chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Impetigo, Skin infection, Skin ulcer, Varicella
Clinical narrative: Was seen for WCC on 5/17/12 & vaccinated with VARIVAX. Seen again in office 5/25/12 and diagnosed with chickenpox. Also diagnosed with impetigo from scratching sores. Currently infected.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Full blood count, Pyrexia, Urine analysis
Clinical narrative: FEVER 101-103.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Gait disturbance, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Came to doctors office at 1540. Left leg swollen, warm to touch, and painful. Child limping. Motrin administered. Dr. rec Benadryl at home.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysgeusia, Headache, Hyperhidrosis, Rash, Wheezing
Clinical narrative: Approx. 30-45mins after leaving office (following appt with Dr.) pt experienced strange taste in mouth followed by onset of profuse sweating rash of upper body including neck, sl wheeze, throbbing (headache that lasted 5-10mins then resolved). Drove back to office, eval by Dr. given 0.2mg epinephrine sq. BP 150/86 AP 100, 10mins later BP160/80 AP 84. States feeling better 10mins after epi, with con't sense of feeling much better after 20mins. Rash resolving, no further wheezing, OK to leave per Dr. after 40mins of observation. Advised to take Benadryl 50 mg at home call back any concerns. Pt states allergic to shellfish (anaphylaxis) bees (carries epi pen) IPV dye, codeine.
Age: 1.13
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: 2.5 inch by 1.25 inch area of redness left thigh with 1 cm hard, red lump where vaccine administered.
Age: 25.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Blood creatine phosphokinase increased, Blood culture, Brain natriuretic peptide abnormal, Cardiomyopathy, Catheterisation cardiac
Clinical narrative: Pt reportedly had Tdap vaccination to the left deltoid area and Varicella vaccination to the right triceps area with development of right arm edema, redness, and pain that banded across his chest starting on May 22nd (the day after vaccination). He was admitted to Medical Center for central, sharp chest pain and ST-segment elevation on EKG. He underwent cardiac catheterization to rule out STEMI and was diagnosed with pericarditis without critical coronary artery stenosis. He was found to have a lateral myocardial wall abnormality and small pericardial effusion. Blood cultures are still pending to rule out bacteremia. Pt reports discovery post-vaccination of prior varicella infection as a child.
Age: 25.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Chest pain, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Erythema, Laboratory test abnormal
Clinical narrative: Pt reportedly had Tdap vaccination to the left deltoid area and Varicella vaccination to the right triceps area with development of right arm edema, redness, and pain that banded across his chest starting on May 22nd (the day after vaccination). He was admitted to Medical Center for central, sharp chest pain and ST-segment elevation on EKG. He underwent cardiac catheterization to rule out STEMI and was diagnosed with pericarditis without critical coronary artery stenosis. He was found to have a lateral myocardial wall abnormality and small pericardial effusion. Blood cultures are still pending to rule out bacteremia. Pt reports discovery post-vaccination of prior varicella infection as a child.
Age: 25.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Metabolic function test abnormal, Oedema peripheral, Pericardial effusion, Pericarditis, Troponin I
Clinical narrative: Pt reportedly had Tdap vaccination to the left deltoid area and Varicella vaccination to the right triceps area with development of right arm edema, redness, and pain that banded across his chest starting on May 22nd (the day after vaccination). He was admitted to Medical Center for central, sharp chest pain and ST-segment elevation on EKG. He underwent cardiac catheterization to rule out STEMI and was diagnosed with pericarditis without critical coronary artery stenosis. He was found to have a lateral myocardial wall abnormality and small pericardial effusion. Blood cultures are still pending to rule out bacteremia. Pt reports discovery post-vaccination of prior varicella infection as a child.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Blister, Chills, Pain, Rash pruritic, Scab
Clinical narrative: Patient developed rash with onset of Saturday 5/19 in the morning before 8AM.  The spots looked like mosquito bites and were itchy. Then on Sunday 5/20 he had more and some turned into blisters.  That same night he had chills, vomiting, body aches. On 5/21 he had some more spots, more than 50 spots. Some blisters are already scabbing. He was diagnosed clinicaly with varicella on 5/20 at a local urgent care.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Varicella post vaccine, Vomiting
Clinical narrative: Patient developed rash with onset of Saturday 5/19 in the morning before 8AM.  The spots looked like mosquito bites and were itchy. Then on Sunday 5/20 he had more and some turned into blisters.  That same night he had chills, vomiting, body aches. On 5/21 he had some more spots, more than 50 spots. Some blisters are already scabbing. He was diagnosed clinicaly with varicella on 5/20 at a local urgent care.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Blister, Chills, Pain, Pruritus, Rash
Clinical narrative: Patient developed rash with onset of Saturday 5/19 in the morning before 8AM.  The spots looked like mosquito bites and were itchy. Then on Sunday 5/20 he had more and some turned into blisters.  That same night he had chills, vomiting, body aches. On 5/21 he had some more spots, more than 50 spots. Some blisters are already scabbing. He was diagnosed clinicaly with varicella on 5/20 at a local urgent care.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Scab, Varicella post vaccine, Vomiting
Clinical narrative: Patient developed rash with onset of Saturday 5/19 in the morning before 8AM.  The spots looked like mosquito bites and were itchy. Then on Sunday 5/20 he had more and some turned into blisters.  That same night he had chills, vomiting, body aches. On 5/21 he had some more spots, more than 50 spots. Some blisters are already scabbing. He was diagnosed clinicaly with varicella on 5/20 at a local urgent care.
