chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Cardiac monitoring normal, Cardioversion, Dizziness, Dyspnoea
Clinical narrative: Information has been received from a registered nurse and a certified medical assistant concerning a 16 year old female with migraine headaches and allergy to cephalosporin who on 27-JUL-2009 was vaccinated with a 0.5 ml IM first dose of GARDASIL (lot no. 661953/1130X). No other vaccines were given that day. Concomitant therapy included ORTHO EVRA. On 28-JUL-2009 the patient stated she developed a rapid heart rate "it feel like it was rushing out of my chest", standing cause her to loose her breath and dizziness. The symptoms continued through the entire day and into the next. On 29-JUL-2009 the patient was seen at emergency room and was diagnosed with supraventricular tachycardia (SVT) with a heart rate of 200 (bmp). The patient was not hospitalized. The patient underwent cardioversion and was released with heart rate in the 90's (sinus rhythm). On an unspecified date, the patient recovered from supraventricular tachycardia. A blood work and a electrocardiogram (EKG) was performed (results not reported). The patient is being followed by a cardiologist and another physician who reported that holter monitor results were "fine." The reporter stated that supraventricular tachycardia was not related to therapy with GARDASIL. Supraventricular tachycardia was considered to be life threatening an other important medical event. A lot check has been initiated. No further information is available.  8/28/09 ER records received DOS 7/29/09. Assessment: Arrhythmia - Supraventricular tachycardia. Patient complains of palpitations and heart racing. Chest pain and difficulty breathing.  10/13/09 ICD-9 Codes received: 427.89 Other specified cardiac dysrhythmia, 780.4 dizziness, 786.05 paroxysmal nocturnal dyspnea, 785.1 palpitations, 785.0 Tachycardia unspecified.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram, Electrocardiogram ambulatory normal, Heart rate increased, Supraventricular tachycardia
Clinical narrative: Information has been received from a registered nurse and a certified medical assistant concerning a 16 year old female with migraine headaches and allergy to cephalosporin who on 27-JUL-2009 was vaccinated with a 0.5 ml IM first dose of GARDASIL (lot no. 661953/1130X). No other vaccines were given that day. Concomitant therapy included ORTHO EVRA. On 28-JUL-2009 the patient stated she developed a rapid heart rate "it feel like it was rushing out of my chest", standing cause her to loose her breath and dizziness. The symptoms continued through the entire day and into the next. On 29-JUL-2009 the patient was seen at emergency room and was diagnosed with supraventricular tachycardia (SVT) with a heart rate of 200 (bmp). The patient was not hospitalized. The patient underwent cardioversion and was released with heart rate in the 90's (sinus rhythm). On an unspecified date, the patient recovered from supraventricular tachycardia. A blood work and a electrocardiogram (EKG) was performed (results not reported). The patient is being followed by a cardiologist and another physician who reported that holter monitor results were "fine." The reporter stated that supraventricular tachycardia was not related to therapy with GARDASIL. Supraventricular tachycardia was considered to be life threatening an other important medical event. A lot check has been initiated. No further information is available.  8/28/09 ER records received DOS 7/29/09. Assessment: Arrhythmia - Supraventricular tachycardia. Patient complains of palpitations and heart racing. Chest pain and difficulty breathing.  10/13/09 ICD-9 Codes received: 427.89 Other specified cardiac dysrhythmia, 780.4 dizziness, 786.05 paroxysmal nocturnal dyspnea, 785.1 palpitations, 785.0 Tachycardia unspecified.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Information has been received from a physician concerning a 63 year old female patient who on 11-JUN-2009 was vaccinated with a single 0.5ml dose of ZOSTAVAX (Merck) (lot number, route and site not reported). Subsequently, the patient experienced significant redness and swelling at the injection site. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Follow-up information received from a medical assistant indicated that on 11-JUN-2009, at 9:15a.m., the patient received the first dose of ZOSTAVAX (Merck) (lot#663177/1413X) subcutaneously into left arm. There were no pre-existing allergies, birth defects, medical conditions and illness at time of vaccination. On 11-JUN-2009, at 10:00a.m., the patient developed erythema at area of injection site and body aches immediately, the patient's temperature was 100 deg F. At the time of the report, the patient's outcome was unknown. Erythema at area of injection site, body aches and fever were considered to be an other important medical events by the medical assistant. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 63 year old female patient who on 11-JUN-2009 was vaccinated with a single 0.5ml dose of ZOSTAVAX (Merck) (lot number, route and site not reported). Subsequently, the patient experienced significant redness and swelling at the injection site. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Follow-up information received from a medical assistant indicated that on 11-JUN-2009, at 9:15a.m., the patient received the first dose of ZOSTAVAX (Merck) (lot#663177/1413X) subcutaneously into left arm. There were no pre-existing allergies, birth defects, medical conditions and illness at time of vaccination. On 11-JUN-2009, at 10:00a.m., the patient developed erythema at area of injection site and body aches immediately, the patient's temperature was 100 deg F. At the time of the report, the patient's outcome was unknown. Erythema at area of injection site, body aches and fever were considered to be an other important medical events by the medical assistant. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Deafness unilateral, Ear pain
