chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Condition aggravated, Muscular weakness
Clinical narrative: Diagnosed him with ALS; leg muscle got worse; Muscle weakness; This spontaneous case was reported by a consumer and describes the occurrence of AMYOTROPHIC LATERAL SCLEROSIS (Diagnosed him with ALS) 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 Muscle weakness (Before vaccine he had some thigh muscle weakness which got worse.).   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 AMYOTROPHIC LATERAL SCLEROSIS (Diagnosed him with ALS) (seriousness criterion medically significant), CONDITION AGGRAVATED (leg muscle got worse) and MUSCULAR WEAKNESS (Muscle weakness). At the time of the report, AMYOTROPHIC LATERAL SCLEROSIS (Diagnosed him with ALS), CONDITION AGGRAVATED (leg muscle got worse) and MUSCULAR WEAKNESS (Muscle weakness) outcome was unknown.            No concomitant information was reported. No treatment information was reported.  Company Comment : Based on  temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information has been request.   This case was linked to MOD-2021-240698 (Patient Link).; Sender's Comments: Based on  temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information has been request.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. 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: U
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Medication error
Clinical narrative: Received 5 Covid Vaccines in the span of a month; Medication error; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 5 Covid Vaccines in the span of a month) and MEDICATION ERROR (Medication error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 28-Jan-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to at an unspecified dose. On 16-Feb-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received 5 Covid Vaccines in the span of a month) (seriousness criterion hospitalization) and MEDICATION ERROR (Medication error) (seriousness criterion hospitalization). At the time of the report, EXTRA DOSE ADMINISTERED (Received 5 Covid Vaccines in the span of a month) had resolved and MEDICATION ERROR (Medication error) 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.   The reporter states that the patient was transferred to a rehabilitation center on 19-MAY-2021 and then looks like she was in the rehabilitation center until 28-MAY-2021. Hospitalization: 19-MAY-2021 to  28-MAY-2021 rehabilitation center.  This report refers to a case of extra doses administered which resulted in a total of 5 Covid vaccines being given with an interval of approximately  1- 2 weeks apart,  who was hospitalized 3 months after receiving the vaccines. Very limited information has been provided at this time. Further information has been requested.; Sender's Comments: This report refers to a case of extra doses administered which resulted in a total of 5 Covid vaccines being given with an interval of approximately  1- 2 weeks apart,  who was hospitalized 3 months after receiving the vaccines. Very limited information has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Delirium, Hallucination, Interchange of vaccine products, Paranoia
Clinical narrative: Hallucinations; Delirium; Psychotic episodes; My sister received the moderns vaccine as the second dose. First was Pfizer; Paranoia; Confusion; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations), DELIRIUM (Delirium) and PSYCHOTIC DISORDER (Psychotic episodes) 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.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (First dose).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), DELIRIUM (Delirium) (seriousness criterion medically significant), PSYCHOTIC DISORDER (Psychotic episodes) (seriousness criterion medically significant), INTERCHANGE OF VACCINE PRODUCTS (My sister received the moderns vaccine as the second dose. First was Pfizer), PARANOIA (Paranoia) and CONFUSIONAL STATE (Confusion). At the time of the report, HALLUCINATION (Hallucinations), DELIRIUM (Delirium), PSYCHOTIC DISORDER (Psychotic episodes), INTERCHANGE OF VACCINE PRODUCTS (My sister received the moderns vaccine as the second dose. First was Pfizer), PARANOIA (Paranoia) and CONFUSIONAL STATE (Confusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products used were not provided by the reporter.  No treatment information was provided.  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: Psychotic disorder
Clinical narrative: Hallucinations; Delirium; Psychotic episodes; My sister received the moderns vaccine as the second dose. First was Pfizer; Paranoia; Confusion; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations), DELIRIUM (Delirium) and PSYCHOTIC DISORDER (Psychotic episodes) 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.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (First dose).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), DELIRIUM (Delirium) (seriousness criterion medically significant), PSYCHOTIC DISORDER (Psychotic episodes) (seriousness criterion medically significant), INTERCHANGE OF VACCINE PRODUCTS (My sister received the moderns vaccine as the second dose. First was Pfizer), PARANOIA (Paranoia) and CONFUSIONAL STATE (Confusion). At the time of the report, HALLUCINATION (Hallucinations), DELIRIUM (Delirium), PSYCHOTIC DISORDER (Psychotic episodes), INTERCHANGE OF VACCINE PRODUCTS (My sister received the moderns vaccine as the second dose. First was Pfizer), PARANOIA (Paranoia) and CONFUSIONAL STATE (Confusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products used were not provided by the reporter.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.   The treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Event was classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical criteria the event was not serious (not medical event listed).; 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. Event was classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical criteria the event was not serious (not medical event listed).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Hypoacusis
