chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash, Urticaria, Wheezing
Clinical narrative: rash (about the size of a half-dollar coin) on the arm and wheezing that required treatment with albuteral & steroid inhaler
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal discomfort, Dyspnoea, Immunisation reaction, Throat irritation
Clinical narrative: Within 1-2 hours after injection, noted scratchy throat and respiratory difficulty.  Saw MD on 11/17/2009 who felt it was a reaction to the vaccine.  Saw another MD on 11/23/09 due to ongoing burning sensation in stomach.  This MD also prescribed a generic version of Prilosec.
Age: 50.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dermatitis contact, Injection site rash
Clinical narrative: Rash around injection site. (R) deltoid under arm and chest, raised area (appears as contact dermatitis) 24 hours after shot Loradine and Benadryl.
Age: 61.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus
Clinical narrative: Itching for 3 days following vaccine, no rash or treatment.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Joint pain, swelling day after vaccine (10/23/09) physician ordered Medrol Dose Pak. No missed time.
Age: 68.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema nodosum, Nodule on extremity, Skin warm
Clinical narrative: Big red nodules on body, warm to the touch erythema nodosum.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Hypersensitivity, Rash macular
Clinical narrative: While waiting 15 minutes after vaccine H1N1 pediatric dose no preservatives, child's cheeks and back of neck became extremely reddened; she had blotches on her upper back and upper arms. No respiratory problems. She was given Benadryl IM as per protocol. Redness continued 911 called and she was taken to local hospital for monitoring.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Mom states child always has some type of mild reaction post receiving any vaccination ie fever, rash or runny nose. Child received H1N1 on Monday & developed hives which were treated with BENADRYL cream and were gone in 48 hours and greatly reduced in 24 hours.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Itching, rash after vaccine same day - no treatment.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Asthenia, Dizziness, Pallor
Clinical narrative: Approx 10 min after flu injection patient felt faint, weak and pale, he was sitting in a char. Patient father layed him down. Dr notified and came immediately and checked out child.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: 11/16/09 Itching, burning pain along L side of back to sternum. Rash developed on 11/22 started antiviral medication on 11/23.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache, chills, aches starting day of shot.  Keen pain started 3 days after injection requiring steroid injection in knee.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Patient claims that after Gardasil. Her periods have not been on time.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Culture urine negative, Influenza serology negative, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Had onset of fever on Saturday 24 October 2009. Seen in ER on 25 Oct 09. No Source found for fever. Also had swelling and itching of Left arm. Fever was 102F-103F on Saturday and Sunday
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Intra-uterine death
Clinical narrative: Patient 32 weeks pregnant. Vaccinated 11/20/09. Fetal demise 11-24-09. No movement noted since 9 am 11/22. Ultrasound confirmed on 11/24/09. 12/03/09 Discharge summary and medical records received for DOS 11/24/09,  11/25/09-11/26/09. G1 P0 presents in labor. EDC 01/18/10.  Reports no fetal movement since 11/22/09. Impression: Fetal demise; active labor, IUP
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: developed congestion, cough and low grade fever 1 day later. cough persisted > 11 days.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Nasal congestion, Pyrexia
Clinical narrative: Developed congestion, cough and low grade fever 1 day later with persistent cough >11 days.
Age: 41.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Blood potassium increased, Blood sodium increased, Blood test
Clinical narrative: Nov 19 in evening. Pain in back of knees. Went to Urgent Care on Nov 20 tx: PREDNISONE. K + was increased na + was decreased.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Basal cell carcinoma, Biopsy, Injection site erythema, Injection site mass
Clinical narrative: Pt reported red bump at injection site. The site stayed red and never "healed" properly. Pt was checked out by his physician and had the site removed. Pt reported that the site was biopsied and came back as basal cell carcinoma.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Wheezing
Clinical narrative: Aprox 4 hours after receiving vaccine injection it became difficult to swallow - then developed dyspnea and wheezing. Received ALBUTEROL neb x 2 - BENADRYL 50 mg and SOLUMEDROL 250 mg and Epi 0.5 mg subcut in ER.