Clinical narrative: Information has been received from a registered nurse concerning an 81 year old female patient already deaf in left ear with hypertension, diabetes, peripheral vascular disease, renal insufficiency, artherosclerosis, coronary artery disease, VOLTAREN allergy, red dye allergy and sotalol allergy and a history of dialysis who on 28-JUL-2009 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (Lot # 664320/0560Y). Concomitant therapy included NEXIUM, SYNTHROID, LASIX, LANTUS, HUMULIN, LIPITOR, COUMADIN, METROGEL, magnesium unspecified), digoxin, ZAROXOLYN and COREG. On 08-AUG-2009 the patient developed pain in her right ear and then became completely deaf in her right ear. The patient went to the office and was given ROCEPHIN. The patient was currently taking KEFLEX and VERAMYST. The patient had a hearing test performed (results not provided) and a procedure called "ear popper" was also done in the office. At the time of this report, the patient had not recovered. Developed pain in her right ear and became completely deaf in her right ear were considered to be disabling. Additional information has been requested.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: None.  I gave Pentacel inadvertently when I should have given Hib.  The parent was notified of mistake by Dr.  No actual adverse event - see attached - this was a report of an inadvertent use of PENTACEL instread of HIB.
Age: 1.3
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash papular, Varicella post vaccine
Clinical narrative: 15 days after varicella vaccine developed defused smaller varicella papule some with vesicles trunk + head shortly after fever to 103-104.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Hypersensitivity, Injection site swelling
Clinical narrative: From knee up on left leg swollen.  Allergic reaction to vaccine - polio shot.
Age: 0.7
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Injection site erythema
Clinical narrative: Redness to thigh quarter sz. 8/13/09.  Warm compresses.  8/14/09 site not as red per mom.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Headache
Clinical narrative: Within 10 minutes of receiving vaccine, Pt c/o abrupt severe H/A 0 SOB 0 hives 0 local reaction.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Borrelia burgdorferi serology, Full blood count, Red blood cell sedimentation rate, Unevaluable event
Clinical narrative: None stated.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Patient received MMR injection left deltoid on 8/14/2009. States she developed a rash starting at the injection site which was covered by a band aid. She has an allergy to adhesive. The band aid used is latex free. She is not on any medications. No food allergies. No new cosmetics or lotions/soaps. The rash has spread to involve her arms, legs and trunk. Rash is fine grain and pruritic. Heart NSR Lungs Clear. No difficulty breathing. No facial swelling or erythema. Has a fine grain erythematous rash on her arms, legs chest, abdomen and back.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: High fever, nausea, stiff neck 103 degree fever according to mother.  Did not go to ER, treated at home.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Dizziness, Nausea, Pallor, Tinnitus
Clinical narrative: 5 min after rec GARDASIL, HAVRIX & VARIVAX inj - pt became pale, lightheaded - nausea ringing in ears - pt laid on exam table recovered.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash papular, Skin discolouration
Clinical narrative: Itching - mostly on chest - arm and head.  This lasted 3 weeks small bumps and uneven skin.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Eyelid oedema
Clinical narrative: Pt noticed right eyelid swollen.  No other symptoms.  Instructed by MD to monitor.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Extreme redness, warmth of left arm from shoulder to elbow.  Swelling also present.  Mother stated left arm looked much better than it had on 08/15/09.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swollen and warm to touch redness about 2 inches in diameter.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache, Heart rate increased
Clinical narrative: Dizzy, headache, increased heart rate.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Erythema, Musculoskeletal pain, Skin warm
Clinical narrative: Pain in chest and along shoulder blade on left side, red & warm to the touch.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Vasovagal syncope w/in 2 minutes of GARDASIL administration.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Eye pain, Myalgia, Nausea, Paraesthesia, Vomiting
Clinical narrative: Pain behind eye vomiting, nausea; paresthesia of right fingertips, aching in thighs; No treatment.
Age: 0.1
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Injection site erythema, Injection site warmth
Clinical narrative: Patient was crying for about 6hrs; Right thigh was red and warm.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site erythema
Clinical narrative: 5x7cm red area noted to LT injection site
Age: 48.0
Sex: M
Vaccine: TD
Symptoms: Rash
Clinical narrative: Rash (localized)
Age: 15.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site lymphadenopathy, Injection site pruritus, Injection site warmth
Clinical narrative: Has large lump - tennis ball size at site of injection. Site red, hot and itchy.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt received PPV23 in his right arm on 08/17/09 at 2:40 p.m. On 08/18/09, pt was complaining of redness, pain, and swelling to right arm where vaccine was administered. Pt denies fever, chills, SOB, or chest pain. Pt was diagnosed with cellulitis on 08/19/09 and started treatment on 08/20/09. Pt is on Keflex 250 mg, four times a day, for 10 days.
