chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test, Thyroiditis, Vaccination site pain
Clinical narrative: Hypothyroid; thyroiditis; Hypertension; Missed her menstrual cycle; Vaccination site pain; urticaria; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOTHYROIDISM (Hypothyroid) and THYROIDITIS (thyroiditis) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heartburn since an unknown date. Concomitant products included VITAMIN D NOS and CALCIUM for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced HYPOTHYROIDISM (Hypothyroid) (seriousness criterion medically significant) and MENSTRUAL DISORDER (Missed her menstrual cycle). 23-Mar-2021, the patient experienced THYROIDITIS (thyroiditis) (seriousness criterion medically significant), HYPERTENSION (Hypertension), VACCINATION SITE PAIN (Vaccination site pain) and INJECTION SITE URTICARIA (urticaria). At the time of the report, HYPOTHYROIDISM (Hypothyroid), THYROIDITIS (thyroiditis), HYPERTENSION (Hypertension), MENSTRUAL DISORDER (Missed her menstrual cycle), VACCINATION SITE PAIN (Vaccination site pain) and INJECTION SITE URTICARIA (urticaria) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 98.2 98.2. On 23-Mar-2021, Thyroid function test: positive (Positive) Thyroiditis confirmed.         Concomitant medications include treatment for heartburn. The patient was started on medication to treat hypothyroid and hypertension.  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 US-MODERNATX, INC.-MOD-2021-058198 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up received on 7-JUL-2021. New events added(Hypertension, Hypothyroid) Race information added, pregnancy information added.; 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. US-MODERNATX, INC.-MOD-2021-058198:Case for first dose
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Skin texture abnormal
Clinical narrative: itching; texture of my skin the different textures in different places I am itching; and I am in pain in a number of places; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching), SKIN TEXTURE ABNORMAL (texture of my skin the different textures in different places I am itching) and MYALGIA (and I am in pain in a number of places) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS and Asthma.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching) (seriousness criterion hospitalization), SKIN TEXTURE ABNORMAL (texture of my skin the different textures in different places I am itching) (seriousness criterion hospitalization) and MYALGIA (and I am in pain in a number of places) (seriousness criterion hospitalization). At the time of the report, PRURITUS (itching), SKIN TEXTURE ABNORMAL (texture of my skin the different textures in different places I am itching) and MYALGIA (and I am in pain in a number of places) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The patient was tested for over a hundred different allergies and was found to have one.  Treatment information was not provided.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: follow-up document received on 02-07-2021, upgraded case seriousness as hospitalization.; 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Cerebrovascular accident; This case was initially received via another Manufacturer (Reference number: PVIUS2021001059) on 14-Jun-2021. The most recent information was received on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021. The license partner had received the report from FDA VAERS (Reference number: 1422940).    This regulatory authority case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided.  No treatment medication details was provided.  Very limited information regarding the event has been provided at this time. Patient's history of diabetes may be a confounding factor. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Event verbatim Updated. Sender's Comments added. Report type of this case updated from spontaneous to Regulatory Authority.; Sender's Comments: Very limited information regarding this event has been provided at this time. Patient's history of diabetes may be a confounding factor.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pericardial effusion
Clinical narrative: Fluid around heart again; Moderate swelling all over my body; This case was initially received via another Manufacturer (Reference number: PVIUS2021001073) on 19-Jun-2021. The most recent information was received on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021. The license partner had received the report from VAERS (Reference number: 1435708).    This regulatory authority case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (Fluid around heart again) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Fibromyalgia, Bipolar affective disorder and Allergy to antibiotic (Ceflosporin).   On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDIAL EFFUSION (Fluid around heart again) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (Moderate swelling all over my body). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERICARDIAL EFFUSION (Fluid around heart again) and OEDEMA PERIPHERAL (Moderate swelling all over my body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PERICARDIAL EFFUSION (Fluid around heart again) and OEDEMA PERIPHERAL (Moderate swelling all over my body) to be possibly related.    The patient had right arm, leg back and left leg are all swollen and starting to get fluid around heart again. Treating with ibuprofen right now did the same after first vaccine. No concomitant medication information was provided.