chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Inappropriate schedule of product administration, Staphylococcal infection, Staphylococcus test
Clinical narrative: MRSA infection; Nose bleeding; >36 days from first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (MRSA infection), EPISTAXIS (Nose bleeding) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>36 days from first vaccination) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer (Lung cancer survivor), Broken wrist in 2018 and Arm fracture (Broke arm prior to vaccine). Concurrent medical conditions included Allergy to vaccine (Tetanus vaccine allergy), Drug allergy (Septocaine) and COPD. Concomitant products included UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>36 days from first vaccination). On 05-May-2021, the patient experienced STAPHYLOCOCCAL INFECTION (MRSA infection) and EPISTAXIS (Nose bleeding). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (SMZ-TMP) for Adverse event, at a dose of UNK (800/160 mg) and MUPIROCIN (topical) for Nose bleed, at an unspecified dose and frequency. On 22-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>36 days from first vaccination) had resolved. On 05-May-2021, EPISTAXIS (Nose bleeding) had resolved. In June 2021, STAPHYLOCOCCAL INFECTION (MRSA infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Staphylococcus test: negative (Negative) MRSA infection was gone.     Concomitant medication also mentioned "rescue inhaler" NOS, and steroids for 3 months prior vaccine for broken arm.  Company Comment: 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.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Haematuria, Haemorrhage urinary tract, Malaise, Urine analysis
Clinical narrative: Feeling groggier than normal; Urine was very dark brown, with a little bit of blood, and blood clots; Their urine was totally black and had blood clots; A little bit of blood in their urine; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (Urine was very dark brown, with a little bit of blood, and blood clots) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced HAEMATURIA (A little bit of blood in their urine). On 18-Aug-2021, the patient experienced HAEMORRHAGE URINARY TRACT (Urine was very dark brown, with a little bit of blood, and blood clots) (seriousness criterion medically significant) and CHROMATURIA (Their urine was totally black and had blood clots). On an unknown date, the patient experienced MALAISE (Feeling groggier than normal). On 19-Aug-2021, HAEMORRHAGE URINARY TRACT (Urine was very dark brown, with a little bit of blood, and blood clots), HAEMATURIA (A little bit of blood in their urine) and CHROMATURIA (Their urine was totally black and had blood clots) had resolved. At the time of the report, MALAISE (Feeling groggier than normal) had not resolved.            Patient was not taking any daily medications. It is reported that patient was self catheterized four times a day. It is stated that as the day went on, the blood in the urine was lessening. It is stated that the patient had not taken anything to help with the symptoms.  Action taken was not applicable.   This case was linked to MOD-2021-292324, MOD-2021-292304 (Patient Link).; 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: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (bad reaction) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (bad reaction). At the time of the report, vaccination complication (bad reaction) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. Patient stated she needs to see a doctor.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days since the first shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot) had resolved.        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 product use was not provided by the reporter.  Patient took second dose on 14AUGUST2021 AT 13:06PM with batch number 062E21A. Treatment information was not provided.  Pharmacist reported that patient was at the pharmacy to receive the second dose, but the first dose was given on 20 May 2021.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow up contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Somnolence
Clinical narrative: she experienced numbness in her limbs; asleep all of the time; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (she experienced numbness in her limbs) and SOMNOLENCE (asleep all of the time) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (she experienced numbness in her limbs) and SOMNOLENCE (asleep all of the time). At the time of the report, HYPOAESTHESIA (she experienced numbness in her limbs) and SOMNOLENCE (asleep all of the time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Patient was Experienced As if they are asleep all of the time.  lab data MRI was provided with unknown results.  No Concomitant medication were provided  No Treatment medication were provided.  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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Myalgia, Oxygen consumption increased
