chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Dizziness, Lethargy, Pallor, Slow response to stimuli
Clinical narrative: She has been very lethargic, pale, weak, and dizzy. Seems extremely out of it in certain periods of time. Her dizziness is so bad that it causes her to vomit from too much motion if she's just eaten. She's not responding like normal. She's always been happy and healthy.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: She has been very lethargic, pale, weak, and dizzy. Seems extremely out of it in certain periods of time. Her dizziness is so bad that it causes her to vomit from too much motion if she's just eaten. She's not responding like normal. She's always been happy and healthy.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tenderness in upper arm reaction on (R) arm - site of PNEUMOVAX flu given in (L) arm.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Febrile convulsion, Influenza, Vaccine positive rechallenge
Clinical narrative: My son was given the FLUZONE flu shot on 12-7-10. Two or three days later he started having flu symptoms, temperature shot up to 103. A week after the flu shot he had a febrile seizure. Happened again after his second dose.
Age: 32.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Edema, erythema, and pain at right upper arm subcutaneous injection site. MD treatment: AUGMENTIN.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Myalgia, Pyrexia, Thrombocytopenia, Vaginal haemorrhage
Clinical narrative: Fever - up to 105 degrees myalgia vaginal bleeding went to Medical Center labs - thrombocytopenia.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Rash
Clinical narrative: Strong reaction to drug. Heavy rash on torso. Some on arms & legs.
Age: 25.0
Sex: F
Vaccine: FLU3, HPV4, PPV, TDAP
Symptoms: Injection site haematoma
Clinical narrative: Pt with large tender raised area around injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Laboratory test, Varicella
Clinical narrative: Pt woke up with blister on palm of her hand, & 2 spots on back. Dermatologist diagnosed it as chicken pox. Pt had chickenpox at 7 years of age.
Age: 1.15
Sex: F
Vaccine: FLU3, HEPA, PNC
Symptoms: Chest X-ray normal, Condition aggravated, Febrile convulsion, Full blood count normal, Metabolic function test
Clinical narrative: 1/28/11 - received Hep A/PCV 13/Flu in AM brought to ED in evening because of febrile seizure. Also w/prior hx of febrile seizure & am in ED. Given antipyretic & Amoxil.
Age: 1.15
Sex: F
Vaccine: FLU3, HEPA, PNC
Symptoms: Urine analysis normal
Clinical narrative: 1/28/11 - received Hep A/PCV 13/Flu in AM brought to ED in evening because of febrile seizure. Also w/prior hx of febrile seizure & am in ED. Given antipyretic & Amoxil.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Guillain-Barre syndrome, Mobility decreased
Clinical narrative: He was walking while doing some shopping and suddenly he could no longer walk and had difficulty moving his legs.  He was admitted to the hospital at medical center and was later transferred to another hospital  for further work-up of his symptoms and diagnosed at that time with Guillain-Barre syndrome by the attending neurologist.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13, VARCEL
Symptoms: Injection site papule, Pyrexia, Upper respiratory tract infection
Clinical narrative: Papule at the site of the injection Fever  Upper Respiratory Symptoms treated with tylenol as needed and compresses at site of injection
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Erythema, Headache, Influenza like illness, Injection site erythema, Lymphadenopathy
Clinical narrative: Flu-like symptoms including malaise, sore throat, mild headache and appearance of flat red lesions over the upper torso. Large area of localized redness at innoculation site X 24-48 hours. Also unilateral axillary adenopathy. Symptomatic treatment with fluid and tylenol.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Macule, Malaise, Oropharyngeal pain, Skin lesion
Clinical narrative: Flu-like symptoms including malaise, sore throat, mild headache and appearance of flat red lesions over the upper torso. Large area of localized redness at innoculation site X 24-48 hours. Also unilateral axillary adenopathy. Symptomatic treatment with fluid and tylenol.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Malaise, Oropharyngeal pain, Skin lesion
Clinical narrative: Flu-like symptoms including malaise, sore throat, mild headache and appearance of flat red lesions over the upper torso. Large area of localized redness at innoculation site X 24-48 hours. Also unilateral axillary adenopathy. Symptomatic treatment with fluid and tylenol.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Folliculitis, Injection site pustule, Rash, Rash macular, Rash pruritic
Clinical narrative: Elevated blotchy rash on back and chest, treated with benadryl by local ER. Improving in these sites when examined today, but pruritic rash is migrating to LEs today.  Additionally scattered pustules "folliculitis-like" around the primary innoculation site and in a patch on the left FA.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Rash pustular
Clinical narrative: Elevated blotchy rash on back and chest, treated with benadryl by local ER. Improving in these sites when examined today, but pruritic rash is migrating to LEs today.  Additionally scattered pustules "folliculitis-like" around the primary innoculation site and in a patch on the left FA.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site pustule, Rash macular, Rash pruritic, Rash pustular
Clinical narrative: Elevated blotchy rash on back and chest, treated with benadryl by local ER. Improving in these sites when examined today, but pruritic rash is migrating to LEs today.  Additionally scattered pustules "folliculitis-like" around the primary innoculation site and in a patch on the left FA.
