chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 03-JUN-2016, the patient was vaccinated with improperly store ROTATEQ (dose and frequency were not reported). The reporter did not know which dose from which lot was administered to the patient and the possible ROTATEQ lot# administered was: lot # L029618 (expiry date: 20-MAY-2017), L038534 (expiry date: 19-AUG-2017) and/or M004508 (expiry date: 29-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patient received a dose of ZOSTAVAX (dose, frequency and route unknown). No concomitant therapy was reported. On an unknown date after receiving the dose of ZOSTAVAX, the patient developed shingles. The outcome of the event was unknown. The causality was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Concurrent or historical condition were not provided. On unknown dates the patients received improperly stored doses of GARDASIL 9 (lot # M004116 with expired date of 12-OCT-2017, lot # L024993 with expired date of 17-OCT-2017, dose and route unknown). Concomitant therapy was not provided. The vaccines were stored under 33F for 1 hour (6 cycles, 10 minutes each cycle). Storage temperature had been back in range. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. This is one of 2 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Concurrent or historical condition was not provided. On unknown dates the patients received improperly stored doses of PEDVAXHIB (lot # L051123 with expired date of 13-OCT-2018, lot # M001813 with expired date of 14-OCT-2018, lot # L042258 with expired date of 18-AUG-2018, dose and route unknown). Concomitant therapy was not provided. The vaccines were stored under 33F for 1 hour (6 cycles, 10 minutes each cycle). Storage temperature had been back in range. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. This is one of 2 reports receiving from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative and refers to a 20 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates in 2010, the patient completed 3 doses of GARDASIL (doses, lots# and expiration dates were not reported). It was reported that on an unknown date in May 2016 (reported as a month ago), the patient forgot they had completed GARDASIL series, and received the first dose of GARDASIL 9 (dose, lot# and expiration date were not reported) inadvertently. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, and unspecified number of patients received doses of improperly stored ROTATEQ (lot # L042215, expired 02-JUN-2017) (dose and frequency were unknown). The vaccine was exposed under 33F for 15 hours. There was no previous exposures. No adverse effect was reported.  Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: This spontaneous report was received from a pharmacy technician, referring to a 67 year old male patient. The patient had no pertinent medical history or drug reactions/allergies to be reported. On 08-JUN-2016, the patient was vaccinated with 0.65 ml of ZOSTAVAX lot # L046897, expiration date 23-FEB-2017, subcutaneous (dose number not reported). The patient was on unspecified concomitant medications. On 22-JUN-2016, the patient went into the pharmacy and reported that he had been experienced generalized muscle aches and joint pain, as well as headaches since an unspecified date of June 2106, after receiving the vaccine. No treatment was given for the events. No laboratories were performed. At the time of the report, the patient had not recovered from the events. The relatedness between generalized muscle aches, joint pain and headaches and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered vaccine experienced the temperature excursion of 8.2 degrees Fahrenheit for 22 hours. Data logger was involved. The previous excursions were as follows: on 14-MAY-2016 6 degrees Fahrenheit for 1.5 hours, on 20-MAY-2016 5.9 degrees Fahrenheit for 5.5 hours, on 08-JUN-2016, 6.9 degrees Fahrenheit for 3 hours, 50 minutes, on 09-JUN-2016 8.2 degrees Fahrenheit for 9 hours, 50 minutes, on 10-JUN-2016 6.6 degrees Fahrenheit for 1 hour, 50 minutes. The freezer returned to proper range in between all excursions. 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 a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-MAY-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered vaccine experienced the temperature excursion of 6 degrees Fahrenheit for 1.5 ours on 14-MAY-2016. Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-MAY-2016, the patient was vaccinated with improperly stored M-M-R II lot # reported as L027434, expiry date 22-JUL-2017, (dose, route and site of administration were not reported. No adverse effect were reported. Administered vaccine experienced the temperature excursion of 6 degrees Fahrenheit for 1.5 hours on 14-MAY-2016. Data logger was involved. This is one of several reports received from the same source. 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 medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dose, route and site of administration were not reported) and M-M-R II lot # reported as L027434, expiry date 22-JUL-2017 (dose, route and site of administration were not reported) for the same indication. No adverse effects were reported. Administered vaccines experienced the temperature excursion of 6 degrees Fahrenheit for 1.5 hours. Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist regarding to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX lot #, dosing details unknown. Concomitant medications were not reported. On an unknown date, the patient diagnosed with shingles. The outcome of shingles was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. This is one of the two 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 medical assistant 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 an unknown dates, the patients were vaccinated with an improperly stored dose of VAQTA injection (lot # L009521, expiration date 28-APR-2017, reported as lot# M003025 with expiration date 26-MAY-2017, lot# L023936 with expiration date 15-MAY-2017, lot# L032749 with expiration date 04-NOV-2016, dose, anatomical location and route of administration were not reported). The vaccine was exposed to 4 hours and 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour and 30 minutes at 51.3 F, also 2 hours at 56.3 F on the seventh of April (year unspecified) and 1 hours at 51.6 F, also 1 hours and 30 minutes on the sixth of May (year unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: This solicited report, was received from the patient's mother, referring to a 14 year old female patient as part of the market research program. The patient had no concurrent conditions or medical history. She was otherwise healthy. In spring 2015, the patient was vaccinated with the first dose of GARDASIL 9 (70mg, lot # and anatomical location were not reported). On an unspecified date on 2015, the patient was vaccinated with the second dose of GARDASIL 9 (lot # and anatomical location were not reported). It was reported that the patient only received 2 out of the 3 recommended doses of the vaccine (Drug use for unapproved schedule). The series of vaccination stopped in Summer 2015. Additional information is not expected since there is no consent to contact the reporter nor the doctor.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding an unspecified number of patients of unknown age and gender. Information on the concurrent condition, pertinent medical history and drug allergies of the patients were not reported. On unspecified dates the patients were vaccinated with improperly stored VAQTA (lot L023936, expiry date 15-MAR-2017, lot/batch # M011839, expiry date 13-SEP-2017, or an unspecified lot and expiry date) (dose number, dose units, route and anatomical location were not reported) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complain (PQC). 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 nurse practitioner regarding an unspecified number of patients of unknown age and gender. Information on the concurrent condition, pertinent medical history and drug allergies of the patients were not reported. On an unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot# L046318, expiry date 28-SEP-2017 or an unspecified lot and expiry date) (dose number, dose units, route and anatomical location were not reported). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complaint (PQC) involved. This one of the reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 2 month old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On 18-JUN-2016, the patient was inadvertently vaccinated with and expired dose of ROTATEQ orally, expiry date 12-JUN-2016 (Lot number, dose were not reported). Concomitant therapies were not provided. No adverse effect was 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 nurse practitioner regarding an unspecified number of patients of unknown age and gender. Information on the concurrent condition, pertinent medical history and drug allergies of the patients were not reported. On an unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot# L019836, expiry date 24-MAR-2017) (dose number, dose units, route and anatomical location were not reported). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complaint (PQC) involved. This one of the reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse and refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, vaccines of VARIVAX (which had a lot # K015970, expiry date on 23-SEP-2016, exact doses and route of administration were not reported), were improperly stored as the freezer was out of range on and off since February 2016. Other doses of VARIVAX which had a lot # L028275 with expiration date on 28-JUL-2017; Lot # L038132 expiration date on 01-OCT-2017; Lot # L029466 expiration date on 06-AUG-2017. Nevertheless, no symptoms were reported. The vaccines experienced the following temperature excursions during 50 minutes: 7.8 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the 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 was received from a Nurse and refers to improperly stored products which had not been administered. On unknown dates, vaccines of VARIVAX (which had a lot # K015970, expiry date on 23-SEP-2016, exact doses and route of administration were not reported), were improperly stored as the freezer was out of range on an off since 06-JUN-2016. Other doses of VARIVAX which had lot # L028275 with expiration date on 28_JUL-2016, Lot # L038132 expiration date on 01-OCT-2017, Lot # L029466 expiration date on 06-AUG-2017. Nevertheless, no symptoms were reported. The vaccines experienced the following temperature excursion during 48 hours (2 days): 10 grades Fahrenheit. Reportedly, there had been previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same source. Additional information had been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse and refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, vaccines of PROQUAD (which had a lot # L031602, expiry date on 18-FEB-2017, exact doses and route of administration were not reported), were improperly stored as the freezer was out of range on an off since February 2016. Other doses of PROQUAD which had a lot # L040415 with expiration date on 13-APR-2017; Lot # L021601 expiration date on 10-DEC-2017. Nevertheless, no symptoms were reported. The vaccines experienced the following temperature excursions during 50 minutes: 7.8 grade Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient or patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date in June 2016 (reported as on unspecified dates since last week), the patient or patients were vaccinated with two dose of improperly stored GARDASIL lot # L040459, expiration date 16-APR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 33.5 degrees Fahrenheit for 28 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date in June 2016 (reported as on unspecified date since last week), the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 lot # L040181, expiration date 18-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33.5 degrees Fahrenheit for 28 minutes. Data logger was involved. There were no previous excursions reported. 