chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Hyperacusis, Hypersensitivity, Hypobarism, Impaired work ability
Clinical narrative: Back of neck expanded with enormous amounts of fluid needed palpation to swallow excess fluid. The right larger than left. Pain and tenderness in both ears, sound sensitivity, overall aches in head. This continued for over a month adding difficulty going over mountains or high elevation experiencing immense pressure and pain. The fluid turned to crepitus and was crunchy all the way to shoulder traps. Had walk in care at work check me out at work immediately after I couldn't handle pressure. My ears had blood in them and I coul blow air through my right ear. Had to wait months for ENT which worked as well. She claimed it was TMJ despite me explaining this all happened because of the flu shot. I was suspended without return of job on Dec 12 2018 because I refused the flu shot for medical reasons.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Loss of employment, Loss of personal independence in daily activities, Pain, Refusal of vaccination, Swelling
Clinical narrative: Back of neck expanded with enormous amounts of fluid needed palpation to swallow excess fluid. The right larger than left. Pain and tenderness in both ears, sound sensitivity, overall aches in head. This continued for over a month adding difficulty going over mountains or high elevation experiencing immense pressure and pain. The fluid turned to crepitus and was crunchy all the way to shoulder traps. Had walk in care at work check me out at work immediately after I couldn't handle pressure. My ears had blood in them and I coul blow air through my right ear. Had to wait months for ENT which worked as well. She claimed it was TMJ despite me explaining this all happened because of the flu shot. I was suspended without return of job on Dec 12 2018 because I refused the flu shot for medical reasons.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Temporomandibular joint syndrome, Tenderness
Clinical narrative: Back of neck expanded with enormous amounts of fluid needed palpation to swallow excess fluid. The right larger than left. Pain and tenderness in both ears, sound sensitivity, overall aches in head. This continued for over a month adding difficulty going over mountains or high elevation experiencing immense pressure and pain. The fluid turned to crepitus and was crunchy all the way to shoulder traps. Had walk in care at work check me out at work immediately after I couldn't handle pressure. My ears had blood in them and I coul blow air through my right ear. Had to wait months for ENT which worked as well. She claimed it was TMJ despite me explaining this all happened because of the flu shot. I was suspended without return of job on Dec 12 2018 because I refused the flu shot for medical reasons.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Joint swelling, Mobility decreased
Clinical narrative: Patient states he awake on 12-11-22 with a swollen left ankle, midsternum pain and generalized weakness, limited range of motion in bilateral arms. Reports that today his only symptom is pain to the right shoulder.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Patient states he awake on 12-11-22 with a swollen left ankle, midsternum pain and generalized weakness, limited range of motion in bilateral arms. Reports that today his only symptom is pain to the right shoulder.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Bivalent dose was given prior to completion of primary series. Pt is receiving primary dose ASAP and will receive booster later.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient received undiluted vaccine 0.2 ml
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient received 0.2 ml undiluted vaccine
Age: 23.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event
Clinical narrative: No immediate reaction, was in office over 5 min after injection & no reaction.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Instead of giving patient 2nd dose Pfizer primary series gave her Pfizer Bivalent booster
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Laboratory test, Loss of personal independence in daily activities, Nausea
Clinical narrative: I had high blood pressure but that was in control until I took the first vaccine, since then its been all over the place; extreme swelling; Joint pain; Nausea; I was not able to drive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EN5318) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: I had high blood pressure but that was in control until I took the first vaccine. Concomitant medication(s) included: LOSARTAN/HYDROCHLOROTHIAZIDE. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "I had high blood pressure but that was in control until I took the first vaccine, since then its been all over the place"; SWELLING (non-serious), outcome "unknown", described as "extreme swelling"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; NAUSEA (non-serious), outcome "unknown"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I was not able to drive". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure increased, swelling, arthralgia, nausea, loss of personal independence in daily activities.  Additional information: Reporter stated that he had high blood pressure but that was in control until he took the first vaccine, since then its been all over the place and also since he had extreme swelling and joint pain, nausea which he had went to so many doctors for. I am in so much debt because of that.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: I had high blood pressure but that was in control until I took the first vaccine, since then its been all over the place; extreme swelling; Joint pain; Nausea; I was not able to drive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EN5318) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: I had high blood pressure but that was in control until I took the first vaccine. Concomitant medication(s) included: LOSARTAN/HYDROCHLOROTHIAZIDE. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "I had high blood pressure but that was in control until I took the first vaccine, since then its been all over the place"; SWELLING (non-serious), outcome "unknown", described as "extreme swelling"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; NAUSEA (non-serious), outcome "unknown"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I was not able to drive". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure increased, swelling, arthralgia, nausea, loss of personal independence in daily activities.  Additional information: Reporter stated that he had high blood pressure but that was in control until he took the first vaccine, since then its been all over the place and also since he had extreme swelling and joint pain, nausea which he had went to so many doctors for. I am in so much debt because of that.
