chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: Ischaemic stroke; This spontaneous case was reported by a consumer and describes the occurrence of ISCHAEMIC STROKE (Ischaemic stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ISCHAEMIC STROKE (Ischaemic stroke) (seriousness criterion medically significant). At the time of the report, ISCHAEMIC STROKE (Ischaemic stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Reporter mentioned that diagnosis from hospital which included magnetic resonance imaging (MRI), computed tomography (CT scans), and echocardiogram (EKG) did not reveal any signs from where the blood clots were originated. No treatment information was provided by the reporter.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Intentional dose omission, Speech disorder, Thrombosis
Clinical narrative: I had a stroke; Blood clot; Speak was bad, couldn't form words, speak was impaired; Missed her dose due to to the decision not to get it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (I had a stroke) and THROMBOSIS (Blood clot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (I had a stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), SPEECH DISORDER (Speak was bad, couldn't form words, speak was impaired) and INTENTIONAL DOSE OMISSION (Missed her dose due to to the decision not to get it). On 16-Feb-2021, CEREBROVASCULAR ACCIDENT (I had a stroke) had resolved. At the time of the report, THROMBOSIS (Blood clot) and SPEECH DISORDER (Speak was bad, couldn't form words, speak was impaired) outcome was unknown and INTENTIONAL DOSE OMISSION (Missed her dose due to to the decision not to get it) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided.  The patient was receiving treatment with clopidogrel (Plavix) 75mg since the stroke (which is a stronger blood thinner TPA drug that resolve the blood clot). Reportedly, the patient was hospitalized for 3 days. Patient also stated that she was nervous about getting her 2nd dose so she missed her dose due to the decision not to get it with regards to the fear of having another stroke.  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.   This case was linked; Sender's Comments:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Dyspnoea, Helicobacter gastritis, Incomplete course of vaccination, Pleural effusion
Clinical narrative: shortness of breath; congestive heart failure; H-pyloria infections in the stomach; fluid around the lungs virus; Missed the second dose due to hospitalization; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath), CARDIAC FAILURE CONGESTIVE (congestive heart failure), HELICOBACTER GASTRITIS (H-pyloria infections in the stomach) and PLEURAL EFFUSION (fluid around the lungs virus) in a 72-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.     The patient's past medical history included No adverse event (No reported adverse event).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criterion hospitalization), HELICOBACTER GASTRITIS (H-pyloria infections in the stomach) (seriousness criteria hospitalization and medically significant), PLEURAL EFFUSION (fluid around the lungs virus) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Missed the second dose due to hospitalization). The patient was hospitalized from 13-Mar-2021 to 26-Mar-2021 due to CARDIAC FAILURE CONGESTIVE, DYSPNOEA, HELICOBACTER GASTRITIS and PLEURAL EFFUSION. At the time of the report, DYSPNOEA (shortness of breath), CARDIAC FAILURE CONGESTIVE (congestive heart failure), HELICOBACTER GASTRITIS (H-pyloria infections in the stomach), PLEURAL EFFUSION (fluid around the lungs virus) and INCOMPLETE COURSE OF VACCINATION (Missed the second dose due to hospitalization) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient missed the second dose due to hospitalization.  Concomitant and treatment information not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neuropathy peripheral, Pain
Clinical narrative: neuropathy in feet prior to start worsened and feet felt like boulders during the flare.; aching all over; Fatigue during flare; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy in feet prior to start worsened and feet felt like boulders during the flare.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy in feet prior to start worsened and feet felt like boulders during the flare.) (seriousness criterion medically significant), PAIN (aching all over) and FATIGUE (Fatigue during flare). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy in feet prior to start worsened and feet felt like boulders during the flare.), PAIN (aching all over) and FATIGUE (Fatigue during flare) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Flare was worsen after second dose and calmed down after Md gave her a steroid shot last week. MEd told her they are unsure if the flare is related to covid or the con-med isn't working because Xeljanz ( Tofacitinib) is been taking for 3 years. Md is concerned about recent study linking xelijanz ( Tofacitinib) and cancer.  