Age: 19.0
Sex: M
Vaccine: RAB
Symptoms: Fatigue, Nausea
Clinical narrative: Feels very tired after each rabies Imovax injection, also c/o nausea symptoms resolve within a few hours.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: A quarter of a dime sized reddened area with moderate amt of Pain at site of injection.  Denies any fever, chills, SOB, or hives.
Age: 1.11
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Hypophagia, Insomnia, Irritability, Pyrexia
Clinical narrative: Pt received immunizations on 5/22/12. MMR, Varicella and Hep A. Pt developed a fever on 5/24/12 with a tmax of 103 rectally. Rash developed later that day. Has a vesicular rash scattered on trunk, face and extremities. Pt has been fussy, decreased oral intake, slight soft stools, no longer sleeping through the night. Twin sister has similar sx which started first.
Age: 1.11
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Pt received immunizations on 5/22/12. MMR, Varicella and Hep A. Pt developed a fever on 5/24/12 with a tmax of 103 rectally. Rash developed later that day. Has a vesicular rash scattered on trunk, face and extremities. Pt has been fussy, decreased oral intake, slight soft stools, no longer sleeping through the night. Twin sister has similar sx which started first.
Age: 1.11
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Fluid intake reduced, Irritability, Poor quality sleep, Pruritus
Clinical narrative: Received MMR, Varicella, and Hep A vaccine on 5/22/12. Developed a low grade temp on the 23rd. On the 24th she developed a high fever of at least 103 rectally. Mother has been treating with TYLENOL and ibu fever improves somewhat. Mom notes rash developed on the 24th and had increased. Twin sister had the same sx. Pt has been fussy, decrease appetite, and fluid intake. Not sleeping well at night. Mom notes that she has been scratching her elbows.
Age: 1.11
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Received MMR, Varicella, and Hep A vaccine on 5/22/12. Developed a low grade temp on the 23rd. On the 24th she developed a high fever of at least 103 rectally. Mother has been treating with TYLENOL and ibu fever improves somewhat. Mom notes rash developed on the 24th and had increased. Twin sister had the same sx. Pt has been fussy, decrease appetite, and fluid intake. Not sleeping well at night. Mom notes that she has been scratching her elbows.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Oedema peripheral, Pyrexia, Urine analysis normal
Clinical narrative: 5/21 - fever, chills, arm and leg fatigue, swelling on arm from shoulder to elbow - per patient. Also c/o dark urine, no Rxs.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Urine colour abnormal
Clinical narrative: 5/21 - fever, chills, arm and leg fatigue, swelling on arm from shoulder to elbow - per patient. Also c/o dark urine, no Rxs.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Administered at pharmacy on 5/21/12.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching and redness (L) arm - at site of injection, no SOB - no chest pain.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Injection site nodule
Clinical narrative: (L) deltoid with sub nodule.
Age: 1.01
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Muscular weakness, Weight bearing difficulty
Clinical narrative: 1 y o female had a flu shot on 12/28/11. The next day she couldn't bear weight on her legs or roll over. Nine days later parents had the child evaluated. Lower extremity weakness was noted but DTR's were present. Neurologist eval the following week. Dx GBS - resolving.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: Itching all over. Patient stated she has a rash (slight) but itching all over her arms & chest. Slight redness around injection site noted - Itching for past "couple days."
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash appeared 24 hrs post injection. Lasted approx 24 hours then resolved w/o complications.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eyelid oedema
Clinical narrative: Swelling under left eye - almost within 1 hour of getting vaccination.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Rash at site of injection, pain & itching. Lasting 1 week.
Age: 19.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Syncope
Clinical narrative: PT FAINTED SUDDENLY 5 TO 10 MIN AFTER GETTING ADACEL (TDAP) AND HAVRIX (HEP A) AROUND 5:55PM.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: When I woke up the arm that received the shot was sore, and I had a slight fever. I took Dayquil throughout the day. That night, once the Dayquil wore off, I had a fever of 100.5. I took some Nyquil and went to bed. The fever was gone when I woke up the next day, but my arm is still slightly sore 2 days later.