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Anxiety, Asthenia, Epstein-Barr virus infection reactivation, Eye pain, Fatigue
Clinical narrative: Light sensitivity, fatigue, brain fog   increased anxiety
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Feeling abnormal, Headache, Hyperacusis, Iritis, Laboratory test
Clinical narrative: Light sensitivity, fatigue, brain fog   increased anxiety
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Loss of personal independence in daily activities, Photophobia, Sinus pain, Stress, Thyroid function test
Clinical narrative: Light sensitivity, fatigue, brain fog   increased anxiety
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Anxiety, Condition aggravated, Epstein-Barr virus test negative, Fatigue, Feeling abnormal
Clinical narrative: Light sensitivity, fatigue, brain fog   increased anxiety
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Photophobia
Clinical narrative: Light sensitivity, fatigue, brain fog   increased anxiety
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITALIZATION
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after one Janssen vaccine
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin normal, Blood test normal, Burning sensation, Injection site rash, Insomnia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SKIN DISORDER (beleives his skin condition was a reaction to the Moderna vaccine) and FAT TISSUE INCREASED (severe side effects with prednisone it caused him to be fat) in a 54-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) solution for injection for an unknown indication and PREDNISONE for an unknown indication.    The patients past medical history, medical treatments, vaccinations and family history were not provided.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form, DUPILUMAB (DUPIXENT) (unknown route) pre filled pen, first dose and PREDNISONE (unknown route) 1st dose. On an unknown date, the patient experienced SKIN DISORDER (beleives his skin condition was a reaction to the Moderna vaccine) and FAT TISSUE INCREASED (severe side effects with prednisone it caused him to be fat). At the time of the report, SKIN DISORDER (beleives his skin condition was a reaction to the Moderna vaccine) and FAT TISSUE INCREASED (severe side effects with prednisone it caused him to be fat) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication list was not provided.  It was not reported if the patient received a corrective treatment for the events.  Company agent was reported as causal.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pruritus, Rash, Urine analysis normal
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SKIN DISORDER (beleives his skin condition was a reaction to the Moderna vaccine) and FAT TISSUE INCREASED (severe side effects with prednisone it caused him to be fat) in a 54-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) solution for injection for an unknown indication and PREDNISONE for an unknown indication.    The patients past medical history, medical treatments, vaccinations and family history were not provided.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form, DUPILUMAB (DUPIXENT) (unknown route) pre filled pen, first dose and PREDNISONE (unknown route) 1st dose. On an unknown date, the patient experienced SKIN DISORDER (beleives his skin condition was a reaction to the Moderna vaccine) and FAT TISSUE INCREASED (severe side effects with prednisone it caused him to be fat). At the time of the report, SKIN DISORDER (beleives his skin condition was a reaction to the Moderna vaccine) and FAT TISSUE INCREASED (severe side effects with prednisone it caused him to be fat) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication list was not provided.  It was not reported if the patient received a corrective treatment for the events.  Company agent was reported as causal.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin, Blood test, Dermatitis contact, Eczema, Skin test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SKIN DISORDER (beleives his skin condition was a reaction to the Moderna vaccine) and FAT TISSUE INCREASED (severe side effects with prednisone it caused him to be fat) in a 54-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) solution for injection for an unknown indication and PREDNISONE for an unknown indication.    The patients past medical history, medical treatments, vaccinations and family history were not provided.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form, DUPILUMAB (DUPIXENT) (unknown route) pre filled pen, first dose and PREDNISONE (unknown route) 1st dose. On an unknown date, the patient experienced SKIN DISORDER (beleives his skin condition was a reaction to the Moderna vaccine) and FAT TISSUE INCREASED (severe side effects with prednisone it caused him to be fat). At the time of the report, SKIN DISORDER (beleives his skin condition was a reaction to the Moderna vaccine) and FAT TISSUE INCREASED (severe side effects with prednisone it caused him to be fat) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication list was not provided.  It was not reported if the patient received a corrective treatment for the events.  Company agent was reported as causal.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fat tissue increased, Skin disorder
