chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Left arm became sore and red.  Increased in size over the next 3 days.  Seen on 05/31/2012 4:30PM.  Left arm swollen and red and warm to touch the size of a soft ball. tx with Keflex 500 mg BID for & days.  Patient to return on 06/04/2012.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Feeling abnormal, Headache, Injection site erythema, Injection site induration, Nausea
Clinical narrative: PATIENT DEVELOPED NAUSEA AND VOMITING, HA AND VISUAL CHANGES. REPORTED "I FELT LIKE I WAS DYING". SITE WITH 4X6 CM RED HARD AREA.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Visual impairment, Vomiting
Clinical narrative: PATIENT DEVELOPED NAUSEA AND VOMITING, HA AND VISUAL CHANGES. REPORTED "I FELT LIKE I WAS DYING". SITE WITH 4X6 CM RED HARD AREA.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Nasopharyngitis, Pyrexia
Clinical narrative: Within about 2-4 hours after injection, I developed cold and flu symptoms with fever. Went to clinic on Thursday when I could not shake this.
Age: 56.0
Sex: M
Vaccine: JEV1, JEV1
Symptoms: Blood test, Chest X-ray, Computerised tomogram thorax, Cough, Dyspnoea
Clinical narrative: Difficulty breathing, shortness of breath, coughing.
Age: 56.0
Sex: M
Vaccine: JEV1, JEV1
Symptoms: Pulmonary function test
Clinical narrative: Difficulty breathing, shortness of breath, coughing.
Age: 0.51
Sex: M
Vaccine: PER
Symptoms: Attention deficit/hyperactivity disorder, Crying, Depression, Pyrexia, Screaming
Clinical narrative: Screaming, crying high fever of 104.5 for three days. Given water, breast milk.
Age: 0.51
Sex: M
Vaccine: PER
Symptoms: Suicide attempt
Clinical narrative: Screaming, crying high fever of 104.5 for three days. Given water, breast milk.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 5-22-12 started as small red dot at injection site. 5-23-12 expanded to larger red are with warm to the touch sensation. Advised pt to call MD.
Sex: U
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Headache, Pain, Pyrexia, Rash, Swelling
Clinical narrative: Pt received FLUZONE, BOOSTRIX, and ZOSTAVAX injection in right arm May 22, 2012 (Tues). Patient has suffered headaches, fever, swollen bulls eye rash, soreness, etc.
Age: 15.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm, red deltoid 2" x 3" no fever.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Syncope
Clinical narrative: Plus or minus 5 minutes after injection, patient dizzy and almost fainted in store aisle. Sat him up and talked to him for 5-10 minutes. He insisted he was ok. Escorted him & his mother to front door. Called him after one hour to verify ok.
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site papule, Injection site pruritus, Injection site swelling
Clinical narrative: 4-12-12 started with sore arm, 4-13-12 arm swollen to size of "baseball" per mom where varicella vaccine given in right arm. Warm to touch, red, temp of 99.2 degrees, c/o itchiness and pimple-like spot in area of where shot given. Size 8x5 cm by 6 cm.
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: 4-12-12 started with sore arm, 4-13-12 arm swollen to size of "baseball" per mom where varicella vaccine given in right arm. Warm to touch, red, temp of 99.2 degrees, c/o itchiness and pimple-like spot in area of where shot given. Size 8x5 cm by 6 cm.
Age: 89.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Rash, Vaccination complication
Clinical narrative: 6 pm rash discovered on lower portion of legs went to group health urgent care at 6:30 PM and rash spread to upper arms and back. Blood tests were given. Follow-up appt made for next day at 11:20 w/ Dr. who stated in patient summary "your rash looks very much like a reaction to the Tdap shot you got yesterday."
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Itching redness red hot lump pain under arm to elbow.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Lymph node pain, Nodule, Swelling
Clinical narrative: Pt received Tdap on 4/10/12. She presented to our triage RN on 4/12 complaining of a "knot" on her shoulder. She was seen by me on 4/13/12. She had pain & redness at injection site. Erythema was 4-5 cm in diameter. She also had a < 1 cm (L) supraclavicular lumph node that was tender. She was seen by another doctor on 5/11/12 & lymph node was resolving. (Some fullness in area - but not LAD).
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Erythema, swelling & pain to area.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red raised itchy bumps on both arms.
Age: 12.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Local swelling
Clinical narrative: Swelling local non erythematous.