Clinical narrative: Lost hearing in his right ear; Partial hearing in his left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Lost hearing in his right ear) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-2021, the patient experienced DEAFNESS UNILATERAL (Lost hearing in his right ear) (seriousness criterion medically significant) and HYPOACUSIS (Partial hearing in his left ear). At the time of the report, DEAFNESS UNILATERAL (Lost hearing in his right ear) and HYPOACUSIS (Partial hearing in his left ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications and treatment details were not provided.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pain, Palpitations, Pneumonia
Clinical narrative: pneumonia; I have experienced my heart pumping; severe pain; coughing; chills; continuous fever.; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (pneumonia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-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 PNEUMONIA (pneumonia) (seriousness criterion medically significant), PALPITATIONS (I have experienced my heart pumping), PAIN (severe pain), COUGH (coughing), CHILLS (chills) and PYREXIA (continuous fever.). At the time of the report, PNEUMONIA (pneumonia), PALPITATIONS (I have experienced my heart pumping), PAIN (severe pain), COUGH (coughing), CHILLS (chills) and PYREXIA (continuous fever.) outcome was unknown.        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.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pneumonia; I have experienced my heart pumping; severe pain; coughing; chills; continuous fever.; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (pneumonia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-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 PNEUMONIA (pneumonia) (seriousness criterion medically significant), PALPITATIONS (I have experienced my heart pumping), PAIN (severe pain), COUGH (coughing), CHILLS (chills) and PYREXIA (continuous fever.). At the time of the report, PNEUMONIA (pneumonia), PALPITATIONS (I have experienced my heart pumping), PAIN (severe pain), COUGH (coughing), CHILLS (chills) and PYREXIA (continuous fever.) outcome was unknown.        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.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the 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: Cerebrovascular accident
Clinical narrative: they believe the cause of death was stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (they believe the cause of death was stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pneumonia vaccine. Past adverse reactions to the above products included Pneumonia with Pneumonia vaccine. Concurrent medical conditions included Egg allergy and Tuberculosis (Tuberculosis in their kidney.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (they believe the cause of death was stroke) (seriousness criteria death and medically significant). The reported cause of death was Stroke. It is unknown if an autopsy was performed.            This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (they believe the cause of death was stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pneumonia vaccine. Past adverse reactions to the above products included Pneumonia with Pneumonia vaccine. Concurrent medical conditions included Egg allergy and Tuberculosis (Tuberculosis in their kidney.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (they believe the cause of death was stroke) (seriousness criteria death and medically significant). The reported cause of death was Stroke. It is unknown if an autopsy was performed.          The patient was on blood pressure medications.  The reporter reports that two days after a family member died two days after they received their first dose of the Moderna COVID-19 vaccine and they believe the cause of death was a stroke.  No laboratory data was provided.  No Treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  Very limited information regarding this event has been provided at this time. No follow up is possible.; Sender's Comments: Very limited information regarding this event has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Stroke
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Cardiac stress test, Cardiomegaly, Dyspnoea, Palpitations
Clinical narrative: Heart palpitations; Shortness of breath; May be I have an enlarged heart; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and DYSPNOEA (Shortness of breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke since 2012. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-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 PALPITATIONS (Heart palpitations), DYSPNOEA (Shortness of breath) and CARDIOMEGALY (May be I have an enlarged heart). The patient was treated with ROSUVASTATIN ongoing since an unknown date at a dose of Daily. At the time of the report, PALPITATIONS (Heart palpitations), DYSPNOEA (Shortness of breath) and CARDIOMEGALY (May be I have an enlarged heart) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood cholesterol: high (High) Dose of rosuvastatin was increased from 5 mg to 10 mg daily.. In May 2021, Cardiac stress test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had the events after 1 month of second vaccine. Patient had 2 stress tests that did not had a clear results. Stress test performed.  It was reported that, palpitations and shortness of breath was occurring 4-5 times a day and though she might have enlarged heart. After receiving the vaccine, Rosuvastatin was increased to 10 mg daily. An angiogram was schedule on the Tuesday following this report.  Company Comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Event description was updated.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blood calcium, Blood test, Diffuse large B-cell lymphoma, Fatigue
