chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Necrotising retinitis, Ocular discomfort, Pain, Pyrexia, Rash
Clinical narrative: Patient with a hx of rheumatoid arthritis who was on active immunosuppressive therapy (specifically, methotrexate, prednisone and Plaquenil) went to an area retail pharmacy and requested and received a varicella zoster vaccine. It was administered by a licensed pharmacist who was certified in vaccine administration. Two weeks later she developed a dermatomal rash low grade fever and mild pain and discomfort in the rash area. Two weeks after the rash onset she began experiencing some left ocular pain, discomfort, and headaches which went on for 2 days. She then developed abrupt onset of decreased vision in that left eye without any other clinical manifestations.  She was seen by her primary ophthalmologist, who made a primary evaluation with possible diagnosis of acute retinal necrosis. She was started on Valtrex 1g TID po on Monday 11/22 and stopped her immunosupression. She was referred to a retinal specialist who admitted her to Hospital. She was seen by Dr. who diagnosed her with acute retinal necrosis secondary to herpes zoster related to recent Zostavax vaccination. I, infectious disease pharmacist, participated in her care in dosing and monitoring of her IV antiviral medications and in reporting of adverse drug events at hospital.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella virus test positive, Visual acuity reduced
Clinical narrative: Patient with a hx of rheumatoid arthritis who was on active immunosuppressive therapy (specifically, methotrexate, prednisone and Plaquenil) went to an area retail pharmacy and requested and received a varicella zoster vaccine. It was administered by a licensed pharmacist who was certified in vaccine administration. Two weeks later she developed a dermatomal rash low grade fever and mild pain and discomfort in the rash area. Two weeks after the rash onset she began experiencing some left ocular pain, discomfort, and headaches which went on for 2 days. She then developed abrupt onset of decreased vision in that left eye without any other clinical manifestations.  She was seen by her primary ophthalmologist, who made a primary evaluation with possible diagnosis of acute retinal necrosis. She was started on Valtrex 1g TID po on Monday 11/22 and stopped her immunosupression. She was referred to a retinal specialist who admitted her to Hospital. She was seen by Dr. who diagnosed her with acute retinal necrosis secondary to herpes zoster related to recent Zostavax vaccination. I, infectious disease pharmacist, participated in her care in dosing and monitoring of her IV antiviral medications and in reporting of adverse drug events at hospital.
Age: 1.92
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site of immunization and beyond the next day after immunization given.  Pt treated with Augmentin.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site erythema
Clinical narrative: Began with noticable erythema surrounding injection site approximately 3x3.5cm, then began c/o some SOB. Escorted to adjacent ED where she received IV Benadryl, Solumedrol and Pepcid and provided with predisone prescription.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Contusion, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Bruising petechiae and ITP.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 4 inch raised hot red itchy area, north to south line on injection site. Injection was given in upper rear arm not in deltoid area, ie posterior upper arm. Treated with Gold Bond ointment not which relieved itching. Area still 4 inches long raised hard red & hot on 12/17/2012.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Blood test, Convulsion, Febrile convulsion
Clinical narrative: Seizure for about 5 minutes. Went to the hospital via ambulance and was diagnosed as a febrile seizure.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Acute coronary syndrome, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest discomfort, Chest pain
Clinical narrative: Patient developed chest pressure which prompted him to visit the ER. Patient was treated for Acute Coronary Syndrome. He was ultimately shown to have an elevation of Troponin I. Chest pain began about 15 minutes after Flumist vaccine.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Troponin I increased
Clinical narrative: Patient developed chest pressure which prompted him to visit the ER. Patient was treated for Acute Coronary Syndrome. He was ultimately shown to have an elevation of Troponin I. Chest pain began about 15 minutes after Flumist vaccine.
