chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old male patient. The concurrent condition, medical history and concomitant medication was unknown. On 16-MAR-2016, the patient was vaccinated with GARDASIL 9 (route, dose, frequency and lot details unavailable). On 17-MAY-2016, the patient received GARDASIL as the second dose (interchange of vaccine products and wrong drug administered). No adverse events was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown gender and ages. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were inadvertently administered with RECOMBIVAX HB (lot # L048849, expiry date: 04-FEB-2018) (route: intramuscular) that had been improperly stored at a temperature of 34.5 F for 5 hours. The outcome of the excursion was reported as supported. No adverse effects were reported. The outcome of the events was unknown. Additional information had been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to eight patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # L033343, expiry date 13-SEP-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of RECOMBIVAX HB underwent temperature excursion at 1.2 Celsius degrees for 54 minutes. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. No current of historical conditions were reported. On 18-MAY-2016 the patient was vaccinated with PEDVAXHIB (lot # L051122, expired date of 12-OCT-2018, dose and route unknown) and ROTATEQ (Lot # L028645, expired date of 25-MAY-2017, oral, dose unknown). The vaccines were improperly stored under 9.1 celsius degree for 30 minutes. No previous temperature excursion. Data logger was involved. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown gender and ages. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were inadvertently vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) (route: intramuscular) that had been improperly stored at a temperature of 34.5 F for 5 hours. The outcome of the excursion was reported as supported. No adverse effects were reported. The outcome of the events was unknown. Additional information had been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. No current of historical conditions were reported. On 17-MAY-2016 the patient was vaccinated with PEDVAXHIB (lot # L051122, expired date of 12-OCT-2018, dose and route unknown). The vaccines were improperly stored under 9.1 celsius degree for 30 minutes. No previous temperature excursion. Data logger was involved. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored dose of GARDASIL 9 lot # L020015 with expiration date of 16-OCT-2017 and lot # L048459 with expiration date of 22-FEB-2018 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was also reported by the Licensed Practical Nurse, that GARDASIL 9 lot # L020015 with expiration date of 16-OCT-2017 was exposed to a temperature excursion of 23.4 degree C for 3842 minutes and lot # L048459 with expiration date of 22-FEB-2018 was exposed to 23.4 degree C for 968 minutes. No previous excursion was stated. Furthermore, no adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a unspecified multiple patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL lot # L039066 with expiration date of 19-MAR-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was also reported by the Licensed Practical Nurse, that the vaccine was exposed to a temperature excursion of 23.4 degree C for a time of 3842 minutes. Data logger was stated. Furthermore, no adverse events were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Dizzy and elevated blood pressure occurred the day after vaccines were administered - follow up visit 5/31/16.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unspecified dates in 2016, the patients were vaccinated with improperly stored ZOSTAVAX lot # L039096, expiry date 08-JAN-2017 (dose, route and site of administration were not reported). No adverse effects were reported. The temperature excursion was noted at 5.7 degrees Fahrenheit for 18 hours. Previous temperature excursion was at 18 degrees Fahrenheit which lasted for 3 hours. Data logger was not involved. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Left inner arm redness, slight swelling, mild itching, slight rash.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L015415, expiration date: 01-AUG-2016. No adverse effect was reported. Administered dose of vaccine experienced the temperature excursion of -9.7 degrees Celsius for 45 minutes. Data logger was involved. There was previous excursion -11.9 degrees Celsius for 30 minutes. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Anxiety, Asthenia, Chest discomfort, Dyspnoea, Electrocardiogram
Clinical narrative: This spontaneous report as received from a male patient in his 30's who refers to himself. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, within 24 hours of receiving the PNEUMOVAX 23, the patient experienced pain and swelling in the left arm. Then, on an unknown date, "red stripes" appeared on the arm and covered his chest a day later. On an unknown date, a week later, the patient experienced tightness of the chest, shortness of breath, anxiety and soreness at the injection site. On an unknown date, the patient felt weak. It was reported that the patient underwent electrocardiogram (EKG) but the results were not performed. The outcome of pain and swelling in the left arm, "red stripes" on the arm and chest, tightness of the chest, shortness of breath, anxiety and soreness at the injection site was unknown (reported as "it was unspecified whether any other symptoms had resolved"). The outcome felt weak was reported as not recovered (also reported as "he continues to feel weak to the day of the report"). The relatedness between adverse events and PNEUMOVAX 23 was not reported. Additional information is not expected because the reporter or Health Care Professional contact details were not provided.