chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gallbladder operation, Lymphadenopathy, Myalgia
Clinical narrative: Gall bladder surgery; missed appointment for second dose/scheduled to received second dose 12 Feb 2021 but was unable to keep the appointment; swollen lymph nodes; body ache; Vomiting; nausea; fever; chills; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GALLBLADDER OPERATION (Gall bladder surgery) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes), MYALGIA (body ache), VOMITING (Vomiting), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). On 12-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed appointment for second dose/scheduled to received second dose 12 Feb 2021 but was unable to keep the appointment). On an unknown date, the patient experienced GALLBLADDER OPERATION (Gall bladder surgery) (seriousness criterion hospitalization). On 12-Feb-2021, PRODUCT DOSE OMISSION ISSUE (missed appointment for second dose/scheduled to received second dose 12 Feb 2021 but was unable to keep the appointment) had resolved. At the time of the report, GALLBLADDER OPERATION (Gall bladder surgery) had resolved and LYMPHADENOPATHY (swollen lymph nodes), MYALGIA (body ache), VOMITING (Vomiting), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Treatment for chills, fever, nausea, vomiting, body ache, fatigue, and swollen lymph nodes included paracetamol.  The patient was scheduled for her second dose on 12 Feb 2021, but was unable to keep the appointment because she went to the emergency room and then had gall bladder surgery. By the time her surgeon had released her,  it was past her appointment time.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: The event of gallbladder surgery was added.  Narrative updated.; Sender's Comments: Very limited information regarding this events has been provided at this time.  The events are assessed unlikely related to product.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Product dose omission issue, Pyrexia, Vomiting
Clinical narrative: Gall bladder surgery; missed appointment for second dose/scheduled to received second dose 12 Feb 2021 but was unable to keep the appointment; swollen lymph nodes; body ache; Vomiting; nausea; fever; chills; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GALLBLADDER OPERATION (Gall bladder surgery) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes), MYALGIA (body ache), VOMITING (Vomiting), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). On 12-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed appointment for second dose/scheduled to received second dose 12 Feb 2021 but was unable to keep the appointment). On an unknown date, the patient experienced GALLBLADDER OPERATION (Gall bladder surgery) (seriousness criterion hospitalization). On 12-Feb-2021, PRODUCT DOSE OMISSION ISSUE (missed appointment for second dose/scheduled to received second dose 12 Feb 2021 but was unable to keep the appointment) had resolved. At the time of the report, GALLBLADDER OPERATION (Gall bladder surgery) had resolved and LYMPHADENOPATHY (swollen lymph nodes), MYALGIA (body ache), VOMITING (Vomiting), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Treatment for chills, fever, nausea, vomiting, body ache, fatigue, and swollen lymph nodes included paracetamol.  The patient was scheduled for her second dose on 12 Feb 2021, but was unable to keep the appointment because she went to the emergency room and then had gall bladder surgery. By the time her surgeon had released her,  it was past her appointment time.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: The event of gallbladder surgery was added.  Narrative updated.; Sender's Comments: Very limited information regarding this events has been provided at this time.  The events are assessed unlikely related to product.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Trouble walking; severe pain in right knee; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Trouble walking) and ARTHRALGIA (severe pain in right knee) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Total knee replacement on 15-Jan-2021. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ARTHRALGIA (severe pain in right knee) (seriousness criterion disability). On an unknown date, the patient experienced GAIT DISTURBANCE (Trouble walking) (seriousness criterion disability). At the time of the report, GAIT DISTURBANCE (Trouble walking) and ARTHRALGIA (severe pain in right knee) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included prednisone and Celecoxib. The patient's physician believed that her knee pain was related to Moderna vaccine because of the timeline and would give her a cortisone injection today, 13 May 2021.  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.  Causality is also confounded by the patient's past medical history of total knee replacement.   This case was linked to MOD-2021-097847 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-May-2021 upgraded the case to serious with seriousness criteria (disabling/incapacitating), newevent, event start date, outcome of event, and treatment information updated.; 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.  Causality is also confounded by the patient's past medical history of total knee replacement.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: soreness after 2nd dose where vaccine was administered; dizziness worst with 2nd dose,heavy dizziness; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness worst with 2nd dose,heavy dizziness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo. Concomitant products included CLONAZEPAM, PRAVASTATIN, IRBESARTAN and PANTOPRAZOLE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (dizziness worst with 2nd dose,heavy dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness after 2nd dose where vaccine was administered). At the time of the report, DIZZINESS (dizziness worst with 2nd dose,heavy dizziness) and VACCINATION SITE PAIN (soreness after 2nd dose where vaccine was administered) outcome was unknown.            Meclizine 25mg for treatment.  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-2021-109616 (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: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia, Rash