Age: 0.24
Sex: F
Vaccine: HEPA, HIBV, MMR
Symptoms: Culture urine negative, Febrile convulsion, Full blood count normal
Clinical narrative: Febrile seizure.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: Pharmacist called patient to thank her for being a new customer and patient stated she believed she had a stroke and was on her way to ER, and she questioned if vaccine could have been cause. Patient stopped in 5/26/2012 to inform pharmacist it was a diagnosed stroke but cause was unknown.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain, Pyrexia, Swelling
Clinical narrative: Temperature Fever Soreness Swelling Chills
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Eosinophil count increased, Eosinophilia, Full blood count abnormal, Injection site erythema, Injection site irritation
Clinical narrative: Initially irritation to vaccination site to Left deltoid, then mild swelling on 5/24, worsened by 5/25 pm.  Presented 5/26 with moderate swelling, 40% larger diameter left upper arm with redness, warmth and swelling.  Patient neurovascularly intact.  Treated with iv Solumedrol and clindamycin.  Redness and swelling decreased by 60% after iv Solumedrol.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Metabolic function test normal, Platelet count decreased
Clinical narrative: Initially irritation to vaccination site to Left deltoid, then mild swelling on 5/24, worsened by 5/25 pm.  Presented 5/26 with moderate swelling, 40% larger diameter left upper arm with redness, warmth and swelling.  Patient neurovascularly intact.  Treated with iv Solumedrol and clindamycin.  Redness and swelling decreased by 60% after iv Solumedrol.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Fatigue, Hypersomnia, Injection site pain
Clinical narrative: SWELLING AND PAIN AT INJECTION SITE DEVELOPED SEVERAL HOURS AFTER INJECTION; GOT WORSE BY EVENING WITH LETHARGY, FATIGUE & MUSCLE ACHES. TEMPERATURE ELEVATED TO 99.8, CALLED ON CALL PHYSICIAN WHO ADVISED USE OF ICE AND IBUPROFEN.  THIS WAS DONE. SLEPT NEARLY 12 HOURS, FEVER REDUCED UPON AWAKENING-HOWEVER PAIN SWELLING HAVE EXTENDED THROUGH THE DAY SATURDAY 05 26/2012, TO INCORPORATE ENTIRE BACK  PORTION OF UPPER ARM, SKIN IS REDDENED AND REMAINS HOT TO TOUCH DESPITE USE OF ICE. TEMPERATURE ELEVATED ABOVE MY NORMAL 97.4 TO ABOUT 98.3 AT THIS TIME.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Lethargy, Myalgia, Skin warm
Clinical narrative: SWELLING AND PAIN AT INJECTION SITE DEVELOPED SEVERAL HOURS AFTER INJECTION; GOT WORSE BY EVENING WITH LETHARGY, FATIGUE & MUSCLE ACHES. TEMPERATURE ELEVATED TO 99.8, CALLED ON CALL PHYSICIAN WHO ADVISED USE OF ICE AND IBUPROFEN.  THIS WAS DONE. SLEPT NEARLY 12 HOURS, FEVER REDUCED UPON AWAKENING-HOWEVER PAIN SWELLING HAVE EXTENDED THROUGH THE DAY SATURDAY 05 26/2012, TO INCORPORATE ENTIRE BACK  PORTION OF UPPER ARM, SKIN IS REDDENED AND REMAINS HOT TO TOUCH DESPITE USE OF ICE. TEMPERATURE ELEVATED ABOVE MY NORMAL 97.4 TO ABOUT 98.3 AT THIS TIME.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Oedema peripheral, Pyrexia, Stomatitis
Clinical narrative: Felt fine after getting the vaccine, and the day after but on 5/21/2012 patient reports vomiting, fever, chills, shaking sores on tongue, tight throat, headaches, swollen feet. Reports feeling better on 5/23/12 then vomiting again on 5/24/12 which prompted a doctors visit.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness, Tremor, Vomiting
Clinical narrative: Felt fine after getting the vaccine, and the day after but on 5/21/2012 patient reports vomiting, fever, chills, shaking sores on tongue, tight throat, headaches, swollen feet. Reports feeling better on 5/23/12 then vomiting again on 5/24/12 which prompted a doctors visit.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Pain, Pyrexia
Clinical narrative: Redness, fever, pain.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Headache, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Very sore arm. Swelling, redness - increasing in size overnight. Headache. Slightly feverish. Ibuprofen.  Ice.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Diarrhoea, Erythema, Hypoaesthesia, Injection site erythema
Clinical narrative: Swelling, hot, and progressing redness at site of injection. Swollen limb, numb at tips of fingers of affected arm, fever, chills, increasing redness, nausea, slight diarrhea.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Nausea, Oedema peripheral, Pyrexia
Clinical narrative: Swelling, hot, and progressing redness at site of injection. Swollen limb, numb at tips of fingers of affected arm, fever, chills, increasing redness, nausea, slight diarrhea.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: Swelling, hot, and progressing redness at site of injection. Swollen limb, numb at tips of fingers of affected arm, fever, chills, increasing redness, nausea, slight diarrhea.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash erythematous, Skin warm
Clinical narrative: Sudden red warm blistering rash looks like shingles.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema
Clinical narrative: C/O redness, no itchiness over Rt. arm. No pain. No fever.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: 2" long red mark at injection site. Arm is sore but not itching. 8 days post shot. No treatment at this time. Will call Dr if condition worsens or doesn't clear up.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Poor quality sleep, Pyrexia, Rash generalised, Screaming
Clinical narrative: 1) Child who previously slept through night has so far spent two weeks waking up screaming several times per night, beginning the night after she was vaccinated. 2) Fever (102.6) began the day of the vaccination.  Two weeks after vaccination, fever still comes and goes despite common causes ruled out by physician. 3) Rash covering entire body began six days after vaccination.