Age: 1.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Rash generalised, Varicella
Clinical narrative: Rash scattered all over patient, identified as chicken pox vesicles by MD.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Guillain-Barre syndrome, Malaise
Clinical narrative: WEAKNESS, MALAISE, FATIGUE- STARTED 12/5/2012. DX. GBS.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash morbilliform, Rhinorrhoea
Clinical narrative: High fever, measle like rash, runny nose, diarrhea.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Hyperacusis, Injection site haematoma, Injection site pain
Clinical narrative: Severe headache with nausea, vomiting, extreme light sensitivity and sound sensitivity. Severe bruising and pain at injection site. Aches, fatigue, malaise. All of the above are still present minus the headache, which eventually resolved.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Nausea, Pain, Photophobia, Vomiting
Clinical narrative: Severe headache with nausea, vomiting, extreme light sensitivity and sound sensitivity. Severe bruising and pain at injection site. Aches, fatigue, malaise. All of the above are still present minus the headache, which eventually resolved.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Erythema, Fall, Head injury, Heart rate increased
Clinical narrative: Child revieved Flumist vaccine, left clinic and played at recess.  Came back into school after recess and went to the bathroom.  When leaving the bathroom, the child became dizzy, pale, sweaty, and fell to the ground without losing consciousness.  When she fell, she hit her head leaving a red raised area.  School nurses measured her O2 sats and found them to be at 85% with an elevated heart rate.  The child was taken to the ER by her grandparents.  The treating physician told her grandparents that Flumist can occasionally cause a drop in B/P and that it was a "fluke" event.  No further treatment was ordered other than to follow-up with her regular physician.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Hyperhidrosis, Pallor, Swelling
Clinical narrative: Child revieved Flumist vaccine, left clinic and played at recess.  Came back into school after recess and went to the bathroom.  When leaving the bathroom, the child became dizzy, pale, sweaty, and fell to the ground without losing consciousness.  When she fell, she hit her head leaving a red raised area.  School nurses measured her O2 sats and found them to be at 85% with an elevated heart rate.  The child was taken to the ER by her grandparents.  The treating physician told her grandparents that Flumist can occasionally cause a drop in B/P and that it was a "fluke" event.  No further treatment was ordered other than to follow-up with her regular physician.
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Joint injury, Pain in extremity, Tenderness
Clinical narrative: DTaP immunization was administered in the left arm/deltoid region. Within several hours, as to be expected with DTaP, the left arm became sore and remained so over the Thanksgiving weekend (11/22-11/25). Pain did not gradually diminish as expected and arm remained too sore for patient to sleep on side, raise arm to wash hair in shower, or carry light laundry basket. Pain partially resolved overnight, but would then resume in morning with activity and become progressively worse during the day. Motrin 600-800 mg bid provided minimal relief of pain, which at its worst, pt rated 6/10. On 12/3, the patient called PCP's office and reported sx to RN. RN advised that since the patient had no fever, redness, swelling, or other signs of infection, to continue monitoring for another week and take motrin around the clock to reduce inflammation/pain. Pain and limited mobility persisted and on 12/10, the pt again contacted PCPs office and was seen that day. Patient is herself a healthcare provider, and reported to her PCP that she suspected she may have SIRVA. Pt presented Dr. with links to peer-reviewed articles on SIRVA, who confirmed that pt's sx and physical exam findings were suggestive of this condition. Dr. offered referral to orthopedics for eval for cortisone injection. Pt declined, asking to increase Motrin to 800mg tid, alternate heat/cold compresses, and rest for 2 more weeks. Dr. concurred with this plan and indicated that she would initiate internal processes to determine if the vaccine administrator had a pattern of inadvertant injections and/or needed re-education and training on proper technique.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Local reaction, Pain, Skin warm
Clinical narrative: Localized Reaction lasting longer than 48 hours.  Red, hot, painful, hard.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash vesicular
Clinical narrative: Started with itching on the right side of his back that broke out into a shingles like rash and spread to his chest. Was seen by his dermatologist, who confirmed shingles and was given anti vral medication and was improved within 2 weeks.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture, Herpes zoster, Rash vesicular
Clinical narrative: Broke out with a shingles like rash on chin. Saw dermatologist who cultured the area and placed her on anti-viral medication.
Age: 55.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: Patient reports having loss of appetite, diarrhea, headache, achiness, tiredness.
