chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Spreading redness beyond the injection site that is raised, hard to touch, and warm to touch, along with red streaks going out from area of redness.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: Shortness of breath, swelling of throat.
Age: 30.0
Sex: F
Vaccine: HEPA, PPV, TDAP, HEPA, PPV, TDAP
Symptoms: Headache, Injection site erythema, Pain, Pyrexia
Clinical narrative: Fever 100.6, pain, redness at injection site starting on 8/22.  She developed body aches and headache.  Patient has been using ibuprofen.
Age: 30.0
Sex: F
Vaccine: HEPA, PPV, TDAP, HEPA, PPV, TDAP
Symptoms: Erythema, Headache, Pain in extremity
Clinical narrative: Fever 100.6, pain, redness at injection site starting on 8/22.  She developed body aches and headache.  Patient has been using ibuprofen.
Age: 30.0
Sex: F
Vaccine: HEPA, PPV, TDAP, HEPA, PPV, TDAP
Symptoms: Headache, Injection site erythema, Pain, Pyrexia
Clinical narrative: Sore left arm, redness, severe headache.  Pt received an injection of Morphine 5mg IM, Phenergan 25 gm IM.
Age: 30.0
Sex: F
Vaccine: HEPA, PPV, TDAP, HEPA, PPV, TDAP
Symptoms: Erythema, Headache, Pain in extremity
Clinical narrative: Sore left arm, redness, severe headache.  Pt received an injection of Morphine 5mg IM, Phenergan 25 gm IM.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Red, swollen, hot arm from shoulder to elbow.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Barium double contrast, Enema administration, Intussusception, Ultrasound scan, X-ray
Clinical narrative: Intussusception.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Numbness over my whole body.  I have CIDP which is the chronic version of Guillain Barre Syndrome.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Rash erythematous, Rash pruritic
Clinical narrative: Unexplained itchy red rash that started behind ears; has moved to chest and back. Denies shortness of breath, dyspnea, tongue or lip swelling. Took one night's worth of Benadryl without noticeable effects. Pt was advised to continue antihistamine of choice x 7 days along with Zantac 150 mg bid x 7 days, and cortisone cream per package instructions. Return for f/u 48-72 if symptoms worsen, or sooner.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Insomnia, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: On Friday 8-17-12 woke up stiff with joint pain in all joints, including neck and fingers.  Had sharp pains in joints with movement.  Joint pain continued for a week.  Had trouble sleeping due to pain and stiffness in joints.  Monday, 8-20-12 missed work due to joint pain.  Throat felt sore and swollen.  Neck was also painful, unable to turn head.  Unable to raise both arms above shoulder level.  Took ibuprofen for pain but reports it did not help.  Denies fever or other symptoms.  On 8-24-12 felt a little better but still not back to normal.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Neck pain, Oropharyngeal pain, Pain, Pharyngeal oedema
Clinical narrative: On Friday 8-17-12 woke up stiff with joint pain in all joints, including neck and fingers.  Had sharp pains in joints with movement.  Joint pain continued for a week.  Had trouble sleeping due to pain and stiffness in joints.  Monday, 8-20-12 missed work due to joint pain.  Throat felt sore and swollen.  Neck was also painful, unable to turn head.  Unable to raise both arms above shoulder level.  Took ibuprofen for pain but reports it did not help.  Denies fever or other symptoms.  On 8-24-12 felt a little better but still not back to normal.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Severe difficulty breathing.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Oedema peripheral, Pruritus
Clinical narrative: Red rash with swelling and itching at site of injection but also on inside of arm down to middle of forearm.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash with swelling and itching at site of injection but also on inside of arm down to middle of forearm.