Age: 18.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Chills, Erythema, Pain in extremity, Pyrexia, Urticaria
Clinical narrative: high fever  103  chills  painful arm with large red welts
Age: 1.05
Sex: M
Vaccine: FLU3, HIBV, MMRV, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: On 1/31/11 mother of patient brought son in for his one year well baby appointment.  At the time of this appointment the patient was given MMRV, PCV-13, Influenza, & Hib-OMP.  The patient was told to return to the clinic in about to weeks to start his Hep-A series.  When the father of patient brought son in for walk-in vaccines on 2/15/11, he was not aware of what all vaccines that his son had earlier.  When the tech looked up the patients information in the electronic vaccination record, it did not show that the child receive his well baby vaccines, so the vaccine provider gave the same vaccines that was given 16 days ago.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Cardioversion, Convulsion, Death, Hypoxic-ischaemic encephalopathy
Clinical narrative: seizure resulting in defribrilation resulting in anoxic brain injury. treated at Hospital.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Erb's palsy
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 14 year old female who on 04-JAN-2010 was vaccinated with a first dose of GARDASIL (Lot# unknown). Second dose of GARDASIL (Lot# unknown) was given on 04-MAR-2010. Third dose of GARDASIL (Lot# 662304/1013Y) was given on 06-JUL-2010. On 22-DEC-2010 the patient delivered a female infant. The infant was diagnosed with "brachial palsy (Erb-Duschenne palsy), left upper arm". At the time of the report, the outcome of the event was unknown. Upon internal review, "brachial palsy (Erb-Duschenne palsy), left upper arm" was considered to be an other important medical event. The mother's experience was captured in WAES# 1008USA01305. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Pneumonia bacterial
Clinical narrative: This medically confirmed spontaneous report (initial receipt 07-FEB-2011) concerns a 79 year old male patient. On 22-SEP-2010, the patient received AFLURIA. On 06-FEB-2011, the patient was diagnosed with H1N1 influenza and bacterial pneumonia. The patient went to the hospital emergency room twice and was released (not hospitalised). The patient received oseltamivir for treatment. The event outcome was unknown. The reporter considered events serious due to intervention required to prevent serious criteria (two trips to ER), significant disability or incapacity and events being life threatening (very weak).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Headache, Pyrexia
Clinical narrative: Fever 99.8 - 101.2, headache, abdominal cramping. Pt instructed to take MOTRIN. Vomiting.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Fever 99.8 - 101.2, headache, abdominal cramping. Pt instructed to take MOTRIN. Vomiting.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Rash, itching started 2/11/11 & continued to get worse no relief with BENADRYL OTC called & presented to clinic 2/15/11 Methylpred sodium su 125 mg IM & Prednisone taper 2/16/11 I left a message for pt to call if symptoms no improved.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC
Symptoms: Injected limb mobility decreased, Muscle contractions involuntary
Clinical narrative: Mother called following day - claim pt could not straighten legs. Pt able to bear wt & move ft. No signs of infection, redness, streak, swell or drainage - advised to apply cool compress, acetamin q4h to call back if worsens.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Genital herpes, Post herpetic neuralgia, Rash
Clinical narrative: Herpes type outbrake on penis three weeks after vacination.One month later again the same outbrake.Five weeks later a rash on left side of stomach and now post-herpetic neuralgia.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus infection, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Herpes type outbrake on penis three weeks after vacination.One month later again the same outbrake.Five weeks later a rash on left side of stomach and now post-herpetic neuralgia.
