chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Fall, Head injury, Nausea, Pallor, Syncope
Clinical narrative: BOOSTRIX given in RM. without incident.  On leaving office had syncope episode.  Mom stated he hit back of head during fall.  Ice pack applied to back of head, no open areas noted.  Pt. awake & alert.  C/o nausea.  Skin color pale.  Speech clear.  AROM.  After 20 mins. no change.  Able to walk.  Instructed mom with concussion protocol.  Call if needed.  Skin color pink.  Dr. eval. pt.  Will follow up with call in  AM.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1), VARCEL
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Erythema and some hardness and tenderness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: Develops rash at injection site. Erythema with small ~ 2 cm area vesicular appearing lesions.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Borrelia test negative, Eyelid function disorder, Facial palsy, Paraesthesia
Clinical narrative: Patient presented to ED with Right sided facial droop and difficulty opening eye lids. Stating "right side of face not working." She was diagnosed in ED with Bell's Palsy.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Borrelia test negative, Dysmorphism, Eyelid disorder, Lip disorder, VIIth nerve paralysis
Clinical narrative: Patient presented to ED with Right sided facial droop and difficulty opening eye lids. Stating "right side of face not working." She was diagnosed in ED with Bell's Palsy.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site papule, Rash maculo-papular
Clinical narrative: 2 small raised erythematous papules at injection site & mild maculo papular rash of torso / abdomen.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Mouth ulceration, Oral pain
Clinical narrative: Big ulceration the Rt buccal mucosa, painful, tender, small Rt submandibular gland.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU(H1N1), IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling @ injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU(H1N1), IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling injection site from shoulder to elbow (R) arm. Treated with  antibiotics.
Age: 64.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Blister, Burning sensation, Hypoaesthesia oral, Lip swelling
Clinical narrative: 64 y.o. M w/ PMH of Hypothyroidism, Arthritis, HL and HTN presented to Primary Care with c/o a blister on the inside of his lip and lip swelling. Pt reported he began feeling swelling in his lip and down his right cheek the night of the vaccination. He also reported his lip feeling numb at times and at other times having a burning sensation. Pt was prescribed Benadryl and allergy listed in pt`s profile. Pt had no previous allergies listed.
Age: 64.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Burning sensation, Hypoaesthesia oral, Lip blister, Lip swelling, Swelling face
Clinical narrative: 64 y.o. M w/ PMH of Hypothyroidism, Arthritis, HL and HTN presented to Primary Care with c/o a blister on the inside of his lip and lip swelling. Pt reported he began feeling swelling in his lip and down his right cheek the night of the vaccination. He also reported his lip feeling numb at times and at other times having a burning sensation. Pt was prescribed Benadryl and allergy listed in pt`s profile. Pt had no previous allergies listed.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU(H1N1), IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L arm redness & swelling at injection site.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Dyspnoea, Insomnia, Malaise, Myalgia
Clinical narrative: Child developed bilateral eye redness soon after shots were given.  Overnight s/s were sudden onset:  Malaise, difficulty sleeping, dizziness, papular rash on trunk & extremities (non - urticarial), difficulty breathing, vomiting & muscle aches, fever of 102, facial swelling.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Ocular hyperaemia, Pyrexia, Rash papular, Swelling face, Vomiting
Clinical narrative: Child developed bilateral eye redness soon after shots were given.  Overnight s/s were sudden onset:  Malaise, difficulty sleeping, dizziness, papular rash on trunk & extremities (non - urticarial), difficulty breathing, vomiting & muscle aches, fever of 102, facial swelling.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Dry skin, Eyelid oedema, Hypersensitivity, Lip swelling, Rash
