chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Device occlusion, Weight
Clinical narrative: they tried to administer it to the patient, they were unable to discharge the vaccine into the patient's arm.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Lot number: HG4664, Expiration Date: Dec2023) at the age of 70 years intramuscular, in arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE OCCLUSION (non-serious) with onset 11Oct2023, outcome "unknown", described as "they tried to administer it to the patient, they were unable to discharge the vaccine into the patient's arm.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller is a pharmacist reporting that they took two syringes of the Pfizer covid-19 vaccine for 12 years and older that they took from the same box and when they tried to administer it to the patient, they were unable to discharge the vaccine into the patient's arm. Caller stated that they called to report these two faulty syringes from the same box and are hoping to have the faulty syringes replaced. He mentioned that he pulled out 2 syringes from the same box and both syringes were unable to discharge the vaccine in to patient's arm but when they took a syringe from a different box, it worked well. They are suspecting that the two syringes are faulty, and they are hoping for a replacement. Site of administration was originally on the left arm and then they also tried her right arm. No prior vaccination (4 weeks prior).  The reporter considered "they tried to administer it to the patient, they were unable to discharge the vaccine into the patient's arm." not related to bnt162b2 omi xbb.1.5. Causality for "they tried to administer it to the patient, they were unable to discharge the vaccine into the patient's arm." was determined associated to device constituent of bnt162b2 omi xbb.1.5.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 14Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 03Oct2023 to 07Oct2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely,Linked Report(s) : US-PFIZER INC-202300328361 same patient, different product/ event;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 14Apr2021 at 16:00 as dose 1, single (Lot number: EE0164), in right arm, on 05May2021 at 16:00 as dose 2, single (Lot number: EW0179), in right arm and on 23Nov2021 at 16:30 as dose 3, single (Lot number: FH8020) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 04Oct2023 to 09Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300328715 Same reporter/patient, different drug, different event.;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 13:00 as dose 2, single (Lot number: GJ2524) at the age of 66 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 10May2022 at 13:00 as dose 1, single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "knee replacement surgery", start date: 20Jul2023 (not ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19 with PAXLOVID from 30Sep2023 to 04Oct2023. Clinical course: Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300328723 same reporter/patient, different product/AE;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Between second and third dose of Pfizer BioNTech Vaccines, the reporter experienced a  Covid 19 infection.; Between second and third dose of Pfizer BioNTech Vaccines, the reporter experienced a  Covid 19 infection.; This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Between second and third dose of Pfizer BioNTech Vaccines, the reporter experienced a Covid 19 infection.". Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Adverse event: Between second and third dose of Pfizer BioNTech Vaccines, the reporter experienced a Covid 19 infection. No treatment was received. No covid was prior vaccination. Covid tested post vaccination was Unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Between the 3rd and 4th doses of Pfizer BioNTech vaccines, the report had a Covid 19 infection.; Between the 3rd and 4th doses of Pfizer BioNTech vaccines, the report had a Covid 19 infection.; This is a spontaneous report received from non-contactable reporter(s) (Physician).  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Between the 3rd and 4th doses of Pfizer BioNTech vaccines, the report had a Covid 19 infection.". Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: There was no covid prior to vaccination and it was unknown if patient tested for covid post vaccination. It was unknown if patient received other vaccine in four weeks. The patient most recent dose was Comirnaty dose 6.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect product cannot be fully excluded.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 56 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid started from 02Oct2023 to 06Oct2023..; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300328745 same reporter/patient, different product/AE;
