chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vertigo
Clinical narrative: Was unconscious on the floor; Couldn't get up; muscle loss (rhabdomyolysis); Ear Infection; Fell on ground; Bad reaction to 2nd dose; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was unconscious on the floor) and RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Was unconscious on the floor) (seriousness criteria hospitalization and medically significant), RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)) (seriousness criterion medically significant), EAR INFECTION (Ear Infection), FALL (Fell on ground), VACCINATION COMPLICATION (Bad reaction to 2nd dose) and VERTIGO (vertigo). On an unknown date, the patient experienced MOBILITY DECREASED (Couldn't get up). At the time of the report, LOSS OF CONSCIOUSNESS (Was unconscious on the floor), RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)), EAR INFECTION (Ear Infection), FALL (Fell on ground), VACCINATION COMPLICATION (Bad reaction to 2nd dose), VERTIGO (vertigo) and MOBILITY DECREASED (Couldn't get up) outcome was unknown.            Ear infection at the time and was given 5 days course of steroids and the unknown medications. for other events. The blood work, CT scan, MRI, and other tests were done but none of them could pinpoint it to the vaccine. Patient was hospitalized for 3 days. No concomitant medication was reported by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Further information is expected.   This case was linked to MOD-2021-052530 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Impaired driving ability, Joint dislocation, Loss of personal independence in daily activities, Seizure
Clinical narrative: seizure/ massive seizure; light headed; Shoulder popped out; not allowed to drive or work; not allowed to drive or work; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizure/ massive seizure), DIZZINESS (light headed) and JOINT DISLOCATION (Shoulder popped out) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Type 2 diabetes mellitus.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced SEIZURE (seizure/ massive seizure) (seriousness criteria hospitalization, medically significant and life threatening), DIZZINESS (light headed) (seriousness criteria hospitalization and life threatening) and JOINT DISLOCATION (Shoulder popped out) (seriousness criterion hospitalization). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (not allowed to drive or work) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not allowed to drive or work). On 05-May-2021, SEIZURE (seizure/ massive seizure) outcome was unknown. At the time of the report, DIZZINESS (light headed), JOINT DISLOCATION (Shoulder popped out), IMPAIRED DRIVING ABILITY (not allowed to drive or work) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not allowed to drive or work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not reported. Treatment was not reported. Patient has never had a seizure before and is also a Type 2 diabetic.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-264175 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow-up received on 22-JUL-2021 Contains updated information on patient demographics, updated event seriousness; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Cardiac Infraction; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Cardiac Infraction) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination.     No relevant medical history was provided.  Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN LOW) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Cardiac Infraction) (seriousness criteria medically significant and intervention required). At the time of the report, MYOCARDIAL INFARCTION (Cardiac Infraction) outcome was unknown.            Patient stated that they put a stent in there. Company comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased
Clinical narrative: Infection; Sick; TSA levels increased and blood work done today and this is coming back to the way that normally/; Blood pressure increased; This spontaneous case was reported by a physician and describes the occurrence of INFECTION (Infection) and ILLNESS (Sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) tablet for Myelofibrosis.    Concurrent medical conditions included Myelofibrosis. Concomitant products included WARFARIN SODIUM (COUMADIN), OLMESARTAN MEDOXOMIL (BENICAR) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 10 mg twice a day. In May 2021, the patient experienced ILLNESS (Sick) (seriousness criterion hospitalization). On an unknown date, the patient experienced INFECTION (Infection) (seriousness criterion hospitalization), BLOOD THYROID STIMULATING HORMONE INCREASED (TSA levels increased and blood work done today and this is coming back to the way that normally/) and BLOOD PRESSURE INCREASED (Blood pressure increased). The patient was hospitalized for 5 days due to ILLNESS and INFECTION. At the time of the report, INFECTION (Infection), ILLNESS (Sick), BLOOD THYROID STIMULATING HORMONE INCREASED (TSA levels increased and blood work done today and this is coming back to the way that normally/) and BLOOD PRESSURE INCREASED (Blood pressure increased) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) Increased. On an unknown date, Blood test: abnormal (abnormal) Abnormal. On an unknown date, Blood thyroid stimulating hormone: increased (High) Increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Concomitant medication and the underlying Myelofibrosis are potential confounders for the event "infection"; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Concomitant medication and the underlying Myelofibrosis are potential confounders for the event "infection"