Age: 4.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Swelling of (Rt) and (Lt) arms, vomiting at 3-4 am the night after (5/30/12 am). Arms are red around injection sites.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 2 1/2 cm x 4 cm erythema & induration lower (L) deltoid area, tender.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain, Rash
Clinical narrative: T12 dermatome rash consistent with shingles on right side of body-painful, sensitive, erythema base with blistering on front & back of patient, not much on lateral side. Treated with MEDROL & VALTREX & CALADRYL.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Rash, Swelling
Clinical narrative: Rash on right side, redness & swelling, vesicle like lesions that look dried up. Prescribed VALTREX.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall, Hyperhidrosis
Clinical narrative: Pt was given HPV GARDASIL #2 Lot # 1171AA, exp: 11/11/2013 on 5/29/12 at approx 350 PM for "nursing visit". Pt mom filled & signed questionnaire & read over VIS - no hx. with problems noted. Pt felt faint & dizzy 10 min after administration & fell to the floor - zero, no injuries sustained. Pt was sweating but denied LOC. Pt brought back & allowed to lay down for 15 more min.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Injection site rash, Injection site urticaria, Pruritus, Rash
Clinical narrative: 5/29/12 evening noticed shoulder itch and rash. Headache on exam 5/31/12 3:00 PM. Hive rash 10cm x 12cm on (R) deltoid.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Mild, large local reaction to Tdap in upper left, lateral deltoid area is warm to touch with 3.5 cm of induration - No redness, streaking or fever present. Symptoms started on 5/29/12 with gradual improvement. Advised to administer ice 15 min on/15 min off and ibuprofen q 6 hrs prn.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous, Rash pruritic, Vaccine positive rechallenge
Clinical narrative: Pt had Hep B #1 and approx 1 week later developed a red raised rash mainly on extremities and joints (itchy). Pt received Hep B #2 11/15/11 developed same rash about 2-3 days later. Denied SOB. Treated with topical steroid cream.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, Asthenia, Body temperature increased, Chills, Myalgia
Clinical narrative: Symptoms began a few hours after immunizations. Elevated temp 99.6, chills, aches, c/o joints hurting. Sore muscles, hands & knuckles hurt. Weakness. No treatment given. Observation.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Pain, Pain in extremity
Clinical narrative: Symptoms began a few hours after immunizations. Elevated temp 99.6, chills, aches, c/o joints hurting. Sore muscles, hands & knuckles hurt. Weakness. No treatment given. Observation.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Borrelia test negative, Complement factor C3, Complement factor C4, Complement factor normal
Clinical narrative: Painful lower extremity joints - knees lumbar, bilat 14 days after MENVEO. No joint inflammation, AF, no rash. On labs, microscopic hematuria. EJR = = 36. Labs nl/ Sx resolved 5-7 d.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Haematuria, Liver function test normal, Red blood cell sedimentation rate increased, Streptococcus test negative
Clinical narrative: Painful lower extremity joints - knees lumbar, bilat 14 days after MENVEO. No joint inflammation, AF, no rash. On labs, microscopic hematuria. EJR = = 36. Labs nl/ Sx resolved 5-7 d.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site rash, Pruritus, Rash erythematous
Clinical narrative: Student broke out after receiving vaccine at school. She did not return to the Health Center that afternoon but came in the next morning. Student presented w/ raised, red rash to (L) upper arm. (L) upper chest, and (L) ankle. (+) pruritis.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site rash, Pruritus, Rash, Rash erythematous
Clinical narrative: Student broke out after receiving vaccine at school. She did not return to the Health Center that afternoon but came in the next morning. Student presented w/ raised, red rash to (L) upper arm. (L) upper chest, and (L) ankle. (+) pruritis.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Hypoaesthesia, Oedema peripheral
Clinical narrative: Approximately 25 minutes after receiving MCV4 and HPV vaccinations, patient reported back to immunization clinic complaining of a raised swollen spot on her left hand that was numb. After administering oral BENADRYL and observing patient for another 45 minutes with provider supervision, patient felt fine.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: GARDASIL vaccine, 3rd dose, administered 5/2/12. Child seen on 5/4/12 9 cm x 10 cm area of (L) upper arm red and hard warm to touch but without cellulitis or lymph involvement.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site urticaria
Clinical narrative: Large wheal reaction at site 6 cm.
Age: 0.25
Sex: M
Vaccine: DTAP
Symptoms: Depressed level of consciousness, Hypophagia, Lethargy, Urine output decreased
Clinical narrative: Within 12 hrs of receiving vaccine pt became lethargic. Didn't really nurse. Difficult to arouse. Decreased urine output.
Age: 31.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Patient given suboptimal dose and don't know where she went, we can't find or contact her. We tried called phone but no return call trying to call her work but not sure where she works. Will keep trying.
Age: 29.0
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Was given suboptimal dose and patient went on a trip for 2 weeks. We were able to contact him when he came back home and his fine & we will be monitoring him weekly.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: - Pain left shoulder (at Tdap site) x 3 weeks. - Hurts to sleep, lift, and raise left arm. - Used hot/cold compress with minimal relief. - Using ALEVE PO BID.
