chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Hypoventilation, Lobar pneumonia, Lung infiltration, Pain, Pleural effusion
Clinical narrative: A serious report of pneumonia, pleural effusion, and dehydration has been received from a study investigator concerning a 34-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 06-Oct-2009. The subject received one dose before the onset of the event. The subject presented to the Emergency department with respiratory distress. Initial symptoms of fever, cough, rhinorrhea, vomiting, and body ache began approximately ten days prior to admission, and this was thought to be influenza. No treatment was initiated at that time. The subject returned four days later with increased work of breathing and continued fever. Chest x-ray demonstrated right lower lobe (RLL) infiltrate, and the subject started on OMNICEF. His fever subsided shortly thereafter, though his breathing continued worsen. The subject's parents noted shallow rapid breathing and difficulty to breath. This prompted their visit to the Emergency department on 30-Oct-2009. At the Emergency department, the subject had tachypnea and shallow breathing, although 02 saturation were stable. He received salbutamol for poor aeration on the right without much improvement. Repeat chest x-rays demonstrated worsening RLL pneumonia and pleural effusion. The subject was treated with intravenous antibiotics. The events were resolved on 03-Nov-2009. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. Alternative etiology for the events was natural causes. The sponsor also assessed the causality for the events as not related to FLUMIST.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Respiratory distress, Rhinorrhoea, Tachypnoea, Tuberculin test negative
Clinical narrative: A serious report of pneumonia, pleural effusion, and dehydration has been received from a study investigator concerning a 34-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 06-Oct-2009. The subject received one dose before the onset of the event. The subject presented to the Emergency department with respiratory distress. Initial symptoms of fever, cough, rhinorrhea, vomiting, and body ache began approximately ten days prior to admission, and this was thought to be influenza. No treatment was initiated at that time. The subject returned four days later with increased work of breathing and continued fever. Chest x-ray demonstrated right lower lobe (RLL) infiltrate, and the subject started on OMNICEF. His fever subsided shortly thereafter, though his breathing continued worsen. The subject's parents noted shallow rapid breathing and difficulty to breath. This prompted their visit to the Emergency department on 30-Oct-2009. At the Emergency department, the subject had tachypnea and shallow breathing, although 02 saturation were stable. He received salbutamol for poor aeration on the right without much improvement. Repeat chest x-rays demonstrated worsening RLL pneumonia and pleural effusion. The subject was treated with intravenous antibiotics. The events were resolved on 03-Nov-2009. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. Alternative etiology for the events was natural causes. The sponsor also assessed the causality for the events as not related to FLUMIST.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Ultrasound chest, Ultrasound scan abnormal, Vomiting
Clinical narrative: A serious report of pneumonia, pleural effusion, and dehydration has been received from a study investigator concerning a 34-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 06-Oct-2009. The subject received one dose before the onset of the event. The subject presented to the Emergency department with respiratory distress. Initial symptoms of fever, cough, rhinorrhea, vomiting, and body ache began approximately ten days prior to admission, and this was thought to be influenza. No treatment was initiated at that time. The subject returned four days later with increased work of breathing and continued fever. Chest x-ray demonstrated right lower lobe (RLL) infiltrate, and the subject started on OMNICEF. His fever subsided shortly thereafter, though his breathing continued worsen. The subject's parents noted shallow rapid breathing and difficulty to breath. This prompted their visit to the Emergency department on 30-Oct-2009. At the Emergency department, the subject had tachypnea and shallow breathing, although 02 saturation were stable. He received salbutamol for poor aeration on the right without much improvement. Repeat chest x-rays demonstrated worsening RLL pneumonia and pleural effusion. The subject was treated with intravenous antibiotics. The events were resolved on 03-Nov-2009. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. Alternative etiology for the events was natural causes. The sponsor also assessed the causality for the events as not related to FLUMIST.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Breath sounds abnormal, Cough, Full blood count abnormal, Infectious mononucleosis, Local swelling