Age: 24.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Contraindication to vaccination
Clinical narrative: Patient noted a history of eczema on the screening form.  The provider reviewed medical records both hard copy and digital and found no documentation of history, nor any prescribed medications for treatment of eczema.  Directed immunizations tech to immunize patient.  Patient denied having any active skin conditions.
Age: 54.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Two days of wide spread urticarial eruption, very pruitic,covering her torso and upper thighs and upper extremities. Treated with oral anti-histamine and resolved in 2-3 days.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Bite, Erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Following my fourth rabies booster shot, I developed a large red lump in the same arm later that day.  It was sore, but did not itch.  It was further down the arm than the shot that was administered.  After a couple days, the swelling and redness decreased, but two weeks later I still have a small lump under the skin.  This is also the same arm that I was bitten.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Pain in extremity, Swelling
Clinical narrative: Following my fourth rabies booster shot, I developed a large red lump in the same arm later that day.  It was sore, but did not itch.  It was further down the arm than the shot that was administered.  After a couple days, the swelling and redness decreased, but two weeks later I still have a small lump under the skin.  This is also the same arm that I was bitten.
Age: 53.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Wide spread urticarial pruitic rash. No respiratory difficulties or systemic symptoms.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Convulsion
Clinical narrative: had seizure 3 days after vaccines given
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: MULTIPLE SATELLITE LESIONS OVER BACK & FACE & ARM 3 WEEKS AFTER VACCINATION
Age: 14.0
Sex: F
Vaccine: MEN, HPV4, MNQ
Symptoms: Asthenia, Blindness transient, Dizziness, Immediate post-injection reaction
Clinical narrative: She got very dizzy immediately after vacinne.  Nurse had to catch her and help me put her in chair.  She sat there for awhile.  Then I took her into the waiting room (had to support her a lot).  I again had to put all of her weight on me to take her to my car and get her home.  I'm VERY disturbed that this could have been serious.  They didn't even have her stay at medical center until she felt better.  She said that she couldn't see while feeling this way.
Age: 14.0
Sex: F
Vaccine: MEN, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: She got very dizzy immediately after vacinne.  Nurse had to catch her and help me put her in chair.  She sat there for awhile.  Then I took her into the waiting room (had to support her a lot).  I again had to put all of her weight on me to take her to my car and get her home.  I'm VERY disturbed that this could have been serious.  They didn't even have her stay at medical center until she felt better.  She said that she couldn't see while feeling this way.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Diarrhoea
Clinical narrative: Pt had Tdap and varicella shots 6/1/09.  Pt's mom reported to me yesterday that pt had bad diarrhea the day after the vaccines were given.  Had seen that Tdap and be associated with Gi sx and reported this to me.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Adverse event
Clinical narrative: Patients mother reports that at 2:00 AM on 8/19/2009, patient had what appeared to her to be a possible seizure. Mother called our office around 8:30AM and was advised to bring her daughter into the office to be seen by Dr.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Erythema, Induration, Mobility decreased, Musculoskeletal pain
Clinical narrative: 8-18-09 Pt with severe left arm induration and erythema extending from elbow to left shoulder with painful ROM.  Tx'd with Medrol dose pack and Benadryl 25mg q 6hrs. 8-21-09 Pt in for f/u appt; Symptoms are resolving and discharged from care.
Age: 39.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Lymphadenopathy
Clinical narrative: Pt was initially vaccinated for smallpox on 08 Jul 09.  he had an equivocal take so he was revaccinated on 12 Aug 09.  pt presented to the clinic 20 Aug 09 with red, hard, swollen knots at vaccination site right shoulder and right clavicle. Also pt had a swollen lymph node on right side of neck.
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Dysphonia, Inappropriate schedule of drug administration, Pruritus, Urticaria
Clinical narrative: Was informed child was on Zithromax day immunization given. Deferred kindergarden shots but gave HIB. Thought  4th Hib needed as only 3 doses  on our record.  Today Mother called stated she had dose 05/04/2006. Also reported 8/20/09 child was hoarse, C/O of scratchy throat and broke out in hives that were itchy on entire body.  Was taken to ER and doctor put on Benadryl.  Thought was due to combination of zithromax and immunization.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Arm where Tdap and varicella vaccines administered reported to have a reddened, hard, warm, soft-ball sized lump at site of Tdap injection.  Also reported that child "felt feverish."
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: 8-20-09--Pt. came to medical center presenting with a rash on his face, torso, back, and legs.  Raised, red, itchy rash noted.  Preceded by 2 days of fever as reported by his mother.  No fever today.  To date pt. had previously recieved 4 Dtap's with the last one on 1-12-06.  He also received 3 IPV's with the last one on 11-5-04.  PHN suggested seeing an MD. Per RN
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Anorexia, Blood creatine phosphokinase increased, Blood creatinine normal, Blood sodium increased, Calcium ionised decreased
Clinical narrative: rapid heart beat,weakness of the left arm and leg,trouble breathing,severe chest pain, pain in the arm and leg, large red welts on left side of neck and left thigh which evoled to bruises,dizziness and trouble walking,loss of appetite,tingling in the hand and arm. Sypmtoms persisted on and off until 8/18/09 when she developed sorethroat and fever. Fever ressolved 8/19/09.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Chest pain, Contusion, Dizziness, Dyspnoea, Gait disturbance
Clinical narrative: rapid heart beat,weakness of the left arm and leg,trouble breathing,severe chest pain, pain in the arm and leg, large red welts on left side of neck and left thigh which evoled to bruises,dizziness and trouble walking,loss of appetite,tingling in the hand and arm. Sypmtoms persisted on and off until 8/18/09 when she developed sorethroat and fever. Fever ressolved 8/19/09.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Heart rate increased, Hemiparesis, Muscular weakness, Nuclear magnetic resonance imaging normal, Oropharyngeal pain
Clinical narrative: rapid heart beat,weakness of the left arm and leg,trouble breathing,severe chest pain, pain in the arm and leg, large red welts on left side of neck and left thigh which evoled to bruises,dizziness and trouble walking,loss of appetite,tingling in the hand and arm. Sypmtoms persisted on and off until 8/18/09 when she developed sorethroat and fever. Fever ressolved 8/19/09.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Pain in extremity, Paraesthesia, Pyrexia, Urticaria, White blood cell count increased
Clinical narrative: rapid heart beat,weakness of the left arm and leg,trouble breathing,severe chest pain, pain in the arm and leg, large red welts on left side of neck and left thigh which evoled to bruises,dizziness and trouble walking,loss of appetite,tingling in the hand and arm. Sypmtoms persisted on and off until 8/18/09 when she developed sorethroat and fever. Fever ressolved 8/19/09.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Laboratory test
Clinical narrative: rapid heart beat,weakness of the left arm and leg,trouble breathing,severe chest pain, pain in the arm and leg, large red welts on left side of neck and left thigh which evoled to bruises,dizziness and trouble walking,loss of appetite,tingling in the hand and arm. Sypmtoms persisted on and off until 8/18/09 when she developed sorethroat and fever. Fever ressolved 8/19/09.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Somnolence
Clinical narrative: PT WAS GIVEN THIRD HEP B TO SOON. OTHER VACCINES WERE ADMINISTERED AT THIS VISIT ALSO. MOM WAS CONCERNED BECAUSE PT WAS SLEEPING ALOT AFTER VACCINES. HP REASURED PT MOM THAT HEP B WOULD NOT HARM PT AND SLEEPINESS WAS PROB COMING FROM PENTACEL THAT WAS GIVEN ON THIS DATE.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Hypotension, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Left deltoid swelling, pain, erythema; hypotension with fever to 102F.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Dizziness, Nausea, Orthostatic hypotension, Viral infection
Clinical narrative: Dizziness, nausea, vomiting starting 4-5 hrs after shot and lasting for several days.  On 8/21/09, orthostatic hypotension noted, temp 99.2.  Viral illness suspected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Dizziness, nausea, vomiting starting 4-5 hrs after shot and lasting for several days.  On 8/21/09, orthostatic hypotension noted, temp 99.2.  Viral illness suspected.
Age: 39.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Dizziness, Gait disturbance, Head discomfort
Clinical narrative: Received vaccines at 4:30 pm. At 11:00 pm she rolled over in bed and head felt heavy. At 5:30 am she woke up dizzy and the room was spinning. Was able to get up after 3 minutes but was wobbly. Upon arrising on 2nd day felt like she was on a "moving ship". This lasted about 10 minutes.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Staphylococcal infection
Clinical narrative: Pt. was given the vaccine at 4:00 PM on 7/30/2009.  He returned to the clinic on 8/1/2009 with a localized area of errythema and edema at the injection site.  He was referred to his PCP.  The PCP diagnosed pt. with a staph infection at the injection site and he was placed on antibiotics for 10 days.  He fully recovered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Arm swelling from elbow to shoulder, skin redness, itching and fluid-filled blisters at injection site.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Within a day after Shingles shot, I developed stiffness and pain on movement of my left shoulder which has persisted from 5/23/09  to the present. Prolem is worse after inactivity, especially if I have been exercising those muscles previously. Most persistent soreness is near biceps tendon, but pain occurs in other areas around the shoulder and neck.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Antinuclear antibody positive, Back pain, Disturbance in attention, Dizziness
Clinical narrative: Light-headed, dizzy, and nauseous immediately after vaccination. Since vaccination: headache, severe fatigue, numbness/tingling in extremities, sharp lower back pain, shoulder pain, hair-loss, memory 'fog'/concentration difficulties, breathing problems, muscle twitching, leg/arm cramping, insomnia, rapid heart beat, overall soreness, GI problems.  9/28/09 Neurology consult received DOS 2/13/08 to 6/6/2008 Assessment: Fibromyalgia. Restless leg syndrome. Patient presents with chronic lower back pain and paresthesias. Developed numbness and tingling "pins and needles" affecting anterior thighs/lower extremities and upper extremities, also including left hand. Gait affected, using wheelchair. Decreased sensation to light touch, pinprick and vibration right upper and lower extremities. Reflexes asymmetrical. Hoffman sign on right. Involutary loss of urine with activity. Post LP headaches, nausea, not eating or drinking very much. Muscle twitching. Difficulty falling asleep.   9/28/09 Rheumatology consult received DOS 2/15/08 to 2/29/08. Assessment: Likely demyelinating process of unclear etiology. Post lumbar puncture headache. Emotional lability brought on by stress of current illness. Patient c/o "legs falling asleep", lower back pain, "pins and needles" right and left arms. Thinning hair. Atypical Raynaud's symptoms, fingers appear dusky, livedo orver dorsum of hand. Eyes dry. Disconjugate movements extraocular muscles.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Electroencephalogram abnormal, Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: Light-headed, dizzy, and nauseous immediately after vaccination. Since vaccination: headache, severe fatigue, numbness/tingling in extremities, sharp lower back pain, shoulder pain, hair-loss, memory 'fog'/concentration difficulties, breathing problems, muscle twitching, leg/arm cramping, insomnia, rapid heart beat, overall soreness, GI problems.  9/28/09 Neurology consult received DOS 2/13/08 to 6/6/2008 Assessment: Fibromyalgia. Restless leg syndrome. Patient presents with chronic lower back pain and paresthesias. Developed numbness and tingling "pins and needles" affecting anterior thighs/lower extremities and upper extremities, also including left hand. Gait affected, using wheelchair. Decreased sensation to light touch, pinprick and vibration right upper and lower extremities. Reflexes asymmetrical. Hoffman sign on right. Involutary loss of urine with activity. Post LP headaches, nausea, not eating or drinking very much. Muscle twitching. Difficulty falling asleep.   9/28/09 Rheumatology consult received DOS 2/15/08 to 2/29/08. Assessment: Likely demyelinating process of unclear etiology. Post lumbar puncture headache. Emotional lability brought on by stress of current illness. Patient c/o "legs falling asleep", lower back pain, "pins and needles" right and left arms. Thinning hair. Atypical Raynaud's symptoms, fingers appear dusky, livedo orver dorsum of hand. Eyes dry. Disconjugate movements extraocular muscles.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased, Hypoaesthesia, Immediate post-injection reaction, Insomnia, Muscle spasms
Clinical narrative: Light-headed, dizzy, and nauseous immediately after vaccination. Since vaccination: headache, severe fatigue, numbness/tingling in extremities, sharp lower back pain, shoulder pain, hair-loss, memory 'fog'/concentration difficulties, breathing problems, muscle twitching, leg/arm cramping, insomnia, rapid heart beat, overall soreness, GI problems.  9/28/09 Neurology consult received DOS 2/13/08 to 6/6/2008 Assessment: Fibromyalgia. Restless leg syndrome. Patient presents with chronic lower back pain and paresthesias. Developed numbness and tingling "pins and needles" affecting anterior thighs/lower extremities and upper extremities, also including left hand. Gait affected, using wheelchair. Decreased sensation to light touch, pinprick and vibration right upper and lower extremities. Reflexes asymmetrical. Hoffman sign on right. Involutary loss of urine with activity. Post LP headaches, nausea, not eating or drinking very much. Muscle twitching. Difficulty falling asleep.   9/28/09 Rheumatology consult received DOS 2/15/08 to 2/29/08. Assessment: Likely demyelinating process of unclear etiology. Post lumbar puncture headache. Emotional lability brought on by stress of current illness. Patient c/o "legs falling asleep", lower back pain, "pins and needles" right and left arms. Thinning hair. Atypical Raynaud's symptoms, fingers appear dusky, livedo orver dorsum of hand. Eyes dry. Disconjugate movements extraocular muscles.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle twitching, Musculoskeletal pain, Nausea, Pain, Pain in extremity
