chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Myelitis transverse, Pain in extremity
Clinical narrative: idiopathic Transverse Myelitis; This is a literature report for the following literature source(s):   A 71-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, administration date: 12Feb2021, for COVID-19 immunisation. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 05Mar2021, outcome "unknown", described as "idiopathic Transverse Myelitis". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging spinal: Normal. Clinical courses: Headache, cramping after 2nd injection; chills, fatigue, leg pain and difficulty walking by the second day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event transverse myelitis  cannot be excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: idiopathic transverse myelitis; This is a literature report. This is a literature report based on a Health Authority database analysis.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, 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: MYELITIS TRANSVERSE (medically significant) with onset 24Jan2021, outcome "recovering", described as "idiopathic transverse myelitis". Adverse event summary was reported as inability to walk. Bowel and urinary dysfunction. Left side numb from toes to breast and right side numb from toes to groin. Left leg weakness. Some recovery of sensation but ongoing bowel and urinary issues. Treated five days high dose steroids. Recovering. Diagnosed as idiopathic transverse myelitis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and close temporal relationship, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event Myelitis transverse. 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.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug/event and different patient;
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: CSF test, Diagnostic procedure, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: Transverse Myelitis; This is a literature report for the following literature source(s):  A 76-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 12Jan2021 at 00:20, outcome "unknown", described as "Transverse Myelitis". The patient underwent the following laboratory tests and procedures: CSF test: showed 6-8 oligoclonal bands, notes: IgG index pending; Diagnostic procedure: probable MS; Magnetic resonance imaging head: showed global atrophy with nonspecific white, notes: matter T2/FLAIR hyperintensities c/w chronic microvascular ischemic disease; Magnetic resonance imaging spinal: No intramedullary or cauda equina abnormalities. Therapeutic measures were taken as a result of myelitis transverse. Clinical courses: Dizziness and nausea 20 minutes after first vaccination, progressing to severe left upper and lower extremity weakness with inability to walk after two days. Sensation intact. Urinary retention, hyperreflexia and left Babinski sign. Treated with intravenous methylprednisolone. Diagnosis: probable MS.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the event is related to the vaccine administration cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: CSF glucose, CSF protein, CSF red blood cell count, CSF test, CSF white blood cell count
Clinical narrative: Meningoencephalitis; transverse myelitis; This is a literature report. This is a literature report based on a Health Authority database analysis.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "weight loss" (unspecified if ongoing); "Night sweats" (unspecified if ongoing); "Paresthesias in her lower extremities" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ENCEPHALITIS (medically significant) with onset 28Jan2021, outcome "unknown", described as "Meningoencephalitis"; MYELITIS TRANSVERSE (medically significant) with onset 28Jan2021, outcome "unknown", described as "transverse myelitis". Adverse event summary reported as generalized tonic-clonic seizure evening of 1st injection. Initially, awake and responsive, then disorientation. Bilateral multifocal pneumonia. Dx. meningoencephalitis. Intubated. Quadraplegic but able to follow commands with her eyes and mouth. Over previous six months, wt loss, night sweats and one week of paresthesias in her lower extremities. Felt that some neurological decline started prior to vaccination. Diagnosed as meningoencephalitis. The patient underwent the following laboratory tests and procedures: CSF glucose: 59; CSF protein: 145; CSF red blood cell count: 14; CSF test: GS 2+ WBCs, no orgs; CSF white blood cell count: 14% PMNs, 76% lymphs, 10% Monos; Gram stain: Negative; Magnetic resonance imaging spinal: longitudinally extensive transverse myelitis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: This is a Literature report. Based on the currently available information, including the evaluation of the safety profile a reasonable possibility that the reported adverse event "Meningoencephalitis"; "transverse myelitis are associated to the administration of the suspect drug BNT162b2 (BNT162B2),  cannot be completely excluded in this patient. The impact of this report on the benefit risk profile of the Pfizer product and 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.  ,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Encephalitis, Gram stain, Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: Meningoencephalitis; transverse myelitis; This is a literature report. This is a literature report based on a Health Authority database analysis.