chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Physician Assistant (P.A) concerning a 15 year old female patient who on 13-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot # not reported). It was reported that the patient fainted right after receiving the first dose of GARDASIL on 13-JUN-2009. It was reported that the patient was was brought to the emergency room and stayed there for a few hours. The patient was not admitted to the hospital. The patient sought medical attention with the Physician Assistant. There was a blood work performed (results not provided). It was reported that the adverse event had improved at the time of the report. All telephone attempts to contact the reporter have been unsuccessful. Follow up information was received from a Physician Assistant (P.A) on 23-JUN-2009 via telephone reported that the patient with no pertinent medical history or known drug allergies was vaccinated with the first dose of GARDASIL (Lot # 661846/1312X) on 13-JUN-2009. On 13-JUN-2009 the patient was very anxious and hadn't eaten since the night before. There were no concomitant medications and no other vaccinations given that day. After having fainted for only a few seconds, the patient was monitored in the office for the next 45 minutes. The vital signs and blood sugars were normal, but the patient was nauseous, lethargic and pale. She was transported to the emergency room. It was unknown what tests - other than blood work - were performed. The event was considered disabling for about five hours. The patient had fully recovered. The reporter considered fainted, nauseous, lethargic and pale to be significant disability/disabling. No further information is available.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC
Symptoms: Antibody test abnormal, Chest X-ray normal, Cough, Pneumonia
Clinical narrative: Follow-up information received from the healthcare provider upgraded the case to serious. It also provided additional concomitant vaccines, test results, medical history, diagnosis and patient demographics. This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 2-year-old female patient who experienced low titer levels, recurrent pneumonia and chronic cough. At 12 months of age, the patient received the fourth dose on 18-May-2007. The patient also received the first dose of PROQUAD (Merck & Co Inc) and the first dose of VAQTA (Merck Sharp & Dome) on 18-May-2007. Concomitant therapy included VAQTA and PROQUAD. The patient experienced recurrent pneumonia on Jun-2008, 14-Jun-2008 and 21-Jan-2009. On 09-Apr-2009, the patient experienced low antibody titer levels. The patient also experienced chronic cough on an unspecified date. The patient recovered from the recurrent pneumonia. The outcome of low antibody titers and cough is unknown. No additional information was available at the time of this report. No additional information was available at the time of this report. See related case (s): US-WYE-H09094309 (adverse event, expedited); US-WYE-H09220109 (adverse event, non-expedited); and US-WYE-H09220309 (adverse event, non-expedited).
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Crying, Heart rate increased, Oxygen saturation normal, Urticaria, Wheezing
Clinical narrative: Vaccines given MMR and Varicella. Whelps at 5 mins after given. Benadryl given, whelps smaller. Sleeps no wheeze, cry when woke 30 minutes after. Sleeping wheeze - Epi Jr given 35 after. Pulse ox 98-99%, HR 125 40 min after. Good cry awake report called to doctor. Transferred to hospital via EMS 45 min after.  7/7/09 ER record received dated  with DX: Acute Allergic Reaction (Anaphylaxis).  Pt presented from MD's office where pt developed red welts at the injection sites immediatedly after receiving MMR and Varivax. Given Benadryl and Epi. Later sleepy and wheezing so transported to ER. Given pred with good response. D/C.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Pain
Clinical narrative: Extreme crying baby in severe pain- can't calm down, mom can't put baby down.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Convulsion, Loss of consciousness, Musculoskeletal stiffness, Staring
Clinical narrative: Mother came to health dept today and reported the following: Client left building where she received IZ "body went stiff, eyes were open x 2-3 minutes." mother caught her & prevented injury from fall. 911 called, taken to ER by ambulance. Mother reports client was told she had a seizure. Referred to neurologist & cardiologist.
Age: 1.38
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Productive cough, Pyrexia, Rhinorrhoea
Clinical narrative: Mo states child spiked temp of 101.4 tues. 6/16/09 after vaccinations received Mon. 6/15/09. Fever broke tues afternoon. Symptoms include runny nose and "wet" cough.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Gastrointestinal haemorrhage, Haematochezia
Clinical narrative: Symptom: Bright red blood in stool - size: about a quarter occurred twice in the evening on the day she received her 2 months vaccinations. I took her to Hospital ER. They tested her stool and it was positive for having blood in it. They diagnosed her with GI bleeding.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Chest pain, Pharyngeal oedema, Swollen tongue
Clinical narrative: Tongue and throat swelling, chest pain 1 1/2-2 hours after vaccine was given IV BENADRYL and PEPCID given in ER.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Hives- Diphenhydramine
Age: 1.5
Sex: M
Vaccine: DTAP, MMR
Symptoms: Otitis media, Pyrexia
Clinical narrative: 5/26/09 Fever, went to ED -> Dx with otitis media.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Parvovirus B19 serology positive, Parvovirus infection
Clinical narrative: Developed elbow and knee burning joint pain. One month after vaccination had Parvovirus infection. Pain continues, no other rheumatologic disease.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Persistent pain in left arm after receiving flu shot.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Computerised tomogram normal, Hypoaesthesia
Clinical narrative: 6/17/09 Dr reported to me that 3 days ago he started with some numbness to left axilla and lateral upper arm.  6/17/09 50% better.  6/22/09 90% better.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chest X-ray, Cough, Pneumonia, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, runny nose, coughing Dx 6/1/09 with pneumonia Rx  AMOXICILLIN.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Irritability, Screaming
Clinical narrative: Extremely fussy, screaming, inconsolable for 2 days. Mom could not put baby down.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema
Clinical narrative: Erythema @ injection site
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Immediately after varicella vaccine, which was given last, client c/o nausea & dizziness. BP 100/60 x2. Juice was given. Remained seated for 15 min. Last BP was 118/78. Pt left with mom.