Clinical narrative: Has DLBCL; lymphoma had metastasized; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL), SPLENOMEGALY (spleen was double in size) and METASTATIC LYMPHOMA (lymphoma had metastasized) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included THYROID (ARMOUR THYROID), LISINOPRIL, SIMVASTATIN and TAMSULOSIN for an unknown indication.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL) (seriousness criteria hospitalization and medically significant), METASTATIC LYMPHOMA (lymphoma had metastasized) (seriousness criteria hospitalization and medically significant),  and MYALGIA (Sore arm). The patient was hospitalized from 22-Mar-2021 to 27-Mar-2021 due to DIFFUSE LARGE B-CELL  LYMPHOMA and METASTATIC LYMPHOMA. At the time of the report, DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL), METASTATIC LYMPHOMA (lymphoma had metastasized), FATIGUE (Fatigue) and MYALGIA (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood calcium: 10.6 (Inconclusive) Inconclusive. In January 2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 08-Apr-2021, Positron emission tomogram: abnormal (abnormal) Test show damage or stunning of kidneys. In 2021, Biopsy: abnormal (abnormal) Bone marrow and lymph nodes biopsy shows large B-cell lymphoma.. In 2021, Blood calcium: 14.4 (High) Calcium level high. In 2021, Platelet count: 81-82 (Low) low platelet level.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.  Treatment information was not provided.; Sender's Comments: Very limited information regarding the events has been provided at this time. An alternative explanation is that the events were more consistent with the increased risk due to advanced age related factors. Further information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Metastatic lymphoma, Myalgia, Platelet count, Positron emission tomogram
Clinical narrative: Has DLBCL; lymphoma had metastasized; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL), SPLENOMEGALY (spleen was double in size) and METASTATIC LYMPHOMA (lymphoma had metastasized) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included THYROID (ARMOUR THYROID), LISINOPRIL, SIMVASTATIN and TAMSULOSIN for an unknown indication.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL) (seriousness criteria hospitalization and medically significant), METASTATIC LYMPHOMA (lymphoma had metastasized) (seriousness criteria hospitalization and medically significant),  and MYALGIA (Sore arm). The patient was hospitalized from 22-Mar-2021 to 27-Mar-2021 due to DIFFUSE LARGE B-CELL  LYMPHOMA and METASTATIC LYMPHOMA. At the time of the report, DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL), METASTATIC LYMPHOMA (lymphoma had metastasized), FATIGUE (Fatigue) and MYALGIA (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood calcium: 10.6 (Inconclusive) Inconclusive. In January 2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 08-Apr-2021, Positron emission tomogram: abnormal (abnormal) Test show damage or stunning of kidneys. In 2021, Biopsy: abnormal (abnormal) Bone marrow and lymph nodes biopsy shows large B-cell lymphoma.. In 2021, Blood calcium: 14.4 (High) Calcium level high. In 2021, Platelet count: 81-82 (Low) low platelet level.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.  Treatment information was not provided.; Sender's Comments: Very limited information regarding the events has been provided at this time. An alternative explanation is that the events were more consistent with the increased risk due to advanced age related factors. Further information has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Fibrin D dimer, Thrombosis
Clinical narrative: high range d dime test / blood clot; brain fog; breathing issues; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (high range d dime test / blood clot) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011dz1a and 022cz1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-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 THROMBOSIS (high range d dime test / blood clot) (seriousness criterion medically significant), FEELING ABNORMAL (brain fog), DYSPNOEA (breathing issues) and FATIGUE (Exhaustion). At the time of the report, THROMBOSIS (high range d dime test / blood clot), FEELING ABNORMAL (brain fog), DYSPNOEA (breathing issues) and FATIGUE (Exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Fibrin D dimer: normal (normal) normal and .55 (High) There is concern for patient that there is a blood clot.         The patient treatment data was not provided. Patient allergies and medical history was not reported. Patient concomitant medication was not reported. Action taken with m-RNA1273 (moderna COVID-19 Vaccination) (Intramuscular) in response to events was not applicable. In between the doses of vaccine patient had done test (d-dime) and original came back in fine range but after second dose patient test came back in high range .55 so there is concern for patient that there is a blood clot.  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 to MOD-2021-243110 (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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Loss of personal independence in daily activities, Myalgia
