chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Erythema, Induration, Injection site erythema, Injection site pain
Clinical narrative: The patient presented to this clinic with complaint of redness and tenderness at the site of a recent Tetanus vaccination on her right arm which she stated was given at Hospital last weekend. There is an area approximately 2 inches in diameter of firmness, erythema and warmth to touch. She stated she has had tetanus vaccine in the past with out any reaction. Dr. assessed the area and feels that this is a local reaction. The patient was told to apply a cool compress several times a day and she may use OTC Ibuprofen 2 tablets every 6 hours as needed for discomfort. The area will be marked and if the area of erythema is increasing the patient needs to come back in for further evaluation. The patient voiced understanding.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction, Skin warm
Clinical narrative: The patient presented to this clinic with complaint of redness and tenderness at the site of a recent Tetanus vaccination on her right arm which she stated was given at Hospital last weekend. There is an area approximately 2 inches in diameter of firmness, erythema and warmth to touch. She stated she has had tetanus vaccine in the past with out any reaction. Dr. assessed the area and feels that this is a local reaction. The patient was told to apply a cool compress several times a day and she may use OTC Ibuprofen 2 tablets every 6 hours as needed for discomfort. The area will be marked and if the area of erythema is increasing the patient needs to come back in for further evaluation. The patient voiced understanding.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Diplopia, Eye operation, Headache, Meningitis, Nuclear magnetic resonance imaging normal
Clinical narrative: Onset of headache 2-3 days following immunization.  On 7/4/10 developed double vision, mother reports eyes turning inward.  Sought care of ophthalmologist.  Eye surgery on 8/30/10, to "tighten the muscles of outside portion of eye" (per mother) by Dr. Vision corrected for a few week then double vision returned.  A second opinion identified the need for surgery again.  Mother states Dr. told her the eye problem was due to menginigitis vaccine and child had a mild case of meningitis.  Mother reports MRI done that was negative.  She reports no lab tests were done.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Strabismus
Clinical narrative: Onset of headache 2-3 days following immunization.  On 7/4/10 developed double vision, mother reports eyes turning inward.  Sought care of ophthalmologist.  Eye surgery on 8/30/10, to "tighten the muscles of outside portion of eye" (per mother) by Dr. Vision corrected for a few week then double vision returned.  A second opinion identified the need for surgery again.  Mother states Dr. told her the eye problem was due to menginigitis vaccine and child had a mild case of meningitis.  Mother reports MRI done that was negative.  She reports no lab tests were done.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity, Screaming
Clinical narrative: Injected shot very high at top edge of shoulder. The nurse injected the medicine quite rapidly which caused participant to holler. Arm and shoulder ached, like a headache for 2 full days, and then only hurt when moving the shoulder at all. Pain at its worse was a 10 and today it is a 2. Unable to cross arms over body to pull off a shirt. Unable to raise arm over head without it hurting. Went to Orthopedic doctor who stated the injection was probably injected into one of the tendons that connected to the rotator cuff. Xrays showed no tearing. Held off on MRI to wait and see if the pain pills and anti-inflammatory medicine worked. Still taking Piroxicam 20mg daily. Orthopod said problem could last 6-12 months. No ice and no heat applied to site.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: Injected shot very high at top edge of shoulder. The nurse injected the medicine quite rapidly which caused participant to holler. Arm and shoulder ached, like a headache for 2 full days, and then only hurt when moving the shoulder at all. Pain at its worse was a 10 and today it is a 2. Unable to cross arms over body to pull off a shirt. Unable to raise arm over head without it hurting. Went to Orthopedic doctor who stated the injection was probably injected into one of the tendons that connected to the rotator cuff. Xrays showed no tearing. Held off on MRI to wait and see if the pain pills and anti-inflammatory medicine worked. Still taking Piroxicam 20mg daily. Orthopod said problem could last 6-12 months. No ice and no heat applied to site.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: LEFT ARM (INJECTION SITE) SWELLING, PAIN AND HEADACHES, CHILLS/FEVER
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Increasing swelling of injection site to 3"x5", pain, itching, tenderness, heat, and continuing fever. A course of Keflex and high doses of Advil helped.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Influenza like illness, Injection site pain, Nervousness, Oedema peripheral
Clinical narrative: swollen hands, shaky with flu like symptoms, mild headache, rt deltoid where shot given sore, tender
Age: 0.68
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Ear infection, Pyrexia, Screaming
Clinical narrative: Fever/ "screamed for 2 hours".  Taken to ED.  Reports also had "ear infection" at same time.
