chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Reflex test abnormal, Respiratory failure, Sinus tachycardia, Tracheostomy, Ultrasound abdomen 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 26 year old female with a history of anaemia, previous-smoker and family history of GBS, on 17-AUG-2009 was vaccinated with a fourth dose of GARDASIL (lot # 662404/0312Y, route unknown) in the left arm. Concomitant therapy included YAZ. On 30-SEP-2009 the patient experienced arachnoid cyst, areflexia, asthenia, back pain, blood product transfusion, endotracheal intubation, Guillain-Barre syndrome, haemothorax, hypoaesthesia, hypoaesthesia oral, influenza like illness, intensive care, muscular weakness, plasmapheresis, reflex test abnormal, respiratory failure and tracheostomy. The patient experienced ascending paralysis, respiratory failure requiring intubation. She had IVIG (intravenous immunoglobulin) for 5 days followed by plasmapheresis for 5 days. The patient remained intubed and was in ICU (intensive care unit). On 22-OCT-2009 Hospital records were received for dates 01-OCT-2009 to 26-OCT-2009. The patient was currently diagnosed as GBS (Guillain-Barre syndrome). On 01-OCT-2009 the patient presented to ER with complaint of numbness in all extremities, pain, weakness in legs, back pain, numbness in mouth. Patient was in ER 1 day prior and sent home. Symptoms increased patient returned to ER. The patient complained of flu like symptoms 10 days prior. Assessment: WNL (Within normal limits) except, absent knee reflexes, hypoflex of lower extremities (+) intramuscular fluid around dpine at occipital cervical junction. The patient's diagnoses at time of assessment were GBS vs idiopathic polyneuropathy vs MS (Multiple Sclerosis). Patient was admitted to medical unit, symptoms deteriorated and she was transferred to ICU. Further assessments: absent deep tendon reflexes of upper and lower extremities, complaint of pain throughout entire spine. MRI of spine (+) arachnoid cyst. On 05-OCT-2009 the patient was intubated, and treatment with IVIG, no response. The patient had lab test of Plasmapheresis. The patient was diagnosed as GBS, respiratory failure and hemothorax. ON 15-OCT-2009 tracheotomy was placed. The patient required ER visit, and the outcome was not reported at the time of report. Diagnostics and labs included: EKG sinus tachycardia; DVT(-); abdominal US(-); CXR abnormal-LLL infiltrates, CT chest (-); LP abnomral-CSF protein(H); CSF glucose(H); CSF WBC(H); CSF ALB 9(L). The listing indicated that one or more of the events required hospitalization, required extended hospital stay , was considered to be immediately life-threatening. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The originally reporting source was not provided. The VAERS ID # is 361227.
Age: 40.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Arthralgia, Full blood count normal, Laboratory test, Red blood cell sedimentation rate normal, Rhesus antibodies negative
Clinical narrative: developed diffuse symmetric joint aches in large and small joints, Lyme negative, aCCP 251 in Dec, treated in ER for joint pain, dx with rheumatoid arthritis
Age: 40.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Rheumatoid arthritis
Clinical narrative: developed diffuse symmetric joint aches in large and small joints, Lyme negative, aCCP 251 in Dec, treated in ER for joint pain, dx with rheumatoid arthritis
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional (office manager) via a GSK representative and described the occurrence of drug use for unapproved indication in a 6-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date in 2009, the subject received KINRIX (unknown) as the 3rd dose in DTAP series, and experienced drug use for unapproved indication, and administered drug to incorrect patient. On an unspecified date in 2009, after vaccination with KINRIX, the subject experienced an unspecified adverse experiences. At the time of reporting the outcome of the events were unspecified. The office manager reported that the subject was inadvertently given KINRIX that was meant for his 4 year old brother instead of receiving either PENTACEL or PEDIARIX two months ago. The office manager reported adverse effects with the subject, which was not specifically reported. No further information was provided to the GSK representative by the office manager.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Body temperature increased, Dyskinesia, Oedema peripheral, Pyrexia, Staring
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of high fever in a 4 year-old male subject who was vaccinated with combined KINRIX, GlaxoSmithKline, FLUVIRIN for prophylaxis. The subject's medical history included normal birth. Concurrent medical conditions included autism spectrum disorder. On 14 September 2009 at 10:30 the subject received unspecified dose of KINRIX (intramuscular, right arm) and the 1st dose of FLUVIRIN (intramuscular, left arm). The subject had previously received four doses of DTaP and three doses of inactivated IPV. On 15 September 2009, 1 day after vaccination with FLUVIRIN and KINRIX, the subject experienced high fever, staring, tremor, extremities jerking, swelling arm and unable to focus (ncs). On 15 September 2009, the events were resolved. The healthcare provider stated that the mother reported high fever occurring during the night with rectal temperature of 104. The subject was staring not focusing, shaking, and then had jerking extremities. The mother reported slight swelling at the right deltoid with no redness noted. At 09:27, on an unspecified date, the subject was more himself, eating and drinking and making eye contact with his mother. At 17:00, on a unspecified date, the healthcare provider called to check on the subject. The mother reported that the subject was doing better, but spiked a temperature of 103 at 15:00. The healthcare professional reported that they were " assuming reaction to vaccine".
