chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Intestinal obstruction, Pain, Product dose omission issue
Clinical narrative: Intestinal obstruction; Unable to receive second dose within 42 day window; Pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTESTINAL OBSTRUCTION (Intestinal obstruction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgical procedure.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced INTESTINAL OBSTRUCTION (Intestinal obstruction) (seriousness criterion hospitalization) and PAIN (Pain). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Unable to receive second dose within 42 day window). At the time of the report, INTESTINAL OBSTRUCTION (Intestinal obstruction), PRODUCT DOSE OMISSION ISSUE (Unable to receive second dose within 42 day window) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. This report also refers to a case of missed dose for mRNA-1273 (Moderna COVID-19 vaccine).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. This report also refers to a case of missed dose for mRNA-1273 (Moderna COVID-19 vaccine).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Chills, Cognitive disorder, Computerised tomogram, Dizziness
Clinical narrative: She can't coordinating in her mind; In bed for 25 or 21 days; Flusing in head/head fluttering; varicose veins in both legs; Medication spasms; Over fatigued; fever; developed chills; sever kidneys infection; urine was with blood; ringing in her ears; body aches; felt dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of KIDNEY INFECTION (sever kidneys infection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced KIDNEY INFECTION (sever kidneys infection) (seriousness criterion medically significant), HAEMATURIA (urine was with blood), TINNITUS (ringing in her ears), PAIN (body aches), DIZZINESS (felt dizziness), CHILLS (developed chills) and PYREXIA (fever). On an unknown date, the patient experienced COGNITIVE DISORDER (She can't coordinating in her mind), BED REST (In bed for 25 or 21 days), HEAD DISCOMFORT (Flusing in head/head fluttering), VARICOSE VEIN (varicose veins in both legs), MUSCLE SPASMS (Medication spasms) and FATIGUE (Over fatigued). At the time of the report, KIDNEY INFECTION (sever kidneys infection), HAEMATURIA (urine was with blood), TINNITUS (ringing in her ears), PAIN (body aches), COGNITIVE DISORDER (She can't coordinating in her mind), BED REST (In bed for 25 or 21 days), HEAD DISCOMFORT (Flusing in head/head fluttering), VARICOSE VEIN (varicose veins in both legs), MUSCLE SPASMS (Medication spasms), CHILLS (developed chills), FATIGUE (Over fatigued) and PYREXIA (fever) outcome was unknown and DIZZINESS (felt dizziness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 antibody test: negative Negative. On an unknown date, Computerised tomogram: normal (normal) The kidneys are normal about 60 days after injection..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was reported as antibiotics. relevant concomitant medications are piroanoctum, vitamin C & D, .   This case was linked to MOD-2021-057443 (Patient Link).; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haematuria, Head discomfort, Kidney infection, Muscle spasms
Clinical narrative: She can't coordinating in her mind; In bed for 25 or 21 days; Flusing in head/head fluttering; varicose veins in both legs; Medication spasms; Over fatigued; fever; developed chills; sever kidneys infection; urine was with blood; ringing in her ears; body aches; felt dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of KIDNEY INFECTION (sever kidneys infection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced KIDNEY INFECTION (sever kidneys infection) (seriousness criterion medically significant), HAEMATURIA (urine was with blood), TINNITUS (ringing in her ears), PAIN (body aches), DIZZINESS (felt dizziness), CHILLS (developed chills) and PYREXIA (fever). On an unknown date, the patient experienced COGNITIVE DISORDER (She can't coordinating in her mind), BED REST (In bed for 25 or 21 days), HEAD DISCOMFORT (Flusing in head/head fluttering), VARICOSE VEIN (varicose veins in both legs), MUSCLE SPASMS (Medication spasms) and FATIGUE (Over fatigued). At the time of the report, KIDNEY INFECTION (sever kidneys infection), HAEMATURIA (urine was with blood), TINNITUS (ringing in her ears), PAIN (body aches), COGNITIVE DISORDER (She can't coordinating in her mind), BED REST (In bed for 25 or 21 days), HEAD DISCOMFORT (Flusing in head/head fluttering), VARICOSE VEIN (varicose veins in both legs), MUSCLE SPASMS (Medication spasms), CHILLS (developed chills), FATIGUE (Over fatigued) and PYREXIA (fever) outcome was unknown and DIZZINESS (felt dizziness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 antibody test: negative Negative. On an unknown date, Computerised tomogram: normal (normal) The kidneys are normal about 60 days after injection..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was reported as antibiotics. relevant concomitant medications are piroanoctum, vitamin C & D, .   This case was linked to MOD-2021-057443 (Patient Link).; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 antibody test, Tinnitus, Varicose vein