Age: 16.0
Sex: F
Vaccine: TYP, YF
Symptoms: Arthralgia, C-reactive protein normal, Chest X-ray normal, Chest pain, Electrocardiogram normal
Clinical narrative: Mild fever (to 101.4), reproduceable chest pain and some generalized arthalgias.  All resolved with Motrin.
Age: 16.0
Sex: F
Vaccine: TYP, YF
Symptoms: Full blood count normal, Metabolic function test normal, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Mild fever (to 101.4), reproduceable chest pain and some generalized arthalgias.  All resolved with Motrin.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site cellulitis, Injection site swelling
Clinical narrative: Swelling of injection site enlareging to an area of 4" x 8"over several days becomeing cellulitis.  Headache for four days.  Antibiotics began on 4th day with inprovement after four more days.
Age: 24.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Cough, Pyrexia, X-ray normal
Clinical narrative: Fever 103 degrees for 3 days. Then began to have a chronic cough. Cough has lasted over 2 months and still currently have it.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Fever up to 102.6 on 5/24/12. On 5/26/12 she developed small red bumps/rash on the trunk of her body, extremities and a few on the face.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood culture negative, Bradycardia, Chest X-ray normal, Continuous positive airway pressure, Dyskinesia
Clinical narrative: Vaccinations given on 5/23 & 5/24. On 5/25, infant had a severe apneic episode with questionable seizure activity (rhythmic jerking of all extremities), as well as several desaturation episodes, requiring CPAP for 24 hrs. Another apneic/bradycardic event with questionable seizure activity was noted on 5/27.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Full blood count normal, Infantile apnoeic attack, Oxygen saturation decreased
Clinical narrative: Vaccinations given on 5/23 & 5/24. On 5/25, infant had a severe apneic episode with questionable seizure activity (rhythmic jerking of all extremities), as well as several desaturation episodes, requiring CPAP for 24 hrs. Another apneic/bradycardic event with questionable seizure activity was noted on 5/27.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Abnormal behaviour, Dyspnoea, Pyrexia
Clinical narrative: Mom reports pt was "acting strange" & having difficulty breathing while sleeping. Reported fever of 102.6 (R).
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Muscle strain, Pain, Pain in extremity, Rash
Clinical narrative: Pain in left leg, (shooting pain) - pt went to ER & was told it was due to muscle pull. Pain continued & pt went to primary MD on 5/24/12. Pain continued. MD prescribed VICODIN for pain. Pt returned to doc 5/24/12 due to increased pain and rash. ER MD dx pt with shingles and prescribed Valcyclovir.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Axillary pain, Blood test, Burning sensation, Herpes zoster
Clinical narrative: Pain in left leg, (shooting pain) - pt went to ER & was told it was due to muscle pull. Pain continued & pt went to primary MD on 5/24/12. Pain continued. MD prescribed VICODIN for pain. Pt returned to doc 5/24/12 due to increased pain and rash. ER MD dx pt with shingles and prescribed Valcyclovir.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Myalgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain in left leg, (shooting pain) - pt went to ER & was told it was due to muscle pull. Pain continued & pt went to primary MD on 5/24/12. Pain continued. MD prescribed VICODIN for pain. Pt returned to doc 5/24/12 due to increased pain and rash. ER MD dx pt with shingles and prescribed Valcyclovir.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Pain in left leg, (shooting pain) - pt went to ER & was told it was due to muscle pull. Pain continued & pt went to primary MD on 5/24/12. Pain continued. MD prescribed VICODIN for pain. Pt returned to doc 5/24/12 due to increased pain and rash. ER MD dx pt with shingles and prescribed Valcyclovir.