Clinical narrative: seizure; Rash on Both legs; Headaches; Fever; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history 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 SEIZURE (seizure) (seriousness criterion medically significant), RASH (Rash on Both legs), HEADACHE (Headaches), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, SEIZURE (seizure), RASH (Rash on Both legs), HEADACHE (Headaches), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.            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.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; Rash on Both legs; Headaches; Fever; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history 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 SEIZURE (seizure) (seriousness criterion medically significant), RASH (Rash on Both legs), HEADACHE (Headaches), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, SEIZURE (seizure), RASH (Rash on Both legs), HEADACHE (Headaches), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.            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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myocardial infarction
Clinical narrative: This spontaneous case was reported by an other health professional (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cough since an unknown date. Concurrent medical conditions included COPD and Diabetes.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and life threatening) and BACK PAIN (Back ache). The patient was hospitalized from 07-Apr-2021 to 09-Apr-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and BACK PAIN (Back ache) 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 considered MYOCARDIAL INFARCTION (Heart attack) and BACK PAIN (Back ache) to be possibly related.    Treatment includes 3 stents placed to right coronary artery. Blood sugar was over 500 and patient was put on insulin.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Gastrointestinal disorder
Clinical narrative: Colitis ulcerative aggravated; Colopathy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COLITIS ULCERATIVE (Colitis ulcerative aggravated) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant) and GASTROINTESTINAL DISORDER (Colopathy). At the time of the report, COLITIS ULCERATIVE (Colitis ulcerative aggravated) and GASTROINTESTINAL DISORDER (Colopathy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GASTROINTESTINAL DISORDER (Colopathy) to be probably related. No further causality assessment was provided for COLITIS ULCERATIVE (Colitis ulcerative aggravated).    Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Covid-19 Positive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 Positive) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 Positive) (seriousness criterion hospitalization). The patient was hospitalized from 21-Apr-2021 to 25-Apr-2021 due to SARS-COV-2 TEST POSITIVE. At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was in quarantine.  Treatment information was not provided.   This case was linked to (E2B Linked Report).; Sender's Comments: Based on biological implausibility the event of COVID-19 infection causality is assessed as not applicable in relation to mRNA-1273. :Case For wife
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cystitis
Clinical narrative: Asthma attack; Bladder infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (Asthma attack) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHMA (Asthma attack) (seriousness criterion hospitalization) and CYSTITIS (Bladder infection). At the time of the report, ASTHMA (Asthma attack) and CYSTITIS (Bladder infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications listed. The treatment medications included steroids, antibiotic, and asthma medication.  Very limited information regarding these events (PT/Asthma and Cystitis) has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events (PT/Asthma and Cystitis) has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Breast cancer recurrent
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST CANCER RECURRENT (Recurrence of her Breast Cancer/got my biopsy result and it says that my cancer is back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (The patient had breast cancer 3 years ago).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced BREAST CANCER RECURRENT (Recurrence of her Breast Cancer/got my biopsy result and it says that my cancer is back) (seriousness criterion medically significant). At the time of the report, BREAST CANCER RECURRENT (Recurrence of her Breast Cancer/got my biopsy result and it says that my cancer is back) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: cancer (abnormal) Patient cancer is back.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. 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. Previous medical history of Breast Cancer is a confounder.; 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. Previous medical history of Breast Cancer is a confounder.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Echocardiogram, Electrocardiogram, Pulmonary fibrosis
Clinical narrative: Chest x-ray showed really bad scarring on both lungs; Diagnosed with COVID-19 for second time; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY FIBROSIS (Chest x-ray showed really bad scarring on both lungs) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M204 and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced PULMONARY FIBROSIS (Chest x-ray showed really bad scarring on both lungs) (seriousness criterion medically significant) and COVID-19 (Diagnosed with COVID-19 for second time). At the time of the report, PULMONARY FIBROSIS (Chest x-ray showed really bad scarring on both lungs) and COVID-19 (Diagnosed with COVID-19 for second time) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, COVID-19: (Positive) diagnosed with COVID-19 for second time. On 03-May-2021, Chest X-ray: scarring on both lungs, really bad. On 03-May-2021, Echocardiogram: (Negative) Negative. On 03-May-2021, Electrocardiogram: no indication of heart attack.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided.  .  No treatment information provided. Action taken with mRNA-1273 in response to the drug was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder, Myasthenia gravis