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Hypoaesthesia, Pallor
Clinical narrative: GARDASIL adm 922 pt c/o feeling dizzy. 930 am SOB & become diaphoretic. Dr was called to exam pt 925 am. Pale weak pulse, vomiting x1. No LOC. Recovered progressively good pulse. Nml. BP 100/70 after 15 minute. pt initially stated numbness of L/A.
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Pulse pressure decreased, Vomiting
Clinical narrative: GARDASIL adm 922 pt c/o feeling dizzy. 930 am SOB & become diaphoretic. Dr was called to exam pt 925 am. Pale weak pulse, vomiting x1. No LOC. Recovered progressively good pulse. Nml. BP 100/70 after 15 minute. pt initially stated numbness of L/A.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: 55 mm redness, swelling around vaccination site. Pt states itchiness at site but denies any other symptoms.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Fainting post injection. Elevated feet & gave patient juice. Took patients blood pressure.
Age: 27.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Back pain, Diarrhoea, Food poisoning, Injection site pain
Clinical narrative: Pt received primary smallpox vaccine (SPV) in left arm on 18 MAY. She also received anthrax (2) vaccine on the same day in her right arm. She denies significant local reactions at vaccination sites. Reports SPV site progressed to a pustule and is now scabbed. On 25 March, post-vaccine day (PVD) 7, patient reports left supraclavicular adenopathy and mild burning type pain at SPV site, with muscle aches and malaise the following day. No fever or chills. Patient self treated with MOTRIN 400 mg and rest with some improvement of symptoms. On PVD 9, 28 may, patient developed nausea, vomiting and diarrhea. She was unable to keep food down and sought evaluation. She was diagnosed with "food poisoning" and was prescribed ZOFRAN and Pepto Bismol, which she did not take. She was placed on bed rest x 24 hours and by 30 May, she was able to tolerate fluids. She reports increased sleep over a 48 hour period, but no persistent fatigue. On 30 May, PVD 12, patient noted pain, first in her right ankle and later in her left ankle. She resumed taking MOTRIN 400 mg which did not relieve the pain. Pain described as "aching" joint pain with pain intensity level of 10/10 at onset, using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Patient denies redness, warmth, or swelling of joints. She denies numbness/tingling and weakness. Joint pain increased with AROM/ By evening of 30 May, patient was experiencing pain in her shoulders, knees (R>L), ankles, wrists (R>L), and lower back/hips.
Age: 27.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Lymphadenopathy, Malaise, Musculoskeletal pain, Myalgia, Nausea
Clinical narrative: Pt received primary smallpox vaccine (SPV) in left arm on 18 MAY. She also received anthrax (2) vaccine on the same day in her right arm. She denies significant local reactions at vaccination sites. Reports SPV site progressed to a pustule and is now scabbed. On 25 March, post-vaccine day (PVD) 7, patient reports left supraclavicular adenopathy and mild burning type pain at SPV site, with muscle aches and malaise the following day. No fever or chills. Patient self treated with MOTRIN 400 mg and rest with some improvement of symptoms. On PVD 9, 28 may, patient developed nausea, vomiting and diarrhea. She was unable to keep food down and sought evaluation. She was diagnosed with "food poisoning" and was prescribed ZOFRAN and Pepto Bismol, which she did not take. She was placed on bed rest x 24 hours and by 30 May, she was able to tolerate fluids. She reports increased sleep over a 48 hour period, but no persistent fatigue. On 30 May, PVD 12, patient noted pain, first in her right ankle and later in her left ankle. She resumed taking MOTRIN 400 mg which did not relieve the pain. Pain described as "aching" joint pain with pain intensity level of 10/10 at onset, using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Patient denies redness, warmth, or swelling of joints. She denies numbness/tingling and weakness. Joint pain increased with AROM/ By evening of 30 May, patient was experiencing pain in her shoulders, knees (R>L), ankles, wrists (R>L), and lower back/hips.
Age: 27.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Somnolence, Vomiting
Clinical narrative: Pt received primary smallpox vaccine (SPV) in left arm on 18 MAY. She also received anthrax (2) vaccine on the same day in her right arm. She denies significant local reactions at vaccination sites. Reports SPV site progressed to a pustule and is now scabbed. On 25 March, post-vaccine day (PVD) 7, patient reports left supraclavicular adenopathy and mild burning type pain at SPV site, with muscle aches and malaise the following day. No fever or chills. Patient self treated with MOTRIN 400 mg and rest with some improvement of symptoms. On PVD 9, 28 may, patient developed nausea, vomiting and diarrhea. She was unable to keep food down and sought evaluation. She was diagnosed with "food poisoning" and was prescribed ZOFRAN and Pepto Bismol, which she did not take. She was placed on bed rest x 24 hours and by 30 May, she was able to tolerate fluids. She reports increased sleep over a 48 hour period, but no persistent fatigue. On 30 May, PVD 12, patient noted pain, first in her right ankle and later in her left ankle. She resumed taking MOTRIN 400 mg which did not relieve the pain. Pain described as "aching" joint pain with pain intensity level of 10/10 at onset, using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Patient denies redness, warmth, or swelling of joints. She denies numbness/tingling and weakness. Joint pain increased with AROM/ By evening of 30 May, patient was experiencing pain in her shoulders, knees (R>L), ankles, wrists (R>L), and lower back/hips.