Clinical narrative: I am short of breath; I am in severe pain all over my body; I require more oxygen; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSPNOEA (I am short of breath), MYALGIA (I am in severe pain all over my body) and OXYGEN CONSUMPTION INCREASED (I require more oxygen) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     Concurrent medical conditions included Lung disease. Concomitant products included OXYCODONE, PREGABALIN (LYRICA), MORPHINE, HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), LOSARTAN, AMBRISENTAN (LETAIRIS), DOMPERIDONE, FUROSEMIDE and APIXABAN (ELIQUIS) for an unknown indication.    On 18-Aug-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 (I am short of breath) (seriousness criterion medically significant), MYALGIA (I am in severe pain all over my body) (seriousness criterion medically significant) and OXYGEN CONSUMPTION INCREASED (I require more oxygen) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (I am short of breath), MYALGIA (I am in severe pain all over my body) and OXYGEN CONSUMPTION INCREASED (I require more oxygen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.   Patient stated that she had lung disease and she find that after her first vaccination that she require more Oxygen and she is short of breath. The pain is so severe that she went to see her Doctor.  Company comment Based on 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 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: had a TIA; This spontaneous case was reported by an other health care professional and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (had a TIA) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (had a TIA) (seriousness criterion medically significant). On 06-Jul-2021, TRANSIENT ISCHAEMIC ATTACK (had a TIA) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported.  Patient does not want to get the booster since this happened to her.  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.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: died from a rapid heartbeat after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (died from a rapid heartbeat after getting the vaccine) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (died from a rapid heartbeat after getting the vaccine) (seriousness criterion death). The reported cause of death was died from a rapid heartbeat after getting the vaccine. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: increased (High) increased.         No concomitant medication details was reported. No treatment medication details was reported.  Company Comment: This case concerns a female patient of unknown age who had a fatal event of HEART RATE INCREASED after receiving mRNA-1273. The reported cause of death was died from a rapid heartbeat after getting the vaccine. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: This case concerns a female patient of unknown age who had a fatal event of HEART RATE INCREASED after receiving mRNA-1273. The reported cause of death was died from a rapid heartbeat after getting the vaccine. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: died from a rapid heartbeat after getting the vaccine
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Arthralgia, Feeling abnormal, Haematochezia, Headache
Clinical narrative: Blood in stool; Break out with red dots; Allergies; Heart rate fast; My leg on left side was swollen; Feeling like poison was flowing in veins; Fever; Headache; Joint pain; Rash down to bottom feet; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool) in a 21-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.     No Medical History information was reported.    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, the patient experienced HAEMATOCHEZIA (Blood in stool) (seriousness criterion medically significant), RASH ERYTHEMATOUS (Break out with red dots), ALLERGY TO VACCINE (Allergies), HEART RATE INCREASED (Heart rate fast), PERIPHERAL SWELLING (My leg on left side was swollen), FEELING ABNORMAL (Feeling like poison was flowing in veins), PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), RASH (Rash down to bottom feet) and MYALGIA (Muscle pain). The patient was treated with SULFACETAMIDE SODIUM (SULFA [SULFACETAMIDE SODIUM]) at a dose of 1 dosage form; TRIAMCINOLONE at an unspecified dose and frequency and CAPSAICIN (CAPZASIN) at a dose of 1 dosage form. At the time of the report, HAEMATOCHEZIA (Blood in stool), RASH ERYTHEMATOUS (Break out with red dots), ALLERGY TO VACCINE (Allergies), HEART RATE INCREASED (Heart rate fast), PERIPHERAL SWELLING (My leg on left side was swollen), FEELING ABNORMAL (Feeling like poison was flowing in veins), PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), RASH (Rash down to bottom feet) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (abnormal) Increased. On an unknown date, Respiratory rate: increased (abnormal) Increased.         No concomitant medication was provided.  