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 was received from a Nurse and refers to improperly stored products which had not been administered. On unknown dates, vaccines of PROQUAD (which had a lot # L031602, expiry date on 18-FEB-2017, exact doses and route of administration were not reported), were improperly stored as the freezer was out of range on and off since 06-JUN-2016. Other doses of PROQUAD which had a lot # L040415 with expiration date on 13-APR-2017; Lot # L021601 expiration date on 10-DEC-2016. Nevertheless, no symptoms were reported. The vaccines experienced the following temperature excursions during 48 hours (2 days): 10 grades Fahrenheit. Reportedly, there were previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same source. 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 medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date in June 2016 (reported as on unspecified date since last week), the patient was vaccinated with one dose of improperly stored RECOMBIVAX HB lot # L027733, expiration date 13-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33.5 degrees Fahrenheit for 28 minutes. Data logger was involved. There were no previous 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 as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date in June 2016 (reported as on unspecified date since last week), the patient was vaccinated with one dose of ROTATEQ lot # M014544, expiration date 27-NOV-2017, oral route of administration (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33.5 degrees Fahrenheit for 28 minutes. Data logger was involved. There was no previous excursions 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 medical assistant refers to a patient or patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date in June 2016 (reported as on unspecified dates since last week), the patient or patients were vaccinated with two doses of improperly stored VAQTA lot # M009377, expiration date 17-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 33.5 degrees Fahrenheit for 28 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 32 years old female patient with drug allergies to sulfa drugs. The patient had no pertinent medical history. On 10-JUN-2016 the patient was vaccinated with VARIVAX (Lot #, expiration date, dose, and the frequency were unspecified), subcutaneously. There was no concomitant therapy. On an unknown date in June 2016, the patient experienced unspecified abdominal pain and the patient was seen in the office on 20-JUN-2016 for the event. A "urine pregnancy test" was performed which came back as positive. The patient became pregnant with last menstrual period (LMP) of 17-MAY-2016 and estimated date of delivery (EDD) of 21-FEB-2017. No treatment was given for the events. The pregnancy outcome was pending. The outcome of abdominal pain was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Red, swollen, hot area in arm vaccine administered, lasted about 5 days, then resolved on own.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Clonus, Demyelination, Fall, Gait disturbance, Lumbar puncture normal
Clinical narrative: 2-3 days after flu vaccination I developed bilateral tingling of hands and feet. It was more pronounced when flexing my neck. In past few years R leg lost muscle mass. I began tripping and falling which has worsened in past 6 months. I returned to see my neurologist. I have weakness in my R leg. I also have developed R foot drop and clonus of my R foot. I was fitted with an AFO on my R leg which helps some. The PT company suggests I try a stimulator which will make my foot raise as I walk. The condition has caught up to me over the years apparently. I had a MRI in 2001 that showed a C-5 transverse myelitis. I had a rpt brain, CX and thoracic spine MRI done in the past few months that showed some residual remnant of the cervical myelitis from 2001.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle atrophy, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: 2-3 days after flu vaccination I developed bilateral tingling of hands and feet. It was more pronounced when flexing my neck. In past few years R leg lost muscle mass. I began tripping and falling which has worsened in past 6 months. I returned to see my neurologist. I have weakness in my R leg. I also have developed R foot drop and clonus of my R foot. I was fitted with an AFO on my R leg which helps some. The PT company suggests I try a stimulator which will make my foot raise as I walk. The condition has caught up to me over the years apparently. I had a MRI in 2001 that showed a C-5 transverse myelitis. I had a rpt brain, CX and thoracic spine MRI done in the past few months that showed some residual remnant of the cervical myelitis from 2001.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Peroneal nerve palsy
Clinical narrative: 2-3 days after flu vaccination I developed bilateral tingling of hands and feet. It was more pronounced when flexing my neck. In past few years R leg lost muscle mass. I began tripping and falling which has worsened in past 6 months. I returned to see my neurologist. I have weakness in my R leg. I also have developed R foot drop and clonus of my R foot. I was fitted with an AFO on my R leg which helps some. The PT company suggests I try a stimulator which will make my foot raise as I walk. The condition has caught up to me over the years apparently. I had a MRI in 2001 that showed a C-5 transverse myelitis. I had a rpt brain, CX and thoracic spine MRI done in the past few months that showed some residual remnant of the cervical myelitis from 2001.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Bursitis, Injected limb mobility decreased, Muscle spasms, Nuclear magnetic resonance imaging abnormal, Periarthritis
Clinical narrative: 3 hours from getting vaccine in my right shoulder, I wasn't able to move my right shoulder. Range of motion. My shoulder was going into muscle spasms. Had MRI done results frozen shoulder, tendinitis, bursitis had several cortisone shot and physical therapy.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Tendonitis
Clinical narrative: 3 hours from getting vaccine in my right shoulder, I wasn't able to move my right shoulder. Range of motion. My shoulder was going into muscle spasms. Had MRI done results frozen shoulder, tendinitis, bursitis had several cortisone shot and physical therapy.