Age: 1.31
Sex: F
Vaccine: DTP, MMR, VARCEL
Symptoms: Erythema multiforme, Rash
Clinical narrative: 5/18/12 began with rash Dx with erythema multiforme minor. No other meds. No other known triggers. Seen in ER and in follow up office visit.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: On 5/23/12 had febrile seizure brief required emergency room visit and f/u visit in office child had history of febrile seizure one previously on 2/14/12 (first episode).
Age: 0.69
Sex: M
Vaccine: DTAP
Symptoms: Bronchiolitis, Chest discomfort, Condition aggravated, Pyrexia, Respiratory distress
Clinical narrative: Initial report was received on 16 May 2012 from a health care professional. An eight month-old male patient at the time of vaccination (also reported as six month-old) who had no illness at the time of vaccination and a history of reactive airway disease with wheezing "a few weeks prior to vaccination", had received on 10 January 2011 a third dose intramuscular right thigh (RT) injection of TRIPEDIA, lot number U3282DA and within an hour to an hour and a half of vaccination (also reported as within 12 hours), developed wheezing, chest tightness, mild respiratory distress and fever of 101 to 101.5. The patient was diagnosed on 27 January 2011 with bronchiolitis, wheezing (also reported as a pre-existing condition). According to the report, the symptoms resolved with "one albuterol aerosol" (also reported the patient recovered in "one to two days without treatment"). Concomitant medications and relevant diagnostic test were reported as none. The patient was to be evaluated by an allergist. The patient had a previous reaction of increased fussiness without fever after receiving his first dose of IPV at age of three months. No further information was available at the time of report. The patient's outcome was recovered. This patient experienced another event captured in case 2012-05169. Documents held by sender: none.
Age: 0.69
Sex: M
Vaccine: DTAP
Symptoms: Wheezing
Clinical narrative: Initial report was received on 16 May 2012 from a health care professional. An eight month-old male patient at the time of vaccination (also reported as six month-old) who had no illness at the time of vaccination and a history of reactive airway disease with wheezing "a few weeks prior to vaccination", had received on 10 January 2011 a third dose intramuscular right thigh (RT) injection of TRIPEDIA, lot number U3282DA and within an hour to an hour and a half of vaccination (also reported as within 12 hours), developed wheezing, chest tightness, mild respiratory distress and fever of 101 to 101.5. The patient was diagnosed on 27 January 2011 with bronchiolitis, wheezing (also reported as a pre-existing condition). According to the report, the symptoms resolved with "one albuterol aerosol" (also reported the patient recovered in "one to two days without treatment"). Concomitant medications and relevant diagnostic test were reported as none. The patient was to be evaluated by an allergist. The patient had a previous reaction of increased fussiness without fever after receiving his first dose of IPV at age of three months. No further information was available at the time of report. The patient's outcome was recovered. This patient experienced another event captured in case 2012-05169. Documents held by sender: none.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Catheterisation cardiac, Myocarditis
Clinical narrative: This case was reported by a pharmacist and described the occurrence of myocarditis in a 46-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included Aspirin. On 21 September 2011 the subject received unspecified dose of FLUARIX (.5 ml, unknown). On 28 September 2011, 7 days after vaccination with FLUARIX, the subject experienced myocarditis. The subject was hospitalised and the pharmacist considered the event was life threatening and clinically significant (or requiring intervention). The subject "required fluids and cardiac cath." At the time of reporting the myocarditis was resolved. The report completed a VAERS report.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal distension, Decreased appetite, Faeces discoloured, Intussusception, Lethargy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 weeks old male with gastrooesophageal reflux and a history of nasal congestion, cough and no known drug allergies who on 05-JAN-2012 was vaccinated with the second dose of ROTATEQ, (lot # 669085/1659Z), "by mouth", (dose not reported). Concomitant vaccines given on the same date included the second dose of PREVNAR, (lot # 917737), I.M, in the right leg and PENTACEL, (lot # C3845AA), I.M, in the right leg. On 11-JAN-2012, the patient experienced decreased appetite / Black stools / Lethargy/ Distended abdomen. Sent to emergency room (ER). Diagnosis (Dx): Intussusception. The following information was obtained through follow-up and/or provided by the government. 13-FEB-2012. Hospital records date of service (DOS) 11-JAN-2012. DX: intussusception, reduced. Chief complaint (CC): decreased appetite; vomiting; diarrhea; abdominal pain; irritability; lethargic; tarry stools. Physical examination (PE): blood streaked stools. Underwent successful reduction by air-contrast enema. Admitted overnight. Released in stable condition. Laboratory tests performed included: Ultrasound in emergency room (ER) / Intussusception. The following information was obtained through follow-up and/or provided by the government. 