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SKIN DISORDER (beleives his skin condition was a reaction to the Moderna vaccine) and FAT TISSUE INCREASED (severe side effects with prednisone it caused him to be fat) in a 54-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) solution for injection for an unknown indication and PREDNISONE for an unknown indication.    The patients past medical history, medical treatments, vaccinations and family history were not provided.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form, DUPILUMAB (DUPIXENT) (unknown route) pre filled pen, first dose and PREDNISONE (unknown route) 1st dose. On an unknown date, the patient experienced SKIN DISORDER (beleives his skin condition was a reaction to the Moderna vaccine) and FAT TISSUE INCREASED (severe side effects with prednisone it caused him to be fat). At the time of the report, SKIN DISORDER (beleives his skin condition was a reaction to the Moderna vaccine) and FAT TISSUE INCREASED (severe side effects with prednisone it caused him to be fat) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication list was not provided.  It was not reported if the patient received a corrective treatment for the events.  Company agent was reported as causal.
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Chills, Fatigue, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 94y.o. male with a past medical history of AML with last round of chemo the day before admission, hypertension, hypercholesterolemia, and OSA. He presented to the emergency room with cough, difficulty breathing, and fever.  Fever was noted during chemotherapy session. He was noted to be COVID-19 positive He was on Nc oxygen and able to be weaned. He was ofllowed by ID and had 5 days of remdesivir with clinical improvement On discharged he Continued acyclovir, cipro and diflucan  He was followed by oncology for his history of AML and cbc was monitored He had CKD3 and we Monitored renal function. He was ambulatory and improved to room air Leukopeni improved and after discussing with ID , we felt stable for discharge home with a short course of steroids
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Full blood count, Pyrexia
Clinical narrative: 94y.o. male with a past medical history of AML with last round of chemo the day before admission, hypertension, hypercholesterolemia, and OSA. He presented to the emergency room with cough, difficulty breathing, and fever.  Fever was noted during chemotherapy session. He was noted to be COVID-19 positive He was on Nc oxygen and able to be weaned. He was ofllowed by ID and had 5 days of remdesivir with clinical improvement On discharged he Continued acyclovir, cipro and diflucan  He was followed by oncology for his history of AML and cbc was monitored He had CKD3 and we Monitored renal function. He was ambulatory and improved to room air Leukopeni improved and after discussing with ID , we felt stable for discharge home with a short course of steroids
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 94y.o. male with a past medical history of AML with last round of chemo the day before admission, hypertension, hypercholesterolemia, and OSA. He presented to the emergency room with cough, difficulty breathing, and fever.  Fever was noted during chemotherapy session. He was noted to be COVID-19 positive He was on Nc oxygen and able to be weaned. He was ofllowed by ID and had 5 days of remdesivir with clinical improvement On discharged he Continued acyclovir, cipro and diflucan  He was followed by oncology for his history of AML and cbc was monitored He had CKD3 and we Monitored renal function. He was ambulatory and improved to room air Leukopeni improved and after discussing with ID , we felt stable for discharge home with a short course of steroids