Clinical narrative: numbness; weakness; paresthesia; internal tremors; muscle pain; fatigue; inhibit her ability to live a normal life; severe neurological reactions; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inhibit her ability to live a normal life) 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.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced NEUROLOGICAL SYMPTOM (severe neurological reactions). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inhibit her ability to live a normal life) (seriousness criterion disability), HYPOAESTHESIA (numbness), ASTHENIA (weakness) and PARAESTHESIA (paresthesia). an unknown date, the patient experienced TREMOR (internal tremors), MYALGIA (muscle pain) and FATIGUE (fatigue). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inhibit her ability to live a normal life) and NEUROLOGICAL SYMPTOM (severe neurological reactions) had not resolved and HYPOAESTHESIA (numbness), ASTHENIA (weakness), PARAESTHESIA (paresthesia), TREMOR (internal tremors), MYALGIA (muscle pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent conditions were unknown. No concomitant medications were reported. No laboratory data was reported. The patient received the first dose of vaccination in January 2021. The patient experienced severe neurological reactions four days after receiving the vaccination. The patient reported that the symptoms left her barely able to function some days, and the internal tremors that created a type of fatigue that she had never experienced in her life. She reported that she was unable to fully participate in the activities that she enjoyed before being vaccinated. She reported that her life had been negatively altered due to vaccine. The patient was worried if she would develop Parkinson's or Multiple sclerosis or  Amyotrophic lateral sclerosis. Treatment information was unknown.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-244099 (E2B Linked Report).; 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. MOD-2021-244099:Cross link - Patient 2 in article
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Paraesthesia, Tremor
Clinical narrative: numbness; weakness; paresthesia; internal tremors; muscle pain; fatigue; inhibit her ability to live a normal life; severe neurological reactions; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inhibit her ability to live a normal life) 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.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced NEUROLOGICAL SYMPTOM (severe neurological reactions). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inhibit her ability to live a normal life) (seriousness criterion disability), HYPOAESTHESIA (numbness), ASTHENIA (weakness) and PARAESTHESIA (paresthesia). an unknown date, the patient experienced TREMOR (internal tremors), MYALGIA (muscle pain) and FATIGUE (fatigue). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inhibit her ability to live a normal life) and NEUROLOGICAL SYMPTOM (severe neurological reactions) had not resolved and HYPOAESTHESIA (numbness), ASTHENIA (weakness), PARAESTHESIA (paresthesia), TREMOR (internal tremors), MYALGIA (muscle pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent conditions were unknown. No concomitant medications were reported. No laboratory data was reported. The patient received the first dose of vaccination in January 2021. The patient experienced severe neurological reactions four days after receiving the vaccination. The patient reported that the symptoms left her barely able to function some days, and the internal tremors that created a type of fatigue that she had never experienced in her life. She reported that she was unable to fully participate in the activities that she enjoyed before being vaccinated. She reported that her life had been negatively altered due to vaccine. The patient was worried if she would develop Parkinson's or Multiple sclerosis or  Amyotrophic lateral sclerosis. Treatment information was unknown.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-244099 (E2B Linked Report).; 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. MOD-2021-244099:Cross link - Patient 2 in article
Sex: F
Vaccine: COVID19
Symptoms: Impaired quality of life, Paraesthesia, Paralysis
Clinical narrative: partial paralysis from the chest down; parasthesia; Diminished quality of life; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (partial paralysis from the chest down), PARAESTHESIA (parasthesia) and IMPAIRED QUALITY OF LIFE (Diminished quality of life) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PARALYSIS (partial paralysis from the chest down) (seriousness criteria hospitalization and medically significant), PARAESTHESIA (parasthesia) (seriousness criterion hospitalization) and IMPAIRED QUALITY OF LIFE (Diminished quality of life) (seriousness criterion disability). The patient was treated with Physical therapy for Paralysis and Physical therapy for Paraesthesia. At the time of the report, PARALYSIS (partial paralysis from the chest down), PARAESTHESIA (parasthesia) and IMPAIRED QUALITY OF LIFE (Diminished quality of life) outcome was unknown.            No concomitant medications were reported. No laboratory data were reported. Treatment medications were not reported.  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 to MOD-2021-244077 (E2B Linked Report).   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. MOD-2021-244077:cross link - Patient 1 in article
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Colonoscopy