Age: 55.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Activities of daily living impaired, Disturbance in attention, Pain in extremity
Clinical narrative: No adverse effects until two days after the injection. Began as sharp pain in the left bicep, radiating to the tricep and elbow. Intense pain also spreads to the left shoulder and forearm. The pain usually begins in the morning if I am sitting at my desk with my arms bent to use the computer. Initially took ibuprofen for the pain, but later had to switch to naproxen as ibuprofen was no longer effective. If I am not working at my computer (i.e., up moving around most of the day), the pain usually will not set in until I sit down to watch TV for the night with my left elbow bent at a 90 degree angle. Discussed the condition with my primary care physician, who said it sounded like a nerve inflammation, especially considering the shot was given higher up in the arm and further around the back of the arm than in previous years. I received the seasonal flu shot last year with no problem, but did not get the H1N1 vaccine. This year's shot was a combination of seasonal and H1N1 (INFs pres free (AFLURIA) 9yrs-adult (Influenza)). The pain has been persistant since two days after receiving the flu shot (almost 60 days ago). Continuing with the OTC naproxyn as needed. Applying heat also seems to help in the evening. The pain does get so intense as to limit my ability to concentrate and work at my desk.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Pain, Pain in extremity
Clinical narrative: Hip, lower back, and leg pain. Unable to transition from laying to standing or sitting to standing without extreme pain.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Pain, Pain in extremity
Clinical narrative: Pain in lower back, hip and leg pain.  Unable to transition from laying to standing or sitting to standing without extreme pain.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Muscle tenderness, Body ache, Fever. Nausea.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Mobility decreased, Pain
Clinical narrative: Felt like dartboard when shot administered. Felt as though shot was given too high on arm. The pain got worse as time went on. Got to where she could not lift arm over head to remove top. Could not sleep lying on Left side. Too Painful. The pain was worse several days after the shot. At it's worst pain rate was 8. Today pain rate is a 4. Still painful when lifting arm above head to remove clothing. Used Tylenol for the pain and it helped some.
Age: 1.59
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: He is allergic to eggs so he was admistered only 10% of the vaccine as per recommendation in the allergist office.  Immediately after getting the shot, he broke out in a rash (tiny dots scattered across body).  The nurse indicated she had never seen this type of reaction before so the remaining dose was not given.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Pain, Rash pustular
Clinical narrative: MEMBER STARTED HAVING ACHES AND CHILLS STARTING ON FRIDAY, 9 DEC, THEY CONTINUED FOR SEVERAL DAYS. ON 15 DEC 2010, THE MEMBER WOKE UP WITH SEVERAL PUSTULE BUMPS ON HIS NECK WITH A LARGE CLUSTER OF BUMPS UNDER HIS CHIN. MEMBER STATED THAT THE BUMPS ARE PAINFUL TO TOUCH, BUT THAT THEY DO NOT ITCH.
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Hypoaesthesia
Clinical narrative: Felt nurse injected vaccine too high on the shoulder, where a shirt has a seam. After the shot, arm felt numb, felt like he hit a bone. Talked to others and now thinks he may have hit the rotator cuff. Did not go to see MD. Received PT exercises to do from mother in law. Taking ibuprofen, but it is not helping. She is overweight but not obese. She is 5'3"/170#. About 80% recovered today.
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Rotator cuff syndrome, Sleep disorder
Clinical narrative: Arm pain since shot administered and never had arm pain until after the shot. Went to MD and had MRI. Two small tears were found in rotator cuff right accross from each other...the tears are not big enough to have surgery. Going to PT. Taking pain medication at bedtime to help sleep...this is when pain is the worst.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Acute sinusitis, Bronchitis, Chest pain, Headache, Laryngitis
Clinical narrative: Patient developed sinus pressure, drainage, malaise, for several days, followed by 3 days of laryngitis. She then developed a productive cough, chest pain and head pressure with cough, and disruption of sleep. OTC remedies did not help with symptoms, and she presented on day #8 of illness.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Productive cough, Sinus headache, Sleep disorder
Clinical narrative: Patient developed sinus pressure, drainage, malaise, for several days, followed by 3 days of laryngitis. She then developed a productive cough, chest pain and head pressure with cough, and disruption of sleep. OTC remedies did not help with symptoms, and she presented on day #8 of illness.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral, Tenderness
Clinical narrative: By the eve of same day as injection patient states her left deltoid was the size of an apple.  By the time she woke up the next morning, her entire upper arm was swollen, red, sore to her elbow. The following day the swelling had passed her elbow, was extremely painful.  Patient self treated w/ ice, Benadryl and elevation.  States it took a week for swelling to go down and tenderness to resolve.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Acute sinusitis, Bronchitis, Discomfort, Nasal congestion, Pain