Clinical narrative: Swelling of face and lips, rash over neck and upper chest.  Completed course of PREDNISOLONE, BENADRYL as needed.  This is a 5-year-old male who had taken a nap and woke up with swelling of his face including his lips.  He started to develop a rash over his neck and upper chest.  He does not have difficulty breathing.  No fevers. No chills.  Breathing without difficulty.  The patient has no complaints.  Pulse 98, respiratory rate 20, temperature 36.6, pulse oximetry 99%.  Normocephalic.  Patient does have moderate swelling about the eyes particularly on the left periorbital tissues.  There is moderate swelling to the upper lip.  There is no swelling about the tongue.  Oropharynx is pink, moist without erythema, without swelling, no uvular deviation.  Neck:  Supple without mass or meningismus. Heart: Regular rate and rhythm without murmur.  Lungs: Clear to auscultation.  No wheeze.  Abdomen:  Soft, nontender.  Musculoskeletal:  No focal neurologic deficit.  No weakness, numbness, cyanosis or edema.  Skin:  Pink, warm, and dry.  Does have urticarial rash over his upper chest and in his neck.  He was given steroids and BENADRYL.  Observed in the emergency department.  Continues to do well.  Swelling is improving.  Rash is improving.  Follow up with primary doctor.  Return with any increased difficulty breathing, swallowing, or any other concerns.  Final Diagnosis 1. Allergic reaction.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Skin warm, Swelling face, Urticaria
Clinical narrative: Swelling of face and lips, rash over neck and upper chest.  Completed course of PREDNISOLONE, BENADRYL as needed.  This is a 5-year-old male who had taken a nap and woke up with swelling of his face including his lips.  He started to develop a rash over his neck and upper chest.  He does not have difficulty breathing.  No fevers. No chills.  Breathing without difficulty.  The patient has no complaints.  Pulse 98, respiratory rate 20, temperature 36.6, pulse oximetry 99%.  Normocephalic.  Patient does have moderate swelling about the eyes particularly on the left periorbital tissues.  There is moderate swelling to the upper lip.  There is no swelling about the tongue.  Oropharynx is pink, moist without erythema, without swelling, no uvular deviation.  Neck:  Supple without mass or meningismus. Heart: Regular rate and rhythm without murmur.  Lungs: Clear to auscultation.  No wheeze.  Abdomen:  Soft, nontender.  Musculoskeletal:  No focal neurologic deficit.  No weakness, numbness, cyanosis or edema.  Skin:  Pink, warm, and dry.  Does have urticarial rash over his upper chest and in his neck.  He was given steroids and BENADRYL.  Observed in the emergency department.  Continues to do well.  Swelling is improving.  Rash is improving.  Follow up with primary doctor.  Return with any increased difficulty breathing, swallowing, or any other concerns.  Final Diagnosis 1. Allergic reaction.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Received Influenza Vaccination 11/03/09 follow two day later with rash entire left arm to mid back. Employee reported on 4/27/10.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Patient has swelling and blister on injection site.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Blood glucose decreased, Computerised tomogram abnormal, Computerised tomogram head, Convulsion, Electroencephalogram abnormal
Clinical narrative: seiaure
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Headache, Skin burning sensation
Clinical narrative: Patient brought to Medical Center by ambulance.  Arrived at 11:30AM.  Received flu shot in school "earlier today" BP 111/83, Pulse 82, Resp 20, Temp 98.5 02 Sat 100% Patient presented with red face, c/o skin burning, headache Pt given "Benadryl PO" by school nurse prior to transfer. Pt given Prelone 15mg/5ml, 8ml po at 11:55AM Benadryl 5ml PO at 11:55AM, and Motrin 10ml PO at 12:55PM in the ER Pt discharged
Age: 0.88
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Muscular weakness
Clinical narrative: Mother observed child to have muscle weakness morning after immunizations (DTaP #3, PCV #3) given. Eval. in ER approx 6 hours later - child had normal exam.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Acoustic stimulation tests normal, Audiogram normal, Erythema, Swelling, Tinnitus
Clinical narrative: Localized swelling and redness, ringing in R ear.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Erythema, Induration
Clinical narrative: 3cm of induration subcutaneous and mild erythema, no fever.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Breath odour, Erythema multiforme, Oropharyngeal pain, Rash, Skin lesion
Clinical narrative: Pt. vaccinated on 7 Apr. Approx 3 days later he develop a few bumps.  Over the past several days he has multiple lesions over his elbows, hands, fingers, knees, and palms.  C/o sore throat with odor.  Rash per pcm almost looks like EM or a Strep A rash.  No other symptoms, pt. otherwise well.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU(H1N1), MMR, VARCEL
Symptoms: Cardiac telemetry, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Heart rate increased
Clinical narrative: Patient received 4 years vaccines on AM of 4/22/2010, presented to ER with elevated heart rate 270's at 9pm on 4/22, went to hospital.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abortion spontaneous
Clinical narrative: SAB reported by patient on 4/27/10.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Pt was not treated or diagnosed in our facility. Diagnosed with Guillain Barre's syndrome at a medical center.
Age: 53.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood thyroid stimulating hormone normal, Computerised tomogram, Dyspnoea, Electrocardiogram, Full blood count normal
Clinical narrative: Patient notes malaise and shortness of breath since vaccination.  Has been presistent since the time of vaccination.  Extensive w/u unremarkable.