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Severe vomiting; is pregnant: Pregnant; last menstrual date: 17Jan2022; delivery date: 07Nov2022/ Vaccine administration date= 22Feb2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 22Feb2022 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing), notes: but off medication due to, pregnancy. Date of last menstrual period: 17Jan2022. The patient was 5 weeks pregnant at the time of exposure to BNT162b2. The patient was 5 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 07Nov2022. Concomitant medication(s) included: MATERNA [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;CUPRIC OXIDE;CYANOCOBALAMIN;ERGOCALCIFEROL;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE, start date: 01May2022, stop date: 21Jul2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: Unknown; Anatomical location: Arm left), administration date: 22Feb2021, when the patient was 36-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: Unknown; Anatomical location: Arm left), administration date: 13May2021, when the patient was 36-year-old, for COVID-19 Immunization, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 22Feb2022 at 14:30, described as "is pregnant: Pregnant; last menstrual date: 17Jan2022; delivery date: 07Nov2022/ Vaccine administration date= 22Feb2022"; VOMITING (non-serious) with onset 21Jul2022 at 01:00, described as "Severe vomiting". Therapeutic measures were not taken as a result of vomiting.  Additional information: The patient had no known allergies. AEs did not result in physician office visit or emergency room visit. Gestation period was also reported as 24 (unit not reported).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (16Dec2022): Follow-up attempts are completed. No further information is expected. This Follow-up is also being submitted to amend the previously reported information that includes: Event LLT recoded to Maternal Exposure During Pregnancy, first trimester. Inappropriate schedule coded as reaction for dose 2 in Historical vaccine. LOE events deleted from Historical vaccines. Deleted lab test for Covid-19. Gestation period allowed to auto populate in patient tab and product tab. Event Severe vomiting and the corresponding data captured in the case. Additional information added. At risk classification removed.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Vomiting
Clinical narrative: Severe vomiting; is pregnant: Pregnant; last menstrual date: 17Jan2022; delivery date: 07Nov2022/ Vaccine administration date= 22Feb2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 22Feb2022 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing), notes: but off medication due to, pregnancy. Date of last menstrual period: 17Jan2022. The patient was 5 weeks pregnant at the time of exposure to BNT162b2. The patient was 5 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 07Nov2022. Concomitant medication(s) included: MATERNA [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;CUPRIC OXIDE;CYANOCOBALAMIN;ERGOCALCIFEROL;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE, start date: 01May2022, stop date: 21Jul2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: Unknown; Anatomical location: Arm left), administration date: 22Feb2021, when the patient was 36-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: Unknown; Anatomical location: Arm left), administration date: 13May2021, when the patient was 36-year-old, for COVID-19 Immunization, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 22Feb2022 at 14:30, described as "is pregnant: Pregnant; last menstrual date: 17Jan2022; delivery date: 07Nov2022/ Vaccine administration date= 22Feb2022"; VOMITING (non-serious) with onset 21Jul2022 at 01:00, described as "Severe vomiting". Therapeutic measures were not taken as a result of vomiting.  Additional information: The patient had no known allergies. AEs did not result in physician office visit or emergency room visit. Gestation period was also reported as 24 (unit not reported).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (16Dec2022): Follow-up attempts are completed. No further information is expected. This Follow-up is also being submitted to amend the previously reported information that includes: Event LLT recoded to Maternal Exposure During Pregnancy, first trimester. Inappropriate schedule coded as reaction for dose 2 in Historical vaccine. LOE events deleted from Historical vaccines. Deleted lab test for Covid-19. Gestation period allowed to auto populate in patient tab and product tab. Event Severe vomiting and the corresponding data captured in the case. Additional information added. At risk classification removed.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Hypotension, SARS-CoV-2 test positive
