chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-OCT-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time out of range of 10.0 hours. On 25-OCT-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 06-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 09-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 30-JUL-2013, lot # H011350 expiration date: 21-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Age: 1.32
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Urticaria
Clinical narrative: Mother called stating that child developed hives/welts over legs, buttock, arms, 2 areas on back and one on face the evening (6 pm) after receiving PENTACEL and PROQUAD at 1015 am. Went to ER for treatment. Clear next day 1/22/14. Had hives again after nap 1/22/14. Not as bad. 4 on legs and on arm.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-OCT-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time out of range of 10.0 hours. On 25-OCT-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 13-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 23-APR-2013 (lot number: H011350; exp date: 21-FEB-2015) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 25-APR-2013 at 07:35, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14 hours. On 29-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt rec'd 12 mo imm at ear (OM) RE-check appt 1/21/14. Fever began that PM (101 - 103 degrees). No site reactions noted. To tx fever with APAP/ibuprofen prn; Increase fluids and call office if no improved in 1 -2 days.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 17-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not reported) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 26 year old female patient. Pertinent Medical History of the patient included prediabetic, gestational high blood pressure, high lipids and irregular menstrual cycle. The patient had none drug reaction/allergies. The nurse reported that a patient had a negative pregnancy test and on 08-JAN-2014 the patient was vaccinated with VARIVAX (Merck) (lot# reported as J002316, Exp date 22-FEB-2015), 0.5 ml, route unspecified. Other suspect therapies included M-M-R II 0.5 ml, route unspecified (lot# reported as J002316, Exp date 22-FEB-2015). Concomitant therapies included vitamins (unspecified), aspirin and metformin. On 13-JAN-2014, the pregnancy test returned results that the patient was pregnant. The Last Menstrual Period (LMP) and expected date of delivery (EDD) was not known. The pregnancy outcome was pending. Patient went to nurse's office for medical attention. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 15-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not reported) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-OCT-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time out of range of 10.0 hours. On 25-OCT-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 18-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 63 year old female patient with. The patient was allergic to latex, crab meat and sactive. No pertinent medical history were reported. On 06-JAN-2014, the patient was vaccinated with ZOSTAVAX lot # J007858, 0.65 ml, subcutaneous in the left arm. Concomitant medication included FLUZONE. On an unknown date in January 2014, after receiving ZOSTAVAX, the patient experienced pain in her left arm at the injection site and decreased range of motion of her left arm. The patient sought medical attention and called the pharmacy. The outcome of the events pain in her left arm at the injection site and decreased range of motion of her left arm was reported as not recovered. The reported did not provided the causality between the event and the suspect drug. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 25-NOV-2013 at 07:45, ZOSTAVAX lot # J008434 was exposed to -12C for an estimated total time out of range of 42.75 hours. On 26-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J008434, Exp. Date: 11-OCT-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-OCT-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time out of range of 10.0 hours. On 25-OCT-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 19-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 13-NOV-2012, the patient was vaccinated with an out of temperature range of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 25-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 15-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 25-APR-2013 at 07:35, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14 hours. On 07-MAY-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12C for an estimated total time out of range of 14 hours. On 01-JUN-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 28-JAN-2013, had been administered a dose of GARDASIL exposed to temperature of 11 C (lot number 672834/0131AE, expiration date 16-OCT-2014) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 15-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H0112576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 14-FEB-2013, had been administered a dose of GARDASIL, lot # 668261/1397AA, expiration date 04-SEP-2013 (dose and route not reported) that was exposed to a temperature of 11 C. No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Foreign body sensation in eyes, Headache, Nausea, Pain in extremity
Clinical narrative: "It started 5 hours after the vaccine with my eyes, it felt like I had something in them, thinking it was makeup I flushed them with saline which made no improvement then my throat became scrtachy, followed by SEVERE headache, nausea, achiness in my legs, uncontrollable shaking, and finally vomiting. This lasted 5-6 hours and then tapered to just the headache for the next 24 hours. I was wiped out for the next day and then by the second day I felt fine.'
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Tremor, Vomiting
Clinical narrative: "It started 5 hours after the vaccine with my eyes, it felt like I had something in them, thinking it was makeup I flushed them with saline which made no improvement then my throat became scrtachy, followed by SEVERE headache, nausea, achiness in my legs, uncontrollable shaking, and finally vomiting. This lasted 5-6 hours and then tapered to just the headache for the next 24 hours. I was wiped out for the next day and then by the second day I felt fine.'
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Injection site red and swollen with visible "knot" and painful to touch. Slight headache. Woke in the night to pain in joints and very painful injection site. Took Tylenol for pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Injection site red and swollen with visible "knot" and painful to touch. Slight headache. Woke in the night to pain in joints and very painful injection site. Took Tylenol for pain.
