chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Splenic thrombosis, Urine analysis abnormal
Clinical narrative: Splenic infarction; fevers; shortness of breath; chest pain; night sweats; left upper abdominal pain; lethargy; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 13Sep2021 17:00 (Batch/Lot Number: Fc3184) at the age of 50 years old as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism, gastrooesophageal reflux disease (GERD), COVID-19 prior vaccination. No known allergies: No. The patient was not pregnancy at time of vaccination. Concomitant medication(s) included levothyroxine, omeprazole (PRILOSEC) and venlafaxine hydrochloride (EFFEXOR), all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: Fa7485), administered in arm left on 23Aug2021 17:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (Nasal Swab: negative). The patient experienced splenic infarction, fevers, shortness of breath, chest pain, night sweats, left upper abdominal pain, lethargy and nausea on 13Sep2021 19:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and was considered a life threatening illness (immediate risk of death from the event). The patient was hospitalized on unspecified dates in 2021 with duration of hospitalization: 7 days. Therapeutic measures were taken as a result of the events. Outcome of events were not recovered.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event splenic infarction cannot be excluded.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chest pain, Dyspnoea, Lethargy, Nausea
Clinical narrative: Splenic infarction; fevers; shortness of breath; chest pain; night sweats; left upper abdominal pain; lethargy; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 13Sep2021 17:00 (Batch/Lot Number: Fc3184) at the age of 50 years old as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism, gastrooesophageal reflux disease (GERD), COVID-19 prior vaccination. No known allergies: No. The patient was not pregnancy at time of vaccination. Concomitant medication(s) included levothyroxine, omeprazole (PRILOSEC) and venlafaxine hydrochloride (EFFEXOR), all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: Fa7485), administered in arm left on 23Aug2021 17:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (Nasal Swab: negative). The patient experienced splenic infarction, fevers, shortness of breath, chest pain, night sweats, left upper abdominal pain, lethargy and nausea on 13Sep2021 19:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and was considered a life threatening illness (immediate risk of death from the event). The patient was hospitalized on unspecified dates in 2021 with duration of hospitalization: 7 days. Therapeutic measures were taken as a result of the events. Outcome of events were not recovered.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event splenic infarction cannot be excluded.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Night sweats, Pyrexia, SARS-CoV-2 test, Splenic infarction
Clinical narrative: Splenic infarction; fevers; shortness of breath; chest pain; night sweats; left upper abdominal pain; lethargy; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 13Sep2021 17:00 (Batch/Lot Number: Fc3184) at the age of 50 years old as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism, gastrooesophageal reflux disease (GERD), COVID-19 prior vaccination. No known allergies: No. The patient was not pregnancy at time of vaccination. Concomitant medication(s) included levothyroxine, omeprazole (PRILOSEC) and venlafaxine hydrochloride (EFFEXOR), all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: Fa7485), administered in arm left on 23Aug2021 17:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (Nasal Swab: negative). The patient experienced splenic infarction, fevers, shortness of breath, chest pain, night sweats, left upper abdominal pain, lethargy and nausea on 13Sep2021 19:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and was considered a life threatening illness (immediate risk of death from the event). The patient was hospitalized on unspecified dates in 2021 with duration of hospitalization: 7 days. Therapeutic measures were taken as a result of the events. Outcome of events were not recovered.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event splenic infarction cannot be excluded.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysstasia, Electrocardiogram, Gait disturbance, Magnetic resonance imaging
Clinical narrative: Within 10-15 minutes after vaccine, patient was waiting in the waiting room but began to feel very dizzy, like she was going to pass out. Brought back to exam room. Had her lie down for several minutes. Vital signs stable. Had her drink some fluids. Pt subsequently able to get up and go home. Patient has continue to feel very dizzy with movements. Has been debilitating. Has difficulty standing, walking, and doing most of her daily activities. Also noting some numbness in her toes. Foggy headedness.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Condition aggravated, Dizziness, Dysstasia, Feeling abnormal
Clinical narrative: Within 10-15 minutes after vaccine, patient was waiting in the waiting room but began to feel very dizzy, like she was going to pass out. Brought back to exam room. Had her lie down for several minutes. Vital signs stable. Had her drink some fluids. Pt subsequently able to get up and go home. Patient has continue to feel very dizzy with movements. Has been debilitating. Has difficulty standing, walking, and doing most of her daily activities. Also noting some numbness in her toes. Foggy headedness.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Loss of personal independence in daily activities, Magnetic resonance imaging head abnormal
Clinical narrative: Within 10-15 minutes after vaccine, patient was waiting in the waiting room but began to feel very dizzy, like she was going to pass out. Brought back to exam room. Had her lie down for several minutes. Vital signs stable. Had her drink some fluids. Pt subsequently able to get up and go home. Patient has continue to feel very dizzy with movements. Has been debilitating. Has difficulty standing, walking, and doing most of her daily activities. Also noting some numbness in her toes. Foggy headedness.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Erythema, Nausea, Pruritus, Throat irritation