Clinical narrative: Symptoms for 4 days - nasal congestion, drainage, tickle in throat. no fevers or chills. Productive cough, no wheezing or shortness of breath. Thera flu not really helpful. Significant pain and discomfort with cough due to his recent surgery. He quit smoking about after his CABG 8 weeks.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Productive cough, Rhinorrhoea, Throat irritation, Upper respiratory tract infection
Clinical narrative: Symptoms for 4 days - nasal congestion, drainage, tickle in throat. no fevers or chills. Productive cough, no wheezing or shortness of breath. Thera flu not really helpful. Significant pain and discomfort with cough due to his recent surgery. He quit smoking about after his CABG 8 weeks.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: GENERAL ACHINESS AND SWOLLEN GLANDS; DEVELOPED FEVER 100.8; WENT TO ER ON 10/10
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Chills, Chronic obstructive pulmonary disease, Cough, Facial pain
Clinical narrative: 8 day history of sinus congestion, was better for a few days, getting worse in last 3 days.  Nasal discharge, PND, facial pain, teeth ache and cough.  Cough that is from PND, coughing up green with blood tinged mucus.  Fever, chills, body aches since last night.   Was seen earlier this week and started on azithromycin 12/1/10.  Has been using Theraflu without relief.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Haemoptysis, Mucosal discolouration, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: 8 day history of sinus congestion, was better for a few days, getting worse in last 3 days.  Nasal discharge, PND, facial pain, teeth ache and cough.  Cough that is from PND, coughing up green with blood tinged mucus.  Fever, chills, body aches since last night.   Was seen earlier this week and started on azithromycin 12/1/10.  Has been using Theraflu without relief.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Sensitivity of teeth, Sinus congestion, Sinusitis
Clinical narrative: 8 day history of sinus congestion, was better for a few days, getting worse in last 3 days.  Nasal discharge, PND, facial pain, teeth ache and cough.  Cough that is from PND, coughing up green with blood tinged mucus.  Fever, chills, body aches since last night.   Was seen earlier this week and started on azithromycin 12/1/10.  Has been using Theraflu without relief.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Oedema, Skin warm, Tenderness, Urticaria
Clinical narrative: mild cellulitis (warm, edematous, tender) with hives inferior to injection site
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus, Rheumatoid arthritis, Skin warm
Clinical narrative: Area app size of a half dollar of my arm was swollen, red, hot, itchy. Was given Cleocin to counteract reaction which I was allergic to (allergic reaction was severe inflammation) and within 6 weeks I got severe rheumatoid arthritis because of this!
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Anxiety, Dyspnoea, Emotional distress
Clinical narrative: Pharmacy student gave flu shot in my presence (Student is certified through APhA.  I verified the quantity given as 0.5ml and pt. was asked prescreening questions and nothing stood out as a problem.  Pt. did have a cold and was coughing a bit but nothing seemed abnormal.  Shot was given and patient was in our presence for about 10 minutes then went to talk to another clinic associate and was counseled to let us know if she had any problems before she left talking to that person (we estimated this would take at least 5 minutes to finish out the 15 minute observation period).  Pt. did not get the H1N1 last year, but has received the flu shot multiple times in the past. She came back to the pharmacy window 30 minutes after the shot was given saying that should couldn't breath and was obviously under distress.  She was rushed back to the the treatment room here at our clinic and was administered diphenhydramine 50mg IM, solu-medrol 125mg IM, 0.3mg epinephrine IM, and albuterol nebulization with 2 liters of O2.  An ambulance was called and she was shipped to Medical Center for observation.  When she left in the ambulance she was doing much better.  It appears to have been an anaphylactic reaction but there may have been some anxiety involved.  The clinic course at medical center is unknown at this time.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Asthenia, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Swelling, redness about the size of a dime and soreness.  As of 12/15/2010  redness has spread to the size of 4 quarters with additional swelling, soreness and pain throughout arm.  Treating with Benadryl and Cortisone Cream.  Pain, weakness, soreness, swelling and redness is continuing to spread.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: General soreness & limited range of motion.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Within 24 hours after vaccination developed serious Bell's Palsy that required ruling out CVA 48 later.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives & itching forearms and abdomen 1:00 PM transported to ER, treated with oral BENADRYL. Released to father 5:30 PM.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt with 5 x 4 cm2 area redness, warmth, and mild tenderness at injection site (R) deltoid; no fluctuance.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: CSF test, Electromyogram, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture
Clinical narrative: Guillian-Barre Syndrome diagnosed 12/7/10. Very weak both arms/numb also. Started 12/4/10. Treated at hospital.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Nerve conduction studies
Clinical narrative: Guillian-Barre Syndrome diagnosed 12/7/10. Very weak both arms/numb also. Started 12/4/10. Treated at hospital.