Age: 1.63
Sex: F
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Crying, Eye irritation, Eyelid ptosis
Clinical narrative: Parents report her (L) eye is appearing "droopy" since this AM. She has been crying & rubbing that eye. They deny discharge, conjunctival redness, not facial asymmetry. On exam no conjunctival infection, tearing, discharge, or facial asymmetry. No treatment required. She received 2 doses of DTap yesterday.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pain, Pruritus, Pyrexia, Skin warm
Clinical narrative: Swelling, redness, warm to touch, itchy. Low grade fever on 1st day, slight pain.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Swelling
Clinical narrative: Swelling, redness, warm to touch, itchy. Low grade fever on 1st day, slight pain.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Pt states the evening of receiving the vaccine she had left arm swelling, area red and hot to touch, also states fever of 101.0.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: PT STARTING DEVELOPING A BRUISE ABOUT 3 DAYS AFTER SHOT GIVEN, BRUISE HAS NOT GONE AWAY YET 8-24-12 3:12PM.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site haematoma, Injection site swelling
Clinical narrative: Significant swelling L thigh to knee, mom said bruising around injection site. Treated at urgent care, dx with cellulitis, placed on antibiotic, MRSA guidelines for whole family. F/U with PCP on 8/23 improving, no leg swelling or bruising.
Age: 18.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Zostavax was given instead of 2nd Varicella injection.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blister, Erythema
Clinical narrative: REDDENED AREA SIZE OF TENNIS BALL BEGAN FIRST AND THEN A SINGLE BLISTER CENTER STARTED AND CONTINUES AT PRESENT.  NO COMFORT MEASURES.  MOTHER ADVISED COOL COMPRESS, IBUPROFEN PRN, MD VISIT IF INCREASE IN REDNESS OR SWELLING NOTED.
Age: 62.0
Sex: F
Vaccine: TTOX
Symptoms: Rash vesicular
Clinical narrative: Several spots on stomach, baring resemblance to chicken pox.  Saw Dr. who confirmed chicken pox/ Shingles type spots.  He prescribed Valacyclovir which I filled immediately and took first pill at 4:00 pm on 08/24/2012.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Eye swelling, Hypersensitivity, Urticaria
Clinical narrative: Woke up the following day after vaccine administration with sx, unsure of exact time of onset. Initially had eye swelling and progressed to hives. However continues to have 3 days of intermittent hives with no known exposure.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Arthrogram, Crying, Injection site pain, Injection site reaction, Joint injection
Clinical narrative: She states that the shot did not hurt at the time, and was just mildly tender the next day.  However, since that time she noticed a gradual worsening of a sharp pain deep in her left arm at the injection site. Per pt, she had decreased ROM, and had a very sharp pain with certain movements.  After the pain occurred, it took a while for it to settle back down. She states that, with certain movements, it is actually was so painful it brought tears to her eyes.  The area was not red, swollen, or warm.  Pt immediately cried out in pain when RN pressed on the exact area in which she got the flu shot.  Since pt initially reported this on 11/17/11, she has been diagnosed with impingement syndrome of the left shoulder, adhesive capsulitis of the left shoulder, and neuropathic pain at the injection site.  She has had 2 cortisone injections into the joint, and referrals to orthopedic specialists.  Treated with gabapentin for neuropathic pain.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Lacrimation increased, Neuralgia, Nuclear magnetic resonance imaging, Pain
Clinical narrative: She states that the shot did not hurt at the time, and was just mildly tender the next day.  However, since that time she noticed a gradual worsening of a sharp pain deep in her left arm at the injection site. Per pt, she had decreased ROM, and had a very sharp pain with certain movements.  After the pain occurred, it took a while for it to settle back down. She states that, with certain movements, it is actually was so painful it brought tears to her eyes.  The area was not red, swollen, or warm.  Pt immediately cried out in pain when RN pressed on the exact area in which she got the flu shot.  Since pt initially reported this on 11/17/11, she has been diagnosed with impingement syndrome of the left shoulder, adhesive capsulitis of the left shoulder, and neuropathic pain at the injection site.  She has had 2 cortisone injections into the joint, and referrals to orthopedic specialists.  Treated with gabapentin for neuropathic pain.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis, Rotator cuff syndrome, X-ray limb
Clinical narrative: She states that the shot did not hurt at the time, and was just mildly tender the next day.  However, since that time she noticed a gradual worsening of a sharp pain deep in her left arm at the injection site. Per pt, she had decreased ROM, and had a very sharp pain with certain movements.  After the pain occurred, it took a while for it to settle back down. She states that, with certain movements, it is actually was so painful it brought tears to her eyes.  The area was not red, swollen, or warm.  Pt immediately cried out in pain when RN pressed on the exact area in which she got the flu shot.  Since pt initially reported this on 11/17/11, she has been diagnosed with impingement syndrome of the left shoulder, adhesive capsulitis of the left shoulder, and neuropathic pain at the injection site.  She has had 2 cortisone injections into the joint, and referrals to orthopedic specialists.  Treated with gabapentin for neuropathic pain.