Age: 0.47
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Mom noticed red, warm area over vaccine site when child woke up in the AM
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 2"x 2" reddened area. Very itchy appeared 10 days at injection site. Alavert 1 tablet given po for itchy feeling.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Blood cholesterol increased, Eye swelling, Nephrotic syndrome, Protein urine present, Weight increased
Clinical narrative: Initial report received from a health care professional on 09 February 2011. A 2-year-old male child received (dose 3) on 03 January 2011 an injection (route and site not reported) of DAPTACEL, lot number C3577AA and an injection (route and site not reported) of Hepatitis A vaccine, Merck lot number not reported. The patient had a history of reactive airway disease. He had no known allergies, no other vaccinations within 4 weeks of the DAPTACEL and no illness at the time of vaccination. The patient takes no medications but has had homeopathic substances. He had two previous doses of DAPTACEL. On 07 February 2011, the patient developed swelling of the eyes, elevated cholesterol, protein in the urine, weight gain of 7 pounds and nephrotic syndrome. The patient required a doctor visit. The outcome was reported as unknown. Documents held by sender: None.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Nephrotic syndrome
Clinical narrative: Initial report received from a health care professional on 09 February 2011. A 2-year-old male child received (dose 3) on 03 January 2011 an injection (route and site not reported) of DAPTACEL, lot number C3577AA and an injection (route and site not reported) of Hepatitis A vaccine, Merck lot number not reported. The patient had a history of reactive airway disease. He had no known allergies, no other vaccinations within 4 weeks of the DAPTACEL and no illness at the time of vaccination. The patient takes no medications but has had homeopathic substances. He had two previous doses of DAPTACEL. On 07 February 2011, the patient developed swelling of the eyes, elevated cholesterol, protein in the urine, weight gain of 7 pounds and nephrotic syndrome. The patient required a doctor visit. The outcome was reported as unknown. Documents held by sender: None.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: Initial case received from a health care professional on 10 February 2011. The reporter identified 1 male patient, in addition to a cluster of "several patients", who experienced adverse events after receiving FLUZONE. A male patient in his 60's, and "several" other unidentified patients, received FLUZONE (unspecified, lot not reported) and subsequently tested positive for influenza. No additional information was reported. Documents held by sender: None.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Influenza, Influenza A virus test positive, Influenza like illness
Clinical narrative: Initial report received from a health care professional on 11 February 2011. A 58-year-old male patient received on 01 September 2010 a right deltoid injection of FLUZONE 2010-2011, sanofi pasteur Inc. lot number U3567BA. The patient had an allergy to sulfa drugs. He had no illness at the time of vaccination, no other vaccinations within 4 weeks of FLUZONE and took no concomitant medications. The patient had received yearly doses of INFLUENZA in the past. In mid November 2010, the patient was seen in the Emergency Department (ED) for flu like symptoms of chills, fever, congestion, cough and runny nose. The patient had an influenza test performed from a nasopharyngeal swab. The patient was discharged from the ED on antibiotics (name not provided). The patient reported that the influenza test was positive for influenza type A but no sub strain information was provided. The outcome was reported as recovered. Documents held by sender: None.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Initial report received from a health care professional on 11 February 2011. A 58-year-old male patient received on 01 September 2010 a right deltoid injection of FLUZONE 2010-2011, sanofi pasteur Inc. lot number U3567BA. The patient had an allergy to sulfa drugs. He had no illness at the time of vaccination, no other vaccinations within 4 weeks of FLUZONE and took no concomitant medications. The patient had received yearly doses of INFLUENZA in the past. In mid November 2010, the patient was seen in the Emergency Department (ED) for flu like symptoms of chills, fever, congestion, cough and runny nose. The patient had an influenza test performed from a nasopharyngeal swab. The patient was discharged from the ED on antibiotics (name not provided). The patient reported that the influenza test was positive for influenza type A but no sub strain information was provided. The outcome was reported as recovered. Documents held by sender: None.
