chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 16 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 02-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 31-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # reported as M027347, expiration date 01-JUN-2018; lot # reported as M000998, expiration date 07-JAN-2018, dose and route not reported). The doses of vaccine were exposed to 3 defrost cycles, each cycle was reaching 6 degree Fahrenheit for 5 minutes. Data logger was involved. There were no prior excursions. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # reported as M031944, expiration date 27-DEC-2017, dose and route not reported). The doses of vaccine were exposed to 3 defrost cycles, each cycle was reaching 6 degree Fahrenheit for 5 minutes. Data logger was involved. There were no prior excursions. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certificated medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concomitant medication were not reported. On 02-NOV-2016 or 03-NOV-2016, the patients were vaccinated with a dose of improperly stored PNEUMOVAX 23 (dose, frequency, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. The call was made due to digital data logger. The dose of the administered vaccine was exposed to temperature of 9.5 degrees Celsius for 28 hours. The vaccine was exposed to previous temperature excursion. There was no product quality complaint involved. 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 was received from a certificated medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concomitant medication were not reported. On 02-NOV-2016 or 03-NOV-2016, the patients were vaccinated with a dose improperly stored VAQTA (dose, frequency, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. The call was made due to digital data logger. The dose of the administered vaccine was exposed to temperature of 9.5 degrees Celsius for 28 hours. The vaccine was exposed to previous temperature excursion. There was no product quality complaint involved. 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 was received from a certified medical assistant worker and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concomitant medication were not reported. On 02-NOV-2016 or 03-NOV-2016, the patients were vaccinated with an improperly stored dose of (Wistar RA 27-3) M-M-R II (dose, frequency, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. The call was made due to digital logger. The dose of the administered vaccine was exposed to temperature of 9.5 degrees Celsius for 28 hours. The vaccine was exposed to previous temperature excursion. There was no product quality complaint involved. 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 was received from a nurse and refers to a patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant therapies were not reported. Since 12-AUG-2016 to 16-AUG-2016, the VAQTA (lot # L009455, expiration date 01-JUN-2017) was stored in 9 Celsius degrees for 5 days. In September 2016, (excursion day unspecified), the VAQTA (lot # L009445, expiration date 01-JUN-2017) was stored in 8.1 Celsius degrees for 45 minutes. Total time out of range was 120 hours, 45 minutes. There were no previous excursions. Information was received from Digital Data Logger. On 27-SEP-2016, and on 07-OCT-2016, an unspecified patients were vaccinated with a improperly stored doses of VAQTA lot # L009445, expiration date 01-JUN-2017 (dose, route of administration were not reported) for an unspecified indication. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates approximately in November 2016, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M007307, expiration date 30-NOV-2017, lot # M007311, expiration date 30-NOV-2017, lot # M007298, expiration date 19-NOV-2017 and lot # M019691, expiration date 02-NOV-2017 (dose was not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of ROTATEQ were stored in the temperature of 47.7 degrees Fahrenheit for 45 minutes on 18-NOV-2016, then in the temperature of 47.5 degrees Fahrenheit for 15 minutes, in the temperature of 48.4 degrees Fahrenheit for 30 minutes and in the temperature of 31.6 degrees Fahrenheit for 5.5 hours (1 cycle) on 19-NOV-2016, then in the temperature of 29.7 degrees Fahrenheit for 11 hours (1 cycle) and in the temperature of 33.4 degrees Fahrenheit for 15 minutes (1 cycle) on 20-NOV-2016. Data logger was involved. There were no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 25-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a multiple unspecified patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates between August 2016 and November 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M004116 with expiration date 12-OCT-2017 (dose, route of administration and anatomical locations were not reported). No adverse effect was reported. Administered doses of GARDASIL 9 experienced temperature excursion of 0 degrees Celsius for 285 hours and 20 minutes in August 2016, 285 hours and 20 min in September 2016, 223 hours and 20 minutes in October 2016 and 200 hours in November 2016. There was no previous temperature excursion. Digital data logger was involved. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has requested.