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: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: Blood in stool; Break out with red dots; Allergies; Heart rate fast; My leg on left side was swollen; Feeling like poison was flowing in veins; Fever; Headache; Joint pain; Rash down to bottom feet; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool) in a 21-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.     No Medical History information was reported.    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, the patient experienced HAEMATOCHEZIA (Blood in stool) (seriousness criterion medically significant), RASH ERYTHEMATOUS (Break out with red dots), ALLERGY TO VACCINE (Allergies), HEART RATE INCREASED (Heart rate fast), PERIPHERAL SWELLING (My leg on left side was swollen), FEELING ABNORMAL (Feeling like poison was flowing in veins), PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), RASH (Rash down to bottom feet) and MYALGIA (Muscle pain). The patient was treated with SULFACETAMIDE SODIUM (SULFA [SULFACETAMIDE SODIUM]) at a dose of 1 dosage form; TRIAMCINOLONE at an unspecified dose and frequency and CAPSAICIN (CAPZASIN) at a dose of 1 dosage form. At the time of the report, HAEMATOCHEZIA (Blood in stool), RASH ERYTHEMATOUS (Break out with red dots), ALLERGY TO VACCINE (Allergies), HEART RATE INCREASED (Heart rate fast), PERIPHERAL SWELLING (My leg on left side was swollen), FEELING ABNORMAL (Feeling like poison was flowing in veins), PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), RASH (Rash down to bottom feet) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (abnormal) Increased. On an unknown date, Respiratory rate: increased (abnormal) Increased.         No concomitant medication was provided.  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: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Respiratory rate
Clinical narrative: Blood in stool; Break out with red dots; Allergies; Heart rate fast; My leg on left side was swollen; Feeling like poison was flowing in veins; Fever; Headache; Joint pain; Rash down to bottom feet; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool) in a 21-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.     No Medical History information was reported.    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, the patient experienced HAEMATOCHEZIA (Blood in stool) (seriousness criterion medically significant), RASH ERYTHEMATOUS (Break out with red dots), ALLERGY TO VACCINE (Allergies), HEART RATE INCREASED (Heart rate fast), PERIPHERAL SWELLING (My leg on left side was swollen), FEELING ABNORMAL (Feeling like poison was flowing in veins), PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), RASH (Rash down to bottom feet) and MYALGIA (Muscle pain). The patient was treated with SULFACETAMIDE SODIUM (SULFA [SULFACETAMIDE SODIUM]) at a dose of 1 dosage form; TRIAMCINOLONE at an unspecified dose and frequency and CAPSAICIN (CAPZASIN) at a dose of 1 dosage form. At the time of the report, HAEMATOCHEZIA (Blood in stool), RASH ERYTHEMATOUS (Break out with red dots), ALLERGY TO VACCINE (Allergies), HEART RATE INCREASED (Heart rate fast), PERIPHERAL SWELLING (My leg on left side was swollen), FEELING ABNORMAL (Feeling like poison was flowing in veins), PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), RASH (Rash down to bottom feet) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (abnormal) Increased. On an unknown date, Respiratory rate: increased (abnormal) Increased.         No concomitant medication was provided.  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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: diverticulitis related to the colon and intestine; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (diverticulitis related to the colon and intestine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M20A) for COVID-19 vaccination.     Medical history was not provided.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D 3), LEVOTHYROXINE SODIUM, CARVEDILOL, CLONIDINE HYDROCHLORIDE (CLONIDINE HCL), ALLOPURINOL, FAMOTIDINE, TELMISARTAN and SPIRONOLACTONE for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced DIVERTICULITIS (diverticulitis related to the colon and intestine) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 12 days due to DIVERTICULITIS. At the time of the report, DIVERTICULITIS (diverticulitis related to the colon and intestine) outcome was unknown.      As treatment the patient received antibiotic (not specified). Patient never had a flare up or anything like that in the past. Company Comment: An alternative explanation is that the serious unexpected event of Diverticulitis with the onset latency of 3 months 27 days following the mRNA-1273 vaccination was more consistent with the increased risk due to age, diet and lifestyle factors.; Sender's Comments: An alternative explanation is that the serious unexpected event of Diverticulitis with the onset latency of 3 months 27 days following the mRNA-1273 vaccination was more consistent with the increased risk due to age, diet and lifestyle factors.