Clinical narrative: A physician reported the serious events of mononucleosis and tonsillitis has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 28-Oct-2009. The subject received one dose before the onset of the event. In the evening, prior to admission, the subject had cough, "strep throat," and noisy breathing. In the morning of admission, his father noticed large swelling on the right side of the subject's neck and brought him to the Emergency room. The subject also had large firm tender right cervical adenitis and some nodes on the left side, as well. Complete blood count showed white blood cell count of 20 K/uL with predominant lymphs and mono." His tonsils were mildly enlarged and slightly red. Beside ultrasound did not indicate abscess. Hospitalization and intravenous antibiotics were recommended. The subject was hospitalized for three days and discharged home in good condition on 21-Nov-2009. The events of mononucleosis and tonsillitis were resolved on 21-Nov-2009. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was mild. Alternative etiologies for mononucleosis and tonsillitis were natural causes and infection, respectively. The sponsor also assessed the causality for the events as not related to FLUMIST.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Lymphadenitis, Lymphadenopathy, Lymphocyte count abnormal, Monocyte count increased, Pharyngeal erythema
Clinical narrative: A physician reported the serious events of mononucleosis and tonsillitis has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 28-Oct-2009. The subject received one dose before the onset of the event. In the evening, prior to admission, the subject had cough, "strep throat," and noisy breathing. In the morning of admission, his father noticed large swelling on the right side of the subject's neck and brought him to the Emergency room. The subject also had large firm tender right cervical adenitis and some nodes on the left side, as well. Complete blood count showed white blood cell count of 20 K/uL with predominant lymphs and mono." His tonsils were mildly enlarged and slightly red. Beside ultrasound did not indicate abscess. Hospitalization and intravenous antibiotics were recommended. The subject was hospitalized for three days and discharged home in good condition on 21-Nov-2009. The events of mononucleosis and tonsillitis were resolved on 21-Nov-2009. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was mild. Alternative etiologies for mononucleosis and tonsillitis were natural causes and infection, respectively. The sponsor also assessed the causality for the events as not related to FLUMIST.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Pharyngitis streptococcal, Tonsillar hypertrophy, Tonsillitis, Ultrasound scan normal, White blood cell count increased
Clinical narrative: A physician reported the serious events of mononucleosis and tonsillitis has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 28-Oct-2009. The subject received one dose before the onset of the event. In the evening, prior to admission, the subject had cough, "strep throat," and noisy breathing. In the morning of admission, his father noticed large swelling on the right side of the subject's neck and brought him to the Emergency room. The subject also had large firm tender right cervical adenitis and some nodes on the left side, as well. Complete blood count showed white blood cell count of 20 K/uL with predominant lymphs and mono." His tonsils were mildly enlarged and slightly red. Beside ultrasound did not indicate abscess. Hospitalization and intravenous antibiotics were recommended. The subject was hospitalized for three days and discharged home in good condition on 21-Nov-2009. The events of mononucleosis and tonsillitis were resolved on 21-Nov-2009. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was mild. Alternative etiologies for mononucleosis and tonsillitis were natural causes and infection, respectively. The sponsor also assessed the causality for the events as not related to FLUMIST.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Cheilitis, Eating disorder, Eosinophil percentage increased, Haematocrit decreased, Haemoglobin normal
Clinical narrative: A serious report of KAWASAKI disease has been received from a local study investigator concerning a 25-month-old male participating in a post-marketing study for FLUMIST, MI-MA162. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 08-Dec-2009. The subject received one dose before the onset of the event. On 01-Jan-2010, the subject was traveling abroad and developed high fever of 102-104.3 Fahrenheit which lasted two days. On 04-Jan-2099, he had red eyes, rash in the body, swollen hands and feet, purple-red lips, and "strawberry tongue." The subject was not eating. On the same day, he went to see the doctor; however, " the medicine did not alleviate the symptoms." On 06-jan-2009, he went to the hospital, was diagnosed with KAWASAKI disease and hospitalized. He improved after several days of treatment. Discharge dates vary: 15-Jan-2010 per billing records and 21-Jan-2010 according to subject's parents. The outcome of the event was ongoing. The investigation assessed the causality for the event to FLUMIST as not related. The severity of the event was moderate. Alternative etiology was natural causes. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Kawasaki's disease, Mean cell volume decreased, Neutrophil percentage decreased, Ocular hyperaemia, Oedema peripheral
Clinical narrative: A serious report of KAWASAKI disease has been received from a local study investigator concerning a 25-month-old male participating in a post-marketing study for FLUMIST, MI-MA162. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 08-Dec-2009. The subject received one dose before the onset of the event. On 01-Jan-2010, the subject was traveling abroad and developed high fever of 102-104.3 Fahrenheit which lasted two days. On 04-Jan-2099, he had red eyes, rash in the body, swollen hands and feet, purple-red lips, and "strawberry tongue." The subject was not eating. On the same day, he went to see the doctor; however, " the medicine did not alleviate the symptoms." On 06-jan-2009, he went to the hospital, was diagnosed with KAWASAKI disease and hospitalized. He improved after several days of treatment. Discharge dates vary: 15-Jan-2010 per billing records and 21-Jan-2010 according to subject's parents. The outcome of the event was ongoing. The investigation assessed the causality for the event to FLUMIST as not related. The severity of the event was moderate. Alternative etiology was natural causes. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Platelet count normal, Pyrexia, Rash generalised, Red blood cell sedimentation rate increased, Strawberry tongue
