chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood glucose increased, Blood pressure increased, Cold sweat, Dizziness
Clinical narrative: Patient was given HPV #3.  Right arm today, complained of pain.  Stated she felt dizzy, tried to get patient to lie down.  Stated she felt better, walked out of room, fell forward, cold, clammy.  Blood pressure 120/80 immediately.  Pox 1007, pulse 103-124.  Stated had headache today.  RBS done 127.  Mother states patient's blood pressure has been up with headache.  170/95 per mother.  Eye doctor called for visit, stated she got pale and weak on days of appointment.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Headache, Nasopharyngitis, Pain, Pallor
Clinical narrative: Patient was given HPV #3.  Right arm today, complained of pain.  Stated she felt dizzy, tried to get patient to lie down.  Stated she felt better, walked out of room, fell forward, cold, clammy.  Blood pressure 120/80 immediately.  Pox 1007, pulse 103-124.  Stated had headache today.  RBS done 127.  Mother states patient's blood pressure has been up with headache.  170/95 per mother.  Eye doctor called for visit, stated she got pale and weak on days of appointment.
Age: 28.0
Sex: M
Vaccine: ANTH, HEP, TDAP, TYP
Symptoms: Erythema, Lymphadenopathy, Oedema peripheral
Clinical narrative: redness, swelling 9.5 x 7.5 erythema on rt arm with l axillary lymph node felt
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain upper, Crying, Diet refusal, Screaming
Clinical narrative: Began screaming inconsolably about 5 hrs after vaccines.  Wouldn't breast feed.  Mom states she acts like her belly hurts.  Suggest Tylenol, warm bath & comf measures.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Local reaction at inj. site. 4" in diameter, reddened area. Area firm and warm to touch. Pt's BP 145/82.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema
Clinical narrative: Erythema about 14x7cm distal to vaccination site noted 11/28/07, resolving by 29Nov07.
Age: 0.7
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Crying, Pyrexia, Vomiting
Clinical narrative: Fever, anorexia, vomiting and crying developed about 4 hours after Fluzone administration (first dose). Symptoms continued for about 48 hours and then completely resolved by 72 hours (Fever max was 102).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Soreness in left upper arm for 4 weeks without resolution.  Hard to move left arm, painful
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Within minutes of the injection, shoulder pain started and hasn't resolved, now fourth week later.  Symptoms: dull ache in right shoulder, twinging pain with lifting arm, inability to use arm for some daily functions due to pain/weakness, pain at night, pain with palpatations at site of injection, treatment so far - ice or heat, ROM, Ultrasound.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RV5
Symptoms: Rotavirus infection
Clinical narrative: Patient developed Rotavirus infection while traveling overseas. Infection confirmed by lab tests.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Vomiting
Clinical narrative: Severe headaches had to see private doctor (also noted) vomiting Dr prescribed Maxalt-MH 10 mg tab
Age: 0.8
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Pyrexia, Tachypnoea, Vomiting
Clinical narrative: Rxn - vomiting, paleness, fever, tachypnea. Tx - Motrin at hospital
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site pain, Injection site swelling, Neck pain, Pyrexia
Clinical narrative: Localized pain/swelling at injection site.  Headache, neck pain, fever last night (11-16-07).  11-17-07 ER visit.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to arthropod sting, Chills, Pruritus generalised, Urticaria
Clinical narrative: I had the flu shot 11-7-07 at around 11:00 am. At around 11:00 pm. I woke up itching all over. By 4:00 a.m. 11-8-07 I had hives all over. I went to the emergency room and was treated. I also had chills. This lasted through Friday evening. 11-9-07
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Lethargy, Pain, Pallor
Clinical narrative: Mom reported the evening of the shot (shot given at 210 PM) he experienced dizziness "all the time" and his color was bad. He's achy and also had a sore throat. Dizziness and paleness continued about a couple days so that's why she called us 11-16-07. He did go back to work, but very groggy and tired - lethargic.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain, Somnolence
Clinical narrative: Mom reported the evening of the shot (shot given at 210 PM) he experienced dizziness "all the time" and his color was bad. He's achy and also had a sore throat. Dizziness and paleness continued about a couple days so that's why she called us 11-16-07. He did go back to work, but very groggy and tired - lethargic.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram ambulatory, Heart rate increased, Palpitations
Clinical narrative: Nov. 2 - Friday - By next morning heart was erratic, pounding, extremely rapid.  Nov. 3 - Saturday - even worse - Sunday - somewhat better.  Monday - called health department.  Saw doctor at 12:00.  Heart monitor for 24 hours.  1 week before results, some improvement.  Nov 12 thru Nov. 16, cardiologist, more improvement.  Today, Nov. 25, still had some erratic throughout day.  Called health department.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Local reaction, Mass, Neck pain, Pain in extremity
Clinical narrative: Large local reaction in left deltoid area with hardened lump and soreness.  States soreness went up into her neck.  Had sinus congestion, no temp.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Sinus congestion
Clinical narrative: Large local reaction in left deltoid area with hardened lump and soreness.  States soreness went up into her neck.  Had sinus congestion, no temp.
