chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: there were a few cases with the moderna vaccine with bell´s palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (there were a few cases with the moderna vaccine with bell´s palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 FACIAL PARALYSIS (there were a few cases with the moderna vaccine with bell´s palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (there were a few cases with the moderna vaccine with bell´s palsy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. Treatment medication not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Further information is requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Flushing, Myalgia, Pyrexia, Reduced facial expression
Clinical narrative: body shocks; Vaccine exposure during pregnancy; face feels tight; flushed; body ache; fever of 103.0; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of SHOCK (body shocks) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy (Live full-term birth) on 20-Apr-2018. Concurrent medical conditions included Drug allergy.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Mar-2021 and the estimated date of delivery was 18-Dec-2021. On an unknown date, the patient experienced SHOCK (body shocks) (seriousness criterion medically significant), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), REDUCED FACIAL EXPRESSION (face feels tight), FLUSHING (flushed), MYALGIA (body ache) and PYREXIA (fever of 103.0). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  At the time of the report, SHOCK (body shocks), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), REDUCED FACIAL EXPRESSION (face feels tight), FLUSHING (flushed), MYALGIA (body ache) and PYREXIA (fever of 103.0) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided  Company comment: This case of a 25-year-old, P1G2 female with who experienced Vaccine exposure during pregnancy.  Last menstrual period was 13-Mar-2021 and estimated date of delivery was 18-Dec-2021. Based on a temporal association between the use of mRNA-1273 vaccine and onset of the other reported events, a causal relationship cannot be excluded. Myalgia and fever are consistent with product safety profile.  Vaccine exposure du7ring pregnancy is assessed as not applicable.; Sender's Comments: This case of a 25-year-old, P1G2 female with who experienced Vaccine exposure during pregnancy.  Last menstrual period was 13-Mar-2021 and estimated date of delivery was 18-Dec-2021. Based on a temporal association between the use of mRNA-1273 vaccine and onset of the other reported events, a causal relationship cannot be excluded. Myalgia and fever are consistent with product safety profile.  Vaccine exposure du7ring pregnancy is assessed as not applicable.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Shock
Clinical narrative: body shocks; Vaccine exposure during pregnancy; face feels tight; flushed; body ache; fever of 103.0; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of SHOCK (body shocks) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy (Live full-term birth) on 20-Apr-2018. Concurrent medical conditions included Drug allergy.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Mar-2021 and the estimated date of delivery was 18-Dec-2021. On an unknown date, the patient experienced SHOCK (body shocks) (seriousness criterion medically significant), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), REDUCED FACIAL EXPRESSION (face feels tight), FLUSHING (flushed), MYALGIA (body ache) and PYREXIA (fever of 103.0). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  At the time of the report, SHOCK (body shocks), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), REDUCED FACIAL EXPRESSION (face feels tight), FLUSHING (flushed), MYALGIA (body ache) and PYREXIA (fever of 103.0) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided  Company comment: This case of a 25-year-old, P1G2 female with who experienced Vaccine exposure during pregnancy.  Last menstrual period was 13-Mar-2021 and estimated date of delivery was 18-Dec-2021. Based on a temporal association between the use of mRNA-1273 vaccine and onset of the other reported events, a causal relationship cannot be excluded. Myalgia and fever are consistent with product safety profile.  Vaccine exposure du7ring pregnancy is assessed as not applicable.; Sender's Comments: This case of a 25-year-old, P1G2 female with who experienced Vaccine exposure during pregnancy.  Last menstrual period was 13-Mar-2021 and estimated date of delivery was 18-Dec-2021. Based on a temporal association between the use of mRNA-1273 vaccine and onset of the other reported events, a causal relationship cannot be excluded. Myalgia and fever are consistent with product safety profile.  Vaccine exposure du7ring pregnancy is assessed as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criteria medically significant and life threatening). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  The patient received treatment with oral Benadryl 50mg (Diphenhydramine). She was given IV push 50mg of benadryl in the ambulance. Then in the hospital, she received Epi-pen (epinephrine) and other medications. Reportedly, the patient had an anaphylactic reaction 10 minutes after the dose was administered and was sent to the emergency room. They observed her there at about 11 AM and discharged her about 5-6 PM. They gave her IV push 50 mg Benadryl and 50 mg oral Benadryl and gave her Epi-pen and other meds in the hospital. Patient does not have a HCP.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood pressure measurement, Cardiac stress test, Chills, Electrocardiogram