Clinical narrative: 87y.o. male patient with bilateral hydronephrosis 2/2 to bladder mass managed with b/l PCNs that were placed by IR on 8/8/22 that presents today for a bilateral PCN removal. Pt recently had R PCN replacement and L PCN exchange on 10/10 and then an additional R PCN exchange on 10/12. Of note, pt had bilateral ureteral stents placed by urology on 10/13/22. Per urology note, pt had PCNS clamped off yesterday and patient had good output in foley. Pt currently on bASA daily. No other blood thinners. ROS limited due to patient's mental status.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Bladder catheterisation, Bladder mass, COVID-19, Hydronephrosis
Clinical narrative: 87y.o. male patient with bilateral hydronephrosis 2/2 to bladder mass managed with b/l PCNs that were placed by IR on 8/8/22 that presents today for a bilateral PCN removal. Pt recently had R PCN replacement and L PCN exchange on 10/10 and then an additional R PCN exchange on 10/12. Of note, pt had bilateral ureteral stents placed by urology on 10/13/22. Per urology note, pt had PCNS clamped off yesterday and patient had good output in foley. Pt currently on bASA daily. No other blood thinners. ROS limited due to patient's mental status.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Mental status changes, SARS-CoV-2 test positive, Ureteral stent insertion
Clinical narrative: 87y.o. male patient with bilateral hydronephrosis 2/2 to bladder mass managed with b/l PCNs that were placed by IR on 8/8/22 that presents today for a bilateral PCN removal. Pt recently had R PCN replacement and L PCN exchange on 10/10 and then an additional R PCN exchange on 10/12. Of note, pt had bilateral ureteral stents placed by urology on 10/13/22. Per urology note, pt had PCNS clamped off yesterday and patient had good output in foley. Pt currently on bASA daily. No other blood thinners. ROS limited due to patient's mental status.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Respiratory distress, SARS-CoV-2 test positive
Clinical narrative: 85y.o. female presenting with acute on chronic hypoxic respiratory failure. She has history of COPD on home oxygen as well as nocturnal BiPAP. Upon presentation, ABG showed significant CO2 retention. She was begun on broad-spectrum antibiotics. She did require temporary transfer to MICU due to worsening hypoxia. Fortunately, patient did improve and did not require intubation. Further work-up included CTA PE protocol which did not show PE but did show partially loculated effusions as well as near complete consolidation of left lower lobe. Patient was seen by infectious disease as well as pulmonology. Eventually, her oxygenation improved back towards her previous baseline. She completed her courses of antibiotics  inpatient. She was also treated with steroid burst due to COPD. She was mobilized with PT/OT and was determined appropriate for home with home care. Following this, she was stable for discharge and was discharged home to complete 1 additional day of her steroid burst. She will follow-up with primary care as well as pulmonology outpatient.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Angiogram pulmonary abnormal, Blood gases abnormal, COVID-19, Chronic obstructive pulmonary disease
Clinical narrative: 85y.o. female presenting with acute on chronic hypoxic respiratory failure. She has history of COPD on home oxygen as well as nocturnal BiPAP. Upon presentation, ABG showed significant CO2 retention. She was begun on broad-spectrum antibiotics. She did require temporary transfer to MICU due to worsening hypoxia. Fortunately, patient did improve and did not require intubation. Further work-up included CTA PE protocol which did not show PE but did show partially loculated effusions as well as near complete consolidation of left lower lobe. Patient was seen by infectious disease as well as pulmonology. Eventually, her oxygenation improved back towards her previous baseline. She completed her courses of antibiotics  inpatient. She was also treated with steroid burst due to COPD. She was mobilized with PT/OT and was determined appropriate for home with home care. Following this, she was stable for discharge and was discharged home to complete 1 additional day of her steroid burst. She will follow-up with primary care as well as pulmonology outpatient.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Hypercapnia, Hypoxia, Intensive care, Lung consolidation