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: arm pain and now can't lift left arm since vaccine was given
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Antinuclear antibody negative, Asthenia, Blood creatine phosphokinase normal, COVID-19, Cardiac output decreased
Clinical narrative: Patient is a 73 y.o. female patient of MD with a history of PMR on chronic prednisone, paroxysmal atrial fibrillation on Eliquis, postmenopausal bleeding s/p surgical hysteroscopy, endometrial ablation/IUD insertion 8/17/23, T2DM, GERD, Urinary Incontinence who presented to Hospital 9/13/2023 with generalized weakness, and two weeks of URI symptoms. She was found to be positive for COVID (9/14/23). Was transferred to the ICU with impending respiratory failure, she was intubated on 9/17/23.Found to have GBS, neurology and PMR followed. IVIG treatment began. Palliative care followed and ultimately with further decline was transitioned to comfort care and compassionately extubated 9/26/23.  Acute Hypoxic Respiratory Failure -Suspected due to aggressive Guillain Barre progression  -Intubated 9/17 due to impending airway compromise -CTPA 9/17: No evidence of PE. Mild GGO, evidence of PAH, decreased Cardiac Output.  -Patient will likely require tracheostomy de to AIDP/GBS prognosis if aggressive care is desired -Methylprednisolone 40 mg x 10 days (EOT 9/27/23) for Covid hypoxemia -Acute change in mental status, not responding to pain. CT head on 9/24 with no acute intracranial process.  -Compassionately extubated 9/26/23 and passed.    Guillain Barre Syndrome -Suspected due to Covid, bloody diarrhea (Possible C. Jejuni) -Ganglioside Monosialic Antibody panel was lipemic. Second Panel still pending. -PMR completed NCS/EMG highly consistent with AIDP (Guillain-Barre Syndrome) concerned will need trach and LTAC placement when medically ready in addition to PEG.  -Neurology consulted for further evaluation, appreciate recommendations. Started IVIG, rate decreased due to suspected hypersensitivity reaction. No further need for LP. -Gabapentin 300 mg TID for neuropathic pain. Continue oxy Q4 with break through diluadid. -IVIG 0.4 gm/kg x 5 days. Premedicated with benadryl and tylenol, slowed rate and response well. -GOC per above.   Quadriparesis Respiratory Weakness -Suspect Secondary to GBS. With PRM, much less likely to be other etiology -Myasthenia Gravis panel pending, Myositits Myo Marker Panel pending  -MRI (9/14/23) and CT Head (9/14/23) Negative for acute infarct or acute intracranial process. Further imaging as above. -CK, ANA, DS-DNA, ENA, P-ANCA all WNL. -MRI Pan scan 9/18 primarily unremarkable -Management as above.   Takotsubo Cardiomyopathy HFrEF -Likely secondary to GBS. Possibly secondary to Covid 19. -TTE (9/18/23) showing apical hypokinesis and LVEF of 28%, no noted LVOT   Covid 19 Infection  -Positive PCR (9/14/23), reportedly experiencing upper respiratory illness for 2x weeks prior to admission -Urine Culture growing GBS (9/13/23) -CXR (9/17/23) with no active disease -Bcx, Sputum Culture NGTD -Isolation removed (9/20/23)    Sinus Tachycardia -Likely in the setting of cardiac arrhythmia's due to GBS, pain  -EKG (9/17/23) NSR, non acute. Patient prior to intubation with no chest pain. -ECHO as above. EKG (9/20/23) Non acute
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Culture urine positive, Death, Diarrhoea haemorrhagic
Clinical narrative: Patient is a 73 y.o. female patient of MD with a history of PMR on chronic prednisone, paroxysmal atrial fibrillation on Eliquis, postmenopausal bleeding s/p surgical hysteroscopy, endometrial ablation/IUD insertion 8/17/23, T2DM, GERD, Urinary Incontinence who presented to Hospital 9/13/2023 with generalized weakness, and two weeks of URI symptoms. She was found to be positive for COVID (9/14/23). Was transferred to the ICU with impending respiratory failure, she was intubated on 9/17/23.Found to have GBS, neurology and PMR followed. IVIG treatment began. Palliative care followed and ultimately with further decline was transitioned to comfort care and compassionately extubated 9/26/23.  Acute Hypoxic Respiratory Failure -Suspected due to aggressive Guillain Barre progression  -Intubated 9/17 due to impending airway compromise -CTPA 9/17: No evidence of PE. Mild GGO, evidence of PAH, decreased Cardiac Output.  -Patient will likely require tracheostomy de to AIDP/GBS prognosis if aggressive care is desired -Methylprednisolone 40 mg x 10 days (EOT 9/27/23) for Covid hypoxemia -Acute change in mental status, not responding to pain. CT head on 9/24 with no acute intracranial process.  -Compassionately extubated 9/26/23 and passed.    