Age: 60.0
Sex: F
Vaccine: DTAP
Symptoms: Adverse drug reaction, Hypoaesthesia, Movement disorder, Nerve injury
Clinical narrative: Numbness, inability to move left arm, hand and fingers.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt seen in EC with complaints of redness, swelling, hot to touch, and soreness at injection site.  Pt assessed and discharged with Benadryl 25 mg and prednisone dose pack.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Erythema, Fatigue, Hyperhidrosis, Oedema peripheral
Clinical narrative: PATIENT REPORTED THAT HE WAS VERY FATIGUED THE DAY AFTER THE INJECTION ACCOMPONIED WITH CHILLS, SWEATS, AND LYING IN THE BED.  STATES THAT HIS ARM WAS VERY TENDER TO TOUCH, ITCHING, EDEMA, AND REDNESS.  PATIENT WAS IN CLINIC MONDAY 17 DEC 2012 AND ARM REDNESS MEASURED 7 INCHES X 4.5 INCHES IN REDNESS AND WARM TO THE TOUCH.  DENIES ANY PAIN AT PRESENT BUT STILL REPORTS ITCHING.  DENIES ANY SOB OR SWELLING OF THE TONGUE AND THROAT.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Skin warm, Tenderness
Clinical narrative: PATIENT REPORTED THAT HE WAS VERY FATIGUED THE DAY AFTER THE INJECTION ACCOMPONIED WITH CHILLS, SWEATS, AND LYING IN THE BED.  STATES THAT HIS ARM WAS VERY TENDER TO TOUCH, ITCHING, EDEMA, AND REDNESS.  PATIENT WAS IN CLINIC MONDAY 17 DEC 2012 AND ARM REDNESS MEASURED 7 INCHES X 4.5 INCHES IN REDNESS AND WARM TO THE TOUCH.  DENIES ANY PAIN AT PRESENT BUT STILL REPORTS ITCHING.  DENIES ANY SOB OR SWELLING OF THE TONGUE AND THROAT.
Age: 60.0
Sex: M
Vaccine: MEA
Symptoms: Blister, Burning sensation, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash on anterior trunk, arms, and neck. The rash is characterized by burning, itchiness, redness and swelling (small bumps/blistery).
Age: 60.0
Sex: M
Vaccine: MEA
Symptoms: Swelling
Clinical narrative: Rash on anterior trunk, arms, and neck. The rash is characterized by burning, itchiness, redness and swelling (small bumps/blistery).
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain and swelling gradually increasing at site of injection.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pneumovax 23 vaccine administered 12/13/12 subcutaneously left upper arm using B-D needle 26G 5/8" length.  Received call ~ 9:30am next morning (12/14/12) from patient reporting redness, swelling and pain in left upper arm.  Instructed to come in right away - seen in office ~ 11AM -  Left upper arm noted with swelling from site of injection down to just above elbow - redness and painful to patient.  Treated Benadryl 25mg, 1 capsule orally 2-3 times per day and Prednisone 20mg, 1 tablet with food or milk, orally, once a day for 3 days - also to keep arm elevated and return to office next day for further assessment.   Patient returned to office 12/15/2012 and arm noted to be less swollen, less red and "pain is gone.   Plan is for patient to return to office 12/18/12 to see Primary Provider.  Spoke with patient on phone 12/17/12 and she remarked there is "no pain" "redness and swelling are much reduced"  -  patient will return 12/18/12 as planned for further assessment.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Erythema multiforme, Full blood count, Metabolic function test, Oedema, Polymerase chain reaction
Clinical narrative: Patient with urticaria multiforme & severe edema. Was hospitalized locally & transferred to another hospital. Rash appeared 12-13-12. Also had RSV, fever, (+) PCR. Tx with AMOXIL same day.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Urticaria
Clinical narrative: Patient with urticaria multiforme & severe edema. Was hospitalized locally & transferred to another hospital. Rash appeared 12-13-12. Also had RSV, fever, (+) PCR. Tx with AMOXIL same day.