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a male patient in his 30's who refers to himself. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, within 24 hours of receiving the PNEUMOVAX 23, the patient experienced pain and swelling in the left arm. Then, on an unknown date, "red stripes" appeared on the arm and covered his chest a day later. On an unknown date, a week later, the patient experienced tightness of the chest, shortness of breath, anxiety and soreness at the injection site. On an unknown date, the patient felt weak. It was reported that the patient underwent electrocardiogram (EKG) but the results were not performed. The outcome of pain and swelling in the left arm, "red stripes" on the arm and chest, tightness of the chest, shortness of breath, anxiety and soreness at the injection site was unknown (reported as "it was unspecified whether any other symptoms had resolved"). The outcome felt weak was reported as not recovered (also reported as "he continues to feel weak to the day of the report"). The relatedness between adverse events and PNEUMOVAX 23 was not reported. Additional information is not expected because the reporter or Health Care Professional contact details were not provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stores VAQTA (dose and route were not reported) lot # L031196, expiration date 05-FEB-2017. It was reported that the vaccine was exposed to 29 Fahrenheit degrees for 96 hours. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to ten patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL injection, lot # K011562, expiry date 08-APR-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of GARDASIL underwent temperature excursion at 1.2 Celsius degrees for 54 minutes. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. No current or historical conditions were reported. On 17-MAY-2016 the patient was vaccinated with PEDVAXHIB (lot # L051122, expired date of 12-OCT-2018, dose and route unknown) and ROTATEQ (Lot # L028645, expired date of 25-MAY-2017, oral and dose unknown). The vaccines were improperly stored under 9.1 Celsius degree for 30 minutes. No previous temperature excursion. Data logger was involved. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to four patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral solution, lot # L038536, expiry date 19-AUG-2017. On an unknown date, the administered doses of ROTATEQ underwent temperature excursion at 1.2 Celsius degrees for 54 minutes. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reported received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drugs reactions or allergies was provided. On 29-APR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L034724, expiration date 09-DEC-2016 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV, TDAP, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drugs reactions or allergies was provided. On 29-APR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L034724, expiration date 09-DEC-2016 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain, Nausea
Clinical narrative: Extreme Pain in shoulder. Today is 06/04/2016 time is 6:25. I woke with same amount of pain as yesterday plus I feel Nauseated. Temp. is 97.1.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient developed fever and significant left upper arm swelling and redness.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Aphasia, Fatigue, Feeling abnormal, Hypersomnia, Lethargy
Clinical narrative: Child woke up in the morning of June 2nd with nausea and lethargic fatigue. Slept most of the morning. Went to bed then woke up screaming at 2:15 in the morning of June 4th. Could not talk, did not want to be held. Said few words, Brain rattle, loud noise, my head is noisy. After one hour he fell asleep again and when he woke up he remembered all what happen and was able to articulate better. Child reported that he wanted to talk but was not able to and it was like his head was shaking inside and a loud noise like a train.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Middle insomnia, Nausea, Screaming, Tinnitus
Clinical narrative: Child woke up in the morning of June 2nd with nausea and lethargic fatigue. Slept most of the morning. Went to bed then woke up screaming at 2:15 in the morning of June 4th. Could not talk, did not want to be held. Said few words, Brain rattle, loud noise, my head is noisy. After one hour he fell asleep again and when he woke up he remembered all what happen and was able to articulate better. Child reported that he wanted to talk but was not able to and it was like his head was shaking inside and a loud noise like a train.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever, body aches, nausea after getting Prevnar 13.
Age: 32.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: About five hours after the second dosage or the oral, typhoid vaccine, I woke up with a fever, which continued over the next 17 hours, reaching 103F. I also had a headache, body aches, tremors, a sore throat, and experienced stomach pain.