Age: 1.3
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-OCT-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a multiple unspecified patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates between August 2016 and November 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M023718 with an expiration date 09-AUG-2016 (strength, doses, route of administration and anatomical location were not reported). No adverse effect was reported. Administered doses of RECOMBIVAX HB experienced temperature excursion of 0 degrees Celsius for 285 hours and 20 minutes in August 2016, 285 hours an 20 min in September 2016, 223 hours and 20 minutes in October 2016 and 200 hours in November 2016. There was no previous temperature excursion. Digital data logger was involved. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 2 year old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 18-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 17-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates approximately in November 2016, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # M027879, expiration date 24-JAN-2018, LOT #M036459, expiration date 18-JAN-2018 and lot # M001815, expiration date 20-SEP-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of VAQTA were stored in the temperature of 47.7 degrees Fahrenheit for 45 minutes of 18-NOV-2016, then in the temperature of 47.5 degrees Fahrenheit for 15 minutes, in the temperature of 48.4 degrees Fahrenheit for 30 minutes and in the temperature of 31.6 degrees Fahrenheit for 5.5 hours (1 cycle) on 19-NOV-2016, then in the temperature of 29.7 degrees Fahrenheit for 11 hours (1 cycles) and in the temperature of 33.4 degrees Fahrenheit for 15 minutes (1 cycle) on 20-NOV-2016. Data logger was involved. There were no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an 18 year old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 18-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of GARDASIL 9 lots # M007764 and M013636 with expiration dates 30-JAN-2018 and 15-FEB-2018 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. Temperature: 35F. Time frame: 12 hours. There was a call because of a data logger. There was no a previous temperature excursion. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 2 year old patient of unknown gender. There was  no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 22-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported). This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 2 year old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 17-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 18-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot reported as M005921; expiration date, site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 16 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 24-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # reported as M005921; expiration date, site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Blood thyroid stimulating hormone, Dyspnoea, Fatigue, Full blood count
Clinical narrative: Muscle aches and pains day after shot fatigue and weakness x 3 weeks SOB still ongoing.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Metabolic function test, Myalgia, Thyroxine free
Clinical narrative: Muscle aches and pains day after shot fatigue and weakness x 3 weeks SOB still ongoing.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates approximately in November 2016, the patients were vaccinated with improperly stored doses of M-M-R II injection, lot # L043703, expiration date 03-NOV-2017, lot # M007277, expiration date 09-FEB-2018, lot # reported as M017347, expiration date 06-APR-2018 and lot # L041457, expiration date 22-OCT-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of M-M-R II were stored in the temperature of 47.7 degrees Fahrenheit for 45 minutes on 18-NOV-2016, then in the temperature of 47.5 degrees Fahrenheit for 15 minutes, in the temperature of 48.4 degrees Fahrenheit for 30 minutes and in the temperature of 31.6 degrees Fahrenheit for 5.5 hours (1 cycle) on 19-NOV-2016, then in the temperature of 29.7 degrees Fahrenheit for 11 hours (1 cycle) and in the temperature of 33.4 degrees Fahrenheit for 15 minutes (1 cycle) on 20-NOV-2016. Data logger was involved. There were no previous temperature excursions 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 healthcare worker and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concomitant medication were not reported. On 02-NOV-2016 or 03-NOV-2016, the patients were vaccinated with a dose of improperly stored ROTATEQ, route of administration defaulted to oral (dose, frequency, lot# and expiration date were not reported). There was no adverse effect reported. The call was made due to digital data logger. The dose of the administered vaccine was exposed to temperature of 9.5 degrees Celsius for 28 hours. The vaccine was exposed to previous temperature excursion. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-NOV-2016, the patient was vaccinated with an expired dose of M-M-R II injection, therapy type: rHA, lot # K021952 (expiry date: 10-NOV-2016), subcutaneously (dose not reported). The patient had not reported an adverse experience. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 23-SEP-2016, the patient was vaccinated with GARDASIL 9 (dose, lot# and expiration date unknown) intramuscularly. On 28-OCT-2016, the patient was vaccinated with GARDASIL 9 (dose, lot# and expiration date unknown) intramuscularly. On 23-NOV-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose unknown, lot # M028323, expiration date: 26-SEP-2018) intramuscularly. No adverse effects were reported. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Pain at site and through entire arm including hand. Entire upper arm pink, warm, swollen. Pt with low grade T-100.7.