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Tremor, Vision blurred
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of high fever in a 4 year-old male subject who was vaccinated with combined KINRIX, GlaxoSmithKline, FLUVIRIN for prophylaxis. The subject's medical history included normal birth. Concurrent medical conditions included autism spectrum disorder. On 14 September 2009 at 10:30 the subject received unspecified dose of KINRIX (intramuscular, right arm) and the 1st dose of FLUVIRIN (intramuscular, left arm). The subject had previously received four doses of DTaP and three doses of inactivated IPV. On 15 September 2009, 1 day after vaccination with FLUVIRIN and KINRIX, the subject experienced high fever, staring, tremor, extremities jerking, swelling arm and unable to focus (ncs). On 15 September 2009, the events were resolved. The healthcare provider stated that the mother reported high fever occurring during the night with rectal temperature of 104. The subject was staring not focusing, shaking, and then had jerking extremities. The mother reported slight swelling at the right deltoid with no redness noted. At 09:27, on an unspecified date, the subject was more himself, eating and drinking and making eye contact with his mother. At 17:00, on a unspecified date, the healthcare provider called to check on the subject. The mother reported that the subject was doing better, but spiked a temperature of 103 at 15:00. The healthcare professional reported that they were " assuming reaction to vaccine".
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUX(H1N1)
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included pandemic vaccine H1N1; non-GSK manufacturer; intranasal given on 16 October 2009. There were not concurrent medications. On 26 October 2009 at 16:00 the subject received unspecified dose of KINRIX (unknown, left arm). On 27 October 2009, 1 day after vaccination with KINRIX, the subject experienced swelling injection site, injection site redness, injection site pruritius and local delayed type hypersensitivity response. At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with KINRIX. The subject consulted a health care professional regarding the event (s). The reporting physician is the subject's father.
Age: 69.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Fall, Gait disturbance, Guillain-Barre syndrome, Pain in extremity
Clinical narrative: Pt states on 12-14-09, that she's had a reaction to her H1N1 vaccine. First she "had extreme pain in her femurs and tib- fibs" she didn't report it right away because she "has a lot of arthritic issues "then she had increase problems walking. She describes it as lurching" Last weekend she fell over backwards in her closet 12-17-09. Referred to her PCP immediately. Pt called to say doctor told her Dx - Guillain Barre Syndrome
Age: 69.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Bone pain, Fall, Gait disturbance, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Pt states on 12-14-09, that she's had a reaction to her H1N1 vaccine. First she "had extreme pain in her femurs and tib- fibs" she didn't report it right away because she "has a lot of arthritic issues "then she had increase problems walking. She describes it as lurching" Last weekend she fell over backwards in her closet 12-17-09. Referred to her PCP immediately. Pt called to say doctor told her Dx - Guillain Barre Syndrome
Age: 69.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Paraesthesia
Clinical narrative: Pt states on 12-14-09, that she's had a reaction to her H1N1 vaccine. First she "had extreme pain in her femurs and tib- fibs" she didn't report it right away because she "has a lot of arthritic issues "then she had increase problems walking. She describes it as lurching" Last weekend she fell over backwards in her closet 12-17-09. Referred to her PCP immediately. Pt called to say doctor told her Dx - Guillain Barre Syndrome
Age: 41.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Facial palsy
Clinical narrative: Bell's Palsy manifested by left facial droop
Age: 43.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Body temperature, Fatigue, Hypersomnia, Induration, Lymphadenopathy
Clinical narrative: Went to bed Monday night 3 hours earlier than usual, and woke up exhausted.   The glands in my throat were hard & swollen, and my temperature was 98.6 when normal for me is 97.2.   I went back to bed and slept until 1:30pm.  Was up for half an hour and slept again until 5pm.  Was back to bed by midnight.  Next day, same thing - slept until 2pm and was ready for bed by 6:30pm.  Took a 2 hour nap, then up until midnight.  My temperature returned to normal (between 96.0 and 97.2 throughout the day) on day 2.   Today is the third day of extreme exhaustion.  Again slept until 3:30pm  and took at nap at 6:30pm.  I've also lost 4lbs (likely due to not eating because I'm sleeping so much).  Will be going to the doctor tomorrow if not feeling better as the info sheet indicated 1-2 days of after effects.
Age: 43.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Weight decreased
Clinical narrative: Went to bed Monday night 3 hours earlier than usual, and woke up exhausted.   The glands in my throat were hard & swollen, and my temperature was 98.6 when normal for me is 97.2.   I went back to bed and slept until 1:30pm.  Was up for half an hour and slept again until 5pm.  Was back to bed by midnight.  Next day, same thing - slept until 2pm and was ready for bed by 6:30pm.  Took a 2 hour nap, then up until midnight.  My temperature returned to normal (between 96.0 and 97.2 throughout the day) on day 2.   Today is the third day of extreme exhaustion.  Again slept until 3:30pm  and took at nap at 6:30pm.  I've also lost 4lbs (likely due to not eating because I'm sleeping so much).  Will be going to the doctor tomorrow if not feeling better as the info sheet indicated 1-2 days of after effects.