Clinical narrative: 85y.o. female presenting with acute on chronic hypoxic respiratory failure. She has history of COPD on home oxygen as well as nocturnal BiPAP. Upon presentation, ABG showed significant CO2 retention. She was begun on broad-spectrum antibiotics. She did require temporary transfer to MICU due to worsening hypoxia. Fortunately, patient did improve and did not require intubation. Further work-up included CTA PE protocol which did not show PE but did show partially loculated effusions as well as near complete consolidation of left lower lobe. Patient was seen by infectious disease as well as pulmonology. Eventually, her oxygenation improved back towards her previous baseline. She completed her courses of antibiotics  inpatient. She was also treated with steroid burst due to COPD. She was mobilized with PT/OT and was determined appropriate for home with home care. Following this, she was stable for discharge and was discharged home to complete 1 additional day of her steroid burst. She will follow-up with primary care as well as pulmonology outpatient.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pleural effusion, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: 85y.o. female presenting with acute on chronic hypoxic respiratory failure. She has history of COPD on home oxygen as well as nocturnal BiPAP. Upon presentation, ABG showed significant CO2 retention. She was begun on broad-spectrum antibiotics. She did require temporary transfer to MICU due to worsening hypoxia. Fortunately, patient did improve and did not require intubation. Further work-up included CTA PE protocol which did not show PE but did show partially loculated effusions as well as near complete consolidation of left lower lobe. Patient was seen by infectious disease as well as pulmonology. Eventually, her oxygenation improved back towards her previous baseline. She completed her courses of antibiotics  inpatient. She was also treated with steroid burst due to COPD. She was mobilized with PT/OT and was determined appropriate for home with home care. Following this, she was stable for discharge and was discharged home to complete 1 additional day of her steroid burst. She will follow-up with primary care as well as pulmonology outpatient.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, FLU4
Symptoms: Death, Eye movement disorder, Respiration abnormal, Respiratory arrest, Resuscitation
Clinical narrative: Stopped breathing; Eyes rolled back; OUT WALKING, COLLAPSED; Initial information received on 13-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-health-care professional.  This case involves 67 years old female patient who went out walking, collapsed, eyes rolled back and stopped breathing after receiving vaccines pfizer biontech COVID-19 vaccine and influenza quadrival A-B high dose HV Vaccine[Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspects influenza quadrival A-B high dose HV Vaccine and pfizer biontech COVID-19 vaccine (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On 29-Oct-2022 the patient who went out walking, collapsed (loss of consciousness), eyes rolled back (eye movement disorder) and stopped breathing (respiratory arrest) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine and (unknown latency) following the administration of pfizer biontech covid-19 vaccine.   Final diagnosis was (fatal) stopped breathing.  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  It is unknown if an autopsy was done. The cause of death was reported as Respiratory arrest.  At time of reporting, the outcome was Fatal for all the events  Seriousness criteria: Medically significant and was leading to death on 29-Oct-2022 for the event Stopped breathing and loss of consciousness. Fatal for event eye movement disorder.; Sender's Comments: Sanofi Company Comment on 16-Dec-2022:This case involves 67 years old female patient who went out walking, collapsed, eyes rolled back and stopped breathing after receiving vaccines pfizer biontech COVID-19 vaccine and influenza quadrival A-B high dose HV Vaccine[Fluzone high-dose quadrivalent]. This reported event stopped breathing  was assessed as medically significant and fatal. Further information regarding medical history during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Stopped breathing
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, FLU4
Symptoms: Syncope
Clinical narrative: Stopped breathing; Eyes rolled back; OUT WALKING, COLLAPSED; Initial information received on 13-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-health-care professional.  This case involves 67 years old female patient who went out walking, collapsed, eyes rolled back and stopped breathing after receiving vaccines pfizer biontech COVID-19 vaccine and influenza quadrival A-B high dose HV Vaccine[Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspects influenza quadrival A-B high dose HV Vaccine and pfizer biontech COVID-19 vaccine (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On 29-Oct-2022 the patient who went out walking, collapsed (loss of consciousness), eyes rolled back (eye movement disorder) and stopped breathing (respiratory arrest) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine and (unknown latency) following the administration of pfizer biontech covid-19 vaccine.   