Guillain Barre Syndrome -Suspected due to Covid, bloody diarrhea (Possible C. Jejuni) -Ganglioside Monosialic Antibody panel was lipemic. Second Panel still pending. -PMR completed NCS/EMG highly consistent with AIDP (Guillain-Barre Syndrome) concerned will need trach and LTAC placement when medically ready in addition to PEG.  -Neurology consulted for further evaluation, appreciate recommendations. Started IVIG, rate decreased due to suspected hypersensitivity reaction. No further need for LP. -Gabapentin 300 mg TID for neuropathic pain. Continue oxy Q4 with break through diluadid. -IVIG 0.4 gm/kg x 5 days. Premedicated with benadryl and tylenol, slowed rate and response well. -GOC per above.   Quadriparesis Respiratory Weakness -Suspect Secondary to GBS. With PRM, much less likely to be other etiology -Myasthenia Gravis panel pending, Myositits Myo Marker Panel pending  -MRI (9/14/23) and CT Head (9/14/23) Negative for acute infarct or acute intracranial process. Further imaging as above. -CK, ANA, DS-DNA, ENA, P-ANCA all WNL. -MRI Pan scan 9/18 primarily unremarkable -Management as above.   Takotsubo Cardiomyopathy HFrEF -Likely secondary to GBS. Possibly secondary to Covid 19. -TTE (9/18/23) showing apical hypokinesis and LVEF of 28%, no noted LVOT   Covid 19 Infection  -Positive PCR (9/14/23), reportedly experiencing upper respiratory illness for 2x weeks prior to admission -Urine Culture growing GBS (9/13/23) -CXR (9/17/23) with no active disease -Bcx, Sputum Culture NGTD -Isolation removed (9/20/23)    Sinus Tachycardia -Likely in the setting of cardiac arrhythmia's due to GBS, pain  -EKG (9/17/23) NSR, non acute. Patient prior to intubation with no chest pain. -ECHO as above. EKG (9/20/23) Non acute
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Double stranded DNA antibody, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram normal, Electromyogram abnormal
Clinical narrative: Patient is a 73 y.o. female patient of MD with a history of PMR on chronic prednisone, paroxysmal atrial fibrillation on Eliquis, postmenopausal bleeding s/p surgical hysteroscopy, endometrial ablation/IUD insertion 8/17/23, T2DM, GERD, Urinary Incontinence who presented to Hospital 9/13/2023 with generalized weakness, and two weeks of URI symptoms. She was found to be positive for COVID (9/14/23). Was transferred to the ICU with impending respiratory failure, she was intubated on 9/17/23.Found to have GBS, neurology and PMR followed. IVIG treatment began. Palliative care followed and ultimately with further decline was transitioned to comfort care and compassionately extubated 9/26/23.  Acute Hypoxic Respiratory Failure -Suspected due to aggressive Guillain Barre progression  -Intubated 9/17 due to impending airway compromise -CTPA 9/17: No evidence of PE. Mild GGO, evidence of PAH, decreased Cardiac Output.  -Patient will likely require tracheostomy de to AIDP/GBS prognosis if aggressive care is desired -Methylprednisolone 40 mg x 10 days (EOT 9/27/23) for Covid hypoxemia -Acute change in mental status, not responding to pain. CT head on 9/24 with no acute intracranial process.  -Compassionately extubated 9/26/23 and passed.    Guillain Barre Syndrome -Suspected due to Covid, bloody diarrhea (Possible C. Jejuni) -Ganglioside Monosialic Antibody panel was lipemic. Second Panel still pending. -PMR completed NCS/EMG highly consistent with AIDP (Guillain-Barre Syndrome) concerned will need trach and LTAC placement when medically ready in addition to PEG.  -Neurology consulted for further evaluation, appreciate recommendations. Started IVIG, rate decreased due to suspected hypersensitivity reaction. No further need for LP. -Gabapentin 300 mg TID for neuropathic pain. Continue oxy Q4 with break through diluadid. -IVIG 0.4 gm/kg x 5 days. Premedicated with benadryl and tylenol, slowed rate and response well. -GOC per above.   Quadriparesis Respiratory Weakness -Suspect Secondary to GBS. With PRM, much less likely to be other etiology -Myasthenia Gravis panel pending, Myositits Myo Marker Panel pending  -MRI (9/14/23) and CT Head (9/14/23) Negative for acute infarct or acute intracranial process. Further imaging as above. -CK, ANA, DS-DNA, ENA, P-ANCA all WNL. -MRI Pan scan 9/18 primarily unremarkable -Management as above.   Takotsubo Cardiomyopathy HFrEF -Likely secondary to GBS. Possibly secondary to Covid 19. -TTE (9/18/23) showing apical hypokinesis and LVEF of 28%, no noted LVOT   Covid 19 Infection  -Positive PCR (9/14/23), reportedly experiencing upper respiratory illness for 2x weeks prior to admission -Urine Culture growing GBS (9/13/23) -CXR (9/17/23) with no active disease -Bcx, Sputum Culture NGTD -Isolation removed (9/20/23)    Sinus Tachycardia -Likely in the setting of cardiac arrhythmia's due to GBS, pain  -EKG (9/17/23) NSR, non acute. Patient prior to intubation with no chest pain. -ECHO as above. EKG (9/20/23) Non acute
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Hypoxia, Immunoglobulin therapy, Intensive care
