainted in office 7-10 mins. after immunizations
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Culture positive, Herpes zoster, Pain
Clinical narrative: Pt states she woke up with painful blisters on her buttocks on 7-13-07. Saw PCP. Culture taken.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Hypoaesthesia oral, Musculoskeletal pain, Peripheral coldness, Swelling
Clinical narrative: Severe left shoulder pain/swelling. Left hand middle finger, joint pain, hand coldness, lips numbness then resolved with a dose of Prednisone orally. Symptoms persisted for 2 weeks after 7 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5x5cm of induration, redness to left deltoid. Motrin for fever and/or pain
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Confusional state, Full blood count, Nausea, Pyrexia
Clinical narrative: Vaccine 6/26/07. Body rash for 7 days. Day 7 - fever, nausea, abdominal pain. Day 6 - transient confusion, seen in emergency room.
Sex: M
Vaccine: MNQ
Symptoms: Rash generalised
Clinical narrative: Vaccine 6/26/07. Body rash for 7 days. Day 7 - fever, nausea, abdominal pain. Day 6 - transient confusion, seen in emergency room.
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Local rash on left arm developed 7/15/07, 4d after vaccine. In next 48 hours rash spread to face, body,neck, leg - mac. papular in nature.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Injection site swelling
Clinical narrative: Rt upper arm swollen.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Agitation, Pyrexia, Vomiting
Clinical narrative: Immunizations given 5/3/07 at 130 PM then at 500PM baby was fussy and has some fever. On 5/4 started vomiting a "yellow foamy liquid" and fever 102. Vomited X 4. Taken to ER 7 PM on 5/4. Given Pedialyte through 5/5 at noon. Okay after that.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Tender, large ipsilateral axillary lymph node appearing after the injection. Regressing some by 3 days later.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray normal, Cough, Dysphonia, Wheezing
Clinical narrative: Received vaccine approximately 7/19/07 - (cough x 3 days prior) hoarseness 7/19 PM and wheezing next AM went to ER seen at medical center ER told "possible reaction to HPV shot".
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain of skin, Pyrexia
Clinical narrative: Pt awoke on 7/18/07 with symptoms of generalized body aches, low grade fever, and skin tenderness lasting throughout the day. Patient took Advil 400mg in the A.M. and Advil 400mg in the afternoon with some relief from symptoms. 7/19/07 symptoms were resolved.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Erythema, Myalgia, Pruritus
Clinical narrative: Itchy, sore muscle underneath right arm sore. Redness (14 x 8) area, right arm.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Cold sweat, Feeling cold, Skin warm
Clinical narrative: Warm to touch left upper arm, aching in left elbow. Chilled (clammy feeling, feverish) no fever, no headaches, no sharp pains (started 7-19-07 PM). He is left handed.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Dizziness, Feeling cold, Musculoskeletal stiffness
Clinical narrative: At 9:45 p.m. client rpts that she became instantly "chilled" and her teeth were chattering so much that she couldn't even talk. Temp 99. Stiff neck, nausea/vomiting x 4, dizziness. Next day she had extreme myalgia as with influenza. Referred to PMD on 7/23/07.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Speech disorder, Vaccination complication, Vomiting
Clinical narrative: At 9:45 p.m. client rpts that she became instantly "chilled" and her teeth were chattering so much that she couldn't even talk. Temp 99. Stiff neck, nausea/vomiting x 4, dizziness. Next day she had extreme myalgia as with influenza. Referred to PMD on 7/23/07.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Fatigue, Head injury, Headache, Pallor, Syncope
Clinical narrative: Shots administered. Received phone call from patients mother stating that child fainted and bumped his head on the curb once arriving to vehicle. Child was pale, responsive and complaining of a headache. Follow up phone call 7/24/07 at 8:20 AM. Patients mother stated child slept all night woke up this morning feeling tired. Denied headache, nausea/vomiting or blurred vision.
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Mother reported that pt broke out in hives on back and arms. Advised to go to primary care doctor or ER.