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up document received on 13 Jul 2021 updated report type as Regulatory authority case. Secondary reporter details added.; 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: patient was diagnosed with COVID-19; fever; fatigue; diagnosed with covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with covid-19) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 021A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced COVID-19 (diagnosed with covid-19) (seriousness criterion medically significant). On an unknown date, the patient experienced DRUG INEFFECTIVE (patient was diagnosed with COVID-19), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, COVID-19 (diagnosed with covid-19), DRUG INEFFECTIVE (patient was diagnosed with COVID-19), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, SARS-CoV-2 test: positive (Positive) Patient was diagnosed with COVID-19.         Concomitant product information was not provided.  Treatment information was not provided.  Based on the current available information and lack of scientific plausibility for the occurrence of the event causal relationship is considered unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information and lack of scientific plausibility for the occurrence of the event causal relationship is considered unlikely related to mRNA-1273.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Dementia, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: It's like experiencing dementia; Stiffness; Slight constipation; Nausea; Body aches (upper and lower body); Consistent headaches (front and back of head); Scratchy throat; Needle pain after the injection; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (It's like experiencing dementia) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acute lymphoblastic leukemia (Acute Lymphoblastic Leukemia  with radiation treatment therapy to brain and central nervous system.) since 1972 and Immunocompromised (Patient belongs to "Immunocompromised population".). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]) for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Needle pain after the injection). On 24-Jun-2021, the patient experienced THROAT IRRITATION (Scratchy throat). On an unknown date, the patient experienced DEMENTIA (It's like experiencing dementia) (seriousness criteria hospitalization and medically significant), MUSCULOSKELETAL STIFFNESS (Stiffness), CONSTIPATION (Slight constipation), NAUSEA (Nausea), MYALGIA (Body aches (upper and lower body)) and HEADACHE (Consistent headaches (front and back of head)). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, DEMENTIA (It's like experiencing dementia), MUSCULOSKELETAL STIFFNESS (Stiffness), CONSTIPATION (Slight constipation), THROAT IRRITATION (Scratchy throat), NAUSEA (Nausea), MYALGIA (Body aches (upper and lower body)), HEADACHE (Consistent headaches (front and back of head)) and VACCINATION SITE PAIN (Needle pain after the injection) outcome was unknown.            The patient stated that he has no history of any illicit drugs use, marijuana, or tobacco.  Company Comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Very limited information regarding the event Dementia has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-235743 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Very limited information regarding the event Dementia has been provided at this time.  Further information has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Throat irritation, Vaccination site pain
Clinical narrative: It's like experiencing dementia; Stiffness; Slight constipation; Nausea; Body aches (upper and lower body); Consistent headaches (front and back of head); Scratchy throat; Needle pain after the injection; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (It's like experiencing dementia) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acute lymphoblastic leukemia (Acute Lymphoblastic Leukemia  with radiation treatment therapy to brain and central nervous system.) since 1972 and Immunocompromised (Patient belongs to "Immunocompromised population".). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]) for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Needle pain after the injection). On 24-Jun-2021, the patient experienced THROAT IRRITATION (Scratchy throat). On an unknown date, the patient experienced DEMENTIA (It's like experiencing dementia) (seriousness criteria hospitalization and medically significant), MUSCULOSKELETAL STIFFNESS (Stiffness), CONSTIPATION (Slight constipation), NAUSEA (Nausea), MYALGIA (Body aches (upper and lower body)) and HEADACHE (Consistent headaches (front and back of head)). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, DEMENTIA (It's like experiencing dementia), MUSCULOSKELETAL STIFFNESS (Stiffness), CONSTIPATION (Slight constipation), THROAT IRRITATION (Scratchy throat), NAUSEA (Nausea), MYALGIA (Body aches (upper and lower body)), HEADACHE (Consistent headaches (front and back of head)) and VACCINATION SITE PAIN (Needle pain after the injection) outcome was unknown.            The patient stated that he has no history of any illicit drugs use, marijuana, or tobacco.  Company Comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Very limited information regarding the event Dementia has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-235743 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Very limited information regarding the event Dementia has been provided at this time.  Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, COVID-19, Drug ineffective