Clinical narrative: Severe heart palpitations; Fever; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Severe heart palpitations) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 03-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tired). On 14-Apr-2021, the patient experienced PALPITATIONS (Severe heart palpitations) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 14-Apr-2021 due to PALPITATIONS. At the time of the report, PALPITATIONS (Severe heart palpitations) outcome was unknown and PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Angiogram: normal (normal) Normal. On 04-Mar-2021, Blood pressure measurement: (High) Increased. On 04-Mar-2021, Cardiac stress test: normal (normal) Normal. On 04-Mar-2021, Electrocardiogram: normal (normal) Normal. On 04-Mar-2021, Heart rate: elevated and (High) Increased. On 04-Mar-2021, Magnetic resonance imaging: normal (normal) Normal. In April 2021, Blood pressure measurement: (High) Elevated. In April 2021, Heart rate: elevated High.         Comments from  the patient: Yesterday 14APR2021 I had severe Heart Palpitations and I was taken to the Hospital. I called an ambulance and they brought me to the Emergency Room. The Doctor performed an EKG and my heart was in normal condition.  I received my second Moderna Covid-19 vaccination on 3MAR2021.By 5PM on 3MAR2021 I had a Fever, Chills, was tired, I woke up at 6AM on 4MAR2021 with an elevated Heart Rate and elevated Blood Pressure. I went to go see my Cardiologist that day and he sent me right to the Hospital. I spent 2 days and 1 night in the Hospital. MRI, MRA, Stress Test, EKG were performed and all tests were normal. I was discharged from the Hospital on 6MAR2021. Then I came home and was fine until early April when my elevated heart beat, elevated blood pressure, and heart palpitations started again. My Cardiologist started me on Diltiazem 30mg three times per day.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Crossinked with First dose case
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Magnetic resonance imaging, Palpitations, Pyrexia
Clinical narrative: Severe heart palpitations; Fever; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Severe heart palpitations) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 03-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tired). On 14-Apr-2021, the patient experienced PALPITATIONS (Severe heart palpitations) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 14-Apr-2021 due to PALPITATIONS. At the time of the report, PALPITATIONS (Severe heart palpitations) outcome was unknown and PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Angiogram: normal (normal) Normal. On 04-Mar-2021, Blood pressure measurement: (High) Increased. On 04-Mar-2021, Cardiac stress test: normal (normal) Normal. On 04-Mar-2021, Electrocardiogram: normal (normal) Normal. On 04-Mar-2021, Heart rate: elevated and (High) Increased. On 04-Mar-2021, Magnetic resonance imaging: normal (normal) Normal. In April 2021, Blood pressure measurement: (High) Elevated. In April 2021, Heart rate: elevated High.         Comments from  the patient: Yesterday 14APR2021 I had severe Heart Palpitations and I was taken to the Hospital. I called an ambulance and they brought me to the Emergency Room. The Doctor performed an EKG and my heart was in normal condition.  I received my second Moderna Covid-19 vaccination on 3MAR2021.By 5PM on 3MAR2021 I had a Fever, Chills, was tired, I woke up at 6AM on 4MAR2021 with an elevated Heart Rate and elevated Blood Pressure. I went to go see my Cardiologist that day and he sent me right to the Hospital. I spent 2 days and 1 night in the Hospital. MRI, MRA, Stress Test, EKG were performed and all tests were normal. I was discharged from the Hospital on 6MAR2021. Then I came home and was fine until early April when my elevated heart beat, elevated blood pressure, and heart palpitations started again. My Cardiologist started me on Diltiazem 30mg three times per day.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Crossinked with First dose case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dyschezia, Heart rate increased, Insomnia, Urinary retention
Clinical narrative: could not  urinate; no sleep; lost 9 pounds; pulse rate is high in the 90s; could not defecate; constant pain in the colon on the left side, pain in my intestines; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (could not  urinate) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY RETENTION (could not  urinate) (seriousness criterion medically significant), INSOMNIA (no sleep), WEIGHT DECREASED (lost 9 pounds), HEART RATE INCREASED (pulse rate is high in the 90s), DYSCHEZIA (could not defecate) and ABDOMINAL PAIN (constant pain in the colon on the left side, pain in my intestines). At the time of the report, URINARY RETENTION (could not  urinate), INSOMNIA (no sleep), WEIGHT DECREASED (lost 9 pounds), HEART RATE INCREASED (pulse rate is high in the 90s), DYSCHEZIA (could not defecate) and ABDOMINAL PAIN (constant pain in the colon on the left side, pain in my intestines) outcome was unknown.            The patient used blood thinners as concomitant medication.  Patient states she took laxatives and other over-the-medications as treatment.  