Clinical narrative: Autoimmune issue; myasthenia gravis; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune issue) and MYASTHENIA GRAVIS (myasthenia gravis) 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 AUTOIMMUNE DISORDER (Autoimmune issue) (seriousness criteria hospitalization and medically significant) and MYASTHENIA GRAVIS (myasthenia gravis) (seriousness criteria hospitalization and medically significant). The patient was treated with Physical therapy for Autoimmune disorder. At the time of the report, AUTOIMMUNE DISORDER (Autoimmune issue) had not resolved and MYASTHENIA GRAVIS (myasthenia gravis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No additional treatment information was provided.  The treatment included therapy. This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune issue) and Myasthenia gravis (Myasthenia gravis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. 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 AUTOIMMUNE DISORDER (Autoimmune issue) (seriousness criteria hospitalization and medically significant) and Myasthenia gravis (Myasthenia gravis) (seriousness criteria hospitalization and medically significant). At the time of the report, AUTOIMMUNE DISORDER (Autoimmune issue) had not resolved and Myasthenia gravis (Myasthenia gravis) (seriousness criteria hospitalization and medically significant) was not resolved.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Dyspnoea, Fatigue, Muscle tightness
Clinical narrative: Condition aggravated; Shortness of breath; Cold symptoms; neck tighing; pain in her knee; Feeling tired; Oxygen saturation decreased; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen saturation decreased), CONDITION AGGRAVATED (Condition aggravated) and DYSPNOEA (Shortness of breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MACITENTAN for Pulmonary hypertension.    The patient's past medical history included Knee arthroplasty. Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included TADALAFIL, AMLODIPINE, SELEXIPAG (UPTRAVI) and OXYGEN for an unknown indication.   In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started MACITENTAN (Oral) 10 mg. In March 2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen saturation decreased) (seriousness criteria medically significant and intervention required), DYSPNOEA (Shortness of breath) (seriousness criteria medically significant and intervention required), NASOPHARYNGITIS (Cold symptoms), MUSCLE TIGHTNESS (neck tighing), ARTHRALGIA (pain in her knee) and FATIGUE (Feeling tired). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion medically significant). At the time of the report, OXYGEN SATURATION DECREASED (Oxygen saturation decreased) was resolving, CONDITION AGGRAVATED (Condition aggravated), DYSPNOEA (Shortness of breath), MUSCLE TIGHTNESS (neck tighing) and FATIGUE (Feeling tired) outcome was unknown and NASOPHARYNGITIS (Cold symptoms) and ARTHRALGIA (pain in her knee) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Oxygen saturation: 71 % (Low) 71%. On an unknown date, Oxygen saturation: 96 % (Inconclusive) improved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that the night after the vaccination the oxygen saturation decreased to 71% on oxygen 10 liters per minute. Treatment for the event included a non-invasive ventilator device (trilogy machine) with improvement of oxygen saturation to 96%.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Condition aggravated; Shortness of breath; Cold symptoms; neck tighing; pain in her knee; Feeling tired; Oxygen saturation decreased; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen saturation decreased), CONDITION AGGRAVATED (Condition aggravated) and DYSPNOEA (Shortness of breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MACITENTAN for Pulmonary hypertension.    The patient's past medical history included Knee arthroplasty. Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included TADALAFIL, AMLODIPINE, SELEXIPAG (UPTRAVI) and OXYGEN for an unknown indication.   In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started MACITENTAN (Oral) 10 mg. In March 2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen saturation decreased) (seriousness criteria medically significant and intervention required), DYSPNOEA (Shortness of breath) (seriousness criteria medically significant and intervention required), NASOPHARYNGITIS (Cold symptoms), MUSCLE TIGHTNESS (neck tighing), ARTHRALGIA (pain in her knee) and FATIGUE (Feeling tired). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion medically significant). At the time of the report, OXYGEN SATURATION DECREASED (Oxygen saturation decreased) was resolving, CONDITION AGGRAVATED (Condition aggravated), DYSPNOEA (Shortness of breath), MUSCLE TIGHTNESS (neck tighing) and FATIGUE (Feeling tired) outcome was unknown and NASOPHARYNGITIS (Cold symptoms) and ARTHRALGIA (pain in her knee) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Oxygen saturation: 71 % (Low) 71%. On an unknown date, Oxygen saturation: 96 % (Inconclusive) improved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that the night after the vaccination the oxygen saturation decreased to 71% on oxygen 10 liters per minute. Treatment for the event included a non-invasive ventilator device (trilogy machine) with improvement of oxygen saturation to 96%.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia, Pneumonia, Pyrexia
Clinical narrative: Pneumonia; cough; fever; headache; bodyache and muscle aches; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), COUGH (cough), PYREXIA (fever), HEADACHE (headache) and MYALGIA (bodyache and muscle aches). At the time of the report, PNEUMONIA (Pneumonia), COUGH (cough), PYREXIA (fever), HEADACHE (headache) and MYALGIA (bodyache and muscle aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Forty-eight hours after receiving the second dose of the vaccine, the patient experienced fever, cough, headache, bodyache and muscle aches.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  This case concerns an adult male with a serious unexpected event of pneumonia. Latency 2 days after second dose mRNA-1273. 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.   This case was linked to MOD-2021-025099 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns an adult male with a serious unexpected event of pneumonia. Latency 2 days after second dose mRNA-1273. 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.