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.  Action taken with mRNA-1273 in response to the event was not applicable.; 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: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Potential adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Potential adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Concurrent medical conditions included Drug allergy (allergic to anesthesia) and Acetylcholinesterase deficiency.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Potential adverse reaction) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (Potential adverse reaction) was resolving.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medications taken by the patient were not provided. Reporter's sister had received Moderna's COVID-19 vaccine and she was hospitalized due to reaction and it was reported as not severe. The symptoms had gradually subsided. The patient had an allergic reaction to anesthesia which was life threatening .Patient had stopped breathing and was sent to the hospital and it was found that patient had pseudocholinesterase deficiency.Treatment information was not provided. Very limited information regarding this event has been provided at this time.  Further information has been requested.  Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Pulmonary congestion
Clinical narrative: COMMON COLD; body aches; chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (chest congestion) in a female 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.     The patient's past medical history included No adverse event (no historical condition reported.).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-1021, the patient experienced PULMONARY CONGESTION (chest congestion) (seriousness criterion medically significant). On 15-Apr-2021, the patient experienced NASOPHARYNGITIS (COMMON COLD) and MYALGIA (body aches). At the time of the report, PULMONARY CONGESTION (chest congestion), NASOPHARYNGITIS (COMMON COLD) and MYALGIA (body aches) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appetite disorder, Dehydration
Clinical narrative: Dehydration; Stomach pain; Apatite; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEHYDRATION (Dehydration) and ABDOMINAL PAIN UPPER (Stomach pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis (The patient was hospitalized before due to the Multiple Sclerosis so many time.) since March 2021.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion hospitalization), ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion hospitalization) and APPETITE DISORDER (Apatite). On 14-Apr-2021, ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown. At the time of the report, DEHYDRATION (Dehydration) and APPETITE DISORDER (Apatite) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Deafness transitory, Diplopia, SARS-CoV-2 test, Tinnitus
Clinical narrative: "I lost hearing in both ears for 20 min, on and off ever since"; "my vision doubled in size"; "It sounds like a buzzing nose, and feels like I'm on a plan and my ears need to pop."; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS TRANSITORY ("I lost hearing in both ears for 20 min, on and off ever since") in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Sore throat (Patient reported that her throat was no longer sore at the time of vaccine just "scratchy."). Concomitant products included CODEINE PHOSPHATE, GUAIFENESIN, PHENIRAMINE MALEATE (ROBITUSSIN A-C) from an unknown date to 13-Apr-2021 for Sore throat.  On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DEAFNESS TRANSITORY ("I lost hearing in both ears for 20 min, on and off ever since") (seriousness criterion medically significant) and DIPLOPIA ("my vision doubled in size"). On an unknown date, the patient experienced TINNITUS ("It sounds like a buzzing nose, and feels like I'm on a plan and my ears need to pop."). On 13-Apr-2021, DIPLOPIA ("my vision doubled in size") had resolved. At the time of the report, DEAFNESS TRANSITORY ("I lost hearing in both ears for 20 min, on and off ever since") and TINNITUS ("It sounds like a buzzing nose, and feels like I'm on a plan and my ears need to pop.") had not resolved.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test: negative (Negative) Patient had received a negative COVID test on the day of the vaccination..  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Patient denies any treatment related to the events.  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.; 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: F