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Asthenia, Dizziness, Dyspnoea
Clinical narrative: Weakness, dizziness, shortness of breath, difficulty breathing.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: On Monday, Dec 13th, pt noticed (L) arm - deltoid area sore, red, warm, itchy and firm from injection site to approx 4" below. Because the discomfort increased, pt. called her physician. Her doctor recommended TYLENOL, BENADRYL and warm compresses to area. Pt took TYLENOL but not BENADRYL. Applied heat to area as per her doctors instructions. On Tuesday, Dec 14th patient experienced persistent discomfort (L) arm with area of redness, warm, itching et tightness now extending from 2" below (L) shoulder down to left elbow. She called her physician who recommended she be evaluated. Pt saw MD on 12/14/10 at 6:15pm. Pt reported that her physician gave her an IM injection of what she thinks was an antibiotic and told her to start Cefadroxil orally the next day. He also prescribed Diclofenac orally which pt started Tuesday evening. On Wednesday, Dec 15th, pt called our Health Center to report incident. (L) arm today she reports is still red, itchy, tight, sore but not as firm as Dec 14th. Area involved remains down to left elbow and pt states had spread to undersurface of left upper arm. She also reported approx. 40 small fluid filled "welts" scattered in an "S" formation one inch from injection site down anterior surface of arm. I advised patient to call her physician to report her symptoms and for further recommendations. Pt acknowledged my advice and will call her physician.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Limb discomfort, Skin tightness, Urticaria
Clinical narrative: On Monday, Dec 13th, pt noticed (L) arm - deltoid area sore, red, warm, itchy and firm from injection site to approx 4" below. Because the discomfort increased, pt. called her physician. Her doctor recommended TYLENOL, BENADRYL and warm compresses to area. Pt took TYLENOL but not BENADRYL. Applied heat to area as per her doctors instructions. On Tuesday, Dec 14th patient experienced persistent discomfort (L) arm with area of redness, warm, itching et tightness now extending from 2" below (L) shoulder down to left elbow. She called her physician who recommended she be evaluated. Pt saw MD on 12/14/10 at 6:15pm. Pt reported that her physician gave her an IM injection of what she thinks was an antibiotic and told her to start Cefadroxil orally the next day. He also prescribed Diclofenac orally which pt started Tuesday evening. On Wednesday, Dec 15th, pt called our Health Center to report incident. (L) arm today she reports is still red, itchy, tight, sore but not as firm as Dec 14th. Area involved remains down to left elbow and pt states had spread to undersurface of left upper arm. She also reported approx. 40 small fluid filled "welts" scattered in an "S" formation one inch from injection site down anterior surface of arm. I advised patient to call her physician to report her symptoms and for further recommendations. Pt acknowledged my advice and will call her physician.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Bloody stool.
Age: 0.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Patient began crying, non stop, less than an hour after vaccines were administered. 3 hours later, child was still crying hysterically. Child was re-examined by Dr. & sent to E.R. as a precaution. At 4:45pm we were notified crying ceased, hospital said all clear & no fever.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Local swelling, Lymphadenopathy, Ultrasound scan
Clinical narrative: Swollen size of a cherry, quite sore lymph node & moderate local swelling & pain site of injection. All resolved.
Age: 68.0
Sex: M
Vaccine: UNK, FLU3, VARZOS
Symptoms: Cyanosis, Hypoaesthesia, Muscle tightness, Nausea, Pain
Clinical narrative: Tingling and numbness in hands and feet 12/13/10 extreme nausea, right arm & neck tight & cramped hands turned purple. Called 911 12/14/10 - ambulance crew gave him oxygen. Seemed to improve after oxygen. Pt chose not to go to hospital. Pain all over. Spoke with wife 12/15/10 - feeling better but feeling run down.
Age: 68.0
Sex: M
Vaccine: UNK, FLU3, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling and numbness in hands and feet 12/13/10 extreme nausea, right arm & neck tight & cramped hands turned purple. Called 911 12/14/10 - ambulance crew gave him oxygen. Seemed to improve after oxygen. Pt chose not to go to hospital. Pain all over. Spoke with wife 12/15/10 - feeling better but feeling run down.