Age: 47.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Patient came to clinic today (5-31-12) after receiving "tetanus shot" at community clinic weeks ago. He reports 3 days after he began having pain at area of injection in pt. upper arm and reports pain rated at 10/10 with movement.
Age: 39.0
Sex: F
Vaccine: MNQ
Symptoms: Oedema peripheral, Swelling
Clinical narrative: Talked w/ client on Thursday May 24th around 1:30. She said her (L) arm, crown of her head, and (L) leg swelled the day after receiving MCV4. Note: Pt. also complained of gastric upset following Hep A injection on 5-15-12.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Vaccines given in left thigh area. Patient seen at clinic and left thigh noted to be swollen and red rash noted around injection site. MD assessed leg.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV1
Symptoms: Unevaluable event
Clinical narrative: none
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Pt reproted a diffuse red rash with a bit of swelling, with no itching or pain in the area of the injection site approximately 3-4 inches in diameter that developed the day after the immunization. At the time of the report, pt denied any systemic effects. When the patient returned to the pharmacy on 5/31/2012, pharmacy manager recommended topical hydrocortisone cream 1% applied to the area to reduce redness. Pt went to see his PCP on 5/31/2012. Dr. recommended Allegra and prescribed cephalexin to treat suspected cellulitis. Pt returned to the pharmacy that day and purchased Allegra but has not filled the cephalexin prescription. Pt prefers to see if symptoms will resolve or worsen before attempting antibiotics.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Diplopia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Headache, dizziness, double vision. Progressed to body aches, nausea and extreme fatigue over the next day.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Headache, dizziness, double vision. Progressed to body aches, nausea and extreme fatigue over the next day.
Age: 45.0
Sex: F
Vaccine: MNQ
Symptoms: Axillary pain, Induration, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: REDNESS AND SWELLING AT INJECTION SITE. The following day developed pain and swelling in arm pit, an area that is hard and tender to touch.
Age: 45.0
Sex: F
Vaccine: MNQ
Symptoms: Tenderness
Clinical narrative: REDNESS AND SWELLING AT INJECTION SITE. The following day developed pain and swelling in arm pit, an area that is hard and tender to touch.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction: Erythema, Pain, Swelling, Warmth, Pruritus. Advised patient to use cool pad and/or take oral OTC analgesic for pain.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pyrexia
Clinical narrative: Pt. states she thinks she may have had a low grade fever, but concerned over lemon sized lump at injection site, warm and red.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal mass, Abnormal behaviour, Apnoeic attack, Autopsy
Clinical narrative: On 5/28/2012 began having diarrhea. On 5/29/12 am, he was a little fussy in the morning - mom gave gripe water and baby oragel.  The babysitter called dad in the afternoon saying that the patient was not himself.  When the dad picked him up he said the child was "out of it".  Went to grandfathers house and called EMS. On EMS arrival patient had pulse in the 140's and RR in the 30's, by the time patient arrived at the ED patient was apneic and asystolic with bag valve mask ventilation being performed.  Resusscitation was unsuccessful and the patient passed away.  Upon attempt at a rectal temperature, bloody stool was noted in the diaper.  There was also a palpable mass in the abdomen.  The medical examiner confirmed the presence of intussusception on the autopsy.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cardiac arrest, Death, Diarrhoea, Flatulence, Haematochezia
Clinical narrative: On 5/28/2012 began having diarrhea. On 5/29/12 am, he was a little fussy in the morning - mom gave gripe water and baby oragel.  The babysitter called dad in the afternoon saying that the patient was not himself.  When the dad picked him up he said the child was "out of it".  Went to grandfathers house and called EMS. On EMS arrival patient had pulse in the 140's and RR in the 30's, by the time patient arrived at the ED patient was apneic and asystolic with bag valve mask ventilation being performed.  Resusscitation was unsuccessful and the patient passed away.  Upon attempt at a rectal temperature, bloody stool was noted in the diaper.  There was also a palpable mass in the abdomen.  The medical examiner confirmed the presence of intussusception on the autopsy.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception, Irritability, Mechanical ventilation, Resuscitation, X-ray abnormal
Clinical narrative: On 5/28/2012 began having diarrhea. On 5/29/12 am, he was a little fussy in the morning - mom gave gripe water and baby oragel.  The babysitter called dad in the afternoon saying that the patient was not himself.  When the dad picked him up he said the child was "out of it".  Went to grandfathers house and called EMS. On EMS arrival patient had pulse in the 140's and RR in the 30's, by the time patient arrived at the ED patient was apneic and asystolic with bag valve mask ventilation being performed.  Resusscitation was unsuccessful and the patient passed away.  Upon attempt at a rectal temperature, bloody stool was noted in the diaper.  There was also a palpable mass in the abdomen.  The medical examiner confirmed the presence of intussusception on the autopsy.