Clinical narrative: Patient was administered the COVID-19 vaccine. Within a few minutes she began to experience pruritus, her throat itching, mild chest tightness, nausea. There are no visible hives, lungs were clear, no angioedema of the oral mucosa and blood pressure was 122/78. Patient denied any throat swelling or difficulty breathing. Patient was talking comfortably. She just kept itching her skin and then the skin would become slightly red. She reported having an allergic reaction to the flu vaccine that required an EpiPen injection. She also has a history of chronic idiopathic urticaria.  She takes Zyrtec daily.   Administered Benadryl 50 mg orally Administered Solu-Medrol 40 mg IM Patient symptoms remain stable Patient was escorted to the ED for further observation and management.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Extra dose administered, Headache, Incorrect dose administered, Injection site pain, Nausea
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, Pain, Product preparation error
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eczema, Mass
Clinical narrative: high fever; headache; fatigue; body ache; This is a spontaneous report from a contactable other hcp (patient).   A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH 9899), via an unspecified route of administration, administered in Arm Left on 06Jan2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant. Previously patient took the first dose of covid-19 vaccine (lot number: EH 9899) on 16Dec2020 16:45 via intramuscular route in left arm for covid-19 immunisation. Medical history included hypothyroidism. No known allergies were reported. Concomitant medications included levothyroxine. No covid prior vaccination. No other vaccine received within in four weeks. The patient experienced high fever, headache, fatigue, body ache on 03Feb2021. No treatment was given. Not covid tested post vaccination. It was reported that after the second dose of vaccine, she developed high fever, headache, fatigue and body ache within 12 hours which lasted for 36 hours. The clinical outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information was expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: high fever; headache; fatigue; body ache; This is a spontaneous report from a contactable other hcp (patient).   A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH 9899), via an unspecified route of administration, administered in Arm Left on 06Jan2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant. Previously patient took the first dose of covid-19 vaccine (lot number: EH 9899) on 16Dec2020 16:45 via intramuscular route in left arm for covid-19 immunisation. Medical history included hypothyroidism. No known allergies were reported. Concomitant medications included levothyroxine. No covid prior vaccination. No other vaccine received within in four weeks. The patient experienced high fever, headache, fatigue, body ache on 03Feb2021. No treatment was given. Not covid tested post vaccination. It was reported that after the second dose of vaccine, she developed high fever, headache, fatigue and body ache within 12 hours which lasted for 36 hours. The clinical outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information was expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Chest injury, Dizziness, Face injury, Fall
Clinical narrative: Per employee, the patient received his second Pfizer injection at 9:30AM on 1025/21. On 10/26/21, he experienced the usual arm soreness but at approximately 11:15PM, he experienced extreme dizziness causing him to fall and hit his chin on the floor requiring multiple stitches to the chin and a dental appointment for a chipped tooth. Patient has already submitted his own report to VAERS (discussed the event with him on 10/29/21).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site pain, Pain, Skin laceration, Suture insertion
Clinical narrative: Per employee, the patient received his second Pfizer injection at 9:30AM on 1025/21. On 10/26/21, he experienced the usual arm soreness but at approximately 11:15PM, he experienced extreme dizziness causing him to fall and hit his chin on the floor requiring multiple stitches to the chin and a dental appointment for a chipped tooth. Patient has already submitted his own report to VAERS (discussed the event with him on 10/29/21).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tooth fracture, Tooth injury, Vertigo
Clinical narrative: Per employee, the patient received his second Pfizer injection at 9:30AM on 1025/21. On 10/26/21, he experienced the usual arm soreness but at approximately 11:15PM, he experienced extreme dizziness causing him to fall and hit his chin on the floor requiring multiple stitches to the chin and a dental appointment for a chipped tooth. Patient has already submitted his own report to VAERS (discussed the event with him on 10/29/21).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fall, Injury, Pain in extremity, Tooth fracture
Clinical narrative: Per employee, the patient received his second Pfizer injection at 9:30AM on 1025/21. On 10/26/21, he experienced the usual arm soreness but at approximately 11:15PM, he experienced extreme dizziness causing him to fall and hit his chin on the floor requiring multiple stitches to the chin and a dental appointment for a chipped tooth. Patient has already submitted his own report to VAERS (discussed the event with him on 10/29/21).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tooth injury
Clinical narrative: Per employee, the patient received his second Pfizer injection at 9:30AM on 1025/21. On 10/26/21, he experienced the usual arm soreness but at approximately 11:15PM, he experienced extreme dizziness causing him to fall and hit his chin on the floor requiring multiple stitches to the chin and a dental appointment for a chipped tooth. Patient has already submitted his own report to VAERS (discussed the event with him on 10/29/21).