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: cellulitis site infection; Injection site warm to touch; Injection site is sore; Injection site is swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis site infection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    The patient's past medical history included No adverse event (Relevant medical history not reported).  On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE PAIN (Injection site is sore) and VACCINATION SITE SWELLING (Injection site is swollen). On an unknown date, the patient experienced CELLULITIS (cellulitis site infection) (seriousness criterion medically significant). At the time of the report, CELLULITIS (cellulitis site infection), VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE PAIN (Injection site is sore) and VACCINATION SITE SWELLING (Injection site is swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Patient was evaluated by a nurse and an antibiotic was prescribed for treatment of the suspected cellulitis. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis bacterial
Clinical narrative: Bacterial bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS BACTERIAL (Bacterial bronchitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported.).   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BRONCHITIS BACTERIAL (Bacterial bronchitis) (seriousness criterion medically significant). At the time of the report, BRONCHITIS BACTERIAL (Bacterial bronchitis) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant medications and relevant medical history were not reported. The patient received her first dose of the vaccine on 23-Mar-2021.  She "got bacterial bronchitis after the second dose starting 02-Apr-2021."     This case was linked; Sender's Comments:  brother case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Hepatitis B, Illness, Incomplete course of vaccination, Jaundice
Clinical narrative: cyst on kidney; cyst on pancreas; Hepatitis B; Jaundice; Cyst on liver; started getting ill; 2nd dose not administered within vaccine schedule window; MRI Abnormal; Ultrasound abnormal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL CYST (cyst on kidney), PANCREATIC CYST (cyst on pancreas), HEPATITIS B (Hepatitis B), JAUNDICE (Jaundice) and CYST (Cyst on liver) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stomach discomfort (Starting back in August 2020 she didn't feel good, had stomach issues off and on.) since August 2020. Concomitant products included LISINOPRIL for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RENAL CYST (cyst on kidney) (seriousness criterion hospitalization), PANCREATIC CYST (cyst on pancreas) (seriousness criterion hospitalization), HEPATITIS B (Hepatitis B) (seriousness criterion hospitalization), JAUNDICE (Jaundice) (seriousness criterion hospitalization), CYST (Cyst on liver) (seriousness criterion hospitalization), MAGNETIC RESONANCE IMAGING ABNORMAL (MRI Abnormal) and ULTRASOUND SCAN ABNORMAL (Ultrasound abnormal). On an unknown date, the patient experienced ILLNESS (started getting ill) and INCOMPLETE COURSE OF VACCINATION (2nd dose not administered within vaccine schedule window). The patient was hospitalized from 05-Feb-2021 to 08-Feb-2021 due to CYST, HEPATITIS B, JAUNDICE, PANCREATIC CYST and RENAL CYST. On 05-Feb-2021, MAGNETIC RESONANCE IMAGING ABNORMAL (MRI Abnormal) and ULTRASOUND SCAN ABNORMAL (Ultrasound abnormal) outcome was unknown. At the time of the report, RENAL CYST (cyst on kidney), PANCREATIC CYST (cyst on pancreas), HEPATITIS B (Hepatitis B), JAUNDICE (Jaundice), CYST (Cyst on liver) and ILLNESS (started getting ill) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (2nd dose not administered within vaccine schedule window) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Hepatitis B: positive Positive. On 05-Feb-2021, Magnetic resonance imaging: abnormal (abnormal) Identified a cyst on her pancreas, cyst on her kidney and cyst on her liver.. On 05-Feb-2021, Ultrasound scan: abnormal (abnormal) Identified a cyst on her pancreas, cyst on her kidney and cyst on her liver..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging abnormal, Pancreatic cyst, Renal cyst, Ultrasound scan
Clinical narrative: cyst on kidney; cyst on pancreas; Hepatitis B; Jaundice; Cyst on liver; started getting ill; 2nd dose not administered within vaccine schedule window; MRI Abnormal; Ultrasound abnormal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL CYST (cyst on kidney), PANCREATIC CYST (cyst on pancreas), HEPATITIS B (Hepatitis B), JAUNDICE (Jaundice) and CYST (Cyst on liver) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stomach discomfort (Starting back in August 2020 she didn't feel good, had stomach issues off and on.) since August 2020. Concomitant products included LISINOPRIL for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RENAL CYST (cyst on kidney) (seriousness criterion hospitalization), PANCREATIC CYST (cyst on pancreas) (seriousness criterion hospitalization), HEPATITIS B (Hepatitis B) (seriousness criterion hospitalization), JAUNDICE (Jaundice) (seriousness criterion hospitalization), CYST (Cyst on liver) (seriousness criterion hospitalization), MAGNETIC RESONANCE IMAGING