chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Stool analysis normal, Ultrasound scan normal, X-ray normal
Clinical narrative: Abdominal pain, nausea Nov. 21 2013 - present. Probiotics, diet change. Ondansetron ODT (11/30/13), Loperamide (11/30/13), omeprazole (12/4/13 - present). Constipation, diarrhea Nov. 21, 2013 - early Jan. 2014 now sometimes but less frequent.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Expired drug administered
Clinical narrative: Gave an outdated (4/21/14) vaccine.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Temporary fainting.
Age: 65.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Headache, Hypersomnia, Increased upper airway secretion, Lethargy, Rhinorrhoea
Clinical narrative: Massive headaches, sinus, wheezing, lethargic, phlegm, sleeping longer than usual, always drinking water, sneezing, sniffling.
Age: 65.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Sinus disorder, Sneezing, Wheezing
Clinical narrative: Massive headaches, sinus, wheezing, lethargic, phlegm, sleeping longer than usual, always drinking water, sneezing, sniffling.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 months old patient of unknown gender. The nurse reported that on 07-FEB-2014, the patient was vaccinated with the second dose of ROTATEQ, (Lot # J007283), expiration date: 27-SEP-2014. Route and dose were not reported. On 10-MAR-2014, the patient received the third dose of ROTATEQ, (Lot # J008735), expiration date not reported. No other co-suspect or concomitant medications were reported. The nurse reported that both doses received by patient were vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the storage temperature reading in the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. No adverse effects reported. This is one of several reports received from the same source.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Rash erythematous
Clinical narrative: Patient instructed to wait in waiting room for a minimum of 20 min where she noticed a rash that was red and beginning to puff up around 1130 ten minutes later she noticed hives locally around the injection site. Patient verbalized no respiratory, or cardiac emergent complications.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local swelling
Clinical narrative: Swollen/Red Deltoid.
Age: 25.0
Sex: M
Vaccine: HEP, HEPA, TTOX
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Balance disorder, Computerised tomogram normal, Confusional state
Clinical narrative: Pt presented to ER three days after Hepatitis A/B vaccination.  Vaccination was given for admit to EMT school and clinical rotation.  Pt was not ill with any sx until three days post vaccine.  Upon presentation to the ED he was nauseated, vomiting, lightheaded, confused and feeling "off balanced".  CT scan was negative other than what the physician described as posterior reversible leukoencephalopathy.  Lab values showed an HGB of 19 with a corresponding HCT of 56, and increased AST 33, ALT 70.  Pt was discharged on 4/1/2014 after treatment with steriods, antibiotics and IV fluids.
Age: 25.0
Sex: M
Vaccine: HEP, HEPA, TTOX
Symptoms: Dizziness, Haematocrit increased, Haemoglobin increased, Haemoglobin normal, Leukoencephalopathy
Clinical narrative: Pt presented to ER three days after Hepatitis A/B vaccination.  Vaccination was given for admit to EMT school and clinical rotation.  Pt was not ill with any sx until three days post vaccine.  Upon presentation to the ED he was nauseated, vomiting, lightheaded, confused and feeling "off balanced".  CT scan was negative other than what the physician described as posterior reversible leukoencephalopathy.  Lab values showed an HGB of 19 with a corresponding HCT of 56, and increased AST 33, ALT 70.  Pt was discharged on 4/1/2014 after treatment with steriods, antibiotics and IV fluids.
Age: 25.0
Sex: M
Vaccine: HEP, HEPA, TTOX
Symptoms: Nausea, Vomiting
Clinical narrative: Pt presented to ER three days after Hepatitis A/B vaccination.  Vaccination was given for admit to EMT school and clinical rotation.  Pt was not ill with any sx until three days post vaccine.  Upon presentation to the ED he was nauseated, vomiting, lightheaded, confused and feeling "off balanced".  CT scan was negative other than what the physician described as posterior reversible leukoencephalopathy.  Lab values showed an HGB of 19 with a corresponding HCT of 56, and increased AST 33, ALT 70.  Pt was discharged on 4/1/2014 after treatment with steriods, antibiotics and IV fluids.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Rash macular
Clinical narrative: Took 3 of 4 doses. On day 3 a macular non-urticarial rash developed.
Age: 0.38
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Body temperature increased, Respiratory rate increased
Clinical narrative: Parent state that at 3a patient had temp of 105, parent was giving patient Tylenol which would lower temps but never lower than 101. Parent also stated that patient was breathing fast. Patient presented to the clinic with a rectal temp of 103.1 and RR of 64. Patient was given rectal Tylenol 80mg and was cooled with ice packs. Patient temp came down to 99.3 and RR 54. Patient remained afebrile thereafter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm swelling and redness.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Skin warm, Swelling
Clinical narrative: Muscle pain, swelling, warm to touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Itching of skin at site with erythema, induration, warmth.  Erythema spreading from site to elbow - cellulitis reaction.
Age: 1.05
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Blood lead, Full blood count, Urticaria
Clinical narrative: Received MMRV#1, Hep A#1, and PCV13#4 vaccines in right leg. Had bloodwork drawn for CBC and lead and then noted to have urticarial lesions all over body.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Eczema, Rash
Clinical narrative: One week after Zostavax developed rash.  Later diagnosed as spongiotic dermatitis. Had never had before vaccine.