Age: 18.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Back pain, Computerised tomogram head normal, Endotracheal intubation, Guillain-Barre syndrome, Haemoglobin decreased
Clinical narrative: I obtained additional history through review of medical records and after talking to neurology specialist patient was doing well until last week, undergoing training, developed headache on a Saturday which kind of worsened on Sunday patient got seen in a local ER/urgent care for some pain medications with Dilaudid on Monday, became more lethargic on Monday evening to Tuesday, was admitted to the hospital, transferred on October 20 with concern for acute encephalopathy suspect secondary to meningitis. Current Care Plan Summary: Young patient developed acute altered mental status and severe encephalopathy with significantly decreased muscle activity, areflexia, respiratory failure requiring mechanical ventilation. No improvement in neurologic status, remains unresponsive with flaccid paralysis. Differential diagnosis includes autoimmune encephalitis, atypical Guillain-Barré, and potential myositis?  Other work-up to date including infectious work-up/multiple lumbar punctures, MRI imaging, continuous EEG, status post botulinum antitoxin, pulse dose steroids x5 days, and plasmapheresis have all been trialed as treatments.  All infectious work-up negative, autoimmune/tickborne/neurologic panel negative to date. Appreciate neurology, infectious disease, rheumatology input. CDC aware of case. Status post muscle biopsy yesterday, awaiting pathology results.
Age: 18.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Headache, Immediate post-injection reaction, Lung consolidation, Magnetic resonance imaging spinal normal, Mental status changes
Clinical narrative: I obtained additional history through review of medical records and after talking to neurology specialist patient was doing well until last week, undergoing training, developed headache on a Saturday which kind of worsened on Sunday patient got seen in a local ER/urgent care for some pain medications with Dilaudid on Monday, became more lethargic on Monday evening to Tuesday, was admitted to the hospital, transferred on October 20 with concern for acute encephalopathy suspect secondary to meningitis. Current Care Plan Summary: Young patient developed acute altered mental status and severe encephalopathy with significantly decreased muscle activity, areflexia, respiratory failure requiring mechanical ventilation. No improvement in neurologic status, remains unresponsive with flaccid paralysis. Differential diagnosis includes autoimmune encephalitis, atypical Guillain-Barré, and potential myositis?  Other work-up to date including infectious work-up/multiple lumbar punctures, MRI imaging, continuous EEG, status post botulinum antitoxin, pulse dose steroids x5 days, and plasmapheresis have all been trialed as treatments.  All infectious work-up negative, autoimmune/tickborne/neurologic panel negative to date. Appreciate neurology, infectious disease, rheumatology input. CDC aware of case. Status post muscle biopsy yesterday, awaiting pathology results.
Age: 18.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Pain, Pain in extremity, Pneumonia, Red blood cell sedimentation rate increased, SARS-CoV-2 test negative
Clinical narrative: I obtained additional history through review of medical records and after talking to neurology specialist patient was doing well until last week, undergoing training, developed headache on a Saturday which kind of worsened on Sunday patient got seen in a local ER/urgent care for some pain medications with Dilaudid on Monday, became more lethargic on Monday evening to Tuesday, was admitted to the hospital, transferred on October 20 with concern for acute encephalopathy suspect secondary to meningitis. Current Care Plan Summary: Young patient developed acute altered mental status and severe encephalopathy with significantly decreased muscle activity, areflexia, respiratory failure requiring mechanical ventilation. No improvement in neurologic status, remains unresponsive with flaccid paralysis. Differential diagnosis includes autoimmune encephalitis, atypical Guillain-Barré, and potential myositis?  Other work-up to date including infectious work-up/multiple lumbar punctures, MRI imaging, continuous EEG, status post botulinum antitoxin, pulse dose steroids x5 days, and plasmapheresis have all been trialed as treatments.  All infectious work-up negative, autoimmune/tickborne/neurologic panel negative to date. Appreciate neurology, infectious disease, rheumatology input. CDC aware of case. Status post muscle biopsy yesterday, awaiting pathology results.