Clinical narrative: Patient is a 73 y.o. female patient of MD with a history of PMR on chronic prednisone, paroxysmal atrial fibrillation on Eliquis, postmenopausal bleeding s/p surgical hysteroscopy, endometrial ablation/IUD insertion 8/17/23, T2DM, GERD, Urinary Incontinence who presented to Hospital 9/13/2023 with generalized weakness, and two weeks of URI symptoms. She was found to be positive for COVID (9/14/23). Was transferred to the ICU with impending respiratory failure, she was intubated on 9/17/23.Found to have GBS, neurology and PMR followed. IVIG treatment began. Palliative care followed and ultimately with further decline was transitioned to comfort care and compassionately extubated 9/26/23.  Acute Hypoxic Respiratory Failure -Suspected due to aggressive Guillain Barre progression  -Intubated 9/17 due to impending airway compromise -CTPA 9/17: No evidence of PE. Mild GGO, evidence of PAH, decreased Cardiac Output.  -Patient will likely require tracheostomy de to AIDP/GBS prognosis if aggressive care is desired -Methylprednisolone 40 mg x 10 days (EOT 9/27/23) for Covid hypoxemia -Acute change in mental status, not responding to pain. CT head on 9/24 with no acute intracranial process.  -Compassionately extubated 9/26/23 and passed.    Guillain Barre Syndrome -Suspected due to Covid, bloody diarrhea (Possible C. Jejuni) -Ganglioside Monosialic Antibody panel was lipemic. Second Panel still pending. -PMR completed NCS/EMG highly consistent with AIDP (Guillain-Barre Syndrome) concerned will need trach and LTAC placement when medically ready in addition to PEG.  -Neurology consulted for further evaluation, appreciate recommendations. Started IVIG, rate decreased due to suspected hypersensitivity reaction. No further need for LP. -Gabapentin 300 mg TID for neuropathic pain. Continue oxy Q4 with break through diluadid. -IVIG 0.4 gm/kg x 5 days. Premedicated with benadryl and tylenol, slowed rate and response well. -GOC per above.   Quadriparesis Respiratory Weakness -Suspect Secondary to GBS. With PRM, much less likely to be other etiology -Myasthenia Gravis panel pending, Myositits Myo Marker Panel pending  -MRI (9/14/23) and CT Head (9/14/23) Negative for acute infarct or acute intracranial process. Further imaging as above. -CK, ANA, DS-DNA, ENA, P-ANCA all WNL. -MRI Pan scan 9/18 primarily unremarkable -Management as above.   Takotsubo Cardiomyopathy HFrEF -Likely secondary to GBS. Possibly secondary to Covid 19. -TTE (9/18/23) showing apical hypokinesis and LVEF of 28%, no noted LVOT   Covid 19 Infection  -Positive PCR (9/14/23), reportedly experiencing upper respiratory illness for 2x weeks prior to admission -Urine Culture growing GBS (9/13/23) -CXR (9/17/23) with no active disease -Bcx, Sputum Culture NGTD -Isolation removed (9/20/23)    Sinus Tachycardia -Likely in the setting of cardiac arrhythmia's due to GBS, pain  -EKG (9/17/23) NSR, non acute. Patient prior to intubation with no chest pain. -ECHO as above. EKG (9/20/23) Non acute
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Left ventricular failure, Lung opacity, Magnetic resonance imaging head normal, Magnetic resonance imaging normal, Mental status changes
Clinical narrative: Patient is a 73 y.o. female patient of MD with a history of PMR on chronic prednisone, paroxysmal atrial fibrillation on Eliquis, postmenopausal bleeding s/p surgical hysteroscopy, endometrial ablation/IUD insertion 8/17/23, T2DM, GERD, Urinary Incontinence who presented to Hospital 9/13/2023 with generalized weakness, and two weeks of URI symptoms. She was found to be positive for COVID (9/14/23). Was transferred to the ICU with impending respiratory failure, she was intubated on 9/17/23.Found to have GBS, neurology and PMR followed. IVIG treatment began. Palliative care followed and ultimately with further decline was transitioned to comfort care and compassionately extubated 9/26/23.  Acute Hypoxic Respiratory Failure -Suspected due to aggressive Guillain Barre progression  -Intubated 9/17 due to impending airway compromise -CTPA 9/17: No evidence of PE. Mild GGO, evidence of PAH, decreased Cardiac Output.  -Patient will likely require tracheostomy de to AIDP/GBS prognosis if aggressive care is desired -Methylprednisolone 40 mg x 10 days (EOT 9/27/23) for Covid hypoxemia -Acute change in mental status, not responding to pain. CT head on 9/24 with no acute intracranial process.  -Compassionately extubated 9/26/23 and passed.    Guillain Barre Syndrome -Suspected due to Covid, bloody diarrhea (Possible C. Jejuni) -Ganglioside Monosialic Antibody panel was lipemic. Second Panel still pending. -PMR completed NCS/EMG highly consistent with AIDP (Guillain-Barre Syndrome) concerned will need trach and LTAC placement when medically ready in addition to PEG.  -Neurology consulted for further evaluation, appreciate recommendations. Started IVIG, rate decreased due to suspected hypersensitivity reaction. No further need for LP. -Gabapentin 300 mg TID for neuropathic pain. Continue oxy Q4 with break through diluadid. -IVIG 0.4 gm/kg x 5 days. Premedicated with benadryl and tylenol, slowed rate and response well. -GOC per above.   Quadriparesis Respiratory Weakness -Suspect Secondary to GBS. With PRM, much less likely to be other etiology -Myasthenia Gravis panel pending, Myositits Myo Marker Panel pending  -MRI (9/14/23) and CT Head (9/14/23) Negative for acute infarct or acute intracranial process. Further imaging as above. -CK, ANA, DS-DNA, ENA, P-ANCA all WNL. -MRI Pan scan 9/18 primarily unremarkable -Management as above.   Takotsubo Cardiomyopathy HFrEF -Likely secondary to GBS. Possibly secondary to Covid 19. -TTE (9/18/23) showing apical hypokinesis and LVEF of 28%, no noted LVOT   Covid 19 Infection  -Positive PCR (9/14/23), reportedly experiencing upper respiratory illness for 2x weeks prior to admission -Urine Culture growing GBS (9/13/23) -CXR (9/17/23) with no active disease -Bcx, Sputum Culture NGTD -Isolation removed (9/20/23)    Sinus Tachycardia -Likely in the setting of cardiac arrhythmia's due to GBS, pain  -EKG (9/17/23) NSR, non acute. Patient prior to intubation with no chest pain. -ECHO as above. EKG (9/20/23) Non acute
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nerve conduction studies abnormal, Quadriparesis, Respiratory disorder, Respiratory symptom, SARS-CoV-2 test positive
Clinical narrative: Patient is a 73 y.o. female patient of MD with a history of PMR on chronic prednisone, paroxysmal atrial fibrillation on Eliquis, postmenopausal bleeding s/p surgical hysteroscopy, endometrial ablation/IUD insertion 8/17/23, T2DM, GERD, Urinary Incontinence who presented to Hospital 9/13/2023 with generalized weakness, and two weeks of URI symptoms. She was found to be positive for COVID (9/14/23). Was transferred to the ICU with impending respiratory failure, she was intubated on 9/17/23.Found to have GBS, neurology and PMR followed. IVIG treatment began. Palliative care followed and ultimately with further decline was transitioned to comfort care and compassionately extubated 9/26/23.  Acute Hypoxic Respiratory Failure -Suspected due to aggressive Guillain Barre progression  -Intubated 9/17 due to impending airway compromise -CTPA 9/17: No evidence of PE. Mild GGO, evidence of PAH, decreased Cardiac Output.  -Patient will likely require tracheostomy de to AIDP/GBS prognosis if aggressive care is desired -Methylprednisolone 40 mg x 10 days (EOT 9/27/23) for Covid hypoxemia -Acute change in mental status, not responding to pain. CT head on 9/24 with no acute intracranial process.  -Compassionately extubated 9/26/23 and passed.    Guillain Barre Syndrome -Suspected due to Covid, bloody diarrhea (Possible C. Jejuni) -Ganglioside Monosialic Antibody panel was lipemic. Second Panel still pending. -PMR completed NCS/EMG highly consistent with AIDP (Guillain-Barre Syndrome) concerned will need trach and LTAC placement when medically ready in addition to PEG.  -Neurology consulted for further evaluation, appreciate recommendations. Started IVIG, rate decreased due to suspected hypersensitivity reaction. No further need for LP. -Gabapentin 300 mg TID for neuropathic pain. Continue oxy Q4 with break through diluadid. -IVIG 0.4 gm/kg x 5 days. Premedicated with benadryl and tylenol, slowed rate and response well. -GOC per above.   Quadriparesis Respiratory Weakness -Suspect Secondary to GBS. With PRM, much less likely to be other etiology -Myasthenia Gravis panel pending, Myositits Myo Marker Panel pending  -MRI (9/14/23) and CT Head (9/14/23) Negative for acute infarct or acute intracranial process. Further imaging as above. -CK, ANA, DS-DNA, ENA, P-ANCA all WNL. -MRI Pan scan 9/18 primarily unremarkable -Management as above.   Takotsubo Cardiomyopathy HFrEF -Likely secondary to GBS. Possibly secondary to Covid 19. -TTE (9/18/23) showing apical hypokinesis and LVEF of 28%, no noted LVOT   Covid 19 Infection  -Positive PCR (9/14/23), reportedly experiencing upper respiratory illness for 2x weeks prior to admission -Urine Culture growing GBS (9/13/23) -CXR (9/17/23) with no active disease -Bcx, Sputum Culture NGTD -Isolation removed (9/20/23)    Sinus Tachycardia -Likely in the setting of cardiac arrhythmia's due to GBS, pain  -EKG (9/17/23) NSR, non acute. Patient prior to intubation with no chest pain. -ECHO as above. EKG (9/20/23) Non acute
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinus tachycardia, Sputum culture, Stress cardiomyopathy, Unresponsive to stimuli, Upper respiratory tract infection