Age: 68.0
Sex: M
Vaccine: UNK, FLU3, VARZOS
Symptoms: Cyanosis, Pain
Clinical narrative: Tingling and numbness in hands and feet 12/13/10 extreme nausea, right arm & neck tight & cramped hands turned purple. Called 911 12/14/10 - ambulance crew gave him oxygen. Seemed to improve after oxygen. Pt chose not to go to hospital. Pain all over. Spoke with wife 12/15/10 - feeling better but feeling run down.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Abscess, Cellulitis, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Seen urgent care 12/15/10 2 day hx (L) arm redness, swelling, pain area "hot" & fever. Started on course KEFLEX 500mg every 6 hrs for 7 days. Cellulitis/abscess.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Seen urgent care 12/15/10 2 day hx (L) arm redness, swelling, pain area "hot" & fever. Started on course KEFLEX 500mg every 6 hrs for 7 days. Cellulitis/abscess.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Gait disturbance, Hypoaesthesia, Nuclear magnetic resonance imaging spinal cord abnormal, Spinal cord disorder
Clinical narrative: (R) LE numbness, gait difficulty abnormal MRI signal mltple T spine cord levels. Most enhanced conus.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PNEUMOVAX 0.5ml IM administered in right arm deltoid on 12/6/10 at 1400. Pt. reported on 12/7/10 that her right arm just above elbow region & (below inject site) was red, warm, swollen, & painful. Onset sometime during the evening of 12/6/10. TYLENOL & cold compress to area prn.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness, Nuclear magnetic resonance imaging, Ophthalmological examination abnormal, Optic nerve disorder, Optic neuritis
Clinical narrative: Information has been received from a physician concerning a 11 year old female patient with no known drug reactions/allergies who in 2008 at 12 years old, was vaccinated IM with all three doses of GARDASIL (lot # not reported). The patient "had a normal eye exam before GARDASIL treatment and after starting GARDASIL treatment a later eye exam within the same year reported optic neuritis" in 2008. The patient sought unknown medical attention. Lab diagnostics test magnetic resonance imaging performed, no results provided. At the time of reporting the patient's optic neuritis did not improve. Follow-up information has been received from the physician concerning the 11 year old female student with exercise induced asthma who was vaccinated IM into the left arm with the first dose of GARDASIL (lot number 658558/1061U) on 25-AUG-2007, the second dose (lot number 658563/1063U) on 15-NOV-2007, and the third dose (lot number 660387/1967U) on 27-MAY-2008. In spring 2008, the patient wanted to opthamologist as could not see at school, bilat, dead spots seen on each optic nerve. Patient had had a normal eye exam in 2005. In 2008, the 11 year old patient experienced optic neuritis after GARDASIL 1 to 3 dose. At the time of this report, the patient's adverse events did not recover. The patient's "could not see at school" and bilat, dead spots seen on each optic nerve were considered to be disabling and other important medical events by the physician. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Back disorder, Back pain, Convulsion, Extraocular muscle paresis, Headache
Clinical narrative: Information has been received via the internet from a 24 year old female consumer with no history of seizures who was vaccinated with the third dose of GARDASIL in June 2007. In August 2007 the patient was hospitalized due to back problems. It was reported that "the following day", the patient experienced seizures (it was also reported that the onset date of back pain and seizures was in June 2007). The patient stated she experienced the following "preliminary symptoms: left eye weakens, strong pain in left side of the head, tremors and no feeling in face etc." After several days of seizures they disappear for several months and then reoccur. The patient stated that she had referred to a neurologist who did not know how to help her. The patient visited an epilepsy clinic where she was told that it was all in her mind because all the tests came positive. The outcome of the back pain was unknown and at the time of this report the patient had not recovered from the seizures. The reporter felt that the seizures were related to therapy with GARDASIL. Upon internal review seizures were considered to be an Other Medical Event. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia facial, Laboratory test abnormal, Tremor
Clinical narrative: Information has been received via the internet from a 24 year old female consumer with no history of seizures who was vaccinated with the third dose of GARDASIL in June 2007. In August 2007 the patient was hospitalized due to back problems. It was reported that "the following day", the patient experienced seizures (it was also reported that the onset date of back pain and seizures was in June 2007). The patient stated she experienced the following "preliminary symptoms: left eye weakens, strong pain in left side of the head, tremors and no feeling in face etc." After several days of seizures they disappear for several months and then reoccur. The patient stated that she had referred to a neurologist who did not know how to help her. The patient visited an epilepsy clinic where she was told that it was all in her mind because all the tests came positive. The outcome of the back pain was unknown and at the time of this report the patient had not recovered from the seizures. The reporter felt that the seizures were related to therapy with GARDASIL. Upon internal review seizures were considered to be an Other Medical Event. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a consumer who has received the information from the internet. The information in the internet was received by the consumer and by the consumer's mother. A 15 year old female patient was vaccinated with 3 doses of GARDASIL at the age of 15. The patient was slowly dying. At the time of reporting, the outcome was unknown. The reporter felt that dying was related to therapy with GARDASIL. Dying was considered to be immediately life-threatening. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Rotavirus infection
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rotavirus in a 13-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included 1st doses of PENTACEL (Sanofi Pasteur) and PREVNAR 7 (Wyeth) both given on 3 November 2009, the same day as the 1st dose of ROTARIX. Second doses of PENTACEL (Sanofi Pasteur) and PREVNAR 7 (Wyeth) were administered on 5 January 2010 along with a 2nd dose of ROTARIX. There were no concurrent medications. On 3 November 2009 at 09:00, at 2 months of age, the subject received 1st oral dose of ROTARIX at 1.0 ml. A little over a year following administration of the 1st dose of ROTARIX, on 14 November 2010, the subject was diagnosed with rotavirus. It was reported that the subject was 13 months old when the onset of the adverse event began, however, the diagnosis date for rotavirus was not until 14 November 2010. The healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting the event was improved. The healthcare professional considered the event was unrelated to vaccination with ROTARIX. A 2nd dose of ROTARIX was administered on 05 January 2010. No additional details were provided concerning the 2nd dosing with ROTARIX.
Age: 1.0
Sex: U
Vaccine: FLU3, HEPA, HIBV, MMR, VARCEL, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Rash macular
Clinical narrative: Rash all over body 9 days after.