Age: 63.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Diarrhoea
Clinical narrative: Diarrhea lasting 1 week
Age: 60.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Burning sensation, Erythema, Oedema peripheral, Rash macular
Clinical narrative: Both hands swollen and red splotches and burning sensation. Also, a 1 inch round bumpy red splotch on right forearm.
Age: 60.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Burning sensation, Rash erythematous
Clinical narrative: Both hands swollen and red splotches and burning sensation. Also, a 1 inch round bumpy red splotch on right forearm.
Age: 48.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Eye pruritus, Eye swelling, Pruritus, Skin disorder, Swelling face
Clinical narrative: Swelling and itching on face, eyes, around eyes, across nose, cheeks after I got out of the shower. Took Benadryl tablet, and 1 prednisone pill I had left over from a sting reaction, Elestat for the itching eyes. Swelling went down but skin still hurts and feels weird. Will go to the doctor after work (or sooner).
Age: 47.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Headache, Rash generalised, Throat tightness
Clinical narrative: Headache within 30 mins of administration and throat tightness. Went home generalized rash next day. Took 1 capsule Benadryl. Seen in ER on 1/6/10 given Allegra. Seen in clinic on 1/10/10 with no improvement in rash so placed on Medrol. Rash improved within 1 day on medication.
Age: 38.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Flushing, Urticaria
Clinical narrative: very flushed, broke out in hives on neck, chest and arms
Age: 11.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug administration error
Clinical narrative: Misadministration of H1N1. The child received 2 0.5 ml's over a 4 week time span.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 10 1/2 - 13 1/2 cm red, swollen, hot, tender area R deltoid
Age: 45.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever, chills, myalgia.
Age: 48.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Chills, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: L arm swelling, redness, fever and chills.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given .5ml dose of lot # UTO34AA from manufacture Sanofi Pasteur, Inc.  .25ml dose should have been given.  Patient's mother contacted on 01/14/2010.  No reaction or complication noted per parent.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Pain from injection site (Rt deltoid) to elbow, "lump" the width of her upper arm, warm and hard. Kept her awake the night.  Taking Advil q4hrs.  Improving, but still sore.
Age: 10.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Erythema, Pruritus, Urine analysis
Clinical narrative: Pt. c/o redness and itching X2 days at site  5X3.5 inches (+)
Age: 4.0
Sex: M
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: DPT shot given in the left leg on 1-12-10, red, raised bump where immunization was given, apply moist heat and TYLENOL.
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Flushing, Heart rate increased, Injection site pain
Clinical narrative: C/O feeling flushed, light headed, racing heart rate, and soreness at injection site.
Age: 24.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Dizziness, Injection site erythema
Clinical narrative: Patient c/o chest discomfort, dizziness, and achiness.  Denies struggling for breath but admits to heaviness of chest and a slight red rash around injection site.
Age: 24.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site rash, Pain, Urine analysis normal
Clinical narrative: Patient c/o chest discomfort, dizziness, and achiness.  Denies struggling for breath but admits to heaviness of chest and a slight red rash around injection site.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia facial, Musculoskeletal stiffness
Clinical narrative: Side of neck where shot was administered got numb and stiff, then numbness progressed to side of face, down the entire leg.  Slight dizziness.  Numbness lessened an hour later, but still present.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient c/o of pain at injection site after school.  Parents checked site and saw that it was swollen and red.  Woke up the morning of the 15th and it was even more swollen, red and painful.  Parents brought child ion for an appt with physician.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Discomfort, Injection site erythema, Injection site induration, Oedema peripheral
Clinical narrative: Localized reaction including redness around the same diameter as a quarter and firm tissue at injection site.  Reports on 01/12/2010 Left knee edema X1 day.  01/15/2010 increased discomfort and reddened area measures 92mm X 42mm.
Age: 37.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Diplopia, Vision blurred, Visual field defect
Clinical narrative: Double vision.  Unable to focus eyes.  Seemed like it lasted a long time, but was probably about a minute.  Nothing like this has happened before.  Also had a blind spot later, around 8pm.  Looking at a person, they would look like a cyclops because I couldn't see their other eye.
Age: 15.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea, Pruritus, Throat irritation
Clinical narrative: Student stated she felt itchy, nauseous, felt like she had an ice cube in her throat. Her BP was 140/90 x 2. She was given 50 mg diphenhydramine IM @ 9:40 AM. Her mother took her to the ED.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Eye burns, Eye pruritus, Eye swelling
Clinical narrative: Patient reports burning/itching/swelling right eye.
Age: 11.0
Sex: M
Vaccine: FLU3, FLUN(H1N1), MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Local erythma, swelling and itchiness in 3x5 area, L) upper arm, adjacent to site Tdap & Menactra injection.