Age: 53.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Malaise, Metabolic function test, Stress echocardiogram
Clinical narrative: Patient notes malaise and shortness of breath since vaccination.  Has been presistent since the time of vaccination.  Extensive w/u unremarkable.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Bradycardia, Chest X-ray normal, Coagulation test normal, Electrocardiogram, Full blood count normal
Clinical narrative: Patient had witnessed syncopal episode immediately following vaccine. Patient was assessed and was bradycardic (40 BPM) and blood pressure was not able to be auscultated or palpated. Patient was questioned immediately following and was conscious and oriented but was persistently bradycardic. Patient then had a second witnessed syncopal episode at 10:55 AM and she remained bradycardic for several more minutes. Patient began to recover and at 11:012 AM her pulse was 58 BPM and blood pressure was 88/48. Her SPO2 remained 100% throughout the entire episode. Patient was never post-ictal and never had any convulsions or seizure activity.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Metabolic function test normal, Syncope, Urine human chorionic gonadotropin negative
Clinical narrative: Patient had witnessed syncopal episode immediately following vaccine. Patient was assessed and was bradycardic (40 BPM) and blood pressure was not able to be auscultated or palpated. Patient was questioned immediately following and was conscious and oriented but was persistently bradycardic. Patient then had a second witnessed syncopal episode at 10:55 AM and she remained bradycardic for several more minutes. Patient began to recover and at 11:012 AM her pulse was 58 BPM and blood pressure was 88/48. Her SPO2 remained 100% throughout the entire episode. Patient was never post-ictal and never had any convulsions or seizure activity.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature normal, Fatigue, Injection site erythema, Injection site haematoma, Injection site pain
Clinical narrative: 99-100 temp, tired, sore at site, rash below inj site and slight bruise, resolving by day 3.  Then day 4, 5 PM mother noted rash, heat at site.  ER physician did not treat but advised to use Benadryl prn for next few days and not ever get another tetanus booster. By day 7-8 patient still getting red and rashy at site, increasing with physical use of affected arm for softball practice. By day 10, mom was still giving Benadryl in the evening, but each day she stated the area affected by rash and redness was less than previous day (resolving).
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: 99-100 temp, tired, sore at site, rash below inj site and slight bruise, resolving by day 3.  Then day 4, 5 PM mother noted rash, heat at site.  ER physician did not treat but advised to use Benadryl prn for next few days and not ever get another tetanus booster. By day 7-8 patient still getting red and rashy at site, increasing with physical use of affected arm for softball practice. By day 10, mom was still giving Benadryl in the evening, but each day she stated the area affected by rash and redness was less than previous day (resolving).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Bordetella test positive, Cough, Respiratory tract congestion
Clinical narrative: Cough/Congestion x 2 wks
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Lymph node pain, Lymphadenopathy, Thrombosis
Clinical narrative: Swelling at injection site about the size of a pencil eraser (normal), then continued to grow throughout Sunday and Monday to the size of a very large grape. Monday my armpit lymph node became swollen and very painful. Saw the doctor Tuesday and she explained there was a clot of blood that has built up in my arm and that I needed to keep warm compresses on it in hopes of it breaking up.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alanine aminotransferase, Albumin globulin ratio, Aspartate aminotransferase, Back pain, Blood alkaline phosphatase
Clinical narrative: Fibromyalgia symptoms: excruciating pain-back, chest, neck, arms, hips and legs, headaches, muscle weakness, generalized swelling-all over body, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility, limited range of motion. Symptoms started in Sept 2009, at onset was mainly back pain with  symptoms progressively worsening to date. Treatment Oct 2009, diagnosed with thoracic sprain, pain med and prednisone prescribed. Primary care physician, Oct 29, 2009- ordered Mobic, Lortab, and Flexeril. Nov 11,2009 Dr stopped Mobic and Flexeril and ordered Zanaflex and ibuprofen. Also ordered physical therapy. started 11/12/2009. After several sessions stopped physical therapy due to increasing pain and inability to tolerate therapy. 11/25/09 MRI cervical and lumbar. Several weeks of chiropractic care- stopped due to inability to tolerate and not improving. Spine clinic- Dr evaluated and referred. 12/16/09 Rehab Several visits - trigger point injections, lidocaine patches, nortriptyline, Lexapro-no improvement. Psychologist-psych eval. - started in March 2010-Has tried several meds without success- Diagnosed with fibromyalgia and referred to another Dr. April 19, 2010, 1st appt with Dr and fibromyalgia diagnosis confirmed. Patient is taking several medications to try to help control symptoms-Neurontin, Savella, Klonopin, and Ultram but so far still no improvement. She still  remains in excruciating uncontolled pain along with increasing weakness, generalized swelling, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility and limited range of motion.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood bilirubin, Blood cortisol, Blood creatine, Disturbance in attention, Fibromyalgia