Sex: M
Vaccine: COVID19
Symptoms: Troponin I
Clinical narrative: Cardiac magnetic resonance (CMR)-proven myocarditis shortly after vaccination; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Cardiac magnetic resonance (CMR)-proven myocarditis shortly after vaccination) in an adult male patient 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 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Cardiac magnetic resonance (CMR)-proven myocarditis shortly after vaccination) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Cardiac magnetic resonance (CMR)-proven myocarditis shortly after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ejection fraction (Unknown-> 55%): 58% (normal) 58%. In 2021, Electrocardiogram: abnormal (abnormal) Sinus rhythm with diffuse ST elevation. In 2021, Magnetic resonance imaging heart: abnormal (abnormal) Short-axis views demonstrating increased T2 signal and LGE in the mid wall and subepicardial layer of the mid-posterolateral segment in a patient who received their second SARS-CoV-2 vaccination 6 days earlier. In 2021, SARS-CoV-2 test: negative (Negative) Patient had negative nasopharyngeal SARS-CoV-2 PCR testing. In 2021, Troponin I: 18.94 ng/ml 18.94 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Cardiac magnetic resonance (CMR)-proven myocarditis shortly after vaccination) to be possibly related.    Concomitant medications were not provided.  No treatment information was provided.  Patient was within the age range 20-25 years, previously healthy with no infectious prodrome.  The symptoms of the patient at presentation included pleuritic and positional chest pain, chills, myalgias, and subjective fever. Patient did not develop any other complications.  Author concluded that although the clinical presentation, CMR findings, and temporal association strongly suggest the possibility of vaccine associated myocarditis in our 6 patients, we cannot conclude definitively that COVID-19 vaccine was causative or that other etiologies for myocarditis can be definitively excluded in our patients. Nevertheless, clinicians should be suspicious of myocarditis in recently vaccinated patients with symptoms consistent with this diagnosis.  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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic myeloid leukaemia, Pain in extremity, White blood cell count
Clinical narrative: Chronic Myeloid Leukemia; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC MYELOID LEUKAEMIA (Chronic Myeloid Leukemia) and PAIN IN EXTREMITY (Sore arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included FLUOXETINE, LISINOPRIL, GLIPIZIDE, METFORMIN, AMITRIPTYLINE, PANTOPRAZOLE, ASPIRIN [ACETYLSALICYLIC ACID], PIOGLITAZONE, FAMOTIDINE, SEMAGLUTIDE (OZEMPIC) and ALLOPURINOL for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHRONIC MYELOID LEUKAEMIA (Chronic Myeloid Leukemia) (seriousness criteria hospitalization and medically significant) and PAIN IN EXTREMITY (Sore arm) (seriousness criterion hospitalization). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, CHRONIC MYELOID LEUKAEMIA (Chronic Myeloid Leukemia) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high (High) High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       The patients latest blood work was better.  Company comment: 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: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: serious danage to my body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (serious danage to my body) 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 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (serious danage to my body) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (serious danage to my body) outcome was unknown.            No concomitant medications are reported.  No treatment medications are reported.  Patient hospitalized from 40 days after vaccination due to serious danage to body.  Very limited information regarding this event has been provided at this time. Further information regarding temporal association (vaccination and event dates) is necessary. Translation of non-english text in narrative is pending.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information regarding temporal association (vaccination and event dates) is necessary. Translation of non-english text in narrative is pending.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Fell down on the floor and died; This spontaneous case was reported by a nurse and describes the occurrence of FALL (Fell down on the floor and died) in a 72-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FALL (Fell down on the floor and died) (seriousness criterion death). The patient died on 20-Aug-2021. The reported cause of death was fell on the floor and died. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient died yesterday after 9 days [unsure of the date] of getting the booster dose of the Moderna COVID-19 vaccine. The patient did not had any side effects with the first 2 doses of the Moderna COVID-19 Vaccine.  Treatment information was not provided.    Company Comment : 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.; Reported Cause(s) of Death: Fell on the floor and died