Age: 0.44
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Red hard lump injection site. One inch.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Redness, swelling, irritation at injection site. Worsened over 3 days. Used hydrocortisone to reduce swelling. Helped relieve symptoms but not fully subsided.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Headache, Local swelling, Mobility decreased, Pain
Clinical narrative: Large red patch (about 20 cm in length) with blanching erythema, not indurated, raised, swollen, warm, painful to touch, and decreased ability to move arm due to swelling and pain, starting 1 day after vaccination (8/22/12), and red patch still present but improving as of 3 days after vaccination (8/24/12). Fever, starting 1 day after vaccination (8/22/12) and resolving that day. Headache starting on day of vaccination (8/21/12) and present daily since then.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Pallor, Pyrexia, Skin warm
Clinical narrative: Large red patch (about 20 cm in length) with blanching erythema, not indurated, raised, swollen, warm, painful to touch, and decreased ability to move arm due to swelling and pain, starting 1 day after vaccination (8/22/12), and red patch still present but improving as of 3 days after vaccination (8/24/12). Fever, starting 1 day after vaccination (8/22/12) and resolving that day. Headache starting on day of vaccination (8/21/12) and present daily since then.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash erythematous, Rash pruritic, Rash pustular, Rash vesicular
Clinical narrative: Was told area where Shingles Vaccine was injected may itch/swell.  It did not at the time, but later the area of injection became a pinkish color, and has remained pinkish in color for over 5 weeks now.  No swelling &/or itching in that area.  However, 2 or 3 days after the injection, I did break out with about a half dozen or so, of what resembled Chicken Pox, on my neck & collar bone area.  They looked like pustules, were red, and had an intense itch.  The itching lasted for approx 3 to 4 weeks.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Body temperature increased, Cough, Headache, Nasal congestion
Clinical narrative: Severe headache, nasal congestion, temp 100 F., sore scratchy throat, sneezing, itchy, red eyes, coughing, nausea, unsteady balance.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Ocular hyperaemia, Oropharyngeal pain, Pruritus, Sneezing
Clinical narrative: Severe headache, nasal congestion, temp 100 F., sore scratchy throat, sneezing, itchy, red eyes, coughing, nausea, unsteady balance.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Severe headache, nasal congestion, temp 100 F., sore scratchy throat, sneezing, itchy, red eyes, coughing, nausea, unsteady balance.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, increased local temperature and marked erythema of site of injection on 8/15/12 - swelling and erythema worsened involving entire ant. surface of the (R) thigh - on 8/17/12 - when I examined child - erythema/swelling/local increased temperature - from medical to distal 1/3 ant. surface of the thigh.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 67 years old male patient with hyperlipidemia, polyps, gastrooesophageal reflux disease (GERD), hypertrophy and drug hypersensitivity to CELEBREX and VIAGRA. The patient's medical history included Guillain Barre Syndrome in 1977 after administration of an unspecified swine flu vaccine (manufacturer unknown) and the patient was hospitalized. The patient was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot # not reported). No other co-suspects were reported. Concomitant medications included pravastatin sodium and NEXIUM. It was reported that on an unknown date the patient may have developed Guillain Barre Syndrome after administration of PNEUMOVAX 23. The reporter stated that the patient was hospitalized at an unspecified hospital for an unspecified period. At the time of the report the patient was seeing an unspecified neurologist for the treatment of Guillain Barre Syndrome. No treatment information was reported. The outcome of may have developed Guillain Barre Syndrome was reported as not recovered. The relatedness for the reported event was not provided for PNEUMOVAX 23. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood test, Pyrexia, Rash generalised, Rash papular
Clinical narrative: Information has been received from a 55 years old female patient reporting on herself. There was no medical history or concurrent conditions. On 26-JUL-2012, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route and lot # were not provided). No other co-suspects were reported. No concomitant medications were reported. On 29-JUL-2012, three days later the patient's entire body was covered with raised, red and big bumps (medically significant). The patient also had low grade fever (medically significant) and she was sick to her stomach (medically significant). First, she went to a clinic, but the treatment they gave her did nothing to help, so they sent her to the ER (emergency room) on 02-AUG-2012 where she saw a physician in the ER. They gave her prednisone (manufacturer unknown), BENADRYL and a steroid shot. Blood work was performed (results were not provided). The patient's outcome was reported as recovered/resolved in August 2012. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Optic neuritis, Visual acuity reduced
