chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Neuralgia, Neurological examination abnormal, Neuropathy peripheral, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: Principal Diagnosis (Reason for admission after study): Guillain-Barre Syndrome. Additional Diagnoses: Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder. History of Present Illness: 64 YO male with a Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder who presents to the emergency department complaining of worsening constipation, urinary retention and neuropathy. Patient reports that the symptoms started 2 weeks ago and were sudden in onset. He first started to feel tingling in his fingertips and toes. This gradually progressed to weakness of lower extremity with difficulty walking. He felt off balance and like he was falling to his left side. He only fell once on his knees and did not hit his head. Then he started to develop shooting pains down his legs and arms. He reports his skin was very sensitive to touch. He had some shoulder pain and weakness in his arms as well. Patient has also experienced constipation for the last 6 days (states that he usually has 2 BMs a day). He endorsed saddle anesthesia that was present several days ago and is now resolved. He also endorses difficulty initiating a urinary stream and emptying his bladder. Denies fecal or urinary incontinence. This has never happened to him before. He did not suffer any trauma prior to the onset of symptoms. He denies any recent illnesses, sick contacts, fevers, chills, night sweats, cough, or diarrhea. Patient visited the ED on Nov 1st with similar symptoms and had a normal work up which included CT head, x-ray of cervical, thoracic and lumbar spine. Was discharged with  diagnosis of possible Diabetic neuropathy and gabapentin was increased and steroid taper was added. Patient has also been given codeine/TYLENOL for the neuropathic pain about 4 days ago which also did not help. Hospital Course: Neurology was consulted and recommended an MRI of the cervical spine and a lumbar puncture. The MRI did not show any obvious lesions so an MRI of the thoracic and lumbar spine were ordered. Anesthesia was consulted to do a lumbar puncture. The MRI were relatively unremarkable however the lumbar puncture showed evidence of Guillain-Barre Syndrome. Neuro recommended IVIG over 5 days. There was slight improvement and no worsening of his weakness. His breathing has remained stable and unchanged his entire stay. He was having bouts of incontinence with the Guillain Barre and urology was consulted. They recommended renal ultrasound, bladder scan every shift--I and O cath for PVR greater than 200 ml PRN if 500 ml, place indwelling foley, might help his constipation if distended bladder, bowel regimen if pt still complains of constipation.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia, Spinal X-ray, Spinal X-ray normal
Clinical narrative: Principal Diagnosis (Reason for admission after study): Guillain-Barre Syndrome. Additional Diagnoses: Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder. History of Present Illness: 64 YO male with a Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder who presents to the emergency department complaining of worsening constipation, urinary retention and neuropathy. Patient reports that the symptoms started 2 weeks ago and were sudden in onset. He first started to feel tingling in his fingertips and toes. This gradually progressed to weakness of lower extremity with difficulty walking. He felt off balance and like he was falling to his left side. He only fell once on his knees and did not hit his head. Then he started to develop shooting pains down his legs and arms. He reports his skin was very sensitive to touch. He had some shoulder pain and weakness in his arms as well. Patient has also experienced constipation for the last 6 days (states that he usually has 2 BMs a day). He endorsed saddle anesthesia that was present several days ago and is now resolved. He also endorses difficulty initiating a urinary stream and emptying his bladder. Denies fecal or urinary incontinence. This has never happened to him before. He did not suffer any trauma prior to the onset of symptoms. He denies any recent illnesses, sick contacts, fevers, chills, night sweats, cough, or diarrhea. Patient visited the ED on Nov 1st with similar symptoms and had a normal work up which included CT head, x-ray of cervical, thoracic and lumbar spine. Was discharged with  diagnosis of possible Diabetic neuropathy and gabapentin was increased and steroid taper was added. Patient has also been given codeine/TYLENOL for the neuropathic pain about 4 days ago which also did not help. Hospital Course: Neurology was consulted and recommended an MRI of the cervical spine and a lumbar puncture. The MRI did not show any obvious lesions so an MRI of the thoracic and lumbar spine were ordered. Anesthesia was consulted to do a lumbar puncture. The MRI were relatively unremarkable however the lumbar puncture showed evidence of Guillain-Barre Syndrome. Neuro recommended IVIG over 5 days. There was slight improvement and no worsening of his weakness. His breathing has remained stable and unchanged his entire stay. He was having bouts of incontinence with the Guillain Barre and urology was consulted. They recommended renal ultrasound, bladder scan every shift--I and O cath for PVR greater than 200 ml PRN if 500 ml, place indwelling foley, might help his constipation if distended bladder, bowel regimen if pt still complains of constipation.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Urinary hesitation, Urinary retention
Clinical narrative: Principal Diagnosis (Reason for admission after study): Guillain-Barre Syndrome. Additional Diagnoses: Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder. History of Present Illness: 64 YO male with a Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder who presents to the emergency department complaining of worsening constipation, urinary retention and neuropathy. Patient reports that the symptoms started 2 weeks ago and were sudden in onset. He first started to feel tingling in his fingertips and toes. This gradually progressed to weakness of lower extremity with difficulty walking. He felt off balance and like he was falling to his left side. He only fell once on his knees and did not hit his head. Then he started to develop shooting pains down his legs and arms. He reports his skin was very sensitive to touch. He had some shoulder pain and weakness in his arms as well. Patient has also experienced constipation for the last 6 days (states that he usually has 2 BMs a day). He endorsed saddle anesthesia that was present several days ago and is now resolved. He also endorses difficulty initiating a urinary stream and emptying his bladder. Denies fecal or urinary incontinence. This has never happened to him before. He did not suffer any trauma prior to the onset of symptoms. He denies any recent illnesses, sick contacts, fevers, chills, night sweats, cough, or diarrhea. Patient visited the ED on Nov 1st with similar symptoms and had a normal work up which included CT head, x-ray of cervical, thoracic and lumbar spine. Was discharged with  diagnosis of possible Diabetic neuropathy and gabapentin was increased and steroid taper was added. Patient has also been given codeine/TYLENOL for the neuropathic pain about 4 days ago which also did not help. Hospital Course: Neurology was consulted and recommended an MRI of the cervical spine and a lumbar puncture. The MRI did not show any obvious lesions so an MRI of the thoracic and lumbar spine were ordered. Anesthesia was consulted to do a lumbar puncture. The MRI were relatively unremarkable however the lumbar puncture showed evidence of Guillain-Barre Syndrome. Neuro recommended IVIG over 5 days. There was slight improvement and no worsening of his weakness. His breathing has remained stable and unchanged his entire stay. He was having bouts of incontinence with the Guillain Barre and urology was consulted. They recommended renal ultrasound, bladder scan every shift--I and O cath for PVR greater than 200 ml PRN if 500 ml, place indwelling foley, might help his constipation if distended bladder, bowel regimen if pt still complains of constipation.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Headache, Pain, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (1st dose received 3 months before the reporting date refer case US2019GSK038417). On 18th February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The patient had very violent reactions. The reporter disconnected before it could clarify what the reactions she experienced. This case was 1 of the 2 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Skin warm, Vaccination complication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (1st dose received 3 months before the reporting date refer case US2019GSK038417). On 18th February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The patient had very violent reactions. The reporter disconnected before it could clarify what the reactions she experienced. This case was 1 of the 2 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (1st dose received 3 months before the reporting date refer case US2019GSK038417). On 18th February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The patient had very violent reactions. The reporter disconnected before it could clarify what the reactions she experienced. This case was 1 of the 2 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (1st dose received 3 months before the reporting date refer case US2019GSK038417). On 18th February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The patient had very violent reactions. The reporter disconnected before it could clarify what the reactions she experienced. This case was 1 of the 2 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site reaction, Muscle twitching
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (1st dose received 3 months before the reporting date refer case US2019GSK038417). On 18th February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The patient had very violent reactions. The reporter disconnected before it could clarify what the reactions she experienced. This case was 1 of the 2 cases, reported by the same reporter.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Antinuclear antibody, Blood uric acid, Full blood count, Injection site pain, Muscular weakness
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 31 years old female patient who experienced severe weakness, having pain can't lift her arm and having pain in the arm at the sight of injection, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. On 14-Feb-2019, the patient received a dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine lot U614AB, exp date: 15 Dec 2020 via unknown route in the left arm. On an unknown date, the patient developed a non-serious severe weakness (asthenia), having pain, can't lift her arm (injected limb mobility decreased), having pain in the arm at the sight of injection (vaccination site pain) (Unknown latency) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. It was reported that the patient is having pain in the arm at the sight of injection as well as severe weakness and also reported having pain can't lift her arm which she received 12 days ago. Other relevant tests were not reported. Final diagnosis was having pain in the arm at the sight of injection, having pain can't lift her arm and severe weakness. It was not reported if the patient received a corrective treatment. The patient's event outcome is not reported for all the events. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 31 years old female patient who experienced severe weakness, having pain can't lift her arm and having pain in the arm at the sight of injection, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. On 14-Feb-2019, the patient received a dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine lot U614AB, exp date: 15 Dec 2020 via unknown route in the left arm. On an unknown date, the patient developed a non-serious severe weakness (asthenia), having pain, can't lift her arm (injected limb mobility decreased), having pain in the arm at the sight of injection (vaccination site pain) (Unknown latency) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. It was reported that the patient is having pain in the arm at the sight of injection as well as severe weakness and also reported having pain can't lift her arm which she received 12 days ago. Other relevant tests were not reported. Final diagnosis was having pain in the arm at the sight of injection, having pain can't lift her arm and severe weakness. It was not reported if the patient received a corrective treatment. The patient's event outcome is not reported for all the events. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 31 years old female patient who experienced severe weakness, having pain can't lift her arm and having pain in the arm at the sight of injection, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. On 14-Feb-2019, the patient received a dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine lot U614AB, exp date: 15 Dec 2020 via unknown route in the left arm. On an unknown date, the patient developed a non-serious severe weakness (asthenia), having pain, can't lift her arm (injected limb mobility decreased), having pain in the arm at the sight of injection (vaccination site pain) (Unknown latency) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. It was reported that the patient is having pain in the arm at the sight of injection as well as severe weakness and also reported having pain can't lift her arm which she received 12 days ago. Other relevant tests were not reported. Final diagnosis was having pain in the arm at the sight of injection, having pain can't lift her arm and severe weakness. It was not reported if the patient received a corrective treatment. The patient's event outcome is not reported for all the events. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At the injection site, the skin became red and spread out across upper arm. It was warm and tender to the touch. There is still a pink circle approximately 2 inches across at the injection site. No longer tender to touch or warm. Two days later, on the inside of the arm down by the elbow, another reaction appeared. It was red and circular in shape. This was also visibly raised as if swollen and hurt when touched. Once the swelling and pinkness subsided, a visible bruise appeared. Was concerned when the second reaction appeared. Went to a clinic. Doctor determined it was a reaction to the shot. Prescribed prednisone and antibiotic.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, HEPA, HPV9, MMRV
Symptoms: Wrong product administered
Clinical narrative: Client inadvertently received HPV9 vaccine by mistake.
Age: 46.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever and Shivering started at 8:00pm on 03/02/2019 (Day 1). Nausea and vomiting started at 8:00pm on 03/03/2019 (Day 2).
Age: 15.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, MMRV, MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient inadvertently received wrong vaccines. KINRIX is not licensed for his age group.
Sex: M
Vaccine: HPV4
Symptoms: Injury
Clinical narrative: This initial spontaneous report was received from a Registered Nurse (RN) who wrote an online article that was posted on social media and refers to her son (age not specified). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the reporter's son received GARDASIL (dose, route, and number in the series he received were not specified). The RN stated in the article that due to the restrictions of the law, her son and thousands of children like him have never been able to have their injuries acknowledged in a court of law. The injuries were not further specified. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1608USA000622:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: This non-valid spontaneous report was received from a nurse, and refers to unspecified patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that between 26-NOV-2018 and 07-FEB-019, one patient received improperly stored VARIVAX (lot # R017640, expiration date 20-JUN-2020 and lot # R02241, expiration date 14-JAN-2019), and two patients received improperly stored PROQUAD (lot # R014353, expiration date 18-NOV-2019), both for prophylaxis (route, dose, and anatomical location were not provided). The doses of VARIVAX and PROQUAD were exposed to a temperature excursion from -9 Celsius degrees (degrees C) to 8 degrees C (-4.8 degrees C) during a timeframe of 52 minutes and 30 seconds, which was detected by the data logger. The vaccines were reconstituted with properly stored sterile diluent. There were no previous temperature excursions. Lot number R02241 is an invalid lot number for VARIVAX.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a health care worker and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On unknown dates, the patient was vaccinated with unspecified number of doses of improperly stored ROTATEQ lot # N022017 and expiration date of 01-MAR-2019, per oral route and unspecified number of doses of improperly stored LIQUID PEDVAXHIB (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 49.6 Fahrenheit degrees for 20 minutes No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved.
Sex: U
Vaccine: HEP, HIBV, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to multiple patients of unknown ages and genders. The patients historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number R021078 and expirtion date 12-JUN-2021, and lot number  R021076 and expirtion date 11-JUN-2021; GARDASIL 9 lot number R023006 and expirtion date 06-MAY-2021,  lot number R025155 and expirtion date 23-MAY-2021, and lot number N026814 and expirtion date 15-JUL-2020;  RECOMBIVAX HB lot number R001529 and expirtion date 07-NOV-2020; and ROTATEQ lot number R015435 and expirtion date 17-APR-2020,  lot number R025733 and expirtion date 30-MAR-2020, and  lot number R017948 and expirtion date 03-MAY-2020; for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of the vaccines experienced a temperature above 47 °F to 53.1 °F for 1 hour, as recorded by a data logger. There was no adverse effect reported. There was not previous temperature. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unspecified date in 2013, the patient was vaccinated with the first dose of GARDASIL for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 26-FEB-2019, the patient received the second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (inappropriate schedule of product administration) (interchange of vaccine products). This was longer than the recommended interval. The outcome of inappropriate schedule of product administration and interchange of vaccine products was not reported.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a supervisor, referring to a currently 15 month old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 06-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000678; US-009507513-1903USA000677; US-009507513-1903USA000680; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000683; US-009507513-1903USA000684; US-009507513-1903USA000685.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies. On 06-FEB-2019, the patient was administered an improperly stored VARIVAX with lot number R012531 and expiration date on 01-MAY-2020 (strength, dose, dose number, anatomical injection site and route of administration were not reported) for prophylaxis. The sterile diluent used for reconstitution of the vaccine was properly stored. It was reported that on an unknown date, the vaccine was exposed to a temperature of -8.1 Celsius degrees for 2 hours and 54 minutes. There was a previous temperature excursion of -10.9 Celsius degrees for 2 hours and 10 minutes. The call was placed because of a Digital Data logger report. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-00950751-1902USA006651.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 28-FEB-2019, the patient was vaccinated with an expired dose of M-M-R II (rHA), lot # M045391, expiration date 14-NOV-18 for prophylaxis (dose and route of administration were not reported) (expired product administered). The vaccine was reconstituted with Diluent MRK lot # R0006343, expiration date 01-DEC-2020. The outcome of expired product administered was not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's concurrent condition, medical history, concomitant medications, previously drug reactions and allergies were not reported. On 27-FEB-2019, the patient received a pediatric dose of VAQTA intramuscular for prophylaxis (strength, anatomical location, lot number and expiration date were not provided) (inappropriate dose of vaccine administered). No adverse effects were reported.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a supervisor, referring to a currently 12 months old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 08-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000678; US-009507513-1902USA012055; US-009507513-1903USA000680; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000683; US-009507513-1903USA000684; US-009507513-1903USA000685.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a supervisor, referring to a currently 15 months old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 11-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000680; US-009507513-1902USA012055; US-009507513-1903USA000677; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000683; US-009507513-1903USA000684; US-009507513-1903USA000685.
Age: 1.75
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a supervisor, referring to a currently 21 months old female patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 12-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000678; US-009507513-1902USA012055; US-009507513-1903USA000677; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000683; US-009507513-1903USA000684; US-009507513-1903USA000685.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a supervisor, referring to a currently 4 years old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 19-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (°F) to 14°F, during 2 hours 20 minutes. However, a previous temperature excursion of 15°F to 46°F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported.; Sender's Comments: US-009507513-1903USA000678: US-009507513-1902USA012055: US-009507513-1903USA000677: US-009507513-1903USA000680: US-009507513-1903USA000682: US-009507513-1903USA000683: US-009507513-1903USA000684: US-009507513-1903USA000685:
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a supervisor, referring to a currently 2 years old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 21-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000678; US-009507513-1902USA012055; US-009507513-1903USA000677; US-009507513-1903USA000680; US-009507513-1903USA000681; US-009507513-1903USA000683; US-009507513-1903USA000684; US-009507513-1903USA000685.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a supervisor, referring to a currently 5 year old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 21-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000678; US-009507513-1902USA012055; US-009507513-1903USA000677; US-009507513-1903USA000680; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000684; US-009507513-1903USA000685.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a supervisor, referring to a currently 12 months old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 25-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000678; US-009507513-1902USA012055; US-009507513-1903USA000677; US-009507513-1903USA000680; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000683; US-009507513-1903USA000685.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a supervisor, referring to a currently 4 year old female patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 25-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000678; US-009507513-1902USA012055; US-009507513-1903USA000677; US-009507513-1903USA000680; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000683; US-009507513-1903USA000684.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 25-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 72 years old female patient who experienced allergy to tetanus toxoid vaccine, while received vaccine Tetanus Toxoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Tetanus Toxoid (lot number and Expiry date unknown) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to tetanus toxoid vaccine (allergy to vaccine) (Unknown latency) following the administration of Tetanus Toxoid. (Other relevant tests included no lab data.) Final diagnosis was allergy to tetanus toxoid vaccine. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional via other company (Pfizer) (2018071202). This case involves a 12 months old patient who received QUADRACEL instead of PREVNAR 13. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR Vaccine; and VARIVAX  (OKA/MERCK). On 14-Dec-2017, the patient received a 0.5 ml single dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine lot C5325BA via intramuscular route in the left arm. It was a case of actual medication error due to wrong vaccine administered. It was reported that no adverse event was observed. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2019SA055109 and 2019SA056156 (same reporter). This case involves a 60 years old male patient who received a 0.5ml single dose of vaccine FLUZONE QUADRIVALENT prefilled syringes batch number: LB549 (expiry date: 30-Jun-2019) via intramuscular route in left deltoid on 11-Jan-2019. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications was taken. It was an actual medication error due to incorrect product storage. FLUZONE QUADRIVALENT had temperature excursion which had already been used on 3 separate patients. The nurse stated that they did not catch the temperature excursion because the data logger did not alert as it was supposed to. It was reported that no adverse event was observed. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2019SA056122 and 2019SA055109. This case involves a eight months old female patient who was vaccinated with 0.5 ml FLUZONE QUADRIVALENT (lot: LB549), expiry date- 30-Jun-2019 via intramuscular route in the left thigh which was on temperature excursion, on 11-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a physician (Rheumatologist) via other company (Pfizer). This case involves an unknown age and gender patient who experienced allergy to immunisation with vaccine INFLUENZA VACCINE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to immunisation with influenza vaccine (allergy to vaccine) with unknown latency. Lab data was not provided. Final diagnosis was allergy to immunisation with influenza vaccine. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to immunisation with influenza vaccine. List of documents held by sender- none.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 25-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves patient (with unknown demographic) who experienced allergy to tetanus toxoid, while received vaccine Tetanus Toxoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Tetanus Toxoid (lot number and Expiry date unknown) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to tetanus toxoid (allergy to vaccine) following the administration of Tetanus Toxoid. Other relevant tests not reported. Final diagnosis was allergy to tetanus toxoid. It was not reported if the patient received a corrective treatment. The patient outcome was reported as unknown for allergy to tetanus toxoid. List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, FLU4, RVX
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid serious case received from a nurse. This case involves a six months old female patient who was vaccinated with 0.5 ml FLUZONE QUADRIVALENT (lot: UT6315RA) via unknown route in the left thigh and 0.25 ml dose of same vaccine with lot: UJ087AB via unknown route in the right thigh, on 26-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PENTACEL for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. It was an actual medication error due to extra dose administered (6 month old patient was administered 2 doses of fluzone (one 0.5ml dose and one 0.25ml dose))  It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid serious case received from a nurse. This case involves a 16 years old patient who was vaccinated with a 0.5 mL dose of FLUZONE QUADRIVALENT on an unknown date and another 0.5 ml dose of it (lot: UJ069AA, expiry date: 30-Jun-2019) via unknown route in the right arm on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENACTRA for Immunisation. It was an actual medication error due to extra dose administered as FLUZONE QUADRIVALENT accidentally given twice to 16 year old. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.