Age: 1.31
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Eye swelling, Hypersensitivity, Psychomotor hyperactivity, Rash, Swelling face
Clinical narrative: Approximately one hour after vaccination parent reports child's eyes appeared puffy.  Progression to red rash on arms, face, and legs by 10:30am 1/13/2010.  No fever.  Child seen in Hospital and given prednisone + Benadryl.  Consultation with pediatrician 1/13/2010 as well - treatment continues as of 1/15/2010.  Parent also reports hyperactivity, which is unusual, but otherwise child is not acting ill or in pain.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood culture, Convulsion, Culture urine, Lumbar puncture, Pyrexia
Clinical narrative: Sudden fever and sudden seizure... Stopped breathing was administered CPR and taken by ambulance to Hospital
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Respiratory arrest
Clinical narrative: Sudden fever and sudden seizure... Stopped breathing was administered CPR and taken by ambulance to Hospital
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt left arm developed redness, swelling and tenderness. Upper left arm. Pt was treated with Prednisone.
Age: 26.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy, No adverse event
Clinical narrative: No adverse reaction. Patient wanted nasal vaccine due to injection available containing thimerasol.
Age: 39.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthenia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tenderness at vaccination site Malaise / Nausea / Weakness Chills / Low Grade Fever
Age: 39.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: Redness, swelling, tenderness at vaccination site Malaise / Nausea / Weakness Chills / Low Grade Fever
Age: 1.48
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Pyrexia, Urticaria
Clinical narrative: hives and fever started 1/13/2010
Age: 58.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Chest pain, Dry mouth, Dyspnoea, Myalgia, Palpitations
Clinical narrative: Myalgias, chest pain, palpitations, dry mouth ; SOB.
Age: 1.26
Sex: F
Vaccine: DTAPIPVHIB, FLU(H1N1), FLU3, MMR
Symptoms: Convulsion, Dyspnoea, Electroencephalogram normal, Pneumonia, Pyrexia
Clinical narrative: Had one seizure, no fever during or before seizure, but developed fever afterwards. Had difficulty breathing, intubated and ventilated for about 36  hours. ?Had pneumonia.
Age: 78.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Bruxism, Ear pain
Clinical narrative: About 10 minutes after she received the vaccine she reported to me that she had felt some pain in one of her ears.  She said it was getting better but she just wanted to tell me about it in case it was caused by the vaccine.  She also said she had been clenching her jaw.
Age: 0.34
Sex: M
Vaccine: HEP, PNC, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: LEFT UPPER THIGH WITH 4-5 CM FIRM, TENDER, RED AREA 1 CM
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Culture throat negative, Streptococcal identification test, Urticaria
Clinical narrative: Pt. seen in office on 01/13/2010 in the evening with a urticarial rash, no fever, not pruritic, Benadryl helps.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Angioedema, Chest discomfort, Dyspnoea, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Shortness of breath and chest tightness, feet tingling, immediately following H1N1 vaccine. Sent to ER. Dx. Acute allergic Rx/ Urticarial Angioedema. Given (Benadryl, Ativan, Prednisone and IV Solumedrol in ER).Follow-up information received 1/26/10; vaccine administration date 12/11/09, 09:05 am; adverse event onset date 12/11/09, 09:15 am.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Shortness of breath and chest tightness, feet tingling, immediately following H1N1 vaccine. Sent to ER. Dx. Acute allergic Rx/ Urticarial Angioedema. Given (Benadryl, Ativan, Prednisone and IV Solumedrol in ER).Follow-up information received 1/26/10; vaccine administration date 12/11/09, 09:05 am; adverse event onset date 12/11/09, 09:15 am.
Age: 1.31
Sex: M
Vaccine: FLU(H1N1), HIBV, PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Local induration and erythemia approx. 4" in diameter right thigh.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Death, Drug exposure during pregnancy, Premature labour
Clinical narrative: Pt reports going into Pre-term delivery 5 days after vaccine was given. Baby died about 1 month after delivery. Delivered 11/23/09.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Aspartate aminotransferase, Blood test normal, Body temperature increased, Borrelia burgdorferi serology, Chills
Clinical narrative: Vaccinated with H1N1 1/6/10. Has felt fatigued, had elevated temps TM. 102 oral, malaise, nausea, decreased appetite, body aches and chills since then.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Decreased appetite, Fatigue, Full blood count, Malaise, Nausea
Clinical narrative: Vaccinated with H1N1 1/6/10. Has felt fatigued, had elevated temps TM. 102 oral, malaise, nausea, decreased appetite, body aches and chills since then.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pain, Red blood cell sedimentation rate
Clinical narrative: Vaccinated with H1N1 1/6/10. Has felt fatigued, had elevated temps TM. 102 oral, malaise, nausea, decreased appetite, body aches and chills since then.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Arthralgia, Asthenia, Computerised tomogram abnormal, Endoscopy, Fatigue
Clinical narrative: Vaccinated with H1N1 1/6/10. Has felt fatigued, had elevated temps TM. 102 oral, malaise, nausea, decreased appetite, body aches and chills since then.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Haematocrit decreased, Laboratory test normal, Lymphocyte count normal, Malaise, Myalgia
Clinical narrative: Vaccinated with H1N1 1/6/10. Has felt fatigued, had elevated temps TM. 102 oral, malaise, nausea, decreased appetite, body aches and chills since then.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Nausea, Pyrexia, Red blood cell count decreased, Vomiting, White blood cell count decreased
Clinical narrative: Vaccinated with H1N1 1/6/10. Has felt fatigued, had elevated temps TM. 102 oral, malaise, nausea, decreased appetite, body aches and chills since then.