Clinical narrative: She can't coordinating in her mind; In bed for 25 or 21 days; Flusing in head/head fluttering; varicose veins in both legs; Medication spasms; Over fatigued; fever; developed chills; sever kidneys infection; urine was with blood; ringing in her ears; body aches; felt dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of KIDNEY INFECTION (sever kidneys infection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced KIDNEY INFECTION (sever kidneys infection) (seriousness criterion medically significant), HAEMATURIA (urine was with blood), TINNITUS (ringing in her ears), PAIN (body aches), DIZZINESS (felt dizziness), CHILLS (developed chills) and PYREXIA (fever). On an unknown date, the patient experienced COGNITIVE DISORDER (She can't coordinating in her mind), BED REST (In bed for 25 or 21 days), HEAD DISCOMFORT (Flusing in head/head fluttering), VARICOSE VEIN (varicose veins in both legs), MUSCLE SPASMS (Medication spasms) and FATIGUE (Over fatigued). At the time of the report, KIDNEY INFECTION (sever kidneys infection), HAEMATURIA (urine was with blood), TINNITUS (ringing in her ears), PAIN (body aches), COGNITIVE DISORDER (She can't coordinating in her mind), BED REST (In bed for 25 or 21 days), HEAD DISCOMFORT (Flusing in head/head fluttering), VARICOSE VEIN (varicose veins in both legs), MUSCLE SPASMS (Medication spasms), CHILLS (developed chills), FATIGUE (Over fatigued) and PYREXIA (fever) outcome was unknown and DIZZINESS (felt dizziness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 antibody test: negative Negative. On an unknown date, Computerised tomogram: normal (normal) The kidneys are normal about 60 days after injection..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was reported as antibiotics. relevant concomitant medications are piroanoctum, vitamin C & D, .   This case was linked to MOD-2021-057443 (Patient Link).; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy (paralyze of the left side of the face); This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (bell's palsy (paralyze of the left side of the face)) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced FACIAL PARALYSIS (bell's palsy (paralyze of the left side of the face)) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (bell's palsy (paralyze of the left side of the face)) had not resolved.      No relevant concomitant medications were reported.  The patient was treated with Valtrex (valaciclovir) and prednisone.  Action taken with mRNA-1273 in response to events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of facial paralysis, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oxygen saturation decreased, Product dose omission issue
Clinical narrative: O2 levels dropped below 80; Supposed to get second dose on 18MAR2021. Had covid. Outside of 42 day mark; covid-19; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN CONSUMPTION DECREASED (O2 levels dropped below 80) and COVID-19 (covid-19) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) 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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced COVID-19 (covid-19) (seriousness criterion medically significant). On 18-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Supposed to get second dose on 18MAR2021. Had covid. Outside of 42 day mark). On an unknown date, the patient experienced OXYGEN CONSUMPTION DECREASED (O2 levels dropped below 80) (seriousness criterion medically significant). On 18-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Supposed to get second dose on 18MAR2021. Had covid. Outside of 42 day mark) had resolved. At the time of the report, OXYGEN CONSUMPTION DECREASED (O2 levels dropped below 80) and COVID-19 (covid-19) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. On 8MAR2021 he went into the hospital for his covid-19 symptoms and was given "the bag of tricks" describing a clinical trial antibody treatment. He was not sure if he received the placebo or experimental treatment. His O2 levels had dropped below 80 with his covid-19. He was given oxygen, zinc, and vitamins which he had been using. He also has been using "cough pills," and an inhaler. His O2 has now improved to 96-98 and he is now "covid free.; Sender's Comments: This case concerns a 67-year-old male hospitalized with serious unexpected events of COVID-19 and hypoxia (oxygen saturation decreased), and nonserious unexpected product dose omission issue. event resolved. 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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Feeling abnormal, Movement disorder, Speech disorder
Clinical narrative: major stroke; cannot speak; cannot move his arms; declining quickly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (major stroke) in a 62-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 effect.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (major stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly). At the time of the report, CEREBROVASCULAR ACCIDENT (major stroke), SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment information were not reported.  The patient was now in intensive care at the Hospital of Bay City in Michigan and he was declining quickly. Company comment:Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture, Body temperature increased, C-reactive protein, Computerised tomogram abnormal, Culture urine
Clinical narrative: systemic inflammatory response syndrome; falls/legs had given out from under her; This literature-non-study case was reported in a literature article and describes the occurrence of SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) in a 65-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.   LITERATURE REFERENCE:     The patient's past medical history included Hypertension and Diabetes.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) (seriousness criterion medically significant) and FALL (falls/legs had given out from under her). At the time of the report, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) and FALL (falls/legs had given out from under her) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood culture: normal (normal) normal. In 2021, Body temperature increased: 39.1 (abnormal) 39.1 degree celsius. In 2021, C-reactive protein: 63.4 (Inconclusive) 63.4 milligram per litre. In 2021, Computerised tomogram abnormal: pulmonary nodule (abnormal) multiple pulmonary nodules measuring up to 1o1 cm. In 2021, Culture urine: normal (normal) normal. In 2021, Fibrin D dimer: high (High) 5267 ng/ml.. In 2021, Heart rate: 88 (normal) 88 BPM. In 2021, Positron emission tomogram: abnormal (abnormal) It showed uptake in the fat stranding posterior to the right deltoid,moderate uptake with in right axillary lymph nodes and diffusely increased uptake in spleen and no uptake in pulmonary nodules showing they are benign.. In 2021, Red blood cell sedimentation rate: 63.4 (Inconclusive) 63.4 mm/h. In 2021, Respiratory rate: 25 (abnormal) 25 breaths per minute. In 2021, SARS-CoV-2 test: negative (Negative) negative.     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.   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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fibrin D dimer, Heart rate, Positron emission tomogram, Red blood cell sedimentation rate
Clinical narrative: systemic inflammatory response syndrome; falls/legs had given out from under her; This literature-non-study case was reported in a literature article and describes the occurrence of SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) in a 65-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.   LITERATURE REFERENCE:     The patient's past medical history included Hypertension and Diabetes.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) (seriousness criterion medically significant) and FALL (falls/legs had given out from under her). At the time of the report, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) and FALL (falls/legs had given out from under her) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood culture: normal (normal) normal. In 2021, Body temperature increased: 39.1 (abnormal) 39.1 degree celsius. In 2021, C-reactive protein: 63.4 (Inconclusive) 63.4 milligram per litre. In 2021, Computerised tomogram abnormal: pulmonary nodule (abnormal) multiple pulmonary nodules measuring up to 1o1 cm. In 2021, Culture urine: normal (normal) normal. In 2021, Fibrin D dimer: high (High) 5267 ng/ml.. In 2021, Heart rate: 88 (normal) 88 BPM. In 2021, Positron emission tomogram: abnormal (abnormal) It showed uptake in the fat stranding posterior to the right deltoid,moderate uptake with in right axillary lymph nodes and diffusely increased uptake in spleen and no uptake in pulmonary nodules showing they are benign.. In 2021, Red blood cell sedimentation rate: 63.4 (Inconclusive) 63.4 mm/h. In 2021, Respiratory rate: 25 (abnormal) 25 breaths per minute. In 2021, SARS-CoV-2 test: negative (Negative) negative.     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.   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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate, SARS-CoV-2 test, Systemic inflammatory response syndrome
Clinical narrative: systemic inflammatory response syndrome; falls/legs had given out from under her; This literature-non-study case was reported in a literature article and describes the occurrence of SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) in a 65-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.   LITERATURE REFERENCE:     The patient's past medical history included Hypertension and Diabetes.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) (seriousness criterion medically significant) and FALL (falls/legs had given out from under her). At the time of the report, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) and FALL (falls/legs had given out from under her) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood culture: normal (normal) normal. In 2021, Body temperature increased: 39.1 (abnormal) 39.1 degree celsius. In 2021, C-reactive protein: 63.4 (Inconclusive) 63.4 milligram per litre. In 2021, Computerised tomogram abnormal: pulmonary nodule (abnormal) multiple pulmonary nodules measuring up to 1o1 cm. In 2021, Culture urine: normal (normal) normal. In 2021, Fibrin D dimer: high (High) 5267 ng/ml.. In 2021, Heart rate: 88 (normal) 88 BPM. In 2021, Positron emission tomogram: abnormal (abnormal) It showed uptake in the fat stranding posterior to the right deltoid,moderate uptake with in right axillary lymph nodes and diffusely increased uptake in spleen and no uptake in pulmonary nodules showing they are benign.. In 2021, Red blood cell sedimentation rate: 63.4 (Inconclusive) 63.4 mm/h. In 2021, Respiratory rate: 25 (abnormal) 25 breaths per minute. In 2021, SARS-CoV-2 test: negative (Negative) negative.     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.   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: Food allergy
Clinical narrative: Allergic reaction; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FOOD ALLERGY (Allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to Food dyes).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced FOOD ALLERGY (Allergic reaction) (seriousness criterion hospitalization). At the time of the report, FOOD ALLERGY (Allergic reaction) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Nurse is currently in the emergency room due to an allergic reaction presumed to be due to food dyes and unrelated to Moderna first dose and says this reaction has happened many times before. Asking if she can still get the second dose of Moderna vaccine which is scheduled tomorrow due to this allergic reaction. Nurse requested information in writing to email provided. Adverse Event reaction occurred after dose 1 Safety consent not granted. Healthcare provider unknown No concomitant drug information was provided. Treatment included  IV decadron and oral steroids.  Very limited information regarding this events has been provided at this time. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Company assessed the events to be unlikely related to company product.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Hypotension, Loss of consciousness
Clinical narrative: brief loss of consciousness; low blood pressure; blurry vision; dizziness; shakiness; cold chills; nausea; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (brief loss of consciousness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not provided.).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (brief loss of consciousness) (seriousness criterion medically significant), HYPOTENSION (low blood pressure), VISION BLURRED (blurry vision), DIZZINESS (dizziness), TREMOR (shakiness), CHILLS (cold chills), NAUSEA (nausea), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). On 24-Mar-2021, LOSS OF CONSCIOUSNESS (brief loss of consciousness) had resolved. At the time of the report, HYPOTENSION (low blood pressure), VISION BLURRED (blurry vision), DIZZINESS (dizziness), TREMOR (shakiness), CHILLS (cold chills), NAUSEA (nausea), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  No treatment was taken. 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Tremor, Vision blurred
Clinical narrative: brief loss of consciousness; low blood pressure; blurry vision; dizziness; shakiness; cold chills; nausea; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (brief loss of consciousness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not provided.).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (brief loss of consciousness) (seriousness criterion medically significant), HYPOTENSION (low blood pressure), VISION BLURRED (blurry vision), DIZZINESS (dizziness), TREMOR (shakiness), CHILLS (cold chills), NAUSEA (nausea), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). On 24-Mar-2021, LOSS OF CONSCIOUSNESS (brief loss of consciousness) had resolved. At the time of the report, HYPOTENSION (low blood pressure), VISION BLURRED (blurry vision), DIZZINESS (dizziness), TREMOR (shakiness), CHILLS (cold chills), NAUSEA (nausea), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  No treatment was taken. 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.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia
Clinical narrative: I was losing strength on my arms and feet; Tingling on my feet and arms; Numbness on my feet and arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (I was losing strength on my arms and feet) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) 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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PARAESTHESIA (Tingling on my feet and arms) and HYPOAESTHESIA (Numbness on my feet and arms). On 02-Apr-2021, the patient experienced ASTHENIA (I was losing strength on my arms and feet) (seriousness criterion hospitalization). The patient was hospitalized on 02-Apr-2021 due to ASTHENIA. At the time of the report, ASTHENIA (I was losing strength on my arms and feet), PARAESTHESIA (Tingling on my feet and arms) and HYPOAESTHESIA (Numbness on my feet and arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received his first dose of the Moderna COVID-19 vaccine on his left non-dominant arm on 11 March 2021. About two weeks later, he started to experience tingling and numbness on his feet and arms. He went to the Emergency Room (ER) twice, on 22 Mar 2021 and on 26 Mar 2021. On 02 Apr 2021, he was admitted to the hospital because he was losing strength from his feet and arms. He did not want to stay longer, so he was discharged the next day. His healthcare professionals are still running tests. He was still experiencing numbness and tingling on his feet and arms. at the time of the report.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Myoclonic epilepsy, Vaccination complication
Clinical narrative: Myoclonic seizures; Vaccination related malaise; This spontaneous case was reported by a consumer and describes the occurrence of MYOCLONIC EPILEPSY (Myoclonic seizures) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCLONIC EPILEPSY (Myoclonic seizures) (seriousness criterion medically significant) and VACCINATION COMPLICATION (Vaccination related malaise). At the time of the report, MYOCLONIC EPILEPSY (Myoclonic seizures) and VACCINATION COMPLICATION (Vaccination related malaise) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided. Treatment information was not available.  Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Loss of sensibility in the left side of the face; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Loss of sensibility in the left side of the face) 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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced FACIAL PARALYSIS (Loss of sensibility in the left side of the face) (seriousness criterion medically significant). On 19-Mar-2021, FACIAL PARALYSIS (Loss of sensibility in the left side of the face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.  This case concerns an adult female with a serious unexpected event of facial paralysis. Event onset 15 minutes after the first dose of mRNA-1273. Event resolved. 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 an adult female with a serious unexpected event of facial paralysis. Event onset 15 minutes after the first dose of mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: blood clots in both legs; severe pain in both his legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in both legs) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008D21A and 011A21A) 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 reported.).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced THROMBOSIS (blood clots in both legs) (seriousness criterion medically significant) and PAIN IN EXTREMITY (severe pain in both his legs). At the time of the report, THROMBOSIS (blood clots in both legs) and PAIN IN EXTREMITY (severe pain in both his legs) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment included Eliquis (apixaban) for three months. Reportedly, the patient was put on apixaban 2 tablets every morning and evening for 14 days and will then take 1 tablet every morning and evening for a total of 3 months. He does think that the medicine is helping.  Patient stated that he never had blood clots before and suspects that it was from the shot.; Sender's Comments: Very limited information has been provided at this time. Further information has been requested. Based on the current information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Diplopia, Eye pain, Headache, Scleritis
Clinical narrative: vision right eye/left eye became little blurry; pain behind the right eye/left eye; losing vision in right eye; hurt behind the eyes; seeing double at a distance; excruciating headache; puking/vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (losing vision in right eye) and SCLERITIS (hurt behind the eyes) in a 40-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. Concomitant products included IBUPROFEN for Back pain, ACICLOVIR SODIUM (ACYCLOVIR) for Cold.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 31-Mar-2021, the patient experienced HEADACHE (excruciating headache) and VOMITING (puking/vomiting). On 06-Apr-2021, the patient experienced SCLERITIS (hurt behind the eyes) (seriousness criterion medically significant) and DIPLOPIA (seeing double at a distance). On an unknown date, the patient experienced BLINDNESS (losing vision in right eye) (seriousness criterion medically significant), VISION BLURRED (vision right eye/left eye became little blurry) and EYE PAIN (pain behind the right eye/left eye). At the time of the report, BLINDNESS (losing vision in right eye), SCLERITIS (hurt behind the eyes), EYE PAIN (pain behind the right eye/left eye), DIPLOPIA (seeing double at a distance), HEADACHE (excruciating headache) and VOMITING (puking/vomiting) outcome was unknown and VISION BLURRED (vision right eye/left eye became little blurry) had not resolved.            Treatment medication was not reported.  Very limited information regarding these events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: vision right eye/left eye became little blurry; pain behind the right eye/left eye; losing vision in right eye; hurt behind the eyes; seeing double at a distance; excruciating headache; puking/vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (losing vision in right eye) and SCLERITIS (hurt behind the eyes) in a 40-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. Concomitant products included IBUPROFEN for Back pain, ACICLOVIR SODIUM (ACYCLOVIR) for Cold.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 31-Mar-2021, the patient experienced HEADACHE (excruciating headache) and VOMITING (puking/vomiting). On 06-Apr-2021, the patient experienced SCLERITIS (hurt behind the eyes) (seriousness criterion medically significant) and DIPLOPIA (seeing double at a distance). On an unknown date, the patient experienced BLINDNESS (losing vision in right eye) (seriousness criterion medically significant), VISION BLURRED (vision right eye/left eye became little blurry) and EYE PAIN (pain behind the right eye/left eye). At the time of the report, BLINDNESS (losing vision in right eye), SCLERITIS (hurt behind the eyes), EYE PAIN (pain behind the right eye/left eye), DIPLOPIA (seeing double at a distance), HEADACHE (excruciating headache) and VOMITING (puking/vomiting) outcome was unknown and VISION BLURRED (vision right eye/left eye became little blurry) had not resolved.            Treatment medication was not reported.  Very limited information regarding these events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.; 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: Chills, Dizziness, Haematemesis, Headache, Pyrexia
Clinical narrative: spitting out blood and blood clots; sluggish; Dizziness; chills; low grade fever; Bad headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (spitting out blood and blood clots) 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 since an unknown date.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced HAEMATEMESIS (spitting out blood and blood clots) (seriousness criterion medically significant), SLUGGISHNESS (sluggish), DIZZINESS (Dizziness), CHILLS (chills), PYREXIA (low grade fever) and HEADACHE (Bad headache). On 26-Mar-2021, HAEMATEMESIS (spitting out blood and blood clots) outcome was unknown. At the time of the report, SLUGGISHNESS (sluggish), DIZZINESS (Dizziness), CHILLS (chills), PYREXIA (low grade fever) and HEADACHE (Bad headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Pyrexia: low (Low) Low.         This case was linked to -MOD-2021-068465 ( Linked Report).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded..-MOD-2021-068465:Dose 1
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: spitting out blood and blood clots; sluggish; Dizziness; chills; low grade fever; Bad headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (spitting out blood and blood clots) 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 since an unknown date.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced HAEMATEMESIS (spitting out blood and blood clots) (seriousness criterion medically significant), SLUGGISHNESS (sluggish), DIZZINESS (Dizziness), CHILLS (chills), PYREXIA (low grade fever) and HEADACHE (Bad headache). On 26-Mar-2021, HAEMATEMESIS (spitting out blood and blood clots) outcome was unknown. At the time of the report, SLUGGISHNESS (sluggish), DIZZINESS (Dizziness), CHILLS (chills), PYREXIA (low grade fever) and HEADACHE (Bad headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Pyrexia: low (Low) Low.         This case was linked to -MOD-2021-068465 ( Linked Report).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded..-MOD-2021-068465:Dose 1
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of consciousness, Product dose omission issue, Urinary tract infection
Clinical narrative: urinary tract infection; passed out; foggy; missed her second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in an 87-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 Urinary tract infection (She was given some medication and has significantly improved with her urinary tract infection.) on 05-Apr-2021. Concurrent medical conditions included Stomach cancer.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), FEELING ABNORMAL (foggy) and PRODUCT DOSE OMISSION ISSUE (missed her second dose). On 05-Apr-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection). On 16-Mar-2021, PRODUCT DOSE OMISSION ISSUE (missed her second dose) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (passed out) was resolving and FEELING ABNORMAL (foggy) and URINARY TRACT INFECTION (urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Her doctor and oncologist have told her to get the vaccine 1 week from today.  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.