Age: 0.12
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Feeding disorder of infancy or early childhood, Resuscitation, Unresponsive to stimuli
Clinical narrative: 12/16/12 baby fed less well. 12/17/12 found unresponsive. Did not respond to resuscitation efforts.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Vomiting
Clinical narrative: Pt denies s.o.b. or swelling - he did vomit, does not believe it is related, vomiting after rash seen.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Influenza like illness, Malaise, Migraine, Muscle atrophy
Clinical narrative: Flu like symptoms, muscle aches, malaise, numbness/tingling in hands and feet and mirgaines. Went to PCP, the did a CT scan. DR said they saw some degeneration in her neck which could cause the mirgraines. RX for prednisone and Medrol. PT is still having weakness in her left foot and numbness/tingling in her hands.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia, Paraesthesia
Clinical narrative: Flu like symptoms, muscle aches, malaise, numbness/tingling in hands and feet and mirgaines. Went to PCP, the did a CT scan. DR said they saw some degeneration in her neck which could cause the mirgraines. RX for prednisone and Medrol. PT is still having weakness in her left foot and numbness/tingling in her hands.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Patient with injection site reaction, left arm, treated with ibuprofen and Benadryl, discharged with Norco and to ice area.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Bone densitometry, Bone scan normal, Full blood count, Hypoaesthesia
Clinical narrative: Pain started in left shoulder, right shoulder. Could not lift arms. All the way to the wrist could not turn wrist anyway to open door. No strength in muscles. Pain down throughout my lower body. Woke the next day right hand and three fingers numb, stiff and painful.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Movement disorder, Musculoskeletal pain, Musculoskeletal stiffness, Nerve conduction studies
Clinical narrative: Pain started in left shoulder, right shoulder. Could not lift arms. All the way to the wrist could not turn wrist anyway to open door. No strength in muscles. Pain down throughout my lower body. Woke the next day right hand and three fingers numb, stiff and painful.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: Pain started in left shoulder, right shoulder. Could not lift arms. All the way to the wrist could not turn wrist anyway to open door. No strength in muscles. Pain down throughout my lower body. Woke the next day right hand and three fingers numb, stiff and painful.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Arthritis, Bone scan abnormal, Injection site pain, Muscular weakness
Clinical narrative: Pain started in left shoulder, right shoulder. Could not lift arms. All the way to the wrist could not turn wrist anyway to open door. No strength in muscles. Pain down throughout my lower body. Woke the next day right hand and three fingers numb, stiff and painful.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Rheumatoid factor positive, X-ray limb abnormal
Clinical narrative: Pain started in left shoulder, right shoulder. Could not lift arms. All the way to the wrist could not turn wrist anyway to open door. No strength in muscles. Pain down throughout my lower body. Woke the next day right hand and three fingers numb, stiff and painful.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Asthenia, Back pain, Mobility decreased, Pain in extremity
Clinical narrative: Having trouble getting up and down, pain in back and calves, shaky and weak.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Having trouble getting up and down, pain in back and calves, shaky and weak.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: Flu like symptoms: headache, joint pain, elevated body temp, chills, sore throat, swollen axillary and cervical lymph nodes, gum ball sized swelling under site of injection, severe fatigue, body aches.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site swelling, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: Flu like symptoms: headache, joint pain, elevated body temp, chills, sore throat, swollen axillary and cervical lymph nodes, gum ball sized swelling under site of injection, severe fatigue, body aches.
Age: 1.26
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Irritability, Vaccination site rash
Clinical narrative: Redness and rash around vaccine site. Very irritable X 24 hours.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pt. c/o increased pain, redness, swelling, warm to touch (L) arm after PNEUMOVAX given.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Arm swelled up (Left arm) red rash appeared, center of shot area got hard, and it itched real bad. Had shot on Nov. 30 and still have small area of red. Was told to use cold compresses and BENADRYL cream.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hot flush, Injected limb mobility decreased, Muscular weakness, Musculoskeletal pain, Pyrexia
Clinical narrative: Severe pain in shoulder and arm weakness and limited use of shoulder and arm that has lasted +2 months. (Hot flushes/fever experienced)