Age: 15.0
Sex: F
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Allergy test, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: VARIVAX given 11-3-09 SC RA, pt c/o R arm pain with swelling and hives at injection site 11-4-09 at 3:30
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Antinuclear antibody positive, Biopsy kidney, Biopsy kidney abnormal, Chills, DNA antibody positive
Clinical narrative: Had onset of feverish feeling, chills and nausea on 26 Sept 09. Persistent nausea for about 10 days to 2 weeks. Then developed leg swelling. Nephrotic syndrome diagnosed on 8 Oct 2009 (2 weeks after receipt of vaccine). Kidney biopsy class 4 lupus nephritis. 12/3/09 Medical records received for date 9/28/09 to 11/12/09. DX: common cold. Pt. c/o fever, chills, HA, vomiting and biting mouth x2days. OV 10/8/09 DX: nephrotic syndrome. Pt c/o bilat leg swelling. 10/27/09 DX: bilat pleural effusion, SLE, nephritis due to SLE. 11/9 OV f/u recent dx. C/o (+)limb swelling. Assessment: limb swelling, (+)facial rash butterfly, decrease breath sounds.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Feeling hot, Lupus nephritis, Nausea, Nephrotic syndrome, Oedema peripheral
Clinical narrative: Had onset of feverish feeling, chills and nausea on 26 Sept 09. Persistent nausea for about 10 days to 2 weeks. Then developed leg swelling. Nephrotic syndrome diagnosed on 8 Oct 2009 (2 weeks after receipt of vaccine). Kidney biopsy class 4 lupus nephritis. 12/3/09 Medical records received for date 9/28/09 to 11/12/09. DX: common cold. Pt. c/o fever, chills, HA, vomiting and biting mouth x2days. OV 10/8/09 DX: nephrotic syndrome. Pt c/o bilat leg swelling. 10/27/09 DX: bilat pleural effusion, SLE, nephritis due to SLE. 11/9 OV f/u recent dx. C/o (+)limb swelling. Assessment: limb swelling, (+)facial rash butterfly, decrease breath sounds.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Had onset of feverish feeling, chills and nausea on 26 Sept 09. Persistent nausea for about 10 days to 2 weeks. Then developed leg swelling. Nephrotic syndrome diagnosed on 8 Oct 2009 (2 weeks after receipt of vaccine). Kidney biopsy class 4 lupus nephritis. 12/3/09 Medical records received for date 9/28/09 to 11/12/09. DX: common cold. Pt. c/o fever, chills, HA, vomiting and biting mouth x2days. OV 10/8/09 DX: nephrotic syndrome. Pt c/o bilat leg swelling. 10/27/09 DX: bilat pleural effusion, SLE, nephritis due to SLE. 11/9 OV f/u recent dx. C/o (+)limb swelling. Assessment: limb swelling, (+)facial rash butterfly, decrease breath sounds.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Decreased appetite, Fatigue, Hyperaesthesia, Hypoaesthesia
Clinical narrative: Severe muscle aches and pains, chills, nausea, fatigue, leg and arm pain, weight loss (10 lbs so far), loss of appetite, numbness and tingling in feet and legs, skin hypersensitivity. Am treating with a neurologist now. 12/1/2009 , 12/10/2009 PCP and Consult  records for visit dates 11/14,11/21,11/25,11/30 and 12/1/2009 patient with c/o's myalgias, fatigue, weakness, tingling in feet, nausea, dysphagia and wt loss.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Myalgia, Nausea, Pain in extremity, Paraesthesia, Weight decreased
Clinical narrative: Severe muscle aches and pains, chills, nausea, fatigue, leg and arm pain, weight loss (10 lbs so far), loss of appetite, numbness and tingling in feet and legs, skin hypersensitivity. Am treating with a neurologist now. 12/1/2009 , 12/10/2009 PCP and Consult  records for visit dates 11/14,11/21,11/25,11/30 and 12/1/2009 patient with c/o's myalgias, fatigue, weakness, tingling in feet, nausea, dysphagia and wt loss.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Bedridden, Disability, Movement disorder, Myalgia, Pain
Clinical narrative: Crippling affect, very difficult moving, movement created  extreme pain causing me to scream when I moved, all muscles hurt (continuous) Bed ridden for two days ... still in severe pain
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Screaming
Clinical narrative: Crippling affect, very difficult moving, movement created  extreme pain causing me to scream when I moved, all muscles hurt (continuous) Bed ridden for two days ... still in severe pain
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cough, Eye swelling, Respiratory distress, Wheezing
Clinical narrative: Child's left eye became swollen.  Pt assessed for resp distress and exp wheezing noted.  Pt also had a cough.  Parent notified sated that child "always swells up like that when he gets a shot."  Pt given 12.5 mg Benadryl and parent picked up.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Cough, Dysphonia, Eye irritation
Clinical narrative: RECEIVED FLU SHOT BECAUSE MY EMPLOYER MADE THIS MANDATORY FOR EMPLOYMENT. I WOULD HAVE NEVER GOTTEN THIS SHOT OTHERWISE. 5:30PM STARTED COUGHING AND WHEEZING(TOOK AN ALLERGY MEDICATION BECAUSE I THOUGHT MY ALLERGIES WERE ACTING UP) 6:30PM CHEST STARTED TO BURN FROM COUGHING 7PM THROAT STARTED HURTING (LIKE I HAD MARBLES IN IT) COUGH STARTED TO SUBSIDE BUT MY VOICE BECAME HOARSE. MY BACK STARTED TO HURT LIKE I HAD A CRAMP IN IT.  MY HOARSE VOICE/SORE THROAT/BACK CRAMPING LASTED ALL NIGHT AND IS STILL THE SAME RIGHT NOW.  7:30PM MY EYES STARTED TO BOTHER ME LIKE I HAD COTTON BALL IN THEM/ITCHING/BURNING/BLURRY VISION AND VERY RED. 8PM WASHED MY EYES OUT WITH BABY SHAMPOO.  8:30PM REVIEWED THE MILDE PROBLEMS FROM INFLUENZA VACCINE. 9PM HAS A MILD FEVER WITH ALLOT OF BODY ACHE.  ALL PROBLEMS ARE STILL EXISTING EXCEPT FOR COUGH AND MY EYES ARE LESS RED. ARM IS SORE AND MY HUSBAND SAID IT LOOKED SWOLLEN
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Limb discomfort, Muscle spasms, Ocular hyperaemia, Oedema peripheral