Age: 49.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Arm within a few hrs of the vaccines turned red, hot & swollen.  Took 5 days for symptoms to resolve on their own.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Discomfort, Erythema, Local reaction, Oedema peripheral, Skin warm
Clinical narrative: Large local Rxn 24 hours after flu shot.  Left arm swollen and tense shoulder to elbow, with redness. Warmth, mild discomfort on arm and hand.  Neurovascular intact.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Tension
Clinical narrative: Large local Rxn 24 hours after flu shot.  Left arm swollen and tense shoulder to elbow, with redness. Warmth, mild discomfort on arm and hand.  Neurovascular intact.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Pyrexia, Rash macular, Skin warm, Urticaria
Clinical narrative: Big red hive on left cheek which was hot and to touch, then migrated to the ear 2 days later. Cheek was then blotchy with a red mark across the upper lip. Physical symptoms ceased on 11-19-07. Later ran a fever for 6 days on and off.
Age: 14.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Area of warmth, redness and swelling from above elbow to mid arm approx 3"-5".  Mom is RN, didn't want appointment, will just observe.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: large induration approx 8 am mottled redness patchy areas length of upper (Rt) arm noticed at hosp. 11-6-07 pain increased, ice x 2 1:30 pm/ 6 pm
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh red, warm, swollen. The reaction started on 11/19/07 right after immunizations were given but progressively worsened over the next 24 hours.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt said she has/having pain on her left arm, and its painful to lift up her arm, especially from the shoulder to elbow. Analgesics and patches helped a little, but still has the same intensity of pain as before. She got the flu vaccine on 10/10/07.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Gaze palsy, Syncope, Tonic clonic movements
Clinical narrative: Syncopal episode, eyes rolled back, 2 tonic clonic jerks and then awake and alert. Episode lasting 30-40 seconds.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: 13 days after the flu vaccine, patient developed Bell Palsy right side of face.  Patient recovered p.o. steroid.  12/18/07 Reviewed ER medical records which reveal patient experienced acute onset right sided facial droop, unable to close right eye or furow forehead.  Tx w/steroids & antiviral meds & to tape eye at night. PMH: seasonal allergies FINAL DX: Bell's palsy.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood pressure, Blood pressure increased, Body temperature increased, Fatigue, Feeling hot
Clinical narrative: Received flu vaccine in left arm and Pneumonia vaccine in right. Left arm swollen and sore. 8 pm felt quite ill, warm. 11:15 pm Checked Temp 100.9 BP up. Felt tired.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Heart rate, Malaise, Oedema peripheral, Pain in extremity
Clinical narrative: Received flu vaccine in left arm and Pneumonia vaccine in right. Left arm swollen and sore. 8 pm felt quite ill, warm. 11:15 pm Checked Temp 100.9 BP up. Felt tired.
Age: 0.8
Sex: M
Vaccine: FLU3, IPV, PNC
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Next day after receiving vaccine noticed a red swollen quarter sized bump over right thigh - injection site.  Given Motrin.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Neuralgic amyotrophy, Peroneal nerve palsy, X-ray
Clinical narrative: 9/25/07 - Patient developed falling when walking on left foot.  9/26/07 - Patient saw doctor - diagnosis given foot drop.  9/27/07 - Patient saw doctor - diagnosis Parsonage Turner Syndrome.  10/17/07 - Patient saw doctor, better but not 100% recovered. 12/18/07-records received for DOS 9/4/07-C/O injury to anke and tendinitis of her peroneal tendons on the right. Visit 9/26/07-Day prior to visit felt a pop in her foot and since then inabiity to raise the toes, some swelling and bruising in leg. Numbness down in her foot. DX: Spontaneous peroneal nerve injury left leg. PE: footdrop which is incomplete and partial. Visit 9/28/07-Antalgic gait consistent with footdroop and 3/5 tenderness and weakness. DX: Viral peroneal nerve-parsonage-turner syndrome. Visit 10/17/07-Regaining full strength.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: red rash 5 cm diameter, appeared 6 day/after shot given Noticed reaction same day-not reported x 6 days
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Drug hypersensitivity, Erythema, Musculoskeletal stiffness, Pruritus, Rash
Clinical narrative: stiff neck within 12 hr-redness-swelling-hot itchy x 24 hr
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Skin warm, Swelling
Clinical narrative: stiff neck within 12 hr-redness-swelling-hot itchy x 24 hr
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient went to doctor's office and complained of pain in shoulder that radiated to the arm.  Doctor said a possible explanation could be due to flu vaccine.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Received Adacel inj at Clinic day prior to developing 103 deg fever.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Febrile convulsion, White blood cell count increased
Clinical narrative: child had a seizure last night. Temp 101.8 seen at hospital. Dx: Febrile seizure. Had WBC cx of 183 Given Rocephin and Tylenol
Age: 82.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out with shingles one week after receiving shingles vaccine.  Doctor prescribed Famciclovir tab 500 mg which was taken for 7 days. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has been received from a pharmacist concerning an 82 year old female, with no medical history and no known drug allergies, who on 09-NOV-2007 was vaccinated with a 0.65 ml subcutaneous dose of ZOSTAVAX (Lot# 658084/0888U). Concomitant vaccine included a dose of influenza virus vaccine (unspecified). On 15-NOV-2007 the patient had a shingles outbreak. The patient was seen by a physician and was prescribed FAMVIR. The patient's shingles persisted. No product quality complaint was involved. Additional information has been requested.