13-FEB-2012. Labs/diagnostics. Hematocrit (Hct) 33.7% (L), White blood cell count (WBC) 11 (N), lymphocyte count (lymphs) 43 (H), neutrophils (neuts) 50 (L). Abdomen X-ray (Abd XR): negative. Abdomen ultrasound (Abd US): target sign suggestive of telescoping of bowel segment is seen in right lower abd consistent with (c/w) intussusception. Upper gastrointestinal (UGI) with Small Bowel Follow Through (SBFT) X-ray: negative. At the time of the report the outcome of the patient for all of the adverse events was unknown. This report was considered serious, immediately life threatening by the agency and required hospitalization for all adverse events. It required emergency room / doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 447372. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669085/1659Z were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 weeks old male with gastrooesophageal reflux and a history of nasal congestion, cough and no known drug allergies who on 05-JAN-2012 was vaccinated with the second dose of ROTATEQ, (lot # 669085/1659Z), "by mouth", (dose not reported). Concomitant vaccines given on the same date included the second dose of PREVNAR, (lot # 917737), I.M, in the right leg and PENTACEL, (lot # C3845AA), I.M, in the right leg. On 11-JAN-2012, the patient experienced decreased appetite / Black stools / Lethargy/ Distended abdomen. Sent to emergency room (ER). Diagnosis (Dx): Intussusception. The following information was obtained through follow-up and/or provided by the government. 13-FEB-2012. Hospital records date of service (DOS) 11-JAN-2012. DX: intussusception, reduced. Chief complaint (CC): decreased appetite; vomiting; diarrhea; abdominal pain; irritability; lethargic; tarry stools. Physical examination (PE): blood streaked stools. Underwent successful reduction by air-contrast enema. Admitted overnight. Released in stable condition. Laboratory tests performed included: Ultrasound in emergency room (ER) / Intussusception. The following information was obtained through follow-up and/or provided by the government. 13-FEB-2012. Labs/diagnostics. Hematocrit (Hct) 33.7% (L), White blood cell count (WBC) 11 (N), lymphocyte count (lymphs) 43 (H), neutrophils (neuts) 50 (L). Abdomen X-ray (Abd XR): negative. Abdomen ultrasound (Abd US): target sign suggestive of telescoping of bowel segment is seen in right lower abd consistent with (c/w) intussusception. Upper gastrointestinal (UGI) with Small Bowel Follow Through (SBFT) X-ray: negative. At the time of the report the outcome of the patient for all of the adverse events was unknown. This report was considered serious, immediately life threatening by the agency and required hospitalization for all adverse events. It required emergency room / doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 447372. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669085/1659Z were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Decreased appetite, Diarrhoea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 weeks old male with gastrooesophageal reflux and a history of nasal congestion, cough and no known drug allergies who on 05-JAN-2012 was vaccinated with the second dose of ROTATEQ, (lot # 669085/1659Z), "by mouth", (dose not reported). Concomitant vaccines given on the same date included the second dose of PREVNAR, (lot # 917737), I.M, in the right leg and PENTACEL, (lot # C3845AA), I.M, in the right leg. On 11-JAN-2012, the patient experienced decreased appetite / Black stools / Lethargy/ Distended abdomen. Sent to emergency room (ER). Diagnosis (Dx): Intussusception. The following information was obtained through follow-up and/or provided by the government. 13-FEB-2012. Hospital records date of service (DOS) 11-JAN-2012. DX: intussusception, reduced. Chief complaint (CC): decreased appetite; vomiting; diarrhea; abdominal pain; irritability; lethargic; tarry stools. Physical examination (PE): blood streaked stools. Underwent successful reduction by air-contrast enema. Admitted overnight. Released in stable condition. Laboratory tests performed included: Ultrasound in emergency room (ER) / Intussusception. The following information was obtained through follow-up and/or provided by the government. 13-FEB-2012. Labs/diagnostics. Hematocrit (Hct) 33.7% (L), White blood cell count (WBC) 11 (N), lymphocyte count (lymphs) 43 (H), neutrophils (neuts) 50 (L). Abdomen X-ray (Abd XR): negative. Abdomen ultrasound (Abd US): target sign suggestive of telescoping of bowel segment is seen in right lower abd consistent with (c/w) intussusception. Upper gastrointestinal (UGI) with Small Bowel Follow Through (SBFT) X-ray: negative. At the time of the report the outcome of the patient for all of the adverse events was unknown. This report was considered serious, immediately life threatening by the agency and required hospitalization for all adverse events. It required emergency room / doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 447372. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669085/1659Z were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Enema administration, Faeces discoloured, Haematochezia, Haematocrit decreased, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 weeks old male with gastrooesophageal reflux and a history of nasal congestion, cough and no known drug allergies who on 05-JAN-2012 was vaccinated with the second dose of ROTATEQ, (lot # 669085/1659Z), "by mouth", (dose not reported). Concomitant vaccines given on the same date included the second dose of PREVNAR, (lot # 917737), I.M, in the right leg and PENTACEL, (lot # C3845AA), I.M, in the right leg. On 11-JAN-2012, the patient experienced decreased appetite / Black stools / Lethargy/ Distended abdomen. Sent to emergency room (ER). Diagnosis (Dx): Intussusception. The following information was obtained through follow-up and/or provided by the government. 13-FEB-2012. Hospital records date of service (DOS) 11-JAN-2012. DX: intussusception, reduced. Chief complaint (CC): decreased appetite; vomiting; diarrhea; abdominal pain; irritability; lethargic; tarry stools. Physical examination (PE): blood streaked stools. Underwent successful reduction by air-contrast enema. Admitted overnight. Released in stable condition. Laboratory tests performed included: Ultrasound in emergency room (ER) / Intussusception. The following information was obtained through follow-up and/or provided by the government. 13-FEB-2012. Labs/diagnostics. Hematocrit (Hct) 33.7% (L), White blood cell count (WBC) 11 (N), lymphocyte count (lymphs) 43 (H), neutrophils (neuts) 50 (L). Abdomen X-ray (Abd XR): negative. Abdomen ultrasound (Abd US): target sign suggestive of telescoping of bowel segment is seen in right lower abd consistent with (c/w) intussusception. Upper gastrointestinal (UGI) with Small Bowel Follow Through (SBFT) X-ray: negative. At the time of the report the outcome of the patient for all of the adverse events was unknown. This report was considered serious, immediately life threatening by the agency and required hospitalization for all adverse events. It required emergency room / doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 447372. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669085/1659Z were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Irritability, Lethargy, Lymphocyte percentage increased, Melaena, Neutrophil percentage decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 weeks old male with gastrooesophageal reflux and a history of nasal congestion, cough and no known drug allergies who on 05-JAN-2012 was vaccinated with the second dose of ROTATEQ, (lot # 669085/1659Z), "by mouth", (dose not reported). Concomitant vaccines given on the same date included the second dose of PREVNAR, (lot # 917737), I.M, in the right leg and PENTACEL, (lot # C3845AA), I.M, in the right leg. On 11-JAN-2012, the patient experienced decreased appetite / Black stools / Lethargy/ Distended abdomen. Sent to emergency room (ER). Diagnosis (Dx): Intussusception. The following information was obtained through follow-up and/or provided by the government. 13-FEB-2012. Hospital records date of service (DOS) 11-JAN-2012. DX: intussusception, reduced. Chief complaint (CC): decreased appetite; vomiting; diarrhea; abdominal pain; irritability; lethargic; tarry stools. Physical examination (PE): blood streaked stools. Underwent successful reduction by air-contrast enema. Admitted overnight. Released in stable condition. Laboratory tests performed included: Ultrasound in emergency room (ER) / Intussusception. The following information was obtained through follow-up and/or provided by the government. 13-FEB-2012. Labs/diagnostics. Hematocrit (Hct) 33.7% (L), White blood cell count (WBC) 11 (N), lymphocyte count (lymphs) 43 (H), neutrophils (neuts) 50 (L). Abdomen X-ray (Abd XR): negative. Abdomen ultrasound (Abd US): target sign suggestive of telescoping of bowel segment is seen in right lower abd consistent with (c/w) intussusception. Upper gastrointestinal (UGI) with Small Bowel Follow Through (SBFT) X-ray: negative. At the time of the report the outcome of the patient for all of the adverse events was unknown. This report was considered serious, immediately life threatening by the agency and required hospitalization for all adverse events. It required emergency room / doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 447372. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669085/1659Z were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, White blood cell count normal, X-ray normal, X-ray with contrast upper gastrointestinal tract normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 weeks old male with gastrooesophageal reflux and a history of nasal congestion, cough and no known drug allergies who on 05-JAN-2012 was vaccinated with the second dose of ROTATEQ, (lot # 669085/1659Z), "by mouth", (dose not reported). Concomitant vaccines given on the same date included the second dose of PREVNAR, (lot # 917737), I.M, in the right leg and PENTACEL, (lot # C3845AA), I.M, in the right leg. On 11-JAN-2012, the patient experienced decreased appetite / Black stools / Lethargy/ Distended abdomen. Sent to emergency room (ER). Diagnosis (Dx): Intussusception. The following information was obtained through follow-up and/or provided by the government. 