Age: 1.13
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Furuncle
Clinical narrative: BOIL DEVELOPED ON LT THIGH. PT TREATED WITH KEFLEX
Age: 91.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: rash
Age: 0.91
Sex: M
Vaccine: FLUX
Symptoms: Conjunctivitis, Eye discharge
Clinical narrative: Gooping of eyes, conjunctivitis
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Arthralgia, Basophil count normal, Basophil percentage decreased, Blood creatine phosphokinase MB, Blood creatine phosphokinase normal
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: C-reactive protein, C-reactive protein increased, Chest discomfort, Echocardiogram normal, Eosinophil count normal
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Eosinophil percentage, Haematocrit normal, Haemoglobin normal, Impaired work ability, Lymphocyte count normal
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume normal, Mean platelet volume decreased
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Monocyte count increased, Monocyte percentage increased, Myalgia, Myocarditis, Neutrophil count normal
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Neutrophil percentage, Nucleated red cells, Platelet count normal, Pulmonary arterial pressure, Red blood cell count decreased
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Red blood cell sedimentation rate increased, Red cell distribution width normal, Troponin I increased, White blood cell count normal
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase MB increased, Cardiac enzymes increased, Myopericarditis, Troponin I increased
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Arthralgia, Basophil count normal, Basophil percentage decreased, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase normal
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: C-reactive protein increased, Chest discomfort, Echocardiogram abnormal, Electrocardiogram normal, Eosinophil count normal
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Eosinophil percentage, Haematocrit normal, Haemoglobin normal, Impaired work ability, Laboratory test
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume normal
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Mean platelet volume decreased, Monocyte count increased, Monocyte percentage increased, Myalgia, Myocarditis
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Neutrophil count normal, Neutrophil percentage, Nucleated red cells, Pericardial disease, Platelet count normal
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Red blood cell count decreased, Red blood cell sedimentation rate increased, Red cell distribution width normal, Troponin I, White blood cell count normal
Clinical narrative: 27y/o with 1 week hx of myalgia/arthralgia, with chest discomfort not associated with position found to have mycarditis likely related to small pox vaccine. Echocardiogram was within normal limits as read by health professional. Pt recieved Motrin and prednisone while inpatient. He can perform ADLs, tolerated PO, and is hemodynamically stable at this time. Cardiology dept with call pt regarding future apt. will be on light limited duty until cardiology sees him with further recommendations. He will be discharged with motrin and prednisone (see med rec discharge).
Age: 0.51
Sex: F
Vaccine: FLUX
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site urticaria, Irritability
Clinical narrative: Incessant crying/irritability, low grade fever, large red welt where vaccine was administered - about the size of a quarter with some swelling.
Age: 0.51
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Incessant crying/irritability, low grade fever, large red welt where vaccine was administered - about the size of a quarter with some swelling.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: pain, swelling and redness at site that has spread down arm
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: pain, swelling and redness at site that has spread down arm
Age: 1.92
Sex: F
Vaccine: DTAP, HEPA, HIBV, MEA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Father called stating left leg is swollen and red.  Instructed to put a cold washcloth on the area to get the heat out of it.  Swelling can last up to 7 days.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: L ARM ERYTHIMA GOING TO ELBOW, EDEMA AND WARM.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: continued pain at injection site and shoulder with decreased mobility
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Erythema, Full blood count normal, Irritability, Rash morbilliform
Clinical narrative: Red, measle like rash over trunk and extremities.  Sseemed resolved on day 14, but worse on day 16 to include entire trunk, face and all extremities with irritability.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Peripheral edema and hives on same arm as injection but not directly at injection site.