Clinical narrative: This spontaneous report was received from a pharmacist refers to her 11 years old daughter. On an unknown date the patient was vaccinated intramuscularly with a first dose of GARDASIL, (dose and duration not reported). On an unknown date the patient experienced optic neuritis and she was hospitalized for one week. Patient received unspecified steroids for adverse event treatment. At the time of the report the patient's state was recovering. "Optic neuritis" was considered as significant disability due to reduced vision by reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Nausea, Paraesthesia, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a 71 years old female patient. On approximately 03-AUG-2012, the patient was vaccinated with ZOSTAVAX (lot#, dose and route were not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient called the pharmacy with adverse event on 15-AUG-2012. The patient complained of numbness and tingling feet to the knees on the right leg and the foot to the hip on the left leg. No outbreaks, no rash. The patient felt nausea, vomiting, two weeks post vaccination, approximately on 17-AUG-2012 and was hospitalized. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Dyskinesia, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 17 year old male who on 06-FEB-2012 was vaccinated with the first dose of GARDASIL (lot # 669796/0840AA). The patient did not receive any other vaccinations that day. The physician reported that approximately two minutes after vaccination with GARDASIL the patient experienced jerking movement with eyes closed for approximately 20 seconds. The patient was lying down at the time and opened his eyes after approximately 20 seconds. The patient was given fluids and observed for 20 minutes. The patient declined to go to the emergency room. The physician stated that the patient was recovered before he left the office on 06-FEB-2012. Follow-up information was received from a physician refers to a 17 years old male patient with no illness at the time of vaccination and no relevant adverse events following prior vaccination. The patient's medical history included previous vasovagal syncope. On 06-FEB-2012 at 09:30 AM, the patient was vaccinated with the first dose of GARDASIL, intramuscularly (IM.) (dose not reported). No other co-suspects were reported. No concomitant medications were reported. On 06-FEB-2012 at 09:30 AM, (also reported as "two minutes after receiving GARDASIL"), the patient started presenting jerking movement and loss of consciousness for few seconds (an approximately 20 seconds). No treatment information was reported. No diagnostics tests were performed. It was reported that on 06-FEB-2012, the patient recovered spontaneously. The relatedness for the patient's events was not reported for GARDASIL. Upon internal review, lost of consciousness was considered to be other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Attached is office visit note.
Age: 43.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Blister, Pruritus, Rash, Skin lesion
Clinical narrative: Rash developed 08/22/2012 - blistery lesions to (R) arm, trunk, face c/o itching no fever Hx of splenectomy 1986 Presented to clinic with symptoms on 08/24/2012.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Loss of consciousness, Somnolence, Staring, Tremor
Clinical narrative: Whole body shaking. Lasted about 5 min. Unable to wake patient during episode. Afterwards patient "out of it" staring into space for at least 10-15 min ambulance ride total duration about 45 min.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Erythema, Oedema peripheral
Clinical narrative: (L) arm swollen proximal 1/2 to mid humerus & pinkish-red, 33cm diameter below deltoid on (L) arm.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Patient called clinic at 11:30 AM and reported to nurse practitioner she was experiencing numbness on the left side of her face. NP advised patient to go to Emergency Department. Patient stated she has history of idiopathic anaphylaxis.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Morning after immunization, pt presented with very swollen, red, hot, full upper arm (L). She went to primary Dr, got Doxycycline 100, then that night, reaction spread. So went to ER and prescribed KEFLEX 500. Doing better.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Nausea, Rash, Vomiting
Clinical narrative: 08/22/12 - reported nausea/vomit/diarrhea and rash evening post vaccination, rash cleared up but returned 1-2 days later, continued to have N/V/D, c/o sore throat. Denial respiratory issue immediately following vaccination but use of inhaler for asthma times 1 during week. Encouraged patient to seek medical assessment with her doctor she verbalized that she would.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Swelling
Clinical narrative: 3 inch redness & swelling around the injection site with pain. Treatment --> ZYRTEC for swelling/itching.