Age: 13.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Chills, Pruritus, Urticaria
Clinical narrative: Via phone mother reports "hives all over body this a.m. (12/3/09)" States having having chill in school. Also there is itching.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Malaise, Syncope
Clinical narrative: Student fainted as per mother, was able to be aroused by nurse, oriented. R18, P84. EMS arrived 4 minutes later, student taken to ER. Student reports not eating lunch well and presently not feeling well.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, VARCEL
Symptoms: Injection site induration, Injection site inflammation
Clinical narrative: Area of induration measuring 8 x 9 cm over R deltoid. 24 hours after receiving vaccine inflammation started per pt. Pt seen 48 hours after vaccination.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injection site pain
Clinical narrative: Given to left deltoid IM 12/29/09. C/o significant pain in left arm and shoulder, inhibiting activities x 14 days. Has since resolved.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Vomiting
Clinical narrative: Recurrent vomiting, no fever, no diarrhea.
Age: 1.01
Sex: M
Vaccine: FLU3, FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Client was given FLUMIST @ 1 yrs of age. Client was a large baby/child and the assumption was make the child was much older than actual age. Age was not verified prior to administration.
Age: 0.66
Sex: M
Vaccine: DTAPHEPBIP, FLU(H1N1), PNC
Symptoms: Abnormal behaviour, Crying, Face oedema, Injection site erythema, Injection site swelling
Clinical narrative: Unexplained crying, fussiness, irritable over 24 hours. Face with edema around eyes and cheeks. Localized erythema and swelling on right leg. "Infant not acting like himself" per Mom.
Age: 0.66
Sex: M
Vaccine: DTAPHEPBIP, FLU(H1N1), PNC
Symptoms: Irritability
Clinical narrative: Unexplained crying, fussiness, irritable over 24 hours. Face with edema around eyes and cheeks. Localized erythema and swelling on right leg. "Infant not acting like himself" per Mom.
Age: 4.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abnormal behaviour, Insomnia, Psychomotor hyperactivity
Clinical narrative: Behavior issues since receiving H1N1. Received the H1N1 vaccine during clinic on Wednesday. That afternoon mom and MGM noticed a distinct change in her behavior that continues today. She is not listening, she is not sleeping well, and she is acting like she has absolutely no control over her hyperactivity. Mom isn't overly concerned, but she doesn't think it's something acute and she truly thinks that the FLU MIST is causing her to act this way. Something similar happened a couple of years ago when she tried CLARITIN and it took about 3 or 4 days, but mom realized that the CLARITIN was causing a change in her behavior.
Age: 34.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site pain, Lip and/or oral cavity cancer
Clinical narrative: Report received from a nurse (also the mother of the patient) on 12-Jan-2010. A 34 year-old female patient received the H1N1 vaccine (batch number unknown) on 01-Oct-2009. The patient's medical history and concomitant medications are unknown. On an unknown date, the patient developed arm soreness at the injection site. On 23-Nov-2009, 7 weeks and 4 days after administration of suspect drug, the patient was diagnosed with oral cancer. The patient also indicated she experienced nothing else out of the ordinary. Treatment details and event outcome are unknown. The patient stated she was not pregnant at the time of vaccination. Further information has been requested. The case was reported as serious because of medical significance. The company considered events to be unassessable in relation to the suspect drug because medical history is unknown.
Age: 34.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Biopsy tongue abnormal, Injection site pain, Tongue neoplasm malignant stage unspecified
Clinical narrative: Report received from a nurse (also the mother of the patient) on 12-Jan-2010. A 34 year-old female patient received the H1N1 vaccine (batch number unknown) on 01-Oct-2009. The patient's medical history and concomitant medications are unknown. On an unknown date, the patient developed arm soreness at the injection site. On 23-Nov-2009, 7 weeks and 4 days after administration of suspect drug, the patient was diagnosed with oral cancer. The patient also indicated she experienced nothing else out of the ordinary. Treatment details and event outcome are unknown. The patient stated she was not pregnant at the time of vaccination. Further information has been requested. The case was reported as serious because of medical significance. The company considered events to be unassessable in relation to the suspect drug because medical history is unknown.
Age: 20.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Asthenia, Cold sweat, Dizziness, Hypotension, Nausea
Clinical narrative: Dizziness, vomiting, weakness, nausea, pale and moist, blood pressure low.
Age: 20.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pallor, Vomiting
Clinical narrative: Dizziness, vomiting, weakness, nausea, pale and moist, blood pressure low.
Age: 45.0
Sex: M
Vaccine: HEPAB, TDAP, TYP, YF
Symptoms: Asthenia, Myalgia, Pyrexia
Clinical narrative: Received telephone call from client's wife on 1/14/2010 to report patient developed a slight fever of 101.7 with muscle aches and pains and weakness on 1/9/2010. On 1/14/2010 symptoms still present. Advised client to seek medical attention at MD office or ER.
Age: 15.0
Sex: F
Vaccine: FLU(H1N1), FLU3, HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a physician and a nurse concerning a 15 year old female patient with unspecified psychological trauma, with a medical history of positive varicella and low vitamin D and with no known drug allergies, who on 10-SEP-2009, was vaccinated with the first dose of GARDASIL (663451/0216Y). Concomitant vaccine therapies included : RECOMBIVAX HB (manufacturer unknown) (Lot No: 664738/0650Y) and Td (Lot No: A023B). No problems were noted after vaccination. On 05-JAN-2010, the patient was vaccinated with the second dose of GARDASIL (Lot No: 665547/1318Y). Concomitant vaccine therapies included influenza virus A (antigen type unspecified) vaccine (H1N1) (Lot No: UP057AA) and influenza virus vaccine (unspecified) (Lot No : U3366AA). The physician reported that after the patient received her second dose of GARDASIL, on 05-JAN-2010, she curled into the "fetal position" and stated that she could not get up". She was also experiencing dizziness and a headache. The physician also reported that after 2 hours, the patient still could not get up so she was taken to the ER by an ambulance. On the same day, 05-JAN-2010, blood pressure and pulse were taken (no results were reported). No treatment was given in the office. The nurse reported that she did not see any "patient's fetal position curling" and she stated that the patient may had been dramatizing for the physician. In the ER, the patient was observed for four hours and no treatment was required. The patient was not admitted. The nurse also reported that on 07-JAN-2010, she spoke to the patient's mother and stated that her daughter recovered except for a minor headache. The patient sought medical attention and was seen by the physician at a hospital. The physician considered "Curled into the fetal position and could not get up", dizziness and headache as other important medical events since the patient was rushed to the hospital in an ambulance. No further information is available.
Age: 0.99
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Renal disorder, Surgery, Urinary tract infection
Clinical narrative: Information has been received from a consumer concerning her currently 5 year old daughter with a history of "born with refluxed uriter" who on an unspecified date, at age of one, was vaccinated with a dose of VARIVAX (Merck) (lot# not reported). There was no concomitant medication. It was reported that the patient was born with ureteral reflux and for the first 2 years of life she was on medication BACTRIM. On an unspecified date, at the age of 4 years, the patient developed a serious urinary tract infection and had to be hospitalized. It also affected the kidneys and the patient had to have surgery done to correct the urinary problem. The patient was doing fine and her kidneys went back to normal since 2008. During that time she was also back on BACTRIM and was taken off sometime in 2008. On an unspecified date in NOV-2009 the patient developed a case of shingles and shortly after the first case, in DEC-2009, the patient developed another case of shingles in the same area but milder. The shingles were on her right side under the armpit, chest and shoulder blade. Unspecified medical attention was sought via office visit. There were no laboratory diagnostics studies performed. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Fatigue, Tachycardia
Clinical narrative: Pt. called to report that after receiving H1N1 vaccine yesterday 1-14-2010 she developed/experienced a tachycardia episode but denied any other sx including dyspnea, diophoresis chest pain or other related sx. Feels well today just some fatigued sx. LPN.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Flushing, Musculoskeletal discomfort, Pharyngeal oedema
Clinical narrative: This case was reported by a physician and described the occurrence of should discomfort in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline).  The were no concurrent medications. On the afternoon of 9 December 2009 the subject received 1st dose of KINRIX at 0.5ml in the left arm. On 10 December 2009, at 07:00, the subject experienced shoulder discomfort, facial flushing and throat swelling. The subject was treated with Benadryl and Tylenol and shoulder discomfort and throat swelling improved. Facial swelling was unresolved at the time of reporting. The physician considered the events were probably related to vaccination with KINRIX. Follow-up information was received on 04 January 2010. It was reported that the events began on 10 December 2009, one day following administration of KINRIX. The events resolved on 10 December 2009 and were considered probably related to treatment with KINRIX. It was reported that no subsequent doses of KINRIX were given.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Flushing, Musculoskeletal discomfort, Pharyngeal oedema, Swelling face, Vaccination complication