Clinical narrative: A serious report of KAWASAKI disease has been received from a local study investigator concerning a 25-month-old male participating in a post-marketing study for FLUMIST, MI-MA162. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 08-Dec-2009. The subject received one dose before the onset of the event. On 01-Jan-2010, the subject was traveling abroad and developed high fever of 102-104.3 Fahrenheit which lasted two days. On 04-Jan-2099, he had red eyes, rash in the body, swollen hands and feet, purple-red lips, and "strawberry tongue." The subject was not eating. On the same day, he went to see the doctor; however, " the medicine did not alleviate the symptoms." On 06-jan-2009, he went to the hospital, was diagnosed with KAWASAKI disease and hospitalized. He improved after several days of treatment. Discharge dates vary: 15-Jan-2010 per billing records and 21-Jan-2010 according to subject's parents. The outcome of the event was ongoing. The investigation assessed the causality for the event to FLUMIST as not related. The severity of the event was moderate. Alternative etiology was natural causes. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: White blood cell count normal
Clinical narrative: A serious report of KAWASAKI disease has been received from a local study investigator concerning a 25-month-old male participating in a post-marketing study for FLUMIST, MI-MA162. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 08-Dec-2009. The subject received one dose before the onset of the event. On 01-Jan-2010, the subject was traveling abroad and developed high fever of 102-104.3 Fahrenheit which lasted two days. On 04-Jan-2099, he had red eyes, rash in the body, swollen hands and feet, purple-red lips, and "strawberry tongue." The subject was not eating. On the same day, he went to see the doctor; however, " the medicine did not alleviate the symptoms." On 06-jan-2009, he went to the hospital, was diagnosed with KAWASAKI disease and hospitalized. He improved after several days of treatment. Discharge dates vary: 15-Jan-2010 per billing records and 21-Jan-2010 according to subject's parents. The outcome of the event was ongoing. The investigation assessed the causality for the event to FLUMIST as not related. The severity of the event was moderate. Alternative etiology was natural causes. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PPV, HEPA, HIBV, MMR, PNC
Symptoms: Rash papular
Clinical narrative: Pt with papular, erythematous, pruritic rash diffusely on face, chest, and back ad extremities no vesicles.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PPV, HEPA, HIBV, MMR, PNC
Symptoms: Rash erythematous, Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Pt with papular, erythematous, pruritic rash diffusely on face, chest, and back ad extremities no vesicles.
Age: 0.2
Sex: M
Vaccine: RV5, RV5, RV5, RV5
Symptoms: Gastrointestinal haemorrhage, Gastrointestinal stoma complication
Clinical narrative: 2.5 mo male infant with a history of bowel resection on day 1 of life with rectal temperature of 101.5 degrees F for one day. Patient had inpatient admission at medical center for 48 hours and blood cultures were drawn. The infant was treated with intravenous vancomycin and piperacillin/tazobactam for 48 hours until cultures were negative. The treating physicians were in contact with study PI. The patients blood cultures were negative and the patient was discharged home without any residual difficulty. All fevers resolved within first day of admission. Patient had been vaccinated with ROTATEQ Vacc. dose number 1 on 1/25/2010. Final report.
Age: 0.2
Sex: M
Vaccine: RV5, RV5, RV5, RV5
Symptoms: Blood culture negative, Body temperature increased
Clinical narrative: 2.5 mo male infant with a history of bowel resection on day 1 of life with rectal temperature of 101.5 degrees F for one day. Patient had inpatient admission at medical center for 48 hours and blood cultures were drawn. The infant was treated with intravenous vancomycin and piperacillin/tazobactam for 48 hours until cultures were negative. The treating physicians were in contact with study PI. The patients blood cultures were negative and the patient was discharged home without any residual difficulty. All fevers resolved within first day of admission. Patient had been vaccinated with ROTATEQ Vacc. dose number 1 on 1/25/2010. Final report.
Age: 0.2
Sex: M
Vaccine: RV5, RV5, RV5, RV5
Symptoms: Bilirubin conjugated, Blood bilirubin normal, Blood culture negative, Enterocutaneous fistula, Explorative laparotomy
Clinical narrative: 2.5 mo male infant with a history of bowel resection on day 1 of life with rectal temperature of 101.5 degrees F for one day. Patient had inpatient admission at medical center for 48 hours and blood cultures were drawn. The infant was treated with intravenous vancomycin and piperacillin/tazobactam for 48 hours until cultures were negative. The treating physicians were in contact with study PI. The patients blood cultures were negative and the patient was discharged home without any residual difficulty. All fevers resolved within first day of admission. Patient had been vaccinated with ROTATEQ Vacc. dose number 1 on 1/25/2010. Final report.