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient presented in the office with her left arm pink, warm to the touch, and itchy. This reaction was at the injection site. Arm was also inflamed. Dr. believed this was an adverse drug reaction and instructed to observe for now.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: BOOSTRIX given on 8/20/12. Pt referred to pharmacy on 8/23/12 reporting itching & rashes on both arms, left chin & neck. Pt given Diphenhydramine 25 mg - 2 stat, 1-2 q 4-6 h prn.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Area around ZOSTAVAX injection site reddened and warm to touch. Tender/red area approximately 2 1/2 inches in diameter. Treated with cold compress & ibuprofen. Referred patient to PCP for evaluation.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: (L) arm injection site induration (5 cm) & warmth at day 4 post injection.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Fever, headache, stomach ache for almost 24 hrs redness/warmth/swelling at site. An 4 inch radius around.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Pyrexia
Clinical narrative: Fever, headache, stomach ache for almost 24 hrs redness/warmth/swelling at site. An 4 inch radius around.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Swelling, redness, rash (L) arm & shoulder; mild fever (antibiotics) PO BID x 10 days.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Tongue blistering
Clinical narrative: Patient has blister like rash on tongue and chest area. Rash develop on 8/22/12 at night after the vaccine. Rash on the chest has subsided but still see rash on tongue.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Some injection site redness.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Some injection site redness.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Loss of consciousness
Clinical narrative: Within 5 minutes of GARDASIL deltoid injection child had a brief loss of consciousness with body jerking < 1 min. Blood pressure was normal/ V.S. nl. She recovered completely. No postictal state.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: (L) deltoid area red, swollen, "> 1/2 dollar size". No fever, fatigue - able to attend school. No N/V/D. Headache on 8/21. Mom concerned of reddened area.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: On Wednesday 8/22/12, arm vaccine was administered in became very red, swollen, itchy, & hot to the touch. Patient visited MD and was prescribed antibiotic.
Age: 78.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: Large red area covering upper arm. Patient went to Dr's office and received prescription for KEFLEX 500mg #40 1 qid.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Scab, Varicella
Clinical narrative: Patient was vaccinated with VARIVAX on 6/27/12. He developed fever on 7/20/12 and a classic chickenpox rash - cluster of vesicles mid back which then transformed later to scabs - followed on 7/21/12.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 20 1/2 cm x 13 cm area of erythema (R) upper arm; entire (R) upper arm red, warm, & swollen.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Contraindication to vaccination
Clinical narrative: FLUMIST given within 1 week of having received MMR and Varicella vaccines. Patient was on aspirin therapy.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient received injections, getting ready to sit down and wait for pharmacy meds when pt collapsed (caught by grandmother). Per Mom pt "passed out". Code Blue called & med staff arrived immediately to evaluate pt & situation. Pt assessed & then assisted to room for further eval. Given H2O & crackers & found to be OK then sent home.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Arm really red, swollen went to Dr's office on Monday 8-6-12 got an Rx for antibiotic (sulfamethoxazole-TMP DS).
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site swelling, Nausea, Vision blurred
Clinical narrative: Mother called the day after the vaccine was given. She stated the site was enlarged & swollen. C/o dizziness, nausea & blurred vision. To come in to clinic or see pediatrician if symptoms worsen. Mom was advised to try cold compresses & ibuprofen. Taken to PMD. Treated with ibuprofen only.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash
Clinical narrative: Redness, rash beside the injection site.
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Cold sweat, Dizziness, Fatigue, Headache
Clinical narrative: 18 hrs after injection, headache, T 100.8, dizziness, fatigue, clammy sweats. No N & V.
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis
Clinical narrative: 18 hrs after injection, headache, T 100.8, dizziness, fatigue, clammy sweats. No N & V.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Erythema and swelling of (L) deltoid on morning 8/20/12 says erythema/swelling started within hours of inj. worse on Tues/Wed with pruritus but better now.