Sex: M
Vaccine: COVID19, UNK
Symptoms: Illness, Infection
Clinical narrative: Infection; Sick; TSA levels increased and blood work done today and this is coming back to the way that normally/; Blood pressure increased; This spontaneous case was reported by a physician and describes the occurrence of INFECTION (Infection) and ILLNESS (Sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) tablet for Myelofibrosis.    Concurrent medical conditions included Myelofibrosis. Concomitant products included WARFARIN SODIUM (COUMADIN), OLMESARTAN MEDOXOMIL (BENICAR) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 10 mg twice a day. In May 2021, the patient experienced ILLNESS (Sick) (seriousness criterion hospitalization). On an unknown date, the patient experienced INFECTION (Infection) (seriousness criterion hospitalization), BLOOD THYROID STIMULATING HORMONE INCREASED (TSA levels increased and blood work done today and this is coming back to the way that normally/) and BLOOD PRESSURE INCREASED (Blood pressure increased). The patient was hospitalized for 5 days due to ILLNESS and INFECTION. At the time of the report, INFECTION (Infection), ILLNESS (Sick), BLOOD THYROID STIMULATING HORMONE INCREASED (TSA levels increased and blood work done today and this is coming back to the way that normally/) and BLOOD PRESSURE INCREASED (Blood pressure increased) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) Increased. On an unknown date, Blood test: abnormal (abnormal) Abnormal. On an unknown date, Blood thyroid stimulating hormone: increased (High) Increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Concomitant medication and the underlying Myelofibrosis are potential confounders for the event "infection"; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Concomitant medication and the underlying Myelofibrosis are potential confounders for the event "infection"
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Bronchitis, Dysphonia, Haemoptysis, Incorrect route of product administration
Clinical narrative: Bronchitis; Pharyngitis; Coughed up blood; Hoarse voice; Treatment non compliance; Inappropriate route of vaccination; This spontaneous case was reported by a health care professional and describes the occurrence of BRONCHITIS (Bronchitis), PHARYNGITIS (Pharyngitis), HAEMOPTYSIS (Coughed up blood) and DYSPHONIA (Hoarse voice) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MACITENTAN for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included TADALAFIL (ADCIRCA) and RIVAROXABAN (XARELTO) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form and MACITENTAN (Oral) 10 mg. On an unknown date, the patient experienced BRONCHITIS (Bronchitis) (seriousness criterion hospitalization), PHARYNGITIS (Pharyngitis) (seriousness criterion hospitalization), HAEMOPTYSIS (Coughed up blood) (seriousness criterion hospitalization), DYSPHONIA (Hoarse voice) (seriousness criterion hospitalization), TREATMENT NONCOMPLIANCE (Treatment non compliance) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). The patient was hospitalized from 28-May-2021 to 01-Jun-2021 due to BRONCHITIS, DYSPHONIA, HAEMOPTYSIS and PHARYNGITIS. At the time of the report, BRONCHITIS (Bronchitis), PHARYNGITIS (Pharyngitis), HAEMOPTYSIS (Coughed up blood), DYSPHONIA (Hoarse voice), TREATMENT NONCOMPLIANCE (Treatment non compliance) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, Blood pressure measurement: low (Low) Low. On 28-May-2021, Oxygen saturation: low (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: Very limited information regarding these  events have  been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these  events have  been provided at this time.  Further information has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pharyngitis, Treatment noncompliance
Clinical narrative: Bronchitis; Pharyngitis; Coughed up blood; Hoarse voice; Treatment non compliance; Inappropriate route of vaccination; This spontaneous case was reported by a health care professional and describes the occurrence of BRONCHITIS (Bronchitis), PHARYNGITIS (Pharyngitis), HAEMOPTYSIS (Coughed up blood) and DYSPHONIA (Hoarse voice) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MACITENTAN for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included TADALAFIL (ADCIRCA) and RIVAROXABAN (XARELTO) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form and MACITENTAN (Oral) 10 mg. On an unknown date, the patient experienced BRONCHITIS (Bronchitis) (seriousness criterion hospitalization), PHARYNGITIS (Pharyngitis) (seriousness criterion hospitalization), HAEMOPTYSIS (Coughed up blood) (seriousness criterion hospitalization), DYSPHONIA (Hoarse voice) (seriousness criterion hospitalization), TREATMENT NONCOMPLIANCE (Treatment non compliance) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). The patient was hospitalized from 28-May-2021 to 01-Jun-2021 due to BRONCHITIS, DYSPHONIA, HAEMOPTYSIS and PHARYNGITIS. At the time of the report, BRONCHITIS (Bronchitis), PHARYNGITIS (Pharyngitis), HAEMOPTYSIS (Coughed up blood), DYSPHONIA (Hoarse voice), TREATMENT NONCOMPLIANCE (Treatment non compliance) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, Blood pressure measurement: low (Low) Low. On 28-May-2021, Oxygen saturation: low (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: Very limited information regarding these  events have  been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these  events have  been provided at this time.  Further information has been requested.