Age: 27.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Local reaction, Pain, Pruritus, Swelling
Clinical narrative: Hot to the touch, red swelling about 2-3 inches in diameter around the vaccination site. Pain itching, mainly swelling. Most likely local reaction to vaccine.
Age: 27.0
Sex: F
Vaccine: SMALL
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to the touch, red swelling about 2-3 inches in diameter around the vaccination site. Pain itching, mainly swelling. Most likely local reaction to vaccine.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: PATIENT'S ARM WAS VERY SWOLLEN. ADMINISTRATION SITE WAS RED AND AS BIG AS A SOFT BALL IN DIAMETER SIZE. THE SKIN WAS ELEVATED AND WARM TO THE TOUCH.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Rash on arm, and swollen gland; patient was advised to use cool compresses and Benadryl.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever 103 orally, body aches, chills.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 20-FEB-2013, had been administered a dose of GARDASIL (dose, route and lot number not reported) that was exposed to temperature of 11 C. No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 25-NOV-2013 at 07:45. ZOSTAVAX lot # J008434 was exposed to -12C for an estimated total time out of range of 42.75 hours. On 26-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J008434, Exp. Date: 11-OCT-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Chills, Dehydration, Dizziness
Clinical narrative: Very early Tues, AM - had sudden onset of symptoms, severe non-stop shaking, quivering chills, event with husband cutting up heat, putting three thick blankets over me. Extreme aching and weakness in muscles and joints all over. Headache, dizziness, ringing in ears, bad neck pain, facial stiffness, nausea, dehydration, could hardly walk Temp. 101.7 all day - B.P. 107/70 and then 98/65 - pulse up to 112 - Took a TYLENOL and B.C. powder Wed. morning - Temperature normal again on Wed. noon. Jan. 18th.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Headache, Heart rate increased, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Very early Tues, AM - had sudden onset of symptoms, severe non-stop shaking, quivering chills, event with husband cutting up heat, putting three thick blankets over me. Extreme aching and weakness in muscles and joints all over. Headache, dizziness, ringing in ears, bad neck pain, facial stiffness, nausea, dehydration, could hardly walk Temp. 101.7 all day - B.P. 107/70 and then 98/65 - pulse up to 112 - Took a TYLENOL and B.C. powder Wed. morning - Temperature normal again on Wed. noon. Jan. 18th.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Neck pain, Pain, Tinnitus, Tremor
Clinical narrative: Very early Tues, AM - had sudden onset of symptoms, severe non-stop shaking, quivering chills, event with husband cutting up heat, putting three thick blankets over me. Extreme aching and weakness in muscles and joints all over. Headache, dizziness, ringing in ears, bad neck pain, facial stiffness, nausea, dehydration, could hardly walk Temp. 101.7 all day - B.P. 107/70 and then 98/65 - pulse up to 112 - Took a TYLENOL and B.C. powder Wed. morning - Temperature normal again on Wed. noon. Jan. 18th.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Computerised tomogram head normal, Electroencephalogram abnormal, Endotracheal intubation, Intensive care, Nuclear magnetic resonance imaging normal
Clinical narrative: Status epilepticus without prior history. Required intubation and ICU stay.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Status epilepticus
Clinical narrative: Status epilepticus without prior history. Required intubation and ICU stay.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Dizziness
Clinical narrative: HPV given, after observing for 15 minutes. Pt got off exam table, walked out exam room door and complained of being "a little dizzy". Taken back into exam room. Lay back VS taken x 2. Dr examined pt.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 06-JUN-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 23-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain, Skin warm, Swelling
Clinical narrative: 1/15/14 Swelling at and below injection site - 7" - 3 1/2" area started swelling warm to the touch. No fever, pain 3 out of 10 on pain scale. Instructed to take CLARITIN and ice - no other symptoms - reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None. Pt requested flu vaccine, Dr ordered. Requested vaccine, when I went to document (after giving injection) I seen pt already received vaccine this flu seasons 13-14.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Dehydration, Influenza, Malaise, Pyrexia
Clinical narrative: State night of 1/7/14, had high-grade fever, malaise. After several days went to ER was dehydrated and diagnosed with "flu" not covered by flu shot. Told ER received flu shot same day as "got sick". Received IV antibiotics in hospital. States hospital informed D/T egg allergy - should not have received and to let this nurse know of adverse event. Denies hives, chest tightness, throat swelling. States last "a couple of weeks".