Clinical narrative: Covid Postive; tested positive for COVID-19; loss of taste and smell; loss of taste and smell; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Covid Postive) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced COVID-19 (Covid Postive) (seriousness criterion medically significant), DRUG INEFFECTIVE (tested positive for COVID-19), AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell). At the time of the report, COVID-19 (Covid Postive), DRUG INEFFECTIVE (tested positive for COVID-19), AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Body temperature: 97.9 (Inconclusive) 97.9°F. On 24-Jun-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included a thyroid medication (not further specified). Treatment information was not reported. Based on the current available information and lack of scientific plausibility for the occurrence of the event causal relationship is considered unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information and lack of scientific plausibility for the occurrence of the event causal relationship is considered unlikely related to mRNA-1273.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Covid Postive; tested positive for COVID-19; loss of taste and smell; loss of taste and smell; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Covid Postive) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced COVID-19 (Covid Postive) (seriousness criterion medically significant), DRUG INEFFECTIVE (tested positive for COVID-19), AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell). At the time of the report, COVID-19 (Covid Postive), DRUG INEFFECTIVE (tested positive for COVID-19), AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Body temperature: 97.9 (Inconclusive) 97.9°F. On 24-Jun-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included a thyroid medication (not further specified). Treatment information was not reported. Based on the current available information and lack of scientific plausibility for the occurrence of the event causal relationship is considered unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information and lack of scientific plausibility for the occurrence of the event causal relationship is considered unlikely related to mRNA-1273.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: sore/swollen throat; sore/swollen throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore/swollen throat) and PHARYNGEAL SWELLING (sore/swollen throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore/swollen throat) (seriousness criterion medically significant) and PHARYNGEAL SWELLING (sore/swollen throat) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (sore/swollen throat) and PHARYNGEAL SWELLING (sore/swollen throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Echocardiogram, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: Increased heart rate to the 100's/abnormal heart rate/elevated heart rate; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heart rate to the 100's/abnormal heart rate/elevated heart rate) and NAUSEA (Nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced HEART RATE INCREASED (Increased heart rate to the 100's/abnormal heart rate/elevated heart rate) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, HEART RATE INCREASED (Increased heart rate to the 100's/abnormal heart rate/elevated heart rate) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Normal. On an unknown date, Echocardiogram: normal (normal) Normal. On an unknown date, Electrocardiogram: abnormal (abnormal) Abnormal. On an unknown date, Heart rate: 100 (High) Heart rate increased.         No concomitant medications reported by reporter. Treatment medication 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.; 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Increased heart rate to the 100's/abnormal heart rate/elevated heart rate; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heart rate to the 100's/abnormal heart rate/elevated heart rate) and NAUSEA (Nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced HEART RATE INCREASED (Increased heart rate to the 100's/abnormal heart rate/elevated heart rate) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, HEART RATE INCREASED (Increased heart rate to the 100's/abnormal heart rate/elevated heart rate) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Normal. On an unknown date, Echocardiogram: normal (normal) Normal. On an unknown date, Electrocardiogram: abnormal (abnormal) Abnormal. On an unknown date, Heart rate: 100 (High) Heart rate increased.         No concomitant medications reported by reporter. Treatment medication 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.; 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: Cytokine storm, Feeding disorder, Inflammation, Rectal haemorrhage, Wheezing
Clinical narrative: Rectal Bleeding; cytokine response; inflammatiory response; inflammatory wheezing; can't eat; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal Bleeding) and CYTOKINE STORM (cytokine response) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder (no longer have). Concurrent medical conditions included Immunocompromised (Immunocompromised/Primary immune deficient).   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 RECTAL HAEMORRHAGE (Rectal Bleeding) (seriousness criterion medically significant), CYTOKINE STORM (cytokine response) (seriousness criterion medically significant), INFLAMMATION (inflammatiory response), WHEEZING (inflammatory wheezing) and FEEDING DISORDER (can't eat). At the time of the report, RECTAL HAEMORRHAGE (Rectal Bleeding), CYTOKINE STORM (cytokine response), INFLAMMATION (inflammatiory response), WHEEZING (inflammatory wheezing) and FEEDING DISORDER (can't eat) outcome was unknown.            Patient had antibiotics which did not work initially.  Patient received steroids.  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 Concomitant products were not provided.  Patient was immunocompromised, primary immunodeficient and received a IGG replacement therapy and also auto-immune.  The action taken for m-RNA-1273 COVID-19 Moderna Vaccine 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