Age: 1.54
Sex: M
Vaccine: FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever with no other symptoms. Fever spiked from 100.4 to 105.6 followed by a 10 to 15 second febrile seizure.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Musculoskeletal pain, Rash, X-ray
Clinical narrative: RASH ON BACK OF THIGHS AND BUTTOCKS; PAIN IN BOTH SHOULDERS  RASH STARTED IN SEPTEMBER; PT SAY DERMATOLOGIST IN OCTOBER; TOPICAL MEDICINE FOR PSORIASIS PRESCRIBED BY MD MADE IT WORSE; 2ND DIAGNOSIS:FUNGAL; MEDICATION DID NOT WORK; 3RD VISIT:UNDIAGNOSED AND PERFORMED BIOPSY; RESULT:NON-CONCLUSIVE YET EXCLUDES PSORIASIS AND FUNGAL INFECTION;
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Pain
Clinical narrative: Lump under skin and pain in right shoulder at injection site.  Pain still persists and has become more intense.  Lump has become larger since 2/11/2011
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Ascites, Laboratory test, Pancreas infection, Pancreatitis necrotising, Type 1 diabetes mellitus
Clinical narrative: The patient is an employee and received ADACEL on 8-05-2009 from the hospital's employee health office. The patient became seriously ill within 2 days and was initially hospitalized on 8-09-2009. Patient had an adverse reaction to the vaccine and developed severe necrotizing pancreatitis, IDDM, ascites, infected pancreatic pseudocysts.
Age: 1.83
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Local reaction, Pain in extremity
Clinical narrative: Leg pain and vaccine local reaction. Recommendations given include: warm compress and clean area well TID. Pt's mother was advised to call the office if there is no improvement or if new or worsening symptoms develop. Doctor prescribed TYLENOL, Childrens of pain.
Age: 25.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Injection site erythema, Injection site pain, Pruritus, Radioallergosorbent test negative, Skin lesion
Clinical narrative: Reports that on 12/3/09 at 1130 she received both the H1N1 and PNEUMOVAX 23 in her right upper arm. When the pt left the clinic after waiting 15 min she noted redness that extended beyond the Band-Aid which she reported to the nurse and was instructed to apply warm moist heat. The pt denied rash, itching, SOB, difficulty breathing/swallowing or angioedema. When the pt arrived home she applied heat and took MOTRIN. By 2200 the pt noted that her upper right arm was painful (3-4/10). There were several (3-4) 2-3 cm red, raised, slightly itchy lesions that covered an area of about 12cm by 6cm. Pt denied generalized urticaria, angioedema, difficulty breathing/swallowing, abd pain or diarrhea. The pt took BENADRYL and MOTRIN. In the am of 12/4/09 the upper right arm had 3-4 distinct areas of redness which were not raised or pruritic. The pain had subsided. The pt took 2 more doses of BENADRYL that day. The next am the lesion were gone.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: (L) arm (GARDASIL #3) w/ redness, swelling, tenderness starting day after vaccine admin.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Bloody mucousy stools post rotavirus vaccine.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Erythema, Nausea, Skin warm, Vomiting
Clinical narrative: Patient reported today (2/16) that he had "red, hot" face with temperature followed by nausea with vomiting beginning about 3:00 am the morning after injection and lasting approximately 12 hours, then resolved.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Allergy test positive, Hypersensitivity, Pruritus, Rash
Clinical narrative: Patient received VARIVAX #2 in office - seemed fine. 15-20 min later developed itching & rash was in local pharmacy at the time, given BENADRYL & EMS called, treated at local ER for allergic reaction & released.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose decreased, Electrocardiogram normal, Hypoglycaemia, Syncope
Clinical narrative: Syncopal episode, hypoglycemia & vasovagal syncope noted on ER notes. Collapsed, was revived & attended to by medical provider. Given PO water & glucose. Transferred to ER, was cleared & released.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Erythema, induration, tenderness. Sulfamethoxazole-Trimethoprim 9ML po Bid x 10 days. Warm compress.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Pt had acute local swelling redness & pain in (R) deltoid region 1 hour after PNEUMOVAX last pm. She took BENADRYL and it has improved some. Circumference at present 3/5 cm.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Left thigh itchy rash 2 x 3 cm developed 10 days after the 1 yr old received MMR and PCV 13 in left thigh. (She also received varicella, HEP A, HIB in right thigh). No treatment required but will recheck. Cautioned avoid direct contact with rash from vaccinated individuals.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: (Temp 98.3) Persisted crying for 3 1/2 hrs. Slight redness and swelling in leg with vaccine. Mom gave no TYLENOL at home. In office ice packs applied to thighs and TYLENOL given. Infant calmed in 20min. Able to breastfeed.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Musculoskeletal stiffness, Pain, Psoriatic arthropathy
Clinical narrative: Subject began to experience severe pain & stiffness in the upper body starting May 2010. She was evaluated by her new M.D. In Nov. 2010 she was given the diagnosis of Psoriatic Arthritis. She is treated HUMIRA injections every other week.