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound scan
Clinical narrative: Severe pain in shoulder and arm weakness and limited use of shoulder and arm that has lasted +2 months. (Hot flushes/fever experienced)
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pain, Pruritus, Skin warm
Clinical narrative: 3 PM day of vaccination - arm hot, red, swelling, itching. Overnight - pain in swollen area. Weekend - swelling moving from injection site down arm to elbow. Circumference of arm increased x 2. Next 4 days - swelling, redness, reached left wrist - visit to Dr. Occasional antihistamine tablet.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: 3 PM day of vaccination - arm hot, red, swelling, itching. Overnight - pain in swollen area. Weekend - swelling moving from injection site down arm to elbow. Circumference of arm increased x 2. Next 4 days - swelling, redness, reached left wrist - visit to Dr. Occasional antihistamine tablet.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, tender square-shaped site around injection site, about 2 inches in width. Warm to the touch. Came on about 20 hours after injection occurred. Pt called 10 am on 12/8 received shot on 12/7/12 advised pt to go to urgent care.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Induration, Nodule, Pruritus, Swelling
Clinical narrative: 11/7/12 Pharmacist admin. Started itching 3 hrs got worse, left arm had a hand size red patch, swollen, hard knot underneath site - saw MD 11/12 "almost anaphylactic shock" prednisone #20 SIG 4 qd x5d.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site induration, Injection site swelling
Clinical narrative: Lots of swelling/bruising/hardening at injection site. Started to improve 11/20/12.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Swelling, warmth to touch, redness, and development of hardened, raised circle developed ~ 24 hours post administration. Treated with ice and 1dose ibuprofen 400mg. In 7 days after, swelling and other symptoms have slowly gone away.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: RN reported 18 year-old student got severe abdominal cramps after 1st dose of VIVOTIF oral typhoid vaccine. Patient took 2nd dose, Dec. 10, 2012, cramps ongoing.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Swelling face
Clinical narrative: Arm swelled and reddened; face swelling.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: CSF lymphocyte count increased, CSF polymorphonuclear cell count increased, CSF white blood cell count increased, Headache, Hypoaesthesia
Clinical narrative: 8/26/12 -> Severe headache. 8/28/12 -> Bladder retention, weakness/numbness/tingling in legs (ascending). Admitted to hosp 8/29 -> 9/7/12. Tentative dx transverse myelitis. Readmitted 9/26 -> 10/1/12 with relapse. New MRI suggestive of transverse myelitis C3-C4.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Maternal exposure during pregnancy, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: 8/26/12 -> Severe headache. 8/28/12 -> Bladder retention, weakness/numbness/tingling in legs (ascending). Admitted to hosp 8/29 -> 9/7/12. Tentative dx transverse myelitis. Readmitted 9/26 -> 10/1/12 with relapse. New MRI suggestive of transverse myelitis C3-C4.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging spinal cord normal, Paraesthesia, Urinary retention
Clinical narrative: 8/26/12 -> Severe headache. 8/28/12 -> Bladder retention, weakness/numbness/tingling in legs (ascending). Admitted to hosp 8/29 -> 9/7/12. Tentative dx transverse myelitis. Readmitted 9/26 -> 10/1/12 with relapse. New MRI suggestive of transverse myelitis C3-C4.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: VIIth nerve paralysis
Clinical narrative: Facial palsy started afternoon of 12/14, pt went to ER-not sure of Tx there, received Rx's for prednisone and VALTREX to treat Bell's palsy.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Swelling
Clinical narrative: Pt started experiencing redness & swelling Friday morning after vaccination on Thursday. By Monday morning approx 2 cm diameter red area around injection site still exists. Patient says area is painful and itches.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Reports shoulder, arm, hand and wrist pain.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Pt. broke out in rash around face/head area within 10 min of administration. Notified MD, gave 2.5 mL po BENADRYL as ordered & monitored pt for 15-20 min after administration of BENADRYL.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: Pt. had a nosebleed after receiving a FLUMIST. Nosebleed lasted about 4-5 min per pt. mom.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling and itching at injection site. Pt visited "walk-in" clinic on 12/16/2012. Physician suggested she take oral diphenhydramine. Pt released. Told to come back if did not get better.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness unilateral
Clinical narrative: Patient has experienced hearing loss to the right ear.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Vaccination complication
Clinical narrative: Pt developed 5 satellite from smallpox vaccine.