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Pain at site and through entire arm including hand. Entire upper arm pink, warm, swollen. Pt with low grade T-100.7.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a consumer refers to his 11 years old son. In June 2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route and lot # not reported). Concomitant therapies included BOOSTRIX and MENACTRA. The patient's dad reported that almost immediately after all three vaccines were administered in June 2016, the patient experienced nausea and vomited for "about 10 minutes". The patient did not seek medical attention and did not received treatment for the adverse events. There were no Lab/diagnosis or studies performed. The patient's dad also reported that his son had the second dose of GARDASIL 9 (route, dose and lot # not reported) "a while ago" and he did not experience any kind of illness at all. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Joint swelling, Pyrexia, Urticaria, Viral infection
Clinical narrative: Information has been received from a physician referring to a 12 year old female patient. Information about concurrent condition, medical history and drug reactions/allergies were not provided. On 15-JUL-2014, the patient vaccinated with a first dose of GARDASIL (dose and route were unknown, lot # H020901, expiration date 05-JUL-2015) and VAQTA (dose and route were unknown, lot # J014584, expiration date 16-JAN-2016). No adverse effect was reported. On 17-SEP-2014, the patient vaccinated with a second dose of GARDASIL (dose and route were unknown, lot # K006095, expiration date 02-FEB-2016). On appropriately 08-OCT-2014 (reported as 3 weeks after administration), the patient had hives, joint swelling and urticarial with a fever. The patient saw at an unspecified allergist office on an unknown date and then at a medical institution on an unspecified date for treatment. Physician stated that the diagnosis was "post viral" and "not related to GARDASIL". The outcome of the aforementioned events was not provided. On 10-AUG-2016, the patient vaccinated with a third dose of GARDASIL (dose and route were unknown, lot # L020015, expiration date 16-AUG-2017) (drug use for unapproved schedule) and VAQTA (dose and route were unknown, lot # L023936, expiration date 15-MAR-2017) (drug use for unapproved schedule). On appropriately 31-AUG-2016 (reported as 3 or 4 weeks after administration), the patient had hives and joint swelling. The outcome of the hives and joint swelling (onset date of 31-AUG-2016) was unknown. The causality assessments between the events (onset date of 31-AUG-2016) and GARDASIL and VAQTA were not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On 31-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that on an unknown date after receiving ZOSTAVAX, the patient was seen by a physician and was prescribed an unspecified steroid for an unspecified reason. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red, sore and swollen last night at bedtime. Pt came in today with the same symptoms.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Clostridium test positive, Haematochezia, Occult blood positive, Ultrasound abdomen normal, White blood cell count increased
Clinical narrative: Bloody stools that started the night of vaccines on 11/29/16. Still occurring on 11/22/16. I saw her at office, then sent her to ER. Ultrasound negative for intussusception.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Child was too old for vaccine (over 6).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Blood cholesterol normal, Death, Feeling hot, Full blood count normal, Malaise
Clinical narrative: I spoke with my mother 11/12/2014 at 5:16 PM and she informed me that she was feeling ill since she received the Flu Vaccine and approximately 9 hours after that conversation she called out to my father, said she was feeling hot with a high fever, pulled her night gown off walked to the kitchen; tried drinking some water, vomited, sat down on the sofa, my dad then went to get her clothing to bring her to the hospital and she stopped breathing. He called 911 and performed CPR. Paramedics arrived and brought her to ER where she expired.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory arrest, Resuscitation, Smooth muscle antibody negative, Vomiting
Clinical narrative: I spoke with my mother 11/12/2014 at 5:16 PM and she informed me that she was feeling ill since she received the Flu Vaccine and approximately 9 hours after that conversation she called out to my father, said she was feeling hot with a high fever, pulled her night gown off walked to the kitchen; tried drinking some water, vomited, sat down on the sofa, my dad then went to get her clothing to bring her to the hospital and she stopped breathing. He called 911 and performed CPR. Paramedics arrived and brought her to ER where she expired.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Mobility decreased, Rotator cuff syndrome
Clinical narrative: Right after the shot I started having pain in my shoulder (left) and by 4 hrs later could not raise my arm from the shoulder. I saw my primary Dr on 10-25-16. The X-ray on 10-26-16 the MRI on 11-1-16 then orthopedic on 11-18-16 and have order for physical therapy. They all say the shot was given in the wrong place, way too high on back of shoulder.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, X-ray limb
Clinical narrative: Right after the shot I started having pain in my shoulder (left) and by 4 hrs later could not raise my arm from the shoulder. I saw my primary Dr on 10-25-16. The X-ray on 10-26-16 the MRI on 11-1-16 then orthopedic on 11-18-16 and have order for physical therapy. They all say the shot was given in the wrong place, way too high on back of shoulder.