Age: 32.0
Sex: F
Vaccine: TYP
Symptoms: Tremor
Clinical narrative: About five hours after the second dosage or the oral, typhoid vaccine, I woke up with a fever, which continued over the next 17 hours, reaching 103F. I also had a headache, body aches, tremors, a sore throat, and experienced stomach pain.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Dyskinesia, Muscle spasms
Clinical narrative: Within two weeks of receiving the flu vaccine, I began noticing spontaneous, random muscle spasms/contractions throughout the major muscles of my body. For example, my leg or arm muscle would contract and move my limb without me causing it too. This continued for approximately three months and slowly got better over time.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called reporting redness, swelling, and heat at site of injection. Advised cold compress, Benadryl, and Tylenol if needed. Advised to report to ER if symptoms of generalized reaction occur.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient's left arm at injection site was red. It was about 3-4 inches in diameter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Hardened lump under skin at injection site, warm to touch, and red area measuring approximately 6" in diameter.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: Fever up to 101° so far. Also chills, sweats, ache at injection site.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Decreased appetite, Fatigue, Lethargy
Clinical narrative: Woke up, felt tired even after 8+ hours of sleep, and body ached all over.  I normally have a good appetite in the morning, but was not feeling hungry and slightly nauseous.  I ate 2 scrambled eggs, 1 piece of toast and some weak coffee. Despite feeling a general malaise with body aches and some lethargy, I went for a 2 mile run at a slow pace at 10:30 AM.  Upon stopping from the run at 11:00 AM, I felt weak and my muscles and joints were in pain.  At 12:00 PM I had to lay down, took my temperature and had a fever of 101.3.  I felt like I might vomit at any minute, but did not.  I slept until 1:30 PM at which time my temperature was now 102.8.  I took 200 mg of Advil at this time.  The fever went down to 101.  I drank a lot of water, had some orange juice, fruit, and carrots and 5.5 oz of yogurt.  I felt a bit better until about 5pm at which time my fever returned, the body aches and lethargy returned, and I took more Advil (400mg).  At 11:15 PM I am feeling slightly better.  I did not have a cold or any signs of ill health prior to the TDap vaccination.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Woke up, felt tired even after 8+ hours of sleep, and body ached all over.  I normally have a good appetite in the morning, but was not feeling hungry and slightly nauseous.  I ate 2 scrambled eggs, 1 piece of toast and some weak coffee. Despite feeling a general malaise with body aches and some lethargy, I went for a 2 mile run at a slow pace at 10:30 AM.  Upon stopping from the run at 11:00 AM, I felt weak and my muscles and joints were in pain.  At 12:00 PM I had to lay down, took my temperature and had a fever of 101.3.  I felt like I might vomit at any minute, but did not.  I slept until 1:30 PM at which time my temperature was now 102.8.  I took 200 mg of Advil at this time.  The fever went down to 101.  I drank a lot of water, had some orange juice, fruit, and carrots and 5.5 oz of yogurt.  I felt a bit better until about 5pm at which time my fever returned, the body aches and lethargy returned, and I took more Advil (400mg).  At 11:15 PM I am feeling slightly better.  I did not have a cold or any signs of ill health prior to the TDap vaccination.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Cheilitis, Rash
Clinical narrative: Rash on lips, arm and leg.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Injection site pain, Nausea, Vomiting
Clinical narrative: Pain at injection site followed by dizziness, nausea and vomiting.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Limb discomfort, Mobility decreased, Paraesthesia
Clinical narrative: A couple hours after receiving vaccine he fell asleep at computer. He woke up with numbness in L arm, difficult lifting his hand at the wrist. The injection site did not look red or swollen but arm did feel a little warm. He could lift arm at the shoulder but couldn't feel hand and felt numbness in his arm.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Mobility decreased, Skin warm
Clinical narrative: A couple hours after receiving vaccine he fell asleep at computer. He woke up with numbness in L arm, difficult lifting his hand at the wrist. The injection site did not look red or swollen but arm did feel a little warm. He could lift arm at the shoulder but couldn't feel hand and felt numbness in his arm.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 63 degrees Fahrenheit for 564 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 63-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 11-FEB-2016, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (1 ml, left deltoid, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 19-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 11-FEB-2016, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (1ml, left deltoid, route of administration: intramuscularly, dose number not reported, lot number: L035881, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 17-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 10-FEB-2016, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (1ml, right deltoid, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of M-M-R II (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccines underwent a temperature excursion of 63 degrees Fahrenheit for 564 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L035508, expiration date 12-MAY-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 63 degrees Fahrenheit for 564 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with more then recommended number of doses of PNEUMOVAX 23 (strength dose, route of administration, anatomical location, lot # and expiration date were not provided). The physician did not provided how many doses of PNEUMOVAX 23 these patients had received. This is one of two reports received from the same reporter. Additional information is not expected as the physician did not wand to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of PNEUMOVAX 23 (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 63 degrees Fahrenheit for 564 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 17.6 degrees Fahrenheit for 84 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of PROQUAD (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 17.6 degrees Fahrenheit for 84 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Hyperhidrosis