Age: 43.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Feeling abnormal, Lethargy, Malaise, Night sweats
Clinical narrative: According to patient, rash with a few spots appeared on 05/26/2012 with a few spots on face.  On 05/28/2012 he was feeling ill and lethargy or "not just right"  Also complained of "night sweats".  TSTs were negative in the past.  Rash on back and upper chest and a 1" x 1 1/2 " reddened, elevated area with oozing and itching noted on 05/30/2012.
Age: 43.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Secretion discharge, Swelling
Clinical narrative: According to patient, rash with a few spots appeared on 05/26/2012 with a few spots on face.  On 05/28/2012 he was feeling ill and lethargy or "not just right"  Also complained of "night sweats".  TSTs were negative in the past.  Rash on back and upper chest and a 1" x 1 1/2 " reddened, elevated area with oozing and itching noted on 05/30/2012.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site warmth, Skin induration, Skin mass
Clinical narrative: After receiving varicella vaccine on 4/3/11 pt states a "red knot, hard, hot and felt like a plate was under the skin." Lasted two weeks and was about 2 inch diameter. No systemic fever; only spot was warm to touch on right upper arm. Took two weeks to go away per pt.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: 2 little spots of rash on the left forearm.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: PT HAS SOME ITCHING, REDNESS, AND BLISTERS ON HIS BACK, RT FOREARM AND LT HAND.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Red and elevated area on left deltoid. Increased warmth at site of MENACTRA injection.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Red and elevated area on left deltoid. Increased warmth at site of MENACTRA injection.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site papule
Clinical narrative: Erythematous papules in circle around injection, (+) edema at injection.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Erythematous papules in circle around injection, (+) edema at injection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Dysuria, Hyperaesthesia, Irritability, Microscopy
Clinical narrative: The day after vaccines patient had a 103 F fever, dysuria, and "has not been right since" per mom. Patient has felt sensitive all over her body and has been irritable.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Urine analysis
Clinical narrative: The day after vaccines patient had a 103 F fever, dysuria, and "has not been right since" per mom. Patient has felt sensitive all over her body and has been irritable.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Right upper arm edema, redness; firm to touch.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Rash, Rash papular, Tenderness
Clinical narrative: Patient recived the small pox and anthrax vaccines (first exposure to each of these vaccines).  Within 3.5 hours he developed slightly tender, erythematous, dime-sized papules over his forearms bilaterally.  The rash did NOT itch, and was confined to his forearms.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Headache, Rash
Clinical narrative: Patient states she has a small raised "bump" on the back of her neck and one behind her right ear. Also complains of headache and low back pain.
Age: 17.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Pallor, Skin warm
Clinical narrative: He becme pale, light headed, dizzy, with warm skin, feels faint. Had patient lie flat with feet elevated, check his blood pressure. It was 110/69. He felt faint, then call EMS, then his mother said that he has always have such a reaction to any vaccine, his father and brother have the same problem. The EMS checked his bp, it was 112/70, monitored him for 15 minutes, then said he was ok, and should not be any problem. I kept him for one more hour. He was fine. I called the next day talked to his mother. He was fine. I faxed the info to his doctor.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient had 1 and 1/2 inch - diameter of red, deep spot on injection site (back of left arm). Rash around the spot, very itchy. Patient had diarrhea.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Eye swelling, Lip swelling, Pruritus, Urticaria
Clinical narrative: Per patient's mother: Approximately 1 hour after vaccines patient broke out with hives, itching and swelling to left eye and lips. Vaccines administered were Tdap and MENACTRA to right deltoid, and GARDASIL #1 to left deltoid.