ABNORMAL (MRI Abnormal) and ULTRASOUND SCAN ABNORMAL (Ultrasound abnormal). On an unknown date, the patient experienced ILLNESS (started getting ill) and INCOMPLETE COURSE OF VACCINATION (2nd dose not administered within vaccine schedule window). The patient was hospitalized from 05-Feb-2021 to 08-Feb-2021 due to CYST, HEPATITIS B, JAUNDICE, PANCREATIC CYST and RENAL CYST. On 05-Feb-2021, MAGNETIC RESONANCE IMAGING ABNORMAL (MRI Abnormal) and ULTRASOUND SCAN ABNORMAL (Ultrasound abnormal) outcome was unknown. At the time of the report, RENAL CYST (cyst on kidney), PANCREATIC CYST (cyst on pancreas), HEPATITIS B (Hepatitis B), JAUNDICE (Jaundice), CYST (Cyst on liver) and ILLNESS (started getting ill) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (2nd dose not administered within vaccine schedule window) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Hepatitis B: positive Positive. On 05-Feb-2021, Magnetic resonance imaging: abnormal (abnormal) Identified a cyst on her pancreas, cyst on her kidney and cyst on her liver.. On 05-Feb-2021, Ultrasound scan: abnormal (abnormal) Identified a cyst on her pancreas, cyst on her kidney and cyst on her liver..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan abnormal
Clinical narrative: cyst on kidney; cyst on pancreas; Hepatitis B; Jaundice; Cyst on liver; started getting ill; 2nd dose not administered within vaccine schedule window; MRI Abnormal; Ultrasound abnormal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL CYST (cyst on kidney), PANCREATIC CYST (cyst on pancreas), HEPATITIS B (Hepatitis B), JAUNDICE (Jaundice) and CYST (Cyst on liver) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stomach discomfort (Starting back in August 2020 she didn't feel good, had stomach issues off and on.) since August 2020. Concomitant products included LISINOPRIL for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RENAL CYST (cyst on kidney) (seriousness criterion hospitalization), PANCREATIC CYST (cyst on pancreas) (seriousness criterion hospitalization), HEPATITIS B (Hepatitis B) (seriousness criterion hospitalization), JAUNDICE (Jaundice) (seriousness criterion hospitalization), CYST (Cyst on liver) (seriousness criterion hospitalization), MAGNETIC RESONANCE IMAGING ABNORMAL (MRI Abnormal) and ULTRASOUND SCAN ABNORMAL (Ultrasound abnormal). On an unknown date, the patient experienced ILLNESS (started getting ill) and INCOMPLETE COURSE OF VACCINATION (2nd dose not administered within vaccine schedule window). The patient was hospitalized from 05-Feb-2021 to 08-Feb-2021 due to CYST, HEPATITIS B, JAUNDICE, PANCREATIC CYST and RENAL CYST. On 05-Feb-2021, MAGNETIC RESONANCE IMAGING ABNORMAL (MRI Abnormal) and ULTRASOUND SCAN ABNORMAL (Ultrasound abnormal) outcome was unknown. At the time of the report, RENAL CYST (cyst on kidney), PANCREATIC CYST (cyst on pancreas), HEPATITIS B (Hepatitis B), JAUNDICE (Jaundice), CYST (Cyst on liver) and ILLNESS (started getting ill) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (2nd dose not administered within vaccine schedule window) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Hepatitis B: positive Positive. On 05-Feb-2021, Magnetic resonance imaging: abnormal (abnormal) Identified a cyst on her pancreas, cyst on her kidney and cyst on her liver.. On 05-Feb-2021, Ultrasound scan: abnormal (abnormal) Identified a cyst on her pancreas, cyst on her kidney and cyst on her liver..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pemphigoid
Clinical narrative: Bullous pemphigoid; Skull itches as well; Digs into rashes until he has marks on his legs and back. Rashes stop itching when they bleed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PEMPHIGOID (Bullous pemphigoid) 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.   Concurrent medical conditions included Drug allergy (Zithromax), Drug allergy (CT scan dye), Drug allergy (Cipro), Drug allergy (Macrolides), Drug allergy (Lansoprazole), Drug allergy (Phenytoin), Drug allergy (Ranitidine), Drug allergy (Sertraline), Drug allergy (Xarelto), Drug allergy (Eliquis) and Drug allergy (Bentyl). Concomitant products included DESMOPRESSIN, DOXAZOSIN, PREDNISONE, LEVOTHYROXINE, LORAZEPAM, LEVETIRACETAM, TRAMADOL, TESTOSTERONE CIPIONATE (TESTOSTERONE CYPIONATE), OMEPRAZOLE, TRIAMCINOLONE, ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, ATENOLOL and VITAMIN D3 for an unknown indication.  On 24-Mar-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) at an unspecified dose. On 24-Mar-2021, the patient experienced PEMPHIGOID (Bullous pemphigoid) (seriousness criterion medically significant), PRURITUS (Skull itches as well) and RASH PRURITIC (Digs into rashes until he has marks on his legs and back. Rashes stop itching when they bleed). At the time of the report, PEMPHIGOID (Bullous pemphigoid), PRURITUS (Skull itches as well) and RASH PRURITIC (Digs into rashes until he has marks on his legs and back. Rashes stop itching when they bleed) outcome was unknown. Not Provided   Treatment for the events included increased Hydroxyzine and Vaseline in hair.  