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Dyspnoea, Echocardiogram
Clinical narrative: Myocarditis; Sick; Fever of 102-103 degrees F; Felt like she had pressure in her chest; Palpitations; Very fatigued; Shortness of breath; Cold chills; This spontaneous case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Breast cancer since an unknown date.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced ILLNESS (Sick), PYREXIA (Fever of 102-103 degrees F) and CHEST DISCOMFORT (Felt like she had pressure in her chest). In February 2021, the patient experienced DYSPNOEA (Shortness of breath), CHILLS (Cold chills), PALPITATIONS (Palpitations) and FATIGUE (Very fatigued). On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant) and STRESS (Stress). In February 2021, CHILLS (Cold chills) had resolved. On 17-Feb-2021, PYREXIA (Fever of 102-103 degrees F) had resolved. On 28-Feb-2021, ILLNESS (Sick) had resolved. At the time of the report, MYOCARDITIS (Myocarditis), DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Felt like she had pressure in her chest), PALPITATIONS (Palpitations), FATIGUE (Very fatigued) and STRESS (Stress) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: high (High) Fever of 102-103 degrees F. In July 2021, Electrocardiogram abnormal: abnormal (abnormal) abnormal electrocardiogram. On an unknown date, Echocardiogram: abnormal (abnormal) diagnosed with myocarditis. On an unknown date, Electrocardiogram ambulatory: abnormal (abnormal) diagnosed with myocarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  About 3-4 weeks ago the patient wanted to be checked out before she went for a magnetic resonance imaging for possible breast cancer. The patient did not get any medication for the myocarditis. Patient was not going to get a booster.  Treatment information was not provided.; 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory, Fatigue, Illness, Myocarditis
Clinical narrative: Myocarditis; Sick; Fever of 102-103 degrees F; Felt like she had pressure in her chest; Palpitations; Very fatigued; Shortness of breath; Cold chills; This spontaneous case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Breast cancer since an unknown date.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced ILLNESS (Sick), PYREXIA (Fever of 102-103 degrees F) and CHEST DISCOMFORT (Felt like she had pressure in her chest). In February 2021, the patient experienced DYSPNOEA (Shortness of breath), CHILLS (Cold chills), PALPITATIONS (Palpitations) and FATIGUE (Very fatigued). On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant) and STRESS (Stress). In February 2021, CHILLS (Cold chills) had resolved. On 17-Feb-2021, PYREXIA (Fever of 102-103 degrees F) had resolved. On 28-Feb-2021, ILLNESS (Sick) had resolved. At the time of the report, MYOCARDITIS (Myocarditis), DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Felt like she had pressure in her chest), PALPITATIONS (Palpitations), FATIGUE (Very fatigued) and STRESS (Stress) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: high (High) Fever of 102-103 degrees F. In July 2021, Electrocardiogram abnormal: abnormal (abnormal) abnormal electrocardiogram. On an unknown date, Echocardiogram: abnormal (abnormal) diagnosed with myocarditis. On an unknown date, Electrocardiogram ambulatory: abnormal (abnormal) diagnosed with myocarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  About 3-4 weeks ago the patient wanted to be checked out before she went for a magnetic resonance imaging for possible breast cancer. The patient did not get any medication for the myocarditis. Patient was not going to get a booster.  Treatment information was not provided.; 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Myocarditis; Sick; Fever of 102-103 degrees F; Felt like she had pressure in her chest; Palpitations; Very fatigued; Shortness of breath; Cold chills; This spontaneous case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Breast cancer since an unknown date.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced ILLNESS (Sick), PYREXIA (Fever of 102-103 degrees F) and CHEST DISCOMFORT (Felt like she had pressure in her chest). In February 2021, the patient experienced DYSPNOEA (Shortness of breath), CHILLS (Cold chills), PALPITATIONS (Palpitations) and FATIGUE (Very fatigued). On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant) and STRESS (Stress). In February 2021, CHILLS (Cold chills) had resolved. On 17-Feb-2021, PYREXIA (Fever of 102-103 degrees F) had resolved. On 28-Feb-2021, ILLNESS (Sick) had resolved. At the time of the report, MYOCARDITIS (Myocarditis), DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Felt like she had pressure in her chest), PALPITATIONS (Palpitations), FATIGUE (Very fatigued) and STRESS (Stress) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: high (High) Fever of 102-103 degrees F. In July 2021, Electrocardiogram abnormal: abnormal (abnormal) abnormal electrocardiogram. On an unknown date, Echocardiogram: abnormal (abnormal) diagnosed with myocarditis. On an unknown date, Electrocardiogram ambulatory: abnormal (abnormal) diagnosed with myocarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  About 3-4 weeks ago the patient wanted to be checked out before she went for a magnetic resonance imaging for possible breast cancer. The patient did not get any medication for the myocarditis. Patient was not going to get a booster.  Treatment information was not provided.; 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: M