Age: 1.95
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Medication error, Wrong drug administered
Clinical narrative: Patient given flu mist 14 days prior to 2nd birthday.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bedridden, Chills, Hypersensitivity, Injection site mass, Injection site swelling
Clinical narrative: Client tCD.  L influenza, R pneumovax at clinic 11-16-07.  11-19-07 reported to PHN had a "severe reaction R arm with fever (102) chills, severe swelling at site with marble-sized lump at injection site.  Did not seek ER but spent 5 days in bed.  Advised by PHN to report reaction to family doctor. Do not repeat pneumovax without Dr order.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Client tCD.  L influenza, R pneumovax at clinic 11-16-07.  11-19-07 reported to PHN had a "severe reaction R arm with fever (102) chills, severe swelling at site with marble-sized lump at injection site.  Did not seek ER but spent 5 days in bed.  Advised by PHN to report reaction to family doctor. Do not repeat pneumovax without Dr order.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Convulsion, Loss of consciousness, Syncope
Clinical narrative: Syncope with questionable brief (seconds) seizure that resolved in 10-15 seconds total. Patient rested in office for 15-20 min and drank some water. Had normal vital signs after event. She passed out 15 min after injection.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Induration, Rash papular, Rash pruritic
Clinical narrative: 11/23 1 wk of itching rash started <24 hours after immunizations, tried Xyzal for itch (papular rash).  11/26 No success with Xyzal, changed to Prednisone 40mg BID tapered close for 10 days (papular firm rash) not hives.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Patient was in severe pain at sight worsened overnight, patient went to hospital and was given a shot for pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pruritus
Clinical narrative: Pt describes redness beginning Mon eve-Tues. increased redness, itching began. Continued thru yesterday. Today, day 4, after initial vaccine was administered-17 mm long with pink discolored skin-12 mm wide with slight bruising.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture, Haematochezia, Occult blood
Clinical narrative: blood in stool, no fever, no vomiting, streaks on multiple samples
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Foreign travel, Haematochezia, Occult blood positive
Clinical narrative: Blood in stool (streaks in multiple samples), no fever, no vomiting.  Clinically following, traveled abroad since vaccines.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure, Body temperature increased, Dyspnoea, Heart rate, Local reaction
Clinical narrative: Patient presented at ER with c/o SOB and hives. She stated she started having hives/vasculitis afternoon 11/27-Now processed large areas of vasculitis, legs back, arms. Large local reaction (L) upper arm.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oxygen saturation normal, Respiratory rate increased, Rheumatoid factor, Urticaria, Vasculitis
Clinical narrative: Patient presented at ER with c/o SOB and hives. She stated she started having hives/vasculitis afternoon 11/27-Now processed large areas of vasculitis, legs back, arms. Large local reaction (L) upper arm.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: X-ray
Clinical narrative: Patient presented at ER with c/o SOB and hives. She stated she started having hives/vasculitis afternoon 11/27-Now processed large areas of vasculitis, legs back, arms. Large local reaction (L) upper arm.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Had significant pain in arm 1st few days after vaccine administered. Pain continues like "dull tooth ache deep down to bone" intermittently and when present affects ability to raise arm (right). She was instructed to see MD
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Agitation, Hallucination, Headache, Malaise, Pyrexia
Clinical narrative: On 10/18/07 around noon she started feeling bad - headache, runny nose, fever. Went to bed around 11:00 PM. Woke me (mother) up yelling. She was hallucinating, very frightened and agitated. Thought her room was "torn up" and "seeing pieces of stuff floating everywhere." Felt very hot (fever). This went on for about 4 hours.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea, Screaming, Skin warm
Clinical narrative: On 10/18/07 around noon she started feeling bad - headache, runny nose, fever. Went to bed around 11:00 PM. Woke me (mother) up yelling. She was hallucinating, very frightened and agitated. Thought her room was "torn up" and "seeing pieces of stuff floating everywhere." Felt very hot (fever). This went on for about 4 hours.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis, Irritability, Medication error
Clinical narrative: Child given Flumist into (L) nose with difficulty. Become upset and blew his nose, then second part of Flumist given (R) nose. Had nose bleed for (R) side. Given Kleenex. Spoke to mom about pressure on (R) side of nose.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt was clothing shopping with mom and fiance. She was trying on clothes and c/o severe throbbing pain (L) elbow to wrist at 1 PM. Was given Advil and went home to ice arm.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Neurological examination, Paraesthesia
Clinical narrative: Tingling and numbness to fingers and feet.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Broke out in hives, couldn't breathe (SOB) 1 hr after administration (imbilatory transfer to hospital for admin 515 PM.