Age: 18.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Spinal pain, Tenderness, Toxicologic test normal, White blood cell count increased
Clinical narrative: I obtained additional history through review of medical records and after talking to neurology specialist patient was doing well until last week, undergoing training, developed headache on a Saturday which kind of worsened on Sunday patient got seen in a local ER/urgent care for some pain medications with Dilaudid on Monday, became more lethargic on Monday evening to Tuesday, was admitted to the hospital, transferred on October 20 with concern for acute encephalopathy suspect secondary to meningitis. Current Care Plan Summary: Young patient developed acute altered mental status and severe encephalopathy with significantly decreased muscle activity, areflexia, respiratory failure requiring mechanical ventilation. No improvement in neurologic status, remains unresponsive with flaccid paralysis. Differential diagnosis includes autoimmune encephalitis, atypical Guillain-Barré, and potential myositis?  Other work-up to date including infectious work-up/multiple lumbar punctures, MRI imaging, continuous EEG, status post botulinum antitoxin, pulse dose steroids x5 days, and plasmapheresis have all been trialed as treatments.  All infectious work-up negative, autoimmune/tickborne/neurologic panel negative to date. Appreciate neurology, infectious disease, rheumatology input. CDC aware of case. Status post muscle biopsy yesterday, awaiting pathology results.
Age: 18.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Areflexia, Biopsy muscle, Borrelia test negative, Electroencephalogram, Encephalitis autoimmune
Clinical narrative: I obtained additional history through review of medical records and after talking to neurology specialist patient was doing well until last week, undergoing training, developed headache on a Saturday which kind of worsened on Sunday patient got seen in a local ER/urgent care for some pain medications with Dilaudid on Monday, became more lethargic on Monday evening to Tuesday, was admitted to the hospital, transferred on October 20 with concern for acute encephalopathy suspect secondary to meningitis. Current Care Plan Summary: Young patient developed acute altered mental status and severe encephalopathy with significantly decreased muscle activity, areflexia, respiratory failure requiring mechanical ventilation. No improvement in neurologic status, remains unresponsive with flaccid paralysis. Differential diagnosis includes autoimmune encephalitis, atypical Guillain-Barré, and potential myositis?  Other work-up to date including infectious work-up/multiple lumbar punctures, MRI imaging, continuous EEG, status post botulinum antitoxin, pulse dose steroids x5 days, and plasmapheresis have all been trialed as treatments.  All infectious work-up negative, autoimmune/tickborne/neurologic panel negative to date. Appreciate neurology, infectious disease, rheumatology input. CDC aware of case. Status post muscle biopsy yesterday, awaiting pathology results.
Age: 18.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Encephalopathy, Guillain-Barre syndrome, Headache, Immunology test normal, Laboratory test normal
Clinical narrative: I obtained additional history through review of medical records and after talking to neurology specialist patient was doing well until last week, undergoing training, developed headache on a Saturday which kind of worsened on Sunday patient got seen in a local ER/urgent care for some pain medications with Dilaudid on Monday, became more lethargic on Monday evening to Tuesday, was admitted to the hospital, transferred on October 20 with concern for acute encephalopathy suspect secondary to meningitis. Current Care Plan Summary: Young patient developed acute altered mental status and severe encephalopathy with significantly decreased muscle activity, areflexia, respiratory failure requiring mechanical ventilation. No improvement in neurologic status, remains unresponsive with flaccid paralysis. Differential diagnosis includes autoimmune encephalitis, atypical Guillain-Barré, and potential myositis?  Other work-up to date including infectious work-up/multiple lumbar punctures, MRI imaging, continuous EEG, status post botulinum antitoxin, pulse dose steroids x5 days, and plasmapheresis have all been trialed as treatments.  All infectious work-up negative, autoimmune/tickborne/neurologic panel negative to date. Appreciate neurology, infectious disease, rheumatology input. CDC aware of case. Status post muscle biopsy yesterday, awaiting pathology results.