Clinical narrative: RECEIVED FLU SHOT BECAUSE MY EMPLOYER MADE THIS MANDATORY FOR EMPLOYMENT. I WOULD HAVE NEVER GOTTEN THIS SHOT OTHERWISE. 5:30PM STARTED COUGHING AND WHEEZING(TOOK AN ALLERGY MEDICATION BECAUSE I THOUGHT MY ALLERGIES WERE ACTING UP) 6:30PM CHEST STARTED TO BURN FROM COUGHING 7PM THROAT STARTED HURTING (LIKE I HAD MARBLES IN IT) COUGH STARTED TO SUBSIDE BUT MY VOICE BECAME HOARSE. MY BACK STARTED TO HURT LIKE I HAD A CRAMP IN IT.  MY HOARSE VOICE/SORE THROAT/BACK CRAMPING LASTED ALL NIGHT AND IS STILL THE SAME RIGHT NOW.  7:30PM MY EYES STARTED TO BOTHER ME LIKE I HAD COTTON BALL IN THEM/ITCHING/BURNING/BLURRY VISION AND VERY RED. 8PM WASHED MY EYES OUT WITH BABY SHAMPOO.  8:30PM REVIEWED THE MILDE PROBLEMS FROM INFLUENZA VACCINE. 9PM HAS A MILD FEVER WITH ALLOT OF BODY ACHE.  ALL PROBLEMS ARE STILL EXISTING EXCEPT FOR COUGH AND MY EYES ARE LESS RED. ARM IS SORE AND MY HUSBAND SAID IT LOOKED SWOLLEN
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Sensation of foreign body, Vision blurred
Clinical narrative: RECEIVED FLU SHOT BECAUSE MY EMPLOYER MADE THIS MANDATORY FOR EMPLOYMENT. I WOULD HAVE NEVER GOTTEN THIS SHOT OTHERWISE. 5:30PM STARTED COUGHING AND WHEEZING(TOOK AN ALLERGY MEDICATION BECAUSE I THOUGHT MY ALLERGIES WERE ACTING UP) 6:30PM CHEST STARTED TO BURN FROM COUGHING 7PM THROAT STARTED HURTING (LIKE I HAD MARBLES IN IT) COUGH STARTED TO SUBSIDE BUT MY VOICE BECAME HOARSE. MY BACK STARTED TO HURT LIKE I HAD A CRAMP IN IT.  MY HOARSE VOICE/SORE THROAT/BACK CRAMPING LASTED ALL NIGHT AND IS STILL THE SAME RIGHT NOW.  7:30PM MY EYES STARTED TO BOTHER ME LIKE I HAD COTTON BALL IN THEM/ITCHING/BURNING/BLURRY VISION AND VERY RED. 8PM WASHED MY EYES OUT WITH BABY SHAMPOO.  8:30PM REVIEWED THE MILDE PROBLEMS FROM INFLUENZA VACCINE. 9PM HAS A MILD FEVER WITH ALLOT OF BODY ACHE.  ALL PROBLEMS ARE STILL EXISTING EXCEPT FOR COUGH AND MY EYES ARE LESS RED. ARM IS SORE AND MY HUSBAND SAID IT LOOKED SWOLLEN
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: RECEIVED FLU SHOT BECAUSE MY EMPLOYER MADE THIS MANDATORY FOR EMPLOYMENT. I WOULD HAVE NEVER GOTTEN THIS SHOT OTHERWISE. 5:30PM STARTED COUGHING AND WHEEZING(TOOK AN ALLERGY MEDICATION BECAUSE I THOUGHT MY ALLERGIES WERE ACTING UP) 6:30PM CHEST STARTED TO BURN FROM COUGHING 7PM THROAT STARTED HURTING (LIKE I HAD MARBLES IN IT) COUGH STARTED TO SUBSIDE BUT MY VOICE BECAME HOARSE. MY BACK STARTED TO HURT LIKE I HAD A CRAMP IN IT.  MY HOARSE VOICE/SORE THROAT/BACK CRAMPING LASTED ALL NIGHT AND IS STILL THE SAME RIGHT NOW.  7:30PM MY EYES STARTED TO BOTHER ME LIKE I HAD COTTON BALL IN THEM/ITCHING/BURNING/BLURRY VISION AND VERY RED. 8PM WASHED MY EYES OUT WITH BABY SHAMPOO.  8:30PM REVIEWED THE MILDE PROBLEMS FROM INFLUENZA VACCINE. 9PM HAS A MILD FEVER WITH ALLOT OF BODY ACHE.  ALL PROBLEMS ARE STILL EXISTING EXCEPT FOR COUGH AND MY EYES ARE LESS RED. ARM IS SORE AND MY HUSBAND SAID IT LOOKED SWOLLEN
Age: 58.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Contusion, Rash
Clinical narrative: Rash on chest and bruise on left upper arm approximately 7cm. Faded with a non bruised center.
Age: 1.34
Sex: F
Vaccine: FLU3
Symptoms: Full blood count abnormal, Lethargy, Pyrexia, Vomiting, White blood cell count decreased
Clinical narrative: Lethargic, fever, vomiting-moderate.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Cough, Decreased appetite, Fatigue, Nasopharyngitis
Clinical narrative: Fever, cough, cold, fatigue with the Seasonal Flu vaccine which lasted about 1 week, then symptoms returned more severely after she was given the H1N1 Vaccine - Fever, cough, chest congestion, wheezing, tiredness, fatigue, loss of appetite 12/2/2009 PCP notes for 11/15 and 12/2/2009, patient with c/o's SOB, wheezing, cough and fever.Rx'd ABX, Pulmicort and Albuterol inhaler. Dx Bronchitis
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion, Wheezing
Clinical narrative: Fever, cough, cold, fatigue with the Seasonal Flu vaccine which lasted about 1 week, then symptoms returned more severely after she was given the H1N1 Vaccine - Fever, cough, chest congestion, wheezing, tiredness, fatigue, loss of appetite 12/2/2009 PCP notes for 11/15 and 12/2/2009, patient with c/o's SOB, wheezing, cough and fever.Rx'd ABX, Pulmicort and Albuterol inhaler. Dx Bronchitis
Age: 16.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itchy skin
Age: 0.81
Sex: M
Vaccine: FLUX
Symptoms: Cough, Ear infection, Fatigue, Pyrexia, Respiratory tract congestion
Clinical narrative: Runny Nose, Congestion, Coughing, Fever, Ear Infection, tiredness, wheezing - symptoms still on going. Amoxicillin & Clavulanate for Ear Infection Albuterol via Nebulizer for Wheezing12/7/2009 ED record for 11/25/2009, patient with c/o's runny nose, fever, cough, wheezing,  ear pain and decreased appetite, tx: Albuterol inhaler, tylenol/motrin DC DX: Bilateral OM and wheezing
Age: 0.81
Sex: M
Vaccine: FLUX
Symptoms: Rhinorrhoea, Wheezing
Clinical narrative: Runny Nose, Congestion, Coughing, Fever, Ear Infection, tiredness, wheezing - symptoms still on going. Amoxicillin & Clavulanate for Ear Infection Albuterol via Nebulizer for Wheezing12/7/2009 ED record for 11/25/2009, patient with c/o's runny nose, fever, cough, wheezing,  ear pain and decreased appetite, tx: Albuterol inhaler, tylenol/motrin DC DX: Bilateral OM and wheezing
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Urticaria
Clinical narrative: HIVES, ITCHING
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: About 2 hours after the vaccination in the L deltoid he began to have stiffness in the deltoid muscle, and then it started aching about 1.5 hours later and has persisted till now (3.5 hours later).  No swelling or warmth, no fever noted.