Clinical narrative: Patient is a 73 y.o. female patient of MD with a history of PMR on chronic prednisone, paroxysmal atrial fibrillation on Eliquis, postmenopausal bleeding s/p surgical hysteroscopy, endometrial ablation/IUD insertion 8/17/23, T2DM, GERD, Urinary Incontinence who presented to Hospital 9/13/2023 with generalized weakness, and two weeks of URI symptoms. She was found to be positive for COVID (9/14/23). Was transferred to the ICU with impending respiratory failure, she was intubated on 9/17/23.Found to have GBS, neurology and PMR followed. IVIG treatment began. Palliative care followed and ultimately with further decline was transitioned to comfort care and compassionately extubated 9/26/23.  Acute Hypoxic Respiratory Failure -Suspected due to aggressive Guillain Barre progression  -Intubated 9/17 due to impending airway compromise -CTPA 9/17: No evidence of PE. Mild GGO, evidence of PAH, decreased Cardiac Output.  -Patient will likely require tracheostomy de to AIDP/GBS prognosis if aggressive care is desired -Methylprednisolone 40 mg x 10 days (EOT 9/27/23) for Covid hypoxemia -Acute change in mental status, not responding to pain. CT head on 9/24 with no acute intracranial process.  -Compassionately extubated 9/26/23 and passed.    Guillain Barre Syndrome -Suspected due to Covid, bloody diarrhea (Possible C. Jejuni) -Ganglioside Monosialic Antibody panel was lipemic. Second Panel still pending. -PMR completed NCS/EMG highly consistent with AIDP (Guillain-Barre Syndrome) concerned will need trach and LTAC placement when medically ready in addition to PEG.  -Neurology consulted for further evaluation, appreciate recommendations. Started IVIG, rate decreased due to suspected hypersensitivity reaction. No further need for LP. -Gabapentin 300 mg TID for neuropathic pain. Continue oxy Q4 with break through diluadid. -IVIG 0.4 gm/kg x 5 days. Premedicated with benadryl and tylenol, slowed rate and response well. -GOC per above.   Quadriparesis Respiratory Weakness -Suspect Secondary to GBS. With PRM, much less likely to be other etiology -Myasthenia Gravis panel pending, Myositits Myo Marker Panel pending  -MRI (9/14/23) and CT Head (9/14/23) Negative for acute infarct or acute intracranial process. Further imaging as above. -CK, ANA, DS-DNA, ENA, P-ANCA all WNL. -MRI Pan scan 9/18 primarily unremarkable -Management as above.   Takotsubo Cardiomyopathy HFrEF -Likely secondary to GBS. Possibly secondary to Covid 19. -TTE (9/18/23) showing apical hypokinesis and LVEF of 28%, no noted LVOT   Covid 19 Infection  -Positive PCR (9/14/23), reportedly experiencing upper respiratory illness for 2x weeks prior to admission -Urine Culture growing GBS (9/13/23) -CXR (9/17/23) with no active disease -Bcx, Sputum Culture NGTD -Isolation removed (9/20/23)    Sinus Tachycardia -Likely in the setting of cardiac arrhythmia's due to GBS, pain  -EKG (9/17/23) NSR, non acute. Patient prior to intubation with no chest pain. -ECHO as above. EKG (9/20/23) Non acute
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ventricular hypokinesia
Clinical narrative: Patient is a 73 y.o. female patient of MD with a history of PMR on chronic prednisone, paroxysmal atrial fibrillation on Eliquis, postmenopausal bleeding s/p surgical hysteroscopy, endometrial ablation/IUD insertion 8/17/23, T2DM, GERD, Urinary Incontinence who presented to Hospital 9/13/2023 with generalized weakness, and two weeks of URI symptoms. She was found to be positive for COVID (9/14/23). Was transferred to the ICU with impending respiratory failure, she was intubated on 9/17/23.Found to have GBS, neurology and PMR followed. IVIG treatment began. Palliative care followed and ultimately with further decline was transitioned to comfort care and compassionately extubated 9/26/23.  Acute Hypoxic Respiratory Failure -Suspected due to aggressive Guillain Barre progression  -Intubated 9/17 due to impending airway compromise -CTPA 9/17: No evidence of PE. Mild GGO, evidence of PAH, decreased Cardiac Output.  -Patient will likely require tracheostomy de to AIDP/GBS prognosis if aggressive care is desired -Methylprednisolone 40 mg x 10 days (EOT 9/27/23) for Covid hypoxemia -Acute change in mental status, not responding to pain. CT head on 9/24 with no acute intracranial process.  -Compassionately extubated 9/26/23 and passed.    Guillain Barre Syndrome -Suspected due to Covid, bloody diarrhea (Possible C. Jejuni) -Ganglioside Monosialic Antibody panel was lipemic. Second Panel still pending. -PMR completed NCS/EMG highly consistent with AIDP (Guillain-Barre Syndrome) concerned will need trach and LTAC placement when medically ready in addition to PEG.  -Neurology consulted for further evaluation, appreciate recommendations. Started IVIG, rate decreased due to suspected hypersensitivity reaction. No further need for LP. -Gabapentin 300 mg TID for neuropathic pain. Continue oxy Q4 with break through diluadid. -IVIG 0.4 gm/kg x 5 days. Premedicated with benadryl and tylenol, slowed rate and response well. -GOC per above.   