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.; 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: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart complication (was not explained) which needed a medical procedure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DISORDER (Heart complication (was not explained) which needed a medical procedure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced CARDIAC DISORDER (Heart complication (was not explained) which needed a medical procedure) (seriousness criterion hospitalization). At the time of the report, CARDIAC DISORDER (Heart complication (was not explained) which needed a medical procedure) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were unknown. Patient reported she underwent a procedure for an unspecified reason and hung up. Concomitant medications were not reported.   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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Atrial fibrillation, Headache, Palpitations, Presyncope
Clinical narrative: a few episodes of a-fib; felt like she might black out; felt like her heart was palpitating; stress; headache; could not sleep; burning in her arm, up through her neck and to her chest.; worry; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (a few episodes of a-fib) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concurrent medical conditions included Heart valve replacement (two artificial heart valves.) since 2004. Concomitant products included WARFARIN SODIUM (COUMADIN) for Heart valve replacement.  On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (burning in her arm, up through her neck and to her chest.). On 18-Apr-2021, the patient experienced SLEEP DISORDER (could not sleep). On an unknown date, the patient experienced ATRIAL FIBRILLATION (a few episodes of a-fib) (seriousness criterion medically significant), PRESYNCOPE (felt like she might black out), PALPITATIONS (felt like her heart was palpitating), ANXIETY (worry), STRESS (stress) and HEADACHE (headache). On 23-Mar-2021, VACCINATION SITE PAIN (burning in her arm, up through her neck and to her chest.) outcome was unknown. At the time of the report, ATRIAL FIBRILLATION (a few episodes of a-fib), PRESYNCOPE (felt like she might black out), PALPITATIONS (felt like her heart was palpitating), SLEEP DISORDER (could not sleep), ANXIETY (worry), STRESS (stress) and HEADACHE (headache) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment for the events included Acetaminophen. Echogram scheduled on 05 May 21.  Company comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Stress, Vaccination site pain
Clinical narrative: a few episodes of a-fib; felt like she might black out; felt like her heart was palpitating; stress; headache; could not sleep; burning in her arm, up through her neck and to her chest.; worry; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (a few episodes of a-fib) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concurrent medical conditions included Heart valve replacement (two artificial heart valves.) since 2004. Concomitant products included WARFARIN SODIUM (COUMADIN) for Heart valve replacement.  On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (burning in her arm, up through her neck and to her chest.). On 18-Apr-2021, the patient experienced SLEEP DISORDER (could not sleep). On an unknown date, the patient experienced ATRIAL FIBRILLATION (a few episodes of a-fib) (seriousness criterion medically significant), PRESYNCOPE (felt like she might black out), PALPITATIONS (felt like her heart was palpitating), ANXIETY (worry), STRESS (stress) and HEADACHE (headache). On 23-Mar-2021, VACCINATION SITE PAIN (burning in her arm, up through her neck and to her chest.) outcome was unknown. At the time of the report, ATRIAL FIBRILLATION (a few episodes of a-fib), PRESYNCOPE (felt like she might black out), PALPITATIONS (felt like her heart was palpitating), SLEEP DISORDER (could not sleep), ANXIETY (worry), STRESS (stress) and HEADACHE (headache) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment for the events included Acetaminophen. Echogram scheduled on 05 May 21.  Company comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: developed more severe arthritis pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHEUMATOID ARTHRITIS (developed more severe arthritis pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Drug allergy (Sulfa).   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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (developed more severe arthritis pain) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (developed more severe arthritis pain) had not resolved. Not Provided          Patient states she received 1st COVID vaccine 10 weeks ago, and 2nd COVID vaccine 6 weeks ago.   Treatment information was not provided.  Company comment: 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.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Thrombosis