Age: 18.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Lethargy, Lumbar puncture, Magnetic resonance imaging, Mechanical ventilation, Meningitis
Clinical narrative: I obtained additional history through review of medical records and after talking to neurology specialist patient was doing well until last week, undergoing training, developed headache on a Saturday which kind of worsened on Sunday patient got seen in a local ER/urgent care for some pain medications with Dilaudid on Monday, became more lethargic on Monday evening to Tuesday, was admitted to the hospital, transferred on October 20 with concern for acute encephalopathy suspect secondary to meningitis. Current Care Plan Summary: Young patient developed acute altered mental status and severe encephalopathy with significantly decreased muscle activity, areflexia, respiratory failure requiring mechanical ventilation. No improvement in neurologic status, remains unresponsive with flaccid paralysis. Differential diagnosis includes autoimmune encephalitis, atypical Guillain-Barré, and potential myositis?  Other work-up to date including infectious work-up/multiple lumbar punctures, MRI imaging, continuous EEG, status post botulinum antitoxin, pulse dose steroids x5 days, and plasmapheresis have all been trialed as treatments.  All infectious work-up negative, autoimmune/tickborne/neurologic panel negative to date. Appreciate neurology, infectious disease, rheumatology input. CDC aware of case. Status post muscle biopsy yesterday, awaiting pathology results.
Age: 18.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Mental status changes, Muscle disorder, Neurological examination normal, Paralysis, Pathology test
Clinical narrative: I obtained additional history through review of medical records and after talking to neurology specialist patient was doing well until last week, undergoing training, developed headache on a Saturday which kind of worsened on Sunday patient got seen in a local ER/urgent care for some pain medications with Dilaudid on Monday, became more lethargic on Monday evening to Tuesday, was admitted to the hospital, transferred on October 20 with concern for acute encephalopathy suspect secondary to meningitis. Current Care Plan Summary: Young patient developed acute altered mental status and severe encephalopathy with significantly decreased muscle activity, areflexia, respiratory failure requiring mechanical ventilation. No improvement in neurologic status, remains unresponsive with flaccid paralysis. Differential diagnosis includes autoimmune encephalitis, atypical Guillain-Barré, and potential myositis?  Other work-up to date including infectious work-up/multiple lumbar punctures, MRI imaging, continuous EEG, status post botulinum antitoxin, pulse dose steroids x5 days, and plasmapheresis have all been trialed as treatments.  All infectious work-up negative, autoimmune/tickborne/neurologic panel negative to date. Appreciate neurology, infectious disease, rheumatology input. CDC aware of case. Status post muscle biopsy yesterday, awaiting pathology results.
Age: 18.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Plasmapheresis, Respiratory failure, Unresponsive to stimuli
Clinical narrative: I obtained additional history through review of medical records and after talking to neurology specialist patient was doing well until last week, undergoing training, developed headache on a Saturday which kind of worsened on Sunday patient got seen in a local ER/urgent care for some pain medications with Dilaudid on Monday, became more lethargic on Monday evening to Tuesday, was admitted to the hospital, transferred on October 20 with concern for acute encephalopathy suspect secondary to meningitis. Current Care Plan Summary: Young patient developed acute altered mental status and severe encephalopathy with significantly decreased muscle activity, areflexia, respiratory failure requiring mechanical ventilation. No improvement in neurologic status, remains unresponsive with flaccid paralysis. Differential diagnosis includes autoimmune encephalitis, atypical Guillain-Barré, and potential myositis?  Other work-up to date including infectious work-up/multiple lumbar punctures, MRI imaging, continuous EEG, status post botulinum antitoxin, pulse dose steroids x5 days, and plasmapheresis have all been trialed as treatments.  All infectious work-up negative, autoimmune/tickborne/neurologic panel negative to date. Appreciate neurology, infectious disease, rheumatology input. CDC aware of case. Status post muscle biopsy yesterday, awaiting pathology results.