Action taken with mRNA-1273 in response to the event was not applicable.   Company Comment: This case concerns a 73-year-old female with a serious unexpected event of urinary retention, and non-serious unexpected dyschezia, abdominal pain, weight decreased and insomnia. Event onset with unknown latency after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 73-year-old female with a serious unexpected event of urinary retention, and nonserious unexpected dyschezia, abdominal pain, weight decreased and insomnia. Event onset with unknown latency after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: could not  urinate; no sleep; lost 9 pounds; pulse rate is high in the 90s; could not defecate; constant pain in the colon on the left side, pain in my intestines; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (could not  urinate) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY RETENTION (could not  urinate) (seriousness criterion medically significant), INSOMNIA (no sleep), WEIGHT DECREASED (lost 9 pounds), HEART RATE INCREASED (pulse rate is high in the 90s), DYSCHEZIA (could not defecate) and ABDOMINAL PAIN (constant pain in the colon on the left side, pain in my intestines). At the time of the report, URINARY RETENTION (could not  urinate), INSOMNIA (no sleep), WEIGHT DECREASED (lost 9 pounds), HEART RATE INCREASED (pulse rate is high in the 90s), DYSCHEZIA (could not defecate) and ABDOMINAL PAIN (constant pain in the colon on the left side, pain in my intestines) outcome was unknown.            The patient used blood thinners as concomitant medication.  Patient states she took laxatives and other over-the-medications as treatment.  Action taken with mRNA-1273 in response to the event was not applicable.   Company Comment: This case concerns a 73-year-old female with a serious unexpected event of urinary retention, and non-serious unexpected dyschezia, abdominal pain, weight decreased and insomnia. Event onset with unknown latency after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 73-year-old female with a serious unexpected event of urinary retention, and nonserious unexpected dyschezia, abdominal pain, weight decreased and insomnia. Event onset with unknown latency after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Headache, Malaise, Pallor
Clinical narrative: kidney failure; not feeling well; shaking; pale; weak; headache; 101.5F fever; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (kidney failure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Kidney failure on 14-Apr-2021.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 14-Apr-2021, the patient experienced RENAL FAILURE (kidney failure) (seriousness criterion medically significant), MALAISE (not feeling well), TREMOR (shaking), PALLOR (pale), ASTHENIA (weak), HEADACHE (headache) and PYREXIA (101.5F fever). At the time of the report, RENAL FAILURE (kidney failure), MALAISE (not feeling well), TREMOR (shaking), PALLOR (pale), ASTHENIA (weak), HEADACHE (headache) and PYREXIA (101.5F fever) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5f (High) 101.5F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   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.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Renal failure, Tremor
Clinical narrative: kidney failure; not feeling well; shaking; pale; weak; headache; 101.5F fever; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (kidney failure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Kidney failure on 14-Apr-2021.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 14-Apr-2021, the patient experienced RENAL FAILURE (kidney failure) (seriousness criterion medically significant), MALAISE (not feeling well), TREMOR (shaking), PALLOR (pale), ASTHENIA (weak), HEADACHE (headache) and PYREXIA (101.5F fever). At the time of the report, RENAL FAILURE (kidney failure), MALAISE (not feeling well), TREMOR (shaking), PALLOR (pale), ASTHENIA (weak), HEADACHE (headache) and PYREXIA (101.5F fever) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5f (High) 101.5F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   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.   Reporter did not allow further contact
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Malaise, Pain in extremity, Thrombosis, Vascular pain
Clinical narrative: Veins was outside and sore; really big and sore red area; really big and sore red area; all the veins in his R leg was protuberate; two blood clot; DGThrombosis; Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (two blood clot) and THROMBOSIS (DGThrombosis) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leg injury (severe damage to right leg, hit by "protellier" small airplane.) in 1977, Surgery ("many surgeries") and Clot blood.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced MALAISE (Felt terrible). On 13-Mar-2021, the patient experienced THROMBOSIS (two blood clot) (seriousness criterion medically significant), THROMBOSIS (DGThrombosis) (seriousness criterion medically significant), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate). At the time of the report, THROMBOSIS (two blood clot), THROMBOSIS (DGThrombosis), MALAISE (Felt terrible), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate) outcome was unknown. Not Provided          Concomitant medication included unspecified statin for high cholesterol.  The patient reported that he is retired. He reported that his leg is functioning well, he has only one of the three arteries in the legs and many damaged veins.  Treatment  medication included Seroto to treat the blood clots.  Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-077978 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-077978:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vein disorder