Age: 1.04
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Injection site atrophy
Clinical narrative: Divot at site of injection on right thigh measuring 2 1/2 cm x 1 1/2 cm. Complete loss of subcutaneous fat.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Local reaction, Myalgia, Neck pain
Clinical narrative: Patient states on last 2 anthrax shots muscular pain spread to back and neck and entire arm on that side. Previously, soreness had been limited to the upper arm where the vaccine had been administered (4 shots previous). This lasted for approximately 24 hours.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity
Clinical narrative: Patient states on last 2 anthrax shots muscular pain spread to back and neck and entire arm on that side. Previously, soreness had been limited to the upper arm where the vaccine had been administered (4 shots previous). This lasted for approximately 24 hours.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: PT. RCV'D 2ND HPV AND 2ND HEP A VACCINE.  HEP A WAS ADMINISTERED FIRST ON RD.  THEN HPV ADMINISTERED TO LD. PT. WAS TO WAIT IN THE ROOM FOR PRINT OUT.  CAME OUT TO WAITING ROOM. PROCEEDED TO FAINT.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Muscle spasms, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Within 20 minutes of shot, muscles in neck and shoulder began to spasm painfully. Spasms ceased after approximately 2 hours, but extremely limited range of motion and severe pain persisted for two weeks. Patient was instructed to take ibuprofen and not "baby" the shoulder. Five weeks after initial shot, range of motion is still not back to normal, and shoulder joint is still painful.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Oedema peripheral
Clinical narrative: Extensive local reaction with swelling of approx half the Left arm.
Age: 28.0
Sex: F
Vaccine: JEV1
Symptoms: Chest discomfort
Clinical narrative: Received vaccine 330 PM on 5/22 and 6-7 PM while driving home got chest tightness - lasted approximately 1 hour.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: Swelling and erythema of left thigh 7/5 cm x 7.5 cm lesion. Treated with ibuprofen, ice & BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red indurated area on left deltoid subcutaneous area with increased warmth at site of MMR injection - Pt came to clinic 48 hours later.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site pain
Clinical narrative: Soreness at site on (R) deltoid & on axilla. Vaccine 5/24/12. Office visit 5/29/12.
Age: 33.0
Sex: M
Vaccine: ANTH, TDAP
Symptoms: Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: Within hours of shot swelling and heat around area and upper arm. Restricts arm movement.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Rash pruritic
Clinical narrative: Day off or day after patient experienced knot in center of injection site and redness. One week out patient presented to pharmacy with a 4 x 6 red raised itchy rash. Her MD recommended BENADRYL and ice. Patient experienced no SOB or chest pain.
Age: 85.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Feeling hot, Oedema peripheral, Pain, Skin discolouration
Clinical narrative: Onset: within 24 hours - very large bruise. Bruises, discolored, achy, hot, with a hard lump under the skin. Bruise is slowly resolving w/o treatment. Arm swollen: bruise 3" in diameter day 1 then 5" by day 2.
Age: 85.0
Sex: F
Vaccine: TDAP
Symptoms: Skin mass
Clinical narrative: Onset: within 24 hours - very large bruise. Bruises, discolored, achy, hot, with a hard lump under the skin. Bruise is slowly resolving w/o treatment. Arm swollen: bruise 3" in diameter day 1 then 5" by day 2.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: It's been 4 days since my vaccine and I still have pain, swelling, redness and itching in the area .. the swelling is really big .. what can I do to ease this discomfort .. can't sleep at night.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder
Clinical narrative: It's been 4 days since my vaccine and I still have pain, swelling, redness and itching in the area .. the swelling is really big .. what can I do to ease this discomfort .. can't sleep at night.
Age: 35.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Dyspnoea, Pruritus, Skin discolouration
Clinical narrative: Shortness of breath, localized itching and skin discoloration beginning days after immunization.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Abortion spontaneous, Foetal death, Metrorrhagia, Muscle spasms, Ultrasound antenatal screen abnormal
Clinical narrative: Began spotting blood and mild cramping that morning.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Body temperature increased, Malaise
Clinical narrative: Not feeling well.  Reported to school nurse.  Temp 103.  Nurse sent him home.
Age: 28.0
Sex: F
Vaccine: YF, YF
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fatigue continuing onto next day 06/02/2012. By 6:00 PM mild headache presented. 7:00 PM fever and aches presented.
Age: 28.0
Sex: F
Vaccine: YF, YF
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue continuing onto next day 06/02/2012. By 6:00 PM mild headache presented. 7:00 PM fever and aches presented.