Age: 14.0
Sex: M
Vaccine: FLUN3, MNQ, VARCEL
Symptoms: Asthenia, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: Received vaccine on 12/3.  Developed T to 100-101 with emesis, nausea, diarrhea.  Fever X2D, diarrhea X3D.  Still with nausea, diarrhea, general feeling of fatigue & weakness.  Neurol normal.
Age: 14.0
Sex: M
Vaccine: FLUN3, MNQ, VARCEL
Symptoms: Vomiting
Clinical narrative: Received vaccine on 12/3.  Developed T to 100-101 with emesis, nausea, diarrhea.  Fever X2D, diarrhea X3D.  Still with nausea, diarrhea, general feeling of fatigue & weakness.  Neurol normal.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Throat tightness
Clinical narrative: At approximately 4:50 pm immediately after flu shot given, patient complained of throat was tightening and was dizzy.  Gave as prescribed CPI injection to left thigh.  Patient stated she felt "completely" normal.  Refused to go with paramedics to ER.  Patient called office 12/6/07 to report no symptoms of anophylaxis.
Age: 62.0
Sex: F
Vaccine: TYP
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Urticaria drug eruption on trunk of patients body. Itchy erythematous patches treating with Triamsinolone oin and antihistamines
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain, Nausea, Pain, Tremor
Clinical narrative: Approx 12 hours after shot was administered I experienced intense nausea, shakiness, and aches.  These symptoms lasted for approx 24 hour, not resulting in any vomiting.  Weakness and some tenderness around injection site still remains 48 hours after shot.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Headache, Oedema peripheral, Pyrexia, Rash
Clinical narrative: Patient is a 21 yr old hispanic female was given the Gardasil vaccine on Right arm on Friday Nov 30, 2007 at 2:30 p.m. She reports mild fever was given Two Advils P.O. On Sat Dec 1, 2007, she reports mild headache and mild coughing no meds taken at this point. On Sunday Dec 2, 2007 she reports mild ongoing coughing with mild rash on body she reports no meds taken. On Monday Dec 3, 2007 she reports swollen hands with lid edema on right leg and a moderate rash on body. At this point she took Benadryl 2 tablets P.O. every 4 hours, with plenty of liquids.
Age: 32.0
Sex: M
Vaccine: ANTH, HEP, YF
Symptoms: Hyperglycaemia, Nuclear magnetic resonance imaging, Type 1 diabetes mellitus
Clinical narrative: Developed hyperglycemia in early Dec 2005. Symptomatic in early 2006 and diagnosed with T1DM in Apr 2006.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash
Clinical narrative: Developed 2-3 cm local reaction at injection site following day.  The rash at side that continued over the body.  Tried Benadryl, was given Prednisone at doc. visit.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Medical device complication, Muscular weakness, Myalgia, Underdose
Clinical narrative: Gave patient shot in (L) deltoid. Upon pressing plunger, influenza squirted out of syringe all over patient and myself. Retracted syringe and regave new dose with new syringe in (R) deltoid. Pt came to me 12-4-07, states sores in area where vaccinated x 2 days then 7 days later muscle weakness, aches in both arms (shoulder to elbow, no fault). Lasted until MD visit 12-3-07 and was prescribed Naproxen and better but not gone.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: severe pain at site of vaccine lasting several days.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Bradycardia, Depressed level of consciousness, Hypotension, Syncope vasovagal
Clinical narrative: Vasovagal reaction with hypotension and bradycardia and decreased consciousness.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood test, Chills, Fatigue, Headache, Inflammation
Clinical narrative: Next day: chills, achiness, headache, fatigue. Very sore arm, swelling of arm. 12-1-07 Arm still very sore and inflamed-swollen and 2 large red splotches. Went to doctor at medical center-Blood tests, taken, Prescribed Amoxicillin for 10 days.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Next day: chills, achiness, headache, fatigue. Very sore arm, swelling of arm. 12-1-07 Arm still very sore and inflamed-swollen and 2 large red splotches. Went to doctor at medical center-Blood tests, taken, Prescribed Amoxicillin for 10 days.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Induration
Clinical narrative: 4 cm by 2 cm induration on left upper arm
Age: 8.0
Sex: M
Vaccine: FLUN3, VARCEL