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: three days after receiving the second dose, she began losing her vision; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (three days after receiving the second dose, she began losing her vision) 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 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 BLINDNESS (three days after receiving the second dose, she began losing her vision) (seriousness criterion medically significant). At the time of the report, BLINDNESS (three days after receiving the second dose, she began losing her vision) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Concomitant medications and treatment medications were not 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Feeling of body temperature change, Gastrointestinal pain, Headache
Clinical narrative: had headache, fever, and a temperature that went from 96 and then 100. She said she felt cold and hot; had headache, fever, and a temperature that went from 96 and then 100. She said she felt cold and hot; had headache, fever, and a temperature that went from 96 and then 100. She said she felt cold and hot; severe intestinal cramps, diaarrhea, sweats, and severe shaking that is almost close to convulsive shaking, muscle aches in her torso, and lower back near the kidney area; severe intestinal cramps, diarrhea, sweats, and severe shaking that is almost close to convulsive shaking, muscle aches in her torso, and lower back near the kidney area; severe intestinal cramps, diarrhea, sweats, and severe shaking that is almost close to convulsive shaking, muscle aches in her torso, and lower back near the kidney area; severe intestinal cramps, diarrhea, sweats, and severe shaking that is almost close to convulsive shaking, muscle aches in her torso, and lower back near the kidney area; severe intestinal cramps, diarrhea, sweats, and severe shaking that is almost close to convulsive shaking, muscle aches in her torso, and lower back near the kidney area; This is a spontaneous report from a non-contactable female consumer reported for herself. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiry date: unknown), via an unspecified route of administration on Jan2021 as 1st dose, single dose for Covid-19 immunization.Patient medical history and concomitant medications were not reported. In Jan2021 the patient experienced severe reactions. These reactions include severe intestinal cramps, diarrhea, sweats, and severe shaking that was almost close to convulsive shaking, muscle aches in her torso, and lower back near the kidney area. She also said she had headache, fever, and a temperature that went from 96 and then 100. She said she felt cold and hot. Patient underwent lab test and procedure body temperature was 96 and then 100 degrees Celsius in Jan2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Pyrexia, Tremor
Clinical narrative: had headache, fever, and a temperature that went from 96 and then 100. She said she felt cold and hot; had headache, fever, and a temperature that went from 96 and then 100. She said she felt cold and hot; had headache, fever, and a temperature that went from 96 and then 100. She said she felt cold and hot; severe intestinal cramps, diaarrhea, sweats, and severe shaking that is almost close to convulsive shaking, muscle aches in her torso, and lower back near the kidney area; severe intestinal cramps, diarrhea, sweats, and severe shaking that is almost close to convulsive shaking, muscle aches in her torso, and lower back near the kidney area; severe intestinal cramps, diarrhea, sweats, and severe shaking that is almost close to convulsive shaking, muscle aches in her torso, and lower back near the kidney area; severe intestinal cramps, diarrhea, sweats, and severe shaking that is almost close to convulsive shaking, muscle aches in her torso, and lower back near the kidney area; severe intestinal cramps, diarrhea, sweats, and severe shaking that is almost close to convulsive shaking, muscle aches in her torso, and lower back near the kidney area; This is a spontaneous report from a non-contactable female consumer reported for herself. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiry date: unknown), via an unspecified route of administration on Jan2021 as 1st dose, single dose for Covid-19 immunization.Patient medical history and concomitant medications were not reported. In Jan2021 the patient experienced severe reactions. These reactions include severe intestinal cramps, diarrhea, sweats, and severe shaking that was almost close to convulsive shaking, muscle aches in her torso, and lower back near the kidney area. She also said she had headache, fever, and a temperature that went from 96 and then 100. She said she felt cold and hot. Patient underwent lab test and procedure body temperature was 96 and then 100 degrees Celsius in Jan2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Noninfective gingivitis, Pain in extremity, Pain of skin