Quadriparesis Respiratory Weakness -Suspect Secondary to GBS. With PRM, much less likely to be other etiology -Myasthenia Gravis panel pending, Myositits Myo Marker Panel pending  -MRI (9/14/23) and CT Head (9/14/23) Negative for acute infarct or acute intracranial process. Further imaging as above. -CK, ANA, DS-DNA, ENA, P-ANCA all WNL. -MRI Pan scan 9/18 primarily unremarkable -Management as above.   Takotsubo Cardiomyopathy HFrEF -Likely secondary to GBS. Possibly secondary to Covid 19. -TTE (9/18/23) showing apical hypokinesis and LVEF of 28%, no noted LVOT   Covid 19 Infection  -Positive PCR (9/14/23), reportedly experiencing upper respiratory illness for 2x weeks prior to admission -Urine Culture growing GBS (9/13/23) -CXR (9/17/23) with no active disease -Bcx, Sputum Culture NGTD -Isolation removed (9/20/23)    Sinus Tachycardia -Likely in the setting of cardiac arrhythmia's due to GBS, pain  -EKG (9/17/23) NSR, non acute. Patient prior to intubation with no chest pain. -ECHO as above. EKG (9/20/23) Non acute
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Anxiety, Chills, Condition aggravated, Confusional state, Diplopia
Clinical narrative: 1. local injection site reaction for 10 days after vaccine (walnut sized knot, warmth, some redness, soreness) 2. chills, fatigue, low grade fever for 48 hours post vaccine 3. extreme fatigue, mental confusion and forgetfulness, neuropathy in hands and now feet, blurry and double vision starting 48 hours after vaccine and still on-going 4. anxiety, panic, and hallucinations during hospitalization for 24 hours, resolved now
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Hallucination, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: 1. local injection site reaction for 10 days after vaccine (walnut sized knot, warmth, some redness, soreness) 2. chills, fatigue, low grade fever for 48 hours post vaccine 3. extreme fatigue, mental confusion and forgetfulness, neuropathy in hands and now feet, blurry and double vision starting 48 hours after vaccine and still on-going 4. anxiety, panic, and hallucinations during hospitalization for 24 hours, resolved now
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth, Memory impairment, Neuropathy peripheral, Panic reaction, Pyrexia
Clinical narrative: 1. local injection site reaction for 10 days after vaccine (walnut sized knot, warmth, some redness, soreness) 2. chills, fatigue, low grade fever for 48 hours post vaccine 3. extreme fatigue, mental confusion and forgetfulness, neuropathy in hands and now feet, blurry and double vision starting 48 hours after vaccine and still on-going 4. anxiety, panic, and hallucinations during hospitalization for 24 hours, resolved now
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Vision blurred
Clinical narrative: 1. local injection site reaction for 10 days after vaccine (walnut sized knot, warmth, some redness, soreness) 2. chills, fatigue, low grade fever for 48 hours post vaccine 3. extreme fatigue, mental confusion and forgetfulness, neuropathy in hands and now feet, blurry and double vision starting 48 hours after vaccine and still on-going 4. anxiety, panic, and hallucinations during hospitalization for 24 hours, resolved now
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Less than 24hrs after vaccination I have the following symptoms at the injection site: soreness, oval-shaped red lump underneath skin about 2in long and 1inch wide. Warm to the touch and lightly firm. These symptoms are localized to the upper arm, at injection site. The redness appears to be decreasing as the day goes on.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain / swelling initially at injection site then increasing 6 inches down from injection site/Sore, swollen, hot to the touch; Pain / swelling initially at injection site then increasing 6 inches down from injection site/Sore, swollen, hot to the touch; Pain / swelling initially at injection site then increasing 6 inches down from injection site/Sore, swollen, hot to the touch; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  An elderly female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "Pain / swelling initially at injection site then increasing 6 inches down from injection site/Sore, swollen, hot to the touch". It was unknown if therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling, vaccination site warmth.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: CSF protein increased, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: ? Guillain-Barré syndrome (GBS) Commenced on IVIG
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cholangiocarcinoma, Jaundice
Clinical narrative: Started having jaundice. Went to doctor 10/12/'23. Dx with cholangeal CA