Age: 88.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Illness, Pyrexia, Saliva discolouration
Clinical narrative: Short breath; Very ill/disperatly ill; Fever; Spittle like form egg whites; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Short breath), ILLNESS (Very ill/disperatly ill) and PYREXIA (Fever) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Disability.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Short breath) (seriousness criterion hospitalization), ILLNESS (Very ill/disperatly ill) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization) and SALIVA DISCOLOURATION (Spittle like form egg whites). At the time of the report, DYSPNOEA (Short breath), ILLNESS (Very ill/disperatly ill), PYREXIA (Fever) and SALIVA DISCOLOURATION (Spittle like form egg whites) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) temperature was 102 that indicated fever.         No relevant concomitant medications were reported. No treatment information was provided.  Very scant and mostly unintelligible information has been received and follow-up has been requested. Based on current available information and the possible temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Very scant and mostly unintelligible information has been received and follow-up has been requested. Based on current available information and the possible temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I'm 100 percent disabled by the Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I'm 100 percent disabled by the Moderna shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I'm 100 percent disabled by the Moderna shot) (seriousness criterion disability). At the time of the report, VACCINATION COMPLICATION (I'm 100 percent disabled by the Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  Very limited information regarding the event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nephrolithiasis
Clinical narrative: Kidney Stone after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney Stone after the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney disorder.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced NEPHROLITHIASIS (Kidney Stone after the first dose) (seriousness criterion medically significant). The patient was treated with CIPROFLOXACIN at a dose of UNK, bid. At the time of the report, NEPHROLITHIASIS (Kidney Stone after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.  Company Comment  Very limited information regarding the event has been provided at this time. Reporter did not provide permission to follow-up.; Sender's Comments: Very limited information regarding the event has been provided at this time. Reporter did not provide permission to follow-up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Dizziness, Interchange of vaccine products, Tinnitus, Vertigo
Clinical narrative: Hearing loss; bilateral tinnitus rushed into my head; Dizziness; Vertigo-like dizziness; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Hearing loss.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant), TINNITUS (bilateral tinnitus rushed into my head), DIZZINESS (Dizziness), VERTIGO (Vertigo-like dizziness) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, DEAFNESS (Hearing loss) outcome was unknown, TINNITUS (bilateral tinnitus rushed into my head), DIZZINESS (Dizziness) and VERTIGO (Vertigo-like dizziness) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.            Concomitant medications were not reported.  Treatment medications were not reported.  Patient initially administered with Pfizer BIONTECH COVID-19 vaccine and started experiencing Tinnitus.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Renal disorder
Clinical narrative: Hospitalized for 17 days because of kidney problems; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Hospitalized for 17 days because of kidney problems) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: METFORMIN, FORXIGA and INSULIN. Concurrent medical conditions included Diabetes. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced RENAL DISORDER (Hospitalized for 17 days because of kidney problems) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 19-May-2021 to 04-Jun-2021 due to RENAL DISORDER. On 04-Jun-2021, RENAL DISORDER (Hospitalized for 17 days because of kidney problems) had resolved.            Patient has to do dialysis three times a week.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Haematological malignancy
Clinical narrative: I have a blood cancer; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOLOGICAL MALIGNANCY (I have a blood cancer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included RITUXIMAB (RITUXAN) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMATOLOGICAL MALIGNANCY (I have a blood cancer) (seriousness criteria medically significant and life threatening). At the time of the report, HAEMATOLOGICAL MALIGNANCY (I have a blood cancer) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Meniere's disease, Vertigo