Clinical narrative: Dysgeusia/Copper taste in my mouth; sore arm; inflamed gums around teeth; hair follicles on scalp were sore to touch/movement of hair; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Jan2021 (at the age of 35 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Recurrent pregnancy loss. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); ubiquinol (UBIQUINOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No Allergies to medications, food, or other products. Since 26Jan2021, the patient experienced sore arm, hair follicles on scalp were sore to touch/movement of hair, inflamed gums around teeth. About 72-96 hrs after inoculation, on 28Jan2021, she started having severe Dysgeusia. There was a copper taste in her mouth that won't go away. No treatment received for the adverse events. Outcome of the event dysgeusia/copper taste in my mouth was not recovered and other events was recovered.  Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Faeces soft, Flatulence, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old patient of an unspecified gender received BNT162B2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 10:30 as SINGLE DOSE for COVID-19 immunization. Medical history included continuous positive airway pressure use a cpap machine, seasonal allergy have hay fever during spring summer, arthropathy the normal joint issues of someone my age nothing major they are controlled by exercise, drug hypersensitivity Allergies: Sulfa drugs. On 21Jan2021, the patient experienced gas, soft strange stools when pooping, sore arm. Gas and Soft strange stools when pooping started the evening after the injection and lasted until the morning of 9/27 Other than that the only problem was a sore arm that started 5 hours after injection and lasted about 24 hours- since it wasn't on the normal adverse effects list. I figured I would report it. The action taken in response to the event for BNT162B2 was not applicable. The outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Pain in extremity
Clinical narrative: She reports that his arm was a little sore; developed diarrhea; weezy feeling stomach; This is a spontaneous report from a contactable consumer.  A 82-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on 25Jan2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that his arm was a little sore on Monday 1st dose 25Jan2021 then next night that is on 26Jan2021 22:30 patient experienced a pain in extremity, diarrhoea, abdominal pain upper. Local pharmacist recommended "Imodium and Pepto" for treating the diarrhoea and asked the patient to call Pfizer. Finally, Patient's wife enquired if adverse events are because of the vaccine and how long diarrhoea might last. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected. Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: This is a spontaneous report from contactable healthcare professional (patient). A 32-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3246) intramuscularly in left arm on 27Jan2021 at 11:00 (at the age of 32 years) as 2nd dose single for COVID-19 immunization. The patient medical history included asthma. The patient previously took codeine and experienced allergy. Concomitant medication of the patient included amphetamine aspartate, amphetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 30 mg received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number:Unknown) intramuscularly in left arm on 04Jan2021 at 13:00 as 1st dose single for COVID-19 immunization. Patient did not receive any vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 27 Jan 2021 post vaccination, patient has been tested for COVID-19 test (Curative) and result was unknown. On 27Jan2021 at 15:00, patient experienced muscle stiffness, dizziness, fatigue, diarrhea, headache, fever, pain in arm, ringing in ears, confusion and nausea. Patient did not receive any treatment for the events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from contactable healthcare professional (patient). A 32-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3246) intramuscularly in left arm on 27Jan2021 at 11:00 (at the age of 32 years) as 2nd dose single for COVID-19 immunization. The patient medical history included asthma. The patient previously took codeine and experienced allergy. Concomitant medication of the patient included amphetamine aspartate, amphetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 30 mg received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number:Unknown) intramuscularly in left arm on 04Jan2021 at 13:00 as 1st dose single for COVID-19 immunization. Patient did not receive any vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 27 Jan 2021 post vaccination, patient has been tested for COVID-19 test (Curative) and result was unknown. On 27Jan2021 at 15:00, patient experienced muscle stiffness, dizziness, fatigue, diarrhea, headache, fever, pain in arm, ringing in ears, confusion and nausea. Patient did not receive any treatment for the events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from contactable healthcare professional (patient). A 32-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3246) intramuscularly in left arm on 27Jan2021 at 11:00 (at the age of 32 years) as 2nd dose single for COVID-19 immunization. The patient medical history included asthma. The patient previously took codeine and experienced allergy. Concomitant medication of the patient included amphetamine aspartate, amphetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 30 mg received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number:Unknown) intramuscularly in left arm on 04Jan2021 at 13:00 as 1st dose single for COVID-19 immunization. Patient did not receive any vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 27 Jan 2021 post vaccination, patient has been tested for COVID-19 test (Curative) and result was unknown. On 27Jan2021 at 15:00, patient experienced muscle stiffness, dizziness, fatigue, diarrhea, headache, fever, pain in arm, ringing in ears, confusion and nausea. Patient did not receive any treatment for the events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.