Age: 0.2
Sex: M
Vaccine: RV5, RV5, RV5, RV5
Symptoms: Intestinal resection
Clinical narrative: 2.5 mo male infant with a history of bowel resection on day 1 of life with rectal temperature of 101.5 degrees F for one day. Patient had inpatient admission at medical center for 48 hours and blood cultures were drawn. The infant was treated with intravenous vancomycin and piperacillin/tazobactam for 48 hours until cultures were negative. The treating physicians were in contact with study PI. The patients blood cultures were negative and the patient was discharged home without any residual difficulty. All fevers resolved within first day of admission. Patient had been vaccinated with ROTATEQ Vacc. dose number 1 on 1/25/2010. Final report.
Age: 0.24
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Double intussusceptum.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Body temperature increased, Mobility decreased, Pain in extremity
Clinical narrative: After getting shots, client's right arm was sore for several days and on 3-9-10 was running a temp 100.3 and couldn't raise her arm above shoulder height.  Advised to see doctor who gave antibiotics.  3-10-10 no fever and was able to go to school.
Age: 22.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: R arm (injection site) with golf ball-sized red, warm, hardened area, no opening in skin, no vesicles, painful and intermittent itching. Noticed pain & swelling 3/17/10 (injection 3/16/10). Hydrocortisone cream applied, pt. going home after P.M. shift now, will take ADVIL, BENADRYL, and apply ice packs.
Age: 22.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site warmth
Clinical narrative: R arm (injection site) with golf ball-sized red, warm, hardened area, no opening in skin, no vesicles, painful and intermittent itching. Noticed pain & swelling 3/17/10 (injection 3/16/10). Hydrocortisone cream applied, pt. going home after P.M. shift now, will take ADVIL, BENADRYL, and apply ice packs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Woke up the day following the vaccine -Left upper arm was slightly red. Redness increased as time went on & began to swell slightly & was warm to touch. Mom called the office on 3-15-10 & brought child to the clinic. Advised BENADRYL. Red area 2 1/2 x 2 3/4.
Age: 0.17
Sex: F
Vaccine: DPP, HEP, HIBV
Symptoms: Crying, Oedema peripheral, Pyrexia, Vaccination complication
Clinical narrative: Leg swelling from hip down below knee. Fever in swelling site. Wailing, crying that went on for 5 hours.  3/16/10 adverse reaction to shots.  Fever of 102.  Tylenol was given day before stopped and fever spiked at 11:00 AM on 16th. Ran low grade fever for 12 hrs.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Hives - all over body treatment with Benadryl.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site vesicles, Pyrexia
Clinical narrative: 2 days after immunizations, had 2 days of high fevers "105 -106" per parents, a few sores with vesicles at site of VARICELLA vaccine.
Age: 5.0
Sex: M
Vaccine: MNQ
Symptoms: Ocular hyperaemia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Shot given 7-23-09. 7-24-09 severe arm pain lasting 2 weeks, full body aches, fever lasting 3 days, 101 degrees. Blood shot eyes.  I don't know.  I reported the reaction to the doctor's office.  I don't know if they reported it or not.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Nodule, Swelling face
Clinical narrative: Mom says 2/10/10 - swollen place on face - know on cheekbone & knot behind ear - saw MD @ clinic - C/T placed on antibiotics LEFTIN X 10 dye; after 6th day increased facial swelling - saw Dr. again - clinic. Went to hospital after - also saw another Dr. at clinic. Given antibiotic by mouth there. Stopped LEFTIN (info from pt's mom by phone).
Age: 58.0
Sex: F
Vaccine: YF
Symptoms: Abdominal pain, Blood creatinine normal, Blood urea normal, Fatigue, Full blood count normal
Clinical narrative: 2/19/10 vaccine administered. 2/26/10 pt called office complaining of "severe" headache, and flu-like symptoms, body aches, fatigue an abdominal cramps beginning last night. H/A better today and pt denies fever. Urine output and appetite ok. Advised symptomatic tx and call prn worsening s and s. 3/2/10 spoke to pt again. Urine output had decreased over the weekend so she had physician friend order labs which were normal. Pt reports feeling improved BUT still has fatigue and H/A. 3/5/10 Pt feeling normal again.