Age: 1.0
Sex: U
Vaccine: FLU3, HEPA, HIBV, MMR, VARCEL, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash all over body 9 days after.
Age: 0.43
Sex: F
Vaccine: FLU3, PNC13, FLU3, FLU3
Symptoms: Death, Decreased appetite, Diarrhoea, Insomnia, Malaise
Clinical narrative: Initial report received from consumer on 10 Dec 2010. This neonate was vaccinated with FLUVIRIN (batch number: unknown), intramuscularly on 10 Nov 2010. 10 hours after vaccination, the patient began to experience fever and diarrhea. The patient's condition rapidly deteriorated and the patient subsequently died on 18 Nov 2010.
Age: 0.43
Sex: F
Vaccine: FLU3, PNC13, FLU3, FLU3
Symptoms: Pyrexia
Clinical narrative: Initial report received from consumer on 10 Dec 2010. This neonate was vaccinated with FLUVIRIN (batch number: unknown), intramuscularly on 10 Nov 2010. 10 hours after vaccination, the patient began to experience fever and diarrhea. The patient's condition rapidly deteriorated and the patient subsequently died on 18 Nov 2010.
Age: 0.43
Sex: F
Vaccine: FLU3, PNC13, FLU3, FLU3
Symptoms: Death, Diarrhoea, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Initial report received from consumer on 10 Dec 2010. This neonate was vaccinated with FLUVIRIN (batch number: unknown), intramuscularly on 10 Nov 2010. 10 hours after vaccination, the patient began to experience fever and diarrhea. The patient's condition rapidly deteriorated and the patient subsequently died on 18 Nov 2010.
Age: 0.43
Sex: F
Vaccine: FLU3, PNC13, FLU3, FLU3
Symptoms: Death, Decreased appetite, Diarrhoea, Irritability, Lethargy
Clinical narrative: Initial report received from consumer on 10 Dec 2010. This neonate was vaccinated with FLUVIRIN (batch number: unknown), intramuscularly on 10 Nov 2010. 10 hours after vaccination, the patient began to experience fever and diarrhea. The patient's condition rapidly deteriorated and the patient subsequently died on 18 Nov 2010.
Age: 57.0
Sex: U
Vaccine: FLUX
Symptoms: Asthma, Dyspnoea, Insomnia, Wheezing
Clinical narrative: Wheezing, asthma, unable to sleep because of difficulty breathing. Treated with OTC inhaler (epinephrine). Symptoms gradually subsided over a period of 3 weeks.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: She said her arm has been in pain since she recd the vaccine on 11/2/10 pain on her arm in between her elbow & shoulder. She also said she has been to her physical therapist & massage therapist.
Age: 7.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Headache, Musculoskeletal pain, Pyrexia, Vomiting
Clinical narrative: Extreme shoulder pain, fever, vomit, headache on top of head
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: LEFT DELTOID AND BICEP PAIN
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Tachycardia
Clinical narrative: 20 mins after vaccine, patient had SOB, tachycardia. No local redness or inflammation at site. Sat with head between knees, ambulance called. Felt better once ambulance got there. 10 min after standing up, experienced same symptoms but worse. Sat with head between knees & went with ambulance upon re-arrival. Patient returned to pharmacy that night to say he was ok.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Headache, chills, fatigue, redness/soreness at injection site, bumpy rash on hands & toes.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Headache, chills, fatigue, redness/soreness at injection site, bumpy rash on hands & toes.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Painful at site. Swelling at site. (Warm to touch). Hoarse voice slight fever TYLENOL.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Left arm red 3 x 4 inch area, pt taking XYZAL and TYLENOL.