Age: 31.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Burning sensation, Erythema, Fatigue, Rash
Clinical narrative: Fatigue and red burning rash around eyes and mouth.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema
Clinical narrative: angioedema
Age: 25.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Muscle spasms
Clinical narrative: I was pregnant. At this time I began cramping and bleeding which lasted through the night. The following morning I had a miscarriage.
Age: 11.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abdominal pain upper, Arthralgia, Blood immunoglobulin G increased, Complex regional pain syndrome, Fatigue
Clinical narrative: severe pain (8-9/10)in multiple sites over body (myalgia + joint), headache, stomach ache, fatigue + malaise persisting now > 2 weeks unremitting.  5/13/10 Follow up: Unremitting intense pain across multiple body locations. Chronic Regional pain syndrome-disabling.
Age: 11.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Headache, Malaise, Myalgia
Clinical narrative: severe pain (8-9/10)in multiple sites over body (myalgia + joint), headache, stomach ache, fatigue + malaise persisting now > 2 weeks unremitting.  5/13/10 Follow up: Unremitting intense pain across multiple body locations. Chronic Regional pain syndrome-disabling.
Age: 26.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Condition aggravated, Convulsion, Laboratory test normal
Clinical narrative: Seizure (no description of seizure was provided) Did not see physician until 48 hrs after incident
Age: 8.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Excessive eye blinking
Clinical narrative: Seems to have a tic (or frequent blinking)of the right eye.  He said it started "after I got the flu shot in in my nose"
Age: 72.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Erythema nodosum, Mass, Tenderness
Clinical narrative: I noticed that I had several red tender lumps located on the back of my lower leg calf and one place on the right leg.  Then there has continued to be more between my ankles and knees.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Musculoskeletal pain, Pain in extremity
Clinical narrative: PT CALLED 11/30/09 SAYING HER ARM/SHOULDER WAS STILL HURTING FROM AFTER GETTING HER FLU SHOT.  HAS BEGAN TO INTERFER WITH DAILY FUNCTIONING.  HAS BEEN TWO MD'S.  THEY HAVE TOLD HER THE SHOT COULD HAVE POSSIBLY HIT A NERVE.  SHE CALLED THE PHARMACY 11/30 AND ASKED IF THERE WAS ANYTHING SHE COULD DO.  SHE WAS TOLD TO KEEP WATCH ON IT AND WAIT IT OUT, IT COULD TAKE A WHILE TO GET BETTER
Age: 2.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Fatigue, Listless, Pyrexia, Vaccination complication
Clinical narrative: This two year old patient with no medical history experienced fever of 103 F approximately 12 hours post nasal vacinnation. The fever lasted 5 days and varied between 101 and 104 F. Was seen at urgent care on 11/Oct/2009 and it was determined that it was a H1N1 vaccine adverse reaction. Treatment including alternating tylenol and motrin every four hours until the fever went away. Other non significant symptoms included fatigue and lack of interest in playing with toys.
Age: 39.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cough, Dysphonia, Dyspnoea, Fatigue, Nasal congestion
Clinical narrative: Co Tiredness, Nasal/chest congestion and dry cough in the morning and continued to the night with fever, runny nose difficulty breathing and hoarse voice.  Over the course until today cough became moist and productive with thick yellow mucus.  I saw my physician who is treating me with antibiotics.