Age: 58.0
Sex: F
Vaccine: YF
Symptoms: Headache, Influenza like illness, Liver function test normal, Pain, Urine output decreased
Clinical narrative: 2/19/10 vaccine administered. 2/26/10 pt called office complaining of "severe" headache, and flu-like symptoms, body aches, fatigue an abdominal cramps beginning last night. H/A better today and pt denies fever. Urine output and appetite ok. Advised symptomatic tx and call prn worsening s and s. 3/2/10 spoke to pt again. Urine output had decreased over the weekend so she had physician friend order labs which were normal. Pt reports feeling improved BUT still has fatigue and H/A. 3/5/10 Pt feeling normal again.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU(H1N1), FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Oxygen saturation normal
Clinical narrative: (L) arm is edematous, red, warm to touch, no wheezing, no sob T-99.2, P-110, O2 Sat- 98%, B/P 90/51
Age: 93.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood urea increased, Electrocardiogram normal, Full blood count, Neutrophil count increased, Rash generalised
Clinical narrative: 3-10-2010-2:00p reported rash over entire body-syncope in ER-IV started ZANTAC 50 mg IV-EKG norm, D/C at 7:00p 3-10-2010 Rx VISTARIL 25 mg 1 QID PRN, ZANTAC 150 mg 1 BID-to report to own physician in 2-3 days.
Age: 93.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Red blood cell count normal, Syncope, White blood cell count increased
Clinical narrative: 3-10-2010-2:00p reported rash over entire body-syncope in ER-IV started ZANTAC 50 mg IV-EKG norm, D/C at 7:00p 3-10-2010 Rx VISTARIL 25 mg 1 QID PRN, ZANTAC 150 mg 1 BID-to report to own physician in 2-3 days.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Amnesia, Balance disorder, Dizziness, Memory impairment
Clinical narrative: Disorient -Loss of memory light headed loss of balance - could not retain thoughts forgetful- on going current today.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red raised on IM location warm to touch. (+) size. MOP stated PT gets this with bug bites. MOP state she gave BENADRYL started the 10 Mar 10 with increase in redness.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Pt stated arm began itching same day her received shot. 2 days later (today) there is redness that covers the entire deltoid area and is hot to touch. Pt to be on if x 2y hours and received KEFLEX for treatment.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased
Clinical narrative: Had 102.8 rectal temp, the night after apt shots 3-16-10.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: Itchy, red bump at vaccine site.
Age: 4.0
Sex: F
Vaccine: HEPA, HIBV, PNC
Clinical narrative: Local skin/soft tissue reaction on mid outer Rt thigh approx 8 cm in diameter. No fever or SOB.
Sex: F
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: PATIENT REC'D 1/2 HEP B VACCINE MIXED WITH 1/2 ADULT TDAP VACCINE
Age: 46.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Cardiac enzymes normal, Cardiac function test normal, Cardiac stress test, Chest pain, Costochondritis
Clinical narrative: Patient stated she started experiencing muscle spasms to left temple and back of neck. Spasms then progressed down left side of body. She reported intermittent numbness to left arm and tingling to left fingers which resolved on 3/14/2010. She also reported sternal pain. She was seen on 3/11/2010 at an urgent care center and when symptoms did not decrease she went to the Hospital on 3/11/2010 at 8:30 pm. There she was diagnosed with chest pain an costochondritis. Multiple tests and labs were completed to rule out any cardiac issues. All cardiac tests were negative. She was prescribed vicodin for pain and discharged from the emergency department 3/12/2010 at 10:29 AM.
Age: 46.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Electrocardiogram normal, Full blood count, Hypoaesthesia, International normalised ratio, Metabolic function test
Clinical narrative: Patient stated she started experiencing muscle spasms to left temple and back of neck. Spasms then progressed down left side of body. She reported intermittent numbness to left arm and tingling to left fingers which resolved on 3/14/2010. She also reported sternal pain. She was seen on 3/11/2010 at an urgent care center and when symptoms did not decrease she went to the Hospital on 3/11/2010 at 8:30 pm. There she was diagnosed with chest pain an costochondritis. Multiple tests and labs were completed to rule out any cardiac issues. All cardiac tests were negative. She was prescribed vicodin for pain and discharged from the emergency department 3/12/2010 at 10:29 AM.