Clinical narrative: Fibromyalgia symptoms: excruciating pain-back, chest, neck, arms, hips and legs, headaches, muscle weakness, generalized swelling-all over body, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility, limited range of motion. Symptoms started in Sept 2009, at onset was mainly back pain with  symptoms progressively worsening to date. Treatment Oct 2009, diagnosed with thoracic sprain, pain med and prednisone prescribed. Primary care physician, Oct 29, 2009- ordered Mobic, Lortab, and Flexeril. Nov 11,2009 Dr stopped Mobic and Flexeril and ordered Zanaflex and ibuprofen. Also ordered physical therapy. started 11/12/2009. After several sessions stopped physical therapy due to increasing pain and inability to tolerate therapy. 11/25/09 MRI cervical and lumbar. Several weeks of chiropractic care- stopped due to inability to tolerate and not improving. Spine clinic- Dr evaluated and referred. 12/16/09 Rehab Several visits - trigger point injections, lidocaine patches, nortriptyline, Lexapro-no improvement. Psychologist-psych eval. - started in March 2010-Has tried several meds without success- Diagnosed with fibromyalgia and referred to another Dr. April 19, 2010, 1st appt with Dr and fibromyalgia diagnosis confirmed. Patient is taking several medications to try to help control symptoms-Neurontin, Savella, Klonopin, and Ultram but so far still no improvement. She still  remains in excruciating uncontolled pain along with increasing weakness, generalized swelling, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility and limited range of motion.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Induration, Insomnia, Joint range of motion decreased, Ligament sprain
Clinical narrative: Fibromyalgia symptoms: excruciating pain-back, chest, neck, arms, hips and legs, headaches, muscle weakness, generalized swelling-all over body, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility, limited range of motion. Symptoms started in Sept 2009, at onset was mainly back pain with  symptoms progressively worsening to date. Treatment Oct 2009, diagnosed with thoracic sprain, pain med and prednisone prescribed. Primary care physician, Oct 29, 2009- ordered Mobic, Lortab, and Flexeril. Nov 11,2009 Dr stopped Mobic and Flexeril and ordered Zanaflex and ibuprofen. Also ordered physical therapy. started 11/12/2009. After several sessions stopped physical therapy due to increasing pain and inability to tolerate therapy. 11/25/09 MRI cervical and lumbar. Several weeks of chiropractic care- stopped due to inability to tolerate and not improving. Spine clinic- Dr evaluated and referred. 12/16/09 Rehab Several visits - trigger point injections, lidocaine patches, nortriptyline, Lexapro-no improvement. Psychologist-psych eval. - started in March 2010-Has tried several meds without success- Diagnosed with fibromyalgia and referred to another Dr. April 19, 2010, 1st appt with Dr and fibromyalgia diagnosis confirmed. Patient is taking several medications to try to help control symptoms-Neurontin, Savella, Klonopin, and Ultram but so far still no improvement. She still  remains in excruciating uncontolled pain along with increasing weakness, generalized swelling, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility and limited range of motion.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mobility decreased, Muscle spasms, Muscular weakness, Pain, Swelling
Clinical narrative: Fibromyalgia symptoms: excruciating pain-back, chest, neck, arms, hips and legs, headaches, muscle weakness, generalized swelling-all over body, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility, limited range of motion. Symptoms started in Sept 2009, at onset was mainly back pain with  symptoms progressively worsening to date. Treatment Oct 2009, diagnosed with thoracic sprain, pain med and prednisone prescribed. Primary care physician, Oct 29, 2009- ordered Mobic, Lortab, and Flexeril. Nov 11,2009 Dr stopped Mobic and Flexeril and ordered Zanaflex and ibuprofen. Also ordered physical therapy. started 11/12/2009. After several sessions stopped physical therapy due to increasing pain and inability to tolerate therapy. 11/25/09 MRI cervical and lumbar. Several weeks of chiropractic care- stopped due to inability to tolerate and not improving. Spine clinic- Dr evaluated and referred. 12/16/09 Rehab Several visits - trigger point injections, lidocaine patches, nortriptyline, Lexapro-no improvement. Psychologist-psych eval. - started in March 2010-Has tried several meds without success- Diagnosed with fibromyalgia and referred to another Dr. April 19, 2010, 1st appt with Dr and fibromyalgia diagnosis confirmed. Patient is taking several medications to try to help control symptoms-Neurontin, Savella, Klonopin, and Ultram but so far still no improvement. She still  remains in excruciating uncontolled pain along with increasing weakness, generalized swelling, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility and limited range of motion.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Blood test, Chest pain
Clinical narrative: Fibromyalgia symptoms: excruciating pain-back, chest, neck, arms, hips and legs, headaches, muscle weakness, generalized swelling-all over body, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility, limited range of motion. Symptoms started in Sept 2009, at onset was mainly back pain with  symptoms progressively worsening to date. Treatment Oct 2009, diagnosed with thoracic sprain, pain med and prednisone prescribed. Primary care physician, Oct 29, 2009- ordered Mobic, Lortab, and Flexeril. Nov 11,2009 Dr stopped Mobic and Flexeril and ordered Zanaflex and ibuprofen. Also ordered physical therapy. started 11/12/2009. After several sessions stopped physical therapy due to increasing pain and inability to tolerate therapy. 11/25/09 MRI cervical and lumbar. Several weeks of chiropractic care- stopped due to inability to tolerate and not improving. Spine clinic- Dr evaluated and referred. 12/16/09 Rehab Several visits - trigger point injections, lidocaine patches, nortriptyline, Lexapro-no improvement. Psychologist-psych eval. - started in March 2010-Has tried several meds without success- Diagnosed with fibromyalgia and referred to another Dr. April 19, 2010, 1st appt with Dr and fibromyalgia diagnosis confirmed. Patient is taking several medications to try to help control symptoms-Neurontin, Savella, Klonopin, and Ultram but so far still no improvement. She still  remains in excruciating uncontolled pain along with increasing weakness, generalized swelling, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility and limited range of motion.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disturbance in attention, Fibromyalgia, Headache, Impaired driving ability, Impaired work ability