Clinical narrative: Activation of Ménière's disease; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (Activation of Ménière's disease) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENIERE'S DISEASE (Activation of Ménière's disease) (seriousness criterion medically significant) and VERTIGO (Vertigo). At the time of the report, MENIERE'S DISEASE (Activation of Ménière's disease) and VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use information was not provided by reporter.  Treatment medication use information was not provided by reporter.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: Ulcerative colitis flare,severe flare; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis flare,severe flare) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis flare,severe flare) (seriousness criterion medically significant). At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis flare,severe flare) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter stated that patient has had a severe flare of his ulcerative colitis that his gastroenterologist has not been able to control the symptoms. Ulcerative colitis flare was due to the vaccine.   No concomitant medications were reported. No treatment information was reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: blood pressure started rising her pressure was very high/However, reached 172 over 56; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Mar2021 (lot Number: EL9261) as single for COVID-19 immunisation. The patient Historical vaccine included first dose of BNT162B2 for Covid-19 immunisation.  Concomitant medications were not reported. As reported, two days after the patient second injection on 30Mar2021 (01Apr2021), her blood pressure started rising her pressure was very high for her as it usually is normal. However, reached 172 over 56. The patient's lab data included Blood pressure 172 over 56 on 01Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My husband and I both were diagnosed with SARS-cov-2 in the past two weeks despite being fully vaccinated with the Pfizer COVID Vaccine; My husband and I both were diagnosed with SARS-cov-2 in the past two weeks despite being fully vaccinated with the Pfizer COVID Vaccine; This is a spontaneous report from a contactable Pfizer colleague reported similar event for herself and her husband, this is for the husband (patient). A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single and via an unspecified route of administration on an unspecified date as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that her husband and she both were diagnosed with sars-cov-2 in the past two weeks despite being fully vaccinated with the pfizer covid vaccine on an unspecified date. Both her husband and she were symptomatic but did not require hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Feeling abnormal, Nausea
Clinical narrative: blood pressure dropped to 90/46; nauseous; felt like I was going to pass out; This is a spontaneous report from a contactable consumer (patient). A 48-Year-Old non pregnant female patient reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL8982), via an unspecified route of administration, administered in left arm on 09Feb2021 at 11:00 AM (at the age of 48 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes arthritis, interstitial cystitis, severe dry eyes. The patient was allergic to Erythromycin, Tramadol and Latex. Concomitant medications included celecoxib (CELEBREX), benzalkonium chloride, sodium chloride (ALIVE) women's gummy vitamins and calcium carbonate, colecalciferol (CALTRATE) all were taken for an unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. Vaccination facility type was hospital. No other vaccine in four weeks. The patient reported as, on 09Feb2021 at 11:00 AM, within 5 minutes of taking the vaccine my blood pressure dropped to 90/46 and I became very nauseous and felt like I was going to pass out. An EMT on site monitored my blood pressure. I was given a bag of fluids intravenous and a dose of zofran intravenous. I was also given a Gatorade to drink and crackers. After about an hour my blood pressure increased to 100/60. That is a normal blood pressure for me. Adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events with Intravenous fluids and Zofran. No covid prior vaccination and not covid tested post vaccination. Outcome of the events was recovered on an unspecified date in Feb 2021 for nauseous and feeling abnormal and event blood pressure dropped to 90/46 was recovered on 09Feb2021.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Lymphadenopathy
Clinical narrative: swollen lymph nodes; chills; fever; body aches; feeling unwell; headache; tiredness; nausea; Was dizzy after the vaccine also; Swollen throat / Throat swelling; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), via intramuscular, administered in left arm on 19May2021 at 11:00 AM (Age at vaccination was 71 years) as DOSE 1, SINGLE for covid-19 immunisation. No medical history included, the patient was healthy and allergic to unknown. No concomitant medications were reported. The patient was not pregnancy at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19May2021, the patient experienced swollen throat / throat swelling; On 20May2021 at 12:00 AM experienced swollen lymph nodes, chills, fever, body aches, feeling unwell, headache, tiredness, nausea and the patient was dizzy after the vaccine also. Patient called office for advice on receiving second Covid vaccine. Stated she had throat swelling after first advised not to vaccine second shot. No relevant test. The seriousness was reported as Important medical event for event swollen throat / throat swelling. No treatment received by the patients for adverse events. Outcome of the event swollen throat / throat swelling was resolved on an unspecified date in May 2021 and remaining events were resolving.  Follow-up attempts are needed. Further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pharyngeal swelling, Pyrexia
