chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Asthenia, Grand mal convulsion, Syncope
Clinical narrative: Patient was given Hepatitis A and VARIVAX; within minutes was syncopal and had tonic-clonic seizure while still in exam room. Pulse 70, B/P 104/62. Observed x 15 minutes, then had a 2nd tonic clonic seizure for 1-2 minutes at the check out desk. Responsive afterward, but very weak - transported to ER. Had similar experience after vaccines given 01/06.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Cold sweat, Erythema, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: After getting 4 y/o shots, 1 day post getting them arm (right arm) blister, red, sore.  Fussy all day 2 days post shots with red lacy rash, clammy, pale, cheeks red with activity.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Irritability, Pallor, Rash
Clinical narrative: After getting 4 y/o shots, 1 day post getting them arm (right arm) blister, red, sore.  Fussy all day 2 days post shots with red lacy rash, clammy, pale, cheeks red with activity.
Age: 38.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Dermographism, Injection site erythema, Injection site pruritus, Tenderness
Clinical narrative: Lt deltoid area of vaccine MIN local reaction of about 1 inch around VACC site-has pooling reaction area under the vaccine site of redness about 6 inches diameter with raised red border - and itches per PT-very sensitive to touch-with some dermographism and probably related to the IM changes of the vaccine.  Still a local reaction and NOT an infection-no nodes or fever.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Full blood count, Headache, Metabolic function test, Nausea, Rash erythematous
Clinical narrative: Generalized Vaccinia characterized by headache nausea and generalized erythematous papules sparing face and neck
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Rash papular, Red blood cell sedimentation rate increased, Vaccinia
Clinical narrative: Generalized Vaccinia characterized by headache nausea and generalized erythematous papules sparing face and neck
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Headache, Nausea, Rash erythematous, Rash generalised, Rash papular
Clinical narrative: Generalized Vaccinia characterized by headache nausea and generalized erythematous papules sparing face and neck
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Red blood cell sedimentation rate increased, Vaccinia
Clinical narrative: Generalized Vaccinia characterized by headache nausea and generalized erythematous papules sparing face and neck
Age: 13.0
Sex: M
Vaccine: MEN, PPV, VARCEL
Symptoms: Asthenia, Blood test normal, Cough, Culture, Dizziness
Clinical narrative: Patient has been running a fever up to 104, dizziness, shakes, muscle ache, headache, weakness, coughing, flush and loss of energy. These symptoms have been present 12 hours after injections and still are present(48 hours later)  Treatment has been extra fluids, advil, tylenol and nebulizer treatment.
Age: 13.0
Sex: M
Vaccine: MEN, PPV, VARCEL
Symptoms: Flushing, Headache, Myalgia, Pyrexia, Tremor
Clinical narrative: Patient has been running a fever up to 104, dizziness, shakes, muscle ache, headache, weakness, coughing, flush and loss of energy. These symptoms have been present 12 hours after injections and still are present(48 hours later)  Treatment has been extra fluids, advil, tylenol and nebulizer treatment.
Age: 13.0
Sex: M
Vaccine: MEN, PPV, VARCEL
Symptoms: X-ray normal
Clinical narrative: Patient has been running a fever up to 104, dizziness, shakes, muscle ache, headache, weakness, coughing, flush and loss of energy. These symptoms have been present 12 hours after injections and still are present(48 hours later)  Treatment has been extra fluids, advil, tylenol and nebulizer treatment.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: Nausea, headaches, frequent illness including viral spinal menengitis, numbness and tingling in different areas of the body. First shot 10/31/08, second shot 12/31/08.  Symptoms began 1/15/09.  No physician is interrested in determining if this is related to Gardasil.  3/6/09 MR received for DOS 2/9-10/2009 with D/C DX: Hx of Aseptic meningitis and Headache. Pt initially presented to local hospital with c/o H/A, neck stiffness and pain, phono/photophobia, GI distress, nausea and vomiting. Pt was DX with aseptic meningitis and admitted x week. Pt currently presnting with transient neuro deficits including L & R sided paresthesias, dysarhtria, and difficulty speaking the last half of words. Pt c/o visual obstruction (like TV snow) during episodes.  BP 86/58. O2 sat 90% RA. PE (+) for mild facial asymmetry-? chronic. Started on Lexapro for depression and OCD traits and possibly developing migraines.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Pyrexia
Clinical narrative: Patient developed temperature of 102F and headache on 2-18-2009 around 1:45pm. Parent reported symptoms to clinic at approximately 4:30pm and reported no OTC analgesics had been given but would begin administering OTC on nurse's recommendations every 4-6 hours.
Age: 22.0
Sex: F
Vaccine: JEV
Symptoms: Pruritus, Rash papular
Clinical narrative: February 17 started to get a papular rash on both feet hands and arms with itching. Took over the counter Benadryl 1 tablet February 18 2009. The rash supsided with just a little on hands with no itching.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Musculoskeletal stiffness, Pain
Clinical narrative: Per TC from pt: sx's began 2-17-09 PM - pain L side only (arm, shoulder, breast). She went to work 2-18 and left early d/t sx's. Co-workers commented that her face was flushed. She has been taking Ibuprofen 2 tabs BID and "feels better" today, however, she continues to c/o L sided neck stiffness - "can't turn my head all the way."  Advised pt to see PCP d/t continued sx's and neck stiffness.  She will c/b 2-20 with f/u.