Final diagnosis was (fatal) stopped breathing.  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  It is unknown if an autopsy was done. The cause of death was reported as Respiratory arrest.  At time of reporting, the outcome was Fatal for all the events  Seriousness criteria: Medically significant and was leading to death on 29-Oct-2022 for the event Stopped breathing and loss of consciousness. Fatal for event eye movement disorder.; Sender's Comments: Sanofi Company Comment on 16-Dec-2022:This case involves 67 years old female patient who went out walking, collapsed, eyes rolled back and stopped breathing after receiving vaccines pfizer biontech COVID-19 vaccine and influenza quadrival A-B high dose HV Vaccine[Fluzone high-dose quadrivalent]. This reported event stopped breathing  was assessed as medically significant and fatal. Further information regarding medical history during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Stopped breathing
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, FLU4
Symptoms: Eye movement disorder, Loss of consciousness, Respiratory arrest
Clinical narrative: Stopped breathing; Eyes rolled back; OUT WALKING, COLLAPSED; Initial information received on 13-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-health-care professional.  This case involves 67 years old female patient who went out walking, collapsed, eyes rolled back and stopped breathing after receiving vaccines pfizer biontech COVID-19 vaccine and influenza quadrival A-B high dose HV Vaccine[Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspects influenza quadrival A-B high dose HV Vaccine and pfizer biontech COVID-19 vaccine (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On 29-Oct-2022 the patient who went out walking, collapsed (loss of consciousness), eyes rolled back (eye movement disorder) and stopped breathing (respiratory arrest) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine and (unknown latency) following the administration of pfizer biontech covid-19 vaccine.   Final diagnosis was (fatal) stopped breathing.  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  It is unknown if an autopsy was done. The cause of death was reported as Respiratory arrest.  At time of reporting, the outcome was Fatal for all the events  Seriousness criteria: Medically significant and was leading to death on 29-Oct-2022 for the event Stopped breathing and loss of consciousness. Fatal for event eye movement disorder.; Sender's Comments: Sanofi Company Comment on 16-Dec-2022:This case involves 67 years old female patient who went out walking, collapsed, eyes rolled back and stopped breathing after receiving vaccines pfizer biontech COVID-19 vaccine and influenza quadrival A-B high dose HV Vaccine[Fluzone high-dose quadrivalent]. This reported event stopped breathing  was assessed as medically significant and fatal. Further information regarding medical history during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Stopped breathing
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from an unspecified administrator and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history or concomitant medications was provided.  On 01-DEC-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, 0.5 ml, lot # U010534, expiration date: 31-OCT-2022) (frequency and route of administration were not provided) for prophylaxis (expired product administered).The vaccine had not undergone any temperature excursions.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from an unspecified administrator and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history or concomitant medications was provided.  On 01-DEC-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, 0.5 ml, lot # U010534, expiration date: 31-OCT-2022) (frequency and route of administration were not provided) for prophylaxis (expired product administered).The vaccine had not undergone any temperature excursions.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram
Clinical narrative: lump under her armpit on that side for 1 month after receiving that dose; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump under her armpit on that side for 1 month after receiving that dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Urinary infection.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (lump under her armpit on that side for 1 month after receiving that dose). At the time of the report, AXILLARY MASS (lump under her armpit on that side for 1 month after receiving that dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: They had done many tests including blood tests and a CT scan. Her pain is still ongoing today. On an unknown date, Computerised tomogram: They had done many tests including blood tests and a CT scan. Her pain is still ongoing today.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that patient had received a second primary dose, and a first booster at unknown times No treatment medications were reported.   This case was linked to MOD-2022-687742 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary mass, Blood test, Computerised tomogram, Pain