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Muscle spasms
Clinical narrative: Leg cramps after 1st dose.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to several unspecified patients of unknown age. The patients may have been vaccinated with GARDASIL (date, route and lot number unknown) that were improperly stored. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. No treatment information was reported. Same reporter link for case 1212USA005070 RECOMBIVAX HB and case 1212USA005071 (VAQTA). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. It was reported that on an unknown date, an unspecified number of patients might have been vaccinated with a dose of GARDASIL (lot number, expiry date, dose, route unspecified) which was exposed to 1 degree Celsius for up to 14 hours (reported as 1 degree Celsius for up to 14 hours was a supported excursion for GARDASIL. No concomitant medications were reported. No adverse event was reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 years old female patient. The patient was vaccinated with a dose of VARIVAX (Merck) (lot number, dose, route and site not reported) "on an unspecified date within the last year" approximately in 2012. No other co-suspects were reported. No concomitant medications were reported. Subsequently the patient was diagnosed with a case of shingles on an unspecified date. No treatment information was reported. The outcome of shingles was unknown. The patient had sought unspecified medical attention. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain, Sleep disorder
Clinical narrative: This spontaneous report was received from a 73 year old male consumer (who is also the patient) refers to himself. The patient was a recovering alcoholic. The patient's medical history included open heart surgery and 4 back operations. Current conditions included shingles. The patient had no drug reactions or allergies. On an unknown date in October 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date and route not reported). Concomitant medications included LUNESTA, SOLARCAINE and chlorothiazide. On an unknown date in October 2012, the patient experienced increased pain. The patient was given ZOSTAVAX by his physician to treat an existing case of shingles in which he had symptoms of pain. After receiving ZOSTAVAX, the patient described the pain which he was experiencing increased to such a degree that he could no longer sleep. The patient also stated that he was not able to use the arm in which the injection was given due to the intense pain. The physician prescribed the patient several painkillers to treat the pain but the patient would not take them as he was a recovering alcoholic. The patient 2 CAT scans done and the results were unknown. The treatment rendered for the event was OXYCONTIN, hydrocodone, gabapentin but the patient would not take them as he was a recovering alcoholic. At the time of this report the patient was not recovered from the events. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Approximately on 09-DEC-2012 reported as about 2 days ago the patient was vaccinated with a dose of ZOSTAVAX (lot number, route and dose were not reported). After vaccinationapproximately on 09-DEC-2012 the patient developed shingles like rash. The patient sought medical attention, the patient saw the physician). No treatment information was reported. The outcome of shingles like rash is not recovered/resolved. The relatedness for shingles like rash is unknown for ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Bronchitis, Pneumonia
Clinical narrative: This spontaneous report as received from nurse refers to currently 75 year old male patient with a concurrent history of cigarette smoking. Approximately in 2005 (when he was 68) the patient was vaccinated with PNEUMOVAX23 (lot number, route and dose not provided). No other co-suspects were reported. No concomitant medications were reported. Since that dose of PNEUMOVAX23 the patient experienced multiple bouts of pneumonia and severe bronchitis. He was treated with antibiotics. On an unknown date the patient recovered. The patient had been seen in the office. The relatedness for multiple bouts of pneumonia and severe bronchitis was not provided for PNEUMOVAX23. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Computerised tomogram, Erythema, Mass, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a 60 year old female patient regarding herself. The patient has auto immune problem, mixed connective tissue disease and is allergic to sulfate. On 01-DEC-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route not reported). Concomitant medications included morphine, SOMA, lisinopril, PRILOSEC and BENTYL. On 01-DEC-2012, the patient stated that 3 or 4 hours after administration of ZOSTAVAX, that she felt a warm feeling on her arm. The redness, itching and burning on her arm was getting more intense. On 02-DEC-2012 (reported as next day), the lump had gotten larger. The patient had MRI (magnetic resonance imaging)and CAT(computed axial tomography) scan done and the results were unknown. The outcome of the reported events were unknown. Treatment rendered for the event was BENADRYL. The patient did not seek medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: This spontaneous report was received from a 60 year old female patient regarding herself. The patient has auto immune problem, mixed connective tissue disease and is allergic to sulfate. On 01-DEC-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route not reported). Concomitant medications included morphine, SOMA, lisinopril, PRILOSEC and BENTYL. On 01-DEC-2012, the patient stated that 3 or 4 hours after administration of ZOSTAVAX, that she felt a warm feeling on her arm. The redness, itching and burning on her arm was getting more intense. On 02-DEC-2012 (reported as next day), the lump had gotten larger. The patient had MRI (magnetic resonance imaging)and CAT(computed axial tomography) scan done and the results were unknown. The outcome of the reported events were unknown. Treatment rendered for the event was BENADRYL. The patient did not seek medical attention. Additional information has been requested.