Age: 0.17
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HIBV
Symptoms: Crying, Pyrexia, Screaming
Clinical narrative: Fever of 102.5 one hour after the  DTaP1/Hib/IVP  shot administered.  Also signs of severe distress, screaming and crying. He continually grasped my shirt. I immediatley reported it to the doctor, and gave him motrin for the fever. Symptoms subsided. However I felt suspicious something worse happened. No one could give me a medical/scientific explaination.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Body temperature decreased, Body temperature increased, Chills, Nausea
Clinical narrative: That night( 2/12/09) he was shivering, temp taken, was 94 degrees. At 2 am,his temp was 103. He had an uneasy stomach for a few days. Nausea but no vomiting,no diarrhea. Next day temp was 100. 3rd day,temp was normal. No rash,no resp.distress. He stated after his first Rabies shot he had an uneasy stomach,achey joint and his legs hurt for 2 days.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Pain in extremity, Stomach discomfort
Clinical narrative: That night( 2/12/09) he was shivering, temp taken, was 94 degrees. At 2 am,his temp was 103. He had an uneasy stomach for a few days. Nausea but no vomiting,no diarrhea. Next day temp was 100. 3rd day,temp was normal. No rash,no resp.distress. He stated after his first Rabies shot he had an uneasy stomach,achey joint and his legs hurt for 2 days.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Blood test, Chest pain, Diarrhoea, Dyspnoea, Haematochezia
Clinical narrative: Two weeks before Thanksgiving, mother says patient had cold symptoms, coughing and nasal congestion. The week of Thanksgiving, Nov. 24, 2008, patient c/o difficulty breathing, chest pains and a headache. To hospital emergency room. Patient was admitted and hospitalized two days in ICU and three days on the hematology unit according to mother. Diagnosis, Pulmonary Embolism.  Another emergency visit to hospital on Feb. 13, 2009 for symptoms of diarrhea and bloody stools. 2/25/09-records received for DOS 11/24-11/28/08-DC DX: Pulmonary embolism. Presented with increasing shortness of breath, worsening cough anc chest wall pain for 2 weeks. Seen in Ed 1 week prior with shortness of breath and CXR determined to be asthma.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Headache, Intensive care, Nuclear magnetic resonance imaging, Pulmonary embolism
Clinical narrative: Two weeks before Thanksgiving, mother says patient had cold symptoms, coughing and nasal congestion. The week of Thanksgiving, Nov. 24, 2008, patient c/o difficulty breathing, chest pains and a headache. To hospital emergency room. Patient was admitted and hospitalized two days in ICU and three days on the hematology unit according to mother. Diagnosis, Pulmonary Embolism.  Another emergency visit to hospital on Feb. 13, 2009 for symptoms of diarrhea and bloody stools. 2/25/09-records received for DOS 11/24-11/28/08-DC DX: Pulmonary embolism. Presented with increasing shortness of breath, worsening cough anc chest wall pain for 2 weeks. Seen in Ed 1 week prior with shortness of breath and CXR determined to be asthma.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Asthma, Chest X-ray abnormal, Chest pain, Computerised tomogram abnormal, Cough
Clinical narrative: Two weeks before Thanksgiving, mother says patient had cold symptoms, coughing and nasal congestion. The week of Thanksgiving, Nov. 24, 2008, patient c/o difficulty breathing, chest pains and a headache. To hospital emergency room. Patient was admitted and hospitalized two days in ICU and three days on the hematology unit according to mother. Diagnosis, Pulmonary Embolism.  Another emergency visit to hospital on Feb. 13, 2009 for symptoms of diarrhea and bloody stools. 2/25/09-records received for DOS 11/24-11/28/08-DC DX: Pulmonary embolism. Presented with increasing shortness of breath, worsening cough anc chest wall pain for 2 weeks. Seen in Ed 1 week prior with shortness of breath and CXR determined to be asthma.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Diarrhoea, Dyspnoea, Haematochezia, Headache, Intensive care
Clinical narrative: Two weeks before Thanksgiving, mother says patient had cold symptoms, coughing and nasal congestion. The week of Thanksgiving, Nov. 24, 2008, patient c/o difficulty breathing, chest pains and a headache. To hospital emergency room. Patient was admitted and hospitalized two days in ICU and three days on the hematology unit according to mother. Diagnosis, Pulmonary Embolism.  Another emergency visit to hospital on Feb. 13, 2009 for symptoms of diarrhea and bloody stools. 2/25/09-records received for DOS 11/24-11/28/08-DC DX: Pulmonary embolism. Presented with increasing shortness of breath, worsening cough anc chest wall pain for 2 weeks. Seen in Ed 1 week prior with shortness of breath and CXR determined to be asthma.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Musculoskeletal chest pain, Nasal congestion, Nasopharyngitis, Pulmonary embolism
Clinical narrative: Two weeks before Thanksgiving, mother says patient had cold symptoms, coughing and nasal congestion. The week of Thanksgiving, Nov. 24, 2008, patient c/o difficulty breathing, chest pains and a headache. To hospital emergency room. Patient was admitted and hospitalized two days in ICU and three days on the hematology unit according to mother. Diagnosis, Pulmonary Embolism.  Another emergency visit to hospital on Feb. 13, 2009 for symptoms of diarrhea and bloody stools. 2/25/09-records received for DOS 11/24-11/28/08-DC DX: Pulmonary embolism. Presented with increasing shortness of breath, worsening cough anc chest wall pain for 2 weeks. Seen in Ed 1 week prior with shortness of breath and CXR determined to be asthma.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Ear pain, Headache, Malaise, Pain in extremity, Vomiting
Clinical narrative: malaise, headache, right earache, left arm pain (same side as vaccination), vomiting x 1.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Alopecia, Blood thyroid stimulating hormone decreased
Clinical narrative: Patient lost his hair- all of it over the course of 3 months and became completly bald. He has not had any new growth.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Left arm pain - stiff after receiving vaccination that has continued to be bothersome
Age: 1.83
Sex: F
Vaccine: DTAP, FLU3, PNC
Symptoms: Incorrect dose administered
Clinical narrative: 0 reaction-Pt received Fluzone MDV 0.5ml, and should have received Fluzone 0.25ml.