Clinical narrative: Light-headed, dizzy, and nauseous immediately after vaccination. Since vaccination: headache, severe fatigue, numbness/tingling in extremities, sharp lower back pain, shoulder pain, hair-loss, memory 'fog'/concentration difficulties, breathing problems, muscle twitching, leg/arm cramping, insomnia, rapid heart beat, overall soreness, GI problems.  9/28/09 Neurology consult received DOS 2/13/08 to 6/6/2008 Assessment: Fibromyalgia. Restless leg syndrome. Patient presents with chronic lower back pain and paresthesias. Developed numbness and tingling "pins and needles" affecting anterior thighs/lower extremities and upper extremities, also including left hand. Gait affected, using wheelchair. Decreased sensation to light touch, pinprick and vibration right upper and lower extremities. Reflexes asymmetrical. Hoffman sign on right. Involutary loss of urine with activity. Post LP headaches, nausea, not eating or drinking very much. Muscle twitching. Difficulty falling asleep.   9/28/09 Rheumatology consult received DOS 2/15/08 to 2/29/08. Assessment: Likely demyelinating process of unclear etiology. Post lumbar puncture headache. Emotional lability brought on by stress of current illness. Patient c/o "legs falling asleep", lower back pain, "pins and needles" right and left arms. Thinning hair. Atypical Raynaud's symptoms, fingers appear dusky, livedo orver dorsum of hand. Eyes dry. Disconjugate movements extraocular muscles.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Light-headed, dizzy, and nauseous immediately after vaccination. Since vaccination: headache, severe fatigue, numbness/tingling in extremities, sharp lower back pain, shoulder pain, hair-loss, memory 'fog'/concentration difficulties, breathing problems, muscle twitching, leg/arm cramping, insomnia, rapid heart beat, overall soreness, GI problems.  9/28/09 Neurology consult received DOS 2/13/08 to 6/6/2008 Assessment: Fibromyalgia. Restless leg syndrome. Patient presents with chronic lower back pain and paresthesias. Developed numbness and tingling "pins and needles" affecting anterior thighs/lower extremities and upper extremities, also including left hand. Gait affected, using wheelchair. Decreased sensation to light touch, pinprick and vibration right upper and lower extremities. Reflexes asymmetrical. Hoffman sign on right. Involutary loss of urine with activity. Post LP headaches, nausea, not eating or drinking very much. Muscle twitching. Difficulty falling asleep.   9/28/09 Rheumatology consult received DOS 2/15/08 to 2/29/08. Assessment: Likely demyelinating process of unclear etiology. Post lumbar puncture headache. Emotional lability brought on by stress of current illness. Patient c/o "legs falling asleep", lower back pain, "pins and needles" right and left arms. Thinning hair. Atypical Raynaud's symptoms, fingers appear dusky, livedo orver dorsum of hand. Eyes dry. Disconjugate movements extraocular muscles.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling from site of injection past elbow. Started approx 24 hours after injection given and has progressed. Denies any temp.
Sex: M
Vaccine: TDAP
Symptoms: Foetal disorder, Streptococcal identification test positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of group b streptococcus in an infant male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On unspecified dates (either within three months prior to or during pregnancy) the subject's mother received prenatal vitamins and calcium. On 18 November 2008 at 10:15 the subject received unspecified dose of BOOSTRIX (.5 ml, transplacentary). The subject was born via spontaneous vaginal delivery at 38 weeks gestation. Weight was 3.28 kg. Apgar scores were 8 at one minute and 9 at five minutes. He was reported to be a healthy infant. At an unspecified time after vaccination with BOOSTRIX, the subject experienced positive group b streptococcus and "meconium". Fetal/neonatal status was reported to be normal; however, chorioanmionitis (see case A0758632A for mother case), positive group b streptococcus and "meconium" were also reported. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Colitis ulcerative, Colonoscopy abnormal, Condition aggravated, Diarrhoea, Gastrointestinal oedema
Clinical narrative: This case was reported and described the occurrence of mild ulcerative colitis in a 52-year-old female subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified). The subject had been passing bloody mucus intermittently for 3 years before a diagnosis of ulcerative proctitis was made at colonoscopy. She improved on sulfasalazine and hydrocortisone enemas, but after stopping medication the subject had recurrent rectal bleeding and coincident uveitis. She was then treated with oral prednisone and the sulfasalazine was restarted. The sigmoidoscopy showed more extensive friability and exudate and the subject was hospitalized for intravenous hydrocortisone. The subject was also started on Mercaptopurine (6-mercaptopurine) at 50mg/day. She improved quickly and was discharged on sulfasalazine, tapering doses of prednisone, and an increase in 6-mercaptopurine to 100mg./day. The sigmoidoscopic appearance had been normal for 4 months when symptoms worsened, with loosening of the stools and reappearance of blood per rectum. On flexible sigmoidmoidoscopy, mucosal friability and edema were again found in rectum and rectosigmoid. The subject stated that her exacerbation had followed an Influenza vaccine shot. After 3 more months on 6-mercaptopurine during which the dose was reduced to 50mg/day because of leukopenia, the subject was much improved, having formed stools with normal mucosa throughout at colonoscopy. After 9 months on 6-mercaptopurine, the subject was in remission. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. After the next vaccination with Influenza vaccine the events recurred. The reporter considered the events were almost certainly related to vaccination with Influenza vaccine. Please refer to case B0589174B for adverse events following the next vaccination with Influenza vaccine.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Leukopenia, Oedema, Proctitis ulcerative, Rectal haemorrhage, Sigmoidoscopy abnormal