Age: 15.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Arthritis, Dizziness, Headache, Pyrexia
Clinical narrative: 7-16-07 Rec'd 4th Rabies shot (Imovax). 7-17-07 woke up with arthralgia, arthritis, dizziness, fever, headache. 7-24-07 arthralgia, arthritis, dizziness is gone. Only signs of headache now.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Musculoskeletal stiffness, Vomiting
Clinical narrative: Stiff hands.  Headache. Vomiting.  One month before.  Tylenol.  Lasted about two hours.   HEADACHE:    Started two hours after vaccination with HPV.  Recurrent HA this AM one month later.  Associated with vomiting.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: On 5/15/2007, 16 week old infant givent first dose of rotavirus oral vaccine. On 7/20/2007, infant returned for six-month old immunizations but not given further doses of rotavirus due to starting first dose after recommended starting age of 12 weeks. No adverse effects identified by parents of baby regarding first dosage of rotavirus.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: On 5/15/2007, 16 week old infant givent first dose of rotavirus oral vaccine. On 7/20/2007, infant returned for six-month old immunizations but not given further doses of rotavirus due to starting first dose after recommended starting age of 12 weeks. No adverse effects identified by parents of baby regarding first dosage of rotavirus.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, TYP
Symptoms: Abdominal pain, Abdominal pain upper, Blood pressure, Blood test, Diarrhoea
Clinical narrative: Nausea, diarrhea, fever, acute GI illness, abdominal cramping, dizziness, and disorientation from time of second pill administration.  Slight symptoms of stomach ache were noted about 36 hours after first pill was taken.  Pills were taken two hours after dinner, exactly 48 hours apart.  Patient felt so bad that she was taken to a physician on Monday 7/23.  Physician recommended immediate fluids and bed rest.  Physician said to discontinue use of Loperamide Hydrochloride tablets and let bowels empty.  Physician considered hospital admission and IV fluids.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, TYP
Symptoms: Disorientation, Dizziness, Gastrointestinal disorder, Nausea, Pyrexia
Clinical narrative: Nausea, diarrhea, fever, acute GI illness, abdominal cramping, dizziness, and disorientation from time of second pill administration.  Slight symptoms of stomach ache were noted about 36 hours after first pill was taken.  Pills were taken two hours after dinner, exactly 48 hours apart.  Patient felt so bad that she was taken to a physician on Monday 7/23.  Physician recommended immediate fluids and bed rest.  Physician said to discontinue use of Loperamide Hydrochloride tablets and let bowels empty.  Physician considered hospital admission and IV fluids.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, TYP
Symptoms: Stool analysis
Clinical narrative: Nausea, diarrhea, fever, acute GI illness, abdominal cramping, dizziness, and disorientation from time of second pill administration.  Slight symptoms of stomach ache were noted about 36 hours after first pill was taken.  Pills were taken two hours after dinner, exactly 48 hours apart.  Patient felt so bad that she was taken to a physician on Monday 7/23.  Physician recommended immediate fluids and bed rest.  Physician said to discontinue use of Loperamide Hydrochloride tablets and let bowels empty.  Physician considered hospital admission and IV fluids.
Age: 52.0
Sex: F
Vaccine: ANTH
Symptoms: Chest pain, Musculoskeletal pain, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Patient was participating as a volunteer plasma donor for anthrax immune globulin given. The patient's last anthrax immunization was 18 Dec 2006. April 4th -- Symptoms began with palms itching.  Donor used topical and parenteral Benadryl, getting some relief. After a few days feet started to swell.  Saw internist who gave her a diuretic.  Symptoms expanded to aching feet, hands, arms and shoulders.  Donor developed chest pain which felt "like severe heartburn".  A rash developed -- big circles on the arms.  Made 2 to 3 visits to doctor.  Physician removed all routine medication and prescribed prednisone.  The patient seemed better and doctor said to resume her medications(Synthroid, Evista, Wellbutrin).  The rash returned in two days.  Rash developed into "itchy hives".  May 18 -- Rash was all over patient's body.  Donor saw an allergist.  Donor began taking Zyrtek, Singular, Alavert, and Ranitidine.  July 18 -- Rash and aches are kept under control with one Ranitidine and two Zyrtek daily.  If 2 doses are missed, the patient experiences itching over entire body and aching in her arms and chest.
Age: 52.0
Sex: F
Vaccine: ANTH
Symptoms: Rash, Urticaria
Clinical narrative: Patient was participating as a volunteer plasma donor for anthrax immune globulin given. The patient's last anthrax immunization was 18 Dec 2006. April 4th -- Symptoms began with palms itching.  Donor used topical and parenteral Benadryl, getting some relief. After a few days feet started to swell.  Saw internist who gave her a diuretic.  Symptoms expanded to aching feet, hands, arms and shoulders.  Donor developed chest pain which felt "like severe heartburn".  A rash developed -- big circles on the arms.  Made 2 to 3 visits to doctor.  Physician removed all routine medication and prescribed prednisone.  The patient seemed better and doctor said to resume her medications(Synthroid, Evista, Wellbutrin).  The rash returned in two days.  Rash developed into "itchy hives".  May 18 -- Rash was all over patient's body.  Donor saw an allergist.  Donor began taking Zyrtek, Singular, Alavert, and Ranitidine.  July 18 -- Rash and aches are kept under control with one Ranitidine and two Zyrtek daily.  If 2 doses are missed, the patient experiences itching over entire body and aching in her arms and chest.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Blood test, Body temperature increased, Injection site vesicles, Skin infection
Clinical narrative: Had blister area just below injection site where DTaP was given in left deltoid on 07/19/07, blister appeared later that night temp of 102.9.  Took to ambulatory care center and had blood drawn, diagnosed with a skin infection, treated with Keflex, silvadene cream, and acyclovir.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm very firm, hot, and red.  Reddened area is 115 mm lengthwise and 100 mm wide.  Patient able to move arm and states it does not hurt.  Area swollen to about 2 times the size of the other arm.  Advised to give Motrin and Benadryl dose and to call back if worsening
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: FEVER 103AXILLARY ONSET MIDNIGHT AFTER IMMUNIZATIONS ADMINISTERED AT 430PM
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Eye rolling, Laryngospasm
Clinical narrative: The night of receiving the vaccines, had an episode which was either seizure like or laryngospasm.  Had susequent episodes over the next few days total of 4 episodes - one with shaking which appeared to be consistent with seizure.  8/27/2007 MR received for DOS 7/19-20/2007 for c/o 3 episodes over 2 days of arm flexing, staring/eyes rolling back and blue lips. Child had another episode during hospitalization where she had trembling of all extremities, staring straight ahead, and unresponsiveness to verbal or tactile stim. This episode was considered to be c/w seizure activity, and the child started on phenobarb. DX: Spells.