Clinical narrative: This case was reported by a physician and described the occurrence of should discomfort in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline).  The were no concurrent medications. On the afternoon of 9 December 2009 the subject received 1st dose of KINRIX at 0.5ml in the left arm. On 10 December 2009, at 07:00, the subject experienced shoulder discomfort, facial flushing and throat swelling. The subject was treated with Benadryl and Tylenol and shoulder discomfort and throat swelling improved. Facial swelling was unresolved at the time of reporting. The physician considered the events were probably related to vaccination with KINRIX. Follow-up information was received on 04 January 2010. It was reported that the events began on 10 December 2009, one day following administration of KINRIX. The events resolved on 10 December 2009 and were considered probably related to treatment with KINRIX. It was reported that no subsequent doses of KINRIX were given.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Aphonia, Arthralgia, Back pain, Cough, Fatigue
Clinical narrative: My left elbow became sore, then my shoulders began to ache, and the skin on my back became very sensitive.  The next day,Sunday, I developed a sore throat and lost my voice somewhat, and my left knee became very sore, to the point that I was limping; I generally felt tired.  On Monday, all of the above symptoms continued through Wednesday, but additionally I lost more and more of my voice which was accompanied with a lot of congestion in my chest and a unremitting cough.  By Thursday, the pain in the elbow, knee and back had disappeared, but the other symptoms remained, and remain at this time.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Gait disturbance, Musculoskeletal pain, Oropharyngeal pain, Upper respiratory tract congestion
Clinical narrative: My left elbow became sore, then my shoulders began to ache, and the skin on my back became very sensitive.  The next day,Sunday, I developed a sore throat and lost my voice somewhat, and my left knee became very sore, to the point that I was limping; I generally felt tired.  On Monday, all of the above symptoms continued through Wednesday, but additionally I lost more and more of my voice which was accompanied with a lot of congestion in my chest and a unremitting cough.  By Thursday, the pain in the elbow, knee and back had disappeared, but the other symptoms remained, and remain at this time.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Pneumonia immunization yesterday and today upper left arm is swollen with fine-grained red rash.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Condition aggravated, Immediate post-injection reaction, Syncope
Clinical narrative: Child fainted immediately after injection. States this has happened before with injections. Epidode lasted 30 seconds. School nurse came and took her to the health office via wheelchair.
Age: 28.0
Sex: F
Vaccine: FLUX(H1N1), TTOX
Symptoms: Injection site erythema, Injection site swelling, Limb discomfort
Clinical narrative: injections site, red and swollen 1 inch diameter, also itchy.  same arm of the injection site has swollen sore armpit.
Age: 24.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Dyspnoea, Muscle spasms, Nausea, Pruritus
Clinical narrative: Pt complained of itching in her arms, tongue and skin, had rash on arm, c/o chest tightness, some SOB, nausea, vomiting x1, leg spasms.  She was given 12.5mg IM Benadryl, EMS was called and they gave her one dose of SoluMedrol en route.  When she got to the ED she looked fine, and was just c/o leg cramps.
Age: 24.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash, Vomiting
Clinical narrative: Pt complained of itching in her arms, tongue and skin, had rash on arm, c/o chest tightness, some SOB, nausea, vomiting x1, leg spasms.  She was given 12.5mg IM Benadryl, EMS was called and they gave her one dose of SoluMedrol en route.  When she got to the ED she looked fine, and was just c/o leg cramps.
Age: 39.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Headache
Clinical narrative: I felt severe shivering between 2 a.m. and 6 a.m. on Jan. 14. After the shivering was gone, then mild or severe headache has been continued until now.
Age: 63.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Pt started with a sore arm same arm as injection site. Pain has progressed and pt does not have full range of motion when lifting arm up.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Dysphonia, Feeling abnormal, Immediate post-injection reaction, Lip swelling, Ocular hyperaemia
Clinical narrative: 1/13/10 Recieved shots at 3:15 PM, 5:30 PM Noticed becoming VERY Hoarse and eyes a bit pink, feeling "run down", 7:30 PM Lip became swollen, felt like "prickly heat - pins and needles", By 6:30 next morning lips not swollen any more, but eyes were crusted shut. 1/14/10 still very run down and not myself, but no other sympyoms.  1/15/10 feeling pretty good.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Paraesthesia
Clinical narrative: 1/13/10 Recieved shots at 3:15 PM, 5:30 PM Noticed becoming VERY Hoarse and eyes a bit pink, feeling "run down", 7:30 PM Lip became swollen, felt like "prickly heat - pins and needles", By 6:30 next morning lips not swollen any more, but eyes were crusted shut. 1/14/10 still very run down and not myself, but no other sympyoms.  1/15/10 feeling pretty good.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Ear disorder, Tinnitus
Clinical narrative: Popping, cracking sound in Right ear
Age: 40.0
Sex: M
Vaccine: FLU3, HEPAB, IPV, TDAP
Symptoms: Rash
Clinical narrative: Rash on right hip only - not painful
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Bacterial test negative, Balance disorder, Dizziness, Dyspepsia
Clinical narrative: On November 12th patient had flu like symptoms for 2 days including severe headache and fever of 102.  On the 13th he noticed difficulty urinating.  By the morning of the 14th he was completely unable to void.  Over the next few weeks he developed other symtoms including:  skin burning, neck stiffness, weakness of feet/legs, bowel and digestive dysfunction, light headedness, balance problems, tremor and visual/sensory disturbances.  He was subsequently diagnosed with acute myelitis.  He has had several brain and spinal MRI's showing inflammation and then abnormalities in both areas, with abnormality getting extremely close to respiratory functions.  He was treated initially with steroids and then with 5 treatments of plasma exchange.  Some of his symptoms have resolved but he still has urinary retention/neurogenic bladder and a few other neurologic symptoms.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Dysuria, Fungus serology test negative, Headache, Inflammation, Influenza like illness