Age: 46.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Muscle spasms, Paraesthesia, Prothrombin time
Clinical narrative: Patient stated she started experiencing muscle spasms to left temple and back of neck. Spasms then progressed down left side of body. She reported intermittent numbness to left arm and tingling to left fingers which resolved on 3/14/2010. She also reported sternal pain. She was seen on 3/11/2010 at an urgent care center and when symptoms did not decrease she went to the Hospital on 3/11/2010 at 8:30 pm. There she was diagnosed with chest pain an costochondritis. Multiple tests and labs were completed to rule out any cardiac issues. All cardiac tests were negative. She was prescribed vicodin for pain and discharged from the emergency department 3/12/2010 at 10:29 AM.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Rash erythematous, Tenderness, X-ray limb normal
Clinical narrative: Received shingles vaccine, had a red rash about 3 inches long for a couple of weeks. Now my right shoulder and muscle on my upper right arm is sore from it. It is tender to the touch. Can't use my arm in the backward motion. X-ray later but couldn't find any thing so I think it just settled in my muscles.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received a Registered Nurse for the pregnancy registry for GARDASIL, concerning a 19 year old female patient with no known allergies and no pertinent medical history, who on 19-JAN-2009 was vaccinated intramuscularly with 0.5 ml of her first and only dose of GARDASIL (Lot# 660391/0063X) while she was pregnant. The urine pregnancy test was positive (LMP: 12-DEC-2008, EED: 18-SEP-2009). As of 15-JAN-2009 the patient was fine. In follow-up the registered nurse reported that they were unable to obtain authorization from the patient. Follow-up information from another registered nurse revealed that the patient has a medical history of Chlamydia infections in September 2007 and January 2009. In February 2009, the patient experienced an elective termination of pregnancy. It was unknown if the fetus was normal or if the products of conception were examined. The patient was seen for LPE (during early-pregnancy) pregnancy test which was positive. The patient did not have obstetric care due to pregnancy terminated per the patient. Upon internal review, elective termination was considered to be an other important medical event. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal growth retardation, Intra-uterine death, Laboratory test abnormal
Clinical narrative: Initial and follow-up information has been received from a consumer and medical assistant, for the Pregnancy Registry for GARDASIL. The consumer is a 22 year old female with a history of gallbladder removal about 10 years ago. On 08-Jan-2010, the patient received a dose of GARDASIL (lot # 663454/0672Y) IM. No concomitant vaccinations were administered at that time. The medical assistant stated that on 24-Feb-2010 the patient reported to the physician that she was pregnant. The patient was referred to the obstetrician. Her last menstrual period was on 23-Dec-2009. The consumer reported that she had a urine test when given the vaccine. The test showed she was not pregnant. A few weeks later, she found out she was pregnant. She went in for a blood work and an ultrasound on 06-Mar-2010 (also reported as 07-Mar-2010). They showed she would be 10 weeks pregnant but the fetus stopped growing at 5 weeks. As of 10-Mar-2010, the consumer was also experiencing spotting. The consumer stated that she had visited her physician's office on 11-Mar-2010 and the physician had confirmed that her baby was not properly developing. The consumer also reported that a dilatation and evacuation had been scheduled for her by the physician on 12-Mar-2010. The medical assistant reported that "the patient's sac was measured at six weeks and the patient had a miscarriage". On 12-Mar-2010, the patient was scheduled for a dilatation and evacuation procedure. Upon internal review, the fetus stopped growing at 5 weeks and miscarriage were considered other important medical events. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test negative, Ultrasound scan abnormal, Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: Initial and follow-up information has been received from a consumer and medical assistant, for the Pregnancy Registry for GARDASIL. The consumer is a 22 year old female with a history of gallbladder removal about 10 years ago. On 08-Jan-2010, the patient received a dose of GARDASIL (lot # 663454/0672Y) IM. No concomitant vaccinations were administered at that time. The medical assistant stated that on 24-Feb-2010 the patient reported to the physician that she was pregnant. The patient was referred to the obstetrician. Her last menstrual period was on 23-Dec-2009. The consumer reported that she had a urine test when given the vaccine. The test showed she was not pregnant. A few weeks later, she found out she was pregnant. She went in for a blood work and an ultrasound on 06-Mar-2010 (also reported as 07-Mar-2010). They showed she would be 10 weeks pregnant but the fetus stopped growing at 5 weeks. As of 10-Mar-2010, the consumer was also experiencing spotting. The consumer stated that she had visited her physician's office on 11-Mar-2010 and the physician had confirmed that her baby was not properly developing. The consumer also reported that a dilatation and evacuation had been scheduled for her by the physician on 12-Mar-2010. The medical assistant reported that "the patient's sac was measured at six weeks and the patient had a miscarriage". On 12-Mar-2010, the patient was scheduled for a dilatation and evacuation procedure. Upon internal review, the fetus stopped growing at 5 weeks and miscarriage were considered other important medical events. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal tenderness, Diet refusal, Intussusception, Malaise, Surgery