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Raised red area very pruritic/raised similar to urticarial wheal. Better after ice applied.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: bad shake's, nauseated, vomiting after 4 hr sweating along w/chills, headache and feeling of faintness. Slight tenderness at site of injection.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Smear cervix, Tremor, Vomiting
Clinical narrative: bad shake's, nauseated, vomiting after 4 hr sweating along w/chills, headache and feeling of faintness. Slight tenderness at site of injection.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Rt arm subcut swelling.  12-4-07 pm-warm, hard to touch & painful, 41 x 27 mm rt. swollen area.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness and discomfort at injection site. Patient advised to apply warm compresses.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness, edema, warmth at injection site 1 day following injection.  Pt. called to report s/s but didn't want to come to clinic to be seen.  Being tx with Zithromax for another condition.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site rash, Pyrexia
Clinical narrative: Rec'd DTaP on 11-19-07. Next day developed fever of 101.4 and rash at injection site followed by cellulitis.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Oedema peripheral
Clinical narrative: Redness/swelling distal (R) arm. Hypersensitivity to vaccine
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: 5 inch band (below injection site) of redness and swelling, cold compress applied night of 11/14/07.  11/15 - patient said getting better, swelling gone down.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Erythema, Rash macular, Skin lesion
Clinical narrative: Quarter-size red blue lesion (R) thigh on 11/17/07. Returned to office on 11/19/07 with macular rash over most of body.
Age: 15.0
Sex: F
Vaccine: IPV
Symptoms: Abasia, Fatigue, Malaise, Muscle twitching, Pyrexia
Clinical narrative: Mom has very broken English but stated pt was tired afternoon of 11-21. Early morning of 11-22, awoke not feeling well, not able to walk, high fever, contractions of arms and hands. Taken to ER and transferred and was released same day.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 13.5 cm x 10.5 cm area of induration surrounding injection site with smaller 4cm x 5cm more erythematous induration at injection site.
Age: 1.21
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC, VARCEL
Symptoms: No adverse reaction
Clinical narrative: No adverse reactions or treatments necessary.
Age: 56.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Hyperhidrosis, Pollakiuria, Pyrexia
Clinical narrative: Uncontrollable chilling-profuse sweating frequent urination-fever of 102-103.
Age: 1.4
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Crying, Fall, Gait disturbance, Hip dysplasia, Injection site inflammation
Clinical narrative: Reaction began w/hives then patient refused to stand/walk-cried and fell down. Due to damage of muscular nerve fibers at injection site there is weakness & inflammation causing a limp and misalignment of hips. Injection site still sore.
Age: 1.4
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Injection site pain, Muscular weakness, Rheumatoid factor negative, Urticaria, X-ray limb abnormal
Clinical narrative: Reaction began w/hives then patient refused to stand/walk-cried and fell down. Due to damage of muscular nerve fibers at injection site there is weakness & inflammation causing a limp and misalignment of hips. Injection site still sore.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Within 24 hrs of shot given swollen (LT) and hot to the touch arm (upper arm/shoulder area).
Age: 1.0
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Urticarial rash, right thigh-worse at injection site-Had approx 4 cm erythema at site and one urticarial lesion
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Headache, Induration, Malaise
Clinical narrative: Local pain, induration, erythema, arthralgia, headache, malaise.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Local pain, induration, erythema, arthralgia, headache, malaise.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: knot at the site of injection and itchy.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Anaphylactic reaction, Eye swelling, Pruritus, Wheezing
Clinical narrative: Anaphylactic reaction. -wheezing -swelling of eyes -Body itch (-) rash
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: DTaP vaccination #5 reaction erythema - possible cellulitis 8 x 7 cm around injection site.