Clinical narrative: Fibromyalgia symptoms: excruciating pain-back, chest, neck, arms, hips and legs, headaches, muscle weakness, generalized swelling-all over body, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility, limited range of motion. Symptoms started in Sept 2009, at onset was mainly back pain with  symptoms progressively worsening to date. Treatment Oct 2009, diagnosed with thoracic sprain, pain med and prednisone prescribed. Primary care physician, Oct 29, 2009- ordered Mobic, Lortab, and Flexeril. Nov 11,2009 Dr stopped Mobic and Flexeril and ordered Zanaflex and ibuprofen. Also ordered physical therapy. started 11/12/2009. After several sessions stopped physical therapy due to increasing pain and inability to tolerate therapy. 11/25/09 MRI cervical and lumbar. Several weeks of chiropractic care- stopped due to inability to tolerate and not improving. Spine clinic- Dr evaluated and referred. 12/16/09 Rehab Several visits - trigger point injections, lidocaine patches, nortriptyline, Lexapro-no improvement. Psychologist-psych eval. - started in March 2010-Has tried several meds without success- Diagnosed with fibromyalgia and referred to another Dr. April 19, 2010, 1st appt with Dr and fibromyalgia diagnosis confirmed. Patient is taking several medications to try to help control symptoms-Neurontin, Savella, Klonopin, and Ultram but so far still no improvement. She still  remains in excruciating uncontolled pain along with increasing weakness, generalized swelling, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility and limited range of motion.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Insomnia, Joint range of motion decreased, Ligament sprain, Mobility decreased
Clinical narrative: Fibromyalgia symptoms: excruciating pain-back, chest, neck, arms, hips and legs, headaches, muscle weakness, generalized swelling-all over body, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility, limited range of motion. Symptoms started in Sept 2009, at onset was mainly back pain with  symptoms progressively worsening to date. Treatment Oct 2009, diagnosed with thoracic sprain, pain med and prednisone prescribed. Primary care physician, Oct 29, 2009- ordered Mobic, Lortab, and Flexeril. Nov 11,2009 Dr stopped Mobic and Flexeril and ordered Zanaflex and ibuprofen. Also ordered physical therapy. started 11/12/2009. After several sessions stopped physical therapy due to increasing pain and inability to tolerate therapy. 11/25/09 MRI cervical and lumbar. Several weeks of chiropractic care- stopped due to inability to tolerate and not improving. Spine clinic- Dr evaluated and referred. 12/16/09 Rehab Several visits - trigger point injections, lidocaine patches, nortriptyline, Lexapro-no improvement. Psychologist-psych eval. - started in March 2010-Has tried several meds without success- Diagnosed with fibromyalgia and referred to another Dr. April 19, 2010, 1st appt with Dr and fibromyalgia diagnosis confirmed. Patient is taking several medications to try to help control symptoms-Neurontin, Savella, Klonopin, and Ultram but so far still no improvement. She still  remains in excruciating uncontolled pain along with increasing weakness, generalized swelling, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility and limited range of motion.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle disorder, Muscle spasms, Muscular weakness, Neck pain, Nuclear magnetic resonance imaging normal
Clinical narrative: Fibromyalgia symptoms: excruciating pain-back, chest, neck, arms, hips and legs, headaches, muscle weakness, generalized swelling-all over body, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility, limited range of motion. Symptoms started in Sept 2009, at onset was mainly back pain with  symptoms progressively worsening to date. Treatment Oct 2009, diagnosed with thoracic sprain, pain med and prednisone prescribed. Primary care physician, Oct 29, 2009- ordered Mobic, Lortab, and Flexeril. Nov 11,2009 Dr stopped Mobic and Flexeril and ordered Zanaflex and ibuprofen. Also ordered physical therapy. started 11/12/2009. After several sessions stopped physical therapy due to increasing pain and inability to tolerate therapy. 11/25/09 MRI cervical and lumbar. Several weeks of chiropractic care- stopped due to inability to tolerate and not improving. Spine clinic- Dr evaluated and referred. 12/16/09 Rehab Several visits - trigger point injections, lidocaine patches, nortriptyline, Lexapro-no improvement. Psychologist-psych eval. - started in March 2010-Has tried several meds without success- Diagnosed with fibromyalgia and referred to another Dr. April 19, 2010, 1st appt with Dr and fibromyalgia diagnosis confirmed. Patient is taking several medications to try to help control symptoms-Neurontin, Savella, Klonopin, and Ultram but so far still no improvement. She still  remains in excruciating uncontolled pain along with increasing weakness, generalized swelling, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility and limited range of motion.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging thoracic normal, Pain, Pain in extremity, Swelling, Wheelchair user