Age: 0.13
Sex: M
Vaccine: DTAP
Symptoms: Crying, Hyporesponsive to stimuli, Lethargy, Pallor
Clinical narrative: At approximately 12:30 PM patient started inconsolably crying. He cried until approximately 3:30 PM. At that time he became lethargic, less responsive, and pale. We called the Dr's office and by the time we had them on the phone he was opening his eyes and more responsive, but still lethargic. They told us to keep an eye on him, and that he had probably worn himself out crying. He recovered after about 1 hour. At the time we weren't that concerned. We are reporting this because a more severe but similar episode occurred at the 4 month vaccination.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Joint range of motion decreased, Muscle spasms, Pain in extremity
Clinical narrative: Severe pain in shoulder surrounding vaccinated area.  Achy, cramping pain.  Severe headache within 90 minutes of vaccine.  Limited range of motion within a few more hours. 4 days later and I still have severe pain in my shoulder.  Almost feels like tendonitis but it isn't related to any tendon. Still having similar headaches every day as well.
Age: 0.3
Sex: M
Vaccine: DTAP
Symptoms: Crying, Hypopnoea, Hyporesponsive to stimuli, Lethargy, Pallor
Clinical narrative: Patient went to sleep shortly after his vaccination. At approximately 1:30 PM he started crying inconsolably. At approximately 3:30 PM he became lethargic, minimally responsive to noxious stimuli, and extremely pale. His respirations were shallow with no cyanosis present. This lasted for about a minute, then his color started returning, and he was more easily arousable, albeit lethargic. Over the course of the next two hours patient returned to normal. I called the Dr office and they stated that it could have been from adrenalin secondary to crying.
Age: 0.79
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Flushing, Pallor, Rash, Skin discolouration
Clinical narrative: Mom went to get him when woken from nap by barking dog and thought he looked purplish in the face. He seemed drowsy, like he wanted to fall asleep as she carried him to answer the door. Neighbor commented on how flushed he looked. Mom splashed some water on him, took his temp. On her thermometer was 97 deg. Checked on neighors' thermometer was same.  Mom gave 3 mL of Tylenol. Called and requested appointment.  In the car to appointment was alert. In clinic, at 6:30 PM found to be quite flushed head to toe, blanching, but otherwise normal exam. Normal heart rate (126) O2 sat (96%). Temp elevated at 100.2 deg F, rectally. Remainder of exam normal: No edema to lips or tongue. No wheezing or respiratory distress. Gave 12.5 mg of PO diphenhydramine in clinic.
Age: 0.79
Sex: M
Vaccine: MMR
Symptoms: Somnolence
Clinical narrative: Mom went to get him when woken from nap by barking dog and thought he looked purplish in the face. He seemed drowsy, like he wanted to fall asleep as she carried him to answer the door. Neighbor commented on how flushed he looked. Mom splashed some water on him, took his temp. On her thermometer was 97 deg. Checked on neighors' thermometer was same.  Mom gave 3 mL of Tylenol. Called and requested appointment.  In the car to appointment was alert. In clinic, at 6:30 PM found to be quite flushed head to toe, blanching, but otherwise normal exam. Normal heart rate (126) O2 sat (96%). Temp elevated at 100.2 deg F, rectally. Remainder of exam normal: No edema to lips or tongue. No wheezing or respiratory distress. Gave 12.5 mg of PO diphenhydramine in clinic.
Age: 1.37
Sex: F
Vaccine: MMR
Symptoms: Developmental delay, Femur fracture, Head injury
Clinical narrative: This female subject was enrolled in an observer blind study. On 11 September 2013, she received a 1st dose of GSK PRIORIX or Merck's M-M-R II co-administered with GSK HAVRIX 720 Junior, Merck's VARIVAX and Pfizer's PREVNAR 13. On 29 October 2013, she received a 2nd dose of GSK PRIORIX or Merck's M-M-R II. On 16 April 2014, six months after the 2nd dose of Blinded vaccine, seven months after the dose of HAVRIX 720 Junior, seven months after the dose of VARIVAX, seven months after the dose of PREVNAR 13, this 22-month-old subject developed developmental delay. The event was disabling. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the developmental delay may have been caused by the investigational product, HAVRIX 720 Junior, VARIVAX and PREVNAR 13. Relevant Risk Factors: Father: Bi-polar Disorder Father's side: Tourette's syndrome. Investigator Comments: Family non-compliant with well child exams. Last well child check was 12 month visit on 7-16-13. Subject missed both 15 month and 18 month well child check up visits. No 18 month MCHAT or ASQ developmental questionnaires to compare with 4-16-14 visit questionnaires. Physician deferred well child check due to traumatic events, head trauma 4-13-14 and diagnosis of undisplaced oblique fracture through the mid to distal right femoral diaphysis 13 April 2014. Subject failed ASQ across all domains on 16 April 2014. Subject will need further evaluation. 4/23/14: Investigator cannot rule out possible relationship of SAE to Investigational product. The subject's last dose of Investigational product was 29 October 2013. Last well child check was 16 July 2013 and developmental delay diagnosis was on 16 April 2014. The subject is scheduled to return on 30 April 2014 for follow up after hospitalization and to complete the well child check. The SAE relationship to Investigational product will be re-evaluated at that time.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 18-FEB-2014, the patient was vaccinated with first dose of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 15-JAN-2014, the patient was vaccinated with  ROTATEQ lot # J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored oral ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm ) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperature was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: (L) arm lesion, redness, swelling for 3 days. No fever, no abdominal pain, no diarrhea, vomiting. Prescription given for ibuprofen 4mL every 6 hrs. KEFLEX 5mL every 8 hrs.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Pruritus generalised, Rash
Clinical narrative: Pt is 38 yo G4 P3 at 32 wks. Was given Tdap today as routine care. After 10-15 min, pt still at laboratory, she started to experience rash on arms and itchy on entire body. No difficulty breath or SOB or throat.