Clinical narrative: Veins was outside and sore; really big and sore red area; really big and sore red area; all the veins in his R leg was protuberate; two blood clot; DGThrombosis; Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (two blood clot) and THROMBOSIS (DGThrombosis) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leg injury (severe damage to right leg, hit by "protellier" small airplane.) in 1977, Surgery ("many surgeries") and Clot blood.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced MALAISE (Felt terrible). On 13-Mar-2021, the patient experienced THROMBOSIS (two blood clot) (seriousness criterion medically significant), THROMBOSIS (DGThrombosis) (seriousness criterion medically significant), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate). At the time of the report, THROMBOSIS (two blood clot), THROMBOSIS (DGThrombosis), MALAISE (Felt terrible), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate) outcome was unknown. Not Provided          Concomitant medication included unspecified statin for high cholesterol.  The patient reported that he is retired. He reported that his leg is functioning well, he has only one of the three arteries in the legs and many damaged veins.  Treatment  medication included Seroto to treat the blood clots.  Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-077978 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-077978:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Haemorrhagic stroke
Clinical narrative: Bleeding stroke; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGIC STROKE (Bleeding stroke) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided). Concomitant products included ROPINIROLE HYDROCHLORIDE (REQUIP) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced HAEMORRHAGIC STROKE (Bleeding stroke) (seriousness criteria hospitalization, disability and medically significant). The patient was hospitalized from 11-Apr-2021 to 14-Apr-2021 due to HAEMORRHAGIC STROKE. At the time of the report, HAEMORRHAGIC STROKE (Bleeding stroke) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Computerised tomogram head: brain bleed Brain Bleed.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient states an Anti seizure medicine was used for treatment. After discharge from hospital, patient states she now has to take therapy.   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. However, Very limited information regarding this event has been provided at this time.  Further information has been requested.; 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. However, Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myocardial infarction, Pyrexia
Clinical narrative: Heart attack; Fever; Chills; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 11-Apr-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 11-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Severe headache). On 14-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown and PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Severe headache) was resolving.            Concomitant product use was not provided by the reporter.   The patient forced himself to his place of employment for work on Tuesday 13Apr2021 and left work around 2PM. By that afternoon he felt terrible. He went to bed and woke up around 4am Wednesday 14Apr2021 with severe chest pain where he was rushed to the emergency room. Then they confirmed the patient had a heart-attack with no other offending agent besides the vaccine. It was not confirmed if the patient is on any other medication regularly.   Treatment medications included Tylenol and Motrin alternating for fever, chills and headache.  Action taken with mRNA-1273 in response to the events 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 these events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: pulmonary embolism; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00922436 and 012D20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-Apr-2021 to 09-Apr-2021 due to PULMONARY EMBOLISM. On 09-Apr-2021, PULMONARY EMBOLISM (pulmonary embolism) had resolved.            The patient's medical history and relevant concomitant medications weren't reported Treatment medication included the Xarelto.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-077614 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-077614:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: high blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (high blood pressure) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Cataract.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to HYPERTENSION. At the time of the report, HYPERTENSION (high blood pressure) was resolving. The patient initially was scheduled for cataract surgery but was hospitalized for high blood pressure      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient takes blood thinners from an unknown date.  No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2021-077862 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded MODERNATX, INC.-MOD-2021-077862:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fall, Head injury, Insomnia, Malaise