Clinical narrative: swollen lymph nodes; chills; fever; body aches; feeling unwell; headache; tiredness; nausea; Was dizzy after the vaccine also; Swollen throat / Throat swelling; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), via intramuscular, administered in left arm on 19May2021 at 11:00 AM (Age at vaccination was 71 years) as DOSE 1, SINGLE for covid-19 immunisation. No medical history included, the patient was healthy and allergic to unknown. No concomitant medications were reported. The patient was not pregnancy at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19May2021, the patient experienced swollen throat / throat swelling; On 20May2021 at 12:00 AM experienced swollen lymph nodes, chills, fever, body aches, feeling unwell, headache, tiredness, nausea and the patient was dizzy after the vaccine also. Patient called office for advice on receiving second Covid vaccine. Stated she had throat swelling after first advised not to vaccine second shot. No relevant test. The seriousness was reported as Important medical event for event swollen throat / throat swelling. No treatment received by the patients for adverse events. Outcome of the event swollen throat / throat swelling was resolved on an unspecified date in May 2021 and remaining events were resolving.  Follow-up attempts are needed. Further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: I had a large amount of pain in my stomach.; This is a spontaneous report from a contactable consumer.   A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 18Apr2021 (Batch/Lot Number: EW0162) as dose 2, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 28Mar2021 (Batch/Lot Number: ER8730) as dose 1, single for COVID-19 immunisation.  The patient stated on 18Apr2021, "I had a large amount of pain in my stomach. The pain was almost to the point where I was considering going to the hospital and it took multiple ibuprofen to even be able to sleep. This pain lasted for about two days before subsiding. The symptom I had did not seem to be one of the listed symptoms of the vaccine so I was a little worried for a day about what the pain could be".  The patient was diagnosed with COVID-19 and not been tested for COVID-19. The event was reported to have led to hospitalization. The outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Memory impairment
Clinical narrative: The patient was disoriented for 4 hours after 2nd dose. She could not remember her name, was asking for her chairs when she meant shoes.; The patient was disoriented for 4 hours after 2nd dose. She could not remember her name, was asking for her chairs when she meant shoes.; This is a spontaneous report from a contactable consumer. A 14-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Jun2021, as a single dose for COVID-19 immunization. It was unknown if the patient was pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in 2021, as a single dose for COVID-19 immunization. The patient received other vaccine in four weeks. It was unknown if the patient was diagnosed with COVID-19, prior to vaccination. It was unknown if the patient was tested for COVID-19, since the vaccination. On an unspecified date in Jun2021, the patient was disoriented for 4 hours after 2nd dose. She could not remember her name, was asking for her chairs when she meant shoes. The patient was taken to the ER and was released. The adverse event resulted in emergency room/department or urgent care. There was no hospitalization prolonged. It was unknown if the patient received treatment for the events. Outcome of the events at the time of last observation was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Areflexia, Asthenia, Back pain, Chest X-ray, Computerised tomogram
Clinical narrative: passed out and fell; Peripheral Diabetic Neuropathy; upper back pain the radiated from side to side; spasm; numbness in hands and feet; numbness in hands and feet; passed out and fell; dizzy; legs began to tingle; lost my ability to swallow correctly; weak; had no gag reflex and couldn't cough; blow my nose; My legs hurt; had no gag reflex and couldn't cough,; This is a spontaneous report from contactable consumer (Patient herself). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6198; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 21Feb2021 11:30 as single dose for COVID-19 immunization. Medical history included diabetes mellitus, lupus-like syndrome, atrial, guillain-barre syndrome, food allergy, contrast media allergy from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMIN), metoprolol tartrate (METOPROLOL TARTRATE), fenofibrate (FENOFIBRATE) taken for an unspecified indication. The patient previously took penicilin g, potassium, chantix and experienced hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Feb2021 11:00 it was reported that, 24 hours after vaccination she started having upper back pain the radiated from side to side. 3 days later she saw PCP who ordered chest x-ray and prescribed muscle relaxer. 4th day pain was worse at night and went to ER, given different medication for spasm. 5th day, pain continued to get worse at night and went to ER had CT of abdomen/Pelvis and given different medication for spasm. 6th day pain worse, returned to ER, had back pain, numbness in hands and feet. Diagnosed with Peripheral Diabetic Neuropathy, given Gabapentin. All this time she had been running on 2 hours a sleep a day. On 10th day, she passed out and fell. On 11th day, she was dizzy and legs began to tingle so went to ER, where she was admitted over the weekend. A CT of Brain and Spine and Doppler were done. Discharged with same diagnosis. Saw Neurologist 6 weeks after onset. During this ordeal on an unspecified dates she lost her ability to swallow correctly and had no gag reflex and couldn't cough, blow her nose. Her legs hurt and she was weak. Diagnosed with GBS. The patient was hospitalized for upper back pain the radiated from side to side, spasm, numbness in hands and feet, numbness in hands and feet for 3 days. Therapeutic measures were taken as a result of weak, upper back pain the radiated from side to side, spasm, numbness in hands and feet, numbness in hands and feet, peripheral diabetic neuropathy, passed out and fell, passed out and fell, dizzy, legs began to tingle, lost my ability to swallow correctly as patient had received pain medication and physical therapy evaluation. Since the vaccination, the patient was not tested for COVID-19. The outcome of all events was not recovered.  Follow-up actions are needed. Further information has been requested.