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Allergy to vaccine
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of allergic reaction in a 61-year-old female patient who received Flu Seasonal TIV Dresden (influenza vaccine). Concurrent medical conditions included drug allergy (Aspirin, Depakote, Doxepin, FLEXERIL, Nefazodone, NEXIUM, Nonsteroidal anti-inflammatory agent, Oxycontin, PAXIL, Risperidone, Trazodone, ZOFRAN, ZOLOFT). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received inactivated influenza vaccine and experienced unknown allergic reaction. This case has been linked with case US2016GSK167086 for drug allergies experienced by the patient.
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of allergic reaction in a 61-year-old female patient who received Flu Seasonal TIV Dresden (influenza vaccine). Concurrent medical conditions included drug allergy (Aspirin, Depakote, Doxepin, FLEXERIL, Nefazodone, NEXIUM, Nonsteroidal anti-inflammatory agent, Oxycontin, PAXIL, Risperidone, Trazodone, ZOFRAN, ZOLOFT). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received inactivated influenza vaccine and experienced unknown allergic reaction. This case has been linked with case US2016GSK167086 for drug allergies experienced by the patient.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB, FLU4, MENB
Symptoms: Chills, Eye swelling, Fatigue, Pyrexia
Clinical narrative: Initial unsolicited case received from a nurse on 21 Nov 2016. This case involves a 17 year old male patient who was vaccinated with fifth dose of FLUZONE QIV (Batch number: UT5598JA, Expiry date: 30 Jun 2017, route of administration was not reported) in right deltoid and first dose of TRUMEMBA (Batch number, expiry date, route of administration was not reported) in left deltoid on 08 Nov 2016. The patient illness at the time of vaccination, birth defects was reported as none and the patient has ibuprofen drug allergy, and any other vaccinations within four weeks of vaccinations was reported as none. The patient's other concomitant medications were not reported. On 08 Nov 2016 in the evening, same day after receiving the vaccine, the patient developed swollen eyes, scratchy throat, fever and fatigue. Lab tests was reported as none. It was reported as the patient mother gave CLARITIN for the swollen eyes but, never called or sought medical treatment for the patient. On an unknown date, four days after event onset, the patient was recovered from events. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB, FLU4, MENB
Symptoms: Activities of daily living impaired, Chills, Eye swelling, Fatigue, Pyrexia
Clinical narrative: Initial unsolicited case received from a nurse on 21 Nov 2016. This case involves a 17 year old male patient who was vaccinated with fifth dose of FLUZONE QIV (Batch number: UT5598JA, Expiry date: 30 Jun 2017, route of administration was not reported) in right deltoid and first dose of TRUMEMBA (Batch number, expiry date, route of administration was not reported) in left deltoid on 08 Nov 2016. The patient illness at the time of vaccination, birth defects was reported as none and the patient has ibuprofen drug allergy, and any other vaccinations within four weeks of vaccinations was reported as none. The patient's other concomitant medications were not reported. On 08 Nov 2016 in the evening, same day after receiving the vaccine, the patient developed swollen eyes, scratchy throat, fever and fatigue. Lab tests was reported as none. It was reported as the patient mother gave CLARITIN for the swollen eyes but, never called or sought medical treatment for the patient. On an unknown date, four days after event onset, the patient was recovered from events. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB, FLU4, MENB