Age: 39.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Productive cough, Pulmonary congestion, Pyrexia, Rhinorrhoea
Clinical narrative: Co Tiredness, Nasal/chest congestion and dry cough in the morning and continued to the night with fever, runny nose difficulty breathing and hoarse voice.  Over the course until today cough became moist and productive with thick yellow mucus.  I saw my physician who is treating me with antibiotics.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), PPV
Symptoms: Asthenia, Decreased appetite, Dizziness, Erythema, Eye irritation
Clinical narrative: tissue infection in right arm with severe pain, weakness, redness, swelling, stiffness, hot-to-touch.  severe (sinus) headache, fever, body aches, fatigue, dizziness, loss of appetite.  infection traveled down arm to wrist/hand and up to neck/head over the course of several days.  started the evening vaccination was given with unusual eye irritation and then flu-like symptoms.  seemed to progress very quickly.  following morning, awoke with intense pain throughout right arm, up through the neck and in head.  arm was painful to touch as well as the slightest movement.  initially given Norco for pain at ER on 11/19 and also at student health on 11/20.  continued worsening over the weekend and then given Septra (for 10 days), more Norco and an arm sling at student health on 11/23. improvement began within one day of starting antibiotics. still recovering.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), PPV
Symptoms: Fatigue, Feeling hot, Headache, Influenza like illness, Musculoskeletal stiffness
Clinical narrative: tissue infection in right arm with severe pain, weakness, redness, swelling, stiffness, hot-to-touch.  severe (sinus) headache, fever, body aches, fatigue, dizziness, loss of appetite.  infection traveled down arm to wrist/hand and up to neck/head over the course of several days.  started the evening vaccination was given with unusual eye irritation and then flu-like symptoms.  seemed to progress very quickly.  following morning, awoke with intense pain throughout right arm, up through the neck and in head.  arm was painful to touch as well as the slightest movement.  initially given Norco for pain at ER on 11/19 and also at student health on 11/20.  continued worsening over the weekend and then given Septra (for 10 days), more Norco and an arm sling at student health on 11/23. improvement began within one day of starting antibiotics. still recovering.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), PPV
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia, Sinus headache
Clinical narrative: tissue infection in right arm with severe pain, weakness, redness, swelling, stiffness, hot-to-touch.  severe (sinus) headache, fever, body aches, fatigue, dizziness, loss of appetite.  infection traveled down arm to wrist/hand and up to neck/head over the course of several days.  started the evening vaccination was given with unusual eye irritation and then flu-like symptoms.  seemed to progress very quickly.  following morning, awoke with intense pain throughout right arm, up through the neck and in head.  arm was painful to touch as well as the slightest movement.  initially given Norco for pain at ER on 11/19 and also at student health on 11/20.  continued worsening over the weekend and then given Septra (for 10 days), more Norco and an arm sling at student health on 11/23. improvement began within one day of starting antibiotics. still recovering.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), PPV
Symptoms: Soft tissue infection, Swelling
Clinical narrative: tissue infection in right arm with severe pain, weakness, redness, swelling, stiffness, hot-to-touch.  severe (sinus) headache, fever, body aches, fatigue, dizziness, loss of appetite.  infection traveled down arm to wrist/hand and up to neck/head over the course of several days.  started the evening vaccination was given with unusual eye irritation and then flu-like symptoms.  seemed to progress very quickly.  following morning, awoke with intense pain throughout right arm, up through the neck and in head.  arm was painful to touch as well as the slightest movement.  initially given Norco for pain at ER on 11/19 and also at student health on 11/20.  continued worsening over the weekend and then given Septra (for 10 days), more Norco and an arm sling at student health on 11/23. improvement began within one day of starting antibiotics. still recovering.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, TDAP
Symptoms: Hyperhidrosis, Pallor, Vomiting
Clinical narrative: Pt turn pale then diaphoretic after the fourth vaccine administration.  Juice was offered, VS taken WNL. Pt vomitted, then wheeled pt to exam table pt layed down for 15 min color came back. Pt left with parents fully ambulatory stable condition.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Convulsion, Febrile convulsion, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Had runny nose/sneezing.  By 3:00pm developed fever.  At 5:30pm vomited. At 11:00 developed fever of 103.9 reported by EMS and had seizure.  Admitted to Emergency Department for febrile seizure.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Vomiting
Clinical narrative: Had runny nose/sneezing.  By 3:00pm developed fever.  At 5:30pm vomited. At 11:00 developed fever of 103.9 reported by EMS and had seizure.  Admitted to Emergency Department for febrile seizure.
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Asthenia, Injected limb mobility decreased, Musculoskeletal pain, Radiculitis brachial
Clinical narrative: Right Shoulder pain ranging from moderate to severe.  Right shoulder weakness and inability to abduct or flex shoulder.  Seen in ER.  Treated with motrin and percocet.  Seen by neurologist on 11/30 and diagnosed with Brachial Neuritis. 12/03/09 PCP records received for DOS 11/20/09 (Work physical). Received Tdap and flu vaccine. 12/09/09 Neurology records received for DOS 11/30/09. Pt. presented c/o pain and weakness in right upper extremity; onset 3 days post vaccination. Physical therapy recommended. DX: Post vaccinal brachial neuritis
Age: 65.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Blister, Blood test, Rash
Clinical narrative: Rash on bottom of both arms.  11/27 more rash on front of left lower leg (shin).  Arm rash had several water blisters.   Treated with 1% hydrocortisone cream with little effect. Treated by physician on 11/28 with hydroxyz HCL 25 mg, 3 tabs per day for 7 days. Noticed some clearing by 11/30, 6:00 PM.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal discomfort, Arthralgia, Dehydration, Fluid replacement, Laboratory test
Clinical narrative: Severe General malaise, palpitations, GI upset (severe), esophagitis, muscle and joint ache for 21 days.  Severe dehydration  Visited urgent care clinic 11/09/09 and Hospital ER on 11/12/09 for 6 hours.  Diagnosed severe dehydration and received multiple IV Saline/Dextrose over a 6-hour stay.  Gastroenterologist appointment 10:30 a.m. on 11/16/09.  Upper GI Scope on 11/17/09 6:45 a.m., GI Ultrasound on 11/18/09 8:00 a.m. Hida Scan on 11/19/09 10:00 a.m.  12/1/2009 ED records for 11/12/2009, patient with c/o's nausea and myalgias. TX: IVF, Phenergan and pepcid. Dc Dx dehydration. F/up with GI MD 12/1/2009 Outpatient dx studies 11/17-11/19/2009 received
Age: 62.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Laparoscopy, Malaise, Myalgia, Oesophagitis, Palpitations
Clinical narrative: Severe General malaise, palpitations, GI upset (severe), esophagitis, muscle and joint ache for 21 days.  Severe dehydration  Visited urgent care clinic 11/09/09 and Hospital ER on 11/12/09 for 6 hours.  Diagnosed severe dehydration and received multiple IV Saline/Dextrose over a 6-hour stay.  Gastroenterologist appointment 10:30 a.m. on 11/16/09.  Upper GI Scope on 11/17/09 6:45 a.m., GI Ultrasound on 11/18/09 8:00 a.m. Hida Scan on 11/19/09 10:00 a.m.  12/1/2009 ED records for 11/12/2009, patient with c/o's nausea and myalgias. TX: IVF, Phenergan and pepcid. Dc Dx dehydration. F/up with GI MD 12/1/2009 Outpatient dx studies 11/17-11/19/2009 received
Age: 15.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Redness and swelling at the injection site.  The next day the redness had grown to softball size and arm was hot and swollen.  Hurt to move or touch the arm.  It is day 8 and the redness has decreased some, but the arm is still very swollen and sore.
Age: 50.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site anaesthesia, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Patient received vaccination on 11/22/09. He states his arm swelled on 11/28/09, with numbness, tingling and pain. He called the pharmacy on 11/30/09 out of concern. We have asked him to visit a physician or urgent care.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU(H1N1), HIBV, PNC
Symptoms: Anticonvulsant drug level therapeutic, Blood magnesium, Blood phosphorus, Blood selenium, Blood thyroid stimulating hormone
Clinical narrative: respiratory distress resulting in death  12/04/09 MR and DC summary for DOS received for DOS 08/29/08 - 11/11/24/09. DX: Cardiopulmonary arrest.  Pt presented with s/p cardiopulmonary arrest on 11/23/09 with MOF, hypotensive, coarse bs. Kidneys not functioning, coagulopathy, metabolic acidosis.  tx: epinephrine, diuretics, vasopressors, bicarbonates, antibiotics.  Pt condition worsened despite ICU tx. Pt expired.  12/29/09 Death Certificate Received. DOD 11/24/09. Cause of Death: Methicillin-Resistant Staphylococcus Aureus Pneumonia.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU(H1N1), HIBV, PNC
Symptoms: Blood zinc, Chest X-ray, Death, Differential white blood cell count, Full blood count
Clinical narrative: respiratory distress resulting in death  12/04/09 MR and DC summary for DOS received for DOS 08/29/08 - 11/11/24/09. DX: Cardiopulmonary arrest.  Pt presented with s/p cardiopulmonary arrest on 11/23/09 with MOF, hypotensive, coarse bs. Kidneys not functioning, coagulopathy, metabolic acidosis.  tx: epinephrine, diuretics, vasopressors, bicarbonates, antibiotics.  Pt condition worsened despite ICU tx. Pt expired.  12/29/09 Death Certificate Received. DOD 11/24/09. Cause of Death: Methicillin-Resistant Staphylococcus Aureus Pneumonia.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU(H1N1), HIBV, PNC
Symptoms: Metabolic function test, Prealbumin, Renal function test, Thyroxine free, Vitamin D
Clinical narrative: respiratory distress resulting in death  12/04/09 MR and DC summary for DOS received for DOS 08/29/08 - 11/11/24/09. DX: Cardiopulmonary arrest.  Pt presented with s/p cardiopulmonary arrest on 11/23/09 with MOF, hypotensive, coarse bs. Kidneys not functioning, coagulopathy, metabolic acidosis.  tx: epinephrine, diuretics, vasopressors, bicarbonates, antibiotics.  Pt condition worsened despite ICU tx. Pt expired.  12/29/09 Death Certificate Received. DOD 11/24/09. Cause of Death: Methicillin-Resistant Staphylococcus Aureus Pneumonia.
Age: 70.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Oedema peripheral, Pruritus, Rash
Clinical narrative: Rash, itch, swelling of hands.
Age: 1.13
Sex: F
Vaccine: FLU3, FLUX(H1N1), HEPA, MMR, PNC, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 1 hive below site of MMR (LT) minutes after1 yr injections. Given 5cc BENADRYL orally and iced site briefly.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Vomiting
Clinical narrative: 11-24-09 PC from client: States she began "hard chills" about 2 hrs after receiving H1N1 inj lasting until morning after. States vomiting started about midnight lasting through this morning. Better now. 1:00 pm.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Anaemia haemolytic autoimmune, Aspiration bone marrow, Blood iron, Blood lactate dehydrogenase, Blood product transfusion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with anaemia, menstruation irregular with heavy flow and a history of treating with growth hormone from age 10-13 on 17-MAR-2008 was vaccinated with the third dose of GARDASIL IM (therapy dose, site unknown) (Lot# 660387/1967U). Concomitant therapy included the second dose of HAVRIX (therapy dose, route and site unknown) (Lot# AHAVB1244) and oral hormonal contraceptives (unspecified). On 31-OCT-2008 the patient experienced anaemia, anaemia haemolytic autoimmune, arthralgia, blood product transfusion, cough, EVANS syndrome, fatigue, haemoglobin decreased, idiopathic thrombocytopenic purpura, iron deficiency, joint swelling, malaise, microcytic anaemia, oropharyngeal pain, platelet count decreased, pyrexia and thrombocytopenia and was hospitalized. These events were considered to be immediately life-threatening. Coombs test was positive (warm Ab) and haemoglobin=6, platelet=20,000. All tests were negative and comprehensive including bone marrow aspirate and BM biopsy, ANA, reticulocyte count, LDH (Lactate dehydrogenase), complements, chest x ray, serologies for Parvo, CMV, HIV, MONO, iron studies and chromosome analysis. Cause was still unknown. The patient was treated with transfusions, IVIG (intravenous immune globulin), steroids and "wait and see" approach. Ultimately the patient was given RITUXAN. The patient was recently on "remission". On 29-SEP-2009 medical records and diagnoses summary received from date of service 01-NOV-2008 to 07-NOV-2008. The diagnosis was EVANS Syndrome, presented with malaise for one month, fatigue, fever, sore throat, joint pain/swelling, cough, night sweats, anemia, thrombocytopenia, Insidious onset of symptomatic microcytic hypochromic hyperproliferative anemia with evidence of iron deficiency. The treatment was IVIG. The original reporting source was not provided. The VAERS ID # is 356835. A standard lot check investigation was performed. All in-process quality checks for lot number 1967U 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 and was released.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Complement factor, Coombs test positive, Cytomegalovirus serology, Evans syndrome, HIV test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with anaemia, menstruation irregular with heavy flow and a history of treating with growth hormone from age 10-13 on 17-MAR-2008 was vaccinated with the third dose of GARDASIL IM (therapy dose, site unknown) (Lot# 660387/1967U). Concomitant therapy included the second dose of HAVRIX (therapy dose, route and site unknown) (Lot# AHAVB1244) and oral hormonal contraceptives (unspecified). On 31-OCT-2008 the patient experienced anaemia, anaemia haemolytic autoimmune, arthralgia, blood product transfusion, cough, EVANS syndrome, fatigue, haemoglobin decreased, idiopathic thrombocytopenic purpura, iron deficiency, joint swelling, malaise, microcytic anaemia, oropharyngeal pain, platelet count decreased, pyrexia and thrombocytopenia and was hospitalized. These events were considered to be immediately life-threatening. Coombs test was positive (warm Ab) and haemoglobin=6, platelet=20,000. All tests were negative and comprehensive including bone marrow aspirate and BM biopsy, ANA, reticulocyte count, LDH (Lactate dehydrogenase), complements, chest x ray, serologies for Parvo, CMV, HIV, MONO, iron studies and chromosome analysis. Cause was still unknown. The patient was treated with transfusions, IVIG (intravenous immune globulin), steroids and "wait and see" approach. Ultimately the patient was given RITUXAN. The patient was recently on "remission". On 29-SEP-2009 medical records and diagnoses summary received from date of service 01-NOV-2008 to 07-NOV-2008. The diagnosis was EVANS Syndrome, presented with malaise for one month, fatigue, fever, sore throat, joint pain/swelling, cough, night sweats, anemia, thrombocytopenia, Insidious onset of symptomatic microcytic hypochromic hyperproliferative anemia with evidence of iron deficiency. The treatment was IVIG. The original reporting source was not provided. The VAERS ID # is 356835. A standard lot check investigation was performed. All in-process quality checks for lot number 1967U 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 and was released.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Haemoglobin decreased, Idiopathic thrombocytopenic purpura, Mononucleosis heterophile test, Parvovirus B19 serology, Platelet count decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with anaemia, menstruation irregular with heavy flow and a history of treating with growth hormone from age 10-13 on 17-MAR-2008 was vaccinated with the third dose of GARDASIL IM (therapy dose, site unknown) (Lot# 660387/1967U). Concomitant therapy included the second dose of HAVRIX (therapy dose, route and site unknown) (Lot# AHAVB1244) and oral hormonal contraceptives (unspecified). On 31-OCT-2008 the patient experienced anaemia, anaemia haemolytic autoimmune, arthralgia, blood product transfusion, cough, EVANS syndrome, fatigue, haemoglobin decreased, idiopathic thrombocytopenic purpura, iron deficiency, joint swelling, malaise, microcytic anaemia, oropharyngeal pain, platelet count decreased, pyrexia and thrombocytopenia and was hospitalized. These events were considered to be immediately life-threatening. Coombs test was positive (warm Ab) and haemoglobin=6, platelet=20,000. All tests were negative and comprehensive including bone marrow aspirate and BM biopsy, ANA, reticulocyte count, LDH (Lactate dehydrogenase), complements, chest x ray, serologies for Parvo, CMV, HIV, MONO, iron studies and chromosome analysis. Cause was still unknown. The patient was treated with transfusions, IVIG (intravenous immune globulin), steroids and "wait and see" approach. Ultimately the patient was given RITUXAN. The patient was recently on "remission". On 29-SEP-2009 medical records and diagnoses summary received from date of service 01-NOV-2008 to 07-NOV-2008. The diagnosis was EVANS Syndrome, presented with malaise for one month, fatigue, fever, sore throat, joint pain/swelling, cough, night sweats, anemia, thrombocytopenia, Insidious onset of symptomatic microcytic hypochromic hyperproliferative anemia with evidence of iron deficiency. The treatment was IVIG. The original reporting source was not provided. The VAERS ID # is 356835. A standard lot check investigation was performed. All in-process quality checks for lot number 1967U 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 and was released.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Reticulocyte count