Clinical narrative: This spontaneous report as received from a patient's brother refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (lot # and expiration were not reported). On an unknown date (reported as at night after vaccination), the patient experienced sweating. No treatment was given for the adverse event. The patient did not seek medical attention. It was reported that the symptoms had subsided by the morning of the next day and the patient completely recovered. The relatedness between the event and GARDASIL was not reported. Additional information is not expected since the reporter's contact details were not provided.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L038522, expiration date 11-AUG-2017 (dose and route of administration were not reported). There were no adverse effect reported. Administered doses of vaccines experienced the temperature excursions of 35.8 degrees Fahrenheit for 15 hours minutes on 18-MAY-2016 and 35.4 degrees Fahrenheit for 15 hours on 23-MAY-2016. Time frame: 30 hours cumulatively. There was no a data logger involved. There were previous excursions reported as 35.2 degrees Fahrenheit for 51.5 hours. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot L034724, expiration date 09-DEC-2016 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead referring to a 18-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in right deltoid (a dose number was not provided). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 29.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 29-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 31-JAN-2016, the patient was vaccinated with an improperly stored dose of hepatitis B vaccine (recombinant) (manufacturer unknown)(left deltoid, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 43.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 43-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 09-FEB-2016, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (place of administration was not reported, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 19-MAR-2016, the patient vaccinated with an improperly stored dose of ZOSTAVAX lot # L034724, expiration date 09-DEC-2016 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-MAR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L034724, expiration date 09-DEC-2016 (dose and route administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of VARIVAX (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 17.6 degrees Fahrenheit for 84 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in May 2016, the patient was vaccinated with an improperly stored does of VARIVAX injection (lot # L037560 with expiry date: 29-SEP-2017) and a dose of M-M-R II injection (lot # L027431 with expiry date: 22-JUL-2017; strength, dose, route and site of administration were unspecified for both). The administrated vaccine underwent the temperature excursion at 50 degrees Fahrenheit for 3.5 hours. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 18-APR-2016, the patient was vaccinated with an improperly stored does of ZOSTAVAX lot L034724, expiration date 09-DEC-2016 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of ROTATEQ (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 63 degrees Fahrenheit for 564 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of VAQTA (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 63 degrees Fahrenheit for 564 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 52-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (1 ml, left deltoid, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Serum sickness
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). On an unknown date, during a presentation to a group of physicians, the patient was diagnosed with serum sickness after administration of PNEUMOVAX 23 (onset date was not provided). The outcome of the event was not reported. The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Additional information is not expected as the physician did not want to be contacted.
Age: 56.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 56-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 02-FEB-2016, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (deltoid, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 66 year old patient of unknown gender. On 02-JUN-2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose, frequency, route of administration and indication were not reported, lot # K010523 with expiration date: 25-FEB-2016). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates in 2016, reported as after 28-MAR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot #L051099, expiry date 17-JUN-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The nurse reported that the doses of the vaccine were stored in the shipping container for 5 days and exposed to unknown temperature (date unspecified). The reporter stated that the excursion, which was outside of the 1 day shipping allowance, occurred due to a late delivery of the vaccine order, and that specific details of the excursion could not be provided by the nurse. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead referring to a 20-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in left deltoid (a dose number was not provided). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead referring to a 48-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, dose unknown, intramuscularly, in left deltoid (a dose number was not provided). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information has been requested.