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Haemorrhage, Pruritus, Scratch, Urticaria
Clinical narrative: Post immunization client developed hives that itched until she scratched and drew blood. They covered neck to toe of her body.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: 6-11-09 After shot, arm swell up, turn red, working down to forearm, painful ! 6-13-09 Medical office provider: PA = Fexofenadine 60mg = Benadryl = Cephalexin  250 mg 4x a day for 10 days.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: On 6/1/09, pt. called & left a message that following having received VARIVAX, she developed a rash on her arm. The message was misplaced, but an RN tried to call pt. on 6/5. Dr. also called, but neither were able to reach her. (She was already on her trip). On 6/22, pt. called to say that she received steroid medication from her PMD before departing on trip. She reports that the rash has cleared up.
Age: 0.3
Sex: F
Vaccine: HIBV, PNC
Symptoms: Haemoglobin decreased, Inflammation, Neutrophil count increased, Pyrexia, White blood cell count increased
Clinical narrative: Fever started about 6 to 8 hours after HIB and Prevnar vaccine. Temperature 103 degrees. Continued fever 101 to 103 for 3 additional days. Evaluation for sepsis revealed high WBC count and also anemia and also thrombocytosis and Rocephin was given. She defervesced within 12 hours and remained afebrile and well the next 2 1/2 weeks, however, she has had continued lab abnormalities last week and as recently as yesterday - 20 days post vaccine. Discussed case with infectious disease doctors. This is thought to represent a systemic inflammatory reaction possibly to the conjugate of tetanus toxoid in the HIB vaccine (v. the conjugate in the Prevnar vaccine).
Age: 59.0
Sex: U
Vaccine: HEP
Symptoms: Arthralgia, Back pain, Laboratory test normal, Musculoskeletal pain, Pain
Clinical narrative: Achey on 6-3-09. Severe pain in arm,shoulders,knees,back and fever of 103.7 6-4-09. ER on 6-5-09 was given Levaquin, Vicoden,Ultram. 6-6-09 pain meds are helping except for shoulder. Saw a ortho Dr. x-rays done all normal. Now still has pain in L arm remains on Vicoden and Ulram. Has MRI scheduled for 6-29-09.
Age: 59.0
Sex: U
Vaccine: HEP
Symptoms: Pain in extremity, Pyrexia, X-ray normal
Clinical narrative: Achey on 6-3-09. Severe pain in arm,shoulders,knees,back and fever of 103.7 6-4-09. ER on 6-5-09 was given Levaquin, Vicoden,Ultram. 6-6-09 pain meds are helping except for shoulder. Saw a ortho Dr. x-rays done all normal. Now still has pain in L arm remains on Vicoden and Ulram. Has MRI scheduled for 6-29-09.
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: Chest discomfort, Chest pain, Dizziness, Metabolic function test, Presyncope
Clinical narrative: Patient had symptoms of dizziness with near syncope, sensation of throat constriction with tightness at the base of his neck.  This was then accompanied by chest pain and tightness.
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: Throat tightness, Urine analysis
Clinical narrative: Patient had symptoms of dizziness with near syncope, sensation of throat constriction with tightness at the base of his neck.  This was then accompanied by chest pain and tightness.
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Dizziness postural, Dysphonia, Dyspnoea, Metabolic function test normal
Clinical narrative: About eight hours after vaccine administration, at about 4:00 AM, patient experienced sensation of throat constriction and inability to breathe deeply.  His voice was hoarse. He also complained of pain at the back of his neck and tightness at the base of the front of his neck and throat.  He was occasionally dizzy, especially on standing and walking.  He took 600mg ibuprofen and 25mg Benadryl at 5:00 AM.  This partially relieved symptoms, but drinking and eating were still uncomfortable.  At 11:00 he took another 25mg Benadryl, and was able to tolerate a dental exam.  At 3:00PM, he called his Primary Physician to report symptoms, and was instructed to go to the emergency room.  At the ED, he had continued symptoms of dizziness and throat tightness. He had blood drawn for CMP (all values within normal ranges  ), and had a light scope of the throat, which found no inflammation or obstruction. After administration of 1000mL of NSS per IV, he was discharged to home with instructions for care of sore throat, which was not one of his complaints.