Clinical narrative: Information has been received from a physician concerning a 4 month old female patient, with no pertinent medical history and no known drug allergies, who on 22-DEC-2009, was vaccinated with a first dose of ROTATEQ (dose, route and lot number not provided). On 03-MAR-2010, the patient received orally the second "0.2 mL" dose of ROTATEQ (lot number 664874/1213Y). Another vaccines administered on the same day included PENTACEL and PREVNAR. Concomitant therapy included an antibiotic (not specified) for the strep throat. On 03-MAR-2010, the patient was admitted in the hospital for intussusceptions after getting ROTATEQ. The physician stated that on 03-MAR-2010, the first symptoms appeared in the form of non-bilious vomiting, not eating, and malaise. Later that day, the patient was taken to the emergency room at the hospital. No computed axial tomography scans or ultrasounds were performed, as it was initially thought the patient had gastroenteritis. There were no bloody stools. Patient was admitted and treated with IV fluids. On 04-MAR-2010, examination showed abdominal tenderness and an unsuccessful barium enema was done. On the same day, the patient had surgery where the intussusception was manually reduced. No predisposing conditions. After surgery, the patient was doing better. The baby was full term. At the time of reporting, the patient had recovered. The physician considered intussusceptions to be disabling and life threatening. No further information is available. On 03-MAR-2010, the patient was admitted in the hospital.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 4 month old female patient, with no pertinent medical history and no known drug allergies, who on 22-DEC-2009, was vaccinated with a first dose of ROTATEQ (dose, route and lot number not provided). On 03-MAR-2010, the patient received orally the second "0.2 mL" dose of ROTATEQ (lot number 664874/1213Y). Another vaccines administered on the same day included PENTACEL and PREVNAR. Concomitant therapy included an antibiotic (not specified) for the strep throat. On 03-MAR-2010, the patient was admitted in the hospital for intussusceptions after getting ROTATEQ. The physician stated that on 03-MAR-2010, the first symptoms appeared in the form of non-bilious vomiting, not eating, and malaise. Later that day, the patient was taken to the emergency room at the hospital. No computed axial tomography scans or ultrasounds were performed, as it was initially thought the patient had gastroenteritis. There were no bloody stools. Patient was admitted and treated with IV fluids. On 04-MAR-2010, examination showed abdominal tenderness and an unsuccessful barium enema was done. On the same day, the patient had surgery where the intussusception was manually reduced. No predisposing conditions. After surgery, the patient was doing better. The baby was full term. At the time of reporting, the patient had recovered. The physician considered intussusceptions to be disabling and life threatening. No further information is available. On 03-MAR-2010, the patient was admitted in the hospital.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain
Clinical narrative: May, 2008 complained of acute severe pain, weakness. (R) leg with numbness. Admitted to local hospital. After seeing numerous MD's, neuromuscular specialist determined due to GARDASIL immunization.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: MCU4 vax administered left upper area 3-16-10. Upper arm redness and itchy 3-17 and 3-18-10.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: 1 am - 3-17-10 T.C. from pt. has hard reddened area around injection site which is painful. Pt started noticing this around 8:30 am on the day after the shot. Discussed local reactions. Pt will take BENADRYL, ibuprofen and use ice on the area. To see Dr. if condition worsens. Denies trouble breathing. Denies hives or rash on any other part of her body. States she had trouble sleeping because her arm was sore. 17-10 - 3:30 pm - Pt. at work today and request this RN to stop by and look at her arm. There is a pinkish/red circular rash on back of (L) arm approx. 4 - 5 inches in diameter. Within this area there is an approx 2 inch oval hardened red area which pt states is painful and warm to touch. Pt denies any other symptoms and is still taking BENADRYL and ibuprofen. She has not seen a Dr. for this. Referred to Dr. and continue with BENADRYL and pain med. 3.18.10 - 10 am. T.C to pt. she states the rash is a little bigger but the site is less painful. She thinks it is getting  better. She does not want to see Dr. Pt is to call Dr. if symptoms worsen. Denies hives or rash else where. Denies trouble breathing.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Sleep disorder
Clinical narrative: 1 am - 3-17-10 T.C. from pt. has hard reddened area around injection site which is painful. Pt started noticing this around 8:30 am on the day after the shot. Discussed local reactions. Pt will take BENADRYL, ibuprofen and use ice on the area. To see Dr. if condition worsens. Denies trouble breathing. Denies hives or rash on any other part of her body. States she had trouble sleeping because her arm was sore. 17-10 - 3:30 pm - Pt. at work today and request this RN to stop by and look at her arm. There is a pinkish/red circular rash on back of (L) arm approx. 4 - 5 inches in diameter. Within this area there is an approx 2 inch oval hardened red area which pt states is painful and warm to touch. Pt denies any other symptoms and is still taking BENADRYL and ibuprofen. She has not seen a Dr. for this. Referred to Dr. and continue with BENADRYL and pain med. 3.18.10 - 10 am. T.C to pt. she states the rash is a little bigger but the site is less painful. She thinks it is getting  better. She does not want to see Dr. Pt is to call Dr. if symptoms worsen. Denies hives or rash else where. Denies trouble breathing.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Tenderness
Clinical narrative: R deltoid erythema/swelling surrounding injection site approximately 1 inch diameter with extension towards axilla, axillary lymphadenopathy, tender/mobile.