Age: 4.0
Sex: F
Vaccine: FLUN3, MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: None - she was given a 3rd dose of MMR on 12/10/10. Had 2 prior doses. Seems well. Unnecessary dose.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dysstasia, Fatigue, Gait disturbance, Headache, Muscular weakness
Clinical narrative: Onset fatigue progressed to bilateral leg weakness & exhaustion. Could not sit/stand for more than 10-15 min at a time. Mild headache. Weakness to the point I could barely walk. PMD & neurologist consulted. Odd neuro symptoms - intermittent drawing of (L) foot, afebrile.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Drug administered at inappropriate site, Erythema, Hypersensitivity, Inflammation
Clinical narrative: The arm was red, inflamed, & bruised. The patient & doctor think it was administered incorrectly (too low) which caused the reaction.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Patient's mom called, said 1 hour after getting shot patient had severe muscle spasms. Today he feels like " he was in a car accident". He has never had a flu shot before.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Bedridden, Cardiac function test normal, Computerised tomogram normal
Clinical narrative: Initial report received from a health care professional on 09 December 2010. A female patient (age not reported) received on 12 October 2010 an intramuscular injection (site not reported) of FLUZONE SV 2010-2011, lot number UH184AA. The patient's medical history and concomitant medications were unknown. The patient had no illness at the time of vaccination and received no other vaccines within 4 weeks. On an unknown date but after the vaccination was administered, the patient developed dizziness, headache, numbness and tingling in all extremities, severe generalized weakness to the point of being bed ridden and needing assistance with care. The patient was seen in the emergency room and also by her physician. She had cardiac studies and a computed tomography (CT) scan of the brain which were negative. The patient was scheduled for a magnetic resonance imaging (MRI) scan and neurology consult. The patient had only a slight improvement. The outcome was reported as not recovered. Documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hypoaesthesia, Paraesthesia, Scan brain
Clinical narrative: Initial report received from a health care professional on 09 December 2010. A female patient (age not reported) received on 12 October 2010 an intramuscular injection (site not reported) of FLUZONE SV 2010-2011, lot number UH184AA. The patient's medical history and concomitant medications were unknown. The patient had no illness at the time of vaccination and received no other vaccines within 4 weeks. On an unknown date but after the vaccination was administered, the patient developed dizziness, headache, numbness and tingling in all extremities, severe generalized weakness to the point of being bed ridden and needing assistance with care. The patient was seen in the emergency room and also by her physician. She had cardiac studies and a computed tomography (CT) scan of the brain which were negative. The patient was scheduled for a magnetic resonance imaging (MRI) scan and neurology consult. The patient had only a slight improvement. The outcome was reported as not recovered. Documents held by sender: None.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1), HIBV
Symptoms: Atelectasis, Body temperature increased, Chest X-ray abnormal, Lung disorder, Pneumonia
Clinical narrative: Initial report received on 23 March 2010 by a health care professional. A female patient (age not reported) was vaccinated on 22 March 2010 with H1N1 (manufacturer and lot number not reported) and HIB (manufacturer and lot number not reported). Within a few hours of vaccination, the patient had a temperature of 103.5 and was given TYLENOL by her parent. The patient's temperature decreased to 101. It was not known at the time of report whether the patient recovered. The event did require a doctor visit. No other information was provided. Follow-up information received from a health care professional on 08 December 2010. A 3-year-old female child received on 22 March 2010 a left deltoid injection (dose 1) of H1N1, lot number UP078AA, and a right deltoid injection (dose 4) of ACTHIB, sanofi pasteur Inc. lot number UF741AA and sanofi pasteur SA lot number D0896-1. The patient had an allergy to penicillin (PCN). She has no illness at the time of vaccination and had no other vaccinations within 4 weeks. The child's mother was referred to the Emergency Room (ER) on the 22 March 2010 but did not go with the child. The mother did not keep the appointed office visits for follow-up on the 23 March 2010 and 29 March 2010. She also could not be reached by phone on the 25 March 2010. On 29 March 2010, the patient was taken to the ER by her mother. She had a chest x-ray performed on 29 March 2010 which showed mild opacity in the right lower lung (RLL) and atelectasis or early pneumonia. The child was diagnosed with possible pneumonia. On 27 April 2010, the patient was seen in the office with the pneumonia resolving. She was prescribed albuterol HFA. The mother did not keep the child's follow-up appointment for 03 May 2010. As of the 20 August 2010, the patient was doing well. The patient received current flu vaccine without any difficulty on 06 October 2010. The outcome was reported as recovered. List of documents held by sender: None
Sex: F
Vaccine: FLUX
Symptoms: Brain oedema, Skin discolouration, Vaccine positive rechallenge
Clinical narrative: Initial report was received from a consumer who is also the patient on 07 December 2010. A female patient (age at the time of the event was not reported) had received an Influenza vaccine (manufacturer, lot number, route and site of administration was not reported) on an unspecified date in 1984 and an unspecified amount of time later experienced "brain swelling" for three days and a four inch by seven inch "black area" on the vaccinated arm. The patient reported to have had the same reaction to an influenza vaccine administered to her in 1976. Treatments for the events were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rash macular, Urticaria
Clinical narrative: Initial report received from a health care professional on 06 December 2010. A 76-year-old female patient received on 15 November 2010 a left deltoid intramuscular injection of FLUZONE SV 2010-2011, lot number U3728AA. The patient had an allergy to penicillin, codeine and CELEBREX. She had a history of H. pylori, left hemi-stroke, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), mild diverticulosis, increased blood pressure and restless leg syndrome. The patient's concomitant medications included PLAVIX, ZYRTEC, METAMUCIL, ASA, calcium and LOTENSIN. She denied any illness at the time of vaccination. On 16 November 2010, the patient, within 24 hours of the vaccine, developed urticaria and a full body red blotchy rash. She was seen by her physician and treated with prednisone. The duration of the rash was unknown since the patient did not follow-up with the requested phone call to the physician's office. The outcome was reported as unknown. Documents held by sender: None.