Age: 0.05
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: RECOMBIVAX 5mcg administered IM on 7/29/12 then again on 8/15/12.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: The evening after receiving the vaccination, mom noticed a baseball sized red area in right deltoid that was warm to touch and firm. No complaints of pain or itching at site. Patient had a fever of 100.2 that evening and given Ibuprofen. Treatment is to use ice and BENADRYL, watch for signs and symptoms of infection.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Urticaria
Clinical narrative: Pt. was given PNEUMOVAX on 8/22/12. Pt. discovered hives on 8/23/12 and has pain in left upper arm. Pt. was given Prednisone taper, advised to continue Naprosyn and ice as needed.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Hot flush, Injection site pain, Nausea
Clinical narrative: Patient received Tdap on 8/14/12 and did not recall it when asked on 8/16/12. She received two Tdap doses within two days. She reported the following: mild soreness at injection site, mild nausea, "hot flashes; she reports all resolved as of 8/21/12.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of unspecified patients who on unknown dates might have received improperly stored dose of and COMVAX (dose, route and lot # not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Excoriation, Rash, Rash generalised, Rash maculo-papular, Rash vesicular
Clinical narrative: Information has been received from a nurse concerning a 19 month old patient who on 04-OCT-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# unspecified). The nurse mentioned that on 01-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several repots from the same source. Follow-up information received from the registered nurse revealed that on 04-OCT-2011 was vaccinated with a first dose of VARIVAX (Merck) (lot# unspecified, also reported as historical). It was mentioned that on 01-JUN-2012, the patient with no pre-existing allergies, birth defects or medical conditions, no illness at time of vaccination and unknown past medical history went to the clinic for a rash described as a generalized vesicular and maculopapular rash, greatest of arms and legs, excoriation, scattered dry and crushed lesions, new small vesicles scattered as well, no scaling, edema, petechia. The patient was diagnosed with varicella. No relevant diagnostic and laboratory tests were done. At the time of the report, the patient's outcome was unknown. This is a several reports form the same source. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 19 month old patient who on 04-OCT-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# unspecified). The nurse mentioned that on 01-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several repots from the same source. Follow-up information received from the registered nurse revealed that on 04-OCT-2011 was vaccinated with a first dose of VARIVAX (Merck) (lot# unspecified, also reported as historical). It was mentioned that on 01-JUN-2012, the patient with no pre-existing allergies, birth defects or medical conditions, no illness at time of vaccination and unknown past medical history went to the clinic for a rash described as a generalized vesicular and maculopapular rash, greatest of arms and legs, excoriation, scattered dry and crushed lesions, new small vesicles scattered as well, no scaling, edema, petechia. The patient was diagnosed with varicella. No relevant diagnostic and laboratory tests were done. At the time of the report, the patient's outcome was unknown. This is a several reports form the same source. No further information is available.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant concerning a patient (gender and age were not provided) who on 15-AUG-2012 was vaccinated with an expired dose of M-M-R II (lot number 668070/1059Z, expiration date 11-AUG-2012). (route was not provided). No adverse events were reported. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 25 years old female patient with no pertinent medical history and no drug reactions/allergies who was not pregnant. The patient was vaccinated with the first and second dose of GARDASIL (dose, route and lot number not provided). No other co-suspects were reported. There were no concomitant medications. On an unknown date the patient tested positive for human papilloma virus (HPV) after receiving first 2 doses of GARDASIL. The patient did not get the third dose yet. The patient had sought unspecified medical attention and no treatment information was given. The patient performed Pap smear test. The outcome of the patient was reported as not recovered/not resolved. Additional information has been requested.