Age: 0.16
Sex: F
Vaccine: DPP, HEP, HIBV, PNC, RV5
Symptoms: Bacteria stool identified, Culture stool negative, Diarrhoea, Laboratory test normal, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a patient with a history of premature birth and with significant past history (unspecified), who was vaccinated with a first and second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) as directed.  It was reported that one week after both doses the patient developed two weeks of diarrhea.  It was reported that there were no other untoward effects and medical intervention was not required.  Current patient status was not reported.  The mother had declined to have the patient receive the third dose of the series.  A product quality complaint was not reported.  No further information was available.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 12/3/2007.  Information has been received from a health professional concerning a 56 day old female with pulmonary stenosis and gastrooesophageal reflux disease with a history of premature birth, fallot's tetralogy (repaired) who on 26-JUL-2007 was vaccinated with ROTATEQ.  Concomitant vaccinations included an intramuscular dose in the left upper thigh of  TRIPEDIA (lot# 2605AA), an intramuscular dose in the left lower thigh of ACTHIB (lot#UF111AA), an intramuscular dose in the right lower thigh of PREVNAR (lot#858845H), and an intramuscular dose in the right upper thigh of RECOMBIVAX HB (lot# "0551U").  There was no reported illness at the time of the vaccinations.  Approximately two weeks (approx 09-AUG-2007), the patient developed diarrhea.  It was reported that there were no other untoward effects and medical intervention was not required.  It was indicated that on an unspecified date, the patient had recovered.  On 02-OCT-2007, she received her second oral dose of ROTATEQ.  Concomitant vaccinations included an intramuscular dose in the left upper thigh of TRIPEDIA (lot# C2765AA), a subcutaneous dose in the right upper thigh of VERO (lot# A0273), an intramuscular dose in the right lower thigh of PREVNAR (lot# U58845M), and an intramuscular dose in the left lower thigh of ACTHIB (lot# UF214AB).  There was no reported illness at the time of the vaccinations.  Approximately two weeks after the vaccinations (approx 14-OCT-2007), she developed diarrhea.  Additional information indicated that after receiving the first and second doses of ROTATEQ, she encountered "3 (*) weeks of diarrhea".  Diagnostic studies approx 01-NOV-2007) included clostridium difficile (negative), ova and parasite (negative), Giardia lamblia (negative), and rotavirus (negative).  Medical attention sought and treatment was not specified.  On an unspecified date, the patient had recovered.  The mother had declined to have the patient receive the third dose of the series.  A product quality complaint was not reported.  Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6-month-old female born prematurely at 34 weeks gestation and with a history of gastroesophageal reflux disease (GERD) who, at four months of age, was vaccinated with the second dose of ROTATEQ (lot number not reported) (first dose administered at 2-months-old). Concomitant vaccinations on that same day at four months of age included a dose in the left leg of PEDIARIX, a dose in the right leg of PREVNAR (Lot #B26510A), a dose in the right leg of ACTHIB (Lot #UE958AA)(manufacturer unknown). There were no illness at the time of vaccination. Other concomitant therapy given on that same day included SYNAGIS. The physician reported that, nine days after receiving the second dose of ROTATEQ, the patient developed diarrhea and vomiting. At that time, medical attention was not sought. No other symptoms were reported. The patient was seen by the physician at six months of age. At the time of this report, the outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/3/2007.  Information has been received from a physician concerning a 18-week-old female born prematurely at 34 weeks gestation and with a history of gastroesophageal reflux disease (GERD) who on 27-AUG-2007 was vaccinated PO with the second dose of ROTATEQ vaccine (Lot #656378/0028U). The physician reported that on 05-SEP-2007, the patient developed diarrhea and vomiting. The patient's mother thought it was rotavirus infection. The patient subsequently recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning 4 patients who were vaccinated with Rotateq. The physician reported that each of the 4 patients received the first dose of Rotateq after 12 weeks and the third dose after 32 weeks. The physician had no other detailed information on the patients. The patient did not report any symptoms. Attempts to obtain patient identifiers are being made. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Irritability, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning her infant daughter with no pertinent medical history or drug allergies who on 28-JUN-2007 and 30-OCT-2007 was vaccinated PO with the first and third 2.0 ml doses of Rotateq. There was no concomitant medication. In approximately 2007 after the first and second doses of Rotateq, the patient experienced immediate vomiting. Subsequently the patient recovered. On 30-OCT-2007 in the evening the patient experienced a delayed response of vomiting 3 days in a row since and was a little fussy. It was noted that the patient had no fever. The patient did not seek medical attention. No labs or diagnostic studies were performed. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Abdominal pain, Irritability