Age: 63.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Inflammation, Injection site injury, Mobility decreased
Clinical narrative: Pain immediately and increasing in intensity over several weeks. Unable to use arm. Unable to sleep. Cortisone injection provided 6 weeks relief. Pain returned. Arm mobility very limited. MRI shows torn infraspinatus tendon (at site of injection) and bursitis. Surgery recommended. Trying physical therapy.
Age: 63.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Bursitis, Immediate post-injection reaction, Injection site reaction, Insomnia, Mobility decreased
Clinical narrative: Pain immediately and increasing in intensity over several weeks. Unable to use arm. Unable to sleep. Cortisone injection provided 6 weeks relief. Pain returned. Arm mobility very limited. MRI shows torn infraspinatus tendon (at site of injection) and bursitis. Surgery recommended. Trying physical therapy.
Age: 63.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Tendon rupture, X-ray
Clinical narrative: Pain immediately and increasing in intensity over several weeks. Unable to use arm. Unable to sleep. Cortisone injection provided 6 weeks relief. Pain returned. Arm mobility very limited. MRI shows torn infraspinatus tendon (at site of injection) and bursitis. Surgery recommended. Trying physical therapy.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Erythema, Furuncle, Lymphadenopathy, Pain
Clinical narrative: Cellulitis of chest wall.  Labs - blood culture, CBC with Diff, CRP, CMP, would culture, ESR, lactate. Meds: TYLENOL or MOTRIN; hydrocodone 5 mg, BACTRIM 800 mg; clindamycin 300 mg.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Blood culture, Blood lactic acid, C-reactive protein, Cellulitis, Culture wound
Clinical narrative: Cellulitis of chest wall.  Labs - blood culture, CBC with Diff, CRP, CMP, would culture, ESR, lactate. Meds: TYLENOL or MOTRIN; hydrocodone 5 mg, BACTRIM 800 mg; clindamycin 300 mg.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Differential white blood cell count, Full blood count, Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Cellulitis of chest wall.  Labs - blood culture, CBC with Diff, CRP, CMP, would culture, ESR, lactate. Meds: TYLENOL or MOTRIN; hydrocodone 5 mg, BACTRIM 800 mg; clindamycin 300 mg.
Age: 1.42
Sex: M
Vaccine: HIBV, DTAP, HIBV, IPV, PNC13
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Refrigerator temperature excursion.
