chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 10-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 3-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 3-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 16-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 1.58
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 19-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a physician and a medical assistant and refers to a currently 19-year-old male patient. The patient had no specific pertinent medical history, no concomitant medications, no known drug allergies. On an unknown date, in childhood, the patient was vaccinated with M-M-R II (lot#, dose, frequency and route of administration were not reported). It was believed the entire M-M-R II series were completed. The patient was seen in the office at unspecified time in recent past (date unknown) as there was an unspecified "outbreak" in community and the patient was verifying immunity, his antibody level for mumps showed "low". It was reported that the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 02-JAN-2019 for the treatment of low antibody to M-M-R II mumps component. The outcome of low antibody level for mumps was reported as not recovered. Causality assessment was not provided.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 12/31/2018, patient called c/o redness and swelling at site. On 1/2/2019 patient called c/o of increased selling, tenderness. Instructed to come in same day, and NP notice swelling, tenderness at site with redness of entire upper arm to the elbow. T 97.7. Diagnose with Cellulitis of Rt arm and placed on Bactrim DS bid x 7 days.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test normal, Dizziness, Fatigue, Headache, Hepatitis viral test negative
Clinical narrative: Prolong headaches (started the day of the shot and I've had one at least twice a week and up to 5 days a week since. I've been very fatigued even though I don't have a lot going on (nothing that should be making me this tired). My arm was sore only a day for the first shot. I was dizzy for about three days during the week of December 9. The second dose was administered 12/27/2018 and the arm soreness lasted close to 4 days. The headaches have continued as before.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Influenza virus test negative, Pain in extremity, Pregnancy test negative, Urine analysis normal
Clinical narrative: Prolong headaches (started the day of the shot and I've had one at least twice a week and up to 5 days a week since. I've been very fatigued even though I don't have a lot going on (nothing that should be making me this tired). My arm was sore only a day for the first shot. I was dizzy for about three days during the week of December 9. The second dose was administered 12/27/2018 and the arm soreness lasted close to 4 days. The headaches have continued as before.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: Per mom pt began to feel lightheaded and started leaning to the side and fainted.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: She is currently 15 weeks pregnant.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Bone pain, Chills, Dysuria, Lung infection, Malaise
Clinical narrative: Developed severe chills, fever, bone pain, malaise that persisted over 3 weeks and then required antibiotics for lung infection. Also had an episode on the the third and fourth night feeling constant and immediate need to void, yet unable to void that lasted all night. This then ceased, no prior urinary, obstruction problems.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Micturition urgency, Pyrexia
Clinical narrative: Developed severe chills, fever, bone pain, malaise that persisted over 3 weeks and then required antibiotics for lung infection. Also had an episode on the the third and fourth night feeling constant and immediate need to void, yet unable to void that lasted all night. This then ceased, no prior urinary, obstruction problems.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Chest pain, Chills
Clinical narrative: 5 hours after administration she had chills and left side chest pain which continued through the night until the following morning. On 11/30/18 she had inflammation in her left wrist and elbow which continued through 11/30/18. Patient did not take any medication for symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Nausea
Clinical narrative: Had dose #2 of SHINGRIX vaccine 9pm Thursday, 1/3/19. Having nausea (no vomiting yet) from 2:30am Friday, 1/4/19 up until & including now (Noon 1/4/19). Also, pain in muscle upon injection, and still having pain in muscle 15 hours later.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased activity, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Patient was administered vaccination without reaction and didn't experience any injection site reactions the day afterward. About 48 hours after the vaccine, he experienced flu-like symptoms with fatigue, headache, and muscle aches. The majority of these symptoms lasted only a few days, but the fatigue lasted about 3 weeks and he had decreased activity for this time.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Movement produces sharp pain.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU4, MMR
Symptoms: Cough, Dizziness, Fall, Gait disturbance, Heart rate normal