Clinical narrative: Ulcerative colitis; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Urticaria and Hypersensitivity reaction. Concurrent medical conditions included Asthma, Penicillin allergy (Rash), Sulfonamide allergy (Sulfa- rash.), Drug allergy (Cefdinir- wekts), Allergy to antibiotic (Moxifloxacin-rash), Diverticulitis since 2018 and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MULTIVITAMIN ACTIVE WOMAN for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 04-Apr-2021 due to COLITIS ULCERATIVE. The patient was treated with MESALAZINE (PENTASA) ongoing from May 2021 for Ulcerative colitis, at an unspecified dose and frequency. At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, Colonoscopy: abnormal (abnormal) Ulcerative colitis.         The GI doctor ordered a colonoscopy on 23-May-2021 and the patient was diagnosed with ulcerative colitis, as a result of adverse reaction to Moderna vaccine. The patient was prescribed Pentasa, but it did not relieve the symptoms. Following the second dose of Moderna, the ulcerative colitis worsened. On 02-Apr-2021, patient went to ER and was admitted on 04-Apr-2021 and spent five and half weeks there. The patient had three blood transfusions. Two infusions of a biologic were given, but did not help. The patient had two more colonoscopies and it was determined that she need ileostomy surgery.  Additional treatment information included an antibiotic (unspecified) for a rash and intravenous steroids.  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-2021-037198 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Additional follow-up contains non-signification information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Colon operation, Intentional product use issue
Clinical narrative: had an colon operation; did not get second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of COLON OPERATION (had an colon operation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-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 COLON OPERATION (had an colon operation) (seriousness criteria hospitalization and medically significant) and INTENTIONAL PRODUCT USE ISSUE (did not get second dose yet). The patient was treated with Surgery for Colon operation. At the time of the report, COLON OPERATION (had an colon operation) and INTENTIONAL PRODUCT USE ISSUE (did not get second dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment medications were reported.  Based on current available information and the temporal association between product use and the start date of the event the Company believes a causal relationship is unlikely.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event the Company believes a causal relationship is unlikely.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Dyspnoea, Fibrin D dimer, Malaise
Clinical narrative: Diagnosed with Post vaccine Viral Pleurisy; Chest pain; Not feeling well post vaccine #2; I was not prepared for the shortness of breath/ I was having significant air hunger.  am still dealing with abnormal breathing, as well as the sensation of needing to take a deep breath; This spontaneous case was reported by a nurse and describes the occurrence of PLEURISY VIRAL (Diagnosed with Post vaccine Viral Pleurisy) and DYSPNOEA (I was not prepared for the shortness of breath/ I was having significant air hunger.  am still dealing with abnormal breathing, as well as the sensation of needing to take a deep breath) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-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 PLEURISY VIRAL (Diagnosed with Post vaccine Viral Pleurisy) (seriousness criterion medically significant), CHEST PAIN (Chest pain), MALAISE (Not feeling well post vaccine #2) and DYSPNOEA (I was not prepared for the shortness of breath/ I was having significant air hunger.  am still dealing with abnormal breathing, as well as the sensation of needing to take a deep breath) (seriousness criterion medically significant). At the time of the report, PLEURISY VIRAL (Diagnosed with Post vaccine Viral Pleurisy), CHEST PAIN (Chest pain), MALAISE (Not feeling well post vaccine #2) and DYSPNOEA (I was not prepared for the shortness of breath/ I was having significant air hunger.  am still dealing with abnormal breathing, as well as the sensation of needing to take a deep breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram thorax: normal (normal) No blood clot found in the lungs.. In 2021, Fibrin D dimer: high (High) Very high level..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was no concomitant medication reported.  There was no treatment medication reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Pleurisy viral
Clinical narrative: Diagnosed with Post vaccine Viral Pleurisy; Chest pain; Not feeling well post vaccine #2; I was not prepared for the shortness of breath/ I was having significant air hunger.  am still dealing with abnormal breathing, as well as the sensation of needing to take a deep breath; This spontaneous case was reported by a nurse and describes the occurrence of PLEURISY VIRAL (Diagnosed with Post vaccine Viral Pleurisy) and DYSPNOEA (I was not prepared for the shortness of breath/ I was having significant air hunger.  am still dealing with abnormal breathing, as well as the sensation of needing to take a deep breath) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-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 PLEURISY VIRAL (Diagnosed with Post vaccine Viral Pleurisy) (seriousness criterion medically significant), CHEST PAIN (Chest pain), MALAISE (Not feeling well post vaccine #2) and DYSPNOEA (I was not prepared for the shortness of breath/ I was having significant air hunger.  am still dealing with abnormal breathing, as well as the sensation of needing to take a deep breath) (seriousness criterion medically significant). At the time of the report, PLEURISY VIRAL (Diagnosed with Post vaccine Viral Pleurisy), CHEST PAIN (Chest pain), MALAISE (Not feeling well post vaccine #2) and DYSPNOEA (I was not prepared for the shortness of breath/ I was having significant air hunger.  am still dealing with abnormal breathing, as well as the sensation of needing to take a deep breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram thorax: normal (normal) No blood clot found in the lungs.. In 2021, Fibrin D dimer: high (High) Very high level..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was no concomitant medication reported.  There was no treatment medication reported.  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.