13-FEB-2012. Hospital records date of service (DOS) 11-JAN-2012. DX: intussusception, reduced. Chief complaint (CC): decreased appetite; vomiting; diarrhea; abdominal pain; irritability; lethargic; tarry stools. Physical examination (PE): blood streaked stools. Underwent successful reduction by air-contrast enema. Admitted overnight. Released in stable condition. Laboratory tests performed included: Ultrasound in emergency room (ER) / Intussusception. The following information was obtained through follow-up and/or provided by the government. 13-FEB-2012. Labs/diagnostics. Hematocrit (Hct) 33.7% (L), White blood cell count (WBC) 11 (N), lymphocyte count (lymphs) 43 (H), neutrophils (neuts) 50 (L). Abdomen X-ray (Abd XR): negative. Abdomen ultrasound (Abd US): target sign suggestive of telescoping of bowel segment is seen in right lower abd consistent with (c/w) intussusception. Upper gastrointestinal (UGI) with Small Bowel Follow Through (SBFT) X-ray: negative. At the time of the report the outcome of the patient for all of the adverse events was unknown. This report was considered serious, immediately life threatening by the agency and required hospitalization for all adverse events. It required emergency room / doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 447372. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669085/1659Z were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.1
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intussusception, Surgery, Ultrasound abdomen
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 4 weeks old female patient with no medical history, no previous illnesses and no known drug allergies was vaccinated on 17-NOV-2011 with the first dose of ROTATEQ (lot # 670010/0321AA), "by mouth", (dose not reported). Secondary suspect vaccine given on the same date included the second dose of RECOMBIVAX HB (lot # 669934/0571AA), I.M., in the right leg, (dose not reported). Concomitant vaccines given on the same date included the first dose of PREVNAR !# (batch # C3732AB), I.M., in the right leg and the first dose of PENTACEL, (batch # C3834AA), I.M., in the left leg. On 05-JAN-2012, the patient experienced intussusception 07-JAN-2012 reduced intraoperatively on 08-JAN-2012. The following information was obtained through follow-up and/or provided by the government. 31-JAN-2012. Hospital records date of service (DOS) 08-JAN-2012 to 12-JAN-2012. Diagnosis (DX): nonreducible intussusception. Chief complaint (CC): lethargy; vomiting; absence of bowel movements (BM). PE: masses palpable to right side of abdomen (abd). Intussusception unable to be reduced by air contrast enema; hence laparoscopy (E-Lap) done with ileocecal resection and primary re-anastomosis. Recovered well; the patient was discharged (DC) in stable condition to f/u with surgery primary care physician (PCP). Laboratory tests performed included serum calcium test 8.8 low, blood hemoglobin test 9.5 low and whole blood hematocrit 28. This report was considered serious, immediately life threatening by the agency and required hospitalization for all adverse events. It required emergency room/doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 447577. A priority lot check investigation for lot # 670010/0321AA has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.1
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal mass, Blood calcium decreased, Colectomy, Constipation, Enema administration
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 4 weeks old female patient with no medical history, no previous illnesses and no known drug allergies was vaccinated on 17-NOV-2011 with the first dose of ROTATEQ (lot # 670010/0321AA), "by mouth", (dose not reported). Secondary suspect vaccine given on the same date included the second dose of RECOMBIVAX HB (lot # 669934/0571AA), I.M., in the right leg, (dose not reported). Concomitant vaccines given on the same date included the first dose of PREVNAR !# (batch # C3732AB), I.M., in the right leg and the first dose of PENTACEL, (batch # C3834AA), I.M., in the left leg. On 05-JAN-2012, the patient experienced intussusception 07-JAN-2012 reduced intraoperatively on 08-JAN-2012. The following information was obtained through follow-up and/or provided by the government. 31-JAN-2012. Hospital records date of service (DOS) 08-JAN-2012 to 12-JAN-2012. Diagnosis (DX): nonreducible intussusception. Chief complaint (CC): lethargy; vomiting; absence of bowel movements (BM). PE: masses palpable to right side of abdomen (abd). Intussusception unable to be reduced by air contrast enema; hence laparoscopy (E-Lap) done with ileocecal resection and primary re-anastomosis. Recovered well; the patient was discharged (DC) in stable condition to f/u with surgery primary care physician (PCP). Laboratory tests performed included serum calcium test 8.8 low, blood hemoglobin test 9.5 low and whole blood hematocrit 28. This report was considered serious, immediately life threatening by the agency and required hospitalization for all adverse events. It required emergency room/doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 447577. A priority lot check investigation for lot # 670010/0321AA has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.