Age: 43.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: After intranasal influenza patient stated dizziness, vertigo, and headaches.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen at injection site. Affected area spread & worsened over the next 4 days after injection. Patient saw doctor & was prescribed KEFLEX.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Pruritus, Rash erythematous
Clinical narrative: Red raised rash at injection site (RA) and red rash on left leg at calf. Patient took BENADRYL for itch.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site induration
Clinical narrative: At injection site pt had 3" raised area reddish in color the center 1" to 1 1/2" dark red and hard to the touch. (6/2/2012 9:15 am) pt went to urgent care at 12:00 noon 6/2/12. Diagnosis: Cellulitis and possible drug/drug rxn with current medications prescribed. BACTRIM DS & prednisone.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Brain oedema, CSF virus identified, Cerebral haemorrhage, Computerised tomogram head abnormal, Crying
Clinical narrative: Patient cried continuously, then stopped crying, stopped breathing and stiffened up entire body and seemed to be having a seizure for approximately 30 seconds to 1 minute. Patient then went completely limp. Patient's father then called 911 and the EMT airlifted patient to ER. He was sent to the PICU for 4 days and had various tests done. He had a CT scan & MRI that showed he had brain swelling and a bleed. A retinal test came back negative for retina hemorrhage. A spinal tap test initially came back positive for enterovirus, but a day and a half later the Dr.'s came back to tell us that the lab test was cross contaminated and he did not have the virus. Patient also had a skeletal survey that came back fine, no broken bones, fractures or anything. He was also given an EEG. Patient has been put on phenobarbital and he now has follow up appointments with a hematologist, a neurosurgeon and a neurologist. He seems currently to have recovered completely.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram, Enterovirus test positive, Hypotonia, Intensive care, Lumbar puncture normal
Clinical narrative: Patient cried continuously, then stopped crying, stopped breathing and stiffened up entire body and seemed to be having a seizure for approximately 30 seconds to 1 minute. Patient then went completely limp. Patient's father then called 911 and the EMT airlifted patient to ER. He was sent to the PICU for 4 days and had various tests done. He had a CT scan & MRI that showed he had brain swelling and a bleed. A retinal test came back negative for retina hemorrhage. A spinal tap test initially came back positive for enterovirus, but a day and a half later the Dr.'s came back to tell us that the lab test was cross contaminated and he did not have the virus. Patient also had a skeletal survey that came back fine, no broken bones, fractures or anything. He was also given an EEG. Patient has been put on phenobarbital and he now has follow up appointments with a hematologist, a neurosurgeon and a neurologist. He seems currently to have recovered completely.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain abnormal, Respiratory arrest, Retinal function test normal, Seizure like phenomena
Clinical narrative: Patient cried continuously, then stopped crying, stopped breathing and stiffened up entire body and seemed to be having a seizure for approximately 30 seconds to 1 minute. Patient then went completely limp. Patient's father then called 911 and the EMT airlifted patient to ER. He was sent to the PICU for 4 days and had various tests done. He had a CT scan & MRI that showed he had brain swelling and a bleed. A retinal test came back negative for retina hemorrhage. A spinal tap test initially came back positive for enterovirus, but a day and a half later the Dr.'s came back to tell us that the lab test was cross contaminated and he did not have the virus. Patient also had a skeletal survey that came back fine, no broken bones, fractures or anything. He was also given an EEG. Patient has been put on phenobarbital and he now has follow up appointments with a hematologist, a neurosurgeon and a neurologist. He seems currently to have recovered completely.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Skeletal survey normal
Clinical narrative: Patient cried continuously, then stopped crying, stopped breathing and stiffened up entire body and seemed to be having a seizure for approximately 30 seconds to 1 minute. Patient then went completely limp. Patient's father then called 911 and the EMT airlifted patient to ER. He was sent to the PICU for 4 days and had various tests done. He had a CT scan & MRI that showed he had brain swelling and a bleed. A retinal test came back negative for retina hemorrhage. A spinal tap test initially came back positive for enterovirus, but a day and a half later the Dr.'s came back to tell us that the lab test was cross contaminated and he did not have the virus. Patient also had a skeletal survey that came back fine, no broken bones, fractures or anything. He was also given an EEG. Patient has been put on phenobarbital and he now has follow up appointments with a hematologist, a neurosurgeon and a neurologist. He seems currently to have recovered completely.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Computerised tomogram, Nuclear magnetic resonance imaging, Unevaluable event
Clinical narrative: Patient cried continuously, then stopped crying, stopped breathing and stiffened up entire body and seemed to be having a seizure for approximately 30 seconds to 1 minute. Patient then went completely limp. Patient's father then called 911 and the EMT airlifted patient to ER. He was sent to the PICU for 4 days and had various tests done. He had a CT scan & MRI that showed he had brain swelling and a bleed. A retinal test came back negative for retina hemorrhage. A spinal tap test initially came back positive for enterovirus, but a day and a half later the Dr.'s came back to tell us that the lab test was cross contaminated and he did not have the virus. Patient also had a skeletal survey that came back fine, no broken bones, fractures or anything. He was also given an EEG. Patient has been put on phenobarbital and he now has follow up appointments with a hematologist, a neurosurgeon and a neurologist. He seems currently to have recovered completely.
Age: 5.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Fatigue, Lethargy, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Fever of 104F. Lethargic. Tired. Hands and feet hurt.  Lasted 2 days.  Day 2 child complained of achy throat.