Age: 1.83
Sex: M
Vaccine: HEPA, PNC, TDAP
Symptoms: Wrong drug administered
Clinical narrative: 0 reaction - Pt received Tdap instead of Dtap
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 0 reaction- Pt received Fluzone MDV 0.5ml instead of 0.25ml.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called and questioned soreness of vaccinated arm.  Patient stated that it was warm to the touch and approximately 2" in diameter.  It was also a little "puffy", but localized to this single spot.  Patient received vaccination in the morning on 2/16/09 and called in the morning on 2/19/09.
Age: 7.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Oedema peripheral, Pain in extremity, Wrong drug administered
Clinical narrative: Right arm swollen and tender and hard after recieving DTaP but should of recieved dT booster instead
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Electroencephalogram, Epilepsy, Neurological examination, Partial seizures, Tremor
Clinical narrative: Family noticed onset of partial seizure like activity the night after vaccines were administered.  Episodes of shaking the head and shaking one arm without loss of consciousness.  No tonic-clonic activity.  Brought into office 3 days after vaccine administration for these symptoms.  Not in any distress in office.
Sex: U
Vaccine: DTPPHIB, PNC, RV5
Symptoms: Eye disorder, Hypersomnia, Hypophagia, Lethargy
Clinical narrative: slept all day after receiving vaccines, lethargic, eyes droopy, woke up 2x only to feed for 8-10 min each time
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Dyspnoea, Injection site pain, Myalgia, Pneumonia
Clinical narrative: We received the following information from a nurse via the agency on 05 FEB 2009: A 68-year-old woman, born on 26 APR 1940, was vaccinated with 0.5 ml FLUVIRIN, batch-no. 87924, i.m, on 10 NOV 2008. On 11 NOV 2008 the patient complained of soreness at injection site. On 12 NOV 2008 severe muscle and bone pain were reported. On 13 NOV 2008 she experienced shortness of breath which worsened and the patient was admitted to the hospital due to pneumonia on 14 NOV 2008. An antibiotic therapy started and she was discharged on 27 NOV 2008. Symptoms were resolved at time of report. Review of manufacturing protocols demonstrated that there were no deviations affecting product. No change in assessment.
Age: 56.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Gastrointestinal disorder, Gastrointestinal haemorrhage, Gastrointestinal pain
Clinical narrative: This case was reported by a lawyer and described the occurrence of arm pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included hysterectomy and knee pain. Concurrent medications included SYNTHROID, LUVOX, CRESTOR, Solgar GTF Trivalent chromium, Travacort, VESICARE, LUTEIN, Glucosamine chondroitin complex, Biotin, B-12 and Calcium. Also mentioned were resue medications 1250 and LDL. On 8 May 2000 and 10 April 2000 the subject received 2nd dose and 1st dose of LYMERIX (unknown). In July 2000, after vaccination with LYMERIX, the subject experienced pain in both arms, pain between the shoulders, and elbow pain. Aspirin and TYLENOL gave no relief and she was prescribed RELAFEN. RELAFEN was not effective and Prednisone was prescribed which worked. These symptoms have improved but reportedly continue to come and go. Also in July 2000, the subject developed fatigue for which she takes PROVIGIL, muscle pain and memory problems. In December 2000, the subject was admitted to the hospital with gastro-intestinal problems including some pain and bleeding. She was fed and medicated intravenously. The pain resolved one week later and she was put on ASACOL to manage this condition. The pain reportedly returned with increased severity in June 2004 and she was put on COLAZAL which effectively managed the symptom. An additional symptom that developed in 2000 was elbow swelling which has since resolved.