Age: 2.3
Sex: U
Vaccine: HIBV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 28 month old patient. The patient was vaccinated with expired haemophilus b conjugate vaccine LIQUID PEDVAXHIB (lot number reported as 0235z, expire date 11-SEP-2012) on 12-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 years old patient. The patient was vaccinated with  (Merck) PROQUAD (lot number not provided) on 30-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Blood count, C-reactive protein, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX23 (Lot # not reported) on 06-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The physician's assistant reported that on 08-DEC-2012, the patient had injection site reaction consisting of redness, tender, warmth and indurations form shoulder down to the wrist. The patient was treated with INVANZ IV. The patient was evaluated at the urgent care clinic "over the weekend". A complete blood county, C-reactive protein and sedimentation rate test were performed (results not provided). The outcome of injection site reaction, from shoulder down to the wrist, warmth, tender and redness was unknown. The relatedness for injection site reaction, indurations from shoulder down to the wrist, tender and redness was unknown for PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site warmth, Red blood cell sedimentation rate
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX23 (Lot # not reported) on 06-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The physician's assistant reported that on 08-DEC-2012, the patient had injection site reaction consisting of redness, tender, warmth and indurations form shoulder down to the wrist. The patient was treated with INVANZ IV. The patient was evaluated at the urgent care clinic "over the weekend". A complete blood county, C-reactive protein and sedimentation rate test were performed (results not provided). The outcome of injection site reaction, from shoulder down to the wrist, warmth, tender and redness was unknown. The relatedness for injection site reaction, indurations from shoulder down to the wrist, tender and redness was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a physician concerning a presently 7 months old patient of unknown gender. On an unknown date in 2012, the patient was vaccinated with an expired dose of ROTATEQ, Oral (lot number, expiry date, dose, route unspecified). It was reported that ROTATEQ, Oral was a month and a half past the expiration date when administered. No concomitant medications were reported. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Blood immunoglobulin G decreased, Varicella virus test negative, Viral titre
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 20 years old female patient with penicillin allergy and exposed to kids with chicken pox growing up. The patient was vaccinated with the first and second dose of VARIVAX (merck) (lot# unspecified) 0.5ml subcutaneously in January 2011 and March 2011. No other co-suspects were reported. No concomitant medications were reported. On 03-DEC-2012 the patient tested "negative to varicella titer at an IBGG titer of 83.4". No treatment information was reported. The outcome of the event was unknown. The patient called physician's office once she received her results. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients patient of unknown age and gender. The health care worker reported that VARIVAX (merck) vials were exposed to temperature as high as 24. 1F from 20-MAY-2012 to 13-AUG-2012. During this times, only 3 days had recorded temperature of below of 5 F and rest of days were above 5 F and it was determined that VARIVAX (merck) were not stable from the original call she made. Specific number of patients involved were unspecified. No adverse effects reported. No concomitant medications were reported. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Dehydration, Infantile spitting up, Intussusception, Surgery, Ultrasound abdomen abnormal
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 "0.3 year" old male patient with previous vaccine illness of intussusception to ROTATEQ (lot # 0923AA) and without medical history and illness at time of vaccine treated orally with the second dose of ROTATEQ on 19-DEC-2012, second suspect vaccine treated orally with the second dose of ROTATEQ on 19-DEC-2012, second suspect vaccine included second dose of PENTACEL (IM into the left leg, Lot # C4077AA) and second dose of PREVNAR 13 (IM into the left leg, lot # 917735). No concomitant medications were reported. On 09-FEB-2012, the patient began spitting up a lot. On 21-FEB-2012 the patient presented to office with increased vomiting and signs of dehydration. The patient was sent to Hospital and diagnosed with Intussusception. Sonogram of abdomen showed positive for intussusception. Surgical intervention incurred. The listing indicated that one or more of the events was hospitalization and life threatening. No further information is available. The original reporting source was not provided. The VAERS ID # is 458351-1(S).
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: 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 "0.3 year" old male patient with previous vaccine illness of intussusception to ROTATEQ (lot # 0923AA) and without medical history and illness at time of vaccine treated orally with the second dose of ROTATEQ on 19-DEC-2012, second suspect vaccine treated orally with the second dose of ROTATEQ on 19-DEC-2012, second suspect vaccine included second dose of PENTACEL (IM into the left leg, Lot # C4077AA) and second dose of PREVNAR 13 (IM into the left leg, lot # 917735). No concomitant medications were reported. On 09-FEB-2012, the patient began spitting up a lot. On 21-FEB-2012 the patient presented to office with increased vomiting and signs of dehydration. The patient was sent to Hospital and diagnosed with Intussusception. Sonogram of abdomen showed positive for intussusception. Surgical intervention incurred. The listing indicated that one or more of the events was hospitalization and life threatening. No further information is available. The original reporting source was not provided. The VAERS ID # is 458351-1(S).