Age: 1.09
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Cyanosis, Fall, Muscle contracture, Pyrexia
Clinical narrative: 3 days after receiving vaccines - developed fever 102 degrees F. Fell to the floor, fingers curled up, turned purple. Recovered without assistance under one minute. Continued with fever intermittently x one week. No further color changes or spastic reactions.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 3 injection sites red and swollen sore. 2-15-11 started went to ER-given VISTARIL po TID cool compresses.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain in extremity, Vertigo, Visual impairment, Vomiting
Clinical narrative: Vaccine at 1515 & by 2130 vomiting & head was spinning non-stop & pain in (R) arm where received injection (limited ROM in arm); had some vision problems too. Lasted for approx. 18 hours.
Age: 44.0
Sex: M
Vaccine: RAB
Symptoms: Angioedema, Purpura, Skin discolouration
Clinical narrative: Initial physician report received on 04 Feb 2011: This patient with an unknown medical history was vaccinated with RABAVERT (batch number: 465011A) pre-exposure series day 0 dose on 27 Jan 2011 and day 7 dose on 03 Feb 2011. The patient did not experience any reaction after day 0 dose. However, after day 7 dose, on 04 Feb 2011 he experienced purpuric discoloration of the skin from the elbow down to the hand on the same arm where day 7 dose was administered. He also experienced a lot of angioedema distally, particularly on the fingers. The outcome was not reported.
Age: 40.0
Sex: M
Vaccine: TDAP, DTAP
Symptoms: Areflexia, Asthenia, CSF protein increased, Guillain-Barre syndrome, Laboratory test normal
Clinical narrative: Weakness, areflexic paralysis, neuropathy consistent with Guillain-Barre Syndrome.
Age: 40.0
Sex: M
Vaccine: TDAP, DTAP
Symptoms: Lumbar puncture abnormal, Neuropathy peripheral, Paralysis
Clinical narrative: Weakness, areflexic paralysis, neuropathy consistent with Guillain-Barre Syndrome.
Age: 40.0
Sex: M
Vaccine: TDAP, DTAP
Symptoms: Bacterial test negative, Borrelia test negative, CSF protein increased, CSF test normal, CSF virus no organisms observed
Clinical narrative: Weakness, areflexic paralysis, neuropathy consistent with Guillain-Barre Syndrome.
Age: 40.0
Sex: M
Vaccine: TDAP, DTAP
Symptoms: Chest X-ray normal, Epstein-Barr virus test negative, Full blood count normal, Guillain-Barre syndrome, HIV test negative
Clinical narrative: Weakness, areflexic paralysis, neuropathy consistent with Guillain-Barre Syndrome.
Age: 40.0
Sex: M
Vaccine: TDAP, DTAP
Symptoms: Herpes simplex serology negative, Immunoglobulin therapy, Metabolic function test, Red blood cell sedimentation rate normal
Clinical narrative: Weakness, areflexic paralysis, neuropathy consistent with Guillain-Barre Syndrome.