Age: 18.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Encephalopathy, Paralysis
Clinical narrative: I obtained additional history through review of medical records and after talking to neurology specialist patient was doing well until last week, undergoing training, developed headache on a Saturday which kind of worsened on Sunday patient got seen in a local ER/urgent care for some pain medications with Dilaudid on Monday, became more lethargic on Monday evening to Tuesday, was admitted to the hospital, transferred on October 20 with concern for acute encephalopathy suspect secondary to meningitis. Current Care Plan Summary: Young patient developed acute altered mental status and severe encephalopathy with significantly decreased muscle activity, areflexia, respiratory failure requiring mechanical ventilation. No improvement in neurologic status, remains unresponsive with flaccid paralysis. Differential diagnosis includes autoimmune encephalitis, atypical Guillain-Barré, and potential myositis?  Other work-up to date including infectious work-up/multiple lumbar punctures, MRI imaging, continuous EEG, status post botulinum antitoxin, pulse dose steroids x5 days, and plasmapheresis have all been trialed as treatments.  All infectious work-up negative, autoimmune/tickborne/neurologic panel negative to date. Appreciate neurology, infectious disease, rheumatology input. CDC aware of case. Status post muscle biopsy yesterday, awaiting pathology results.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Incorrect dose administered, Injection site pain
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Breast pain, Cough, Decreased appetite, Diarrhoea
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Emotional distress, Fatigue, Feeling abnormal, Headache
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness, Immunisation, Incorrect dose administered, Lymphoedema, Menstruation delayed
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Overdose, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product preparation error, Pyrexia
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.  On 20-SEP-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1707457, expiration date 23-FEB-2022) and hib vaccine conj (ompc) (PEDVAXHIB) (lot# T026961, expiration date 02-APR-2023) (strength, dose, dose number and route were not reported) for prophylaxis after temperature excursion (product storage error).  The vaccines were exposed to temperature excursion of 48.7 degrees Fahrenheit (F) for a time frame of 74 hours and 10 minutes. No previous temperature excursion was involved. The call was due to a data logger.
Age: 14.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no further AE; the dose expired on 16Sep2021 and was administered today 28Sep2021; the vaccine was administered to a patient outside of the age range in the PI; This spontaneous report was received from a nurse, referring to a 14 months old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.  On 28-SEP-2021, an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S028914, expiration date 16-SEP-2021, 0.5 milliliter one time, therapy type recombinant human albumin (rHA); strength and route were not reported) was vaccinated to the patient outside of the age range in the PI (package insert) for prophylaxis (expired product administered and product administered to patient of inappropriate age). The vaccine has not undergone a temperature excursion. No additional adverse event (AE)/ product quality complaint (PQC) presented.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No other issues or concerns reported at time of call; Names of vaccines involved (...): ROTATEQ / Temperature: 48.2 F; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 04-OCT-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # T033634, expiration date 16-MAR-2022 for prophylaxis (exact dose and anatomical location were not reported).  The vaccine was stored at the temperature that was reported as 48.2 degrees of Fahrenheit for 5 hours and 19 minutes. It was not reported if there was a previous temperature excursion. No other issues or concerns reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; an expired dose of MMR II was administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 11-OCT-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml injection, lot # S029454 was confirmed to be valid, expiration date 19-SEP-2021 (albumin status rHA) (route of administration and injection site were not provided) for prophylaxis. No additional adverse events were reported. There were no excursions reported.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; No other AEs reported; This spontaneous report has been received from a registered nurse referring to a 5-month-old patient of unreported gender. The patient's pertinent medical history, concomitant medication, drug reactions, and allergies were not reported.       On an unspecified date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number T030458, expiration date 11-APR-2021, which has been verified to be valid) was involved in a temperature excursion of 35 degrees Fahrenheit (F) for 30 minutes (product storage error). There was no previous temperature excursion. On 18-OCT-2021 (also reported as "after temperature excursion"), the patient was vaccinated with the involved rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliters, for prophylaxis (dose number, vaccination scheme, and route of administration were not reported).       No other adverse events (AE) were reported (no adverse event).