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Vaccine positive rechallenge, 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 "0.3 year" old male patient with previous vaccine illness of intussusception to ROTATEQ (lot # 0923AA) and without medical history and illness at time of vaccine treated orally with the second dose of ROTATEQ on 19-DEC-2012, second suspect vaccine treated orally with the second dose of ROTATEQ on 19-DEC-2012, second suspect vaccine included second dose of PENTACEL (IM into the left leg, Lot # C4077AA) and second dose of PREVNAR 13 (IM into the left leg, lot # 917735). No concomitant medications were reported. On 09-FEB-2012, the patient began spitting up a lot. On 21-FEB-2012 the patient presented to office with increased vomiting and signs of dehydration. The patient was sent to Hospital and diagnosed with Intussusception. Sonogram of abdomen showed positive for intussusception. Surgical intervention incurred. The listing indicated that one or more of the events was hospitalization and life threatening. No further information is available. The original reporting source was not provided. The VAERS ID # is 458351-1(S).
Age: 60.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Constant pain (L) shoulder area. Flu shot given (L) shoulder area. Severe pain w/ shoulder movement.
Age: 60.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Constant pain (L) shoulder area. Flu shot given (L) shoulder area. Severe pain w/ shoulder movement.
Age: 50.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Breast swelling, Breast tenderness, Chills, Musculoskeletal chest pain, Pyrexia
Clinical narrative: 36 hrs after immunization, awoke with shaking chills & fever of 101.4. Had fever x 2 days. Also developed left breast swelling - remained x one week. Injection site was left upper arm - no abnormalities at injection site.
Age: 50.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Breast swelling, Chills, Pyrexia, Tremor
Clinical narrative: 36 hrs after immunization, awoke with shaking chills & fever of 101.4. Had fever x 2 days. Also developed left breast swelling - remained x one week. Injection site was left upper arm - no abnormalities at injection site.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Bronchospasm, Dyspnoea, Hyporesponsive to stimuli, Hypotonia, Pallor
Clinical narrative: Pale, less responsive, limp, "couldn't breathe", goose bumps, no hives, no angioedema on exam, slightly pale, air not moving. Epinephrine & O2 Bronchospasm & fever.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Piloerection, Pyrexia
Clinical narrative: Pale, less responsive, limp, "couldn't breathe", goose bumps, no hives, no angioedema on exam, slightly pale, air not moving. Epinephrine & O2 Bronchospasm & fever.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Vomiting
Clinical narrative: Within 1 hr child had headache. Child took pediacare ibuprofen took nap 3hrs. Child ate dinner around 5pm. 8pm child vomited. 9:45PM child vomited again.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Injection site pain, Malaise, Pain in extremity
Clinical narrative: Sore arm, fever, cough, congestion, chills, malaise. Lasting one month. Arm still sore at injection site on 12/17/2012.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Sore arm, fever, cough, congestion, chills, malaise. Lasting one month. Arm still sore at injection site on 12/17/2012.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Hypertensive crisis, Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 years old male immunocompromised patient with hypertension, diabetes, allergic to glipizide. The patient's medical history included kidney and pancreas transplant in 2003. The patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported) on 29-NOV-2012. No other co-suspects were reported. Concomitant medications included tacrolimus, CELLCEPT, amlodipine, omeprazole, fenofibrate, metoprolol, trazodone, pravastatin and KLONOPIN. On an unknown date in 2012 the patient developed a fever, nausea, vomiting and was confused. The patient was also experiencing a severe hypertensive crisis. The patient was hospitalized for medical attention. Treatment and intervention included injectable blood pressure medications, antibiotics, promethazine, IV immunosuppressive drugs. The patient was not recovered at the time of report. The adverse events were considered as medically significant, disability and life threatening by the reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a female patient of unknown age. On 30-NOV-2011 the patient was vaccinated with dose 2, 0.5 milliliter (ml) GARDASIL (lot #, expiration date not reported) intramuscularly (IM). No other co-suspects were reported. No concomitant medications were reported. The patient was in office on 11-DEC-2012 to receive her dose 3, 0.5 ml GARDASIL (lot # and expiration date not reported) IM. No adverse effects reported. Additional information is not expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date and route not reported) in the arm. Other suspect therapies included Influenza Virus Vaccine (manufacturer unknown) (lot #, expiration date and route not reported) in the same arm. No concomitant medications were reported. After this, on an unknown date the patient experienced cellulitis on the arm where the injections were given. The outcome of the event was unknown. It was unspecified whether lab studies were performed. The patient sought medical attention by calling the pharmacy. It was unspecified whether treatment was given for the patient. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Heart rate decreased, Hyperhidrosis, Hypotension, Syncope
Clinical narrative: Patient, fainted, flushed paramedics came low blood pressure pulse, sweating gave water revived.