Age: 1.43
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC13
Symptoms: Skin discolouration, Vasculitis
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 months old male patient with drug reactions/allergies to milk and with no pertinent medical history. The patient was vaccinated with M-M-R II (Lot#, dose/frequency, duration unspecified) on 08-JUL-2008. No other co-suspects were reported. Concomitant medications included DTaP (unspecified), HIB (manufacture unspecified), PREVNAR 13 and IPV (unspecified) also on the same day 08-JUL-2008. The nurse reported that the patient developed purple spots on the face (described as vasculitis of the face) on 08-JUL-2008, "the same day he received M-M-R II". The physician associated with the case was retired. It was unspecified whether the patient had sought medical attention or not. No lab diagnostics studies performed and no treatment was given for the adverse event. The outcome was reported as recovered/resolved (date unspecified). Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. It was reported that on 16-SEP-2010 and 24-JUL-2012 the patient was vaccinated intramuscularly with a first and a second 0.5 ml doses of GARDASIL respectively. Lot # for first dose was 660612/0229X, exp date 20-OCT-2010, for a second one lot # and exp date were not reported. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning 3 patients, who on approximately 18-JUN-2012 might have received improperly stored ROTATEQ orally (lot # 672509/0277AE, expiry date 20-SEP-2013, dose not reported). The vaccine was reported to be exposed to room temperature for 48 hours. Also reported that the ROTATEQ was shipped on 14-JUN-2012 and supposedly delivered by 15-JUN-2012, but the vaccine was not delivered until 18-JUN-2012. No adverse effects reported. This is one of the several repots from the same source. All telephone attempts to obtain follow up information have been unsuccessful. All telephone attempts to obtain follow up information have been unsuccessful. Additional information will be provided if available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, route and duration were unspecified) in August 2009, "3 years ago". No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient experienced shingles in February 2011, "one and a half years ago". VZVIP packet not offered since the patient has recovered from the shingles. It was unspecified whether the patient had sought medical attention or not. Not treatment information was reported. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Aphthous stomatitis, Blister, Excoriation, Papule, Rash macular
Clinical narrative: Information has been received from a nurse concerning a 20 month old patient who on 15-MAR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot# 669795/1381AA). The nurse mentioned that on 23-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. Follow-up has been received from a registered nurse provided information that patient with hearing problems, infantile, Seborrheic Dermatitis and Flat Foot, who at 5:30 PM on 15-MAR-2012 was vaccinated with the first dose of VARIVAX (Merck) (lot# 669795/1381AA) SC into the left leg, came to clinic on 21-MAY-2012, diagnosed with viral exanthem and aphthous stomatitis. The patient returned on 23-MAY-2012 with worsened rash described as "many erythematous macules, small papules, and open vesicles with surrounding excoriation of arms, hands and legs". No scaling. Lab diagnostic test were not performed. None illness at time of vaccination. On 29-MAY-2012 the patient recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Viral rash
Clinical narrative: Information has been received from a nurse concerning a 20 month old patient who on 15-MAR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot# 669795/1381AA). The nurse mentioned that on 23-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. Follow-up has been received from a registered nurse provided information that patient with hearing problems, infantile, Seborrheic Dermatitis and Flat Foot, who at 5:30 PM on 15-MAR-2012 was vaccinated with the first dose of VARIVAX (Merck) (lot# 669795/1381AA) SC into the left leg, came to clinic on 21-MAY-2012, diagnosed with viral exanthem and aphthous stomatitis. The patient returned on 23-MAY-2012 with worsened rash described as "many erythematous macules, small papules, and open vesicles with surrounding excoriation of arms, hands and legs". No scaling. Lab diagnostic test were not performed. None illness at time of vaccination. On 29-MAY-2012 the patient recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient with none pertinent medical history and none drug reaction/allergies. The patient was vaccinated with a dose of with ZOSTAVAX (lot # (0069AE, Expiration date 03-APR-2013) 0.65ml, SQ on 13-AUG-2012. No other co-suspects were reported. Concomitant therapy included hydrochlorothiazide (HCTZ). On an unknown date in August 2012the patient experienced "injection site it is swollen and red and warm which is the size of 4 to 5 inch diameter". The patient had phoned call and visited the pharmacy. As a treatment BENADRYL was given. The outcome of patient was reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker and a consumer refers to a patient of unknown age. On unknown date the patient was vaccinated with the first dose of M-M-R II (lot number and route not reported) approximately in November 2011 (at age 18 months, on an unspecified date approximately 9 months ago) (also reported as age one by the healthcare worker). Following the first dose of M-M-R II the patient experienced a slight fever The patient appeared to be "doing fine" following the second dose of M-M-R II the patient experienced a slight fever The patient appeared to be "doing fine" following the second dose of M-M-R II (lot number and route not reported) on 15-AUG-2012 at age 27 months (also reported as age 2 by the healthcare worker). Additional information is not expected.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a 1 month old patient. The patient was inadvertently vaccinated with 2 doses of pediatric RECOMBIVAX HB (5mcg/0.5ml, lot number unknown) during one office visit on an unspecified date. 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: 49.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information was received from a male patient who on 19-APR-2012 was administered a dose of PNEUMOVAX and developed cellulitis. The patient sought medical treatment and was treated with an antibiotic injection. The patient recovered on 22-APR-2012. Additional information is not expected as the patient did not provide contact information.