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "weight loss" (unspecified if ongoing); "Night sweats" (unspecified if ongoing); "Paresthesias in her lower extremities" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ENCEPHALITIS (medically significant) with onset 28Jan2021, outcome "unknown", described as "Meningoencephalitis"; MYELITIS TRANSVERSE (medically significant) with onset 28Jan2021, outcome "unknown", described as "transverse myelitis". Adverse event summary reported as generalized tonic-clonic seizure evening of 1st injection. Initially, awake and responsive, then disorientation. Bilateral multifocal pneumonia. Dx. meningoencephalitis. Intubated. Quadraplegic but able to follow commands with her eyes and mouth. Over previous six months, wt loss, night sweats and one week of paresthesias in her lower extremities. Felt that some neurological decline started prior to vaccination. Diagnosed as meningoencephalitis. The patient underwent the following laboratory tests and procedures: CSF glucose: 59; CSF protein: 145; CSF red blood cell count: 14; CSF test: GS 2+ WBCs, no orgs; CSF white blood cell count: 14% PMNs, 76% lymphs, 10% Monos; Gram stain: Negative; Magnetic resonance imaging spinal: longitudinally extensive transverse myelitis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: This is a Literature report. Based on the currently available information, including the evaluation of the safety profile a reasonable possibility that the reported adverse event "Meningoencephalitis"; "transverse myelitis are associated to the administration of the suspect drug BNT162b2 (BNT162B2),  cannot be completely excluded in this patient. The impact of this report on the benefit risk profile of the Pfizer product and 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.  ,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Ascending flaccid paralysis, CSF cell count, CSF glucose, CSF protein, Culture
Clinical narrative: Iodiopathic Transverse myelitis; Ascending paralysis c/w transverse myelitis; This is a literature report for the following literature source(s):   A 73-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, 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: ASCENDING FLACCID PARALYSIS (medically significant) with onset 26Feb2021, outcome "unknown", described as "Ascending paralysis c/w transverse myelitis"; MYELITIS TRANSVERSE (medically significant) with onset 26Feb2021, outcome "unknown", described as "Iodiopathic Transverse myelitis". The patient underwent the following laboratory tests and procedures: CSF cell count: elevated; CSF glucose: low; CSF protein: elevated; Culture: negative; Gram stain: elevated.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the reported events Myelitis transverse, ascending flaccid paralysis cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article;drug/different patient;
Sex: F
Vaccine: COVID19
Symptoms: Gram stain, Myelitis transverse
Clinical narrative: Iodiopathic Transverse myelitis; Ascending paralysis c/w transverse myelitis; This is a literature report for the following literature source(s):   A 73-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, 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: ASCENDING FLACCID PARALYSIS (medically significant) with onset 26Feb2021, outcome "unknown", described as "Ascending paralysis c/w transverse myelitis"; MYELITIS TRANSVERSE (medically significant) with onset 26Feb2021, outcome "unknown", described as "Iodiopathic Transverse myelitis". The patient underwent the following laboratory tests and procedures: CSF cell count: elevated; CSF glucose: low; CSF protein: elevated; Culture: negative; Gram stain: elevated.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the reported events Myelitis transverse, ascending flaccid paralysis cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article;drug/different patient;
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, CSF cell count, CSF oligoclonal band, CSF protein, Investigation
Clinical narrative: Iodiopathic Transverse myelitis; This is a literature report for the following literature source(s):   A 75-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, 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: MYELITIS TRANSVERSE (medically significant) with onset 24Jan2021, outcome "recovering", described as "Iodiopathic Transverse myelitis". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: unknown results, notes: nml; CSF cell count: 2 nucleated cells; CSF oligoclonal band: negative; CSF protein: 50 mg/dl; Exam findings: mild hyperreflexia in the left leg, notes: and a T5-6 sensory level; Magnetic resonance imaging: contrast enhancing lesion at T5; Magnetic resonance imaging head: normal; Magnetic resonance imaging spinal: normal. Therapeutic measures were taken as a result of myelitis transverse. Clinical courses: Acute left leg weakness and sensory loss and T10 senosry level, progressing to numbness and paresthesias in the right leg. Exam findings included mild hyperreflexia in the left leg and a T5-6 sensory level. Treated with IV methylprednisolone x5 days and transferred to rehab. Significantly improved with residual numbness in the left leg. Diagnosis: iodiopathic TM.  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 information provided, a causal association between suspect drug and the reported event cannot be completely excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: Iodiopathic Transverse myelitis; This is a literature report for the following literature source(s):   A 75-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, 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: MYELITIS TRANSVERSE (medically significant) with onset 24Jan2021, outcome "recovering", described as "Iodiopathic Transverse myelitis". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: unknown results, notes: nml; CSF cell count: 2 nucleated cells; CSF oligoclonal band: negative; CSF protein: 50 mg/dl; Exam findings: mild hyperreflexia in the left leg, notes: and a T5-6 sensory level; Magnetic resonance imaging: contrast enhancing lesion at T5; Magnetic resonance imaging head: normal; Magnetic resonance imaging spinal: normal. Therapeutic measures were taken as a result of myelitis transverse. Clinical courses: Acute left leg weakness and sensory loss and T10 senosry level, progressing to numbness and paresthesias in the right leg. Exam findings included mild hyperreflexia in the left leg and a T5-6 sensory level. Treated with IV methylprednisolone x5 days and transferred to rehab. Significantly improved with residual numbness in the left leg. Diagnosis: iodiopathic TM.  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 information provided, a causal association between suspect drug and the reported event cannot be completely excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: Iodiopathic Transverse myelitis; This is a literature report for the following literature source(s): This is a literature report based on a Health Authority database analysis.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 03May2021, outcome "unknown", described as "Iodiopathic Transverse myelitis".  Adverse event summary reported as headache fatigue and cramping evening of the second vaccination. Following evening: chills, fatigue, pain and heaviness in lower extremities legs, progressing to inability to walk. Treatment symptomatic. Dianosed as iodiopathic transverse myelitis. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging spinal: normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and temporal relationship, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event Myelitis transverse. 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.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/ drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis, Myelitis transverse
Clinical narrative: Iodiopathic Transverse myelitis; Patient with Multiple Sclerosis; This is a literature report.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 22Feb2021, outcome "unknown", described as "Iodiopathic Transverse myelitis"; MULTIPLE SCLEROSIS (medically significant) with onset 22Feb2021, outcome "unknown", described as "Patient with Multiple Sclerosis". Therapeutic measures were taken as a result of myelitis transverse, multiple sclerosis.  Clinical course: Patient with Multiple Sclerosis. Developed pain in the right arm after 2nd COVID-19 vaccination, which steadily intensified and spread quickly to upper torso. Severe back pain. Ascending numbness and paresthesias in her legs to lower abdomen. Unable to stand. Received 1 gram IV solumedrol and high dose oral prednisone taper. Some improvement in right leg function improved but still unable to stand.; Sender's Comments: Based on the available information in the case, an association between the reported events MYELITIS TRANSVERSE , MULTIPLE SCLEROSIS and The suspected drug cannot be ruled out.  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.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article;drug/different patient;
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I found that the first shot I had a sore arm for about two or three weeks; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I found that the first shot I had a sore arm for about two or three weeks".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146398 Same patient, same vaccine but different doses with different events;
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Off label use, Product use issue
Clinical narrative: feeling tired; Name: Comirnaty; Route: Subcutaneously; Name: Comirnaty; Route: Subcutaneously; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; NOVOLOG; PROLIA. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset Feb2021, outcome "unknown" and all described as "Name: Comirnaty; Route: Subcutaneously"; FATIGUE (non-serious) with onset Feb2021, 2 days after the suspect product(s) administration, outcome "recovered" (Feb2021), described as "feeling tired".  Additional Information: Consumer reported feeling tired on day 2 following Covid vaccine, fully resolved by day three.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; suspected COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation; BNT162b2 (BNT162B2), 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), outcome "recovered"; SUSPECTED COVID-19 (medically significant), outcome "recovered". Clinical course: Consumer reported that her mother got COVID after three to four shots of Pfizer COVID vaccine. It was not serious and it resolved quickly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Drug ineffective, Hypertension, Obesity, Suspected COVID-19
Clinical narrative: Drug ineffective; Have COVID several times; High blood pressure; Morbidly obese; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, 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), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Have COVID several times"; HYPERTENSION (non-serious), outcome "unknown", described as "High blood pressure"; OBESITY (non-serious), outcome "unknown", described as "Morbidly obese". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Clinical Course: Patient had COVID several times, had high blood pressure and was considered morbidly obese. Patient had many health issues and had taken Pfizer for each and all of COVID shots including the booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, Medication error, No adverse event, Product use in unapproved indication, Tuberculin test