Clinical narrative: This case was reported and described the occurrence of mild ulcerative colitis in a 52-year-old female subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified). The subject had been passing bloody mucus intermittently for 3 years before a diagnosis of ulcerative proctitis was made at colonoscopy. She improved on sulfasalazine and hydrocortisone enemas, but after stopping medication the subject had recurrent rectal bleeding and coincident uveitis. She was then treated with oral prednisone and the sulfasalazine was restarted. The sigmoidoscopy showed more extensive friability and exudate and the subject was hospitalized for intravenous hydrocortisone. The subject was also started on Mercaptopurine (6-mercaptopurine) at 50mg/day. She improved quickly and was discharged on sulfasalazine, tapering doses of prednisone, and an increase in 6-mercaptopurine to 100mg./day. The sigmoidoscopic appearance had been normal for 4 months when symptoms worsened, with loosening of the stools and reappearance of blood per rectum. On flexible sigmoidmoidoscopy, mucosal friability and edema were again found in rectum and rectosigmoid. The subject stated that her exacerbation had followed an Influenza vaccine shot. After 3 more months on 6-mercaptopurine during which the dose was reduced to 50mg/day because of leukopenia, the subject was much improved, having formed stools with normal mucosa throughout at colonoscopy. After 9 months on 6-mercaptopurine, the subject was in remission. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. After the next vaccination with Influenza vaccine the events recurred. The reporter considered the events were almost certainly related to vaccination with Influenza vaccine. Please refer to case B0589174B for adverse events following the next vaccination with Influenza vaccine.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Uveitis, Vaccination complication
Clinical narrative: This case was reported and described the occurrence of mild ulcerative colitis in a 52-year-old female subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified). The subject had been passing bloody mucus intermittently for 3 years before a diagnosis of ulcerative proctitis was made at colonoscopy. She improved on sulfasalazine and hydrocortisone enemas, but after stopping medication the subject had recurrent rectal bleeding and coincident uveitis. She was then treated with oral prednisone and the sulfasalazine was restarted. The sigmoidoscopy showed more extensive friability and exudate and the subject was hospitalized for intravenous hydrocortisone. The subject was also started on Mercaptopurine (6-mercaptopurine) at 50mg/day. She improved quickly and was discharged on sulfasalazine, tapering doses of prednisone, and an increase in 6-mercaptopurine to 100mg./day. The sigmoidoscopic appearance had been normal for 4 months when symptoms worsened, with loosening of the stools and reappearance of blood per rectum. On flexible sigmoidmoidoscopy, mucosal friability and edema were again found in rectum and rectosigmoid. The subject stated that her exacerbation had followed an Influenza vaccine shot. After 3 more months on 6-mercaptopurine during which the dose was reduced to 50mg/day because of leukopenia, the subject was much improved, having formed stools with normal mucosa throughout at colonoscopy. After 9 months on 6-mercaptopurine, the subject was in remission. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. After the next vaccination with Influenza vaccine the events recurred. The reporter considered the events were almost certainly related to vaccination with Influenza vaccine. Please refer to case B0589174B for adverse events following the next vaccination with Influenza vaccine.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Colectomy total, Colitis ulcerative, Condition aggravated, Cushingoid
Clinical narrative: This case was reported in a literature article and described the occurrence of severe exacerbation of ulcerative colitis in a 52-year-old female subject who was vaccinated with Influenza (manufacturer unspecified). Please refer to case B0589174A for adverse events following vaccinations with previous dose of Influenza vaccine. The subject's medical history included bloody mucus, leukopenia, loose stools, rectal bleeding, ulcerative colitis flare, ulcerative proctitis and uveitis. Concurrent medication included Mercaptopurine. After 9 months on 6-mercaptopurine and while in remission, the subject received an injection of Influenza vaccine (subcutaneous, unknown injection site), lot number not provided. At night, the developed abdominal pain and bloody diarrhea. On examination she had very active ulcerative colitis with friability, ulceration and exudate. The subject also had recurrence of bilateral uveitis. She was hospitalized and treated with intravenous adrenocorticotropin hormone (ACTH) followed by tapering doses of prednisone. Again