Age: 56.0
Sex: F
Vaccine: LYME
Symptoms: Joint swelling, Memory impairment, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a lawyer and described the occurrence of arm pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included hysterectomy and knee pain. Concurrent medications included SYNTHROID, LUVOX, CRESTOR, Solgar GTF Trivalent chromium, Travacort, VESICARE, LUTEIN, Glucosamine chondroitin complex, Biotin, B-12 and Calcium. Also mentioned were resue medications 1250 and LDL. On 8 May 2000 and 10 April 2000 the subject received 2nd dose and 1st dose of LYMERIX (unknown). In July 2000, after vaccination with LYMERIX, the subject experienced pain in both arms, pain between the shoulders, and elbow pain. Aspirin and TYLENOL gave no relief and she was prescribed RELAFEN. RELAFEN was not effective and Prednisone was prescribed which worked. These symptoms have improved but reportedly continue to come and go. Also in July 2000, the subject developed fatigue for which she takes PROVIGIL, muscle pain and memory problems. In December 2000, the subject was admitted to the hospital with gastro-intestinal problems including some pain and bleeding. She was fed and medicated intravenously. The pain resolved one week later and she was put on ASACOL to manage this condition. The pain reportedly returned with increased severity in June 2004 and she was put on COLAZAL which effectively managed the symptom. An additional symptom that developed in 2000 was elbow swelling which has since resolved.
Sex: M
Vaccine: HEPAB
Symptoms: Drug exposure during pregnancy, Hyperbilirubinaemia neonatal, Immature respiratory system, Premature baby
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of vaccine exposure during pregnancy in a male neonate exposed to TWINRIX (GlaxoSmithKline) given to the mother while pregnant. The case was also reported by the subject. Previous vaccination received by the mother included 1st dose of TWINRIX (GlaxoSmithKline) given on 10 March 2008. From 04 to 06 December 2007, the mother had received Ofloxacin, 0.3 percent daily for pink eye. On 10 April 2008, at 09:30, the 23 year old mother received 2nd dose of TWINRIX at 1.0 ml intramuscularly in the left arm. Thus, the baby (the subject) was exposed to TWINRIX transplacentary. This was at approximately four weeks gestation. Information received on 10 February 2009 via a Pregnancy Registry Outcome Form indicated that the male, neonate subject was born premature (36 weeks gestation) on 24 January 2009, via induced vaginal delivery with vacuum extraction. The infant weighed 6 pounds and 13 ounces and was 19 inches in length. It was reported that the mother had been on bed rest for 10 days prior to delivery due to preterm labor. Labor was induced due to extreme back pain in the mother. The neonate was born with hyperbilirubinemia and lung immaturity. The outcome of the events was not reported. For details concerning the mother case, please refer to A0724362A.
Age: 23.0
Sex: F
Vaccine: HEPAB
Symptoms: Back pain, Drug exposure during pregnancy, Induced labour, Premature labour
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of pregnancy in an adult female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The case was also reported by the subject. Previous vaccination included 1st dose of TWINRIX (GlaxoSmithKline) given on 10 March 2008. On 10 April 2008 the subject received 2nd dose of TWINRIX (1 ml, 09:30 am) in the left arm. Approximately two hours after vaccination with TWINRIX, the subject discovered that she was pregnant. Follow-up information received on 08 May 2008 regarding the pregnancy indicated that the subject (the pregnant mother) was 23 at the time of event. Her last menstrual period was 07 March 2008 and expected date of delivery, 18 December 2008. Only one fetus in this pregnancy. The 1st dose of TWINRIX was administered just before or around the time of conception. The 2nd dose of TWINRIX was administered at approximately four weeks of pregnancy. From 04 to 06 December 2007, the subject received ofloxacin, 0.3 percent daily for pink eye. No adverse events were reported as of 05 May 2008. Follow-up information received on 27 March 2008 via a Pregnancy Registry Registration Form indicated that the subject's due date is 23 December 2008. The subject experienced a normal conception and there has been no evidence of defect on prenatal test. The mother has no relevant medical history and no history of previous pregnancies. The father of the fetus has a history of juvenile myoclonic epilepsy. TWINRIX was administered intramuscularly. Follow-up information received on 10 February 2009 via a Pregnancy Registry Outcome Form indicated that the subject gave birth to a premature (36 weeks gestation) male infant on 24 January 2009, via induced vaginal delivery with vacuum extraction. The infant weighed 6 pounds and 13 ounces and was 19 inches in length. It was reported that the subject was on bed rest for 10 days prior to delivery due to preterm labor. Labor was induced due to extreme back pain. The neonate was born with hyperbilirubinemia and lung immaturity. For details concerning the baby case, please refer to A0724362B.
Age: 17.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Rash on abdomen and spread to back with itching, stinging and pain. Pain constant treated with VALTREX 1g tid x 7 days and NEUROTIN 500mg bid. Herpes Zoster.
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling at site, Dorsal portion of Left arm in subcutaneous area. 4 cm round.
Age: 1.1
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash fever all over body 10 days after immunization pt examined 2/9/09 rash resolved
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Rash, Urticaria
Clinical narrative: Rash - Hive like. Swollen Rt leg - redness.