Clinical narrative: Acthib took 0.5 ml 1x for TB skin test ,with no reported adverse event; patient accidently received 2 doses of ACTHIB,with no reported adverse event; Initial information was received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 65 years old male patient who experienced patient accidently received 2 doses of HIB (PRP/T) vaccine [ACT-HIB] and took 0.5 ml 1x for tb skin test ,with no reported adverse event vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) vaccine at dose of Total 0.5 ml via intramuscular route in unknown administration site (strength, formulation, batch number, expiry date: Unknown) for Immunization (immunization) and TB skin test (Mycobacterium tuberculosis complex test) with no reported adverse event (product use in unapproved indication) (unknown latency)  On 03-Apr-2023 the patient developed a non-serious patient accidently received 2 doses of acthib with no reported adverse event (extra dose administered) (unknown latency) following the administration of HIB (PRP/T) vaccine.  No lab data reported.  Action taken: not applicable.  Outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACT-HIB was administered to a patient, with no reported adverse event; Initial information received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Patient of unknown age and gender who received expired HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of expired vaccine suspect HIB (PRP/T) VACCINE intramuscular (Frequency: once ) (Strength: standard) (lot number, expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination with no adverse event (expired product administered) (latency: same day).  Treatment: The clinic calling the manufacturer  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: mixed ACT-HIB with the wrong diluent on the patients 4th dose with no reported adverse event; Initial information received on 06-Apr-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 18 months old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] mixed with the wrong diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On 04-Apr-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) VACCINE (lot UJ787AAA, strength - standard, frequency - once, expiry date - 11 Aug-2023) via intramuscular route in the left thigh for prophylactic vaccination (immunization).  On 04-Apr-2023 the patient received act-hib mixed with the wrong diluent with no reported adverse event (product preparation error) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired dose of Act-HIB, with no reported adverse event; Initial information received on 06-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves male child patient who  was administered an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included influenza vaccine and pneumococcal vaccine both for Immunisation.  On an unknown date, the patient was administered an expired dose of HIB (PRP/T) vaccine [ACT-HIB] powder and solvent for solution for injection (batch/lot number, expiry date, dose, route and strength: not reported) in unknown administration site for prophylactic vaccination, with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Chest X-ray abnormal, Computerised tomogram head normal, Encephalopathy
Clinical narrative: 75 y.o. male with a history of Diabetes, Hyperlipidemia, Prostate cancer, Hypertension, Chronic kidney disease who presented 3/12/2023 with generalized weakness and altered mental status. Found to be COVID positive, hyponatremic, and chest x-ray concerning for pneumonia. Started on antibiotics. AMS and generalized work up included CT head and MRI brain, which were unremarkable. Neuro also evaluated. Both improved with antibiotic therapy for pneumonia. Patient ready for discharge home, transitioned Ceftriaxone to Augmentin 875-125mg BID for 4 more doses.   1. Sepsis, Pneumonia: COVID positive but also with possible LLL infiltrate. Improved with antibiotics. Plan for 5 day course, transition IV Ceftriaxone to PO ugmentin 875-125mg BID for 4 more doses (end date 3/17) 2. Acute Encephalopathy: due to infection, resolved 3. COVID 19: positive on 3/12, no requiring supplemental O2, no steroids used. Monitor for continued improvement 4. Hyponatremia: 131 on admit, improving. Repeat BMP in 1 week to ensure resolution 5. Urinary Incontinence: per patient's wife has been ongoing for the past 6 weeks. May benefit from urology evaluation outpatient. 6. Pleuritic Chest Pain 7. Generalized Weakness 8. Normocytic Anemia: repeat iron studies on follow up to determine need for PO iron 9. Type 2DM: resume home meds 10. Hypertension: resume home meds 11. Hyperlipidemia: resume home meds 12. CKD 13. Vit D def 14. Prostate Cancer
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hyponatraemia, Magnetic resonance imaging head normal, Mental status changes, Normocytic anaemia, Pleuritic pain