Age: 0.79
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to one of 18 years old female twins. The patient was testing "low" for anti-HBs after having received doses of an unspecified RECOMBIVAX HB (manufacturer was unknown, lot # was unknown) on the following dates: 18-Mar-1994, 18-Apr-1994, 14-Dec-1994. The nurse reported that the patient was going to college and blood titers for the anti-HBs were below the acceptable range. The patient did physical examination for medical attention. No other adverse event had been observed and reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 5 patients of unknown age and gender. On an unknown date in 2012 the patients were vaccinated with a dose of RECOMBIVAX HB (dose, route not reported), (lot # (671326/1522AA), exp date 21-APR-2014 which was stored in a refrigerator reading 36-46 F, but in a section of the refrigerator with intermittent excursion to 30 F since 11-JUN-2012. No adverse effect reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 81 years old female patient with cholesterol and hypertension and no known drug reaction allergies. The patient was vaccinated in left arm with a dose of ZOSTAVAX (dose, route and lot # not reported) on 30-JUL-2012. No other co-suspects were reported. There were unspecified concomitant medications. The pharmacist stated that the patient was vaccinated with ZOSTAVAX and on approximately August 2012 unspecified date she developed a red, itchy rash below the injection site of the the arm. The patient would follow-up with her health care provider. The patient had sought medical attention called pharmacist. No specify treatment information was reported. No other information was provided. At the time of the report, the patient had not recovered from red, itchy rash below the injection site of the left arm. The relatedness for red itchy rash below the injection site of the left arm was unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The nurse reported that the patient was vaccinated with a dose of GARDASIL (doses, route and lot # not provided) on 14-APR-2009 and on 29-OCT-2009. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. No other information provided. No treatment information was reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from a physician refers to a 14 years old female patient with a history of one seizure as a child, who on 07-OCT-2011, 08-DEC-2011 and on 12-APR-2012, was vaccinated with the first, second and third dose of GARDASIL respectively (doses, routes and lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that about a month ago, in approximately July 2012, the patient developed unexplained alopecia after completion of the GARDASIL series. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for the patient had developed unexplained alopecia after completion of the GARDASIL series was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Biopsy site unspecified normal, Cervical dysplasia, Colposcopy abnormal, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 19 years old female patient with no drug reactions or allergies. The patient was vaccinated intramuscularly with dose 1 lot # (672834/0131AE: exp date 26-OCT-2014) and dose 2 lot # (1696AA: exp date 12-SEP-2014), 0.5 ml of GARDASIL on 07-JUN-2012 and 16-AUG-2012 respectively. No other co-suspects were reported. There was no concomitant medication. The nurse practitioner mentioned that the patient had follow up treatment for cervical dysplasia. Nurse practitioner reports a colposcopy was done on 10-JUL-2012, a cervical biopsy that resulted in Cervical intraepithelial Neoplasia I (CINI) low grade and an endocervical component with a benign finding. The patient was going to have a repeat PAP smear in 4 months. Nurse practitioner reported that the patient was suppose to get DEPO-PROVERA and instead accidentally received the 2nd dose of GARDASIL on 16-AUG-2012. The patient had a pregnancy test prior to vaccination on 16-AUG-2012 and it was negative for pregnancy. The patient was suppose to go back in 10 days for another pregnancy test. The patient sought medical attention at the office and no treatment was given for the events. The outcome of cervical dysplasia, CIN1 low grade was reported as not recovered. The relatedness for cervical dysplasia CIN1 low grade was not reported for GARDASIL. Additional information has been requested.