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with anaemia, menstruation irregular with heavy flow and a history of treating with growth hormone from age 10-13 on 17-MAR-2008 was vaccinated with the third dose of GARDASIL IM (therapy dose, site unknown) (Lot# 660387/1967U). Concomitant therapy included the second dose of HAVRIX (therapy dose, route and site unknown) (Lot# AHAVB1244) and oral hormonal contraceptives (unspecified). On 31-OCT-2008 the patient experienced anaemia, anaemia haemolytic autoimmune, arthralgia, blood product transfusion, cough, EVANS syndrome, fatigue, haemoglobin decreased, idiopathic thrombocytopenic purpura, iron deficiency, joint swelling, malaise, microcytic anaemia, oropharyngeal pain, platelet count decreased, pyrexia and thrombocytopenia and was hospitalized. These events were considered to be immediately life-threatening. Coombs test was positive (warm Ab) and haemoglobin=6, platelet=20,000. All tests were negative and comprehensive including bone marrow aspirate and BM biopsy, ANA, reticulocyte count, LDH (Lactate dehydrogenase), complements, chest x ray, serologies for Parvo, CMV, HIV, MONO, iron studies and chromosome analysis. Cause was still unknown. The patient was treated with transfusions, IVIG (intravenous immune globulin), steroids and "wait and see" approach. Ultimately the patient was given RITUXAN. The patient was recently on "remission". On 29-SEP-2009 medical records and diagnoses summary received from date of service 01-NOV-2008 to 07-NOV-2008. The diagnosis was EVANS Syndrome, presented with malaise for one month, fatigue, fever, sore throat, joint pain/swelling, cough, night sweats, anemia, thrombocytopenia, Insidious onset of symptomatic microcytic hypochromic hyperproliferative anemia with evidence of iron deficiency. The treatment was IVIG. The original reporting source was not provided. The VAERS ID # is 356835. A standard lot check investigation was performed. All in-process quality checks for lot number 1967U 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 and was released.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Anaemia, Anaemia haemolytic autoimmune, Antinuclear antibody negative, Arthralgia, Aspiration bone marrow
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with anaemia, menstruation irregular with heavy flow and a history of treating with growth hormone from age 10-13 on 17-MAR-2008 was vaccinated with the third dose of GARDASIL IM (therapy dose, site unknown) (Lot# 660387/1967U). Concomitant therapy included the second dose of HAVRIX (therapy dose, route and site unknown) (Lot# AHAVB1244) and oral hormonal contraceptives (unspecified). On 31-OCT-2008 the patient experienced anaemia, anaemia haemolytic autoimmune, arthralgia, blood product transfusion, cough, EVANS syndrome, fatigue, haemoglobin decreased, idiopathic thrombocytopenic purpura, iron deficiency, joint swelling, malaise, microcytic anaemia, oropharyngeal pain, platelet count decreased, pyrexia and thrombocytopenia and was hospitalized. These events were considered to be immediately life-threatening. Coombs test was positive (warm Ab) and haemoglobin=6, platelet=20,000. All tests were negative and comprehensive including bone marrow aspirate and BM biopsy, ANA, reticulocyte count, LDH (Lactate dehydrogenase), complements, chest x ray, serologies for Parvo, CMV, HIV, MONO, iron studies and chromosome analysis. Cause was still unknown. The patient was treated with transfusions, IVIG (intravenous immune globulin), steroids and "wait and see" approach. Ultimately the patient was given RITUXAN. The patient was recently on "remission". On 29-SEP-2009 medical records and diagnoses summary received from date of service 01-NOV-2008 to 07-NOV-2008. The diagnosis was EVANS Syndrome, presented with malaise for one month, fatigue, fever, sore throat, joint pain/swelling, cough, night sweats, anemia, thrombocytopenia, Insidious onset of symptomatic microcytic hypochromic hyperproliferative anemia with evidence of iron deficiency. The treatment was IVIG. The original reporting source was not provided. The VAERS ID # is 356835. A standard lot check investigation was performed. All in-process quality checks for lot number 1967U 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 and was released.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Biopsy bone marrow normal, Blood iron normal, Blood lactate dehydrogenase, Blood product transfusion, Chest X-ray normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with anaemia, menstruation irregular with heavy flow and a history of treating with growth hormone from age 10-13 on 17-MAR-2008 was vaccinated with the third dose of GARDASIL IM (therapy dose, site unknown) (Lot# 660387/1967U). Concomitant therapy included the second dose of HAVRIX (therapy dose, route and site unknown) (Lot# AHAVB1244) and oral hormonal contraceptives (unspecified). On 31-OCT-2008 the patient experienced anaemia, anaemia haemolytic autoimmune, arthralgia, blood product transfusion, cough, EVANS syndrome, fatigue, haemoglobin decreased, idiopathic thrombocytopenic purpura, iron deficiency, joint swelling, malaise, microcytic anaemia, oropharyngeal pain, platelet count decreased, pyrexia and thrombocytopenia and was hospitalized. These events were considered to be immediately life-threatening. Coombs test was positive (warm Ab) and haemoglobin=6, platelet=20,000. All tests were negative and comprehensive including bone marrow aspirate and BM biopsy, ANA, reticulocyte count, LDH (Lactate dehydrogenase), complements, chest x ray, serologies for Parvo, CMV, HIV, MONO, iron studies and chromosome analysis. Cause was still unknown. The patient was treated with transfusions, IVIG (intravenous immune globulin), steroids and "wait and see" approach. Ultimately the patient was given RITUXAN. The patient was recently on "remission". On 29-SEP-2009 medical records and diagnoses summary received from date of service 01-NOV-2008 to 07-NOV-2008. The diagnosis was EVANS Syndrome, presented with malaise for one month, fatigue, fever, sore throat, joint pain/swelling, cough, night sweats, anemia, thrombocytopenia, Insidious onset of symptomatic microcytic hypochromic hyperproliferative anemia with evidence of iron deficiency. The treatment was IVIG. The original reporting source was not provided. The VAERS ID # is 356835. A standard lot check investigation was performed. All in-process quality checks for lot number 1967U 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 and was released.