Age: 0.31
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers 3 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 17-JAN-2014, the patient was vaccinated with dose 2 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. (R) thigh measures 10cm at injection site. (L) upper thigh measures 20 cm at injection site. (L) lower thigh measures 15 cm at injection site.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 31-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.22
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 06-FEB-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 12-FEB-2014, the patient was vaccinated with dose 2 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.63
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 7 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 31-JAN-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age. On 2008 the patient was vaccinated with a pediatric dose of RECOMBIVAX HB 0.5 ml, intramuscular and then in January 2014, the patient received an adult dose of RECOMBIVAX HB 1 ml intramuscular. No adverse effects were reported. Additional information is not expected.
Age: 92.0
Sex: F
Vaccine: TDAP
Symptoms: Aphonia, Chills, Cough, Dizziness, Nausea
Clinical narrative: Swelling in throat, dizziness and nausea same day very sleepy that day next day chills cough, lost her voice, ST two days later - Bad cough described as "whooping" x 2 days.
Age: 92.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pertussis, Pharyngeal oedema, Somnolence
Clinical narrative: Swelling in throat, dizziness and nausea same day very sleepy that day next day chills cough, lost her voice, ST two days later - Bad cough described as "whooping" x 2 days.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site anaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: Information was received from a pharmacist regarding an approximately 76 year old male patient, with an allergy to iodine. On 08-MAR-2014, the patient was vaccinated with ZOSTAVAX, lot # J011830, expiration date 26-DEC-2014 (dosage and route of administration not provided). Concomitant therapies included AUROBINDO, VICTOZA, LUPIN, and hydrochlorothiazide (+) spironolactone, metformin, levothyroxine sodium, and glimepiride (manufacturers unknown). The pharmacist reported that the patient developed transient numbness and tingling at the injection site following vaccination with ZOSTAVAX that has continued through the date of the report. The pharmacist did not know how soon after the ZOSTAVAX the patient developed the transient numbness and tingling. No treatment was given. The outcome of the transient numbness and tingling at the injection site was reported as not recovered. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt stated he has had no symptoms or signs post-vaccine administration.
Age: 1.1
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Culture throat, Unevaluable event
Clinical narrative: None stated.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site induration, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Red firm rash on leg. Varicella was administered x4 days. Red pinpoint rash on torso last wk, that has since resolved.
Age: 44.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema multiforme, Pain, Rash, Swelling
Clinical narrative: Pt experienced rash and swelling for approx 1 weeks post injection; rash from should to elbow. Stated had pain for about 1 1/2 months after injection.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Hypoaesthesia, Malaise, Pain in extremity
Clinical narrative: Patient complaint: Since 7 Nov flu injection, has pain in R arm, states he's been sick since. Always gets sick when he get the injection. Went to ER states he was given some meds and sent home. Fingers numb, with burning.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 21-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot # J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degree F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperature for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64/8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Rash, Rash pruritic
Clinical narrative: Per PCP note 11/15/13: Patient complains of: rash on anterior abdominal wall x 2 weeks. Hx of DM, HTN, depression, anxiety, abdal obesity. Rash started in midline of chest wall about 2 days after received the flu and hepatitis A vaccinations. Has spread and is very itchy. Had received the same vaccinations 3/13 in liver clinic. Methylprednisolone 80 mg once, diphenhydramine PRN.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Diagnosis of cellulitis - Rx.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Blood glucose, Dizziness, Nausea, Vomiting
Clinical narrative: 1205pm patient felt dizzy and nauseous, instructed to lie down. 1206pm patient given apple juice as requested by mom. 1210pm patient vomited. 1210 BP checked. 1211 glucose checked. 1226 symptoms resolved without intervention.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Vaccination complication, Visual acuity tests
Clinical narrative: Adverse reaction to shingles vaccine ZOSTAVAX mild redness and minor swelling. Patient allergic to BENADRYL. Recommended cold compress and Ibuprofen and patient has recovered.
Age: 0.54
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 12-FEB-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 10-FEB-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 30-JAN-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 11-FEB-2014, the patient was vaccinated with dose 2 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.15
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 1 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 31-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.49
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 5 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 03-FEB-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.