Clinical narrative: lump under her armpit on that side for 1 month after receiving that dose; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump under her armpit on that side for 1 month after receiving that dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Urinary infection.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (lump under her armpit on that side for 1 month after receiving that dose). At the time of the report, AXILLARY MASS (lump under her armpit on that side for 1 month after receiving that dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: They had done many tests including blood tests and a CT scan. Her pain is still ongoing today. On an unknown date, Computerised tomogram: They had done many tests including blood tests and a CT scan. Her pain is still ongoing today.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that patient had received a second primary dose, and a first booster at unknown times No treatment medications were reported.   This case was linked to MOD-2022-687742 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal X-ray, Activated partial thromboplastin time, Acute hepatic failure, Acute kidney injury, Alpha-1 anti-trypsin
Clinical narrative: Went to ER-04/03/2021-Acute Liver Failure, Elevated INR, Hypoglycemia, Increased Ammonia Level-378, Septic Shock, Hepatic Encephalopathy, Acute Kidney Injury (HCC), Volume Overload, Anemia, Scleral Icterus, Elevated LFTs, Transaminitis, Bandemia, Coagulation, Tinnitus and Hyperbilirubinemia. Transferred on 04/03/2021 to alternate location. Transferred from alternate hospital on  04/04/2021 to 2nd ICU-released 04/12/2021.  Ongoing health issues continue after receiving the Pfizer Covid Vaccine injection-Debilitating Tinnitus, Sjogren's, Fibromyalgia, Migraines, Raynaud's, Leukopenia, Anemia, Positive ANA, Chronic Pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ammonia increased, Anaemia, Analgesic drug level, Antimitochondrial antibody, Antinuclear antibody positive
Clinical narrative: Went to ER-04/03/2021-Acute Liver Failure, Elevated INR, Hypoglycemia, Increased Ammonia Level-378, Septic Shock, Hepatic Encephalopathy, Acute Kidney Injury (HCC), Volume Overload, Anemia, Scleral Icterus, Elevated LFTs, Transaminitis, Bandemia, Coagulation, Tinnitus and Hyperbilirubinemia. Transferred on 04/03/2021 to alternate location. Transferred from alternate hospital on  04/04/2021 to 2nd ICU-released 04/12/2021.  Ongoing health issues continue after receiving the Pfizer Covid Vaccine injection-Debilitating Tinnitus, Sjogren's, Fibromyalgia, Migraines, Raynaud's, Leukopenia, Anemia, Positive ANA, Chronic Pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bandaemia, Blood culture, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M
Clinical narrative: Went to ER-04/03/2021-Acute Liver Failure, Elevated INR, Hypoglycemia, Increased Ammonia Level-378, Septic Shock, Hepatic Encephalopathy, Acute Kidney Injury (HCC), Volume Overload, Anemia, Scleral Icterus, Elevated LFTs, Transaminitis, Bandemia, Coagulation, Tinnitus and Hyperbilirubinemia. Transferred on 04/03/2021 to alternate location. Transferred from alternate hospital on  04/04/2021 to 2nd ICU-released 04/12/2021.  Ongoing health issues continue after receiving the Pfizer Covid Vaccine injection-Debilitating Tinnitus, Sjogren's, Fibromyalgia, Migraines, Raynaud's, Leukopenia, Anemia, Positive ANA, Chronic Pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood phosphorus increased, Chest X-ray, Culture urine, Cytomegalovirus test, Electrocardiogram
Clinical narrative: Went to ER-04/03/2021-Acute Liver Failure, Elevated INR, Hypoglycemia, Increased Ammonia Level-378, Septic Shock, Hepatic Encephalopathy, Acute Kidney Injury (HCC), Volume Overload, Anemia, Scleral Icterus, Elevated LFTs, Transaminitis, Bandemia, Coagulation, Tinnitus and Hyperbilirubinemia. Transferred on 04/03/2021 to alternate location. Transferred from alternate hospital on  04/04/2021 to 2nd ICU-released 04/12/2021.  Ongoing health issues continue after receiving the Pfizer Covid Vaccine injection-Debilitating Tinnitus, Sjogren's, Fibromyalgia, Migraines, Raynaud's, Leukopenia, Anemia, Positive ANA, Chronic Pain.