Age: 1.51
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Onset of chicken pox disease on 2-19-09
Age: 1.1
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: Patient developed #3 1-2 mm papules red on right thigh 1 week after shots
Age: 1.1
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Parvovirus B19 serology, Unevaluable event
Clinical narrative: None stated.   7/7/09 Medical records received DOS 12/26/07 to 6/23/09. Assessment: Rash Patient presented with erythematous maculopapular rash all over body. Fussy last night. Diarrhea, vomiting. Bite mark.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: On 2-19-09 donor reported a rash she developed following a Hep B injection she received on 2-17-09. Rash on 2-18-09 stretched across abdomen and up into axillary on Lt side. Rash occurred the evening of the injection.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Differential white blood cell count normal, Full blood count normal, Platelet count normal, Pyrexia
Clinical narrative: High fever reported by parent to be 105.6 degrees F. Office temperature within normal limits 97.2 degrees F without other symptoms. Lab work completed and also within normal limits.
Age: 32.0
Sex: U
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Biopsy skin normal, Chest X-ray normal, Immunology test, Pain, Polymerase chain reaction
Clinical narrative: Multiple erythematous vesiculopapular eruptions over arms, hands, legs, heels, chest, upper back, upper trunk, onset 17 days following receipt of SPV, HEPB#1, AVA#1, TYPHOID vaccines; initially mildly pruritic, then became painful; no fever/chills or other significant symptoms; initial derm evaluation 2/4/2009 yielded prelim dx dermatitis with DDX to include hypersensitivity reaction to SMALLPOX vaccine, HSV, VZV, less likely generalized vaccinia; initially prescribed VALTREX; on 2/9/2009 oral steroids with taper was prescribed with fairly rapid improvement of tenderness and gradual crusting of all vesicles; labs & tissue biopsies ruled out viral etiologies; delayed hypersensitivity reaction was included in differential. VHC recommended medical temporary vaccine exemptions for both ANTHRAX & HEPB vaccinations to be given approx 4 weeks after completion of oral steroids, singly a week apart, & only if skin lesions fully resolved without recurrence; and medical reactive exemption for SMALLPOX vaccine.
Age: 32.0
Sex: U
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Scab, Viral DNA test positive
Clinical narrative: Multiple erythematous vesiculopapular eruptions over arms, hands, legs, heels, chest, upper back, upper trunk, onset 17 days following receipt of SPV, HEPB#1, AVA#1, TYPHOID vaccines; initially mildly pruritic, then became painful; no fever/chills or other significant symptoms; initial derm evaluation 2/4/2009 yielded prelim dx dermatitis with DDX to include hypersensitivity reaction to SMALLPOX vaccine, HSV, VZV, less likely generalized vaccinia; initially prescribed VALTREX; on 2/9/2009 oral steroids with taper was prescribed with fairly rapid improvement of tenderness and gradual crusting of all vesicles; labs & tissue biopsies ruled out viral etiologies; delayed hypersensitivity reaction was included in differential. VHC recommended medical temporary vaccine exemptions for both ANTHRAX & HEPB vaccinations to be given approx 4 weeks after completion of oral steroids, singly a week apart, & only if skin lesions fully resolved without recurrence; and medical reactive exemption for SMALLPOX vaccine.
Age: 32.0
Sex: U
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Biopsy, Blister, Dermatitis, Herpes simplex serology negative, Hypersensitivity
Clinical narrative: Multiple erythematous vesiculopapular eruptions over arms, hands, legs, heels, chest, upper back, upper trunk, onset 17 days following receipt of SPV, HEPB#1, AVA#1, TYPHOID vaccines; initially mildly pruritic, then became painful; no fever/chills or other significant symptoms; initial derm evaluation 2/4/2009 yielded prelim dx dermatitis with DDX to include hypersensitivity reaction to SMALLPOX vaccine, HSV, VZV, less likely generalized vaccinia; initially prescribed VALTREX; on 2/9/2009 oral steroids with taper was prescribed with fairly rapid improvement of tenderness and gradual crusting of all vesicles; labs & tissue biopsies ruled out viral etiologies; delayed hypersensitivity reaction was included in differential. VHC recommended medical temporary vaccine exemptions for both ANTHRAX & HEPB vaccinations to be given approx 4 weeks after completion of oral steroids, singly a week apart, & only if skin lesions fully resolved without recurrence; and medical reactive exemption for SMALLPOX vaccine.
Age: 32.0
Sex: U
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Laboratory test, Pain, Polymerase chain reaction, Rash erythematous, Rash pruritic
Clinical narrative: Multiple erythematous vesiculopapular eruptions over arms, hands, legs, heels, chest, upper back, upper trunk, onset 17 days following receipt of SPV, HEPB#1, AVA#1, TYPHOID vaccines; initially mildly pruritic, then became painful; no fever/chills or other significant symptoms; initial derm evaluation 2/4/2009 yielded prelim dx dermatitis with DDX to include hypersensitivity reaction to SMALLPOX vaccine, HSV, VZV, less likely generalized vaccinia; initially prescribed VALTREX; on 2/9/2009 oral steroids with taper was prescribed with fairly rapid improvement of tenderness and gradual crusting of all vesicles; labs & tissue biopsies ruled out viral etiologies; delayed hypersensitivity reaction was included in differential. VHC recommended medical temporary vaccine exemptions for both ANTHRAX & HEPB vaccinations to be given approx 4 weeks after completion of oral steroids, singly a week apart, & only if skin lesions fully resolved without recurrence; and medical reactive exemption for SMALLPOX vaccine.