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Facial pain, Pain in extremity, Staphylococcal infection, White blood cell count
Clinical narrative: White blood cell count decreased; Staphylococcus lugdunensis infection; Leg pain; Redness; Pain in face; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (Staphylococcus lugdunensis infection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis. Concurrent medical conditions included Type 2 diabetes mellitus.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced FACIAL PAIN (Pain in face). On 10-May-2021, the patient experienced STAPHYLOCOCCAL INFECTION (Staphylococcus lugdunensis infection) (seriousness criterion medically significant), PAIN IN EXTREMITY (Leg pain) and ERYTHEMA (Redness). In June 2021, the patient experienced WHITE BLOOD CELL COUNT DECREASED (White blood cell count decreased). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; CODEINE at a dose of 1 dosage form; CLINDAMYCIN at a dose of 1 dosage form; DOXYCYCLINE at a dose of 1 dosage form and DAPSONE at a dose of 1 dosage form. On 17-Apr-2021, FACIAL PAIN (Pain in face) outcome was unknown. At the time of the report, STAPHYLOCOCCAL INFECTION (Staphylococcus lugdunensis infection), PAIN IN EXTREMITY (Leg pain), ERYTHEMA (Redness) and WHITE BLOOD CELL COUNT DECREASED (White blood cell count decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) Low White Blood Count.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient on 1985 post partum & post Rubella vaccine and  had a similar skin lesion but patient not sure if was the same infection. Patient medication was taken probiotic.  Action taken with mRNA-1273 in response to the events was not applicable.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: White blood cell count decreased; Staphylococcus lugdunensis infection; Leg pain; Redness; Pain in face; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (Staphylococcus lugdunensis infection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis. Concurrent medical conditions included Type 2 diabetes mellitus.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced FACIAL PAIN (Pain in face). On 10-May-2021, the patient experienced STAPHYLOCOCCAL INFECTION (Staphylococcus lugdunensis infection) (seriousness criterion medically significant), PAIN IN EXTREMITY (Leg pain) and ERYTHEMA (Redness). In June 2021, the patient experienced WHITE BLOOD CELL COUNT DECREASED (White blood cell count decreased). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; CODEINE at a dose of 1 dosage form; CLINDAMYCIN at a dose of 1 dosage form; DOXYCYCLINE at a dose of 1 dosage form and DAPSONE at a dose of 1 dosage form. On 17-Apr-2021, FACIAL PAIN (Pain in face) outcome was unknown. At the time of the report, STAPHYLOCOCCAL INFECTION (Staphylococcus lugdunensis infection), PAIN IN EXTREMITY (Leg pain), ERYTHEMA (Redness) and WHITE BLOOD CELL COUNT DECREASED (White blood cell count decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) Low White Blood Count.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient on 1985 post partum & post Rubella vaccine and  had a similar skin lesion but patient not sure if was the same infection. Patient medication was taken probiotic.  Action taken with mRNA-1273 in response to the events was not applicable.  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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: Heart attack; Blood clot; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) and THROMBOSIS (Blood clot) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033b21a) for COVID-19 vaccination.     No Medical History information was reported.  On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and THROMBOSIS (Blood clot) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Patient received first dose of Moderna COVID-19 on 19-MAY-2021 with lot number 045b21a intramuscularly.  No concomitant medications were provided.  No lab data was provided.  No treatment information was provided.  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 requested.; 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 requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Product availability issue, Product dose omission issue