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Rotateq. It was reported that one to two weeks after the vaccination the patient developed abdominal pain and irritability. Current patient status was not reported. A product quality complaint was not reported. Further information was not available. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 34 or 25 week old patient received a third dose of Rotateq. No adverse experience was related to that event. A product quality complaint was not reported. Further information was not available. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Culture wound negative, Incisional drainage, Injection site abscess sterile, Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 week (4 months) old white female birth weight 3.72 kg with a history of being hospitalized for respiratory syncytial virus infection (RSV) and no history of drug reactions/allergies who on an unspecified date was vaccinated with first dose of COMVAX. The patient did not have a reaction with the first injection. On 20-SEP-2006, the patient was vaccinated with second dose of COMVAX (lot # 653773/0197F) 0.5 ml intramuscularly right thigh at 1030 hours. Concomitant therapy also given on 20-SEP-2006 included PREVNAR. The nurse reported that the injection site was found to be red shortly afterwards. Medical attention was sought. The nurse was not sure how many days after the injection, the redness occurred, however, the site was still red presently and it was 1 month after the injection. The site was red (approximately 1.5 cm) but there was no pain. At the time of reporting, the patient had not recovered. At the time of reporting, no further information was available. Additional information was received from the physician. At the time of vaccination, the patient had no illness and no pre-existing medical conditions, allergies, or birth defects. On 20-SEP-2006, the patient developed a lump at the vaccination site on her right thigh. This slowly progressed and came to the surface and an abscess developed. It was subsequently incised and drained. A culture of the abscess did not reveal any bacterial growth. On 10-NOV-2006, the patient recovered. The event was reported as non-serious. Additional information was received by the LPN. The patient reported that the patient developed a sterile abscess at the immunization site that required an incision and drainage. Culture was negative for organisms. Additional information was received from the patient's mother who reported that she believes her child was given the first dose at 4 months of age and dose 2 was given at 6 months of age but she was not positive. Her daughter also developed a hard knot at the injection site with dose 1. PREVNAR was also given on the same day as dose 2 but was not sure if it was a different site. She did not know if PREVNAR was administered with dose 1 as well. Her daughter developed a "sterile abscess" at the injection site on her leg where the second dose of COMVAX was administered. It initially developed as a hard knot a couple days after administration but after a month it came to a "head". The physician lanced the area and had the sample analyzed. Results came back that it was sterile. At the time of reporting, the patient was recovering (reported as recovered by the physician). No additional information is expected.
Age: 25.0
Sex: F
Vaccine: HBHEPB
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 year old female with no medical history and no known drug allergies who on 03-Jan-2007 at 08:48 was vaccinated intramuscularly with a first 0.5 ml dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (Lot #654992/0984F).  Concomitant therapy included ethinyl estradiol/norgestimate (Orthotri-cyclen Lo).  The patient received hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) in error and was intended to receive her first dose of HPV VLP vaccine (yeast) (MSD).  No laboratory diagnostic studies were performed.  No problems had been reported.  At the time of this report, the outcome was unknown.  No product quality complaint was involved.  It was reported that the patient was vaccinated with a first dose of HPV VLP vaccine (yeast) (MSD) (lot #655619/1427F) on 11-Jan-2007.  Additional information is not expected.
Sex: U
Vaccine: HBHEPB, MEN
Symptoms: Bedridden, Lethargy
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who, when she was younger, was vaccinated with COMVAX and meningococcal vaccine (manufacturer unknown). Subsequently, the patient had a reaction that resulted in lethargic symptoms and confined to bed for several days. As of 20-FEB-2007, it was unknown if the patient sought medical attention. The patient's outcome was not reported. Additional information has been requested. Information has been received from a nurse practitioner concerning a patient who, "when she was younger," was vaccinated with HEPATITIS B virus vaccine (manufacturer unknown) and meningococcal polysaccharide vaccine (manufacturer unknown). Subsequently, the patient had a reaction that resulted in lethargic symproms and she was confined to bed for several days. It  was unknown if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Information has been received from a nurse practitioner concerning a patient who, "when she was younger", was vaccinated with HEPATITIS B virus vaccine (manufacturer unknown). Subsequently, the patient had a reaction that resulted in lethargic symptoms and she was confined to bed for several days. It was unknown if medical attention was sought. The patient's outcome was not reported. There was no product complaint involved. No further information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Herpes zoster, Hypersensitivity
Clinical narrative: Within 24 hours of vaccination, pt developed herpes zoster in same dermatomal area of injection.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Herpes zoster
Clinical narrative: Within 24 hours of vaccination, pt developed herpes zoster in same dermatomal area of injection.
Age: 31.0
Sex: F
Vaccine: ANTH, FLU3
Symptoms: Erythema, Fatigue, Incorrect route of drug administration, Influenza like illness, Pain
Clinical narrative: Pt was given her 4th Anthrax vaccine one month early and was incorrectly administered distal to the deltoid. Also pt recieved the FLU vaccine on the same day. As a result on the following day, the patient c/o of flu like symptoms with fever, bodyaches, fatigue, abnormal swelling and redness in L arm from Anthrax vaccination.