Clinical narrative: On November 12th patient had flu like symptoms for 2 days including severe headache and fever of 102.  On the 13th he noticed difficulty urinating.  By the morning of the 14th he was completely unable to void.  Over the next few weeks he developed other symtoms including:  skin burning, neck stiffness, weakness of feet/legs, bowel and digestive dysfunction, light headedness, balance problems, tremor and visual/sensory disturbances.  He was subsequently diagnosed with acute myelitis.  He has had several brain and spinal MRI's showing inflammation and then abnormalities in both areas, with abnormality getting extremely close to respiratory functions.  He was treated initially with steroids and then with 5 treatments of plasma exchange.  Some of his symptoms have resolved but he still has urinary retention/neurogenic bladder and a few other neurologic symptoms.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Intestinal functional disorder, Muscular weakness, Musculoskeletal stiffness, Myelitis, Nervous system disorder
Clinical narrative: On November 12th patient had flu like symptoms for 2 days including severe headache and fever of 102.  On the 13th he noticed difficulty urinating.  By the morning of the 14th he was completely unable to void.  Over the next few weeks he developed other symtoms including:  skin burning, neck stiffness, weakness of feet/legs, bowel and digestive dysfunction, light headedness, balance problems, tremor and visual/sensory disturbances.  He was subsequently diagnosed with acute myelitis.  He has had several brain and spinal MRI's showing inflammation and then abnormalities in both areas, with abnormality getting extremely close to respiratory functions.  He was treated initially with steroids and then with 5 treatments of plasma exchange.  Some of his symptoms have resolved but he still has urinary retention/neurogenic bladder and a few other neurologic symptoms.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Neurogenic bladder, Neurological symptom, Plasmapheresis, Pyrexia, Sensory disturbance
Clinical narrative: On November 12th patient had flu like symptoms for 2 days including severe headache and fever of 102.  On the 13th he noticed difficulty urinating.  By the morning of the 14th he was completely unable to void.  Over the next few weeks he developed other symtoms including:  skin burning, neck stiffness, weakness of feet/legs, bowel and digestive dysfunction, light headedness, balance problems, tremor and visual/sensory disturbances.  He was subsequently diagnosed with acute myelitis.  He has had several brain and spinal MRI's showing inflammation and then abnormalities in both areas, with abnormality getting extremely close to respiratory functions.  He was treated initially with steroids and then with 5 treatments of plasma exchange.  Some of his symptoms have resolved but he still has urinary retention/neurogenic bladder and a few other neurologic symptoms.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Skin burning sensation, Spinal disorder, Tremor, Urinary retention, Viral test negative
Clinical narrative: On November 12th patient had flu like symptoms for 2 days including severe headache and fever of 102.  On the 13th he noticed difficulty urinating.  By the morning of the 14th he was completely unable to void.  Over the next few weeks he developed other symtoms including:  skin burning, neck stiffness, weakness of feet/legs, bowel and digestive dysfunction, light headedness, balance problems, tremor and visual/sensory disturbances.  He was subsequently diagnosed with acute myelitis.  He has had several brain and spinal MRI's showing inflammation and then abnormalities in both areas, with abnormality getting extremely close to respiratory functions.  He was treated initially with steroids and then with 5 treatments of plasma exchange.  Some of his symptoms have resolved but he still has urinary retention/neurogenic bladder and a few other neurologic symptoms.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: On November 12th patient had flu like symptoms for 2 days including severe headache and fever of 102.  On the 13th he noticed difficulty urinating.  By the morning of the 14th he was completely unable to void.  Over the next few weeks he developed other symtoms including:  skin burning, neck stiffness, weakness of feet/legs, bowel and digestive dysfunction, light headedness, balance problems, tremor and visual/sensory disturbances.  He was subsequently diagnosed with acute myelitis.  He has had several brain and spinal MRI's showing inflammation and then abnormalities in both areas, with abnormality getting extremely close to respiratory functions.  He was treated initially with steroids and then with 5 treatments of plasma exchange.  Some of his symptoms have resolved but he still has urinary retention/neurogenic bladder and a few other neurologic symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Blood testosterone normal, Blood thyroid stimulating hormone normal, Rash, Skin test positive
Clinical narrative: Small bumps first appeared on my back. I have a lengthy description of the different courses of treatments I have undergone since the onset of this skin rash. In general, I have been seen by 2 internists, two dermatoligists, and my endocrinologist. I have tried myriades of ointments both prescription & OTC. I have received large dosages of Prednisone on numerous occasions, had three biopsies performed and several blood tests taken. I have also had skin patch tests.