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Apparent life threatening event, Blood electrolytes normal, Chest X-ray normal, Differential white blood cell count normal, Electrocardiogram normal
Clinical narrative: (ALTE) 4 hours after pt had her 2 m.o. shots, she went limp and became unresponsive during a diaper change, stopped breathing and was given 5 rescue breaths by grandmother and resumed regular respirations. The event lasted about 1 minute. Was brought to the ED via paramedics, looked well on arrival. Admitted for obs from 1/20 -1/22/14 and remained asymptomatic.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Hypotonia, Respiratory arrest, Unresponsive to stimuli, Urine analysis normal, White blood cell count increased
Clinical narrative: (ALTE) 4 hours after pt had her 2 m.o. shots, she went limp and became unresponsive during a diaper change, stopped breathing and was given 5 rescue breaths by grandmother and resumed regular respirations. The event lasted about 1 minute. Was brought to the ED via paramedics, looked well on arrival. Admitted for obs from 1/20 -1/22/14 and remained asymptomatic.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 25-NOV-2013 at 07:45, ZOSTAVAX lot # J008434 was exposed to -12C for an estimated total time out of range of 42.75 hours. On 27-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J008434, Exp. Date: 11-OCT-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Oedema
Clinical narrative: Patient describes developing large local reaction manifested by erythema and edema from the elbow to the top of the scapula within 24 hours after vaccination with anthrax #4 administered subcutaneously on 11 May 2004. No associated neurovascular compromise or other systemic symptoms. Symptoms resolved within one week with supportive care to include ice and TYLENOL. No further sequelae. Patient has subsequently tolerated 5 additional anthrax vaccines with no adverse events.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for am estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, not as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 25-APR-2013 at 07:35,  ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14 hours. On 31-MAY-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with high blood pressure, thyroid disorder, high cholesterol. Patient did not have any drug allergy. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J007211, .65 ml, subcutaneous. No concomitant medications were there. On 15-JAN-2014, 3 days after onset of therapy the patient experienced bumps, redness, itching and swelling at the ZOSTAVAX. The outcome of bumps, redness, itching and swelling at the ZOSTAVAX and injection site is unknown. No laboratory tests were done. Medical attention was sought by consulting pharmacist. The pharmacist advised the patients to stop scratching the area and to apply a cold compress to the area. This case is linked to 1401USA010679 due to same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 25-NOV-2013 at 07:45, ZOSTAVAX lot # J008434 was exposed to -12C for an estimated total time out of range of 42.75 hours. On 02-DEC-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J008434, Exp. Date: 11-OCT-2014). No adverse experienced had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age with high blood pressure, thyroid disorder, high cholesterol. Patient did not have any allergy. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J007211, .65 ml, subcutaneous. No concomitant medications were there. On 15-JAN-2014, 3 days after onset of therapy the patient experienced bumps, redness, itching and swelling at the ZOSTAVAX. The outcome of bumps, redness, itching and swelling at the ZOSTAVAX and injection site is unknown. No laboratory tests were done. Medical attention was sought by consulting pharmacist. The pharmacist advised the patients to stop scratching the area and to apply a cold compress to the area. This case is linked to 1401USA008040 due to same reporter link. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Malaise, Nausea, Somnolence
Clinical narrative: Student reported "being sick, sleepy, dizzy, nauseated, headache" after receiving influenza vaccine on 12/13/13. Symptoms began, per student, in the afternoon after receiving the immunization. Lasted "until Sunday 12/15/13".
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 25-NOV-2013 at 07:45, ZOSTAVAX lot # J008434 was exposed to -12C for an estimated total time out of range of 42.75 hours. On 04-DEC-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J008434, Exp. Date: 11-OCT-2014). No adverse experience had been reported. This is one of 182 repots from the same source. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: FEVER, GENERALIZED RASH.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Crying, Injection site erythema, Irritability, Pyrexia, Respiratory rate increased
Clinical narrative: Fever of 102.6 Degrees F, Red spot around vaccination site, crying, fast breathing, whining while sleeping.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Vomiting
Clinical narrative: Patient complains of vomiting and headache.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, C-reactive protein increased, Chondropathy, Cough, Dry eye
Clinical narrative: Diagnosis by primary care physician was serum sickness; with 100.3 low grade fever, muscle and joint pain, difficulty chewing, dry cough without congestion, extremely dry eyes. Elevated CRP and ESR of 106. Progressed to inflammation of cartilage in both ears as of 11/22/13 and was diagnosed as relapsing polycondritis by clinic.  Symptoms went into spontaneous remission around 12/21/13 without use of prednisone.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Mastication disorder, Myalgia, Polychondritis, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Diagnosis by primary care physician was serum sickness; with 100.3 low grade fever, muscle and joint pain, difficulty chewing, dry cough without congestion, extremely dry eyes. Elevated CRP and ESR of 106. Progressed to inflammation of cartilage in both ears as of 11/22/13 and was diagnosed as relapsing polycondritis by clinic.  Symptoms went into spontaneous remission around 12/21/13 without use of prednisone.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Rheumatoid factor, Serum sickness
Clinical narrative: Diagnosis by primary care physician was serum sickness; with 100.3 low grade fever, muscle and joint pain, difficulty chewing, dry cough without congestion, extremely dry eyes. Elevated CRP and ESR of 106. Progressed to inflammation of cartilage in both ears as of 11/22/13 and was diagnosed as relapsing polycondritis by clinic.  Symptoms went into spontaneous remission around 12/21/13 without use of prednisone.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Dyskinesia, Pyrexia, Seizure like phenomena
Clinical narrative: Fever up to 102.6, seizure like jerking.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash pruritic
Clinical narrative: Demarcated red area/itchy rash, approximately 4 inches in diameter. Has been applying hydrocortisone cream 1%.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: I received a Pneumococcal Polysaccharide Vaccine injection in my left arm about 4 inches above my elbow. I experienced pain with limited mobility of my left arm, swelling around my elbow and a red streak that extended my elbow to my axillary area and my arm was warm to touch. I also had a low grade temperature of 99.4.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Skin warm
Clinical narrative: I received a Pneumococcal Polysaccharide Vaccine injection in my left arm about 4 inches above my elbow. I experienced pain with limited mobility of my left arm, swelling around my elbow and a red streak that extended my elbow to my axillary area and my arm was warm to touch. I also had a low grade temperature of 99.4.