Age: 31.0
Sex: F
Vaccine: ANTH, FLU3
Symptoms: Pyrexia, Swelling
Clinical narrative: Pt was given her 4th Anthrax vaccine one month early and was incorrectly administered distal to the deltoid. Also pt recieved the FLU vaccine on the same day. As a result on the following day, the patient c/o of flu like symptoms with fever, bodyaches, fatigue, abnormal swelling and redness in L arm from Anthrax vaccination.
Age: 44.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Asthenia, Body temperature increased, Bone pain, Headache, Myalgia
Clinical narrative: Body aches and pain (skeletal and muscular soreness).  Elevated temperature, low energy level, headaches, nasal congestion, sore throat.
Age: 44.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Nasal congestion, Pain, Pharyngolaryngeal pain
Clinical narrative: Body aches and pain (skeletal and muscular soreness).  Elevated temperature, low energy level, headaches, nasal congestion, sore throat.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Rash generalised
Clinical narrative: Rash x 5 days generalized lower extremities, burning right thigh, raised blisters away from site.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Stillbirth
Clinical narrative: Initial and follow up information has been received via the Merck pregnancy registry, from a physician's assistant (PA), concerning a female patient (birthdate invalid; age previously reported as age 11), with a drug hypersensitivity to DEPAKOTE and no previous pregnancies, who had her LMP on 19-JUN-2007, and on 23-JUL-2007 was vaccinated IM with the first dose, 0.5 ml, of Gardasil (Lot # 654885/1424F). Concomitant therapy included ORTHO TRI-CYCLEN. Following the vaccination (date not specified) the patient had a positive urine pregnancy test confirming that she was pregnant (estimated date of delivery was 25-MAR-2008). Follow up information received from the PA reported that on approximately 13-NOV-2007 ("21 weeks from LMP"), the patient experienced the death/stillbirth of her fetus (details not provided). It was unknown if the fetus was normal, or if the products of conception were examined. The sex of the fetus was not reported. The PA noted that the patient had a blood type of Rh negative (type A-), and the paternal blood type was Rh positive. No further details were provided. The PA added that the patient had married and moved (address not provided). The patient sought unspecified medical attention. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Metrorrhagia, Migraine, Nausea
Clinical narrative: Information has been received from a physician and healthcare worker concerning a 23 year old female who on 31-OCT-2007 was vaccinated with a first dose of Gardasil (Lot #658560/1062U). Concomitant therapy included ORTHO TRI-CYCLEN. On 31-OCT-2007 the patient experienced severe nausea, migraines, dizziness and "breakthrough bleeding". The physician was going to double the dose of the ORTHO TRI-CYCLEN for 3-4 days. There was no laboratory or diagnostic tests performed. Subsequently, the patient recovered from severe nausea, migraines and dizziness, but had been spotting for a month. Upon internal review, nausea, dizziness, breakthrough bleeding and migraines were considered to be other important medical events. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea, Pulmonary embolism, Seasonal allergy
Clinical narrative: Information has been received from a registered nurse, concerning a 16 year old female patient with hay fever and no other pertinent medical history, who was vaccinated IM with the first and second dose, 0.5 ml, of Gardasil as follows: on 03-APR-2007 with the first dose (lot #654702/0011U), and on 19-JUN-2007 and the second dose (lot # 657622/0388U). Concomitant therapy on 03-APR-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer not specified). Noted therapy initiated on approximately 07-SEP0-2007 ("one month prior" to the event), included MIRCETTE (dose not reported). On 07-OCT-2007, approximately 4 months after the second vaccination, the patient experienced shortness of breath and chest discomfort. On 10-OCT-2007, she presented to a walk-in clinic and a diagnostic "blood test" and CAT scan of tee lungs revealed a pulmonary embolus. She was hospitalized and treated with oxygen and IV heparin LOVENOX. On 15-OCT-2007, she was discharged from the hospital. On an unknown date, enoxaparin sodium was discontinued and COUMADIN was initiated, and continued. A consultation was planned with a hematologist or oncologist to rule out any blood dyscrasia. At the time of this report, the patient was recovering. The nurse considered pulmonary embolus to be immediately life-threatening and serious as an other important medical event. Additional information has been requested. 12/13/07-records received for DOS 10/10-10/15/07-DC DX: Pulmonary embolism. Presented to ED with shortness of breath.Exertional dyspnea began last Sunday, three days ago.
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse (RN) concerning a female patient (age not reported), who in approximately 2006 ("about one year ago") was vaccinated with the first dose of Gardasil (lot # not reported). On the same day, the patient found out she was pregnant. Subsequently the patient terminated her pregnancy (date not reported). The nurse stated that the pregnancy was not intended, and the "termination had nothing to do with the Gardasil vaccine." At the time of this report, the outcome of the event was unknown. No additional details were available. Upon internal review, the event of "terminated her pregnancy" was considered to be serious, as an other significant medical event. No further information is expected.