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 17.0
Sex: M
Vaccine: COVID19-2, FLUR4
Symptoms: Incorrect dose administered
Clinical narrative: Patient at age of 17 was given Flublock vaccine
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Acne, Back pain, Bone pain, Chest pain, Herpes zoster
Clinical narrative: Note that I do not know the precise flu shot I received; I simply picked the first flu shot in the dropdown list.  Timeline of events: Oct 2, 2023: received flu shot in left should (don't know which kind of flu shot) Oct 5ish: I began feeling pain in my chest and back. It was decidedly not muscular pain ? it felt like it was in my bones. Oct 8: rash/pimples characteristic of shingles appear on the right side of my chest Oct 9: go to doctor; receive confirmation that I have shingles Oct 18: am writing this with shingles  At 29 years of age, to suddenly get shingles is certainly odd? the only thing that happened in the preceding days is me getting the flu shot, which almost perfectly coincides with the onset of pain three days later that preceded the outwardly visible shingles.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Note that I do not know the precise flu shot I received; I simply picked the first flu shot in the dropdown list.  Timeline of events: Oct 2, 2023: received flu shot in left should (don't know which kind of flu shot) Oct 5ish: I began feeling pain in my chest and back. It was decidedly not muscular pain ? it felt like it was in my bones. Oct 8: rash/pimples characteristic of shingles appear on the right side of my chest Oct 9: go to doctor; receive confirmation that I have shingles Oct 18: am writing this with shingles  At 29 years of age, to suddenly get shingles is certainly odd? the only thing that happened in the preceding days is me getting the flu shot, which almost perfectly coincides with the onset of pain three days later that preceded the outwardly visible shingles.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Pericarditis
Clinical narrative: Pericarditis- chest pain beginning 5 hours after vaccination.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: The patient was given the vaccine. During the 15-minute observation period the patient became lightheaded, blacked out and slid out of the chair he was sitting in. The patient was asked to lay down. The patient asked for water and chocolate and was given both. Emergency medical services were called (fire department). The firemen took the patient's blood pressure and asked if he wanted to be taken to the hospital. The patient refused to be transported to the hospital. The patient was then asked to remain seated for an additional 10 minutes and was picked up from the pharmacy by his friend.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: one-sided headache pain
Sex: U
Vaccine: RSV
Symptoms: SARS-CoV-2 test negative
Clinical narrative: low grade fever, 99.5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for respiratory syncytial virus immunisation; for respiratory syncytial virus immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "low grade fever, 99.5". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: "Inquiry: Rsv vaccine side effects. I had the vaccine yesterday. My arm is not sore but i do have a low grade fever, 99.5. Is that a normal side effect? I did a covid test for safety and am negative. How long will the fever last? Is a low grade fever normal after the RSv vaccine?".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: 6 hrs post vax, felt malaise that lasted into Friday all day.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP/high Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for influenza immunisation, on 14Sep2023 as dose number unknown, single. The following information was reported: MALAISE (non-serious) with onset 12Oct2023 at 15:00, outcome "recovered" (Oct2023), described as "6 hrs post vax, felt malaise that lasted into Friday all day.". Therapeutic measures were not taken as a result of malaise.  Additional information: Patient received vaccine in PRIVACY clinic.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Taste disorder
Clinical narrative: Bad mouth taste for three days; Terrible heartburn one day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Cephalexin" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: TASTE DISORDER (non-serious) with onset 07Oct2023, outcome "recovered" (Oct2023), described as "Bad mouth taste for three days"; DYSPEPSIA (non-serious) with onset 07Oct2023, outcome "recovered" (Oct2023), described as "Terrible heartburn one day". Therapeutic measures were not taken as a result of taste disorder, dyspepsia.  Additional information: Patient received no other vaccine in four weeks and no COVID prior vaccination and not COVID tested post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.