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR, VARCEL
Symptoms: Product administered at inappropriate site, Product storage error
Clinical narrative: No additional AE was reported; temperature excursion for VARIVAX; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 19-OCT-2021, the patient was vaccinated with improper stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T024287,expiration date 15-JUL-2022, 0.5 milliliter, route and strength were not provided) for prophylaxis (product storage error). The vaccine administered experienced temperature excursion of 8 Degree Celsius for 1 hour 47 minutes. There was no previous temperature excursion. No additional adverse event was reported.  Follow up information has been received from vaccine coordinator on 26-OCT-2021.  Information has been received regarding a 20-month-old female patient who weights 6lb 12Oz at the time of birth. She had 2 sisters.   On 19-OCT-2021, she was vaccinated with an improperly stored first dose of varicella virus vaccine live (oka/merck) (VARIVAX) administered subcutaneously (SQ) through right arm; with the first dose of diphtheria vaccine toxoid (+) hepatitis B vaccine rhbsag (yeast) (+) hib vaccine conj (menigococcal protein) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (VAXELIS) (dosage regimen not provided), lot# U7124AA, expiration date 13-JUL-2024 administered intramuscularly (IM) through left thigh; with the first dose of hepatitis A vaccine (dosage regimen not provided), lot# 2JD3Y, expiration date 04-DEC-2022, IM through left thigh; and with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) (dosage regimen not provided), lot# S039316, expiration date 04-DEC-2021, SQ through left arm. All vaccines were storage in clinical practice administered as prophylaxis. On that day, second dose of pneumococcal vaccine conj 13v (CRM197) (PREVENAR 13) (dosage regimen was not provided) lot# DL2971, expiration date 30-NOV-2022, IM through right thigh for prophylaxis. It was reported that the operator was trained, and the vaccine was used according to the instruction's leaflet; however, the vaccine was not available for return because was used.  On that day, the clinic lost power and the vaccine was administered to the patient before being cleared by manufacturer for use. On 20-OCT-2021, the manufacturer was contacted and were cleared all affected vaccines for use. The patient involved had not reported any adverse reactions to immunization. All staff clinic was aware to have vaccines cleared by manufacturer after a temperature excursion. The temperature excursion occurred as a result of a reading from the digital data logger.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: She denied further AE.; administered to a patient after experiencing a temperature excursion.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 04-OCT-2021 the patient was vaccinated with with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot # T013204 was confirmed to be valid with expiration date 03-DEC-2021 (route of administration, anatomical location were not reported) for prophylaxis. The administered dose underwent a temperature excursion of 50.5 degrees Fahrenheit for 30 minutes. There were no previous temperature excursions. No additional adverse effect was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2110USA007288: US-009507513-2110USA007310: US-009507513-2110USA007316:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additioanl AE details available; Vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a Medical Assistant, referring to a 12 month old patient of unknown gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 13-OCT-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), with lot # T032932 and expiration date on 28-SEP-2022 (route was not provided) for prophylaxis, after the vaccine experienced a temperature excursion (product storage error).  Varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit (8.5F), for 0 hours, 18 minutes 0 seconds and 6 degree Fahrenheit to 14 degree Fahrenheit (11.9F) for 1 hour 0 minutes 0 seconds. Cumulative timeframe of the exposure was 1 hour and 18 minutes.  The vaccine was not exposed to any other previous temperature excursion. No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA007447:
Age: 1.42
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; Vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a Medical Assistant, referring to a 17 month old patient of unknown gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 14-OCT-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), with lot # T032932 and expiration date on 28-SEP-2022 (route was not provided) for prophylaxis, after the vaccine experienced a temperature excursion (product storage error).  Varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit (8.5F), for 0 hours, 18 minutes 0 seconds and 6 degree Fahrenheit to 14 degree Fahrenheit (11.9F) for 1 hour 0 minutes 0 seconds. Cumulative timeframe of the exposure was 1 hour and 18 minutes.  The vaccine was not exposed to any other previous temperature excursion. No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA007438:
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; vaccines were administered after experiencing temperature excursion.; Information has been received from a medical assistant referring to a 2 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 18-OCT-2021, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T032317, expiration date 22-SEP-2022, dose, strength and route were unknown) for prophylaxis. The vaccine had experiencing temperature excursion between 6 to 14 degrees Fahrenheit (8.5 degrees Fahrenheit) for 18 minutes and between 6 to 14 degrees Fahrenheit (11.9 degrees Fahrenheit) for 1 hour (product storage error). There was no previous temperature excursion. No additional AE details available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: herpes zoster; Information has been received from a lawyer refers to a patient of unknown age and gender, concerning a case in litigation. The patient's concurrent conditions, historical conditions and concomitant therapy were not reported. In or around 01-NOV-2016, Patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered blisters on the left side of the suprapubic area that cross the midline with burning type pain and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. As a direct and proximate result of company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).