Age: 1.42
Sex: M
Vaccine: HIBV, DTAP, HIBV, IPV, PNC13
Symptoms: Incorrect product storage
Clinical narrative: Refrigerator temperature excursion.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Fatigue, Myalgia, Nausea, Pruritus
Clinical narrative: Onset of symptoms within 24 hrs., rash on trunk 100.3 fever, general malaise, presented at urgent care on 6/4/16, rash bilateral, thought to be chickenpox, titer done, no results at this pint, prescript for antiviral. 6/9 follow up call. Chicken-pox dx verified. Pox not spreading. Starting to subside. 1 more day on anti-viral medication. Side effects still persisting. Nausea and dehydration, recommended visit to primary car for follow-up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Varicella virus test
Clinical narrative: Onset of symptoms within 24 hrs., rash on trunk 100.3 fever, general malaise, presented at urgent care on 6/4/16, rash bilateral, thought to be chickenpox, titer done, no results at this pint, prescript for antiviral. 6/9 follow up call. Chicken-pox dx verified. Pox not spreading. Starting to subside. 1 more day on anti-viral medication. Side effects still persisting. Nausea and dehydration, recommended visit to primary car for follow-up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Dehydration, Malaise, Nausea, Pyrexia
Clinical narrative: Onset of symptoms within 24 hrs., rash on trunk 100.3 fever, general malaise, presented at urgent care on 6/4/16, rash bilateral, thought to be chickenpox, titer done, no results at this pint, prescript for antiviral. 6/9 follow up call. Chicken-pox dx verified. Pox not spreading. Starting to subside. 1 more day on anti-viral medication. Side effects still persisting. Nausea and dehydration, recommended visit to primary car for follow-up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Varicella
Clinical narrative: Onset of symptoms within 24 hrs., rash on trunk 100.3 fever, general malaise, presented at urgent care on 6/4/16, rash bilateral, thought to be chickenpox, titer done, no results at this pint, prescript for antiviral. 6/9 follow up call. Chicken-pox dx verified. Pox not spreading. Starting to subside. 1 more day on anti-viral medication. Side effects still persisting. Nausea and dehydration, recommended visit to primary car for follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Fever, flu symptoms, neck pain, back blisters lower back to neck headache constipation, muscles aches, itching.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Constipation, Headache, Influenza, Myalgia
Clinical narrative: Fever, flu symptoms, neck pain, back blisters lower back to neck headache constipation, muscles aches, itching.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Neck pain, Pruritus, Pyrexia, Viral test
Clinical narrative: Fever, flu symptoms, neck pain, back blisters lower back to neck headache constipation, muscles aches, itching.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Fever, flu symptoms, neck pain, back blisters lower back to neck headache constipation, muscles aches, itching.
Age: 24.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Erythema multiforme, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Initial unsolicited report received from a nurse on 21 June 2016. This case involves a 25-year-old female patient who was vaccinated with a dose of YELLOW FEVER VACCINE (unknown manufacturer) (batch number, expiration date, dose, site and route of administration were not reported) on an unspecified date. The patient's medical and concomitant medications were not reported. On an unspecified date, week following the vaccination the patient developed sudden onset of very itchy, pink, raised rash on lower legs and forearms. It was also reported that after treatment itching decreased faded on legs but advanced to hands. On an unspecified date, following the vaccination patient was diagnosed with erythema multiforme minor. Patient's lab data was not reported. The patient corrective treatment included topical steroids and steroid taper. Outcome of the events was unknown. Upon internal review the case was considered as serious because of important medical event: erythema multiforme minor and pink raised rash. It was reported that the dermatologist considered it to be a reaction to the live vaccine. List of documents held by sender: none. Sender's Comments: This case is poorly documented and refers to a 25 years old female patient who received yellow fever vaccine and experienced erythema multiforme minor. This case lacks information regarding dates of vaccination, dates of occurrence of events and relevant medical history. Based on the limited available information, temporal association between the suspect vaccine and the reported events cannot be established, hence causality cannot be assessed for now.