Clinical narrative: Blood clots; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031L209) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (The patient was in recovery from cancer).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Computerised tomogram: blood clots (abnormal) Blood clots.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Concomitant medications were not provided.  Description: The patient developed blood clots (medically significant) two weeks after receiving his second dose of the vaccine . The patient was in recovery from cancer and was required to have computerized tomography (CT) scans. He had a computerized tomography (CT) scan within two weeks of taking his second dose and the blood clots were discovered. The patient had never had blood clots before.  The patient had already been in contact with his oncologist and was prescribed apixaban.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.; 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.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary fibrosis
Clinical narrative: Pulmonary Fibrosis; Shortness of breath that required oxygen; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PULMONARY FIBROSIS (Pulmonary Fibrosis) and DYSPNOEA (Shortness of breath that required oxygen) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Urothelial carcinoma.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath that required oxygen) (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced PULMONARY FIBROSIS (Pulmonary Fibrosis) (seriousness criterion hospitalization). The patient was hospitalized on 12-Apr-2021 due to DYSPNOEA and PULMONARY FIBROSIS. At the time of the report, PULMONARY FIBROSIS (Pulmonary Fibrosis) and DYSPNOEA (Shortness of breath that required oxygen) outcome was unknown.        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.   Concomitant medications included were many medications for underlying urothelial cancer. Treatment included for the events was oxygen high flow nasal cannula.  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.; 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.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Liver disorder
Clinical narrative: sever liver problems; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIVER DISORDER (sever liver problems) in a 46-year-old male patient who received mRNA-1273 (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced LIVER DISORDER (sever liver problems) (seriousness criteria hospitalization). The patient was hospitalized from 04-Apr-2021 to 07-Apr-2021 due to LIVER DISORDER. At the time of the report, LIVER DISORDER (sever liver problems) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, COVID-19: negative (Negative) Negative.     mRNA-1273 (Intramuscular) was withdrawn on an unknown date.       No concomitant medications reported.  Treatment of this event was not 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.; 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pneumonia
Clinical narrative: pneumonia; sore back maybe from coughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (sore back maybe from coughing). On 03-Apr-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) and BACK PAIN (sore back maybe from coughing) had not resolved. 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.   The patient's treatment included Prednisone 20mg 2pills for 5 days, Doxycycline 100mg twice a day for 10 days and Cefuroxime 500mg twice a day for 7 days.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Purpura
Clinical narrative: sent to the emergency room because his doctor thought he was having a stroke.; blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported.). Concomitant products included DULAGLUTIDE (TRULICITY) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) (seriousness criteria hospitalization and medically significant) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 14-Apr-2021 due to CEREBROVASCULAR ACCIDENT and PURPURA. At the time of the report, CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) outcome was unknown.            The lot number of the second vaccine was thought by the patient to be 0L161521A but patient was unsure.  The patient was hospitalized for one day due to the events.  Magnetic resonance imaging (MRI) and computerized axial tomography (CAT) scan were performed (results not provided).  Treatment information was not provided. Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-080378, US-MODERNATX, INC.-MOD-2021-080378 (E2B Linked Report). This case was linked to MOD-2021-080340 (Patient Link).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. -MODERNATX, INC.-MOD-2021-080378:Physician case -MODERNATX, INC.-MOD-2021-080378: