chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Splenic thrombosis
Clinical narrative: blood clot on spleen; This spontaneous case was reported by a consumer and describes the occurrence of SPLENIC THROMBOSIS (blood clot on spleen) 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 (No relevant medical history provided).   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SPLENIC THROMBOSIS (blood clot on spleen) (seriousness criterion medically significant). At the time of the report, SPLENIC THROMBOSIS (blood clot on spleen) outcome was unknown. Not Provided          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 event, a causal relationship cannot be excluded.   This case was linked to MOD21-076398, US-MODERNATX, INC.-MOD-2021-078083 (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. MOD21-076398: US-MODERNATX, INC.-MOD-2021-078083:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO MEDICAL HISTORY REPORTED).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 18-Mar-2021, the patient experienced HERPES ZOSTER (Shingles) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (Shingles) had resolved.       mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Patient had shingles symptoms included neuropathy pain, blisters in right quadrant and mid area and rash on arm. Treatment medications included Atorvastatin 40 mg and Aciclovir 1000 mg for 7 days.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster. Patient has a history of shingles
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Inappropriate schedule of product administration, Thrombosis
Clinical narrative: a blood clot right below his lung on the left side; his chest was hurting; he couldn't breath; Second shot three weeks later; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (a blood clot right below his lung on the left side) in a 32-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 (No medical history reported).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (a blood clot right below his lung on the left side) (seriousness criterion medically significant), CHEST PAIN (his chest was hurting), DYSPNOEA (he couldn't breath) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot three weeks later). At the time of the report, THROMBOSIS (a blood clot right below his lung on the left side), CHEST PAIN (his chest was hurting) and DYSPNOEA (he couldn't breath) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot three weeks later) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THROMBOSIS (a blood clot right below his lung on the left side), CHEST PAIN (his chest was hurting) and DYSPNOEA (he couldn't breath) to be related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot three weeks later).    Patient was taken to the ER (Emergency Room). Treatment Xarelto was started.  Patient has Cardiologist appointment on 28-APR-2021.  Company comment:Limited information regarding the blood clot, chest pain and difficulty breathing has been provided at this time and a causal relationship cannot be excluded.  Inappropriate schedule of vaccine administered is unrelated to the vaccine and is not reported as specifically resulting in adverse events.   This case was linked to MOD21-076660 (Linked Report).; Sender's Comments: Limited information regarding the blood clot, chest pain and difficulty breathing has been provided at this time and a causal relationship cannot be excluded.  Inappropriate schedule of vaccine administered is unrelated to the vaccine and is not reported as specifically resulting in adverse events. MOD21-076660:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysarthria, Head injury, Influenza like illness, Loss of consciousness
Clinical narrative: hurt her head; fell unconscious in the bathroom; trying to say few words; Flu like symptoms; chills and teeth were shattering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEAD INJURY (hurt her head) and LOSS OF CONSCIOUSNESS (fell unconscious in the bathroom) 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 No adverse event (No medical history reported).    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (chills and teeth were shattering). On 07-Apr-2021, the patient experienced HEAD INJURY (hurt her head) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (fell unconscious in the bathroom) (seriousness criterion medically significant) and DYSARTHRIA (trying to say few words). The patient was hospitalized from 07-Apr-2021 to 08-Apr-2021 due to HEAD INJURY. On 06-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (chills and teeth were shattering) had resolved. On 07-Apr-2021, LOSS OF CONSCIOUSNESS (fell unconscious in the bathroom) and DYSARTHRIA (trying to say few words) had resolved. At the time of the report, HEAD INJURY (hurt her head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported getting an IV and other medications in the hospital, however not aware of which medications were given for treatment.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information is required. Causality for the events flu-like symptoms and chills is possible.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Hyperhidrosis, Loss of consciousness, Pain
Clinical narrative: seizure; passed out due to extreme vomiting as per doctor in ER; vomiting every 40 minutes; stomachaches; body pain; Sweating; Headache; This case was received via an unknown source no reference has been entered for a health authority or license partner on 15-Apr-2021 and was forwarded to Moderna on 15-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizure) and LOSS OF CONSCIOUSNESS (passed out due to extreme vomiting as per doctor in ER) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) 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 medical history provided.).    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (passed out due to extreme vomiting as per doctor in ER) (seriousness criterion medically significant), HEADACHE (Headache), ABDOMINAL PAIN UPPER (stomachaches), VOMITING (vomiting every 40 minutes), PAIN (body pain) and HYPERHIDROSIS (Sweating). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SEIZURE (seizure), LOSS OF CONSCIOUSNESS (passed out due to extreme vomiting as per doctor in ER), HEADACHE (Headache), ABDOMINAL PAIN UPPER (stomachaches), VOMITING (vomiting every 40 minutes), PAIN (body pain) and HYPERHIDROSIS (Sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history or concomitant medications provided. Patient used ibuprofen for treatment of headache.  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Vomiting
Clinical narrative: seizure; passed out due to extreme vomiting as per doctor in ER; vomiting every 40 minutes; stomachaches; body pain; Sweating; Headache; This case was received via an unknown source no reference has been entered for a health authority or license partner on 15-Apr-2021 and was forwarded to Moderna on 15-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizure) and LOSS OF CONSCIOUSNESS (passed out due to extreme vomiting as per doctor in ER) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) 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 medical history provided.).    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (passed out due to extreme vomiting as per doctor in ER) (seriousness criterion medically significant), HEADACHE (Headache), ABDOMINAL PAIN UPPER (stomachaches), VOMITING (vomiting every 40 minutes), PAIN (body pain) and HYPERHIDROSIS (Sweating). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SEIZURE (seizure), LOSS OF CONSCIOUSNESS (passed out due to extreme vomiting as per doctor in ER), HEADACHE (Headache), ABDOMINAL PAIN UPPER (stomachaches), VOMITING (vomiting every 40 minutes), PAIN (body pain) and HYPERHIDROSIS (Sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history or concomitant medications provided. Patient used ibuprofen for treatment of headache.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; anaphylactic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of the first episode of ANAPHYLACTIC REACTION (anaphylactic reaction) and the second episode of ANAPHYLACTIC REACTION (anaphylactic reaction) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included EPINEPHRINE (EPIPEN) for Allergy, ALBUTEROL SULFATE for Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced the first episode of ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). On 09-Apr-2021, the patient experienced the second episode of ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). On 11-Apr-2021, last episode of ANAPHYLACTIC REACTION (anaphylactic reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced an anaphylactic reaction of constricted throat, face and neck turning red, tingling and numbness in her face and throat, red bumps on her face and throat, and her face felt like it was burning. She used her EpiPen and it wasn't enough (didn't improve the reaction), so she went to the emergency room. They gave 2 prednisone tabs and prescribed prednisone and gave her IV saline and antihistamine. They released her 2 hours later. Her doctor advised her against getting the second dose. After the patient recovered from initial anaphylactic reaction on 12Mar2021, she had 2 episodes of anaphylactic reaction on 09APR2021, requiring the use of two EpiPens, Benadryl, Prednisone, and albuterol. On 10APR2021 at 0100 another anaphylactic reaction requiring EpiPen, Benadryl, Prednisone, and Albuterol. And at 4pm another anaphylactic reaction requiring Benadryl, EpiPen, and albuterol. Currently she has recovered.  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. However, patient's medical history of asthma and allergy may have been contributory.; 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. However, patient's medical history of asthma and allergy may have been contributory.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Swelling face, Swollen tongue
Clinical narrative: Difficulty in breathing; Swelling of face; Swelling of face and tongue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty in breathing), SWELLING FACE (Swelling of face) and SWOLLEN TONGUE (Swelling of face and tongue) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Not sure about the allergy).    On 15-Apr-2021 at 1:52 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021 at 2:22 PM, the patient experienced DYSPNOEA (Difficulty in breathing) (seriousness criteria medically significant and intervention required), SWELLING FACE (Swelling of face) (seriousness criteria medically significant and intervention required) and SWOLLEN TONGUE (Swelling of face and tongue) (seriousness criteria medically significant and intervention required). At the time of the report, DYSPNOEA (Difficulty in breathing), SWELLING FACE (Swelling of face) and SWOLLEN TONGUE (Swelling of face and tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   EpiPen and 50 mg of Benadryl were given intramuscularly as a treatment for the events. 9-1-1 was called for further evaluation. No information on concomitant medications. 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: Blood glucose, Hyperglycaemia, Renal function test, Renal impairment
Clinical narrative: kidney function was low; Blood sugar was upto 950; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERGLYCAEMIA (Blood sugar was upto 950) and RENAL IMPAIRMENT (her kidney function was low) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Kidney absent.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HYPERGLYCAEMIA (Blood sugar was upto 950) (seriousness criterion hospitalization). On 11-Mar-2021, the patient experienced RENAL IMPAIRMENT (her kidney function was low) (seriousness criterion hospitalization). The patient was hospitalized from 11-Mar-2021 to 14-Mar-2021 due to HYPERGLYCAEMIA and RENAL IMPAIRMENT. At the time of the report, HYPERGLYCAEMIA (Blood sugar was upto 950) and RENAL IMPAIRMENT (her kidney function was low) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Blood glucose: 950. On 09-Mar-2021, Renal function test:. On 11-Mar-2021, Renal function test: Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was back on insulin after two years of being off insulin. Concomitant medications were not reported.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Thrombosis
Clinical narrative: Blood clot in left leg and moved down to bottom of her heal; Hard Time Walking due to blood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clot in left leg and moved down to bottom of her heal) in a 59-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 No adverse event (No medical history was provided.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced THROMBOSIS (Blood clot in left leg and moved down to bottom of her heal) (seriousness criterion medically significant) and GAIT DISTURBANCE (Hard Time Walking due to blood clot). At the time of the report, THROMBOSIS (Blood clot in left leg and moved down to bottom of her heal) and GAIT DISTURBANCE (Hard Time Walking due to blood clot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that doctor prescribed prednisone to treat the symptoms.  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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Cerebrovascular accident, Chills
Clinical narrative: Cerebral Stroke; Headache; Dizziness; Imbalance of her body; severe weakness; Vomiting; Nausea; Fever; Fatigue; Chills; Muscle pain; Joint pain; Flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebral Stroke) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (mild stroke) in 2017.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). On 10-Apr-2021, the patient experienced DIZZINESS (Dizziness), BALANCE DISORDER (Imbalance of her body), ASTHENIA (severe weakness), HEADACHE (Headache) and VOMITING (Vomiting). On 13-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebral Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebral Stroke), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Dizziness), BALANCE DISORDER (Imbalance of her body), ASTHENIA (severe weakness), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.            On 10 Apr 2021 the Patient went to Emergency room and  her Computerized tomography (CT) scan done for stomach, results are not provided. On 13Apr 2021 the patient was again taken to ER and her Magnetic Resonance Imaging  (MRI) was done and diagnosed with Cerebral Stroke. The treatment medications include Acetaminophen , Promethazine, Apixaban  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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Cerebral Stroke; Headache; Dizziness; Imbalance of her body; severe weakness; Vomiting; Nausea; Fever; Fatigue; Chills; Muscle pain; Joint pain; Flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebral Stroke) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (mild stroke) in 2017.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). On 10-Apr-2021, the patient experienced DIZZINESS (Dizziness), BALANCE DISORDER (Imbalance of her body), ASTHENIA (severe weakness), HEADACHE (Headache) and VOMITING (Vomiting). On 13-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebral Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebral Stroke), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Dizziness), BALANCE DISORDER (Imbalance of her body), ASTHENIA (severe weakness), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.            On 10 Apr 2021 the Patient went to Emergency room and  her Computerized tomography (CT) scan done for stomach, results are not provided. On 13Apr 2021 the patient was again taken to ER and her Magnetic Resonance Imaging  (MRI) was done and diagnosed with Cerebral Stroke. The treatment medications include Acetaminophen , Promethazine, Apixaban  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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Cerebral Stroke; Headache; Dizziness; Imbalance of her body; severe weakness; Vomiting; Nausea; Fever; Fatigue; Chills; Muscle pain; Joint pain; Flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebral Stroke) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (mild stroke) in 2017.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). On 10-Apr-2021, the patient experienced DIZZINESS (Dizziness), BALANCE DISORDER (Imbalance of her body), ASTHENIA (severe weakness), HEADACHE (Headache) and VOMITING (Vomiting). On 13-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebral Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebral Stroke), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Dizziness), BALANCE DISORDER (Imbalance of her body), ASTHENIA (severe weakness), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.            On 10 Apr 2021 the Patient went to Emergency room and  her Computerized tomography (CT) scan done for stomach, results are not provided. On 13Apr 2021 the patient was again taken to ER and her Magnetic Resonance Imaging  (MRI) was done and diagnosed with Cerebral Stroke. The treatment medications include Acetaminophen , Promethazine, Apixaban  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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood lactic acid increased, Blood potassium, Blood pressure decreased, Body temperature, Cold sweat
Clinical narrative: Vomited for an hour; light headed; broke out in a cold sweat; body cramped up; nauseus; Sore left Arm; convulsions; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (convulsions) and VOMITING (Vomited for an hour) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 031L20A) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 06-Apr-2021, the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant), VOMITING (Vomited for an hour) (seriousness criterion hospitalization), DIZZINESS (light headed), COLD SWEAT (broke out in a cold sweat), MUSCLE SPASMS (body cramped up), NAUSEA (nauseus) and VACCINATION SITE PAIN (Sore left Arm). The patient was hospitalized from 06-Apr-2021 to 08-Apr-2021 due to VOMITING. On 08-Apr-2021, SEIZURE (convulsions), VOMITING (Vomited for an hour), DIZZINESS (light headed), COLD SWEAT (broke out in a cold sweat), MUSCLE SPASMS (body cramped up), NAUSEA (nauseus) and VACCINATION SITE PAIN (Sore left Arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood lactic acid increased: increased (abnormal) increased. On an unknown date, Blood potassium: decreased (abnormal) decreased. On an unknown date, Blood pressure decreased: decreased (Low) decreased. On an unknown date, Body temperature: decreased (Low) decreased.  No concomitant medications were reported.  No treatment 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscle spasms, Nausea, Seizure, Vaccination site pain
Clinical narrative: Vomited for an hour; light headed; broke out in a cold sweat; body cramped up; nauseus; Sore left Arm; convulsions; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (convulsions) and VOMITING (Vomited for an hour) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 031L20A) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 06-Apr-2021, the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant), VOMITING (Vomited for an hour) (seriousness criterion hospitalization), DIZZINESS (light headed), COLD SWEAT (broke out in a cold sweat), MUSCLE SPASMS (body cramped up), NAUSEA (nauseus) and VACCINATION SITE PAIN (Sore left Arm). The patient was hospitalized from 06-Apr-2021 to 08-Apr-2021 due to VOMITING. On 08-Apr-2021, SEIZURE (convulsions), VOMITING (Vomited for an hour), DIZZINESS (light headed), COLD SWEAT (broke out in a cold sweat), MUSCLE SPASMS (body cramped up), NAUSEA (nauseus) and VACCINATION SITE PAIN (Sore left Arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood lactic acid increased: increased (abnormal) increased. On an unknown date, Blood potassium: decreased (abnormal) decreased. On an unknown date, Blood pressure decreased: decreased (Low) decreased. On an unknown date, Body temperature: decreased (Low) decreased.  No concomitant medications were reported.  No treatment 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited for an hour; light headed; broke out in a cold sweat; body cramped up; nauseus; Sore left Arm; convulsions; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (convulsions) and VOMITING (Vomited for an hour) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 031L20A) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 06-Apr-2021, the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant), VOMITING (Vomited for an hour) (seriousness criterion hospitalization), DIZZINESS (light headed), COLD SWEAT (broke out in a cold sweat), MUSCLE SPASMS (body cramped up), NAUSEA (nauseus) and VACCINATION SITE PAIN (Sore left Arm). The patient was hospitalized from 06-Apr-2021 to 08-Apr-2021 due to VOMITING. On 08-Apr-2021, SEIZURE (convulsions), VOMITING (Vomited for an hour), DIZZINESS (light headed), COLD SWEAT (broke out in a cold sweat), MUSCLE SPASMS (body cramped up), NAUSEA (nauseus) and VACCINATION SITE PAIN (Sore left Arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood lactic acid increased: increased (abnormal) increased. On an unknown date, Blood potassium: decreased (abnormal) decreased. On an unknown date, Blood pressure decreased: decreased (Low) decreased. On an unknown date, Body temperature: decreased (Low) decreased.  No concomitant medications were reported.  No treatment 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.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Fatigue, Headache, Hypoxia
Clinical narrative: low oxygen; upset stomach; high fever, 102; nausea; fatigue; headache; rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (low oxygen) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 038B21A) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced HYPOXIA (low oxygen) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (high fever, 102), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and RASH (rash). At the time of the report, HYPOXIA (low oxygen), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (high fever, 102), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and RASH (rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degree Celsius Fever.         Tylenol was taken as treatment medication. Concomitant medications were not provided.  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.; 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash
Clinical narrative: low oxygen; upset stomach; high fever, 102; nausea; fatigue; headache; rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (low oxygen) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 038B21A) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced HYPOXIA (low oxygen) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (high fever, 102), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and RASH (rash). At the time of the report, HYPOXIA (low oxygen), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (high fever, 102), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and RASH (rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degree Celsius Fever.         Tylenol was taken as treatment medication. Concomitant medications were not provided.  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.; 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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Throat tightness
Clinical narrative: throat started feeling tight; Throat was swollen; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (throat started feeling tight) and PHARYNGEAL SWELLING (Throat was swollen) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Allergy to animal and Allergy to chemicals (possible polyethylene glycol allergy).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced THROAT TIGHTNESS (throat started feeling tight) (seriousness criterion life threatening) and PHARYNGEAL SWELLING (Throat was swollen) (seriousness criterion life threatening). At the time of the report, THROAT TIGHTNESS (throat started feeling tight) and PHARYNGEAL SWELLING (Throat was swollen) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment medication was not provided. Based on the current available information which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphemia, Feeling abnormal, Hypertension, Transient ischaemic attack
Clinical narrative: had a mini stroke; was stuttering; wasn't feeling good; blood pressure was high; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (had a mini stroke) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 040B21A) 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 medical history reported).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (had a mini stroke) (seriousness criterion medically significant), DYSPHEMIA (was stuttering), FEELING ABNORMAL (wasn't feeling good) and HYPERTENSION (blood pressure was high). On 23-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (had a mini stroke), DYSPHEMIA (was stuttering), FEELING ABNORMAL (wasn't feeling good) and HYPERTENSION (blood pressure was high) had resolved.            The Patient has not provided with any Treatment medications. There are no concomitant medications provided.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Dyspnoea, Pulmonary embolism, X-ray
Clinical narrative: found several blood clots in her lungs; it (difficulty breathing) became worse; difficulty breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (found several blood clots in her lungs) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZ1A) 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 medical history reported.). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (difficulty breathing). On 05-Apr-2021, the patient experienced CONDITION AGGRAVATED (it (difficulty breathing) became worse). On 07-Apr-2021, the patient experienced PULMONARY EMBOLISM (found several blood clots in her lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-Apr-2021 to 11-Apr-2021 due to PULMONARY EMBOLISM. On 15-Apr-2021, DYSPNOEA (difficulty breathing) and CONDITION AGGRAVATED (it (difficulty breathing) became worse) had resolved. At the time of the report, PULMONARY EMBOLISM (found several blood clots in her lungs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, COVID-19: negative (Negative) Test results came back negative on 06Apr2021. On 07-Apr-2021, X-ray: abnormal (abnormal) Blood clots in lungs.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After x-ray at urgent care on 07-Apr-2021 showed several blood clots in lungs, the patient was taken to the ER (emergency room) and was subsequently admitted to the hospital.  Treatment information was not provided.  On 12-Apr-2021 the patient went to their PCP (primary care physician) who stated that the clots most likely were not due to the vaccination and that the 2nd dose was safe for her to receive. At the time of this report on 15-Apr-2021, the patient reported feeling fine.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events 1-3 days after the vaccination, a causal relationship cannot be excluded. Very limited information regarding these events 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 events 1-3 days after the vaccination, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperpyrexia, Pain in extremity
Clinical narrative: fever of 107.2°F; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (fever of 107.2°F) in a 50-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.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included INFLIXIMAB (REMICADE) for Rheumatoid arthritis, ATORVASTATIN, LISINOPRIL, FUROSEMIDE (LASIX [FUROSEMIDE]), GLYCERYL TRINITRATE (NITROSTAT), BISOPROLOL, GABAPENTIN, SULFASALAZINE, DICLOFENAC DIETHYLAMINE (VOLTAREN [DICLOFENAC DIETHYLAMINE]), TIZANIDINE HYDROCHLORIDE (ZANAFLEX), METHOTREXATE, CICLOSPORIN (RESTASIS), SUCRALFATE, CARBAMAZEPINE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FOLIC ACID, SALBUTAMOL (VENTOLINE [SALBUTAMOL]), FLUOXETINE HYDROCHLORIDE (PROZAC), TRAZODONE, HYDROXYZINE, PANTOPRAZOLE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), FERROUS SULFATE, MECLIZINE [MECLOZINE] and VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced HYPERPYREXIA (fever of 107.2°F) (seriousness criterion medically significant) and PAIN IN EXTREMITY (arm hurt). At the time of the report, HYPERPYREXIA (fever of 107.2°F) was resolving and PAIN IN EXTREMITY (arm hurt) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included acetaminophen. The patient also used cold bath and Ice.  Company comment:Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-077761 (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, excluding other etiologies causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-077761:Mother