Clinical narrative: Patient received the above vaccines without difficulty and was able to pick out his stickers afterwards. Patient walked out the office with mother and mother's friend talking about plans for after leaving the office. About 5-10 minutes later, the nurse was called to the front hallway where the patient was laying in his mother's lap sitting on the floor. Patient looked drowsy and was not talking. Nurse felt the boy and skin was warm to touch. The nurse removed his jacket and began cooling him down. Mother states the child began coughing and said he was feeling dizzy when seconds later he was not able to walk straight where he then collapsed into his mother's arms. Water was brought to him and he was able to sit up and drink without difficulties. Nurse felt pulse and heart rate, within normal limits. Child was able to answer questions from nurse and mother appropriately. After the child had a few sips of water the nurse asked the child to walk without assistance to the nearest door and back. The child was able to ambulate without assistance. The patient, mother, and mother's friend was then escorted to the lobby to remain for observation. Roughly 5- 10 minutes later the child was reassessed by the nurse. Mother was instructed to monitor him closely for the remainder of the day and the days to follow and if child's symptoms worsen or do not improve, notify pediatrician and/or Emergency Room. Mother verbalizes understanding and states they are ready to go home. Child was asked by mother if he wanted to walk or be carried, and child shook head and motioned towards mother to be carried.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU4, MMR
Symptoms: Skin warm, Somnolence
Clinical narrative: Patient received the above vaccines without difficulty and was able to pick out his stickers afterwards. Patient walked out the office with mother and mother's friend talking about plans for after leaving the office. About 5-10 minutes later, the nurse was called to the front hallway where the patient was laying in his mother's lap sitting on the floor. Patient looked drowsy and was not talking. Nurse felt the boy and skin was warm to touch. The nurse removed his jacket and began cooling him down. Mother states the child began coughing and said he was feeling dizzy when seconds later he was not able to walk straight where he then collapsed into his mother's arms. Water was brought to him and he was able to sit up and drink without difficulties. Nurse felt pulse and heart rate, within normal limits. Child was able to answer questions from nurse and mother appropriately. After the child had a few sips of water the nurse asked the child to walk without assistance to the nearest door and back. The child was able to ambulate without assistance. The patient, mother, and mother's friend was then escorted to the lobby to remain for observation. Roughly 5- 10 minutes later the child was reassessed by the nurse. Mother was instructed to monitor him closely for the remainder of the day and the days to follow and if child's symptoms worsen or do not improve, notify pediatrician and/or Emergency Room. Mother verbalizes understanding and states they are ready to go home. Child was asked by mother if he wanted to walk or be carried, and child shook head and motioned towards mother to be carried.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Headache, Pain, Pain in extremity
Clinical narrative: The vaccine made my right arm really sore and red, some stinging and itching also. The day I got the injection it put me in bed by that evening. I had headache, body aches, stomach upset for 2 and 1/2 days. I had to stay in bed most of the time.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: The vaccine made my right arm really sore and red, some stinging and itching also. The day I got the injection it put me in bed by that evening. I had headache, body aches, stomach upset for 2 and 1/2 days. I had to stay in bed most of the time.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Rigors for 4 hours.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: I am a healthy active 75-year old male. This was my 2nd dose of SHINGRIX (1st dose was a little over 2 months ago. Reaction was extreme chill and fever 100.2. I had to get into bed under heavy covers to warm up. Episode lasted several hours. MY CONCERN IS THAT A PATIENT WHO IS IN A WEAKENED CONDITION AND OLDER SHOULD BE MONITORED FOLLOWING THIS VACCINE. HAS THERE BEEN AN EVALUATION OF THE RISK DURING A VACCINE REACTION ON OLDER WEAKENED PATIENTS?
Age: 16.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 16-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-DEC-2018, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB thimerosal-free, lot # R001530, expiration date 07-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000128.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 11-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 9-week-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 3-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-week-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 6-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 10.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 10-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB thimerosal-free, lot # R001530, expiration date 07-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 16.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 16-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB thimerosal-free, lot # R001530, expiration date 07-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 17.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 17-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB thimerosal-free, lot # R001530, expiration date 07-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 17.0
Sex: U
Vaccine: HEP, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 17-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB thimerosal-free, lot # R001530, expiration date 07-NOV-2020 and of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (for both, doses and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 6.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 6-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB thimerosal-free, lot # R001530, expiration date 07-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 17-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 6.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 6-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 5.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 16-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 11-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 11-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 14-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.