Age: 36.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: numbness and pain in right hand, pressure in head, chest tightness, pain in right thigh
Age: 2.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Erythema, Injection site swelling, Joint swelling, Pruritus, Rash
Clinical narrative: Marked erythematous papular large rash, large urticaria Type 1, with severe pruritus and edema. Beginning shortly past a course of amoxicillin & receiving PREVNAR. Treatment IV diphenhydramine and IV methylprednisolone. Then changed to hydroxyzine and ranitidine. Discharge medications ORAPRED 1 mg/kg 1 dose BID for 3 days then 1mg/kg/dose for 3 days. Epi Jr. hydroxyzine & ranitidine.
Age: 2.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Oedema, Pruritus, Rash papular, Urticaria
Clinical narrative: Marked erythematous papular large rash, large urticaria Type 1, with severe pruritus and edema. Beginning shortly past a course of amoxicillin & receiving PREVNAR. Treatment IV diphenhydramine and IV methylprednisolone. Then changed to hydroxyzine and ranitidine. Discharge medications ORAPRED 1 mg/kg 1 dose BID for 3 days then 1mg/kg/dose for 3 days. Epi Jr. hydroxyzine & ranitidine.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Aspiration bone marrow abnormal, Bone marrow failure, Full blood count abnormal, Haemoglobin decreased, Idiopathic thrombocytopenic purpura
Clinical narrative: Patient developed a fever of 100.5. The following night it increased to 101.6.  At this point we called the doctor and got blood work done which is when we found that her platelets and hemoglobin were extremely low.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Platelet count decreased, Platelet transfusion, Pyrexia, Transfusion
Clinical narrative: Patient developed a fever of 100.5. The following night it increased to 101.6.  At this point we called the doctor and got blood work done which is when we found that her platelets and hemoglobin were extremely low.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anaemia, Biopsy bone marrow, Biopsy liver, Body temperature increased, Cough
Clinical narrative: Patient developed a fever of 100.5. The following night it increased to 101.6.  At this point we called the doctor and got blood work done which is when we found that her platelets and hemoglobin were extremely low.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cytogenetic analysis, Full blood count, Hepatic fibrosis, Leukocytosis, Myelofibrosis
Clinical narrative: Patient developed a fever of 100.5. The following night it increased to 101.6.  At this point we called the doctor and got blood work done which is when we found that her platelets and hemoglobin were extremely low.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Packed red blood cell transfusion, Platelet transfusion, Thrombocytopenia
Clinical narrative: Patient developed a fever of 100.5. The following night it increased to 101.6.  At this point we called the doctor and got blood work done which is when we found that her platelets and hemoglobin were extremely low.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Lip swelling, Paraesthesia, Paraesthesia oral, Swollen tongue, Urticaria
Clinical narrative: 01/31/11 tingling of lips, tongue, arms, hives on chest & axillary area, slight swelling lips, tongue. 20 mins after vaccine. Drove self to pharmacy for BENADRYL - took 25 mg x 6 at one time. Symptoms improved quickly & resolved in 24 hrs.
Age: 1.52
Sex: F
Vaccine: HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Developed generalized urticaria 24 hrs. after vaccination. No other known exposures. No other symptoms or physical findings. Pt. seen day of rash and started on BENADRYL.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Bacterial test, Colonoscopy abnormal, Diarrhoea, Endoscopy abnormal, Gastrointestinal disorder
Clinical narrative: Nausea, vomitting, severe diahhrea. The diahrrea was for 25 days and was minimum 12 bouts per day. 2 different hospitals tested him for all known viruses, food borne illnesses, bacteria, parasites. They did an endoscope and colonoscopy. What they reported was "an allergy in the gut." He had damage in his gut.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Hypersensitivity, Nausea, Parasite blood test, Viral test, Vomiting
Clinical narrative: Nausea, vomitting, severe diahhrea. The diahrrea was for 25 days and was minimum 12 bouts per day. 2 different hospitals tested him for all known viruses, food borne illnesses, bacteria, parasites. They did an endoscope and colonoscopy. What they reported was "an allergy in the gut." He had damage in his gut.