Age: 24.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Erythema multiforme, Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Initial unsolicited report received from a nurse on 21 June 2016. This case involves a 25-year-old female patient who was vaccinated with a dose of YELLOW FEVER VACCINE (unknown manufacturer) (batch number, expiration date, dose, site and route of administration were not reported) on an unspecified date. The patient's medical and concomitant medications were not reported. On an unspecified date, week following the vaccination the patient developed sudden onset of very itchy, pink, raised rash on lower legs and forearms. It was also reported that after treatment itching decreased faded on legs but advanced to hands. On an unspecified date, following the vaccination patient was diagnosed with erythema multiforme minor. Patient's lab data was not reported. The patient corrective treatment included topical steroids and steroid taper. Outcome of the events was unknown. Upon internal review the case was considered as serious because of important medical event: erythema multiforme minor and pink raised rash. It was reported that the dermatologist considered it to be a reaction to the live vaccine. List of documents held by sender: none. Sender's Comments: This case is poorly documented and refers to a 25 years old female patient who received yellow fever vaccine and experienced erythema multiforme minor. This case lacks information regarding dates of vaccination, dates of occurrence of events and relevant medical history. Based on the limited available information, temporal association between the suspect vaccine and the reported events cannot be established, hence causality cannot be assessed for now.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Foetal hypokinesia
Clinical narrative: This is a prospective pregnancy case. This female subject was enrolled in an open label study. The subject received BOOSTRIX on 21st June 2016. The subject received BOOSTRIX at week 32 of the pregnancy and during the third trimester of pregnancy. In June 2016, an unknown time after receiving BOOSTRIX, the subject developed fetal movements decreased. Serious criteria included GSK medically significant. Additional event(s) included vaccine exposure during pregnancy. The outcome of fetal movements decreased was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the fetal movements decreased and vaccine exposure during pregnancy to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's date of birth was refused. The patient was at 32 weeks of gestation and had an exposure to BOOSTRIX. The patient also experienced decreased fetal movement. The reporter was unable to quantify the decreased fetal movement. The reported lot number (7RJ98) for BOOSTRIX did not exist and was updated to 7RJ9B, according to sales database.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: This is a prospective pregnancy case. This female subject was enrolled in an open label study. The subject received BOOSTRIX on 21st June 2016. The subject received BOOSTRIX at week 32 of the pregnancy and during the third trimester of pregnancy. In June 2016, an unknown time after receiving BOOSTRIX, the subject developed fetal movements decreased. Serious criteria included GSK medically significant. Additional event(s) included vaccine exposure during pregnancy. The outcome of fetal movements decreased was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the fetal movements decreased and vaccine exposure during pregnancy to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's date of birth was refused. The patient was at 32 weeks of gestation and had an exposure to BOOSTRIX. The patient also experienced decreased fetal movement. The reporter was unable to quantify the decreased fetal movement. The reported lot number (7RJ98) for BOOSTRIX did not exist and was updated to 7RJ9B, according to sales database.
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient who was currently approximately 18 or 19 years old. No medical history and concurrent conditions were reported. On an unknown date the patient started therapy with GARDASIL injection (dosing regimen, frequency and route unknown) (lot number and expiry date unknown). There were no concomitant medications reported. On an unknown date at the age of 16 years, the patient completed receiving the series of GARDASIL. On an unknown date the patient was diagnosed with cervical cancer (medically significant). On an unknown date, the patient underwent a pap smear test which revealed cervical cancer. It was also reported as therapy with GARDASIL was discontinued. It was also reported that the patient was currently "fine and cleared". The outcome of cervical cancer was considered as recovered. The relatedness of the event cervical cancer to the therapy with GARDASIL was unknown. There was no product quality complaint (PQC) reported. Upon internal review, the event cervical cancer was considered to be medically significant. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Large red swelling itchy nodule around injection site that remained there for 4 days post injection.  Headache.  Aches.  Patient took Benadryl and naproxen with some relief for headache, but no relief for swelling and itching. Day 5 the swelling disappeared.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Large red swelling itchy nodule around injection site that remained there for 4 days post injection.  Headache.  Aches.  Patient took Benadryl and naproxen with some relief for headache, but no relief for swelling and itching. Day 5 the swelling disappeared.
Age: 0.7
Sex: M
Vaccine: PNC13
Symptoms: Cough, Crying, Decreased appetite, Depression, Ear infection
Clinical narrative: High fever, malaise, fatigue, inconsolable crying, fussiness, loss of appetite, dis-engaged, lethargic, green runny poops, developed ear infection, sinus congestion, coughing, depression, altered mood, irregular sleep, irritability.
Age: 0.7
Sex: M
Vaccine: PNC13
Symptoms: Faeces discoloured, Fatigue, Irritability, Lethargy, Malaise
Clinical narrative: High fever, malaise, fatigue, inconsolable crying, fussiness, loss of appetite, dis-engaged, lethargic, green runny poops, developed ear infection, sinus congestion, coughing, depression, altered mood, irregular sleep, irritability.
Age: 0.7
Sex: M
Vaccine: PNC13
Symptoms: Mood altered, Pyrexia, Sinus congestion, Sleep disorder, Social avoidant behaviour
Clinical narrative: High fever, malaise, fatigue, inconsolable crying, fussiness, loss of appetite, dis-engaged, lethargic, green runny poops, developed ear infection, sinus congestion, coughing, depression, altered mood, irregular sleep, irritability.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an officer manager via a company representative and refers to an unspecified number of anonymous patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (route of administration, lot numbers and expiry dates were not reported). It was reported that, VARIVAX was stored at 40 degrees Fahrenheit for 72 continuous hours on unspecified dates. Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Brain injury, Cardiac arrest, Chest X-ray abnormal, Coma, Death
Clinical narrative: Patient did not feel well at all within 1 hr of receiving the flu and PREVNAR 13 vaccines. On Feb 18 he started complaining of feeling like he had fluid on his lungs, went to emergency room. They did EKG was ok, chest x-ray showed small amount of fluid in left lung. Was given LASIX seemed to clear up. This was a Thurs doctor not in on Fri, was going to go to Dr on Tues, but early Tues 2/23/16 morning around 1:30 am was having trouble getting air into lungs went to hospital by ambulance around 6 AM. Heart stopped on way to hospital lungs so full of fluid his heart could not beat. Was resuscitated but due to already depleted oxygen level irreparable brain damage occurred, was in coma 2 weeks and passed. I know him being given the flu vaccine and the PREVNAR 13 vaccines at the same time killed my husband. This practice has to stop! He was transferred from one hospital to another. While in hospital we were advised of bacterial pneumonia, fungal pneumonia and B3 staph were present. Previously thought CHF or COPD but was never diagnosed with this. X-rays of 2/3/16 show all clear no signs of problems. Testosterone usage was not understood by doctor, at all. He used 1 mL every 10 days NOT 200 mg a week. Doctors in hospital said his usage had no relation to his condition. Once pneumonia found CHF and COPD dismissed.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Dyspnoea, Electrocardiogram normal, Malaise, Oxygen saturation decreased, Pleural effusion
Clinical narrative: Patient did not feel well at all within 1 hr of receiving the flu and PREVNAR 13 vaccines. On Feb 18 he started complaining of feeling like he had fluid on his lungs, went to emergency room. They did EKG was ok, chest x-ray showed small amount of fluid in left lung. Was given LASIX seemed to clear up. This was a Thurs doctor not in on Fri, was going to go to Dr on Tues, but early Tues 2/23/16 morning around 1:30 am was having trouble getting air into lungs went to hospital by ambulance around 6 AM. Heart stopped on way to hospital lungs so full of fluid his heart could not beat. Was resuscitated but due to already depleted oxygen level irreparable brain damage occurred, was in coma 2 weeks and passed. I know him being given the flu vaccine and the PREVNAR 13 vaccines at the same time killed my husband. This practice has to stop! He was transferred from one hospital to another. While in hospital we were advised of bacterial pneumonia, fungal pneumonia and B3 staph were present. Previously thought CHF or COPD but was never diagnosed with this. X-rays of 2/3/16 show all clear no signs of problems. Testosterone usage was not understood by doctor, at all. He used 1 mL every 10 days NOT 200 mg a week. Doctors in hospital said his usage had no relation to his condition. Once pneumonia found CHF and COPD dismissed.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pneumonia bacterial, Pneumonia fungal, Resuscitation, Staphylococcal infection
Clinical narrative: Patient did not feel well at all within 1 hr of receiving the flu and PREVNAR 13 vaccines. On Feb 18 he started complaining of feeling like he had fluid on his lungs, went to emergency room. They did EKG was ok, chest x-ray showed small amount of fluid in left lung. Was given LASIX seemed to clear up. This was a Thurs doctor not in on Fri, was going to go to Dr on Tues, but early Tues 2/23/16 morning around 1:30 am was having trouble getting air into lungs went to hospital by ambulance around 6 AM. Heart stopped on way to hospital lungs so full of fluid his heart could not beat. Was resuscitated but due to already depleted oxygen level irreparable brain damage occurred, was in coma 2 weeks and passed. I know him being given the flu vaccine and the PREVNAR 13 vaccines at the same time killed my husband. This practice has to stop! He was transferred from one hospital to another. While in hospital we were advised of bacterial pneumonia, fungal pneumonia and B3 staph were present. Previously thought CHF or COPD but was never diagnosed with this. X-rays of 2/3/16 show all clear no signs of problems. Testosterone usage was not understood by doctor, at all. He used 1 mL every 10 days NOT 200 mg a week. Doctors in hospital said his usage had no relation to his condition. Once pneumonia found CHF and COPD dismissed.
Age: 1.05
Sex: M
Vaccine: HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Administration error.