Age: 49.0
Sex: F
Vaccine: FLUR3
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 25-NOV-2013 at 07:45, ZOSTAVAX lot # J008434 was exposed to -12C for an estimated total time out of range of 42.75 hours. 0n 03-DEC-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J008434, Exp. Date: 11-OCT-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a Pharmacist via a Company Representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (Lot number was not reported). Secondary and concomitant therapies were not reported. Primary reporter reported that a patient received a dose of ZOSTAVAX and began to had herpes simplex on her lips. The patient had no history of herpes simplex lesions, until after she received ZOSTAVAX. The outcome of was reported as not recovered. The causality was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash
Clinical narrative: After administering vaccination patient returned to pharmacy w/in 15 min and there were 2 large (size of a pencil eraser) above injection site, called doctor who prescribed VALTREX 1gm TID x 7 days and BENADRYL.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 17-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose and number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness (2 x 4) and swelling. Warm to touch.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified patients of unknown age and gender. The reporter stated that RECOMBIVAX HB were exposed to 5 hours each day with a lowest temperature of 28 F from 03-JAN-2014 to 17-JAN-2014. The reporter also stated that during this time period, there were approximately 15 to 20 patients who received this vaccine. No adverse experiences reported. The outcome of the events were unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified patients of unknown age and gender. The reporter stated that GARDASIL were exposed to 5 hours each day with a lowest temperature of 28 F from 03-JAN-2014 to 17-JAN-2014. The reporter also stated that during this time period, there were approximately 15 to 20 patients who received this vaccine. No adverse experiences reported. The outcome of the events were unknown. This is one of several reports from the same source.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified patients of unknown age and gender. The reporter stated that VAQTA 50/1.0 U/ML were exposed to 5 hours each day with a lowest temperature of 28 F from 03-JAN-2014 to 17-JAN-2014. The reporter also stated that during this time period, there were approximately 15 to 20 patients who received this vaccine. No adverse experiences reported. The outcome of the events were unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 20-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pharyngeal oedema, Pruritus generalised
Clinical narrative: Swelling to injection site w/ redness. Patient stated throat started swelling. Itchiness all over body.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 28-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Lip swelling, Rash, Rash generalised, Rash pruritic
Clinical narrative: After about 45 min of vaccine, pt reportedly had a itchy rash and swelling of lips. Rash was on body and face. Pt felt dizzy. Taken to hosp in private car and pt fainted (syncope) at hosp parking lot. Evaluated at the ED at hosp. In ED exam normal - (no rash).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: After about 45 min of vaccine, pt reportedly had a itchy rash and swelling of lips. Rash was on body and face. Pt felt dizzy. Taken to hosp in private car and pt fainted (syncope) at hosp parking lot. Evaluated at the ED at hosp. In ED exam normal - (no rash).
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 26-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 20-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route of administration were not provided) (lot # H016765 (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 1.88
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, VARCEL
Symptoms: Influenza A virus test negative, Influenza B virus test, Laboratory test normal, Pyrexia, Rash
Clinical narrative: Developed fever of 103F on 1/19/14, fever then subsided and developed rash on 1/23/14, they then saw physician.
Age: 1.88
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, VARCEL
Symptoms: Streptococcus test negative
Clinical narrative: Developed fever of 103F on 1/19/14, fever then subsided and developed rash on 1/23/14, they then saw physician.