Age: 5.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Streptococcus test negative
Clinical narrative: Fever of 104F. Lethargic. Tired. Hands and feet hurt.  Lasted 2 days.  Day 2 child complained of achy throat.
Age: 5.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Body temperature increased
Clinical narrative: Fever of 104F. Lethargic. Tired. Hands and feet hurt.  Lasted 2 days.  Day 2 child complained of achy throat.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Tenderness, Vaccination complication
Clinical narrative: Size of injection about a quarter.  Each day the redness has gotten larger and the swelling has increased.  Injection was given on the inside of my left arm.  Today, June 3rd.  Swelling in near elbow and redness is 4 inches.  Used triple antibiotic ointment for itch. A nurse at church today looked at it and said I was having a reaction.  I also had the pharmacist look at my arm on Saturday.  He advised to use Advil/and the ointment for itching.  No longer have itching.  Arm is sore to the touch.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Pain in extremity
Clinical narrative: Patient reported weakness approximately 25 minutes after receiving vaccine.  Assisted to supine position with lower extremities elevated.  Approximately 10 minutes later complained of all four extremities and joints aching.  BP 80s to 90s/50s with HR 70s.  No wheezing or shortness of breath.  Respirations unlabored.  Oxygen administered along with IM epinephrine and IM Benadryl.  Symptoms resolved over approximately 10-15 minutes.  Patient evaluated by paramedics and taken to Emergency Department by parent.  Discharged by Emergency Department to home same day.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Headache
Clinical narrative: Approximately 40 minutes after receiving vaccine patient complained of worsening headache that had occurred after receiving vaccine and feeling like something bad was going to happen inside of her.  Denied pain or shortness of breath.  No swelling, pain or redness at vaccine site.  Assisted supine position with legs elevated.  BP 118/64 HR 76 initially then to 108/66 with HR 64.  Resp unlabored at 18/min.  Symptoms did not resolve with rest and observation.  Student treated with supplemental oxygen with no resolution of symptoms, and then with IM epinephrine.  Student transported to emergency room via paramedics.  Evaluated and discharged home same day.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Became nauseous, lost consciousness.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swollen, red and itchy area about 5 inches around.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase normal, Chest discomfort, Troponin T
Clinical narrative: This study case was received from the investigator in a trial on 22 May 2012. A 29-year-old male subject received the following vaccinations on 07 February 2012: an injection of ACAM2000 (lot number not reported), TYPHIM VI, sanofi pasteur (lot number not reported), ANTHRAX (manufacturer and lot number not reported). On 21 February 2012, the subject had a normal troponin I and ECG. Results from the subject's echocardiogram were not available. On 22 February 2012, the subject was diagnosed with other, chest pain. The patient had no significant medical history. The outcome was not reported. Additional information will be requested. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase normal, Chest discomfort, Troponin T increased
Clinical narrative: This study case was received from the investigator in a trial on 22 May 2012. A 29-year-old male subject received the following vaccinations on 07 February 2012: an injection of ACAM2000 (lot number not reported), TYPHIM VI, sanofi pasteur (lot number not reported), ANTHRAX (manufacturer and lot number not reported). On 21 February 2012, the subject had a normal troponin I and ECG. Results from the subject's echocardiogram were not available. On 22 February 2012, the subject was diagnosed with other, chest pain. The patient had no significant medical history. The outcome was not reported. Additional information will be requested. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Echocardiogram, Electrocardiogram normal, Troponin I, Troponin normal
Clinical narrative: This study case was received from the investigator in a trial on 22 May 2012. A 29-year-old male subject received the following vaccinations on 07 February 2012: an injection of ACAM2000 (lot number not reported), TYPHIM VI, sanofi pasteur (lot number not reported), ANTHRAX (manufacturer and lot number not reported). On 21 February 2012, the subject had a normal troponin I and ECG. Results from the subject's echocardiogram were not available. On 22 February 2012, the subject was diagnosed with other, chest pain. The patient had no significant medical history. The outcome was not reported. Additional information will be requested. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Small nickle size red spot &I swelling. Skin hot to touch at injection site. Less that 12 hours later, swelling progressed to approximately 3in by 3in. Less than 12 hours more, swelling progressed to approximately 5 in. By 5 in area with swollen welt, redness, itching, hot to touch and soreness.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Small nickle size red spot &I swelling. Skin hot to touch at injection site. Less that 12 hours later, swelling progressed to approximately 3in by 3in. Less than 12 hours more, swelling progressed to approximately 5 in. By 5 in area with swollen welt, redness, itching, hot to touch and soreness.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chills, Dyspnoea, Headache, Injection site erythema
Clinical narrative: Pain at injection site (left upper arm), fever (over 101), back and arm are very sore, difficulty moving arm, chills, redness and sore lump on arm where vaccine was injected, breathing stressed and required nebulizer treatments, headache, itching all over body.