Clinical narrative: couldn't sleep; Felt sick; Fell; Body went stiff; Hit head on the wall; Vomiting; Fainted; Had seizures twice; Back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted) and SEIZURE (Had seizures twice) in a 24-year-old female patient who received mRNA-1273  for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (Back pain). On 03-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), SEIZURE (Had seizures twice) (seriousness criterion medically significant), INSOMNIA (couldn't sleep), MALAISE (Felt sick), FALL (Fell), MUSCULOSKELETAL STIFFNESS (Body went stiff), HEAD INJURY (Hit head on the wall) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Fainted), SEIZURE (Had seizures twice), BACK PAIN (Back pain), INSOMNIA (couldn't sleep), MALAISE (Felt sick), FALL (Fell), MUSCULOSKELETAL STIFFNESS (Body went stiff), HEAD INJURY (Hit head on the wall) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Labs included Electrocardiogram: and Urine analysis, no test results provided.  Treatment information not provided.  Company comment: 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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Seizure, Syncope, Vomiting
Clinical narrative: couldn't sleep; Felt sick; Fell; Body went stiff; Hit head on the wall; Vomiting; Fainted; Had seizures twice; Back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted) and SEIZURE (Had seizures twice) in a 24-year-old female patient who received mRNA-1273  for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (Back pain). On 03-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), SEIZURE (Had seizures twice) (seriousness criterion medically significant), INSOMNIA (couldn't sleep), MALAISE (Felt sick), FALL (Fell), MUSCULOSKELETAL STIFFNESS (Body went stiff), HEAD INJURY (Hit head on the wall) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Fainted), SEIZURE (Had seizures twice), BACK PAIN (Back pain), INSOMNIA (couldn't sleep), MALAISE (Felt sick), FALL (Fell), MUSCULOSKELETAL STIFFNESS (Body went stiff), HEAD INJURY (Hit head on the wall) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Labs included Electrocardiogram: and Urine analysis, no test results provided.  Treatment information not provided.  Company comment: 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chills, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID Pneumonitis; fever; chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (COVID Pneumonitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced COVID-19 PNEUMONIA (COVID Pneumonitis) (seriousness criterion medically significant), PYREXIA (fever) and CHILLS (chills). At the time of the report, COVID-19 PNEUMONIA (COVID Pneumonitis), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Symptoms included dyspnea and  Hypoxemia    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were antibiotics given intramuscularly and orally, albuterol, steroids and her respiratory status was monitored at home. Patient wanted to know if she can still get her second dose. Concomitant medications were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Malaise, Nausea, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Pulmonary embolism; Nausea; Vomiting; Chest pain/right upper quadratic thoracic pain; Feeling unwell; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced MALAISE (Feeling unwell). On 15-Mar-2021, the patient experienced CHEST PAIN (Chest pain/right upper quadratic thoracic pain). On 15-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion hospitalization), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was hospitalized on 15-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism), CHEST PAIN (Chest pain/right upper quadratic thoracic pain), MALAISE (Feeling unwell), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.         On 17 Mar 2021 the patient had an x-ray and EKG performed because she was not feeling well and had chest pain- no results provided.  On15 Apr 2021 the patient went to emergency room and was hospitalized for multiple pulmonary embolisms with parts being infracted.   No treatment information was provided. No relevant concomitant medications were reported.  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: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Pulmonary embolism; Nausea; Vomiting; Chest pain/right upper quadratic thoracic pain; Feeling unwell; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced MALAISE (Feeling unwell). On 15-Mar-2021, the patient experienced CHEST PAIN (Chest pain/right upper quadratic thoracic pain). On 15-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion hospitalization), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was hospitalized on 15-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism), CHEST PAIN (Chest pain/right upper quadratic thoracic pain), MALAISE (Feeling unwell), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.         On 17 Mar 2021 the patient had an x-ray and EKG performed because she was not feeling well and had chest pain- no results provided.  On15 Apr 2021 the patient went to emergency room and was hospitalized for multiple pulmonary embolisms with parts being infracted.   No treatment information was provided. No relevant concomitant medications were reported.  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.