Clinical narrative: 75 y.o. male with a history of Diabetes, Hyperlipidemia, Prostate cancer, Hypertension, Chronic kidney disease who presented 3/12/2023 with generalized weakness and altered mental status. Found to be COVID positive, hyponatremic, and chest x-ray concerning for pneumonia. Started on antibiotics. AMS and generalized work up included CT head and MRI brain, which were unremarkable. Neuro also evaluated. Both improved with antibiotic therapy for pneumonia. Patient ready for discharge home, transitioned Ceftriaxone to Augmentin 875-125mg BID for 4 more doses.   1. Sepsis, Pneumonia: COVID positive but also with possible LLL infiltrate. Improved with antibiotics. Plan for 5 day course, transition IV Ceftriaxone to PO ugmentin 875-125mg BID for 4 more doses (end date 3/17) 2. Acute Encephalopathy: due to infection, resolved 3. COVID 19: positive on 3/12, no requiring supplemental O2, no steroids used. Monitor for continued improvement 4. Hyponatremia: 131 on admit, improving. Repeat BMP in 1 week to ensure resolution 5. Urinary Incontinence: per patient's wife has been ongoing for the past 6 weeks. May benefit from urology evaluation outpatient. 6. Pleuritic Chest Pain 7. Generalized Weakness 8. Normocytic Anemia: repeat iron studies on follow up to determine need for PO iron 9. Type 2DM: resume home meds 10. Hypertension: resume home meds 11. Hyperlipidemia: resume home meds 12. CKD 13. Vit D def 14. Prostate Cancer
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pneumonia, SARS-CoV-2 test positive, Sepsis, Urinary incontinence, Vitamin D deficiency
Clinical narrative: 75 y.o. male with a history of Diabetes, Hyperlipidemia, Prostate cancer, Hypertension, Chronic kidney disease who presented 3/12/2023 with generalized weakness and altered mental status. Found to be COVID positive, hyponatremic, and chest x-ray concerning for pneumonia. Started on antibiotics. AMS and generalized work up included CT head and MRI brain, which were unremarkable. Neuro also evaluated. Both improved with antibiotic therapy for pneumonia. Patient ready for discharge home, transitioned Ceftriaxone to Augmentin 875-125mg BID for 4 more doses.   1. Sepsis, Pneumonia: COVID positive but also with possible LLL infiltrate. Improved with antibiotics. Plan for 5 day course, transition IV Ceftriaxone to PO ugmentin 875-125mg BID for 4 more doses (end date 3/17) 2. Acute Encephalopathy: due to infection, resolved 3. COVID 19: positive on 3/12, no requiring supplemental O2, no steroids used. Monitor for continued improvement 4. Hyponatremia: 131 on admit, improving. Repeat BMP in 1 week to ensure resolution 5. Urinary Incontinence: per patient's wife has been ongoing for the past 6 weeks. May benefit from urology evaluation outpatient. 6. Pleuritic Chest Pain 7. Generalized Weakness 8. Normocytic Anemia: repeat iron studies on follow up to determine need for PO iron 9. Type 2DM: resume home meds 10. Hypertension: resume home meds 11. Hyperlipidemia: resume home meds 12. CKD 13. Vit D def 14. Prostate Cancer
Age: 59.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Acute myocardial infarction, Arrhythmia, Blood test abnormal, Dizziness, Echocardiogram
Clinical narrative: On 04/06/2023, I had exercised for an hour and was about to go shopping. I was in a store, and I suddenly felt like I was going to black out. Everything went black before my eyes briefly. I went to my car until I felt ok to drive home. On my way home, I could tell my heart was out of rhythm. When I got home, my pulse was at 185. I tried some maneuvers that I've been taught to get my pulse down myself. When that was unsuccessful, I called an ambulance. I was transported to a local hospital. From there, I was in the emergency room for a long time. They decided on my blood work, to admit me. My cardiac enzymes were rising, so they admitted me on an observational basis. I was discharged the next day and saw my cardiologist who said that I had a type 2 myocardial infarction based on the elevated heart rate. He did some medication changes, and I will follow up with him to discuss further options.
Age: 59.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Electrocardiogram, Heart rate increased, Myocardial necrosis marker increased, Visual impairment
Clinical narrative: On 04/06/2023, I had exercised for an hour and was about to go shopping. I was in a store, and I suddenly felt like I was going to black out. Everything went black before my eyes briefly. I went to my car until I felt ok to drive home. On my way home, I could tell my heart was out of rhythm. When I got home, my pulse was at 185. I tried some maneuvers that I've been taught to get my pulse down myself. When that was unsuccessful, I called an ambulance. I was transported to a local hospital. From there, I was in the emergency room for a long time. They decided on my blood work, to admit me. My cardiac enzymes were rising, so they admitted me on an observational basis. I was discharged the next day and saw my cardiologist who said that I had a type 2 myocardial infarction based on the elevated heart rate. He did some medication changes, and I will follow up with him to discuss further options.
Age: 61.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Computerised tomogram, Laboratory test, Pulmonary embolism
Clinical narrative: I had a pulmonary embolism on 01/13/2023. I went to the hospital where all kinds of tests were done such as CT scans performed on 01/13/2023. I have recovered from my symptoms today. I stayed two days at the hospital for observation.
Age: 36.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: 03/23/2023 I had a sore throat, intermittent cough, body aches, headaches, no appetite, cold extremities, shortness of breath, High Grade fever, I called PCP telehealth line and left a message and heard from them within 24 hours. I was prescribed a course of PAXLOVID. I still have lingering fatigue I usually sleep about 6-7 hours a night since COVID-19 I am so fatigued that I sleep 10-12 hours per night. I took OTC DAYQUIL, NYQUIL, TYLENOL, ALEVE, cough drops and a VICKS vaporizer for congestion.
Age: 36.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Headache, Hypersomnia, Oropharyngeal pain, Pain, Peripheral coldness
Clinical narrative: 03/23/2023 I had a sore throat, intermittent cough, body aches, headaches, no appetite, cold extremities, shortness of breath, High Grade fever, I called PCP telehealth line and left a message and heard from them within 24 hours. I was prescribed a course of PAXLOVID. I still have lingering fatigue I usually sleep about 6-7 hours a night since COVID-19 I am so fatigued that I sleep 10-12 hours per night. I took OTC DAYQUIL, NYQUIL, TYLENOL, ALEVE, cough drops and a VICKS vaporizer for congestion.
Age: 36.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: 03/23/2023 I had a sore throat, intermittent cough, body aches, headaches, no appetite, cold extremities, shortness of breath, High Grade fever, I called PCP telehealth line and left a message and heard from them within 24 hours. I was prescribed a course of PAXLOVID. I still have lingering fatigue I usually sleep about 6-7 hours a night since COVID-19 I am so fatigued that I sleep 10-12 hours per night. I took OTC DAYQUIL, NYQUIL, TYLENOL, ALEVE, cough drops and a VICKS vaporizer for congestion.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Computerised tomogram thorax abnormal, Condition aggravated, Dyspnoea
Clinical narrative: Patient Is a 54-year-old female with a past medical history of COPD on 2 L nasal cannula chronically, HFpEF, hypertension, hyperlipidemia, hypothyroidism, GERD, IBS who presents with shortness of breath and wheezing. Patient states that last week her mother was admitted to the hospital with COVID-19.  She picked her mother up from the hospital upon discharge and had to spend some time with her to help care for her.  She received a DuoNeb as well as Decadron in the ED, ultimately able to be weaned down to 2 L however she still had significant wheezing.  She had a CT chest which is negative for PE though she does have right middle lobe attenuation of the bronchial tree consistent with a superimposed pneumonia.  Lab work in ED is otherwise unremarkable.  She did test positive for COVID-19.  Patient states she is vaccinated and has received 2/3 boosters.  Patient is admitted to surgical unit for acute on chronic hypoxia, COPD exacerbation and COVID-19 infection.     Clinical Summary Patient was treated with decadron and remdesivir for COVID-19 as well as Azithro.  Patient's breathing improved to where she no longer needed oxygen and wasn't wheezing.    I discussed with the patient, she should receive 3 doses of Remdesivir to prevent progression of COVID since she is at high risk.  Patient states though she has to get home to take care of her husband.   Will DC with short decadron taper and 2 more days of Azythromycin.  Patient has inhalers at home.  Patient instructed to return if she wheezes and to isolate for 10 days.   Discharge diagnosis COVID-19 Infection
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Hypoxia, Laboratory test normal, Lung opacity, Pneumonia
Clinical narrative: Patient Is a 54-year-old female with a past medical history of COPD on 2 L nasal cannula chronically, HFpEF, hypertension, hyperlipidemia, hypothyroidism, GERD, IBS who presents with shortness of breath and wheezing. Patient states that last week her mother was admitted to the hospital with COVID-19.  She picked her mother up from the hospital upon discharge and had to spend some time with her to help care for her.  She received a DuoNeb as well as Decadron in the ED, ultimately able to be weaned down to 2 L however she still had significant wheezing.  She had a CT chest which is negative for PE though she does have right middle lobe attenuation of the bronchial tree consistent with a superimposed pneumonia.  Lab work in ED is otherwise unremarkable.  She did test positive for COVID-19.  Patient states she is vaccinated and has received 2/3 boosters.  Patient is admitted to surgical unit for acute on chronic hypoxia, COPD exacerbation and COVID-19 infection.     Clinical Summary Patient was treated with decadron and remdesivir for COVID-19 as well as Azithro.  Patient's breathing improved to where she no longer needed oxygen and wasn't wheezing.    I discussed with the patient, she should receive 3 doses of Remdesivir to prevent progression of COVID since she is at high risk.  Patient states though she has to get home to take care of her husband.   Will DC with short decadron taper and 2 more days of Azythromycin.  Patient has inhalers at home.  Patient instructed to return if she wheezes and to isolate for 10 days.   Discharge diagnosis COVID-19 Infection