Symptoms: Throat irritation
Clinical narrative: Initial unsolicited case received from a nurse on 21 Nov 2016. This case involves a 17 year old male patient who was vaccinated with fifth dose of FLUZONE QIV (Batch number: UT5598JA, Expiry date: 30 Jun 2017, route of administration was not reported) in right deltoid and first dose of TRUMEMBA (Batch number, expiry date, route of administration was not reported) in left deltoid on 08 Nov 2016. The patient illness at the time of vaccination, birth defects was reported as none and the patient has ibuprofen drug allergy, and any other vaccinations within four weeks of vaccinations was reported as none. The patient's other concomitant medications were not reported. On 08 Nov 2016 in the evening, same day after receiving the vaccine, the patient developed swollen eyes, scratchy throat, fever and fatigue. Lab tests was reported as none. It was reported as the patient mother gave CLARITIN for the swollen eyes but, never called or sought medical treatment for the patient. On an unknown date, four days after event onset, the patient was recovered from events. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB, FLU4, MENB
Symptoms: Eye swelling, Fatigue, Pyrexia, Throat irritation
Clinical narrative: Initial unsolicited case received from a nurse on 21 Nov 2016. This case involves a 17 year old male patient who was vaccinated with fifth dose of FLUZONE QIV (Batch number: UT5598JA, Expiry date: 30 Jun 2017, route of administration was not reported) in right deltoid and first dose of TRUMEMBA (Batch number, expiry date, route of administration was not reported) in left deltoid on 08 Nov 2016. The patient illness at the time of vaccination, birth defects was reported as none and the patient has ibuprofen drug allergy, and any other vaccinations within four weeks of vaccinations was reported as none. The patient's other concomitant medications were not reported. On 08 Nov 2016 in the evening, same day after receiving the vaccine, the patient developed swollen eyes, scratchy throat, fever and fatigue. Lab tests was reported as none. It was reported as the patient mother gave CLARITIN for the swollen eyes but, never called or sought medical treatment for the patient. On an unknown date, four days after event onset, the patient was recovered from events. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MENB, TDAP, MENB, TDAP
Symptoms: Pain in extremity, Wrong drug administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 11-year-old female patient who received BEXSERO (batch number 158701A, expiry date 30th September 2017). Concomitant products included BOOSTRIX. On 17th November 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 17th November 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain and wrong vaccine administered. On an unknown date, the outcome of the injection site pain and wrong vaccine administered were unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The medical assistant reported that a dose of BEXSERO was inadvertently administered to the patient instead of MENVEO. Thus, it led to an administration of wrong vaccine. On the same day, the patient received 1st dose of BOOSTRIX intramuscularly on left arm concomitantly. The medical assistant reported that the patient's right arm was sore at the site of the BEXSERO injection. The medical assistant's call was transferred to GlaxoSmithKline Biological's medical information department requesting for additional medical information. The reported lot number (G522H) for BOOSTRIX did not exist and was updated to GS22H, according to sales database.