Age: 8.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Abnormal behaviour, Activities of daily living impaired, Aggression, Autoimmune disorder, Convulsion
Clinical narrative: Regression in autistic symptomology and PANDAS diagnosis.  Had recently begun to show some affection toward parents through hugs and then abruptly quit after the vaccinations, ritualistic/repetitive behavior has begun to interfere with daily functioning, aggressive behaviors have resurfaced, can not make easy transitions in routine now.  His school sent home a note asking what had happened to him recently because they noted he had regressed by three years in his behavior.  They have been calling behavioral services into the classroom again for him sometimes up to twice a day.  At home, I noticed a couple of episodes where his seizure activity was stronger.  These were problems he had in the past and was finally overcoming in the past few months.  Lastly, his digestion is somewhat off and he is having some toileting issues.  We have begun antibiotic treatment and prescription strength probiotics.  We will be consulting with a doctor to determine how we can boost his immune system to repair this damage.
Age: 8.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Gastrointestinal disorder, Regressive behaviour
Clinical narrative: Regression in autistic symptomology and PANDAS diagnosis.  Had recently begun to show some affection toward parents through hugs and then abruptly quit after the vaccinations, ritualistic/repetitive behavior has begun to interfere with daily functioning, aggressive behaviors have resurfaced, can not make easy transitions in routine now.  His school sent home a note asking what had happened to him recently because they noted he had regressed by three years in his behavior.  They have been calling behavioral services into the classroom again for him sometimes up to twice a day.  At home, I noticed a couple of episodes where his seizure activity was stronger.  These were problems he had in the past and was finally overcoming in the past few months.  Lastly, his digestion is somewhat off and he is having some toileting issues.  We have begun antibiotic treatment and prescription strength probiotics.  We will be consulting with a doctor to determine how we can boost his immune system to repair this damage.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception, Pain, Posture abnormal, Screaming
Clinical narrative: Information has been received from a nurse concerning her 8 weeks grand daughter who on an unspecified date was vaccinated with the first 2ml dose of ROTATEQ. 3 days later the patient was doubled over, clearly pain, and screaming. The patient's mother called her mother, the nurse, for help. The patient's mother did not contact the patient's doctor or visit the emergency room. The nurse stated the patient experienced moderate reaction of intussusception. The patient's symptoms lasted for 24 hours and resolved itself. It was reported that the therapy with ROTATEQ was discontinued and was not reintroduced. Upon internal review, moderate reaction of intussusception was determined to be an other important medical event. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Condition aggravated, Convulsion, Growth retardation, Speech disorder developmental
Clinical narrative: This case was considered medically important.  Information regarding PREVNAR 13 was received from a healthcare professional regarding a 28-month-old male patient who experienced seizure and condition aggravated.  At 28 months of age, the patient received the fourth dose on 27-Sep-2010.  Patient received the 4th dose of PREVNAR 13 on 27-Sep-2010.  On that same day, the patient experienced a seizure and condition aggravated.  Outcome was not provided.  Follow-up (09FEB2011): Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information.  As a consequence of the migration, the follow-up report may indicate in the appropriate field that it is an initial report.  New information provided from a contactable physician included birth weight, birth date, medical history, outcome of the event, an additional event and updated vaccines administered.  The patient's mother was on Keppra and PNV.  The physician reported the patient has a speech delay.  As of the date of this report, the patient has not recovered and is taking Keppra.  Follow-up attempts completed.  No further information expected.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Headache, Lymphadenopathy, Pharyngeal oedema, Pyrexia, Swelling
Clinical narrative: Six days after immunization child developed fever x 2 days (highest 101 degrees), swelling of (R) cheek, jaw & glands, headache, and swollen throat bilaterally which mother described as "white with red veins through it". Glands still slightly swollen.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Got VARIVAX inj around 3:30 2-9-11 that night started with swelling - redness - hot to touch - painful. Parents have done cold compress, BENADRYL (L) arm height=6 1/4 in width=6 inches pt notified to do CORTAID & ice.