Age: 86.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood thyroid stimulating hormone normal, Diarrhoea
Clinical narrative: 1. Diarrhea - started after shot 1/12/10 2. Elevated INR 5.1 - started 1/29/10 3. Acute rhabdomyolysis w/elevated CPK - 2/5/10
Age: 86.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Full blood count normal, International normalised ratio increased, Metabolic function test normal, Red blood cell sedimentation rate normal, Rhabdomyolysis
Clinical narrative: 1. Diarrhea - started after shot 1/12/10 2. Elevated INR 5.1 - started 1/29/10 3. Acute rhabdomyolysis w/elevated CPK - 2/5/10
Age: 45.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Blood test, Chills, Diarrhoea haemorrhagic, Nausea
Clinical narrative: Started with fever, chills, nausea. Then threw up and had diarrhea through out the remainder of early morning with severe bloody diarrhea. Abdominal pain was intense like child labor. Went to hospital in morning abount 9 am.
Age: 45.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Vomiting
Clinical narrative: Started with fever, chills, nausea. Then threw up and had diarrhea through out the remainder of early morning with severe bloody diarrhea. Abdominal pain was intense like child labor. Went to hospital in morning abount 9 am.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Fungal infection, Rash generalised, Rash pruritic
Clinical narrative: Unexplained rash. Very itchy. Rash occurred all over body. Rash appearance different on each body part. Rash dissappears & returns. Approx. 1 week later went to Drs. I was put on Prednisone for 10 days with little effect. After prednisone I have been taking Benadryl. This helps alleviate the itch but not the strange rash. It has been 6 weeks I still have symptoms with less severity. Since the vaccine. I had a physical/pap smear. A vaginal yeast infection was discovered. On 3/18/2010 a prescription for Diflucan was issued. I have had 2 pay out of pocket for 2 drs visits & 2 prescription as well as several OTC for Benadryl. I can not afford to go to a dermatologist to find another way to keep this reaction @ bay. The bizzare reaction I think really needs to be noted as a possible side effect or allergy to vaccine.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Moderate pain, swelling, warm to touch and an area of erythema aprox 80mm at injection site (L Deltoid).  Instructed to take Motrin and apply ice pks.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Decreased appetite, Lethargy, Screaming
Clinical narrative: Prolonged inconsolable crying/screaming (3-4 hours stretches) over the course of 3 days (crying would only stop once she fell asleep). After 3 days had passed, she was very quiet and still, almost like she had been drugged. Took upwards of two weeks to get any normal reaction out of her. Decreased appetite (only nursed a few times a day the first 5 days after the vaccine).
Age: 41.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Feeling hot, Pharyngeal oedema
Clinical narrative: PT C/O "BEING REALLY HOT WITH MY THROAT FEELING SWOLLEN AND FEELING WEAK ABOUT 4HRS AFTER GETTING THE SHOT."
Age: 2.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Erythema, Eye swelling, Immediate post-injection reaction, Swelling face
Clinical narrative: Immediate swelling of eyes, redness/swelling of cheeks. Treated with Benadryl 20 mg PO, prednisone 30 mg PO. By 11:20, decrease in redness/swelling.
Age: 37.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, UNK, ANTH, FLU3, TYP
Symptoms: Rash
Clinical narrative: rash
Age: 37.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, UNK, ANTH, FLU3, TYP
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Skin lesion, Vaccinia virus infection
Clinical narrative: rash
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Decreased appetite, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: ADACEL given 3-1-10 parent reports fever and nausea all day 3-2-10, pain at injection site, redness and swelling, headache, fever 102.2 early am then controlled with TYLENOL. 3-3-10 child had 99 temp in AM and had a lack of appetite.
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: ADACEL given 3-1-10 parent reports fever and nausea all day 3-2-10, pain at injection site, redness and swelling, headache, fever 102.2 early am then controlled with TYLENOL. 3-3-10 child had 99 temp in AM and had a lack of appetite.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Injection given, child calm then began crying and holding (L) leg. (L) leg red with firm raised area at injection site, area covering lateral aspect between hip and knee.