Clinical narrative: Fibromyalgia symptoms: excruciating pain-back, chest, neck, arms, hips and legs, headaches, muscle weakness, generalized swelling-all over body, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility, limited range of motion. Symptoms started in Sept 2009, at onset was mainly back pain with  symptoms progressively worsening to date. Treatment Oct 2009, diagnosed with thoracic sprain, pain med and prednisone prescribed. Primary care physician, Oct 29, 2009- ordered Mobic, Lortab, and Flexeril. Nov 11,2009 Dr stopped Mobic and Flexeril and ordered Zanaflex and ibuprofen. Also ordered physical therapy. started 11/12/2009. After several sessions stopped physical therapy due to increasing pain and inability to tolerate therapy. 11/25/09 MRI cervical and lumbar. Several weeks of chiropractic care- stopped due to inability to tolerate and not improving. Spine clinic- Dr evaluated and referred. 12/16/09 Rehab Several visits - trigger point injections, lidocaine patches, nortriptyline, Lexapro-no improvement. Psychologist-psych eval. - started in March 2010-Has tried several meds without success- Diagnosed with fibromyalgia and referred to another Dr. April 19, 2010, 1st appt with Dr and fibromyalgia diagnosis confirmed. Patient is taking several medications to try to help control symptoms-Neurontin, Savella, Klonopin, and Ultram but so far still no improvement. She still  remains in excruciating uncontolled pain along with increasing weakness, generalized swelling, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility and limited range of motion.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea, Pruritus
Clinical narrative: Tightness in chest, "difficulty breathing," which was present in the evening but resolved in the morning.  In the evening she also began developing pruritus over her entire body and small bumps where she feels the pruritus.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Left hand/fingers swollen and painful
Age: 13.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood test, Diarrhoea
Clinical narrative: Our son has had regular recurrence of diarrhea since late 2009 (2-3X per week).  The vaccine was administered on 12/1/2009.  We don't have an exact date as to when the diarrhea began. For the past two months, we have been exploring other medical intervention to determine the cause, and it has recently occurred to us that he received the H1N1 vaccination during the same season.  We have no idea if there is a connection between his diarrhea and the H1N1 vaccination, but felt it was worth reporting.  If there are others who have had similar reactions, we would like to be contacted.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatinine normal, Blood glucose normal, Blood potassium decreased, Blood sodium normal, Blood urea normal
Clinical narrative: @ 5:18pm: Pt called saying that she had the flu shot around 4:30 and thinks that she is having a reaction towards the shot. The back of her mouth feels "weird/fat throat feels scratchy", and she says it started on her L side of her chin. She is not allergic to eggs or prior flu vacc. 5:28PM: MD called Pt back and was told to take some Benadryl and head to the ER.  ER: was given 1 liter of normal saline, IV Benadryl 25mg and Solu-Medrol 125mg IV. Was given Benadryl and some prednisone
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Haematocrit decreased, Haemoglobin normal, No reaction on previous exposure to drug, Oedema mouth, Oral discomfort
Clinical narrative: @ 5:18pm: Pt called saying that she had the flu shot around 4:30 and thinks that she is having a reaction towards the shot. The back of her mouth feels "weird/fat throat feels scratchy", and she says it started on her L side of her chin. She is not allergic to eggs or prior flu vacc. 5:28PM: MD called Pt back and was told to take some Benadryl and head to the ER.  ER: was given 1 liter of normal saline, IV Benadryl 25mg and Solu-Medrol 125mg IV. Was given Benadryl and some prednisone
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, White blood cell count normal
Clinical narrative: @ 5:18pm: Pt called saying that she had the flu shot around 4:30 and thinks that she is having a reaction towards the shot. The back of her mouth feels "weird/fat throat feels scratchy", and she says it started on her L side of her chin. She is not allergic to eggs or prior flu vacc. 5:28PM: MD called Pt back and was told to take some Benadryl and head to the ER.  ER: was given 1 liter of normal saline, IV Benadryl 25mg and Solu-Medrol 125mg IV. Was given Benadryl and some prednisone
Age: 25.0
Sex: M
Vaccine: ANTH, DTP, MMRV, OPV
Symptoms: Abdominal pain upper, Bladder disorder, Constipation, Cough, Diarrhoea
Clinical narrative: Flu like, stomache, diarrhea, constipation, uncontrollable leg movements, bladder problems, leg pain, feet pain, fever chills, coughing.
Age: 25.0
Sex: M
Vaccine: ANTH, DTP, MMRV, OPV
Symptoms: Dyskinesia, Inappropriate schedule of drug administration, Influenza like illness, Laboratory test, Pain in extremity
Clinical narrative: Flu like, stomache, diarrhea, constipation, uncontrollable leg movements, bladder problems, leg pain, feet pain, fever chills, coughing.
Age: 25.0
Sex: M
Vaccine: ANTH, DTP, MMRV, OPV
Symptoms: Pyrexia
Clinical narrative: Flu like, stomache, diarrhea, constipation, uncontrollable leg movements, bladder problems, leg pain, feet pain, fever chills, coughing.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Irritability, Rash generalised, Rash papular
Clinical narrative: 4/12 Fussy Behavior exhibited out of character, continues as of 4/27 4/22 rash on right calf 4/23 rash on neck, back, and stomach 4/24 rash continued covering all body, head, hands, legs, bottom... small red raised bumps.  extreme fussiness 4/27 rash has begun to subside
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Injection site swelling, Vomiting
Clinical narrative: Vomiting x 3, site swelling 80 mm in size.