Age: 32.0
Sex: U
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Rash pustular, Scab, Smear test, Tenderness, Vaccinia
Clinical narrative: Multiple erythematous vesiculopapular eruptions over arms, hands, legs, heels, chest, upper back, upper trunk, onset 17 days following receipt of SPV, HEPB#1, AVA#1, TYPHOID vaccines; initially mildly pruritic, then became painful; no fever/chills or other significant symptoms; initial derm evaluation 2/4/2009 yielded prelim dx dermatitis with DDX to include hypersensitivity reaction to SMALLPOX vaccine, HSV, VZV, less likely generalized vaccinia; initially prescribed VALTREX; on 2/9/2009 oral steroids with taper was prescribed with fairly rapid improvement of tenderness and gradual crusting of all vesicles; labs & tissue biopsies ruled out viral etiologies; delayed hypersensitivity reaction was included in differential. VHC recommended medical temporary vaccine exemptions for both ANTHRAX & HEPB vaccinations to be given approx 4 weeks after completion of oral steroids, singly a week apart, & only if skin lesions fully resolved without recurrence; and medical reactive exemption for SMALLPOX vaccine.
Age: 32.0
Sex: U
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Viral DNA test positive
Clinical narrative: Multiple erythematous vesiculopapular eruptions over arms, hands, legs, heels, chest, upper back, upper trunk, onset 17 days following receipt of SPV, HEPB#1, AVA#1, TYPHOID vaccines; initially mildly pruritic, then became painful; no fever/chills or other significant symptoms; initial derm evaluation 2/4/2009 yielded prelim dx dermatitis with DDX to include hypersensitivity reaction to SMALLPOX vaccine, HSV, VZV, less likely generalized vaccinia; initially prescribed VALTREX; on 2/9/2009 oral steroids with taper was prescribed with fairly rapid improvement of tenderness and gradual crusting of all vesicles; labs & tissue biopsies ruled out viral etiologies; delayed hypersensitivity reaction was included in differential. VHC recommended medical temporary vaccine exemptions for both ANTHRAX & HEPB vaccinations to be given approx 4 weeks after completion of oral steroids, singly a week apart, & only if skin lesions fully resolved without recurrence; and medical reactive exemption for SMALLPOX vaccine.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Expired drug administered
Clinical narrative: Pt was give 1 dose of MENACTRA that had expired 2 days before no problems.
Age: 0.79
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Blood gases abnormal, Chest X-ray, Complement factor C3 decreased, Complement factor C4, Decreased appetite
Clinical narrative: On 15 Oct 2008 his mother brought him to immunizations to receive his 6 month old shots and Synagis. Mom reported the child was cranky having a URI. He was given Respiratory Syncytial vaccine (RSV), DTaP, Hib B (PRP-T), and PNEUMOCOCCAL vaccines. His current weight was 6.2 kg. That evening mom reported child had fevers up to 101 easing with TYLENOL, increased heart rate, fussiness, increased work with breathing with his O2 Sats  decreasing to 80's on 4 L/O2 n/c, poor sleep and decreased appetite. She brought him to ER on 16 Oct 2008 where he was admitted to PICU.  2/27/09 Received medical records of 10/16-10/20/2008 & clinic records. FINAL DX: respiratory distress, vented;, DIC, improved,  Records reveal patient experienced irritability, sleep disturbance, oral intake reduced, fever, tachypnea, increased WOB, desats at home while on oxygen x 1 day. Deteriorated overnight & intubated.  Surgery & Cardio consults done.  Tx w/IV antibiotics, pressor support for hypotension, PRBCs, FFP, TPN.  Transferred to tertiary care facility x 3 wks before d/c to home.  .
Age: 0.79
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Dyspnoea, Full blood count, Heart rate increased, Influenza serology, Irritability
Clinical narrative: On 15 Oct 2008 his mother brought him to immunizations to receive his 6 month old shots and Synagis. Mom reported the child was cranky having a URI. He was given Respiratory Syncytial vaccine (RSV), DTaP, Hib B (PRP-T), and PNEUMOCOCCAL vaccines. His current weight was 6.2 kg. That evening mom reported child had fevers up to 101 easing with TYLENOL, increased heart rate, fussiness, increased work with breathing with his O2 Sats  decreasing to 80's on 4 L/O2 n/c, poor sleep and decreased appetite. She brought him to ER on 16 Oct 2008 where he was admitted to PICU.  2/27/09 Received medical records of 10/16-10/20/2008 & clinic records. FINAL DX: respiratory distress, vented;, DIC, improved,  Records reveal patient experienced irritability, sleep disturbance, oral intake reduced, fever, tachypnea, increased WOB, desats at home while on oxygen x 1 day. Deteriorated overnight & intubated.  Surgery & Cardio consults done.  Tx w/IV antibiotics, pressor support for hypotension, PRBCs, FFP, TPN.  Transferred to tertiary care facility x 3 wks before d/c to home.  .
Age: 0.79
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Oxygen saturation decreased, Poor quality sleep, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: On 15 Oct 2008 his mother brought him to immunizations to receive his 6 month old shots and Synagis. Mom reported the child was cranky having a URI. He was given Respiratory Syncytial vaccine (RSV), DTaP, Hib B (PRP-T), and PNEUMOCOCCAL vaccines. His current weight was 6.2 kg. That evening mom reported child had fevers up to 101 easing with TYLENOL, increased heart rate, fussiness, increased work with breathing with his O2 Sats  decreasing to 80's on 4 L/O2 n/c, poor sleep and decreased appetite. She brought him to ER on 16 Oct 2008 where he was admitted to PICU.  2/27/09 Received medical records of 10/16-10/20/2008 & clinic records. FINAL DX: respiratory distress, vented;, DIC, improved,  Records reveal patient experienced irritability, sleep disturbance, oral intake reduced, fever, tachypnea, increased WOB, desats at home while on oxygen x 1 day. Deteriorated overnight & intubated.  Surgery & Cardio consults done.  Tx w/IV antibiotics, pressor support for hypotension, PRBCs, FFP, TPN.  Transferred to tertiary care facility x 3 wks before d/c to home.  .
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Eye infection, Eye pain, Eye pruritus, Ocular hyperaemia
Clinical narrative: developed bilateral red eyes, itching, pain similar to 4/29/05 eye infection 2 hours after receiving both IM influenza 10/2005 and FLUMIST 10/2006.  Problems resolved after nights sleep but was present for 12 hours.  Ear pain, Red eyes, Itchy Eye lids.
Age: 51.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Arrhythmia, Arthralgia, Aspartate aminotransferase increased, Blood creatine phosphokinase MB, Blood creatine phosphokinase increased
Clinical narrative: I received 3 AVA vaccinations in 2007 and continued to experience cough, fatigue, myalgia, arthralgia, dizziness,and short term memory problems.
Age: 51.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Blood potassium increased, Blood thyroid stimulating hormone, Borrelia burgdorferi serology negative, Brain natriuretic peptide normal, Chest X-ray normal
Clinical narrative: I received 3 AVA vaccinations in 2007 and continued to experience cough, fatigue, myalgia, arthralgia, dizziness,and short term memory problems.
Age: 51.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Cough, Dizziness, Electrocardiogram, Electrocardiogram T wave inversion, Fatigue
Clinical narrative: I received 3 AVA vaccinations in 2007 and continued to experience cough, fatigue, myalgia, arthralgia, dizziness,and short term memory problems.
Age: 51.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Fibrin D dimer normal, Full blood count abnormal, Laboratory test normal, Mean cell volume increased, Memory impairment
Clinical narrative: I received 3 AVA vaccinations in 2007 and continued to experience cough, fatigue, myalgia, arthralgia, dizziness,and short term memory problems.
Age: 51.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Monocyte count increased, Myalgia, Nuclear magnetic resonance imaging abnormal, Red blood cell sedimentation rate increased, Troponin I
Clinical narrative: I received 3 AVA vaccinations in 2007 and continued to experience cough, fatigue, myalgia, arthralgia, dizziness,and short term memory problems.
Age: 51.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Troponin increased, Urine analysis normal
Clinical narrative: I received 3 AVA vaccinations in 2007 and continued to experience cough, fatigue, myalgia, arthralgia, dizziness,and short term memory problems.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Barium enema, Diagnostic procedure, Intussusception
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a less than 6 month old male who in April 2008, was vaccinated with a dose of ROTATEQ. On an unspecified date between April and July 2008, the patient experienced intussusception went to the emergency room and was hospitalized (the course of treatment and duration was not provided). Subsequently, the patient recovered from intussusception. Intussusception was considered to be life-threatening. The VAERS ID # is 320883. This report was also received from the FDA through the Freedom of Information Act. A 6 month old patient with no medical history was orally vaccinated the first dose of ROTATEQ (lot #659773/0020X) on 10-APR-2008. On the same day patient was also vaccinated with the first dose of PREVENAR (lot #C49921) IM, IPOL (lot #A03012) IM, INFANRIX (lot # AC14B049AA) IM and ACTHIB (lot # UF224AA) IM. The laboratory test included barium enema. In May 2008, the patient experienced intussusception. Subsequently the patient recovered on unspecified date. The original reporting source was a physician. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center for and was released. No further information is available.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Activated partial thromboplastin time, Bacteria urine, Band neutrophil percentage, Blood chloride increased, Blood creatinine normal
Clinical narrative: A serious post-marketed study report of hydronephrosis and ureteric obstruction has been received from a study investigator concerning a four-year old male subject, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history included a left sided abdominal mass found on routine physical examination on 08-Jun-2007 which was diagnosed on 18-Jul-2007 as non-existent, non-functioning, fluid filled space left kidney via renal scan. Concomitant medications were not reported. The subject received FLUMIST 0.25 ml per nostril for influenza immunization on 18-Oct-2007. On 05-Nov-2007, the subject was hospitalized for hydronephrosis and ureteric obstructions. Laparoscopic left simple nephrectomy was performed on the same day. Intra-operative findings included giant hydronephrosis of left kidney with normal ureters suggestive of UPC obstruction and greater than 500 ml of cloudy, but not frankly purulent fluid within the kidney. The patient had uncomplicated surgery with stable vital signs post-operatively. He was discharged from the hospital on 07-Nov-2007. On 19-Nov-2007, the patient was seen at follow-up for possible hypertension secondary to non functioning kidney. Examination revealed an asymptomatic patient, BP of 109/70 and normal examination two-weeks post-surgery. The patient's final pathologic diagnosis was hydronephrosis with interstitial chronic inflammation, fibrosis and glomerular sclerosis, and a haphazard arrangement of smooth muscle proliferation seen in renal pelvis consistent with UPU obstruction of left kidney. The adverse events resolved on 19-Nov-2007. The investigator assessed the events of hydronephrosis and ureteric obstruction as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST. Additional information including hospital records was received on 16 Jan 2009 and incorporated in the narrative: patient's demographics, medical history, suspect drug information, laboratory and diagnostic tests results, adverse events information, outcome of the events.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Blood urine present
Clinical narrative: A serious post-marketed study report of hydronephrosis and ureteric obstruction has been received from a study investigator concerning a four-year old male subject, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history included a left sided abdominal mass found on routine physical examination on 08-Jun-2007 which was diagnosed on 18-Jul-2007 as non-existent, non-functioning, fluid filled space left kidney via renal scan. Concomitant medications were not reported. The subject received FLUMIST 0.25 ml per nostril for influenza immunization on 18-Oct-2007. On 05-Nov-2007, the subject was hospitalized for hydronephrosis and ureteric obstructions. Laparoscopic left simple nephrectomy was performed on the same day. Intra-operative findings included giant hydronephrosis of left kidney with normal ureters suggestive of UPC obstruction and greater than 500 ml of cloudy, but not frankly purulent fluid within the kidney. The patient had uncomplicated surgery with stable vital signs post-operatively. He was discharged from the hospital on 07-Nov-2007. On 19-Nov-2007, the patient was seen at follow-up for possible hypertension secondary to non functioning kidney. Examination revealed an asymptomatic patient, BP of 109/70 and normal examination two-weeks post-surgery. The patient's final pathologic diagnosis was hydronephrosis with interstitial chronic inflammation, fibrosis and glomerular sclerosis, and a haphazard arrangement of smooth muscle proliferation seen in renal pelvis consistent with UPU obstruction of left kidney. The adverse events resolved on 19-Nov-2007. The investigator assessed the events of hydronephrosis and ureteric obstruction as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST. Additional information including hospital records was received on 16 Jan 2009 and incorporated in the narrative: patient's demographics, medical history, suspect drug information, laboratory and diagnostic tests results, adverse events information, outcome of the events.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Computerised tomogram abnormal, Culture urine negative, Fibrosis, Full blood count normal, Glomerulosclerosis
Clinical narrative: A serious post-marketed study report of hydronephrosis and ureteric obstruction has been received from a study investigator concerning a four-year old male subject, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history included a left sided abdominal mass found on routine physical examination on 08-Jun-2007 which was diagnosed on 18-Jul-2007 as non-existent, non-functioning, fluid filled space left kidney via renal scan. Concomitant medications were not reported. The subject received FLUMIST 0.25 ml per nostril for influenza immunization on 18-Oct-2007. On 05-Nov-2007, the subject was hospitalized for hydronephrosis and ureteric obstructions. Laparoscopic left simple nephrectomy was performed on the same day. Intra-operative findings included giant hydronephrosis of left kidney with normal ureters suggestive of UPC obstruction and greater than 500 ml of cloudy, but not frankly purulent fluid within the kidney. The patient had uncomplicated surgery with stable vital signs post-operatively. He was discharged from the hospital on 07-Nov-2007. On 19-Nov-2007, the patient was seen at follow-up for possible hypertension secondary to non functioning kidney. Examination revealed an asymptomatic patient, BP of 109/70 and normal examination two-weeks post-surgery. The patient's final pathologic diagnosis was hydronephrosis with interstitial chronic inflammation, fibrosis and glomerular sclerosis, and a haphazard arrangement of smooth muscle proliferation seen in renal pelvis consistent with UPU obstruction of left kidney. The adverse events resolved on 19-Nov-2007. The investigator assessed the events of hydronephrosis and ureteric obstruction as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST. Additional information including hospital records was received on 16 Jan 2009 and incorporated in the narrative: patient's demographics, medical history, suspect drug information, laboratory and diagnostic tests results, adverse events information, outcome of the events.