Clinical narrative: Couldn't breathe; When she called her HCP, they said they were out of vaccine.; She still has not received her 2nd dose as of today (29Jun2021); This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Couldn't breathe) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced DYSPNOEA (Couldn't breathe) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (When she called her HCP, they said they were out of vaccine.) and PRODUCT DOSE OMISSION ISSUE (She still has not received her 2nd dose as of today (29Jun2021)). On 09-Jun-2021, DYSPNOEA (Couldn't breathe) had resolved. At the time of the report, PRODUCT AVAILABILITY ISSUE (When she called her HCP, they said they were out of vaccine.) and PRODUCT DOSE OMISSION ISSUE (She still has not received her 2nd dose as of today (29Jun2021)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that the patient stated that she is currently taking medication for blood pressure.  The patient also stated that she is also using nebulizer breathing machine. No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the Dyspnea event, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, a causal association between the Product Dose Omission Issue and Product Availability Issue mRNA-1273 is assessed as 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 Dyspnea event, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, a causal association between the Product Dose Omission Issue and Product Availability Issue mRNA-1273 is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: Hospitalization; This spontaneous case was reported by an other health care professional and describes the occurrence of HOSPITALISATION (Hospitalization) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Hospitalization) 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 did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not provided. Very limited information regarding the event has been provided at this time.; Sender's Comments: Very limited information regarding the event has been provided at this time.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; 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 MYOCARDIAL INFARCTION (Heart attack) 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 MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and Treatment were were not provided. Consent for follow-up declined.  have had 2 heart attacks and have cops.  Very limited information regarding this event has been provided at this time.   Further information is not expected.; Sender's Comments: Very limited information regarding this event has been provided at this time.   Further information is not expected
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Hyperhidrosis, Pain in extremity, Pruritus
Clinical narrative: Chest pain; Cough; Hyperhidrosis; Pain in extremity; Pruritus; Throat tightness; Wheezing; This case was received via FDA VAERS (Reference number: 1402783) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain), COUGH (Cough), HYPERHIDROSIS (Hyperhidrosis), PAIN IN EXTREMITY (Pain in extremity), PRURITUS (Pruritus), THROAT TIGHTNESS (Throat tightness) and WHEEZING (Wheezing) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Seasonal allergy, Drug allergy (Aspirin), Drug allergy (Ibuprofen), Drug allergy (Zofran), Drug allergy (Pepcid), Food allergy (Kiwi) and Food allergy (Paprika). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion life threatening), COUGH (Cough) (seriousness criterion life threatening), HYPERHIDROSIS (Hyperhidrosis) (seriousness criterion life threatening), PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion life threatening), PRURITUS (Pruritus) (seriousness criterion life threatening), THROAT TIGHTNESS (Throat tightness) (seriousness criterion life threatening) and WHEEZING (Wheezing) (seriousness criterion life threatening). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain), COUGH (Cough), HYPERHIDROSIS (Hyperhidrosis), PAIN IN EXTREMITY (Pain in extremity), PRURITUS (Pruritus), THROAT TIGHTNESS (Throat tightness) and WHEEZING (Wheezing) had resolved.        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.   Treatment of the events also included, steroids in ER. Patient under went chest X-ray, results were not provided.  Post vaccination patient experienced, pain in chest, wheezing, uncontrollable coughing, which lead to throat felt like it was closing, sweating and feeling itchy all over body and am hurt super bad.; 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Wheezing
Clinical narrative: Chest pain; Cough; Hyperhidrosis; Pain in extremity; Pruritus; Throat tightness; Wheezing; This case was received via FDA VAERS (Reference number: 1402783) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain), COUGH (Cough), HYPERHIDROSIS (Hyperhidrosis), PAIN IN EXTREMITY (Pain in extremity), PRURITUS (Pruritus), THROAT TIGHTNESS (Throat tightness) and WHEEZING (Wheezing) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Seasonal allergy, Drug allergy (Aspirin), Drug allergy (Ibuprofen), Drug allergy (Zofran), Drug allergy (Pepcid), Food allergy (Kiwi) and Food allergy (Paprika). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion life threatening), COUGH (Cough) (seriousness criterion life threatening), HYPERHIDROSIS (Hyperhidrosis) (seriousness criterion life threatening), PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion life threatening), PRURITUS (Pruritus) (seriousness criterion life threatening), THROAT TIGHTNESS (Throat tightness) (seriousness criterion life threatening) and WHEEZING (Wheezing) (seriousness criterion life threatening). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain), COUGH (Cough), HYPERHIDROSIS (Hyperhidrosis), PAIN IN EXTREMITY (Pain in extremity), PRURITUS (Pruritus), THROAT TIGHTNESS (Throat tightness) and WHEEZING (Wheezing) had resolved.        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.   Treatment of the events also included, steroids in ER. Patient under went chest X-ray, results were not provided.  Post vaccination patient experienced, pain in chest, wheezing, uncontrollable coughing, which lead to throat felt like it was closing, sweating and feeling itchy all over body and am hurt super bad.; 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.