Vaccine: COVID19
Symptoms: Dysuria, Prostatomegaly, Sepsis
Clinical narrative: Three different hospitalizations with sepsis; Difficulties to urinate; prostate growth; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Three different hospitalizations with sepsis) 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.     No medical history was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, 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 experienced SEPSIS (Three different hospitalizations with sepsis) (seriousness criteria hospitalization and medically significant), DYSURIA (Difficulties to urinate) and PROSTATOMEGALY (prostate growth). The patient was treated with LEVOFLOXACIN (intravenous) on 10-Aug-2021 for Sepsis, at a dose of 200 mg and Surgery for Prostatomegaly. At the time of the report, SEPSIS (Three different hospitalizations with sepsis), DYSURIA (Difficulties to urinate) and PROSTATOMEGALY (prostate growth) outcome was unknown.            Concomitant product use was not provided by the reporter.  On 29-Jun-2021 patient had an elective surgery on his prospate (because it had grown and caused him difficulties to urinate) and after that had three different hospitalizations with sepsis and has been on IV antibiotics.  Is schedule to get the third dose of the Moderna COVID-19 vaccine on 28Aug2021 and wants the booster to do the best job it can. Wants to know if the antibiotics can interfere in any way. Caller does not think the vaccine is related at all with the surgery/antibiotic treatment and was not really interested in providing further information to report the AE.  Company Comment Based on reporter's causality and events being a possible complication of elective surgery described after 4 months of vaccination, the events are assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on reporter's causality and events being a possible complication of elective surgery described after 4 months of vaccination, the events are assessed as unlikely related to mRNA-1273.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Gastric cancer stage I
Clinical narrative: Diagnosed with stomach cancer 1st stage; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC CANCER STAGE I (Diagnosed with stomach cancer 1st stage) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, GLIPIZIDE and LISINOPRIL for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced GASTRIC CANCER STAGE I (Diagnosed with stomach cancer 1st stage) (seriousness criterion medically significant). At the time of the report, GASTRIC CANCER STAGE I (Diagnosed with stomach cancer 1st stage) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Company Comment: 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: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram
Clinical narrative: Chest pain; This literature-non-study case was reported in a literature article and describes the occurrence of CHEST PAIN (Chest pain) in a 20-year-old male patient 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 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization). At the time of the report, CHEST PAIN (Chest pain) had resolved. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: 88 mg/l (High) CRP elevation and 2.5 mg/l (normal) 2.5mg/L. On an unknown date, Echocardiogram: unknown (Inconclusive) Revealed a Left Ventricular Ejection Fraction (LVEF) 45% with  moderate hypokinesis of the apex and apical septum. On an unknown date, Electrocardiogram: abnormal (abnormal) Down-sloping PR depressions, diffuse ST elevations. On an unknown date, Serology test: negative (Negative) Negative. On an unknown date, Troponin I: >27,000 pg/ml (High) More than (>) 27,000 pg/mL Troponin elevation and 0.03 ng/dl (normal) 0.03 ng/dL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHEST PAIN (Chest pain) to be possibly related.    No concomitant medication was provided by the reporter.  Patient was presented with a 2 day history of progressive chest pain, 2 days after receiving his second dose of the Moderna vaccine. His symptoms started with a viral prodrome approximately 10 days prior to the onset of his chest pain. Viral serologies for HIV, hepatitis B and C viruses, coxsackie virus  type b, and EBV were all undetectable. Outpatient cardiac  magnetic resonance imaging (CMR) remains pending. His chest pain resolved the following day. On  day 3 he was discharged from hospital. He presented to clinic 11 days after discharged for lab tests.  No treatment medication information was provided by the reporter.  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.   This case was linked to MOD-2021-293677, MOD-2021-293733 (Patient Link).; 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.