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: Neck pain, Oropharyngeal pain, Throat tightness
Clinical narrative: About eight hours after vaccine administration, at about 4:00 AM, patient experienced sensation of throat constriction and inability to breathe deeply.  His voice was hoarse. He also complained of pain at the back of his neck and tightness at the base of the front of his neck and throat.  He was occasionally dizzy, especially on standing and walking.  He took 600mg ibuprofen and 25mg Benadryl at 5:00 AM.  This partially relieved symptoms, but drinking and eating were still uncomfortable.  At 11:00 he took another 25mg Benadryl, and was able to tolerate a dental exam.  At 3:00PM, he called his Primary Physician to report symptoms, and was instructed to go to the emergency room.  At the ED, he had continued symptoms of dizziness and throat tightness. He had blood drawn for CMP (all values within normal ranges  ), and had a light scope of the throat, which found no inflammation or obstruction. After administration of 1000mL of NSS per IV, he was discharged to home with instructions for care of sore throat, which was not one of his complaints.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Nausea, Pyrexia, Vomiting
Clinical narrative: Developed nausea and vomiting, insomnia and mild fever approx. 10 hours after vaccine administration. Vomited repeatedly during night. Able to eat soda crackers and sip soda in morning, attended class but felt nausea x 2 days. Well on 3rd day.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client was given a Dtap/Polio IM injection in the left deltoid on Wednesday 6/24/2009. Client and mother returned to clinic at 9:00AM on Friday 6/26/2009. Client's mother was concerned because client's arm was red, slightly swollen and warm. Client's mother was instructed to follow-up with family physician.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT HAD KINRIX ON 06-23-2009. DEVELOPED RED RAISED SWELLING AT INJECTION SITE ON 06-24-2009. SEEN BY DR. ON 06-25-2009. ALSO AREA WAS WARM BUT NOT TENDER. SIZE OF REDNESS ABOUT 15CM DIAMETER. NO FEVER.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: itchy red welt, larger then usual
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema
Clinical narrative: Large area of erythema with a slight hemorrhagic appearance, encompassing almost entire L thigh
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Rash macular
Clinical narrative: red, blotchy, hard, swollen around the injection site. 4-inch diameter around the injection site. Localized
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: red, raised swollen area approx 4x4 inches  bendryl taken
Age: 0.17
Sex: M
Vaccine: DTPPHIB, HEP, PNC, RV1
Symptoms: Culture stool, Diarrhoea, Pyrexia, Rotavirus test positive, Vomiting
Clinical narrative: Several hours after receiving Oral RotaRix vaccine, 2 month old baby developed fever (100.9-101.2) for four days, acute onset copious watery non-bloody diarrhea (nearly "continuous", needing 3-4 new diapers/hr, per his mom, a very reliable historian) for four days (but still ongoing at time of reporting), and intermittent vomiting (2-4 times/day).  Mom reported that he did have a softer-than-usual stool on the morning before the vaccine, but it was NOT watery and nothing like what he had that afternoon.  At the time of this reporting, the child still has copious diarrhea and is being cared for at home, but I expect he will need hospitalization/IV fluids in the next day or two if this continues.  7/30/09 Hospital records received inpatient DOS 6/26/09 to 6/27/09 ER visit 7/1/09, and inpatient 7/3/09 to 7/10/09. Assessment Gastroenteritis. Fever. Patient presents with 5 days of fever, vomiting, and diarrhea. Stool appears watery, foul smelling. Emesis non-bloody. Maculopapular rash on torso.  Returned with fever, will not drink, sleeping. Called back to ER after discharge for lumbar puncture because of positive blood culture. Readmitted for fever and placed on antibiotics.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chest discomfort, Diarrhoea, Dyspnoea, Headache
Clinical narrative: A couple hours after the vaccination, I felt my head starting to ache. Then later I felt like there  was an elephant on my chest. I  was having difficulty breathing. My body started to ache. I went to bed thinking it would go away. the next morning it  was worse so I called the doctor. He  said to go on bed rest and call the next day if it was not better. This day 2 days after I feel better, but no good and have a severe stomach and diarehha.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: A couple hours after the vaccination, I felt my head starting to ache. Then later I felt like there  was an elephant on my chest. I  was having difficulty breathing. My body started to ache. I went to bed thinking it would go away. the next morning it  was worse so I called the doctor. He  said to go on bed rest and call the next day if it was not better. This day 2 days after I feel better, but no good and have a severe stomach and diarehha.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Oedema peripheral, Pain in extremity
Clinical narrative: Her arm was swollen all the way down to elbow.  It is really sore and she had very back headache and joint pain
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine administered inadvertantly.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine administered inadvertantly.
Age: 13.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Patient received Menactra and varivax injection.  Patient fainted 3-5 minutes after injection was given while in the elevator.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abasia, Arthralgia, Histone antibody positive, Immediate post-injection reaction, Joint swelling
Clinical narrative: Immediately following vaccine, patient began to complain of mild symptoms (my shoulder hurts, my wrist hurts, look at these spots on my leg.  On the 5th of January, she came home from school with pain in both of her ankles but after resting and and Advil, she felt ok to go school.  She came home from school on the 6th screaming in pain.  Her ankles were so swollen, we had a lot of trouble getting her boots off.  She couldn't walk and had a rash all over her legs and ankles.  We saw a pediatrician who immediately sent us to hospital.  She had lots of tests and IV steroids and antibiotics.  They later diagnosed her with Lupus.  PCP records received as well as note from admission DOS 7/7-12/2009. Pt initially presented Jan 8, 2008 with c/o 5 day hx of bilateral ankle pain and rash of the ankle, calf and thigh. Seen in ER with PE (+) for petechial purpuric rash and low grade fever. Tx with abx and steroids and d/c for outpt f/u.  Rheum consult PE (+) for L ankle effusion and decreased ROM. R ankle (+) for synovial thickening. Scant petechial lesions on LEs. ? Gardasil trigger for autoimmune disease with arthritis. F/U 1/15/09 with dx:  Lupus. F/U 2/19/09, 4/6/09 with Impression:  The presence of anti-histone AB suggests drug-induced Lupus 2' to Gardasil. F/U 6/22/09 with c/o H/A, joint pain, mouth sores and rash. Assess:  Worsening Lupus now with nephritis.  Admitted 7/7-12/09 with D/C DX:  Lupus cerebritis, lupus glomerulonephritis for c/o difficulty with word finding and increasing clumsiness. Nephrology consult for hematuria and proteinuria.  7/31/09 Hospital discharge summary received DOS 7/7/09 to 7/12/09. Assessment: Lupus cerebritis, lupus glomerulonephritis.  Patient presented with 6 days of increasing difficulty finding words and general confusion. Choreiform movements and difficulty with memory. Palmar peeling after Cytoxan treatment. Papules on tongue. Malar rash. ICD-9: Diagnosis 710.0 Systemic lupus erythematosus  Other causes of encephalitis and encephalomyelitis: 323.814,
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal pain, Rash, Screaming, Systemic lupus erythematosus, Urine analysis
Clinical narrative: Immediately following vaccine, patient began to complain of mild symptoms (my shoulder hurts, my wrist hurts, look at these spots on my leg.  On the 5th of January, she came home from school with pain in both of her ankles but after resting and and Advil, she felt ok to go school.  She came home from school on the 6th screaming in pain.  Her ankles were so swollen, we had a lot of trouble getting her boots off.  She couldn't walk and had a rash all over her legs and ankles.  We saw a pediatrician who immediately sent us to hospital.  She had lots of tests and IV steroids and antibiotics.  They later diagnosed her with Lupus.  PCP records received as well as note from admission DOS 7/7-12/2009. Pt initially presented Jan 8, 2008 with c/o 5 day hx of bilateral ankle pain and rash of the ankle, calf and thigh. Seen in ER with PE (+) for petechial purpuric rash and low grade fever. Tx with abx and steroids and d/c for outpt f/u.  Rheum consult PE (+) for L ankle effusion and decreased ROM. R ankle (+) for synovial thickening. Scant petechial lesions on LEs. ? Gardasil trigger for autoimmune disease with arthritis. F/U 1/15/09 with dx:  Lupus. F/U 2/19/09, 4/6/09 with Impression:  The presence of anti-histone AB suggests drug-induced Lupus 2' to Gardasil. F/U 6/22/09 with c/o H/A, joint pain, mouth sores and rash. Assess:  Worsening Lupus now with nephritis.  Admitted 7/7-12/09 with D/C DX:  Lupus cerebritis, lupus glomerulonephritis for c/o difficulty with word finding and increasing clumsiness. Nephrology consult for hematuria and proteinuria.  7/31/09 Hospital discharge summary received DOS 7/7/09 to 7/12/09. Assessment: Lupus cerebritis, lupus glomerulonephritis.  Patient presented with 6 days of increasing difficulty finding words and general confusion. Choreiform movements and difficulty with memory. Palmar peeling after Cytoxan treatment. Papules on tongue. Malar rash. ICD-9: Diagnosis 710.0 Systemic lupus erythematosus  Other causes of encephalitis and encephalomyelitis: 323.814,
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: X-ray
Clinical narrative: Immediately following vaccine, patient began to complain of mild symptoms (my shoulder hurts, my wrist hurts, look at these spots on my leg.  On the 5th of January, she came home from school with pain in both of her ankles but after resting and and Advil, she felt ok to go school.  She came home from school on the 6th screaming in pain.  Her ankles were so swollen, we had a lot of trouble getting her boots off.  She couldn't walk and had a rash all over her legs and ankles.  We saw a pediatrician who immediately sent us to hospital.  She had lots of tests and IV steroids and antibiotics.  They later diagnosed her with Lupus.  PCP records received as well as note from admission DOS 7/7-12/2009. Pt initially presented Jan 8, 2008 with c/o 5 day hx of bilateral ankle pain and rash of the ankle, calf and thigh. Seen in ER with PE (+) for petechial purpuric rash and low grade fever. Tx with abx and steroids and d/c for outpt f/u.  Rheum consult PE (+) for L ankle effusion and decreased ROM. R ankle (+) for synovial thickening. Scant petechial lesions on LEs. ? Gardasil trigger for autoimmune disease with arthritis. F/U 1/15/09 with dx:  Lupus. F/U 2/19/09, 4/6/09 with Impression:  The presence of anti-histone AB suggests drug-induced Lupus 2' to Gardasil. F/U 6/22/09 with c/o H/A, joint pain, mouth sores and rash. Assess:  Worsening Lupus now with nephritis.  Admitted 7/7-12/09 with D/C DX:  Lupus cerebritis, lupus glomerulonephritis for c/o difficulty with word finding and increasing clumsiness. Nephrology consult for hematuria and proteinuria.  7/31/09 Hospital discharge summary received DOS 7/7/09 to 7/12/09. Assessment: Lupus cerebritis, lupus glomerulonephritis.  Patient presented with 6 days of increasing difficulty finding words and general confusion. Choreiform movements and difficulty with memory. Palmar peeling after Cytoxan treatment. Papules on tongue. Malar rash. ICD-9: Diagnosis 710.0 Systemic lupus erythematosus  Other causes of encephalitis and encephalomyelitis: 323.814,
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abasia, Antinuclear antibody, Arthralgia, DNA antibody, Histone antibody positive
Clinical narrative: Immediately following vaccine, patient began to complain of mild symptoms (my shoulder hurts, my wrist hurts, look at these spots on my leg.  On the 5th of January, she came home from school with pain in both of her ankles but after resting and and Advil, she felt ok to go school.  She came home from school on the 6th screaming in pain.  Her ankles were so swollen, we had a lot of trouble getting her boots off.  She couldn't walk and had a rash all over her legs and ankles.  We saw a pediatrician who immediately sent us to hospital.  She had lots of tests and IV steroids and antibiotics.  They later diagnosed her with Lupus.  PCP records received as well as note from admission DOS 7/7-12/2009. Pt initially presented Jan 8, 2008 with c/o 5 day hx of bilateral ankle pain and rash of the ankle, calf and thigh. Seen in ER with PE (+) for petechial purpuric rash and low grade fever. Tx with abx and steroids and d/c for outpt f/u.  Rheum consult PE (+) for L ankle effusion and decreased ROM. R ankle (+) for synovial thickening. Scant petechial lesions on LEs. ? Gardasil trigger for autoimmune disease with arthritis. F/U 1/15/09 with dx:  Lupus. F/U 2/19/09, 4/6/09 with Impression:  The presence of anti-histone AB suggests drug-induced Lupus 2' to Gardasil. F/U 6/22/09 with c/o H/A, joint pain, mouth sores and rash. Assess:  Worsening Lupus now with nephritis.  Admitted 7/7-12/09 with D/C DX:  Lupus cerebritis, lupus glomerulonephritis for c/o difficulty with word finding and increasing clumsiness. Nephrology consult for hematuria and proteinuria.  7/31/09 Hospital discharge summary received DOS 7/7/09 to 7/12/09. Assessment: Lupus cerebritis, lupus glomerulonephritis.  Patient presented with 6 days of increasing difficulty finding words and general confusion. Choreiform movements and difficulty with memory. Palmar peeling after Cytoxan treatment. Papules on tongue. Malar rash. ICD-9: Diagnosis 710.0 Systemic lupus erythematosus  Other causes of encephalitis and encephalomyelitis: 323.814,
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Joint swelling, Musculoskeletal pain, Rash generalised, Screaming
Clinical narrative: Immediately following vaccine, patient began to complain of mild symptoms (my shoulder hurts, my wrist hurts, look at these spots on my leg.  On the 5th of January, she came home from school with pain in both of her ankles but after resting and and Advil, she felt ok to go school.  She came home from school on the 6th screaming in pain.  Her ankles were so swollen, we had a lot of trouble getting her boots off.  She couldn't walk and had a rash all over her legs and ankles.  We saw a pediatrician who immediately sent us to hospital.  She had lots of tests and IV steroids and antibiotics.  They later diagnosed her with Lupus.  PCP records received as well as note from admission DOS 7/7-12/2009. Pt initially presented Jan 8, 2008 with c/o 5 day hx of bilateral ankle pain and rash of the ankle, calf and thigh. Seen in ER with PE (+) for petechial purpuric rash and low grade fever. Tx with abx and steroids and d/c for outpt f/u.  Rheum consult PE (+) for L ankle effusion and decreased ROM. R ankle (+) for synovial thickening. Scant petechial lesions on LEs. ? Gardasil trigger for autoimmune disease with arthritis. F/U 1/15/09 with dx:  Lupus. F/U 2/19/09, 4/6/09 with Impression:  The presence of anti-histone AB suggests drug-induced Lupus 2' to Gardasil. F/U 6/22/09 with c/o H/A, joint pain, mouth sores and rash. Assess:  Worsening Lupus now with nephritis.  Admitted 7/7-12/09 with D/C DX:  Lupus cerebritis, lupus glomerulonephritis for c/o difficulty with word finding and increasing clumsiness. Nephrology consult for hematuria and proteinuria.  7/31/09 Hospital discharge summary received DOS 7/7/09 to 7/12/09. Assessment: Lupus cerebritis, lupus glomerulonephritis.  Patient presented with 6 days of increasing difficulty finding words and general confusion. Choreiform movements and difficulty with memory. Palmar peeling after Cytoxan treatment. Papules on tongue. Malar rash. ICD-9: Diagnosis 710.0 Systemic lupus erythematosus  Other causes of encephalitis and encephalomyelitis: 323.814,
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Systemic lupus erythematosus, Urine analysis, X-ray limb
Clinical narrative: Immediately following vaccine, patient began to complain of mild symptoms (my shoulder hurts, my wrist hurts, look at these spots on my leg.  On the 5th of January, she came home from school with pain in both of her ankles but after resting and and Advil, she felt ok to go school.  She came home from school on the 6th screaming in pain.  Her ankles were so swollen, we had a lot of trouble getting her boots off.  She couldn't walk and had a rash all over her legs and ankles.  We saw a pediatrician who immediately sent us to hospital.  She had lots of tests and IV steroids and antibiotics.  They later diagnosed her with Lupus.  PCP records received as well as note from admission DOS 7/7-12/2009. Pt initially presented Jan 8, 2008 with c/o 5 day hx of bilateral ankle pain and rash of the ankle, calf and thigh. Seen in ER with PE (+) for petechial purpuric rash and low grade fever. Tx with abx and steroids and d/c for outpt f/u.  Rheum consult PE (+) for L ankle effusion and decreased ROM. R ankle (+) for synovial thickening. Scant petechial lesions on LEs. ? Gardasil trigger for autoimmune disease with arthritis. F/U 1/15/09 with dx:  Lupus. F/U 2/19/09, 4/6/09 with Impression:  The presence of anti-histone AB suggests drug-induced Lupus 2' to Gardasil. F/U 6/22/09 with c/o H/A, joint pain, mouth sores and rash. Assess:  Worsening Lupus now with nephritis.  Admitted 7/7-12/09 with D/C DX:  Lupus cerebritis, lupus glomerulonephritis for c/o difficulty with word finding and increasing clumsiness. Nephrology consult for hematuria and proteinuria.  7/31/09 Hospital discharge summary received DOS 7/7/09 to 7/12/09. Assessment: Lupus cerebritis, lupus glomerulonephritis.  Patient presented with 6 days of increasing difficulty finding words and general confusion. Choreiform movements and difficulty with memory. Palmar peeling after Cytoxan treatment. Papules on tongue. Malar rash. ICD-9: Diagnosis 710.0 Systemic lupus erythematosus  Other causes of encephalitis and encephalomyelitis: 323.814,
Age: 19.0
Sex: M
Vaccine: HEPAB, IPV, MMR, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Pt given TWINRIX 1ml, Tdap 0.5 ml, IPV 0.5 ml, MMR 0.5 ml and PPD 0.05 ml. Pt passed out in 1 minute and was given smelling salt and recovered.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient was given an MMR by agency while was 5 weeks pregnant.
Sex: U
Vaccine: MMR
Symptoms: Antibody test, Body temperature increased, Dizziness, Hyperhidrosis
Clinical narrative: Temp 102 sweats, dizziness.
Age: 1.28
Sex: U
Vaccine: MMR, TDAP
Symptoms: Urticaria
Clinical narrative: Diffuse urticaria that started about 12-24h after vaccine administration. Treated with diphenhydramine.
Sex: F
Vaccine: DTAP, IPV
Symptoms: Irritability, Oedema peripheral
Clinical narrative: Arm swelling - 1 1/2 cm circumferential difference, irritable. Shoulder --> wrist, dorsum of hand slight edema.
Age: 1.2
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: Per mother of child: See attachment telephone conversation 6/25/09 3:30 PM.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: DTaP given 6/24/09. 6/26/09 woke with painful, red and swollen arm.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Bronchospasm, Dysphagia, Dyspnoea, Hypersensitivity
Clinical narrative: 30 minutes after receiving GARDASIL vaccine Pt. developed dyspnea, dysphagia, stabbing, sharp pain (R) arm and hip, neck pain. Dx: Allergic reaction. Bronchospasm.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pain in extremity
Clinical narrative: 30 minutes after receiving GARDASIL vaccine Pt. developed dyspnea, dysphagia, stabbing, sharp pain (R) arm and hip, neck pain. Dx: Allergic reaction. Bronchospasm.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: After few minutes of MMR + Varicella vaccines administration child's right thigh became red and indurated.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Crying
Clinical narrative: Child with 3hr prolonged crying episode. Started roughly 3hrs after getting vaccines. Resolved with warm compresses to the thighs.
Sex: M
Vaccine: DTAP
Symptoms: Abdominal pain, Nausea, Pain, Pyrexia
Clinical narrative: Received imms. 6/9/09. On 6/10/09 was achy and 102 degrees fever. On 6/13/09 pt again at clinic c/o nausea, abd cramping, and fever.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: R arm red with warmth ~ 6-7 cm diameter no induration.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Agitation, Amnesia, Amnesia, Anxiety, Bradyphrenia
Clinical narrative: On March 24,2009 received injection of Zostavax and by April 8th, experienced extreame anxiety, inability to sleep, and by May 7th was hospitalized for anxiety, loss of memory and by May 16th has slipped into severe depression and again hospitlized and  treated with 12 ECT (Electro Convulsive Therapy)to encourage brain activity.  Brain had slowed down drastically -patient very non-communicative and very agitated/depressed. Currently taking 300 mg. Vistaril, 20 mg. Lexapro, 50 mg. Trazodone, and 30 mg. daily to treat depression and axiety.  Patient recovering at home. 7/22/10 Continued Anxiety/Nervous disoder.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Communication disorder, Depression, Electroconvulsive therapy, Insomnia, Nervous system disorder
Clinical narrative: On March 24,2009 received injection of Zostavax and by April 8th, experienced extreame anxiety, inability to sleep, and by May 7th was hospitalized for anxiety, loss of memory and by May 16th has slipped into severe depression and again hospitlized and  treated with 12 ECT (Electro Convulsive Therapy)to encourage brain activity.  Brain had slowed down drastically -patient very non-communicative and very agitated/depressed. Currently taking 300 mg. Vistaril, 20 mg. Lexapro, 50 mg. Trazodone, and 30 mg. daily to treat depression and axiety.  Patient recovering at home. 7/22/10 Continued Anxiety/Nervous disoder.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Nervousness, Sleep disorder
Clinical narrative: On March 24,2009 received injection of Zostavax and by April 8th, experienced extreame anxiety, inability to sleep, and by May 7th was hospitalized for anxiety, loss of memory and by May 16th has slipped into severe depression and again hospitlized and  treated with 12 ECT (Electro Convulsive Therapy)to encourage brain activity.  Brain had slowed down drastically -patient very non-communicative and very agitated/depressed. Currently taking 300 mg. Vistaril, 20 mg. Lexapro, 50 mg. Trazodone, and 30 mg. daily to treat depression and axiety.  Patient recovering at home. 7/22/10 Continued Anxiety/Nervous disoder.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Contusion, Fall, Head injury, Headache, Loose tooth
Clinical narrative: SYNCOPE,CONTUSION TO FACE,HEADACHE,DIZZINESS
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Mouth injury, Syncope
Clinical narrative: SYNCOPE,CONTUSION TO FACE,HEADACHE,DIZZINESS
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Computerised tomogram, Contusion, Dizziness, Face injury, Full blood count
Clinical narrative: SYNCOPE,CONTUSION TO FACE,HEADACHE,DIZZINESS
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Metabolic function test, Syncope
Clinical narrative: SYNCOPE,CONTUSION TO FACE,HEADACHE,DIZZINESS
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Computerised tomogram, Fall, Head injury, No reaction on previous exposure to drug, Syncope
Clinical narrative: SYNCOPE,CONTUSION TO FACE,HEADACHE,DIZZINESS
Age: 2.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: fussy, loss of appetite, fever as high as 102.9 after having pneumococal conjugate and hepA vaccines on 6/23/08.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated, Sinusitis
Clinical narrative: severe asthma attack, no fever, sinus infection. pt treated with iv decadron followed by po taper of prednisone
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: PATIENT STARTED WITH A FEVER 6/27 ON THE MORNING OF 6/28 BROKE OUT WITH A RASH WHICH CONSISTED OF ABOUT 10-20 ERYTHEMATOUS MACULPAPULES EACH ABOUT 5 - 10 MM A FEW WITH A CENTRAL PAPULE NONE WITH A CLEAR VESICLE.
Sex: U
Vaccine: MEN
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received on 22 June 2009 from another manufacturer whose initial reporter was a health care professional. A patient received a MENINGOCOCCAL vaccine (manufacturer and lot number not known) on an unspecified date. Post vaccination, on an unspecified date, the patient developed Guillain-Barre Syndrome. No further details were provided. List of documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Convulsion, Fall, Head injury, Syncope
Clinical narrative: Information has been received from a company representative concerning her neighbor's friend's daughter a 13 year old female patient who "earlier this week" on approximately 15-JUN-2009 was vaccinated with a dose of GARDASIL. The patient had two episodes of seizures starting 2 days after administration of GARDASIL on approximately 17-JUN-2009. The patient was currently in the hospital. The patient had not recovered. Additional information has been received from the field employee who provided the patient's name (date of birth, provider name and phone number unknown). The field employee reported while in the pediatrician's office and after the patient and received the second dose of GARDASIL, the patient fell on the floor and had a grand mal seizure. An ambulance took the patient from the physician's office to the hospital. The health care professional contacted during telephone follow-up could not supply the following information: date of birth, date of vaccination, dose number (if applicable), lot number (if applicable), date of event, hospital name (if applicable), healthcare provider name and contact information. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Convulsion, Fall, Grand mal convulsion
Clinical narrative: Information has been received from a company representative concerning her neighbor's friend's daughter a 13 year old female patient who "earlier this week" on approximately 15-JUN-2009 was vaccinated with a dose of GARDASIL. The patient had two episodes of seizures starting 2 days after administration of GARDASIL on approximately 17-JUN-2009. The patient was currently in the hospital. The patient had not recovered. Additional information has been received from the field employee who provided the patient's name (date of birth, provider name and phone number unknown). The field employee reported while in the pediatrician's office and after the patient and received the second dose of GARDASIL, the patient fell on the floor and had a grand mal seizure. An ambulance took the patient from the physician's office to the hospital. The health care professional contacted during telephone follow-up could not supply the following information: date of birth, date of vaccination, dose number (if applicable), lot number (if applicable), date of event, hospital name (if applicable), healthcare provider name and contact information. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received from a healthcare professional through a Pregnancy Registry for GARDASIL concerning a 17 year old female with depression, attention deficit disorder, obsessive compulsive disorder and post-traumatic stress disorder who on 20-FEB-2008, 21-APR-2008 and 26-AUG-2008 was vaccinated with the first, second and third dose of GARDASIL, the second dose on 21-APR-2008 and third dose on 26-AUG-2008 (lot#s 659653/1448U, unidentifiable and 660620/0571X respectively). Concomitant therapies included ABILIFY, PROZAC and TRILEPTAL. The patient's last menstrual period was reported as 08-AUG-2009, EDD: 15-MAY-2009. Follow up information was received from nurse in physician's office via a phone call who reported the patient had a termination in November 2008. The patient was doing fine and there was no sequelae from the vaccination. Upon internal review, a termination (abortion) was determined to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Gaze palsy, Muscle twitching, Nausea, Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 18-JUN-2009 was vaccinated IM, 0.5 ml with the first dose of GARDASIL (lot # 661954/1131X). On 18-JUN-2009 after being given GARDASIL, the patient "fainted and had shaking episodes and seizure like reactions. She regained consciousness and the shaking and seizure like activity stopped, but then started again." The adverse effect "stopped and started over a 3 hour period before she was ready to leave." The mother said that the patient was "fine" by then, but also said that the patient had "similar reactions" to "other vaccines" in the past. The doctor did not specify which vaccines the patient had the reaction to. The patient sought unspecified medical attention. The patient had recovered on 18-JUN-2009. Additional information has been received from a medical assistant on 22-JUN-2009 who reported the patient had no pertinent medical history other than the fact that the patient had "similar reactions" to childhood vaccines (no specifics available). The patient had no known drug allergies (NKDA). Concomitant therapy included SOLODYN and unspecified oral contraceptive. No other vaccines were administered at that time. Seizure like symptoms included twitching and eye rolling. The patient also had mild nausea. Blood pressure (B/P) at start of incident was 90/60; later it was 118/60. The patient did not go to the emergency room (ER). Event not considered as life threatening. Upon internal review, it was determined that eye rolling/twitching (convulsion) were serious as an other important medical events. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tremor
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 18-JUN-2009 was vaccinated IM, 0.5 ml with the first dose of GARDASIL (lot # 661954/1131X). On 18-JUN-2009 after being given GARDASIL, the patient "fainted and had shaking episodes and seizure like reactions. She regained consciousness and the shaking and seizure like activity stopped, but then started again." The adverse effect "stopped and started over a 3 hour period before she was ready to leave." The mother said that the patient was "fine" by then, but also said that the patient had "similar reactions" to "other vaccines" in the past. The doctor did not specify which vaccines the patient had the reaction to. The patient sought unspecified medical attention. The patient had recovered on 18-JUN-2009. Additional information has been received from a medical assistant on 22-JUN-2009 who reported the patient had no pertinent medical history other than the fact that the patient had "similar reactions" to childhood vaccines (no specifics available). The patient had no known drug allergies (NKDA). Concomitant therapy included SOLODYN and unspecified oral contraceptive. No other vaccines were administered at that time. Seizure like symptoms included twitching and eye rolling. The patient also had mild nausea. Blood pressure (B/P) at start of incident was 90/60; later it was 118/60. The patient did not go to the emergency room (ER). Event not considered as life threatening. Upon internal review, it was determined that eye rolling/twitching (convulsion) were serious as an other important medical events. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Headache, Nausea
Clinical narrative: Information has been received from a healthcare student concerning a 19-year-old female patient who was vaccinated with the first dose of GARDASIL on an unspecified date. After receiving the vaccine the patient developed dizziness, nausea and difficulty breathing. The patient had sought office visit medical attention. At the time of the report, the patient's status was recovered. The patient's dizziness, nausea and difficulty breathing was considered to be life threatening. Additional information from a phone call to a nurse stated that the patient received the first dose of GARDASIL (Lot# 661953/1130X) on 20-APR-2009. There were no concomitant vaccinations given at that time. Approximately 30 minutes after the patient received the GARDASIL (Lot# 661953/1130X) vaccination she had dizziness and nausea. On 21-APR-2009, the patient had difficulty breathing and had a headache. The patient went to her PCP to sought medical attention, and was given BENADRYL (route not reported). The patient came to office on 22-JUN-2009 for the second GARDASIL vaccination. The N.P. stated that she did not administer the GARDASIL vaccination. The N.P. stated that she felt the patient's difficulty breathing was considered life-threatening. Additional information from a phone call to the patient's PCP doctor reported that on 22-APR-2009 the patient was seen by a P.A. The patient complained of having difficulty breathing. The P.A. did not think that the patient's difficulty breathing was related to the GARDASIL vaccination. The P.A. documented that she thought the difficulty breathing was "coincidental and was possibly due to a viral infection". The patient was prescribed a MEDROL (DOSE PACK). The P.A. documented that she wanted to speak with the patient's GYN physician before the patient received the second dose of GARDASIL. The patient had not been back to the doctor's office since 22-APR-2009. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Immobile
Clinical narrative: Information has been received from a consumer concerning his fiancee who on 22-JUN-2009 was vaccinated with the first dose of GARDASIL.  Subsequently, the patient "could not get up" after vaccination.  Then the patient was hospitalized.  At the time of the report, the patient's outcome was unknown.  No further information is available.
Age: 72.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Arthritis, Rheumatoid factor negative, Vaccine positive rechallenge
Clinical narrative: Patient experienced two episodes of debilitating inflammatory arthritis after the second and third rounds of Hepatitis B vaccination. The interval of onset of joint symptoms following the second and third vaccination was nearly identical. Patient received the RECOMBIVAX HB vaccine. Patient was not receiving relief from CELEBREX. So, it was suggested that patient discontinue CELEBREX and switch to a short course of oral steroids, prednisone 15mg daily for one week, 10mg daily for one week, and then 5mg daily for one week. Symptoms resolved with use of the oral steroid regimen.  7/3/09 Rheumatology consult received    with DX:  Recurrent inflammatory polyarthritis.  Most likely culprit is hepatitis B vaccine. Pt developed joint aching of the hands, wrists and shoulders as well as swelling of fingers following 2nd and 3rd Hep B shots.  Pain noted on abduction, bursal tenderness and synovial thickening.  Tx: steroids and anti-inflammatories.