Age: 11.0
Sex: F
Vaccine: MENB, TDAP, MENB, TDAP
Symptoms: Injection site pain, Wrong drug administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 11-year-old female patient who received BEXSERO (batch number 158701A, expiry date 30th September 2017). Concomitant products included BOOSTRIX. On 17th November 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 17th November 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain and wrong vaccine administered. On an unknown date, the outcome of the injection site pain and wrong vaccine administered were unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The medical assistant reported that a dose of BEXSERO was inadvertently administered to the patient instead of MENVEO. Thus, it led to an administration of wrong vaccine. On the same day, the patient received 1st dose of BOOSTRIX intramuscularly on left arm concomitantly. The medical assistant reported that the patient's right arm was sore at the site of the BEXSERO injection. The medical assistant's call was transferred to GlaxoSmithKline Biological's medical information department requesting for additional medical information. The reported lot number (G522H) for BOOSTRIX did not exist and was updated to GS22H, according to sales database.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling
Clinical narrative: PATIENT DESCRIBED A BASEBALL SIZE BUMP ON THE INNER PART OF HER UPPER ARM.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Oropharyngeal pain, Pruritus, Vomiting
Clinical narrative: Itching, sore throat, nausea, and vomiting 30 minutes after influenza shot. Visited ED and received prednisone 60 mg, Benadryl 50 mg, and famotidine 20 mg all orally. Symptoms resolved.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Angiogram normal, Cardiac stress test normal, Chest discomfort, Computerised tomogram head normal, Computerised tomogram thorax normal
Clinical narrative: 15 minutes after receiving influenza vaccine, patient became dizzy, non-excruciating headache, and lightheaded. Patient had sudden onset of pallor and pre-syncope. She developed significant nausea and substernal non-radiating chest pressure. Symptoms indicated that this was a vasovagal event. Patient had systolic blood pressure 90 and heart rate between 50-60s. Patient taking propranolol for migraine prophylaxis and medication was discontinued.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Echocardiogram normal, Electrocardiogram QT prolonged, Electrocardiogram ST-T change, Electrocardiogram T wave abnormal
Clinical narrative: 15 minutes after receiving influenza vaccine, patient became dizzy, non-excruciating headache, and lightheaded. Patient had sudden onset of pallor and pre-syncope. She developed significant nausea and substernal non-radiating chest pressure. Symptoms indicated that this was a vasovagal event. Patient had systolic blood pressure 90 and heart rate between 50-60s. Patient taking propranolol for migraine prophylaxis and medication was discontinued.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, High density lipoprotein decreased, Low density lipoprotein increased, Nausea, Pallor
Clinical narrative: 15 minutes after receiving influenza vaccine, patient became dizzy, non-excruciating headache, and lightheaded. Patient had sudden onset of pallor and pre-syncope. She developed significant nausea and substernal non-radiating chest pressure. Symptoms indicated that this was a vasovagal event. Patient had systolic blood pressure 90 and heart rate between 50-60s. Patient taking propranolol for migraine prophylaxis and medication was discontinued.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Presyncope
Clinical narrative: 15 minutes after receiving influenza vaccine, patient became dizzy, non-excruciating headache, and lightheaded. Patient had sudden onset of pallor and pre-syncope. She developed significant nausea and substernal non-radiating chest pressure. Symptoms indicated that this was a vasovagal event. Patient had systolic blood pressure 90 and heart rate between 50-60s. Patient taking propranolol for migraine prophylaxis and medication was discontinued.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Abasia, Arthralgia, Bone pain, Headache, Myalgia
Clinical narrative: Pain in muscles, pain in bones, fever, headache, pain on knees and legs, can't walk.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pain in muscles, pain in bones, fever, headache, pain on knees and legs, can't walk.
Sex: F
Vaccine: HPV4, MMR
Symptoms: Chemotherapy, Laboratory test, Ovarian germ cell teratoma
Clinical narrative: This spontaneous report was received from a nurse refers to an adult female patient of unknown age. The patient's current condition included asthma. There were no medical history, drug reactions/allergies and concomitant medications reported. On unknown dates prior to 2015, the patient was vaccinated with GARDASIL and M-M-R II (dosing details not provided). Approximately in May 2015, the patient was diagnosed with immature ovarian teratoma. Nurse reported that the patient was seen and treated by unspecified healthcare providers, and had several unspecified lab/diagnostic testing at unspecified locations on unspecified dates. The patient required medical attention and was treated with six rounds of chemotherapy with several medications including cisplatin, etoposide and bleomycin. However, the patient was not hospitalized. Nurse stated that the patient was incapacitated for an unspecified reason for an unspecified amount of time after an unspecified treatment for immature ovarian teratoma. Outcome of the event was reported as not recovered. Nurse reported that it was decided to re-vaccinate the patient with M-M-R II on unspecified date in September or October 2016, due to possible effect of chemotherapy treatment on the immunity of measles, mumps and rubella. It was unknown whether the patient was re-vaccinated or not. Reporting nurse had not assessed the causality of the event with respect to both vaccines, GARDASIL and M-M-R II. Nurse considered the event to serious due to disability. Upon internal review, the event immature ovarian teratoma was considered to be medically significant. Additional information has been requested.