Age: 23.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Rash
Clinical narrative: 24 y/o male receives multiple vaccinations including primary SMALLPOX, AVA #1, TYPHOID, and TWINRIX vaccines and developed skin rash approximately 2 days later. Rash has been recurrent and chronic over the years but controlled only with the chronic and daily use of ALLEGRA and ZYRTEC antihistamine therapy.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Confusional state, Electroencephalogram, Grand mal convulsion, Loss of consciousness
Clinical narrative: Vocal cords seizing made me go in her room to see her having a gran mal seizure then pass out and wake not knowing anyone or anything. Continues having 4 more seizures since.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Vocal cord disorder
Clinical narrative: Vocal cords seizing made me go in her room to see her having a gran mal seizure then pass out and wake not knowing anyone or anything. Continues having 4 more seizures since.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Intestinal resection, Intussusception
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 12 weeks old male with no medical history, no allergies reported and no preexisting illness was vaccinated with a dose of ROTATEQ (Lot # 664292/0433Y) by mouth on 27-OCT-2009. Concomitant vaccination given on the same day included DTAOIOVHIB (lot # C3482AA), IM and PREVNAR (lot # D90888), IM. A discharge summary was received on 05-JAN-2010 for date of service on 16-DEC-2009. The patient diagnosis was intussusception. On 16-DEC-2009, the patient presented with several days with nausea and vomiting. The patient was found with intussusception and was taken to the operation room. A radiography was performed which confirmed intussusception. The patient underwent resection of terminal ileum and cecum. The status post operation was good. The patient had lib breastfed. The patient was discharged in good condition with no fever or symptoms of infection. The listing indicated that one or more of the events were considered to be immediately life-threatening. ER visit was required. No further information is available. The original reporting source was not provided. VAERS ID # 375896. 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 for Biologics Evaluation and Research and was released.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Imaging procedure, Intestinal resection, Intussusception, Nausea, Vomiting
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 12 weeks old male with no medical history, no allergies reported and no preexisting illness was vaccinated with a dose of ROTATEQ (Lot # 664292/0433Y) by mouth on 27-OCT-2009. Concomitant vaccination given on the same day included DTAOIOVHIB (lot # C3482AA), IM and PREVNAR (lot # D90888), IM. A discharge summary was received on 05-JAN-2010 for date of service on 16-DEC-2009. The patient diagnosis was intussusception. On 16-DEC-2009, the patient presented with several days with nausea and vomiting. The patient was found with intussusception and was taken to the operation room. A radiography was performed which confirmed intussusception. The patient underwent resection of terminal ileum and cecum. The status post operation was good. The patient had lib breastfed. The patient was discharged in good condition with no fever or symptoms of infection. The listing indicated that one or more of the events were considered to be immediately life-threatening. ER visit was required. No further information is available. The original reporting source was not provided. VAERS ID # 375896. 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 for Biologics Evaluation and Research and was released.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU3
Symptoms: Blood human chorionic gonadotropin increased, Drug exposure during pregnancy, Haemorrhage, Intra-uterine death, Laboratory test
Clinical narrative: Initial report received on 25 February 2010 from the Centers for Disease Control (CDC), who had received the original report from a patient's mother-in-law, who is a Sanofi Pasteur employee. Follow-up information was received on 02 March 2010 from the facility where he vaccine was administered. A 32-year-old female patient had received a 0.5 mL intramuscular left deltoid injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP001AA, expiration date 09 March 2011) on 11 October 2009. The patient was approximately 1 month pregnant at the time. The patient subsequently received a 0.5 mL intramuscular right deltoid injection of FLUZONE (lot number UT3251AA, expiration date 30 June 2010) on 14 November 2009. The patient was approximately 2 months pregnant at that time. The date of the patient's last menstrual period was not reported. The patient's expected date of delivery was 12 June 2010. The patient had a doctor visit 33 days after receiving the FLUZONE, which was also 67 days after receiving the Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, and the fetal heart beat was not heard. A "D&E" (dilation and evacuation) was performed the following day for intrauterine fetal death (known as miscarriage). Medical and obstetrical history was not provided. The patient had not received any other vaccinations within 4 weeks prior to 11 October 2009. At the time of this report, the patient had recovered. Additional information has been requested. Follow-up information received on 16 April 2010 from an employee of the manufacturer who received the information from the patient. The patient had received FLUZONE vaccination the last 3 years (including the dose received on 14 November 2009) with no adverse events reported for the 2 prior FLUZONE vaccinations. The patient's obstetrical history includes 2 prior pregnancies that resulted in C-sections. She takes no concomitant medications, had no medical complications, and does not smoke. The date of the patient's last menstrual period was on 27 August 2009. Per the patient, she had no symptoms prior to the fetal death and all physical examinations up to that point were "great." An ultrasound in November 2009 showed the baby's heart pulsating and the baby was moving around. At 16 weeks gestation, no fetal heartbeat was noted by the OBGYN physician and the patient underwent a D&C. The patient was subsequently seen in the emergency room on 30 January 2010 for another D&C to remove more retained placental tissue. Follow-up care was required and the patient was seen by a specialist who performed another D&C for retained placental tissue not removed during prior D&C procedures. The patient had her last visit with her physician on 16 April 2010 and was recovered at that time. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU3