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Brain injury, Convulsion, Cytogenetic analysis, Gait disturbance
Clinical narrative: Information has been received from a consumer who had received the information from the internet.  The information in the internet was received by a consumer concerning her healthy daughter who was vaccinated with the first and second dose of GARDASIL shortly after the patient experienced seizures.  The firstly seizure caused the patient to loss breath and she was hospitalized for 4 months.  The patient experienced brain damage, memory deficiency, behavioral problems, extreme mood changes, walking disorder, tics and seizures.  The patient had lost one year of school and would be able to return to school only when the medication would better control her seizures.  The patient underwent 4 months of tests to detect metabolic disorders, genetic disorders and several rare conditions with no results yet.  By the time of this report the outcome is unknown.  The reporter felt that seizures, brain damage, memory deficiency, behavioral problems, extreme mood change, walking disorder and tics were related to therapy with GARDASIL.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Memory impairment, Metabolic function test, Mood altered, Movement disorder
Clinical narrative: Information has been received from a consumer who had received the information from the internet.  The information in the internet was received by a consumer concerning her healthy daughter who was vaccinated with the first and second dose of GARDASIL shortly after the patient experienced seizures.  The firstly seizure caused the patient to loss breath and she was hospitalized for 4 months.  The patient experienced brain damage, memory deficiency, behavioral problems, extreme mood changes, walking disorder, tics and seizures.  The patient had lost one year of school and would be able to return to school only when the medication would better control her seizures.  The patient underwent 4 months of tests to detect metabolic disorders, genetic disorders and several rare conditions with no results yet.  By the time of this report the outcome is unknown.  The reporter felt that seizures, brain damage, memory deficiency, behavioral problems, extreme mood change, walking disorder and tics were related to therapy with GARDASIL.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Respiratory arrest, Tic
Clinical narrative: Information has been received from a consumer who had received the information from the internet.  The information in the internet was received by a consumer concerning her healthy daughter who was vaccinated with the first and second dose of GARDASIL shortly after the patient experienced seizures.  The firstly seizure caused the patient to loss breath and she was hospitalized for 4 months.  The patient experienced brain damage, memory deficiency, behavioral problems, extreme mood changes, walking disorder, tics and seizures.  The patient had lost one year of school and would be able to return to school only when the medication would better control her seizures.  The patient underwent 4 months of tests to detect metabolic disorders, genetic disorders and several rare conditions with no results yet.  By the time of this report the outcome is unknown.  The reporter felt that seizures, brain damage, memory deficiency, behavioral problems, extreme mood change, walking disorder and tics were related to therapy with GARDASIL.  No further information is available.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Movement disorder, Syncope
Clinical narrative: A serious spontaneous report of seizure-like-activity and fainting has been received from a health professional concerning a child, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown date, the patient received FLUMIST. After receiving FLUMIST, the patient fainted and experienced seizure-like-activity lasting a few seconds. The seizure-like-activity was noted within five minutes of receiving FLUMIST. The outcome of the events of seizure-like-activity and fainting was unknown.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC
Symptoms: Pyrexia
Clinical narrative: As of 8am on Thursday, December 16, 2010, the child still is running a high fever. This has been continuous since the onset of symptoms on the date of vaccination. We do not know yet if there will be any other adverse events related to this episode. If so, we will complete a seperate report. Infant Ibuprofen was administered on Tuesday evening, 12/14/10 to bring down fever, which was 103.5 at the time. Further doses of infant Ibuprofen have been administered on the morning of 12/15/10 around 9am, and approximately every 4 hours since, except that he slept through the night and this morning, on 12/16/10 he received 3/4 tsp of Children's Acetaminophen instead. The temperature this morning was still over 102.2. We are concerned that the fever may continue for several more days and does not seem to be going away. In the past, he has never had a fever more more than a few hours. There was no underlying illness at the time of vaccination.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Vomiting
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: severe urticaria
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Asthma, Blood test normal, Chest X-ray normal, Chest pain
Clinical narrative: Started extremely abruptly with scratchy throat and burning chest. Went into asthma attack, then stuffy head and runny nose, chills, fever, body aches, racing heart, high blood pressure, nausea, vomiting, weakness, dizzy, extremely bloodshot eyes.  Had to go to ER.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Culture negative, Culture urine negative, Dizziness, Electrocardiogram normal
Clinical narrative: Started extremely abruptly with scratchy throat and burning chest. Went into asthma attack, then stuffy head and runny nose, chills, fever, body aches, racing heart, high blood pressure, nausea, vomiting, weakness, dizzy, extremely bloodshot eyes.  Had to go to ER.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Influenza A virus test negative, Nausea, Ocular hyperaemia, Pain
Clinical narrative: Started extremely abruptly with scratchy throat and burning chest. Went into asthma attack, then stuffy head and runny nose, chills, fever, body aches, racing heart, high blood pressure, nausea, vomiting, weakness, dizzy, extremely bloodshot eyes.  Had to go to ER.