she improved, but incompletely. The 6-mercaptopurine was increased to 150 mg/day and the subject required larger doses of steroids, becoming very cushingoid. The ulcerative colitis was never again brought under control so that the subject was steroid-resistant and steroid-dependent. This time the ulcerative colitis was fulminant and clearly related in time. One year after the diagnosis of ulcerative colitis was established, the chronicity of her illness and the complications of steroids warranted surgical intervention. The subject underwent a total colectomy with establishment of an ileoanal pouch anastomosis. Pathology confirmed the presence of a universal ulcerative colitis and there was no involvement of the terminal ileum. After 1 year with intermittent pouchitis, the pouch and the ileum looked normal. At the time of reporting the events were resolved. The author considered the events were almost certainly related to vaccination with Influenza vaccine.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea haemorrhagic, Intestinal anastomosis, Pouchitis, Surgery, Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of severe exacerbation of ulcerative colitis in a 52-year-old female subject who was vaccinated with Influenza (manufacturer unspecified). Please refer to case B0589174A for adverse events following vaccinations with previous dose of Influenza vaccine. The subject's medical history included bloody mucus, leukopenia, loose stools, rectal bleeding, ulcerative colitis flare, ulcerative proctitis and uveitis. Concurrent medication included Mercaptopurine. After 9 months on 6-mercaptopurine and while in remission, the subject received an injection of Influenza vaccine (subcutaneous, unknown injection site), lot number not provided. At night, the developed abdominal pain and bloody diarrhea. On examination she had very active ulcerative colitis with friability, ulceration and exudate. The subject also had recurrence of bilateral uveitis. She was hospitalized and treated with intravenous adrenocorticotropin hormone (ACTH) followed by tapering doses of prednisone. Again she improved, but incompletely. The 6-mercaptopurine was increased to 150 mg/day and the subject required larger doses of steroids, becoming very cushingoid. The ulcerative colitis was never again brought under control so that the subject was steroid-resistant and steroid-dependent. This time the ulcerative colitis was fulminant and clearly related in time. One year after the diagnosis of ulcerative colitis was established, the chronicity of her illness and the complications of steroids warranted surgical intervention. The subject underwent a total colectomy with establishment of an ileoanal pouch anastomosis. Pathology confirmed the presence of a universal ulcerative colitis and there was no involvement of the terminal ileum. After 1 year with intermittent pouchitis, the pouch and the ileum looked normal. At the time of reporting the events were resolved. The author considered the events were almost certainly related to vaccination with Influenza vaccine.
Age: 1.4
Sex: F
Vaccine: DTAP, MEN, TTOX
Symptoms: Computerised tomogram normal, Crying, Dry skin, Endotracheal intubation, Floppy infant
Clinical narrative: This female subject was enrolled in a prophylactic open study. On 26 June 2009, she received the dose of MENINGOCOCCAL-TETANUS TOXIOD. On 12 August 2009, 47 days after the 1st dose of INFANRIX, 47 days after the 1st dose of MENINGOCOCCAL-TETANUS TOXIOD, this 18-month old subject became floppy. The subject was hospitalised and the event was life-threatening and clinically significant (or requiring intervention). The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the floppy infant may have been caused by INFANRIX and MENINGOCOCCAL-TETANUS TOXIOD. Investigator Comments: Normally healthy child 'not acting right' when she awoke from a nap at 9.00pm on 12 August 2009. On arrival at ER (emergency room) child's extremities were flaccid and she could not hold her head up. At the time she was alert and demonstrated abdominal muscle breathing without respiratory distress, although her pulse oximeter reading was 79%. Demonstrated withdrawal to pain with PIV placement, crying on assessment and during PIV placement, remaining alert. On initial exam her pupils were round and reactive, she was crying and she slightly withdrew when stuck for blood but demonstrated no other muscle action except for movements of her head. Her neck was supple at all exams. Within 30 minutes her pupils became pinpoint and she became unresponsive to touch or voice. She was intubated at that time. PO was still 100% on oxygen and she still demonstrated abdominal breathing. CV: tachycardia. Lungs - clear. Abdomen - soft. Diaper area - no trauma, no rashes. Back: few papules consistent with mosquito bites. Extremities - flaccid, no bruising, warm and dry. Neuro: initially appeared alert with appropriate cry then deteriorated to unresponsive, but was able to cry again when initial preparations to intubation occurred. CT of head without contrast - normal. CBC and BMP - normal. Anesthesia at bedside for intubation - 50mcg of PROPOFOL. Fentanyl and Versed administered post-procedure. Child with spontaneous respirations. Placed on CPAP Fio2 50% rate 25. Transferred to hospital as in critical condition without confirmed diagnosis. No further information available at this time. Additional information 14 August 2009: On the evening of August 12 the child was with grandmother and upon mom's return home she noticed that the child was not acting as usual - the ER is very close by, so mom took the child in - (child became unresponsive, POx 79% and was intubated in ER then transferred to another hospital where continues to be intubated but slowly becoming responsive; head CT was negative).