Symptoms: Thrombosis, Ultrasound scan, Uterine dilation and curettage
Clinical narrative: Initial report received on 25 February 2010 from the Centers for Disease Control (CDC), who had received the original report from a patient's mother-in-law, who is a Sanofi Pasteur employee. Follow-up information was received on 02 March 2010 from the facility where he vaccine was administered. A 32-year-old female patient had received a 0.5 mL intramuscular left deltoid injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP001AA, expiration date 09 March 2011) on 11 October 2009. The patient was approximately 1 month pregnant at the time. The patient subsequently received a 0.5 mL intramuscular right deltoid injection of FLUZONE (lot number UT3251AA, expiration date 30 June 2010) on 14 November 2009. The patient was approximately 2 months pregnant at that time. The date of the patient's last menstrual period was not reported. The patient's expected date of delivery was 12 June 2010. The patient had a doctor visit 33 days after receiving the FLUZONE, which was also 67 days after receiving the Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, and the fetal heart beat was not heard. A "D&E" (dilation and evacuation) was performed the following day for intrauterine fetal death (known as miscarriage). Medical and obstetrical history was not provided. The patient had not received any other vaccinations within 4 weeks prior to 11 October 2009. At the time of this report, the patient had recovered. Additional information has been requested. Follow-up information received on 16 April 2010 from an employee of the manufacturer who received the information from the patient. The patient had received FLUZONE vaccination the last 3 years (including the dose received on 14 November 2009) with no adverse events reported for the 2 prior FLUZONE vaccinations. The patient's obstetrical history includes 2 prior pregnancies that resulted in C-sections. She takes no concomitant medications, had no medical complications, and does not smoke. The date of the patient's last menstrual period was on 27 August 2009. Per the patient, she had no symptoms prior to the fetal death and all physical examinations up to that point were "great." An ultrasound in November 2009 showed the baby's heart pulsating and the baby was moving around. At 16 weeks gestation, no fetal heartbeat was noted by the OBGYN physician and the patient underwent a D&C. The patient was subsequently seen in the emergency room on 30 January 2010 for another D&C to remove more retained placental tissue. Follow-up care was required and the patient was seen by a specialist who performed another D&C for retained placental tissue not removed during prior D&C procedures. The patient had her last visit with her physician on 16 April 2010 and was recovered at that time. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU3
Symptoms: Drug exposure during pregnancy, Evacuation of retained products of conception, Intra-uterine death, No reaction on previous exposure to drug, Ultrasound scan abnormal
Clinical narrative: Initial report received on 25 February 2010 from the Centers for Disease Control (CDC), who had received the original report from a patient's mother-in-law, who is a Sanofi Pasteur employee. Follow-up information was received on 02 March 2010 from the facility where he vaccine was administered. A 32-year-old female patient had received a 0.5 mL intramuscular left deltoid injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP001AA, expiration date 09 March 2011) on 11 October 2009. The patient was approximately 1 month pregnant at the time. The patient subsequently received a 0.5 mL intramuscular right deltoid injection of FLUZONE (lot number UT3251AA, expiration date 30 June 2010) on 14 November 2009. The patient was approximately 2 months pregnant at that time. The date of the patient's last menstrual period was not reported. The patient's expected date of delivery was 12 June 2010. The patient had a doctor visit 33 days after receiving the FLUZONE, which was also 67 days after receiving the Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, and the fetal heart beat was not heard. A "D&E" (dilation and evacuation) was performed the following day for intrauterine fetal death (known as miscarriage). Medical and obstetrical history was not provided. The patient had not received any other vaccinations within 4 weeks prior to 11 October 2009. At the time of this report, the patient had recovered. Additional information has been requested. Follow-up information received on 16 April 2010 from an employee of the manufacturer who received the information from the patient. The patient had received FLUZONE vaccination the last 3 years (including the dose received on 14 November 2009) with no adverse events reported for the 2 prior FLUZONE vaccinations. The patient's obstetrical history includes 2 prior pregnancies that resulted in C-sections. She takes no concomitant medications, had no medical complications, and does not smoke. The date of the patient's last menstrual period was on 27 August 2009. Per the patient, she had no symptoms prior to the fetal death and all physical examinations up to that point were "great." An ultrasound in November 2009 showed the baby's heart pulsating and the baby was moving around. At 16 weeks gestation, no fetal heartbeat was noted by the OBGYN physician and the patient underwent a D&C. The patient was subsequently seen in the emergency room on 30 January 2010 for another D&C to remove more retained placental tissue. Follow-up care was required and the patient was seen by a specialist who performed another D&C for retained placental tissue not removed during prior D&C procedures. The patient had her last visit with her physician on 16 April 2010 and was recovered at that time. Documents held by sender: None.